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Ceprocon
Ciprofloxacin
Ceprocon
Ciprofloxacin
Indications
Urinary tract infection
Indication detailsView
Ciprofloxacin is indicated for the treatment of Respiratory Tract Infections,Urinary tract infections, Pelvic Inflammatory Diseases, Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera), Typhoid fever, Intra-abdominal infections, Prostatitis, Skin and Soft Tissue Infections, Bone and Joint Infections, Gonorrhea, Neutropenic patients with fever due to bacterial infection, Meningitis, Surgical prophylaxis.
Therapeutic classView
4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs
PharmacologyView
Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.
DosageView
Tablet: Adult:
Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.
For IV infusion:
- Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
- Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
- Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
- Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
- Typhoid fever: 500 mg twice daily (7 days)
- Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
- Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
- Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
- Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
- Gonorrhea: 500 mg as a single dose
- Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
- Meningitis: 500 mg as a single dose.
- Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.
Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.
For IV infusion:
- Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
- Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
- Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
- Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
- Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
- Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
- Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
- Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.
AdministrationView
Instruction for the use of Ciprofloxacin IV infusion-
- Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
- Do not use if the solution is cloudy or a precipitate is present.
- Do not use flexible bags in series connections.
- Close flow control clamp of administration set.
- Remove cover from port at bottom of bag.
- Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
- Suspend bag from hanger.
- Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
- Open flow control clamp to expel air from set.Close clamp.
- Regulate rate of administration with flow control clamp
Side effectsView
Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.
ContraindicationsView
It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.
PrecautionsView
Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.
InteractionsView
Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.
Pediatric usageView
Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.
Overdose effectsView
Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
Ceproval
Cephradine
Ceproval
Cephradine
Indications
Urinary tract infection
Indication detailsView
Cephradine is indicated for the treatment of infections caused by sensitive Gram-positive and Gram-negative bacteria. These include-
- Undesirable Upper respiratory tract infections: sinusitis, pharyngitis, tonsillitis, laryngo-tracheo bronchitis and otitis media, and also
- Lower respiratory tract infections: bronchitis (acute and chronic), lobar pneumonia and bronchopneumonia.
- Urinary tract infections: cystitis, urethritis and pyelonephritis.
- Skin and soft tissue infections: abscess, cellulitis, furunculosis and impetigo.
- Gram-positive: Staphylococci (both penicillin sensitive and resistant strains and penicillinase-producing species), Streptococci, Streptococci pyogenes (beta haemolytic), Streptococcus pneumonia.
- Gram-negative: Escherichia coli, Klebsiella spp, Proteus mirabilis, Haemophilus influenza, Shigella spp, Salmonella spp (including Salmonella typhi), Neisseria spp Many strains of E.coli and Staphylococcus aureus that produce the enzyme penicillinase and thus are ampicillin resistant, are susceptible to Cephradine which is unaffected by this enzyme.
Therapeutic classView
First generation Cephalosporins
PharmacologyView
Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.
DosageView
For oral administration-
Adults:
For injectable administration-
Adults:
- Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
- Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
- Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.
- Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
- Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
- Maximum daily dosage: 4 gm
For injectable administration-
- Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
- Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.
Side effectsView
Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.
- Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
- Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
- Psychiatric disorders- Unknown: Confusion, sleep disturbances
- Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
- Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
- Renal and urinary disorders- Unknown: Reversible interstitial nephritis
- Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.
ContraindicationsView
Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.
PrecautionsView
- Prolonged use of an anti-infective may result in the development of superinfection due to the emergence of resistant organisms.
- Cephradine should be administered with care to patients hypersensitive to penicillins because of the risk of cross-sensitivity between beta-lactam antibiotics.
- Cephalosporin antibiotics may cause a positive result in Coombs’ testing. When Coombs testing is performed on neonates whose mothers received cephalosporins prior to labour, it should be noted that a positive result may be due to the drug.
- Cephradine may cause a false positive urine glucose result when Benedict’s or Fehling’s solutions or tablets such as Clinitest are used in the testing. This does not occur with enzyme-based tests (e.g. Clinistix, Diastix).
- Dosage adjustment is necessary in renal impairment.
- This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
InteractionsView
The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.
Pregnancy & lactationView
Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.
Pediatric usageView
Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:
Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.
- CrCl: >20 ml/min: 500 mg every 6 hours
- CrCl: 5-20 ml/min: 250 mg every 6 hours
- CrCl: <5 ml/min: 250 mg every 50-70 hours.
- 250 mg at the start of haemodialysis
- 250 mg 6 to 12 hours after the start
- 250 mg 36 to 48 hours after the start
- 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.
Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.
Overdose effectsView
The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.
StorageView
Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician
Ceproval
Cephradine
Ceproval
Cephradine
Indications
Urinary tract infection
Indication detailsView
Cephradine is indicated for the treatment of infections caused by sensitive Gram-positive and Gram-negative bacteria. These include-
- Undesirable Upper respiratory tract infections: sinusitis, pharyngitis, tonsillitis, laryngo-tracheo bronchitis and otitis media, and also
- Lower respiratory tract infections: bronchitis (acute and chronic), lobar pneumonia and bronchopneumonia.
- Urinary tract infections: cystitis, urethritis and pyelonephritis.
- Skin and soft tissue infections: abscess, cellulitis, furunculosis and impetigo.
- Gram-positive: Staphylococci (both penicillin sensitive and resistant strains and penicillinase-producing species), Streptococci, Streptococci pyogenes (beta haemolytic), Streptococcus pneumonia.
- Gram-negative: Escherichia coli, Klebsiella spp, Proteus mirabilis, Haemophilus influenza, Shigella spp, Salmonella spp (including Salmonella typhi), Neisseria spp Many strains of E.coli and Staphylococcus aureus that produce the enzyme penicillinase and thus are ampicillin resistant, are susceptible to Cephradine which is unaffected by this enzyme.
Therapeutic classView
First generation Cephalosporins
PharmacologyView
Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.
DosageView
For oral administration-
Adults:
For injectable administration-
Adults:
- Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
- Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
- Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.
- Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
- Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
- Maximum daily dosage: 4 gm
For injectable administration-
- Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
- Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.
Side effectsView
Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.
- Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
- Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
- Psychiatric disorders- Unknown: Confusion, sleep disturbances
- Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
- Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
- Renal and urinary disorders- Unknown: Reversible interstitial nephritis
- Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.
ContraindicationsView
Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.
PrecautionsView
- Prolonged use of an anti-infective may result in the development of superinfection due to the emergence of resistant organisms.
- Cephradine should be administered with care to patients hypersensitive to penicillins because of the risk of cross-sensitivity between beta-lactam antibiotics.
- Cephalosporin antibiotics may cause a positive result in Coombs’ testing. When Coombs testing is performed on neonates whose mothers received cephalosporins prior to labour, it should be noted that a positive result may be due to the drug.
- Cephradine may cause a false positive urine glucose result when Benedict’s or Fehling’s solutions or tablets such as Clinitest are used in the testing. This does not occur with enzyme-based tests (e.g. Clinistix, Diastix).
- Dosage adjustment is necessary in renal impairment.
- This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
InteractionsView
The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.
Pregnancy & lactationView
Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.
Pediatric usageView
Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:
Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.
- CrCl: >20 ml/min: 500 mg every 6 hours
- CrCl: 5-20 ml/min: 250 mg every 6 hours
- CrCl: <5 ml/min: 250 mg every 50-70 hours.
- 250 mg at the start of haemodialysis
- 250 mg 6 to 12 hours after the start
- 250 mg 36 to 48 hours after the start
- 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.
Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.
Overdose effectsView
The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.
StorageView
Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician
Ceptin-R
Ranitidine Hydrochloride
Ceptin-R
Ranitidine Hydrochloride
Indications
Zollinger-Ellison syndrome
Indication detailsView
Ranitidine is indicated in:
- Treatment of active duodenal ulcer
- Benign gastric ulcer
- Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
- Post operative stress ulcer.
- Zollinger-Ellison Syndrome.
- Gastroesophageal reflux disease (GERD).
- Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
- Recurrent haemorrhage in patients with bleeding peptic ulcer.
- Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
Therapeutic classView
H2 receptor antagonist
PharmacologyView
Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
DosageView
Ranitidine Tablet & Syrup:
Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.
Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.
Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.
Maintenance: 150 mg at night for preventing recurrences.
Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.
Ranitidine IV injection & IV Infusion:
Ranitidine injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Ranitidine injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.
Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day. Safety and effectiveness of Ranitidine injection have not been established in case of children.
Side effectsView
Ranitidine is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
ContraindicationsView
Patients hypersensitive to Ranitidine
PrecautionsView
Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
InteractionsView
Delayed absorption and increased peak serum concentration with propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
Pregnancy & lactationView
Pregnancy: Ranitidine crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Pediatric usageView
Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
Overdose effectsView
Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
ReconstitutionView
Slow IV inj: Ranitidine 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Intermittent slow IV infusion: Ranitidine 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Continuous IV infusion: Ranitidine 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Ranitidine should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
StorageView
Store in a cool and dry place. protect from light.
Ceptiva
Ethinyl Estradiol + Desogestrel (0.03 mg)
Ceptiva
Ethinyl Estradiol + Desogestrel (0.03 mg)
Indications
Oral contraceptives
Indication detailsView
This is indicated to prevent pregnancy. Oral contraceptives are a very effective method of birth control. When taken correctly (without missing tablets), the chance of becoming pregnant is very low.
Therapeutic classView
Oral Contraceptive preparations
DosageView
This pack contains 21 tablets. On the pack, each tablet is marked with the day of the week on which it is to be taken. Take your tablet at about the same time each day, with some water if necessary. Follow the direction of the arrows until all 21 tablets have been taken. During the next 7 days you take no tablets. A period should begin during these 7 days (the withdrawal bleed). Usually, it will start on day 2-3 after the last tablet. Start taking your next pack on the 8th day even if your period continues. This means that you will always start new packs on the same day of the week, and also that you have your withdrawal bleed on about the same days, each month.
Starting your first pack of this tablet-
When you want to stop taking this tablet: You can stop taking this tablet at any time you want. If you do not want to become pregnant, ask your doctor about other methods of birth control.
If you stop taking this tablet because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive. This helps you to work out when the baby will be due.
Starting your first pack of this tablet-
- When no hormonal contraceptive has been used in the past month: Start taking this tablet on the first day of your cycle, i.e. the first day of menstrual bleeding. Take a tablet marked with that day of the week. For example, if your period starts on a Friday, take a tablet marked Friday. Then follow the day's in order. You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method (barrier method) for the first 7 days of tablet taking in the first cycle.
- When changing from another combined Pill: You can start taking this tablet the day after you take the last tablet from your present Pill pack (this means no tablet free break). If your present Pill pack also contains inactive tablets you can start this tablet on the day after taking the last active tablet (if you are not sure which this is, ask your doctor or pharmacist). You can also start later, but never later than the day following the tablet-free break of your present Pill (or the day after the last inactive tablet of your present Pill).
- When changing from a progestagen-only Pill (minipill): You can stop taking the minipill any day and start taking this tablet the next day, at the same time. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet taking when having intercourse.
