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Mefrad

Cephradine

Capsule 500 mg Allopathic First generation Cephalosporins

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.

The following microorganisms are susceptible, in vitro to Cephradine:

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:

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.

Children:

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

Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

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:

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.

Recommendations for patients on chronic, intermittent haemodialysis:

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.

Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

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

Mega Cef

Cephradine

Powder for Suspension 125 mg/5 ml Allopathic First generation Cephalosporins

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.

The following microorganisms are susceptible, in vitro to Cephradine:

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:

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.

Children:

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

Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

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:

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.

Recommendations for patients on chronic, intermittent haemodialysis:

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.

Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

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

Mega Cef

Cephradine

Capsule 500 mg Allopathic First generation Cephalosporins

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.

The following microorganisms are susceptible, in vitro to Cephradine:

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:

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.

Children:

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

Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

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:

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.

Recommendations for patients on chronic, intermittent haemodialysis:

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.

Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

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

Mega Flox

Sparfloxacin

Tablet 200 mg Allopathic 4-Quinolone preparations

Indications

Upper and lower respiratory tract infections

Indication detailsView

Sparfloxacin is indicated for the treatment of the following infections due to susceptible microorganisms:

Upper and lower respiratory tract infections including sinusitis, acute exacerbation of chronic bronchitis, community and hospital acquired pneumonia.
Urinary tract infections including gonococcal and non-gonococcal urethritis, chancroid and other sexually transmitted diseases.
Skin and soft tissue infections.
Prophylactic use in different urological and ophthalmic operations.

Therapeutic classView

4-Quinolone preparations

PharmacologyView

Sparfloxacin is a synthetic, broad-spectrum antibacterial agent from the difluoroquinolone family. It has been reported to be more active in vitro than ciprofloxacin against some organisms, including staphylococci and Mycobacteria, and has a much longer plasma half-life (16 hours).

Sparfloxacin inhibits the supercoiling activity of DNA gyrase which is an enzyme essential for DNA replication thus promoting the breakage of DNA structures. It has activity against S. pneumoniae, S. aureus, H. influenzae, K. pneumoniae, M. catarrhalis and Mycobacterium spp.

DosageView

In patients with normal renal function the recommended daily dose is two tablets of Sparfloxacin 200 mg on first day as a loading dose, thereafter take one tablet of Sparfloxacin 200 mg every 24 hours for a total of 10 days of therapy.

The recommended daily dose of Sparfloxacin in patients with renal impairment (Creatinine clearance < 30 ml/min) is two tablets of 200 mg taken on the first day as a loading dose. Thereafter, should be taken one tablet of 200 mg every 48 hours for total of 9 days of therapy.

AdministrationView

Sparfloxacin can be taken with or without food.

Side effectsView

Most of the adverse events were mild to moderate in severity and transient in nature. The most frequently reported events among the Sparfloxacin treated patients with the recommended dosage are: diarrhea, nausea, headache, dyspepsia, dizziness, insomnia, abdominal pain and QTc interval prolongation.

ContraindicationsView

Sparfloxacin is contraindicated for individuals with a history of hypersensifivity and in achilles tend in its following the use of fluoroquinolone and in pregnancy and lactation. Sparfloxacin is contraindicated in patients with known QTc prolongation or in patients being treated concomitantly with medications known to produce an increase in the QTc interval and/or torsade depointes.

PrecautionsView

It should be used with caution in renal diseases, gastric ulcers and with concomitant use of NSAIDs. In renal failure of third degree severity (creatinine clearance < 30 ml/min) dosage modification is recommended 400 mg on 1st day, 200 mg on 2nd and 3rd day followed by 200 mg every 48 hours. Because fluoroquinolones have been associated with tendon rupture, Sparfloxacin should be discontinued at the first sign of tendon pain. Exposure to UV radiation during treatment should be avoided.

InteractionsView

On concomitant use with Quinidine, Sotalol, Erythromycin, Astemizole, Terfenadine, vinca alkaloids there is increased risk of arrhythmia. Salts, oxides and hydroxides of Magnesium, Aluminium and Calcium decrease absorption of Sparfloxacin.

Pregnancy & lactationView

There are no adequate and well controlled studies in pregnant women. Sparfloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric usageView

Use in children: Safety and effectiveness have not been established in patients below the age of 18 years.

StorageView

Store at temperature below 30° C.

Mega-C

Vitamin C [Ascorbic acid]

Injection 500 mg/5 ml Allopathic Vitamin-C Preparations

Indications

Vitamin C deficiency

Indication detailsView

Vitamin C is indicated for prevention and treatment of scurvy. It may be indicated in pregnancy, lactation, infection, trauma, burns, cold exposure, following surgery, fever, stress, peptic ulcer, cancer, methaemoglobinaemia and in infants receiving unfortified formulas. It is also prescribed for haematuria, dental caries, pyorrhea, acne, infertility, atherosclerosis, fractures, leg ulcers, hay fever, vascular thrombosis prevention, levodopa toxicity, succinyl-choline toxicity, arsenic toxicity etc. To reduce the risk of stroke in the elderly, long-term supplementation with Vitamin C is essential.

Therapeutic classView

Vitamin-C Preparations

PharmacologyView

vitamin C, the water-soluble vitamin, is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues. It is believed to be involved in biological oxidations and reductions used in cellular respiration. It is essential for the synthesis of collagen and intracellular material. Vitamin C deficiency develops when the dietary intake is inadequate and when increased demand is not fulfilled. Deficiency leads to the development of well defined syndrome known as scurvy, which is characterized by capillary fragility, bleeding (especially from small blood vessels and the gums), anaemia, cartilage and bone lesions and slow healing of wounds.

DosageView

Oral administration-

For the prevention of scurvy: 1 tablet daily
For the treatment of scurvy: 1-2 tablets daily; but dose may be increased depending on the severity of the condition.
For the reduction of risk of stroke in the elderly: 1-2 tablets daily.
In other cases: 1 tablet daily or as directed by the physician.
Maximum safe dose is 2000 mg daily in divided doses.

Parenteral administration-

Vitamin C is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered IM, IV, or subcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM administration and that is the preferred parenteral route.
For intravenous injection, dilution into a large volume parenteral such as Normal Saline, Water for Injection, or Glucose is recommended to minimize the adverse reactions associated with intravenous injection.
The average protective dose of vitamin C for adults is 70 to 150 mg daily. In the presence of scurvy, doses of 300 mg to 1 g daily are recommended. However, as much as 6 g has been administered parenterally to normal adults without evidence of toxicity.
To enhance wound healing, doses of 300 to 500 mg daily for a week or ten days both preoperatively and postoperatively are generally considered adequate, although considerably larger amounts have been recommended. In the treatment of burns, doses are governed by the extent of tissue injury. For severe burns, daily doses of 1 to 2 g are recommended. In other conditions in which the need for vitamin C is increased, three to five times the daily optimum allowances appear to be adequate.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

Side effectsView

Vitamin C has little toxicity and only mega-doses of vitamin C may cause diarrhoea, abdominal bloating, iron over-absorption that is harmful in patients with thalassaemia, sideroblastic anemia, and haemochromatosis; hyperoxaluria, hyperuricosuria, and hemolysis in patients with glucose-6 phosphate dehydrogenase deficiency. A pregnant woman taking more than 5 gm/day may suffer fetal abortion.

PrecautionsView

Ingestion of megadose (more than 1000 mg daily) of vitamin C during pregnancy has resulted in scurvy in neonates. Vitamin C in mega-doses has been contraindicated for patients with hyperoxaluria. Vitamin C itself is a reactive substance in the redox system and can give rise to false positive reactions in certain analytical tests for glucose, uric acid, creatine and occult blood.

InteractionsView

Potentially hazardous interactions: Ascorbic acid is incompatible in solution with aminophylline, bleomycin, erythromycin, lactobionate, nafcillin, nitrofurantoin sodium, conjugated oestrogen, sodium bicarbonate, sulphafurazole diethanolamine, chloramphenicol sodium succinate, chlorthiazide sodium and hydrocortisone sodium succinate.

Useful interactions: Ascorbic acid increases the apparent half-life of paracetamol and enhances iron absorption from the gastrointestinal tract.

Pregnancy & lactationView

The drug is safe in normal doses in pregnant women, but a daily intake of 5 gm or more is reported to have caused abortion. The drug may be taken safely during lactation.

StorageView

Should be stored in a dry place below 30˚C.

Mega-C

Vitamin C [Ascorbic acid]

Chewable Tablet 250 mg Allopathic Vitamin-C Preparations

Indications

Vitamin C deficiency

Indication detailsView

Vitamin C is indicated for prevention and treatment of scurvy. It may be indicated in pregnancy, lactation, infection, trauma, burns, cold exposure, following surgery, fever, stress, peptic ulcer, cancer, methaemoglobinaemia and in infants receiving unfortified formulas. It is also prescribed for haematuria, dental caries, pyorrhea, acne, infertility, atherosclerosis, fractures, leg ulcers, hay fever, vascular thrombosis prevention, levodopa toxicity, succinyl-choline toxicity, arsenic toxicity etc. To reduce the risk of stroke in the elderly, long-term supplementation with Vitamin C is essential.

Therapeutic classView

Vitamin-C Preparations

PharmacologyView

vitamin C, the water-soluble vitamin, is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues. It is believed to be involved in biological oxidations and reductions used in cellular respiration. It is essential for the synthesis of collagen and intracellular material. Vitamin C deficiency develops when the dietary intake is inadequate and when increased demand is not fulfilled. Deficiency leads to the development of well defined syndrome known as scurvy, which is characterized by capillary fragility, bleeding (especially from small blood vessels and the gums), anaemia, cartilage and bone lesions and slow healing of wounds.

DosageView

Oral administration-

For the prevention of scurvy: 1 tablet daily
For the treatment of scurvy: 1-2 tablets daily; but dose may be increased depending on the severity of the condition.
For the reduction of risk of stroke in the elderly: 1-2 tablets daily.
In other cases: 1 tablet daily or as directed by the physician.
Maximum safe dose is 2000 mg daily in divided doses.

Parenteral administration-

Vitamin C is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered IM, IV, or subcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM administration and that is the preferred parenteral route.
For intravenous injection, dilution into a large volume parenteral such as Normal Saline, Water for Injection, or Glucose is recommended to minimize the adverse reactions associated with intravenous injection.
The average protective dose of vitamin C for adults is 70 to 150 mg daily. In the presence of scurvy, doses of 300 mg to 1 g daily are recommended. However, as much as 6 g has been administered parenterally to normal adults without evidence of toxicity.
To enhance wound healing, doses of 300 to 500 mg daily for a week or ten days both preoperatively and postoperatively are generally considered adequate, although considerably larger amounts have been recommended. In the treatment of burns, doses are governed by the extent of tissue injury. For severe burns, daily doses of 1 to 2 g are recommended. In other conditions in which the need for vitamin C is increased, three to five times the daily optimum allowances appear to be adequate.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

Side effectsView

Vitamin C has little toxicity and only mega-doses of vitamin C may cause diarrhoea, abdominal bloating, iron over-absorption that is harmful in patients with thalassaemia, sideroblastic anemia, and haemochromatosis; hyperoxaluria, hyperuricosuria, and hemolysis in patients with glucose-6 phosphate dehydrogenase deficiency. A pregnant woman taking more than 5 gm/day may suffer fetal abortion.

PrecautionsView

Ingestion of megadose (more than 1000 mg daily) of vitamin C during pregnancy has resulted in scurvy in neonates. Vitamin C in mega-doses has been contraindicated for patients with hyperoxaluria. Vitamin C itself is a reactive substance in the redox system and can give rise to false positive reactions in certain analytical tests for glucose, uric acid, creatine and occult blood.

InteractionsView

Potentially hazardous interactions: Ascorbic acid is incompatible in solution with aminophylline, bleomycin, erythromycin, lactobionate, nafcillin, nitrofurantoin sodium, conjugated oestrogen, sodium bicarbonate, sulphafurazole diethanolamine, chloramphenicol sodium succinate, chlorthiazide sodium and hydrocortisone sodium succinate.

Useful interactions: Ascorbic acid increases the apparent half-life of paracetamol and enhances iron absorption from the gastrointestinal tract.

Pregnancy & lactationView

The drug is safe in normal doses in pregnant women, but a daily intake of 5 gm or more is reported to have caused abortion. The drug may be taken safely during lactation.

StorageView

Should be stored in a dry place below 30˚C.

Megabac

Colistimethate Sodium

IM/IV Injection 2 MIU Allopathic Other antibacterial preparation

Indications

Bacterial infections

Indication detailsView

Colistimethate is indicated for the treatment of acute or chronic infections caused by sensitive strains of certain gram-negative bacilli. It is particularly indicated in the infection caused by sensitive strains of Pseudomonas aeruginosa. Colistimethate is not indicated for infections due to Proteus or Neisseria. Colistimethate is very effective in the treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.

Therapeutic classView

Other antibacterial preparation

PharmacologyView

Colistimethate is a surface active agent which penetrates into and disrupts the bacterial cell membrane. Colistimethate is polycationic and has both hydrophobic and lipophilic moieties. It interacts with the bacterial cytoplasmic membrane, changing its permeability. This effect is bactericidal. There is also evidence that polymyxins enter the cell and precipitate cytoplasmic components, primarily ribosomes.

DosageView

Maintenance dose: 9 MIU/day in 2-3 divided doses. In patients who are critically ill, a loading dose of 9 MIU should be administered.

Renal impairment patients: Dose adjustments in renal impairment patients are necessary. Dose reductions are recommended for patients with creatinine clearance < 50 ml/min. Twice daily dosing is recommended.