- When changing from an injectable or implant: Start using this tablet when your next injection is due or on the day that your implant is removed. But make sure you also use an additional contraceptive method (a barrier method) for the first 7 days of tablet-taking when having intercourse.
- After having a baby: If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking this tablet. Sometimes it is possible to start sooner. Your doctor will advise you. If you are breast-feeding and want to take this tablet, you should discuss this first with your doctor.
- After a miscarriage or an abortion: Your doctor will advise you.
When you want to stop taking this tablet: You can stop taking this tablet at any time you want. If you do not want to become pregnant, ask your doctor about other methods of birth control.
If you stop taking this tablet because you want to get pregnant, it is generally recommended that you wait until you have had a natural period before trying to conceive. This helps you to work out when the baby will be due.
AdministrationView
If you forget tablets:
1 tablet missed in week 1: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Use extra contraceptive precautions (barrier method) for the next 7 days. If you had sexual intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. So tell your doctor immediately.
1 tablet missed in week 2: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. The reliability of the Pill is maintained. You need not use extra contraceptive precautions.
1 tablet missed in week 3: You may choose either of the following options, without the need for extra contraceptive precautions.
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Start the next pack as soon as the current pack is finished so that no gap is left between packs. You may not have a withdrawal bleed until the end of the second pack but you may have spotting or breakthrough bleeding on tablet-taking days. Or
Stop taking tablets from your current pack, have a tabletfree break of 7 days or less (also count the day you
missed your tablet) and continue with the next pack. When following this method, you can always start your next pack on the same day of the week as you usually do.
If you have forgotten tablets in a pack and you do not have the expected period in the first normal tablet-free break, you may be pregnant. Consult your doctor before you start with the next pack.
you vomit: If you vomit within 3 to 4 hours after taking your this tablet, the active ingredients may not have been completely absorbed. This is like missing a tablet. Therefore, follow the advice for missed tablets.
you want to delay your period: you can delay your period if you start with your next pack of this tablet immediately after finishing your current pack. You can continue with this pack for as long as you wish, until this pack is empty. When you wish your period to begin, just stop tablet taking. While using the second pack you may have some breakthrough bleeding or spotting on tablet-taking days. Start with your next pack after the usual 7 day tablet-free break.
you want to change the starting day of your period: If you take your tablets as directed, you will have your period on about the same day every 4 weeks. If you want to change this, just shorten, (never lengthen) the next tablet-free break. For example, if your period usually starts on a Friday and in future you want it to start on Tuesday (3 days earlier) you should now start your next pack 3 days sooner than you usually do. If you make your tablet-free break very short (e.g. 3 days or less) you may not have a bleeding during the break. You may have some breakthrough bleeding or spotting during the use of the next pack.
You have unexpected bleeding: With all Pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to the pill (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor.
you have missed a period: If you have taken all of your tablets at the right time, and you have not vomited, or used other medicines then you are very unlikely to be pregnant. Continue to take this tablet as usual. If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of this tablet until your doctor has checked you are not pregnant.
- If you are less than 12 hours late in taking a tablet, the reliability of the Pill is maintained. Take the tablet as soon as you remember and take the next tablets at the usual times.
- If you are more than 12 hours late in taking any tablet, the reliability of the Pill may be reduced. The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. There is a particularly high risk of becoming pregnant if you miss tablets at the beginning or at the end of the pack. Therefore you should follow the rules given below.
1 tablet missed in week 1: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Use extra contraceptive precautions (barrier method) for the next 7 days. If you had sexual intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. So tell your doctor immediately.
1 tablet missed in week 2: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. The reliability of the Pill is maintained. You need not use extra contraceptive precautions.
1 tablet missed in week 3: You may choose either of the following options, without the need for extra contraceptive precautions.
Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablets at the usual time. Start the next pack as soon as the current pack is finished so that no gap is left between packs. You may not have a withdrawal bleed until the end of the second pack but you may have spotting or breakthrough bleeding on tablet-taking days. Or
Stop taking tablets from your current pack, have a tabletfree break of 7 days or less (also count the day you
missed your tablet) and continue with the next pack. When following this method, you can always start your next pack on the same day of the week as you usually do.
If you have forgotten tablets in a pack and you do not have the expected period in the first normal tablet-free break, you may be pregnant. Consult your doctor before you start with the next pack.
you vomit: If you vomit within 3 to 4 hours after taking your this tablet, the active ingredients may not have been completely absorbed. This is like missing a tablet. Therefore, follow the advice for missed tablets.
you want to delay your period: you can delay your period if you start with your next pack of this tablet immediately after finishing your current pack. You can continue with this pack for as long as you wish, until this pack is empty. When you wish your period to begin, just stop tablet taking. While using the second pack you may have some breakthrough bleeding or spotting on tablet-taking days. Start with your next pack after the usual 7 day tablet-free break.
you want to change the starting day of your period: If you take your tablets as directed, you will have your period on about the same day every 4 weeks. If you want to change this, just shorten, (never lengthen) the next tablet-free break. For example, if your period usually starts on a Friday and in future you want it to start on Tuesday (3 days earlier) you should now start your next pack 3 days sooner than you usually do. If you make your tablet-free break very short (e.g. 3 days or less) you may not have a bleeding during the break. You may have some breakthrough bleeding or spotting during the use of the next pack.
You have unexpected bleeding: With all Pills, for the first few months, you can have irregular vaginal bleeding (spotting or breakthrough bleeding) between your periods. You may need to use sanitary protection, but continue to take your tablets as normal. Irregular vaginal bleeding usually stops once your body has adjusted to the pill (usually after about 3 tablet-taking cycles). If it continues, becomes heavy or starts again, tell your doctor.
you have missed a period: If you have taken all of your tablets at the right time, and you have not vomited, or used other medicines then you are very unlikely to be pregnant. Continue to take this tablet as usual. If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack of this tablet until your doctor has checked you are not pregnant.
Side effectsView
Possible side effects: The following side effects have been reported by users of the Pill, although they need not be caused by the Pill. These side effects may occur in the first few months that you are using the Pill and usually lessen with time.
- breast tenderness, pain and secretion;
- headache;
- changes in sexual drive; depressive moods;
- contact lens intolerance;
- nausea, vomiting and feeling sick;
- changes in vaginal secretion;
- various skin reactions;
- fluid retention;
- changes in body weight;
- hypersensitivity reactions.
ContraindicationsView
Do not use the combined Pill if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use this tablet. Your doctor may advise you to use a different type of Pill or an entirely different (non-hormonal) method of birth control.
- If you have, or have ever had a disorder affecting the blood circulation. In particular, those conditions relating to thrombosis. Thrombosis is the formation of a blood clot. This may occur in the blood vessels of the legs (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart attack), the brain (stroke), or other parts of the body.
- If you have or have ever had a condition that may be a first sign of a heart attack (such as angina pectoris or chest pain) or stroke (such as transient ischaemic attack or small reversible stroke).
- If you have diabetes mellitus with blood vessel damage.
- If you have jaundice (yellowing of the skin) or severe liver disease.
- If you have or have had cancer of the breast or the genital organs.
- If you have or have had a benign or malignant tumour in the liver.
- If you have any unexplained vaginal bleeding.
- If you are pregnant or think you might be pregnant.
- If you are allergic to any of the ingredients of this tablet.
PrecautionsView
Before you start to use this tablet: If the combined Pill is used in the presence of any of the conditions listed below you may need to be kept under close observation. Your doctor can explain this to you. Therefore, if any of these apply to you, tell your doctor before starting to use this tablet
The Pill and Thrombosis: A thrombosis is the formation of a blood clot, which may block a blood vessel. A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called "Pulmonary embolism." Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. It can also happen if you become pregnant. The risk is higher in Pill-users than in non-users, but it is not as high as the risk during pregnancy.
Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). Extremely rarely blood clots can occur in the liver, gut, kidney or eye.
Very occasionally a thrombosis may cause serious permanent disabilities or may even be fatal.
The risk of having a heart attack or stroke increases, as you get older. It also increases the more you smoke. When using the Pill you should stop smoking, especially if you are older than about 35 years of age.
If you develop high blood pressure while using the Pill, you may be told to stop using it.
The risk of having a deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (for example, when you have your leg or legs in plaster or splints). In women who use the Pill, the risk may be yet higher. Tell your doctor you are using the Pill well in advance of any expected hospitalisation or surgery. Your doctor may tell you to stop taking the Pill several weeks before surgery or at the time of immobilisation. Your doctor will also tell you when you can start taking the Pill again after you are back on your feet. If you notice possible signs of a thrombosis, stop taking the Pill and consult your doctor immediately.
The Pill and cancer: Breast cancer has been diagnosed, slightly more often in women who use the Pill than in women of the same age who do not use the Pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after stopping use of the Pill. It is not known whether the difference is caused by the Pill. It may be that the women were examined more often, so that the breast cancer was noticed earlier. In rare cases benign liver tumours and even more rarely, malignant liver tumours have been reported in users of the Pill. These tumours may lead to internal bleeding. Contact your doctor immediately if you have severe pain in your stomach.
Cervical cancer has been reported to occur more often in women using the Pill for a long time. This finding may not be caused by the Pill but may be related to sexual behaviour and other factors.
The Pill and other Medicines: Some medicines may stop the Pill from working properly. These include medicines used for the treatment of epilepsy (eg. primidone, phenytoin, barbiturates) and tuberculosis (eg. rifampicin); and antibiotics (eg. ampcillin, tetracyclines, griseofulvin) for some other infectious diseases. Always tell the doctor, who prescribes the Pill, which medicines you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use this tablet. They can tell you if you need to take additional contraceptive precautions and if so, for how long.
The Pill and Ability to Drive: There are no observed effects.
- you smoke;
- you have diabetes;
- you are overweight;
- you have high blood pressure;
- you have a heart valve disorder or a certain heart rhythm disorder;
- you have an inflammation of your veins (superficial phlebitis);
- you have varicose veins;
- anyone in your immediate family has had a thrombosis, a heart attack or a stroke;
- you suffer from migraine;
- you suffer from epilepsy;
- you or someone in your immediate family have or had high blood levels of cholesterol or triglycerides (fatty substances);
- anyone in your immediate family has had breast cancer;
- you have liver or gallbladder disease;
- you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
- you have systemic lupus eryhematosus (SLE; a disease affecting the skin all over the body);
- you have haemolytic uraemic syndrome (HUS; a disorder of blood coagulation causing failure of the kidneys);
- you have sickle cell disease;
- you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face): if so, avoid too much exposure to the sun or ultraviolet radiation.
The Pill and Thrombosis: A thrombosis is the formation of a blood clot, which may block a blood vessel. A thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called "Pulmonary embolism." Deep venous thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. It can also happen if you become pregnant. The risk is higher in Pill-users than in non-users, but it is not as high as the risk during pregnancy.
Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). Extremely rarely blood clots can occur in the liver, gut, kidney or eye.
Very occasionally a thrombosis may cause serious permanent disabilities or may even be fatal.
The risk of having a heart attack or stroke increases, as you get older. It also increases the more you smoke. When using the Pill you should stop smoking, especially if you are older than about 35 years of age.
If you develop high blood pressure while using the Pill, you may be told to stop using it.
The risk of having a deep venous thrombosis is temporarily increased as a result of an operation or immobilisation (for example, when you have your leg or legs in plaster or splints). In women who use the Pill, the risk may be yet higher. Tell your doctor you are using the Pill well in advance of any expected hospitalisation or surgery. Your doctor may tell you to stop taking the Pill several weeks before surgery or at the time of immobilisation. Your doctor will also tell you when you can start taking the Pill again after you are back on your feet. If you notice possible signs of a thrombosis, stop taking the Pill and consult your doctor immediately.
The Pill and cancer: Breast cancer has been diagnosed, slightly more often in women who use the Pill than in women of the same age who do not use the Pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after stopping use of the Pill. It is not known whether the difference is caused by the Pill. It may be that the women were examined more often, so that the breast cancer was noticed earlier. In rare cases benign liver tumours and even more rarely, malignant liver tumours have been reported in users of the Pill. These tumours may lead to internal bleeding. Contact your doctor immediately if you have severe pain in your stomach.
Cervical cancer has been reported to occur more often in women using the Pill for a long time. This finding may not be caused by the Pill but may be related to sexual behaviour and other factors.
The Pill and other Medicines: Some medicines may stop the Pill from working properly. These include medicines used for the treatment of epilepsy (eg. primidone, phenytoin, barbiturates) and tuberculosis (eg. rifampicin); and antibiotics (eg. ampcillin, tetracyclines, griseofulvin) for some other infectious diseases. Always tell the doctor, who prescribes the Pill, which medicines you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you use this tablet. They can tell you if you need to take additional contraceptive precautions and if so, for how long.
The Pill and Ability to Drive: There are no observed effects.
Pregnancy & lactationView
The Pill and Breastfeeding: This tablet is generally not recommended for use during breast feeding. If you wish to take the Pill while breastfeeding, please seek the advice of your doctor.
The Pill and Pregnancy: This tablet must not be used by women who are pregnant, or who think they may be pregnant.
The Pill and Pregnancy: This tablet must not be used by women who are pregnant, or who think they may be pregnant.
StorageView
Store in a cool & dry place in between 2-25° C, protect from light. Keep out of the reach of children.
Cerenin
Vinpocetine
Cerenin
Vinpocetine
Indications
Ischaemic events
Indication detailsView
Acute Cerebro-Vascular Accidents (Strokes): Ischaemic strokes due to cerebral thrombosis, cerebral embolism, acute circulatory disorder, hypertensive crisis; the acute cardiovascular disorders, ischaemic neurological defcit, complete stroke (CS), multiinfarct dementia, cerebral arteriosclerosis, hypertensive encephalopathy, post-apoplectic conditions with the background of haemorrhagic strokes etc.
Senile Disorder: For relief of psychosomatic symptoms in the elderly due to cerebral insufciency eg. forgetfulness, memory disturbances, slow thinking, lack of concentration, dizziness, mood instability, aphasia, sleep disturbances, vasovegetative symptoms of menopausal syndrome etc.
Visual Disorder: Vascular disorders of the choroid and retina due to arteriosclerosis. Vasospasm, macula degenerations, arterial or venous thrombosis or embolism and glaucoma secondary to the above mentioned disorders.
Hearing Disorder: For the treatment of impaired hearing of vascular or toxic (iatrogenic) origin presbyacusis, meniere's disease, cochleovestibular neuritis, tinnitus and dizziness of labirynth origin.
Senile Disorder: For relief of psychosomatic symptoms in the elderly due to cerebral insufciency eg. forgetfulness, memory disturbances, slow thinking, lack of concentration, dizziness, mood instability, aphasia, sleep disturbances, vasovegetative symptoms of menopausal syndrome etc.
Visual Disorder: Vascular disorders of the choroid and retina due to arteriosclerosis. Vasospasm, macula degenerations, arterial or venous thrombosis or embolism and glaucoma secondary to the above mentioned disorders.
Hearing Disorder: For the treatment of impaired hearing of vascular or toxic (iatrogenic) origin presbyacusis, meniere's disease, cochleovestibular neuritis, tinnitus and dizziness of labirynth origin.
Therapeutic classView
Cerebral vasodilator & Neurosensory oxygenator drugs
PharmacologyView
Vinpocetine increases cerebral metabolism; it increases glucose and O2 consumption; improves cerebral hypoxia tolerance; shifts glucose metabolism to the energetically more favourable aerobic pathway, but it increases the anaerobic pathway as well; it elevates the ATP concentration and the ATP/AMP ratio in the brain, and elevates the cerebral norepinephrine, dopamine and serotonin levels.
Vinpocetine considerably improves cerebral microcirculation by inhibiting platelet aggregation, reducing the pathologically increased blood viscosity, and increases erythrocyte deformability. It also promotes O2 transport into the tissues by reducing the O2 affinity of erythrocytes.
It selectively and intensely increases cerebral blood flow and the share of the brain in cardiac output, it reduces cerebral vascular resistance without affecting systemic circulation (blood pressure, heart rate, cardiac output, total peripheral resistance). It does not elicit steal phenomenon; on the contrary, it primarily improves the blood supply of the injured and ischaemic area while it remains unchanged in the intact areas (inverse steal effect). It further increases blood flow which is already increased as a result of hypoxia.
Vinpocetine considerably improves cerebral microcirculation by inhibiting platelet aggregation, reducing the pathologically increased blood viscosity, and increases erythrocyte deformability. It also promotes O2 transport into the tissues by reducing the O2 affinity of erythrocytes.
It selectively and intensely increases cerebral blood flow and the share of the brain in cardiac output, it reduces cerebral vascular resistance without affecting systemic circulation (blood pressure, heart rate, cardiac output, total peripheral resistance). It does not elicit steal phenomenon; on the contrary, it primarily improves the blood supply of the injured and ischaemic area while it remains unchanged in the intact areas (inverse steal effect). It further increases blood flow which is already increased as a result of hypoxia.
DosageView
Tablet: 1-2 tablets thrice daily, the maintenance dose is 1 tablet thrice daily.
IM Injection: Daily dose of 20-40 mg are to be given until improvement of symptoms is reached (for not longer than 10 days) then oral treatment should be applied. If this regimen fails, infusion treatment should be started.
IV Infusion: The daily starting dose is 20 mg in slow drip infusion (2 ampoules in 500-1000 ml infusion solution). This dose can be increased to 1 mg/kg body weight during 3 to 4 days. Treatment should be continued for 10-14 days depending on the tolerance of the patients and the dose should be gradually reduced before discontinuation of treatment.
IM Injection: Daily dose of 20-40 mg are to be given until improvement of symptoms is reached (for not longer than 10 days) then oral treatment should be applied. If this regimen fails, infusion treatment should be started.
IV Infusion: The daily starting dose is 20 mg in slow drip infusion (2 ampoules in 500-1000 ml infusion solution). This dose can be increased to 1 mg/kg body weight during 3 to 4 days. Treatment should be continued for 10-14 days depending on the tolerance of the patients and the dose should be gradually reduced before discontinuation of treatment.
Side effectsView
Transient hypotension, tachycardia may occur.
ContraindicationsView
Parenteral treatment- Severe ischaemic heart disease, severe rhythm disorders and pregnancy.
PrecautionsView
In the acute stage until the improvement of symptoms parenteral treatment is recommended followed by oral treatment. In chronic cases oral therapy should be applied.
InteractionsView
The injection is chemically incompatible with heparin, therefore, it should not be injected in the same syringe.
Pregnancy & lactationView
In Pregnancy and Lactation the drug is contraindicated.
StorageView
Store in a cool and dry place, protected from light and moisture.
Cereton
Vinpocetine
Cereton
Vinpocetine
Indications
Ischaemic events
Indication detailsView
Acute Cerebro-Vascular Accidents (Strokes): Ischaemic strokes due to cerebral thrombosis, cerebral embolism, acute circulatory disorder, hypertensive crisis; the acute cardiovascular disorders, ischaemic neurological defcit, complete stroke (CS), multiinfarct dementia, cerebral arteriosclerosis, hypertensive encephalopathy, post-apoplectic conditions with the background of haemorrhagic strokes etc.
Senile Disorder: For relief of psychosomatic symptoms in the elderly due to cerebral insufciency eg. forgetfulness, memory disturbances, slow thinking, lack of concentration, dizziness, mood instability, aphasia, sleep disturbances, vasovegetative symptoms of menopausal syndrome etc.
Visual Disorder: Vascular disorders of the choroid and retina due to arteriosclerosis. Vasospasm, macula degenerations, arterial or venous thrombosis or embolism and glaucoma secondary to the above mentioned disorders.
Hearing Disorder: For the treatment of impaired hearing of vascular or toxic (iatrogenic) origin presbyacusis, meniere's disease, cochleovestibular neuritis, tinnitus and dizziness of labirynth origin.
Senile Disorder: For relief of psychosomatic symptoms in the elderly due to cerebral insufciency eg. forgetfulness, memory disturbances, slow thinking, lack of concentration, dizziness, mood instability, aphasia, sleep disturbances, vasovegetative symptoms of menopausal syndrome etc.
Visual Disorder: Vascular disorders of the choroid and retina due to arteriosclerosis. Vasospasm, macula degenerations, arterial or venous thrombosis or embolism and glaucoma secondary to the above mentioned disorders.
Hearing Disorder: For the treatment of impaired hearing of vascular or toxic (iatrogenic) origin presbyacusis, meniere's disease, cochleovestibular neuritis, tinnitus and dizziness of labirynth origin.
Therapeutic classView
Cerebral vasodilator & Neurosensory oxygenator drugs
PharmacologyView
Vinpocetine increases cerebral metabolism; it increases glucose and O2 consumption; improves cerebral hypoxia tolerance; shifts glucose metabolism to the energetically more favourable aerobic pathway, but it increases the anaerobic pathway as well; it elevates the ATP concentration and the ATP/AMP ratio in the brain, and elevates the cerebral norepinephrine, dopamine and serotonin levels.
Vinpocetine considerably improves cerebral microcirculation by inhibiting platelet aggregation, reducing the pathologically increased blood viscosity, and increases erythrocyte deformability. It also promotes O2 transport into the tissues by reducing the O2 affinity of erythrocytes.
It selectively and intensely increases cerebral blood flow and the share of the brain in cardiac output, it reduces cerebral vascular resistance without affecting systemic circulation (blood pressure, heart rate, cardiac output, total peripheral resistance). It does not elicit steal phenomenon; on the contrary, it primarily improves the blood supply of the injured and ischaemic area while it remains unchanged in the intact areas (inverse steal effect). It further increases blood flow which is already increased as a result of hypoxia.
Vinpocetine considerably improves cerebral microcirculation by inhibiting platelet aggregation, reducing the pathologically increased blood viscosity, and increases erythrocyte deformability. It also promotes O2 transport into the tissues by reducing the O2 affinity of erythrocytes.