Creatinine clearance <50-30 ml/min: daily dose 5.5-7.5 MIU
Creatinine clearance <30-10 ml/min: daily dose 4.5-5.5 MIU
Creatinine clearance <10 ml/min: daily dose 3.5 MIU

Haemodialysis (HD) patients:

No-HD days: 2.25 MIU/day (2.2-2.3 MIU/day).
HD days: 3 MIU/day (Should be given after the HD session) Twice daily dosing is recommended.

Pediatric population: The dose should be based on lean body weight.

Children ≤40 kg: 75,000-150,000 IU/kg/day divided into 3 doses.
Children >40 kg: >150,000 IU/kg/day has been reported in children with cystic fibrosis.

Hepatic impairment patients: There are no data in patients with hepatic impairment. Caution is advised when administering colistimethate sodium in these patients.

AdministrationView

Direct Intermittent Administration- Slowly inject one-half of the total daily dose over a period of 3 to 5 minutes every 12 hours.

Continuous Infusion- Slowly inject one-half of the total daily dose over 3 to 5 minutes. Add the remaining half of the total daily dose of Colistimethate for injection to one of the following:

0.9% NaCl
5% dextrose in 0.9% NaCl
5% dextrose in water
5% dextrose in 0.45% NaCl
5% dextrose in 0.225% NaCl
Lactated Ringer's solution

There are not sufficient data to recommend usage of Colistimethate for injection with other drugs or other than the above listed infusion solutions. Administer the second half of the total daily dose by slow intravenous infusion, starting 1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the presence of impaired renal function, reduce the infusion rate depending on the degree of renal impairment. The choice of intravenous solution and the volume to be employed are dictated by the requirements of fluid and electrolyte management. Any infusion solution containing Colistimethate sodium should be freshly prepared and used for no longer than 24 hours.

Alternative method- As per specialized references for intermittent infusion: Prescribed dose can be diluted in 50-100 ml 0.9% NaCl and administer over 30-60 minutes in IV route.

Side effectsView

The following adverse reactions have been reported: gastrointestinal upset, tingling of extremities and tongue, slurred speech, dizziness, vertigo and paresthesia, generalized itching, urticaria and rash, fever, increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance, respiratory distress and apnea, nephrotoxicity and decreased urine output.

ContraindicationsView

The use of Colistimethate Sodium Parenteral is contraindicated for patients with a history of sensitivity to the drug or any of its components.

PrecautionsView

Colistimethate should be used with caution in patient with impaired renal function. When actual renal impairment is present, Colistimethate may be used, but the greatest caution should be exercised and the dosage should be reduced in proportion to the extent of the impairment. Colistimethate should be used with caution in neonates, infants and children.

InteractionsView

Colistimethate should not be given with certain antibiotics like- aminoglycosides and polymyxin due to report of interfere with the nerve transmission at the neuromuscular junction. It should not be given with muscle relaxants e.g., tubocurarine and other drugs including ether, succinylcholine, gallamine, decamethonium and sodium citrate. The concomitant use of Sodium Cephalothin and Colistimethate should be avoided.

Pregnancy & lactationView

There are no adequate and well-controlled studies about the use of Colistimethate in pregnant women. Since colistimethate is transferred across the placental barrier in humans, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Colistimethate is excreted in human breast milk. Therefore, caution should be exercised when administered to nursing women.

Overdose effectsView

Overdosage with colistimethate sodium can cause neuromuscular blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, disorders of speech and apnea. Respiratory muscle paralysis may lead to apnea, respiratory arrest and death. Overdosage with the drug can also cause acute renal failure, manifested as decreased urine output and increases in serum concentrations of B.U.N and creatinine. As in any case of overdose, Colistimethate Sodium therapy should be discontinued and general supportive measures should be utilized.

ReconstitutionView

For IM injection: Reconstitute the contents of the vial with 2 ml water for injection only.
For bolus injection: Reconstitute the contents of the vial with 5 ml water for injection.
For infusion: The contents of the reconstituted vial may be diluted, usually with 50 ml-100ml 0.9% sodium chloride.

StorageView

Before reconstitution: Store below 30°C. After reconstitution: Store at 2°C to 8°C (Do not freeze) and use within 24 hours.

Megabac

Colistimethate Sodium

IM/IV Injection 1 MIU Allopathic Other antibacterial preparation

Indications

Bacterial infections

Indication detailsView

Colistimethate is indicated for the treatment of acute or chronic infections caused by sensitive strains of certain gram-negative bacilli. It is particularly indicated in the infection caused by sensitive strains of Pseudomonas aeruginosa. Colistimethate is not indicated for infections due to Proteus or Neisseria. Colistimethate is very effective in the treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.

Therapeutic classView

Other antibacterial preparation

PharmacologyView

Colistimethate is a surface active agent which penetrates into and disrupts the bacterial cell membrane. Colistimethate is polycationic and has both hydrophobic and lipophilic moieties. It interacts with the bacterial cytoplasmic membrane, changing its permeability. This effect is bactericidal. There is also evidence that polymyxins enter the cell and precipitate cytoplasmic components, primarily ribosomes.

DosageView

Maintenance dose: 9 MIU/day in 2-3 divided doses. In patients who are critically ill, a loading dose of 9 MIU should be administered.

Renal impairment patients: Dose adjustments in renal impairment patients are necessary. Dose reductions are recommended for patients with creatinine clearance < 50 ml/min. Twice daily dosing is recommended.

Creatinine clearance <50-30 ml/min: daily dose 5.5-7.5 MIU
Creatinine clearance <30-10 ml/min: daily dose 4.5-5.5 MIU
Creatinine clearance <10 ml/min: daily dose 3.5 MIU

Haemodialysis (HD) patients:

No-HD days: 2.25 MIU/day (2.2-2.3 MIU/day).
HD days: 3 MIU/day (Should be given after the HD session) Twice daily dosing is recommended.

Pediatric population: The dose should be based on lean body weight.

Children ≤40 kg: 75,000-150,000 IU/kg/day divided into 3 doses.
Children >40 kg: >150,000 IU/kg/day has been reported in children with cystic fibrosis.

Hepatic impairment patients: There are no data in patients with hepatic impairment. Caution is advised when administering colistimethate sodium in these patients.

AdministrationView

Direct Intermittent Administration- Slowly inject one-half of the total daily dose over a period of 3 to 5 minutes every 12 hours.

Continuous Infusion- Slowly inject one-half of the total daily dose over 3 to 5 minutes. Add the remaining half of the total daily dose of Colistimethate for injection to one of the following:

0.9% NaCl
5% dextrose in 0.9% NaCl
5% dextrose in water
5% dextrose in 0.45% NaCl
5% dextrose in 0.225% NaCl
Lactated Ringer's solution

There are not sufficient data to recommend usage of Colistimethate for injection with other drugs or other than the above listed infusion solutions. Administer the second half of the total daily dose by slow intravenous infusion, starting 1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the presence of impaired renal function, reduce the infusion rate depending on the degree of renal impairment. The choice of intravenous solution and the volume to be employed are dictated by the requirements of fluid and electrolyte management. Any infusion solution containing Colistimethate sodium should be freshly prepared and used for no longer than 24 hours.