It selectively and intensely increases cerebral blood flow and the share of the brain in cardiac output, it reduces cerebral vascular resistance without affecting systemic circulation (blood pressure, heart rate, cardiac output, total peripheral resistance). It does not elicit steal phenomenon; on the contrary, it primarily improves the blood supply of the injured and ischaemic area while it remains unchanged in the intact areas (inverse steal effect). It further increases blood flow which is already increased as a result of hypoxia.
DosageView
Tablet: 1-2 tablets thrice daily, the maintenance dose is 1 tablet thrice daily.
IM Injection: Daily dose of 20-40 mg are to be given until improvement of symptoms is reached (for not longer than 10 days) then oral treatment should be applied. If this regimen fails, infusion treatment should be started.
IV Infusion: The daily starting dose is 20 mg in slow drip infusion (2 ampoules in 500-1000 ml infusion solution). This dose can be increased to 1 mg/kg body weight during 3 to 4 days. Treatment should be continued for 10-14 days depending on the tolerance of the patients and the dose should be gradually reduced before discontinuation of treatment.
IM Injection: Daily dose of 20-40 mg are to be given until improvement of symptoms is reached (for not longer than 10 days) then oral treatment should be applied. If this regimen fails, infusion treatment should be started.
IV Infusion: The daily starting dose is 20 mg in slow drip infusion (2 ampoules in 500-1000 ml infusion solution). This dose can be increased to 1 mg/kg body weight during 3 to 4 days. Treatment should be continued for 10-14 days depending on the tolerance of the patients and the dose should be gradually reduced before discontinuation of treatment.
Side effectsView
Transient hypotension, tachycardia may occur.
ContraindicationsView
Parenteral treatment- Severe ischaemic heart disease, severe rhythm disorders and pregnancy.
PrecautionsView
In the acute stage until the improvement of symptoms parenteral treatment is recommended followed by oral treatment. In chronic cases oral therapy should be applied.
InteractionsView
The injection is chemically incompatible with heparin, therefore, it should not be injected in the same syringe.
Pregnancy & lactationView
In Pregnancy and Lactation the drug is contraindicated.
StorageView
Store in a cool and dry place, protected from light and moisture.
Cereton
Vinpocetine
Cereton
Vinpocetine
Indications
Ischaemic events
Indication detailsView
Acute Cerebro-Vascular Accidents (Strokes): Ischaemic strokes due to cerebral thrombosis, cerebral embolism, acute circulatory disorder, hypertensive crisis; the acute cardiovascular disorders, ischaemic neurological defcit, complete stroke (CS), multiinfarct dementia, cerebral arteriosclerosis, hypertensive encephalopathy, post-apoplectic conditions with the background of haemorrhagic strokes etc.
Senile Disorder: For relief of psychosomatic symptoms in the elderly due to cerebral insufciency eg. forgetfulness, memory disturbances, slow thinking, lack of concentration, dizziness, mood instability, aphasia, sleep disturbances, vasovegetative symptoms of menopausal syndrome etc.
Visual Disorder: Vascular disorders of the choroid and retina due to arteriosclerosis. Vasospasm, macula degenerations, arterial or venous thrombosis or embolism and glaucoma secondary to the above mentioned disorders.
Hearing Disorder: For the treatment of impaired hearing of vascular or toxic (iatrogenic) origin presbyacusis, meniere's disease, cochleovestibular neuritis, tinnitus and dizziness of labirynth origin.
Senile Disorder: For relief of psychosomatic symptoms in the elderly due to cerebral insufciency eg. forgetfulness, memory disturbances, slow thinking, lack of concentration, dizziness, mood instability, aphasia, sleep disturbances, vasovegetative symptoms of menopausal syndrome etc.
Visual Disorder: Vascular disorders of the choroid and retina due to arteriosclerosis. Vasospasm, macula degenerations, arterial or venous thrombosis or embolism and glaucoma secondary to the above mentioned disorders.
Hearing Disorder: For the treatment of impaired hearing of vascular or toxic (iatrogenic) origin presbyacusis, meniere's disease, cochleovestibular neuritis, tinnitus and dizziness of labirynth origin.
Therapeutic classView
Cerebral vasodilator & Neurosensory oxygenator drugs
PharmacologyView
Vinpocetine increases cerebral metabolism; it increases glucose and O2 consumption; improves cerebral hypoxia tolerance; shifts glucose metabolism to the energetically more favourable aerobic pathway, but it increases the anaerobic pathway as well; it elevates the ATP concentration and the ATP/AMP ratio in the brain, and elevates the cerebral norepinephrine, dopamine and serotonin levels.
Vinpocetine considerably improves cerebral microcirculation by inhibiting platelet aggregation, reducing the pathologically increased blood viscosity, and increases erythrocyte deformability. It also promotes O2 transport into the tissues by reducing the O2 affinity of erythrocytes.
It selectively and intensely increases cerebral blood flow and the share of the brain in cardiac output, it reduces cerebral vascular resistance without affecting systemic circulation (blood pressure, heart rate, cardiac output, total peripheral resistance). It does not elicit steal phenomenon; on the contrary, it primarily improves the blood supply of the injured and ischaemic area while it remains unchanged in the intact areas (inverse steal effect). It further increases blood flow which is already increased as a result of hypoxia.
Vinpocetine considerably improves cerebral microcirculation by inhibiting platelet aggregation, reducing the pathologically increased blood viscosity, and increases erythrocyte deformability. It also promotes O2 transport into the tissues by reducing the O2 affinity of erythrocytes.
It selectively and intensely increases cerebral blood flow and the share of the brain in cardiac output, it reduces cerebral vascular resistance without affecting systemic circulation (blood pressure, heart rate, cardiac output, total peripheral resistance). It does not elicit steal phenomenon; on the contrary, it primarily improves the blood supply of the injured and ischaemic area while it remains unchanged in the intact areas (inverse steal effect). It further increases blood flow which is already increased as a result of hypoxia.
DosageView
Tablet: 1-2 tablets thrice daily, the maintenance dose is 1 tablet thrice daily.
IM Injection: Daily dose of 20-40 mg are to be given until improvement of symptoms is reached (for not longer than 10 days) then oral treatment should be applied. If this regimen fails, infusion treatment should be started.
IV Infusion: The daily starting dose is 20 mg in slow drip infusion (2 ampoules in 500-1000 ml infusion solution). This dose can be increased to 1 mg/kg body weight during 3 to 4 days. Treatment should be continued for 10-14 days depending on the tolerance of the patients and the dose should be gradually reduced before discontinuation of treatment.
IM Injection: Daily dose of 20-40 mg are to be given until improvement of symptoms is reached (for not longer than 10 days) then oral treatment should be applied. If this regimen fails, infusion treatment should be started.
IV Infusion: The daily starting dose is 20 mg in slow drip infusion (2 ampoules in 500-1000 ml infusion solution). This dose can be increased to 1 mg/kg body weight during 3 to 4 days. Treatment should be continued for 10-14 days depending on the tolerance of the patients and the dose should be gradually reduced before discontinuation of treatment.
Side effectsView
Transient hypotension, tachycardia may occur.
ContraindicationsView
Parenteral treatment- Severe ischaemic heart disease, severe rhythm disorders and pregnancy.
PrecautionsView
In the acute stage until the improvement of symptoms parenteral treatment is recommended followed by oral treatment. In chronic cases oral therapy should be applied.
InteractionsView
The injection is chemically incompatible with heparin, therefore, it should not be injected in the same syringe.
Pregnancy & lactationView
In Pregnancy and Lactation the drug is contraindicated.
StorageView
Store in a cool and dry place, protected from light and moisture.
Cerevas
Vinpocetine
Cerevas
Vinpocetine
Indications
Ischaemic events
Indication detailsView
Acute Cerebro-Vascular Accidents (Strokes): Ischaemic strokes due to cerebral thrombosis, cerebral embolism, acute circulatory disorder, hypertensive crisis; the acute cardiovascular disorders, ischaemic neurological defcit, complete stroke (CS), multiinfarct dementia, cerebral arteriosclerosis, hypertensive encephalopathy, post-apoplectic conditions with the background of haemorrhagic strokes etc.
Senile Disorder: For relief of psychosomatic symptoms in the elderly due to cerebral insufciency eg. forgetfulness, memory disturbances, slow thinking, lack of concentration, dizziness, mood instability, aphasia, sleep disturbances, vasovegetative symptoms of menopausal syndrome etc.
Visual Disorder: Vascular disorders of the choroid and retina due to arteriosclerosis. Vasospasm, macula degenerations, arterial or venous thrombosis or embolism and glaucoma secondary to the above mentioned disorders.
Hearing Disorder: For the treatment of impaired hearing of vascular or toxic (iatrogenic) origin presbyacusis, meniere's disease, cochleovestibular neuritis, tinnitus and dizziness of labirynth origin.
Senile Disorder: For relief of psychosomatic symptoms in the elderly due to cerebral insufciency eg. forgetfulness, memory disturbances, slow thinking, lack of concentration, dizziness, mood instability, aphasia, sleep disturbances, vasovegetative symptoms of menopausal syndrome etc.
Visual Disorder: Vascular disorders of the choroid and retina due to arteriosclerosis. Vasospasm, macula degenerations, arterial or venous thrombosis or embolism and glaucoma secondary to the above mentioned disorders.
Hearing Disorder: For the treatment of impaired hearing of vascular or toxic (iatrogenic) origin presbyacusis, meniere's disease, cochleovestibular neuritis, tinnitus and dizziness of labirynth origin.
Therapeutic classView
Cerebral vasodilator & Neurosensory oxygenator drugs
PharmacologyView
Vinpocetine increases cerebral metabolism; it increases glucose and O2 consumption; improves cerebral hypoxia tolerance; shifts glucose metabolism to the energetically more favourable aerobic pathway, but it increases the anaerobic pathway as well; it elevates the ATP concentration and the ATP/AMP ratio in the brain, and elevates the cerebral norepinephrine, dopamine and serotonin levels.
Vinpocetine considerably improves cerebral microcirculation by inhibiting platelet aggregation, reducing the pathologically increased blood viscosity, and increases erythrocyte deformability. It also promotes O2 transport into the tissues by reducing the O2 affinity of erythrocytes.
It selectively and intensely increases cerebral blood flow and the share of the brain in cardiac output, it reduces cerebral vascular resistance without affecting systemic circulation (blood pressure, heart rate, cardiac output, total peripheral resistance). It does not elicit steal phenomenon; on the contrary, it primarily improves the blood supply of the injured and ischaemic area while it remains unchanged in the intact areas (inverse steal effect). It further increases blood flow which is already increased as a result of hypoxia.
Vinpocetine considerably improves cerebral microcirculation by inhibiting platelet aggregation, reducing the pathologically increased blood viscosity, and increases erythrocyte deformability. It also promotes O2 transport into the tissues by reducing the O2 affinity of erythrocytes.
It selectively and intensely increases cerebral blood flow and the share of the brain in cardiac output, it reduces cerebral vascular resistance without affecting systemic circulation (blood pressure, heart rate, cardiac output, total peripheral resistance). It does not elicit steal phenomenon; on the contrary, it primarily improves the blood supply of the injured and ischaemic area while it remains unchanged in the intact areas (inverse steal effect). It further increases blood flow which is already increased as a result of hypoxia.
DosageView
Tablet: 1-2 tablets thrice daily, the maintenance dose is 1 tablet thrice daily.
IM Injection: Daily dose of 20-40 mg are to be given until improvement of symptoms is reached (for not longer than 10 days) then oral treatment should be applied. If this regimen fails, infusion treatment should be started.
IV Infusion: The daily starting dose is 20 mg in slow drip infusion (2 ampoules in 500-1000 ml infusion solution). This dose can be increased to 1 mg/kg body weight during 3 to 4 days. Treatment should be continued for 10-14 days depending on the tolerance of the patients and the dose should be gradually reduced before discontinuation of treatment.
IM Injection: Daily dose of 20-40 mg are to be given until improvement of symptoms is reached (for not longer than 10 days) then oral treatment should be applied. If this regimen fails, infusion treatment should be started.
IV Infusion: The daily starting dose is 20 mg in slow drip infusion (2 ampoules in 500-1000 ml infusion solution). This dose can be increased to 1 mg/kg body weight during 3 to 4 days. Treatment should be continued for 10-14 days depending on the tolerance of the patients and the dose should be gradually reduced before discontinuation of treatment.
Side effectsView
Transient hypotension, tachycardia may occur.
ContraindicationsView
Parenteral treatment- Severe ischaemic heart disease, severe rhythm disorders and pregnancy.
PrecautionsView
In the acute stage until the improvement of symptoms parenteral treatment is recommended followed by oral treatment. In chronic cases oral therapy should be applied.
InteractionsView
The injection is chemically incompatible with heparin, therefore, it should not be injected in the same syringe.
Pregnancy & lactationView
In Pregnancy and Lactation the drug is contraindicated.
StorageView
Store in a cool and dry place, protected from light and moisture.
Cerinib
Ceritinib
Cerinib
Ceritinib
Indication detailsView
Ceritinib is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
PharmacologyView
Ceritinib is a kinase inhibitor. Targets of Ceritinib inhibition identified in either biochemical or cellular assays at clinically relevant concentrations include ALK, insulin- like growth factor 1 receptor (IGF-1R), insulin receptor (InsR), and ROS1. Among these, Ceritinib is most active against ALK. Ceritinib inhibited autophosphorylation of ALK, ALK-mediated phosphorylation of the downstream signaling protein STAT3, and proliferation of ALK dependent cancer cells in in vitro and in vivo assays.
Absorption: After a single oral administration of Ceritinib in patients, peak plasma levels (Cmax) of Ceritinib were achieved at approximately 4 to 6 hours, and AUC and C max increased dose proportionally over 50 to 750 mg under fasted conditions. The absolute bioavailability of Ceritinib has not been determined.
Distribution: Ceritinib is 97% bound to human plasma proteins, independent of drug concentration. The apparent volume of distribution is 4230 L following a single 750 mg fasted Ceritinib dose in patients. Ceritinib also has a slight preferential distribution to red blood cells, relative to plasma, with a mean in vitro blood-to-plasma ratio of 1.35.
Elimination: Following a single 750 mg fasted Ceritinib dose, the geometric mean apparent plasma terminal half life (t½) of Ceritinib was 41 hours in patients. Ceritinib demonstrates nonlinear PK over time. The geometric mean apparent clearance of Ceritinib was lower at steady-state (33.2 L/h) after 750 mg daily dosing than after a single 750 mg dose (88.5 L/h).
Metabolism: In vitro studies demonstrated that CYP3A was the major enzyme involved in the metabolic clearance of Ceritinib. Following oral administration of a single 750 mg radiolabeled Ceritinib dose under fasted conditions, Ceritinib as the parent compound was the main circulating component (82%) in human plasma.
Excretion: Following oral administration of a single 750 mg radiolabeled Ceritinib dose under fasted conditions, 92.3% of the administered dose was recovered in the feces (with 68% as unchanged parent compound) while 1.3% of the administered dose was recovered in the urine.
Absorption: After a single oral administration of Ceritinib in patients, peak plasma levels (Cmax) of Ceritinib were achieved at approximately 4 to 6 hours, and AUC and C max increased dose proportionally over 50 to 750 mg under fasted conditions. The absolute bioavailability of Ceritinib has not been determined.
Distribution: Ceritinib is 97% bound to human plasma proteins, independent of drug concentration. The apparent volume of distribution is 4230 L following a single 750 mg fasted Ceritinib dose in patients. Ceritinib also has a slight preferential distribution to red blood cells, relative to plasma, with a mean in vitro blood-to-plasma ratio of 1.35.
Elimination: Following a single 750 mg fasted Ceritinib dose, the geometric mean apparent plasma terminal half life (t½) of Ceritinib was 41 hours in patients. Ceritinib demonstrates nonlinear PK over time. The geometric mean apparent clearance of Ceritinib was lower at steady-state (33.2 L/h) after 750 mg daily dosing than after a single 750 mg dose (88.5 L/h).
Metabolism: In vitro studies demonstrated that CYP3A was the major enzyme involved in the metabolic clearance of Ceritinib. Following oral administration of a single 750 mg radiolabeled Ceritinib dose under fasted conditions, Ceritinib as the parent compound was the main circulating component (82%) in human plasma.
Excretion: Following oral administration of a single 750 mg radiolabeled Ceritinib dose under fasted conditions, 92.3% of the administered dose was recovered in the feces (with 68% as unchanged parent compound) while 1.3% of the administered dose was recovered in the urine.
DosageView
Patients should be selected for treatment of metastatic NSCLC with Ceritinib based on the presence of ALK positivity in tumor specimens. The recommended dose of Ceritinib is 450 mg orally once daily with food until disease progression or unacceptable toxicity. If a dose of Ceritinib is missed, that dose should be made up unless the next dose is due within 12 hours. If vomiting occurs during the course of treatment, an additional dose should not be administered and the next scheduled dose of Ceritinib should be continued. Or, as directed by the registered physician.
Side effectsView
- Gastrointestinal Adverse Reactions
- Hepatotoxicity
- Interstitial Lung Disease/Pneumonitis
- QT Interval Prolongation
- Hyperglycemia
- Bradycardia
- Pancreatitis
ContraindicationsView
It is contraindicated in patients with known hypersensitivity to Ceritinib or any other components of this product.
PrecautionsView
Gastrointestinal Adverse Reactions: Severe gastrointestinal toxicity occurred in patients treated with Ceritinib 750 mg under fasted conditions. Diarrhea, nausea, vomiting, or abdominal pain occurred in 95% of 925 patients, including severe cases (Grade 3 or 4) in 14% of patients treated with Ceritinib across clinical studies. Diarrhea, nausea, vomiting, or abdominal pain leading to dose interruptions or reductions occurred in 36% of patients and leading to treatment discontinuation occurred in 1.6% of patients. Patients should be monitored and managed using standards of care, including antidiarrheals, antiemetics, or fluid replacement, as indicated. Based on the severity of the adverse drug reaction, Ceritinib should be withheld with resumption at a reduced dose.
Hepatotoxicity: Drug-induced hepatotoxicity occurred in patients treated with Ceritinib. Elevations in alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (ULN) occurred in 28% and elevations in aspartate aminotransferase (AST) greater than 5 times ULN occurred in 16% of 925 patients across clinical studies. Concurrent elevations in ALT greater than 3 times the ULN and total bilirubin greater than 2 times the ULN, with alkaline phosphatase less than 2 times the ULN occurred in 0.3% of patients across clinical studies. Approximately 1.0% of patients required permanent discontinuation due to hepatotoxicity. It should be monitor with liver laboratory tests including ALT, AST, and total bilirubin once a month and as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Based on the severity of the adverse drug reaction, Ceritinib should be withheld with resumption at a reduced dose, or permanently discontinue Ceritinib.
Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD/pneumonitis occurred in patients treated with Ceritinib. Across clinical studies, ILD/pneumonitis was reported in 2.4% of 925 patients treated with Ceritinib. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3 or 4 ILD/pneumonitis was reported in 1.3% of patients, with fatal events reported in 0.2% of patients. Ten patients (1.1%) discontinued Ceritinib across clinical studies due to ILD/pneumonitis. Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis.
QT Interval Prolongation: QTc interval prolongation, which may lead to an increased risk for ventricular tachyarrhythmia (e.g., torsades de pointes) or sudden death, occurred in patients treated with Ceritinib. Across clinical studies, 6% of 919 patients with at least one post-baseline ECG assessment experienced a QTc interval increase over baseline of greater than 60 msec. Approximately 1.3% of patients taking Ceritinib 750 mg fasted were found to have a QTc greater than 500 msec. When possible, use of Ceritinib should be avoided in patients with congenital long QT syndrome. Periodic monitoring should be conducted with electrocardiograms (ECGs) and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or those who are taking medications that are known to prolong the QTc interval.
Hyperglycemia: Hyperglycemia occurred in patients receiving Ceritinib. Across clinical studies, CTCAE Grade 3 or 4 hyperglycemia, based on laboratory values, occurred in 13% of 925 patients. Fasting serum glucose should be monitored prior to the start of Ceritinib treatment and periodically thereafter as clinically indicated. Based on the severity of the adverse drug reaction, Ceritinib should be withheld until hyperglycemia is adequately controlled, then resume Ceritinib at a reduced dose.
Bradycardia: Bradycardia occurred in patients receiving Ceritinib. Across clinical studies, sinus bradycardia, defined as a heart rate of less than 50 beats per minute (bpm), was noted as a new finding in 1% of 925 patients. Bradycardia was reported as an adverse drug reaction in 1% of patients. No patient required discontinuation and 0.1% required interruption with subsequent dose reduction for bradycardia. Using Ceritinib should be avoided in combination with other agents known to cause bradycardia (e.g., beta-blockers, nondihydropyridine calcium channel blockers, clonidine, and digoxin) to the extent possible. Heart rate and blood pressure should be regularly monitored. In cases of symptomatic bradycardia that is not life threatening, Ceritinib should be withheld until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, evaluate the use of concomitant medications, and adjust the dose of Ceritinib.
Pancreatitis: Pancreatitis occurred in patients receiving Ceritinib. Pancreatitis, including one fatality, occurred in less than 1% of patients receiving Ceritinib in clinical studies. CTCAE Grade 3 or 4 elevations of amylase occurred in 7% of patients receiving Ceritinib across clinical studies, while CTCAE Grade 3 or 4 elevations of lipase occurred in 14% of patients. Lipase and amylase should be monitored prior to the start of Ceritinib treatment and periodically thereafter as clinically indicated. Based on the severity of the laboratory abnormalities, Ceritinib should be withheld with resumption at a reduced dose.
Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animal studies, Ceritinib can cause fetal harm when administered to a pregnant woman. Pregnant women should be advised of the potential risk to a fetus. Females of reproductive potential should be advised to use effective contraception during treatment with Ceritinib and for 6 months following completion of therapy. Based on the potential for genotoxicity, males with female partners of reproductive potential should be advised to use condoms during treatment with Ceritinib and for 3 months following completion of therapy.