Alternative method- As per specialized references for intermittent infusion: Prescribed dose can be diluted in 50-100 ml 0.9% NaCl and administer over 30-60 minutes in IV route.

Side effectsView

The following adverse reactions have been reported: gastrointestinal upset, tingling of extremities and tongue, slurred speech, dizziness, vertigo and paresthesia, generalized itching, urticaria and rash, fever, increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance, respiratory distress and apnea, nephrotoxicity and decreased urine output.

ContraindicationsView

The use of Colistimethate Sodium Parenteral is contraindicated for patients with a history of sensitivity to the drug or any of its components.

PrecautionsView

Colistimethate should be used with caution in patient with impaired renal function. When actual renal impairment is present, Colistimethate may be used, but the greatest caution should be exercised and the dosage should be reduced in proportion to the extent of the impairment. Colistimethate should be used with caution in neonates, infants and children.

InteractionsView

Colistimethate should not be given with certain antibiotics like- aminoglycosides and polymyxin due to report of interfere with the nerve transmission at the neuromuscular junction. It should not be given with muscle relaxants e.g., tubocurarine and other drugs including ether, succinylcholine, gallamine, decamethonium and sodium citrate. The concomitant use of Sodium Cephalothin and Colistimethate should be avoided.

Pregnancy & lactationView

There are no adequate and well-controlled studies about the use of Colistimethate in pregnant women. Since colistimethate is transferred across the placental barrier in humans, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Colistimethate is excreted in human breast milk. Therefore, caution should be exercised when administered to nursing women.

Overdose effectsView

Overdosage with colistimethate sodium can cause neuromuscular blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, disorders of speech and apnea. Respiratory muscle paralysis may lead to apnea, respiratory arrest and death. Overdosage with the drug can also cause acute renal failure, manifested as decreased urine output and increases in serum concentrations of B.U.N and creatinine. As in any case of overdose, Colistimethate Sodium therapy should be discontinued and general supportive measures should be utilized.

ReconstitutionView

For IM injection: Reconstitute the contents of the vial with 2 ml water for injection only.
For bolus injection: Reconstitute the contents of the vial with 5 ml water for injection.
For infusion: The contents of the reconstituted vial may be diluted, usually with 50 ml-100ml 0.9% sodium chloride.

StorageView

Before reconstitution: Store below 30°C. After reconstitution: Store at 2°C to 8°C (Do not freeze) and use within 24 hours.

Megabac

Colistimethate Sodium

IM/IV Injection 3 MIU Allopathic Other antibacterial preparation

Indications

Bacterial infections

Indication detailsView

Colistimethate is indicated for the treatment of acute or chronic infections caused by sensitive strains of certain gram-negative bacilli. It is particularly indicated in the infection caused by sensitive strains of Pseudomonas aeruginosa. Colistimethate is not indicated for infections due to Proteus or Neisseria. Colistimethate is very effective in the treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.

Therapeutic classView

Other antibacterial preparation

PharmacologyView

Colistimethate is a surface active agent which penetrates into and disrupts the bacterial cell membrane. Colistimethate is polycationic and has both hydrophobic and lipophilic moieties. It interacts with the bacterial cytoplasmic membrane, changing its permeability. This effect is bactericidal. There is also evidence that polymyxins enter the cell and precipitate cytoplasmic components, primarily ribosomes.

DosageView

Maintenance dose: 9 MIU/day in 2-3 divided doses. In patients who are critically ill, a loading dose of 9 MIU should be administered.

Renal impairment patients: Dose adjustments in renal impairment patients are necessary. Dose reductions are recommended for patients with creatinine clearance < 50 ml/min. Twice daily dosing is recommended.

Creatinine clearance <50-30 ml/min: daily dose 5.5-7.5 MIU
Creatinine clearance <30-10 ml/min: daily dose 4.5-5.5 MIU
Creatinine clearance <10 ml/min: daily dose 3.5 MIU

Haemodialysis (HD) patients:

No-HD days: 2.25 MIU/day (2.2-2.3 MIU/day).
HD days: 3 MIU/day (Should be given after the HD session) Twice daily dosing is recommended.

Pediatric population: The dose should be based on lean body weight.

Children ≤40 kg: 75,000-150,000 IU/kg/day divided into 3 doses.
Children >40 kg: >150,000 IU/kg/day has been reported in children with cystic fibrosis.

Hepatic impairment patients: There are no data in patients with hepatic impairment. Caution is advised when administering colistimethate sodium in these patients.

AdministrationView

Direct Intermittent Administration- Slowly inject one-half of the total daily dose over a period of 3 to 5 minutes every 12 hours.

Continuous Infusion- Slowly inject one-half of the total daily dose over 3 to 5 minutes. Add the remaining half of the total daily dose of Colistimethate for injection to one of the following:

0.9% NaCl
5% dextrose in 0.9% NaCl
5% dextrose in water
5% dextrose in 0.45% NaCl
5% dextrose in 0.225% NaCl
Lactated Ringer's solution

There are not sufficient data to recommend usage of Colistimethate for injection with other drugs or other than the above listed infusion solutions. Administer the second half of the total daily dose by slow intravenous infusion, starting 1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the presence of impaired renal function, reduce the infusion rate depending on the degree of renal impairment. The choice of intravenous solution and the volume to be employed are dictated by the requirements of fluid and electrolyte management. Any infusion solution containing Colistimethate sodium should be freshly prepared and used for no longer than 24 hours.

Alternative method- As per specialized references for intermittent infusion: Prescribed dose can be diluted in 50-100 ml 0.9% NaCl and administer over 30-60 minutes in IV route.

Side effectsView

The following adverse reactions have been reported: gastrointestinal upset, tingling of extremities and tongue, slurred speech, dizziness, vertigo and paresthesia, generalized itching, urticaria and rash, fever, increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance, respiratory distress and apnea, nephrotoxicity and decreased urine output.

ContraindicationsView

The use of Colistimethate Sodium Parenteral is contraindicated for patients with a history of sensitivity to the drug or any of its components.

PrecautionsView

Colistimethate should be used with caution in patient with impaired renal function. When actual renal impairment is present, Colistimethate may be used, but the greatest caution should be exercised and the dosage should be reduced in proportion to the extent of the impairment. Colistimethate should be used with caution in neonates, infants and children.

InteractionsView

Colistimethate should not be given with certain antibiotics like- aminoglycosides and polymyxin due to report of interfere with the nerve transmission at the neuromuscular junction. It should not be given with muscle relaxants e.g., tubocurarine and other drugs including ether, succinylcholine, gallamine, decamethonium and sodium citrate. The concomitant use of Sodium Cephalothin and Colistimethate should be avoided.