Hepatotoxicity: Drug-induced hepatotoxicity occurred in patients treated with Ceritinib. Elevations in alanine aminotransferase (ALT) greater than 5 times the upper limit of normal (ULN) occurred in 28% and elevations in aspartate aminotransferase (AST) greater than 5 times ULN occurred in 16% of 925 patients across clinical studies. Concurrent elevations in ALT greater than 3 times the ULN and total bilirubin greater than 2 times the ULN, with alkaline phosphatase less than 2 times the ULN occurred in 0.3% of patients across clinical studies. Approximately 1.0% of patients required permanent discontinuation due to hepatotoxicity. It should be monitor with liver laboratory tests including ALT, AST, and total bilirubin once a month and as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Based on the severity of the adverse drug reaction, Ceritinib should be withheld with resumption at a reduced dose, or permanently discontinue Ceritinib.
Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD/pneumonitis occurred in patients treated with Ceritinib. Across clinical studies, ILD/pneumonitis was reported in 2.4% of 925 patients treated with Ceritinib. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3 or 4 ILD/pneumonitis was reported in 1.3% of patients, with fatal events reported in 0.2% of patients. Ten patients (1.1%) discontinued Ceritinib across clinical studies due to ILD/pneumonitis. Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis.
QT Interval Prolongation: QTc interval prolongation, which may lead to an increased risk for ventricular tachyarrhythmia (e.g., torsades de pointes) or sudden death, occurred in patients treated with Ceritinib. Across clinical studies, 6% of 919 patients with at least one post-baseline ECG assessment experienced a QTc interval increase over baseline of greater than 60 msec. Approximately 1.3% of patients taking Ceritinib 750 mg fasted were found to have a QTc greater than 500 msec. When possible, use of Ceritinib should be avoided in patients with congenital long QT syndrome. Periodic monitoring should be conducted with electrocardiograms (ECGs) and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or those who are taking medications that are known to prolong the QTc interval.
Hyperglycemia: Hyperglycemia occurred in patients receiving Ceritinib. Across clinical studies, CTCAE Grade 3 or 4 hyperglycemia, based on laboratory values, occurred in 13% of 925 patients. Fasting serum glucose should be monitored prior to the start of Ceritinib treatment and periodically thereafter as clinically indicated. Based on the severity of the adverse drug reaction, Ceritinib should be withheld until hyperglycemia is adequately controlled, then resume Ceritinib at a reduced dose.
Bradycardia: Bradycardia occurred in patients receiving Ceritinib. Across clinical studies, sinus bradycardia, defined as a heart rate of less than 50 beats per minute (bpm), was noted as a new finding in 1% of 925 patients. Bradycardia was reported as an adverse drug reaction in 1% of patients. No patient required discontinuation and 0.1% required interruption with subsequent dose reduction for bradycardia. Using Ceritinib should be avoided in combination with other agents known to cause bradycardia (e.g., beta-blockers, nondihydropyridine calcium channel blockers, clonidine, and digoxin) to the extent possible. Heart rate and blood pressure should be regularly monitored. In cases of symptomatic bradycardia that is not life threatening, Ceritinib should be withheld until recovery to asymptomatic bradycardia or to a heart rate of 60 bpm or above, evaluate the use of concomitant medications, and adjust the dose of Ceritinib.
Pancreatitis: Pancreatitis occurred in patients receiving Ceritinib. Pancreatitis, including one fatality, occurred in less than 1% of patients receiving Ceritinib in clinical studies. CTCAE Grade 3 or 4 elevations of amylase occurred in 7% of patients receiving Ceritinib across clinical studies, while CTCAE Grade 3 or 4 elevations of lipase occurred in 14% of patients. Lipase and amylase should be monitored prior to the start of Ceritinib treatment and periodically thereafter as clinically indicated. Based on the severity of the laboratory abnormalities, Ceritinib should be withheld with resumption at a reduced dose.
Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animal studies, Ceritinib can cause fetal harm when administered to a pregnant woman. Pregnant women should be advised of the potential risk to a fetus. Females of reproductive potential should be advised to use effective contraception during treatment with Ceritinib and for 6 months following completion of therapy. Based on the potential for genotoxicity, males with female partners of reproductive potential should be advised to use condoms during treatment with Ceritinib and for 3 months following completion of therapy.
InteractionsView
Effect of Other Drugs on Ceritinib: Strong CYP3A Inhibitors: A strong CYP3A4/P-gp inhibitor (ketoconazole) increased the systemic exposure of Ceritinib so it should be avoided. If concomitant use of strong CYP3A inhibitors including certain antivirals (e.g., ritonavir), macrolide antibiotics (e.g., telithromycin), antifungals (e.g., ketoconazole), and nefazodone is unavoidable, the Ceritinib dose should be reduced by approximately one third, rounded to the nearest multiple of the 150 mg dosage strength. After discontinuation of a strong CYP3A inhibitor, the Ceritinib dose should be resumed that was taken prior to initiating the strong CYP3A inhibitor. Grapefruit and grapefruit juice should not be consumed as they may inhibit CYP3A.
Strong CYP3A Inducers: A strong CYP3A4/P-gp inducer (Rifampin) decreased the systemic exposure of Ceritinib. Concurrent use of strong CYP3A inducers (e.g., Carbamazepine, Phenytoin, Rifampin, and St. John's Wort) should be avoided during treatment with Ceritinib.
Effect of Ceritinib on Other Drugs: CYP3A Substrates: Ceritinib increased the systemic exposure of a sensitive CYP3A substrate (Midazolam) so it should be avoided. If concomitant use is unavoidable, dose reduction of the sensitive CYP3A substrates should be considered. If Ceritinib is coadministered with other CYP3A substrates, it should be referred to the CYP3A substrate labeling for dosage recommendation with strong CYP3A inhibitors.
CYP2C9 Substrates: Ceritinib increased the systemic exposure of a CYP2C9 substrate (Warfarin). The frequency of INR monitoring should be increased if coadministration with warfarin is unavoidable as the anti-coagulant effect of Warfarin may be enhanced. Coadministration of Ceritinib should be avoided with CYP2C9 substrates for which minimal concentration changes may lead to serious toxicities. If concomitant use of such CYP2C9 substrates is unavoidable, dose reduction should be considered for the coadministered CYP2C9 substrates.
Strong CYP3A Inducers: A strong CYP3A4/P-gp inducer (Rifampin) decreased the systemic exposure of Ceritinib. Concurrent use of strong CYP3A inducers (e.g., Carbamazepine, Phenytoin, Rifampin, and St. John's Wort) should be avoided during treatment with Ceritinib.
Effect of Ceritinib on Other Drugs: CYP3A Substrates: Ceritinib increased the systemic exposure of a sensitive CYP3A substrate (Midazolam) so it should be avoided. If concomitant use is unavoidable, dose reduction of the sensitive CYP3A substrates should be considered. If Ceritinib is coadministered with other CYP3A substrates, it should be referred to the CYP3A substrate labeling for dosage recommendation with strong CYP3A inhibitors.
CYP2C9 Substrates: Ceritinib increased the systemic exposure of a CYP2C9 substrate (Warfarin). The frequency of INR monitoring should be increased if coadministration with warfarin is unavoidable as the anti-coagulant effect of Warfarin may be enhanced. Coadministration of Ceritinib should be avoided with CYP2C9 substrates for which minimal concentration changes may lead to serious toxicities. If concomitant use of such CYP2C9 substrates is unavoidable, dose reduction should be considered for the coadministered CYP2C9 substrates.
Pregnancy & lactationView
Ceritinib can cause fetal harm when administered to a pregnant woman. If it is used during pregnancy or if the patient becomes pregnant while taking it, the patient should be apprised of the potential hazard to the fetus. There are no data regarding the presence of Ceritinib or its metabolites in human milk, the effects of Ceritinib on the breastfed infant, or its effects on milk production. Because of the potential for serious adverse reactions including gastrointestinal adverse reactions, hepatotoxicity, pneumonitis, bradycardia and pancreatitis, a woman should be advised not to breastfeed during treatment with Cerinib and for 2 weeks following completion of therapy.
Pediatric usageView
Females: Ceritinib can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should be advised to use effective contraception during treatment with Ceritinib and for 6 months following completion of therapy.
Males: Based on the potential for genotoxicity, males with female partners of reproductive potential should be advised to use condoms during treatment with Ceritinib and for 3 months following completion of therapy.
Pediatric Use: The safety and effectiveness of Ceritinib in pediatric patients have not been established.
Geriatric Use: Of the 925 patients in clinical studies of Ceritinib, 18% were 65 years or older, while 5% were 75 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Hepatic Impairment: For patients with severe hepatic impairment (Child-Pugh C), the dose of Ceritinib should be reduced by approximately one-third, rounded to the nearest multiple of the 150 mg dosage strength. No dose adjustment is recommended in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
Males: Based on the potential for genotoxicity, males with female partners of reproductive potential should be advised to use condoms during treatment with Ceritinib and for 3 months following completion of therapy.
Pediatric Use: The safety and effectiveness of Ceritinib in pediatric patients have not been established.
Geriatric Use: Of the 925 patients in clinical studies of Ceritinib, 18% were 65 years or older, while 5% were 75 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Hepatic Impairment: For patients with severe hepatic impairment (Child-Pugh C), the dose of Ceritinib should be reduced by approximately one-third, rounded to the nearest multiple of the 150 mg dosage strength. No dose adjustment is recommended in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
StorageView
Store below 30°C in a cool and dry place, away from sunlight. Keep out of reach of children.
Ceritec
Cetirizine Hydrochloride
Ceritec
Cetirizine Hydrochloride
Indications
Urticaria
Indication detailsView
It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.
Therapeutic classView
Sedating Anti-histamine
PharmacologyView
Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.
Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.
Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.
DosageView
Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).
Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.
Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.
Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.
Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.
Side effectsView
The most common side effects that occurred more frequently on Cetirizine is somnolence.
ContraindicationsView
It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.
PrecautionsView
Caution should be exercised when driving a car or operating a heavy machinery.
InteractionsView
No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.
Pregnancy & lactationView
US FDA Pregnancy Category of Cetirizine Hydrochloride is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Cerivin
Vinpocetine
Cerivin
Vinpocetine
Indications
Ischaemic events
Indication detailsView
Acute Cerebro-Vascular Accidents (Strokes): Ischaemic strokes due to cerebral thrombosis, cerebral embolism, acute circulatory disorder, hypertensive crisis; the acute cardiovascular disorders, ischaemic neurological defcit, complete stroke (CS), multiinfarct dementia, cerebral arteriosclerosis, hypertensive encephalopathy, post-apoplectic conditions with the background of haemorrhagic strokes etc.
Senile Disorder: For relief of psychosomatic symptoms in the elderly due to cerebral insufciency eg. forgetfulness, memory disturbances, slow thinking, lack of concentration, dizziness, mood instability, aphasia, sleep disturbances, vasovegetative symptoms of menopausal syndrome etc.
Visual Disorder: Vascular disorders of the choroid and retina due to arteriosclerosis. Vasospasm, macula degenerations, arterial or venous thrombosis or embolism and glaucoma secondary to the above mentioned disorders.
Hearing Disorder: For the treatment of impaired hearing of vascular or toxic (iatrogenic) origin presbyacusis, meniere's disease, cochleovestibular neuritis, tinnitus and dizziness of labirynth origin.
Senile Disorder: For relief of psychosomatic symptoms in the elderly due to cerebral insufciency eg. forgetfulness, memory disturbances, slow thinking, lack of concentration, dizziness, mood instability, aphasia, sleep disturbances, vasovegetative symptoms of menopausal syndrome etc.
Visual Disorder: Vascular disorders of the choroid and retina due to arteriosclerosis. Vasospasm, macula degenerations, arterial or venous thrombosis or embolism and glaucoma secondary to the above mentioned disorders.
Hearing Disorder: For the treatment of impaired hearing of vascular or toxic (iatrogenic) origin presbyacusis, meniere's disease, cochleovestibular neuritis, tinnitus and dizziness of labirynth origin.
Therapeutic classView
Cerebral vasodilator & Neurosensory oxygenator drugs
PharmacologyView
Vinpocetine increases cerebral metabolism; it increases glucose and O2 consumption; improves cerebral hypoxia tolerance; shifts glucose metabolism to the energetically more favourable aerobic pathway, but it increases the anaerobic pathway as well; it elevates the ATP concentration and the ATP/AMP ratio in the brain, and elevates the cerebral norepinephrine, dopamine and serotonin levels.
Vinpocetine considerably improves cerebral microcirculation by inhibiting platelet aggregation, reducing the pathologically increased blood viscosity, and increases erythrocyte deformability. It also promotes O2 transport into the tissues by reducing the O2 affinity of erythrocytes.
It selectively and intensely increases cerebral blood flow and the share of the brain in cardiac output, it reduces cerebral vascular resistance without affecting systemic circulation (blood pressure, heart rate, cardiac output, total peripheral resistance). It does not elicit steal phenomenon; on the contrary, it primarily improves the blood supply of the injured and ischaemic area while it remains unchanged in the intact areas (inverse steal effect). It further increases blood flow which is already increased as a result of hypoxia.
Vinpocetine considerably improves cerebral microcirculation by inhibiting platelet aggregation, reducing the pathologically increased blood viscosity, and increases erythrocyte deformability. It also promotes O2 transport into the tissues by reducing the O2 affinity of erythrocytes.
It selectively and intensely increases cerebral blood flow and the share of the brain in cardiac output, it reduces cerebral vascular resistance without affecting systemic circulation (blood pressure, heart rate, cardiac output, total peripheral resistance). It does not elicit steal phenomenon; on the contrary, it primarily improves the blood supply of the injured and ischaemic area while it remains unchanged in the intact areas (inverse steal effect). It further increases blood flow which is already increased as a result of hypoxia.
DosageView
Tablet: 1-2 tablets thrice daily, the maintenance dose is 1 tablet thrice daily.
IM Injection: Daily dose of 20-40 mg are to be given until improvement of symptoms is reached (for not longer than 10 days) then oral treatment should be applied. If this regimen fails, infusion treatment should be started.
IV Infusion: The daily starting dose is 20 mg in slow drip infusion (2 ampoules in 500-1000 ml infusion solution). This dose can be increased to 1 mg/kg body weight during 3 to 4 days. Treatment should be continued for 10-14 days depending on the tolerance of the patients and the dose should be gradually reduced before discontinuation of treatment.
IM Injection: Daily dose of 20-40 mg are to be given until improvement of symptoms is reached (for not longer than 10 days) then oral treatment should be applied. If this regimen fails, infusion treatment should be started.
IV Infusion: The daily starting dose is 20 mg in slow drip infusion (2 ampoules in 500-1000 ml infusion solution). This dose can be increased to 1 mg/kg body weight during 3 to 4 days. Treatment should be continued for 10-14 days depending on the tolerance of the patients and the dose should be gradually reduced before discontinuation of treatment.
Side effectsView
Transient hypotension, tachycardia may occur.
ContraindicationsView
Parenteral treatment- Severe ischaemic heart disease, severe rhythm disorders and pregnancy.
PrecautionsView
In the acute stage until the improvement of symptoms parenteral treatment is recommended followed by oral treatment. In chronic cases oral therapy should be applied.
InteractionsView
The injection is chemically incompatible with heparin, therefore, it should not be injected in the same syringe.
Pregnancy & lactationView
In Pregnancy and Lactation the drug is contraindicated.
StorageView
Store in a cool and dry place, protected from light and moisture.
Cero
Ciprofloxacin
Cero
Ciprofloxacin
Indications
Urinary tract infection
Indication detailsView
Ciprofloxacin is indicated for the treatment of Respiratory Tract Infections,Urinary tract infections, Pelvic Inflammatory Diseases, Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera), Typhoid fever, Intra-abdominal infections, Prostatitis, Skin and Soft Tissue Infections, Bone and Joint Infections, Gonorrhea, Neutropenic patients with fever due to bacterial infection, Meningitis, Surgical prophylaxis.
Therapeutic classView
4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs
PharmacologyView
Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.
DosageView
Tablet: Adult:
Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.
For IV infusion:
- Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
- Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
- Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
- Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
- Typhoid fever: 500 mg twice daily (7 days)
- Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
- Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
- Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
- Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
- Gonorrhea: 500 mg as a single dose
- Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
- Meningitis: 500 mg as a single dose.
- Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.
Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.
For IV infusion:
- Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
- Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
- Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
- Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
- Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
- Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
- Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
- Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.
AdministrationView
Instruction for the use of Ciprofloxacin IV infusion-
- Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
- Do not use if the solution is cloudy or a precipitate is present.
- Do not use flexible bags in series connections.
- Close flow control clamp of administration set.
- Remove cover from port at bottom of bag.
- Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
- Suspend bag from hanger.
- Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
- Open flow control clamp to expel air from set.Close clamp.
- Regulate rate of administration with flow control clamp
Side effectsView
Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.
ContraindicationsView
It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.
PrecautionsView
Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.
InteractionsView
Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.
Pediatric usageView
Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.
Overdose effectsView
Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.
StorageView
Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.
Cero
Ciprofloxacin (Ophthalmic)
Cero
Ciprofloxacin (Ophthalmic)
Indications
Superficial ophthalmic infections
Indication detailsView
Ciprofloxacin 0.3% Eye/Ear Drops is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
- Corneal Ulcers: Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae.
- Bacterial Conjunctivitis: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae. It is also indicated in the treatment of keratitis, kerato-conjunctivitis, blepharitis, blepharo-conjunctivitis, dacryocistitis, prophylaxis of ocular infections due to Neisseria gonorrhea or Chlamydia trachomatis, prevention of ocular infections after removal of a corneal or physical agent before or after ocular surgery.
- Ear: Otitis externa, acute otitis media, chronic suppurative otitis media. Prophylaxis in otic surgeries such as mastoid surgery.
Therapeutic classView
Aural Anti-bacterial preparations, Ophthalmic antibacterial drugs
PharmacologyView
Ciprofloxacin is a synthetic broad-spectrum antimicrobial agent for intravenous administration. The bactericidal action of Ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.
DosageView
Corneal ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first 6 hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill 2 drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelization has not been occurred.
Bacterial conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
Ear infections: For all infections, 2-3 drops every 2-3 hours initially, reducing the frequency of the instillation with control of infection. Treatment should be continued at least 7 days.
Bacterial conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
Ear infections: For all infections, 2-3 drops every 2-3 hours initially, reducing the frequency of the instillation with control of infection. Treatment should be continued at least 7 days.
Side effectsView
Local burning or discomfort, itching, foreign body sensation, crystalline precipitates, lid margin crusting, conjunctival hyperemia and a bad taste following administration. Photophobia and nausea may be reported.
ContraindicationsView
Hypersensitivity to quinolone group of antibacterials or any of the components of the formulation.
PrecautionsView
Prolonged ocular use of Ciprofloxacin may result in overgrowth of non-susceptible organisms, including fungi. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.
InteractionsView
Specific drug interaction studies have not been observed with ophthalmic Ciprofloxacin.
Pregnancy & lactationView
Do not use unless the potential benefits outweigh the potential risk during pregnancy. It is not known whether excretion in human milk occurs following topical ophthalmic administration. Caution should be exercised in the nursing mothers.
Pediatric usageView
Pediatric use: Safety and effectiveness in children under 1 year of age have not been established.
Overdose effectsView
A topical overdose may be flushed from the eye/s with warm tap water.
StorageView
Store below 30° C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.
Cero
Ciprofloxacin (Ophthalmic)
Cero
Ciprofloxacin (Ophthalmic)
Indications
Superficial ophthalmic infections
Indication detailsView
Ciprofloxacin 0.3% Eye/Ear Drops is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
- Corneal Ulcers: Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae.
- Bacterial Conjunctivitis: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae. It is also indicated in the treatment of keratitis, kerato-conjunctivitis, blepharitis, blepharo-conjunctivitis, dacryocistitis, prophylaxis of ocular infections due to Neisseria gonorrhea or Chlamydia trachomatis, prevention of ocular infections after removal of a corneal or physical agent before or after ocular surgery.
- Ear: Otitis externa, acute otitis media, chronic suppurative otitis media. Prophylaxis in otic surgeries such as mastoid surgery.
Therapeutic classView
Aural Anti-bacterial preparations, Ophthalmic antibacterial drugs
PharmacologyView
Ciprofloxacin is a synthetic broad-spectrum antimicrobial agent for intravenous administration. The bactericidal action of Ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.
DosageView
Corneal ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first 6 hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill 2 drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelization has not been occurred.
Bacterial conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
Ear infections: For all infections, 2-3 drops every 2-3 hours initially, reducing the frequency of the instillation with control of infection. Treatment should be continued at least 7 days.
Bacterial conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
Ear infections: For all infections, 2-3 drops every 2-3 hours initially, reducing the frequency of the instillation with control of infection. Treatment should be continued at least 7 days.
Side effectsView
Local burning or discomfort, itching, foreign body sensation, crystalline precipitates, lid margin crusting, conjunctival hyperemia and a bad taste following administration. Photophobia and nausea may be reported.
ContraindicationsView
Hypersensitivity to quinolone group of antibacterials or any of the components of the formulation.
PrecautionsView
Prolonged ocular use of Ciprofloxacin may result in overgrowth of non-susceptible organisms, including fungi. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.
InteractionsView
Specific drug interaction studies have not been observed with ophthalmic Ciprofloxacin.
Pregnancy & lactationView
Do not use unless the potential benefits outweigh the potential risk during pregnancy. It is not known whether excretion in human milk occurs following topical ophthalmic administration. Caution should be exercised in the nursing mothers.
Pediatric usageView
Pediatric use: Safety and effectiveness in children under 1 year of age have not been established.
Overdose effectsView
A topical overdose may be flushed from the eye/s with warm tap water.
StorageView
Store below 30° C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.