Pregnancy & lactationView

There are no adequate and well-controlled studies about the use of Colistimethate in pregnant women. Since colistimethate is transferred across the placental barrier in humans, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Colistimethate is excreted in human breast milk. Therefore, caution should be exercised when administered to nursing women.

Overdose effectsView

Overdosage with colistimethate sodium can cause neuromuscular blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, disorders of speech and apnea. Respiratory muscle paralysis may lead to apnea, respiratory arrest and death. Overdosage with the drug can also cause acute renal failure, manifested as decreased urine output and increases in serum concentrations of B.U.N and creatinine. As in any case of overdose, Colistimethate Sodium therapy should be discontinued and general supportive measures should be utilized.

ReconstitutionView

For IM injection: Reconstitute the contents of the vial with 2 ml water for injection only.
For bolus injection: Reconstitute the contents of the vial with 5 ml water for injection.
For infusion: The contents of the reconstituted vial may be diluted, usually with 50 ml-100ml 0.9% sodium chloride.

StorageView

Before reconstitution: Store below 30°C. After reconstitution: Store at 2°C to 8°C (Do not freeze) and use within 24 hours.

Megacilin

Piperacillin + Tazobactam

IV Infusion (4 gm+0.5 gm)/vial Allopathic Other beta-lactam Antibiotics

Indications

Skin and skin sructure infections

Indication detailsView

Piperacillin and tazobactam is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below.

Intra-abdominal Infections: Appendicitis (complicated by rupture or abscess) and peritonitis caused by β-lactamase producing isolates of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilis, B. ovatus, B. thetaiotaomicron, or B. vulgatus.

Skin and Skin Structure Infections: Uncomplicated and complicated skin and skin structure infections, including Cellulites, cutaneous abscesses and ischemic/diabetic foot infections caused by β-lactamase producing isolates of Staphylococcus aureus.

Female Pelvic Infections: Postpartum endometritis or pelvic inflammatory disease caused by β-lactamase producing isolates of Escherichia coli.

Community-acquired pneumonia: Community-acquired pneumonia (moderate severity only) caused by β lactamase producing isolates of Haemophilus influenzae.

Nosocomial pneumonia: Nosocomial pneumonia (moderate to severe) caused by β-lactamase producing isolates of Staphylococcus aureus and by piperacillin/tazobactam-susceptible Acinetobacter baumanii, Haemophilus influenzae, Klebsiella pneumoniae, and Pseudomonas aeruginosa (Nosocomial pneumonia caused by P. aeruginosa should be treated in combination with an aminoglycoside).

Therapeutic classView

Broad spectrum penicillins, Other beta-lactam Antibiotics

PharmacologyView

Piperacillin, a broad spectrum, semi-synthetic penicillin active against many gram-positive and gram-negative aerobic and anaerobic bacteria, exerts bactericidal activity by inhibition of both septum and cell wall synthesis. Tazobactam is a potent inhibitor of many beta-lactamases, including the plasmid and chromosomally mediated enzymes that commonly cause resistance to penicillins. Tazobactam enhances and extends the antibiotic spectrum of Piperacillin to include many beta-lactamase-producing bacteria normally resistant to it. Thus, this infusion combines the properties of a broad-spectrum antibiotic and a beta-lactamase inhibitor.

DosageView

Piperacillin and tazobactam should be administered by intravenous infusion over 30 minutes.

Adult Patients: The usual total daily dose of Piperacillin and tazobactam for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of treatment is from 7 to 10 days.

Nosocomial Pneumonia: Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin/2.0 g tazobactam). The recommended duration of the treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeroginosa is isolated.

Pediatric Patients: For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended piperacillin and tazobactam dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended dosage based on Pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. It has not been determined how to adjust piperacillin and tazobactam dosage in pediatric patients with renal impairment.

Side effectsView

Adverse events primarily involving the skin, including rash, pruritus and Purpura; the gastrointestinal system including diarrhea, Constipation, nausea, vomiting, Dyspepsia and Abdominal Pain; General disorders and administration site conditions including Fever, Injection site reaction (≤1%) and Rigors. (≤1%), Immune hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock) (≤1%), Infections-Candidiasis and Pseudomembranous colitis (≤1%), Metabolism and nutrition disorders- Hypoglycemia (≤1%), Musculoskeletal and connective tissue disorders- Myalgia and Arthralgia (≤1%), Psychiatric disorders Insomnia, Vascular disorders- Phlebitis Thrombophlebitis(≤1%), Hypotension(≤1%), Flushing(≤1%), Respiratory, thoracic and mediastinal disorders- Epistaxis (≤1%).

ContraindicationsView

Piperacillin and tazobactam is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or β -lactamase inhibitors.

PrecautionsView

Serious hypersensitivity reactions (anaphylactic/anaphylactoid) reactions have been reported in patients receiving Piperacillin and tazobactam. Discontinue Piperacillin and tazobactam if a reaction occurs.

Piperacillin and tazobactam may cause severe cutaneous adverse reactions, such as Stevens- Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. Discontinue Piperacillin and tazobactam for progressive rashes.

Hematological effects (including bleeding, leukopenia and neutropenia) have occurred. Monitor hematologic tests during prolonged therapy.

Nephrotoxicity in critically ill patients has been observed; the use of Piperacillin and tazobactam was found to be an independent risk factor for renal failure and was associated with delayed recovery of renal function as compared to other beta-lactam antibacterial drugs in a randomized, multicenter, controlled trial in critically ill patients. Based on this study, alternative treatment options should be considered in the critically ill population. If alternative treatment options are inadequate or unavailable, monitor renal function during treatment with Piperacillin and tazobactam.

Clostridium difficile associated diarrhea: Evaluate patients if diarrhea occurs.

InteractionsView

Aminoglycosides: Piperacillin may inactivate aminoglycosides by converting them to microbiologically inert amides. When aminoglycosides are administered in conjunction with piperacillin to patients with end-stage renal disease requiring hemodialysis, the concentrations of the aminoglycosides (especially tobramycin) may be significantly reduced and should be monitored.

Sequential administration of pipercillin and tazobactam and tobramycin to patients with either normal renal function or mild to moderate renal impairment has been shown to modestly decrease serum concentrations of tobramycin but no dosage adjustment is considered necessary.

Probenecid: Probenecid administered concomitantly with piperacillin and tazobactam prolongs the half-life of piperacillin by 21% and that of tazobactam by 71% because probenecid inhibits tubular renal secretion of both piperacillin and tazobactam. Probenecid should not be co-administered with Pipercillin and tazobactam unless the benefit outweighs the risk.

Anticoagulants: Coagulation parameters should be tested more frequently and monitored regularly during simultaneous administration of high doses of heparin, oral anticoagulants, or other drugs that may affect the blood coagulation system or the thrombocyte function.

Vecuronium: Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vacuronium, piperacillin and tazobactam could produce the same phenomenon if given along with vecuronium. Due to their similar mechanism of action, it is expected that the neuromuscular blockade produced by any of the non-depolarizing muscle relaxants could be prolonged in the presence of piperacillin.

Methotrexate: Limited data suggests that co-administration of methotrexate and piperacillin may reduce the clearance of methotrexate due to competition for renal secretion. The impact of tazobactam on the elimination of methotrexate has not been evaluated. If concurrent therapy is necessary, serum concentrations of methotrexate as well as the signs and symptoms of methotrexate toxicity should be frequently monitored.

Pregnancy & lactationView

Piperacillin and tazobactam cross the placenta in humans. However, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. No information is available on the effects of piperacillin and tazobactam on the breastfed child or on milk production.

Pediatric usageView

Pediatric Use: Use of Piperacillin and tazobactam in pediatric patients 2 months of age or older with appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. It has not been determined how to adjust Piperacillin and tazobactam dosage in pediatric patients with renal impairment.

Geriatric Use: Patients over 65 years are not at an increased risk of developing adverse effects solely because of age. However, dosage should be adjusted in the presence of renal impairment. This may be clinically important with regard to such diseases as congestive heart failure.

Renal Impairment: In patients with creatinine clearance ≤40 mL/min and dialysis patients (hemodialysis and CAPD), the intravenous dose of Piperacillin and tazobactam should be reduced to the degree of renal function impairment.

Hepatic Impairment: Dosage adjustment of Piperacillin and tazobactam is not warranted in patients with hepatic cirrhosis.

Patients with Cystic Fibrosis: As with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients

Overdose effectsView

There have been post marketing reports of overdose with piperacillin/tazobactam. The majority of those events experienced, including nausea, vomiting, and diarrhea, have also been reported with the usual recommended dosages. Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure). Treatment should be supportive and symptomatic according the patient's clinical presentation.

ReconstitutionView

Administration by intravenous infusion should be continued over 30 minutes. Withdraw 20 ml diluent (0.9% w/v Sodium Chloride solution) by the disposable syringe and push into the vial containing Piperacillin and Tazobactam powder. Mix to become the vial contents a complete solution. Withdraw the total solution by the syringe and push into the bottle of 0.9% w/v Sodium Chloride solution. Vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20°C to 25°C) or after 48 hours if stored at refrigerated temperature (20°C to 80°C). Vials should not be frozen after reconstitution. Prior to reconstitution, store piperacillin and tazobactam powder for intravenous infusion at controlled room temperature 20°-25° C. Protect from light and keep out of children's reach.

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Megadox

Doxycycline Hydrochloride

Capsule 100 mg Allopathic Tetracycline group of drugs

Indications

Uncomplicated gonorrhoea

Indication detailsView

Doxycycline Hydrochloride is indicated in the following infections caused by susceptible microorganisms:

Respiratory tract infections: Pneumonia, influenza, sinusitis, bronchitis, tonsillitis, tracheitis.
Gastrointestinal tract infections: Cholera, traveler's diarrhea, shigella dysentery, acute intestinal amebiasis.
Chlamydial infections: Lympho-granuloma venereum, psittacosis, trachoma.
Sexually transmitted diseases: Non gonococcal urethritis, acute pelvic inflammatory disease, uncomplicated urethral and endocervical or rectal infections, gonorrhoea, syphilis, pyelonephritis, cystitis.
Other infections: Impetigo, furunculosis, inclusion conjunctivitis, brucellosis, tularemia, cellulitis, acne and Q-fever.

Therapeutic classView

Tetracycline group of drugs

PharmacologyView

Doxycycline Hydrochloride is a semisynthetic tetracycline antibiotic with broad spectrum activity. It is primarily a bacteriostatic antibiotic. It has a similar spectrum of activity to other tetracyclines but in particular is more active against Staphylococcus aureus and Nocardia. The drug is often active against penicillin-resistant strains of Staphylococcus aureus and against strains of those organisms that are resistant to other Tetracyclines. Certain Gram-negative strains of E. coli, Proteus mirabilis and Klebsiella, which are often resistant to Tetracycline, may be sensitive to Doxycycline. In addition, 70-90% of the various anaerobes are sensitive to Doxycycline and Bacteroides fragilis is more likely to be sensitive to Doxycycline than to other tetracyclines.

Doxycycline is active against most strains of Haemophilus influenzaeand is particularly useful for infections with H. ducreyi, Actinomyces, Brucella and Vibrio cholerae. It is also active against Nocardia, Chlamydia, Mycoplasma and a wide range of Rickettsiae. Doxycycline is active against spirochetes such as Borellia recurrentis, Treponema pallidum and Treponema pertenue. It is also active against Plasmodium falciparum.

DosageView

Usual dose: 200 mg on first day, then 100 mg daily for 7-10 days.
Severe infections (including refractory urinary tract infections): 200 mg daily for 10 days.
Acne: 100 mg daily.
Uncomplicated genital chlamydia, non-gonococcal urethritis: 100 mg twice daily for 7-21 days (14-21 days in pelvic inflammatory disease).

AdministrationView

Capsules should be swallowed whole with plenty of fluid during meals while sitting or standing.

Side effectsView

Nausea, vomiting, diarrhoea, skin rashes, hemolytic anaemia, eosinophilia may be reported.

ContraindicationsView

Doxycycline is contraindicated to the patients who have shown hypersensitivity to any of the tetracyclines. Doxycycline is contraindicated to the children under 8 years of age. It is also contraindicated to pregnant women and to the lactating mothers.

PrecautionsView

The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of teeth. Tetracyclines drugs, therefore should not be used in this age group.

InteractionsView

Absorption of tetracyclines is impaired by antacid containing aluminium, calcium or magnesium, and iron containing preparation. Absorption of tetracyclines is also impaired by bismuth salicylate. Barbiturates, carbamazepine and phenytoin decrease half-life of doxycycline. Concurrent use of tetracyclines may render oral contraceptive less effective. Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosages. It is advisable to avoid giving tetracyclines in conjunction with penicillin.

Pregnancy & lactationView

Doxycycline should be avoided in pregnant women, because of the risk of both staining and effect on bone growth in the foetus. Doxycyclines enter breast milk, and mothers taking these drugs should not breastfeed their child.

StorageView

Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.

Megafen

Diclofenac Sodium

IM Injection 75 mg/3 ml Allopathic Drugs for Osteoarthritis

Indications

Tendonitis

Indication detailsView

Rheumatology: Inflammatory and degenerative forms of rheumatism, chronic involutive, polyarthritis, ankylosing spondylarthritis, osteoarthritis, spondylarthroses, acute gout, peri-articular rheumatic disorders.

Surgery and Traumatology: Sprain, bruises, dislocations, fractures, softtissue injuries, surgical interventions.

Obstetrics and Gynecology: Primary dysmenorrhoea, episiotomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.

Otorhinolaryngology: As pre-operative medication for the prevention of pain, inflammation, and swelling.

Dentistry: Post-operative and post-traumatic pain, inflammation, and swelling.

Other indications: For the prevention of pain and treatment of inflammation and swelling of patients operated in the urogenital tract, renal and biliary colic.