Cero-HC
Ciprofloxacin + Hydrocortisone Acetate
Cero-HC
Ciprofloxacin + Hydrocortisone Acetate
Indications
Steroid-responsive inflammatory ocular conditions
Indication detailsView
This is indicated in Steroid responsive inflammatory ocular conditions, Otitis media, Otitis externa, Ocular inflammation associated with infection, Post-operative inflammation of ear and eye, Corneal Ulcers, Bacterial Conjunctivitis
Therapeutic classView
Aural steroid & antibiotic combined preparations
PharmacologyView
Ciprofloxacin promotes breakage of double-stranded DNA in susceptible organisms and inhibits DNA gyrase, which is essential in reproduction of bacterial DNA.
Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
DosageView
Eye: Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcer is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Eye: Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
Ear: Four drops instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the suspension should be instilled. This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear.
Eye: Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.
Ear: Four drops instilled into the affected ear twice daily for seven days. The suspension should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness, which may result from the instillation of a cold suspension. The patient should lie with the affected ear upward, and then the suspension should be instilled. This position should be maintained for 60 seconds. Repeat, if necessary, for the opposite ear.
Side effectsView
The most frequently reported drug-related adverse reactions seen with Ciprofloxacin are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness and eye pain. Rare reports of dizziness have been received.
The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior sub-capsular cataract formation and delayed wound healing.
The reactions due to the steroid component are elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior sub-capsular cataract formation and delayed wound healing.
ContraindicationsView
Known hypersensitivity to any ingredient of the product. Herpes simplex and other viral conditions, mycosis, glaucoma, newborn babies, fungal diseases of ocular or auricular structures.
PrecautionsView
Prolonged use may result in overgrowth of nonsusceptible organisms including fungi; in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior sub capsular cataract formation. Patients wearing contact lenses must not use the drops during the time the lenses are worn.
InteractionsView
May increase plasma concentrations of CYP1A2 substrates (e.g. clozapine, ropinirole, theophylline). Enhances effect of oral anticoagulants (e.g. warfarin) and glibenclamide. Increased toxicity of methotrexate. Plasma concentrations may be increased by probenecid. Reduced absorption with oral multivitamins and mineral supplements containing divalent or trivalent cations (e.g. Fe, Zn, Ca) and antacids containing Al, Ca or Mg. Concomitant use with class IA antiarrhythmics (e.g. quinidine, procainamide), class III antiarrhythmics (e.g. amiodarone, sotalol), TCAs, macrolides and antipsychotics may result in additive effects on QT interval prolongation. Concurrent use with corticosteroids may increase risk of severe tendon disorders. Increased risk of CNS stimulation with NSAIDs. Altered serum concentrations of phenytoin.
Potentially Fatal: Marked elevation in serum levels of tizanidine which is associated with potentiated hypotensive and sedative effect.
Thiazides may enhance hyperglycaemia and hypokalaemia caused by corticosteroids. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents. Ethanol may enhance gastric mucosal irritation. Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Mutual inhibition of metabolism between ciclosporin and corticosteroids increase plasma cone of both drugs. Enhanced effect in women taking oestrogens or oral contraceptives.
Potentially Fatal: Marked elevation in serum levels of tizanidine which is associated with potentiated hypotensive and sedative effect.
Thiazides may enhance hyperglycaemia and hypokalaemia caused by corticosteroids. Increased incidence of peptic ulcer or Gl bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum cone of salicylates and antimuscarinic agents. Ethanol may enhance gastric mucosal irritation. Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Mutual inhibition of metabolism between ciclosporin and corticosteroids increase plasma cone of both drugs. Enhanced effect in women taking oestrogens or oral contraceptives.
Pregnancy & lactationView
Pregnancy Category C+D.Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Lactation: Excretion in breast milk unknown; not recommended.
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Lactation: Excretion in breast milk unknown; not recommended.
Pediatric usageView
Paediatric Use:
- Ear: Safety and effectiveness of this suspension in pediatric (6 months of age and older) patients for ear application have been established.
- Eye: Safety and effectiveness of this suspension in pediatric patients for eye application have not been established.
StorageView
Should be stored in cool and dry place.
Cerodex
Ciprofloxacin + Dexamethasone
Cerodex
Ciprofloxacin + Dexamethasone
Indications
Steroid-responsive inflammatory ocular conditions
Indication detailsView
Eye: This combination eye drop is indicated for the treatment of steroid responsive inflammatory ocular conditions where bacterial infections or risk of bacterial infections co-exist. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection.
Ear: It is indicated for the treatment of ear infections accompanied by inflammation such as otitis externa, otitis media and chronic suppurative otitis media etc. The combination can also be used for post-operative inflammation of ear.
Ear: It is indicated for the treatment of ear infections accompanied by inflammation such as otitis externa, otitis media and chronic suppurative otitis media etc. The combination can also be used for post-operative inflammation of ear.
Therapeutic classView
Aural steroid & antibiotic combined preparations
PharmacologyView
Dexamethasone is glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. It reduces prostaglandin synthesis by inhibiting the enzyme phospholipase A2. Also, Dexamethasone inhibits the chemotactic infiltration of neutrophils into the site of inflammation.
Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms, possessing the greatest antibacterial activity of all quinolones. The bactericidal action of Ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.
Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms, possessing the greatest antibacterial activity of all quinolones. The bactericidal action of Ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.
DosageView
For Eye: 1 drop to be instilled into conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every two hours.
For Ear:
For Ear:
- Acute otitis media in pediatric patients with typanastomy tube: 4 drops instilled into the affected ear 2 times daily for 7 days.
- Acute otitis externa: 4 drops instilled into the affected ear 2 times daily for 7 days.
Side effectsView
Frequently reported adverse reactions are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, photophobia, conjunctivitis/ keratitis, Periocular/ facial edema, foreign body sensation, blurred vision, tearing, dryness, and eye pain. Elevation of IOP with development of glaucoma, and delayed wound healing may rarely occur.
ContraindicationsView
Known hypersensitivity to any ingredient of the product. Herpes simplex and other viral conditions, mycosis, glaucoma, newborn babies, fungal diseases of ocular or auricular structures.
PrecautionsView
Prolonged use may result in overgrowth of nonsusceptible organisms including fungi; in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior sub capsular cataract formation. Patients wearing contact lenses must not use the drops during the time the lenses are worn.
InteractionsView
Specific drug interaction studies have not been conducted with ophthalmic Ciprofloxacin and Dexamethasone. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant warfarin and its derivatives and have been associated with transient elevations in serum creatinine in patients receiving cyclosporin concomitantly.
Pregnancy & lactationView
Use in pregnancy: This should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. It is also not known whether ciprofloxacin is excreted in human milk following topical administration. Because many drugs are excreted in human milk, caution should be exercised when the combination is administered to a nursing woman.
Use in lactation: It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. It is also not known whether ciprofloxacin is excreted in human milk following topical administration. Because many drugs are excreted in human milk, caution should be exercised when the combination is administered to a nursing woman.
Pediatric usageView
Use in children: Safety & effectiveness for the use of this eye drops in children below the age of one year have not been established.
StorageView
Store in a cool and dry place, away from light. Keep out of reach of children. Shake well before each use.
Cerox CV
Cefuroxime Axetil + Clavulanic Acid
Cerox CV
Cefuroxime Axetil + Clavulanic Acid
Indications
Urinary tract infection
Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
- Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
- Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
- Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli.
- Acute bacterial exacerbation of chronic bronchitis and secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
- Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
- Uncomplicated urinary tract infections caused by E.coli or Klebsiella pneumoniae.
- Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
- Uncomplicated Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
- Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
- Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Haemophilus influenzae (including ampicillin-resistant strains) & Klebsiella spp.
- Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis & Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
- Switch therapy (Injectable to oral)
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.
Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.
Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.
DosageView
Adolescents and adults (13 years and older)-
- Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
- Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
- Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
- Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
- Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
- Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
- Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
- Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
- MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
- Early Lyme disease: 500 mg b.i.d. for 20 days
- Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
- Acute otitis media: 30 mg/kg/day b.i.d for 10 days
- Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
- Impetigo: 30 mg/kg/day b.i.d for 10 days
AdministrationView
Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.
Side effectsView
Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.
ContraindicationsView
Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.
InteractionsView
Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.
Pregnancy & lactationView
While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.
StorageView
Store in a cool, dry place (below 30o C), away from light and moisture. Keep out of the reach of children.
Cerox CV
Cefuroxime Axetil + Clavulanic Acid
Cerox CV
Cefuroxime Axetil + Clavulanic Acid
Indications
Urinary tract infection
Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
- Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
- Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
- Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli.
- Acute bacterial exacerbation of chronic bronchitis and secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
- Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
- Uncomplicated urinary tract infections caused by E.coli or Klebsiella pneumoniae.
- Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
- Uncomplicated Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
- Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
- Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Haemophilus influenzae (including ampicillin-resistant strains) & Klebsiella spp.
- Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis & Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
- Switch therapy (Injectable to oral)
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.
Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.
Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.
DosageView
Adolescents and adults (13 years and older)-
- Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
- Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
- Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
- Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
- Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
- Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
- Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
- Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
- MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
- Early Lyme disease: 500 mg b.i.d. for 20 days
- Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
- Acute otitis media: 30 mg/kg/day b.i.d for 10 days
- Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
- Impetigo: 30 mg/kg/day b.i.d for 10 days
AdministrationView
Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.
Side effectsView
Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.
ContraindicationsView
Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.
InteractionsView
Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.
Pregnancy & lactationView
While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.
StorageView
Store in a cool, dry place (below 30o C), away from light and moisture. Keep out of the reach of children.
Cerox CV
Cefuroxime Axetil + Clavulanic Acid
Cerox CV
Cefuroxime Axetil + Clavulanic Acid
Indications
Urinary tract infection
Indication detailsView
It is indicated for the treatment of infections caused by sensitive bacteria.
- Pharyngitis/Tonsillitis caused by Streptococcus pyogenes.
- Acute Bacterial Otitis Media caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis (beta-lactamase producing strains) or Streptococcus pyogenes.
- Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non beta-lactamase producing strains)
- Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, E. coli.
- Acute bacterial exacerbation of chronic bronchitis and secondary bacterial infections of Acute bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (beta-lactamase negative strains) or Haemophilus parainfluenzae (beta-lactamase negative strains).
- Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes.
- Uncomplicated urinary tract infections caused by E.coli or Klebsiella pneumoniae.
- Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
- Uncomplicated Gonorrhoea caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae.
- Early Lyme Disease (erythema migrans) caused by Borrelia burgdorferi.
- Septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, E.coli, Haemophilus influenzae (including ampicillin-resistant strains) & Klebsiella spp.
- Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis & Staphylococcus aureus (penicillinase and non-penicillinase producing strains)
- Switch therapy (Injectable to oral)
Therapeutic classView
Second generation Cephalosporins
PharmacologyView
Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.
Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.
Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.
DosageView
Adolescents and adults (13 years and older)-
- Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
- Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
- Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
- Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days
- Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
- Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
- Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
- Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
- MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
- Early Lyme disease: 500 mg b.i.d. for 20 days
- Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
- Acute otitis media: 30 mg/kg/day b.i.d for 10 days
- Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
- Impetigo: 30 mg/kg/day b.i.d for 10 days
AdministrationView
Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.
Side effectsView
Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.
ContraindicationsView
Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.
PrecautionsView
Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.
InteractionsView
Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.
Pregnancy & lactationView
While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.
StorageView
Store in a cool, dry place (below 30o C), away from light and moisture. Keep out of the reach of children.