Therapeutic classView

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

PharmacologyView

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

DosageView

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Side effectsView

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

ContraindicationsView

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

PrecautionsView

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

Pregnancy & lactationView

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

StorageView

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

Megafen

Diclofenac Sodium

Tablet 50 mg Allopathic Drugs for Osteoarthritis

Indications

Tendonitis

Indication detailsView

Rheumatology: Inflammatory and degenerative forms of rheumatism, chronic involutive, polyarthritis, ankylosing spondylarthritis, osteoarthritis, spondylarthroses, acute gout, peri-articular rheumatic disorders.

Surgery and Traumatology: Sprain, bruises, dislocations, fractures, softtissue injuries, surgical interventions.

Obstetrics and Gynecology: Primary dysmenorrhoea, episiotomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.

Otorhinolaryngology: As pre-operative medication for the prevention of pain, inflammation, and swelling.

Dentistry: Post-operative and post-traumatic pain, inflammation, and swelling.

Other indications: For the prevention of pain and treatment of inflammation and swelling of patients operated in the urogenital tract, renal and biliary colic.

Therapeutic classView

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

PharmacologyView

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

DosageView

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Side effectsView

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

ContraindicationsView

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

PrecautionsView

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

Pregnancy & lactationView

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

StorageView

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

Megafen Plus

Diclofenac Sodium + Lidocaine Hydrochloride

IM Injection (75 mg+20 mg)/2 ml Allopathic Drugs for Osteoarthritis

Indications

Osteoarthritis (degenerative arthritis)

Indication detailsView

The injection contains Diclofenac Sodium that is used to relief all grades of pain and inflammation in a wide range of conditions including:

Arthritic conditions such as rheumatoid arthritis, osteoarthritis, juvenile chronic arthritis, ankylosing spondylitis, acute gout.
Acute musculoskeletal disorders such as periarthritis (e.g., Frozen shoulder), tendinitis, tenosynovitis, bursitis.
Other painful conditions resulting from trauma including, fracture, low back pain, sprains, strains, dislocations, control of pain and inflammation in orthopaedic, dental and other minor surgeries, postoperative pain, pain of renal colic etc.

The injection also contains Lidocaine which acts as a local anaesthetic. Therefore the possibility of pain at the injection site, which is most likely to occur after intramuscular injection, is minimized if the Lidocaine containing injection is used in the above indications.

Therapeutic classView

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

PharmacologyView

Diclofenac Sodium is a potent nonsteroidal antiinflammatory drug (NSAID) with marked analgesic and antipyretic properties. It also has some uricosuric effects. The action of Diclofenac appeared to be associated with the inhibition of prostaglandin synthesis. Diclofenac may inhibit synthesis of prostaglandins by inhibiting cyclooxygenase, an enzyme that catalyses the formation of prostaglandin precursors from arachidonic acid. Peak plasma concentration is achieved within half an hour following injection. Lidocaine is the most widely used local anaesthetic drug. It acts more rapidly and is more stable than most other local anaesthetics. It is a very useful surface anaesthetic. Like other local anaesthetics, Lidocaine impairs the generation and conduction of nerve impulses by slowing depolarization. The onset of anaesthesia of Lidocaine Hydrochloride is more rapid and the duration is 1-2 hours.

DosageView

Adult: One ampoule once (or in severe cases, twice) daily by intramuscular injection.

Renal colic: One ampoule once daily intramuscularly. A second dose may be administered after 30 minutes if necessary.

Children: In Juvenile chronic arthritis, 1-3 mg of Diclofenac Sodium per kg body weight daily in divided doses.

Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, commensurate with age and physical status, or as prescribed by the physician.

Side effectsView

Side effects to Diclofenac Sodium and Lidocaine injection are usually mild and transient. However if serious side effects occur the injection should be discontinued. Gastrointestinal discomfort, nausea, diarrhea and occasionally bleeding may occur. In very rare instances, injection site disorder may occur. In isolated cases, abscesses and local necrosis may occur. The adverse effects due to Lidocaine mainly involve the CNS, are usually of short duration, and are dose related. The CNS reactions may be manifested by drowsiness, dizziness, disorientation, confusion, lightheadedness etc.

ContraindicationsView

It is contraindicated for those patients who are hypersensitive to Diclofenac. In patients with active or suspected peptic ulcer or gastrointestinal bleeding or for those patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by Aspirin or other NSAIDs possessing prostaglandin synthetase inhibiting activity Diclofenac is also contraindicated. Because of the presence of Lidocaine, this injection is also contraindicated for those patients who are hypersensitive to local anaesthetics of the amide type, although the incidence is very rare. In patients with Adams-Stokes syndrome or with severe degrees of SA, AV, or intraventricular heart block in the absence of an artificial pacemaker, and for those patients who are hypersensitive to any of the excipients used in the formulation (Sodium Metabisulphite, Disodium Edetate, Benzyl Alcohol, Sodium Hydroxide, Propylene Glycol), this injection is also contraindicated.

PrecautionsView

Renal: Patients with severe hepatic, cardiac or renal insufficiency or the elderly should be kept under close observation, since the use of NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function should be monitored.

Hepatic: If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Diclofenac should be discontinued. All patients who are receiving long term treatment with NSAIDs should be monitored as a precautionary measure (e.g., renal, hepatic function and blood counts).

InteractionsView

Lithium and Digoxin: Diclofenac may increase plasma concentrations of Lithium and Digoxin.

Anticoagulants: There are isolated reports of an increased risk of haemorrhage with the combined use of Diclofenac and anticoagulant therapy, although clinical investigations do not appear to indicate any influence on anticoagulant effect.

Antidiabetic agents: Clinical studies have shown that Diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect.

Cyclosporin: Cases of nephrotoxicity have been reported in patients receiving Cyclosporin and Diclofenac concomitantly.

Methotrexate: Cases of serious toxicity have been reported when Methotrexate and NSAIDs are given within 24 hours of each other.

Quinolone antimicrobials: Convulsions may occur due to an interaction between quinolones and NSAIDs. Therefore, caution should be exercised when considering concomitant therapy of NSAIDs and quinolones.

Other NSAIDs and steroids: Co-administration of Diclofenac with other systemic NSAIDs and steroids may increase the frequency of unwanted effects. With Aspirin, the plasma levels of each are lowered, although no clinical significance is known.

Diuretics: Various NSAIDs are liable to inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels. So, serum potassium should be monitored.

Pregnancy & lactationView

It should not be prescribed during pregnancy unless there are compelling reasons for doing so. The lowest effective dosage should be used. These types of drugs are not recommended during the last trimester of pregnancy. Very small quantities of Diclofenac may be detected in breast milk, but no undesirable effects on the infant are to be expected.

StorageView

Store at temparature not exceeding 30°C in a dry place. Protected from light.

Megafen-SR

Diclofenac Sodium

Tablet (Sustained Release) 100 mg Allopathic Drugs for Osteoarthritis

Indications

Tendonitis

Indication detailsView

Rheumatology: Inflammatory and degenerative forms of rheumatism, chronic involutive, polyarthritis, ankylosing spondylarthritis, osteoarthritis, spondylarthroses, acute gout, peri-articular rheumatic disorders.

Surgery and Traumatology: Sprain, bruises, dislocations, fractures, softtissue injuries, surgical interventions.

Obstetrics and Gynecology: Primary dysmenorrhoea, episiotomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.

Otorhinolaryngology: As pre-operative medication for the prevention of pain, inflammation, and swelling.

Dentistry: Post-operative and post-traumatic pain, inflammation, and swelling.

Other indications: For the prevention of pain and treatment of inflammation and swelling of patients operated in the urogenital tract, renal and biliary colic.

Therapeutic classView

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

PharmacologyView

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

DosageView

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Side effectsView

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

ContraindicationsView

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

PrecautionsView

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

Pregnancy & lactationView

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

StorageView

Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.

Megafil

Tadalafil

Tablet 20 mg Allopathic Drugs for Erectile Dysfunction

Indications

Pulmonary arterial hypertension

Indication detailsView

Tadalafil is indicated in-

Erectile Dysfunction (ED)
Benign Prostatic Hyperplasia (BPH)
Both Erectile Dysfunction and signs and symptoms of Benign Prostatic Hyperplasia

Therapeutic classView

Drugs for Erectile Dysfunction

PharmacologyView

Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. cGMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 increases cGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.

DosageView

Erectile Dysfunction: For most patients the recommended starting dose is 10 mg. The dose may be increased to 20 mg or decreased to 5 mg based on requirement. The maximum dosing frequency is once daily. Tadalafil is effective for up to 36 hours.

Benign prostatic hyperplasia: The recommended dose is 5 mg taken at the same time every day.

Combined Erectile Dysfunction and Benign prostatic hyperplasia: The recommended dose is 5 mg at the same time every day.

Side effectsView

Headache, Dyspepsia, Back pain, Myalgia, Nasal pharyngitis, Nasal congestion are common side effects. Change in Color Vision, Sudden vision loss, Hearing loss, Stevens-Johnson Syndrome, Exfoliative dermatitis, Angina, Stroke, Myocardial infarction, Severe hypotension, Tachycardia may also occur rarely.

ContraindicationsView

Use of Nitrates (for example, Nitroglycerine, Isosorbide): may increase hypotensive effects of Nitrates
Hypersensitivity reactions to Tadalafil

PrecautionsView

Angina, renal impairment, hepatic impairment, bleeding concomitant with Nitrates, Alpha Blockers, Alcohol, CYP3A4 Inhibitors (for example, Ritonavir, Ketoconazole, Itraconazole), other PDE5 inhibitors precaution should be taken in all these conditions.

InteractionsView

May interact with Nitrates for example, Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesuim hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin & Phenobarbital.

Pregnancy & lactationView

Tadalafil has been assigned to pregnancy category B by the USFDA. Tadalafil is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of Tadalafil in human milk. Caution should be used when administering tadalafil to nursing women.

StorageView

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Megafil

Tadalafil

Tablet 10 mg Allopathic Drugs for Erectile Dysfunction

Indications

Pulmonary arterial hypertension

Indication detailsView

Tadalafil is indicated in-

Erectile Dysfunction (ED)
Benign Prostatic Hyperplasia (BPH)
Both Erectile Dysfunction and signs and symptoms of Benign Prostatic Hyperplasia

Therapeutic classView

Drugs for Erectile Dysfunction

PharmacologyView

Tadalafil is a selective phosphodiesterase type 5 (PDE5) inhibitor. Inhibition of PDE5 increases cGMP in smooth muscle cells. cGMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum, causing penile erection. PDE5 also is present in smooth muscles of the prostate and bladder wall. Inhibiting PDE5 increases cGMP concentrations leading to relaxation of smooth muscle in the prostate and bladder. Smooth muscle relaxation may improve blood flow to the urinary tract and widen the opening of the bladder neck, resulting in improved voiding.

DosageView

Erectile Dysfunction: For most patients the recommended starting dose is 10 mg. The dose may be increased to 20 mg or decreased to 5 mg based on requirement. The maximum dosing frequency is once daily. Tadalafil is effective for up to 36 hours.

Benign prostatic hyperplasia: The recommended dose is 5 mg taken at the same time every day.

Combined Erectile Dysfunction and Benign prostatic hyperplasia: The recommended dose is 5 mg at the same time every day.

Side effectsView

Headache, Dyspepsia, Back pain, Myalgia, Nasal pharyngitis, Nasal congestion are common side effects. Change in Color Vision, Sudden vision loss, Hearing loss, Stevens-Johnson Syndrome, Exfoliative dermatitis, Angina, Stroke, Myocardial infarction, Severe hypotension, Tachycardia may also occur rarely.

ContraindicationsView

Use of Nitrates (for example, Nitroglycerine, Isosorbide): may increase hypotensive effects of Nitrates
Hypersensitivity reactions to Tadalafil

PrecautionsView

Angina, renal impairment, hepatic impairment, bleeding concomitant with Nitrates, Alpha Blockers, Alcohol, CYP3A4 Inhibitors (for example, Ritonavir, Ketoconazole, Itraconazole), other PDE5 inhibitors precaution should be taken in all these conditions.

InteractionsView

May interact with Nitrates for example, Isosorbide, Nitroglycerin, Alpha adrenergic blockers, Antihypertensives, Alcohol, Antacids (magnesuim hydroxide/aluminum hydroxide), Ketoconazole, Ritonavir, Erythromycin, Itraconazole, Grapefruit juice, other HIV protease inhibitors, Rifampin, Carbamazepine, Phenytoin & Phenobarbital.

Pregnancy & lactationView

Tadalafil has been assigned to pregnancy category B by the USFDA. Tadalafil is only recommended for use during pregnancy when benefit outweighs risk. There are no data on the excretion of Tadalafil in human milk. Caution should be used when administering tadalafil to nursing women.

StorageView

Keep in a dry place, away from light and heat. Keep out of the reach of children.

Megajoy

Yohimbine Hydrochloride

Tablet 5.4 mg Herbal Herbal and Nutraceuticals

Indications

Libido

Indication detailsView

Yohimbine is indicated in erectile dysfunction, loss of libido & exhaustion.

Therapeutic classView

Herbal and Nutraceuticals

PharmacologyView

Yohimbe is a potent alpha-2 adrenoceptor blocker and a weak alpha-1 adrenergic antagonist with some antidopaminergic properties. Yohimbe interacts with adrenoceptors that are selectively stimulated by clonidine, alpha-methylnorepinephrine, tramazoline, guanabenz & guanfacin. It also interacts with compounds that are nonselectively stimulated by norepinephrine and epinephrine. Yohimbe has a modest beneficial effect in the management of erectile dysfunction. Because of the alpha-2 adrenergic blockade, the drug is an effective treatment for sexual disorders such as decreased libido and decreased sexual response, caused by selective serotonin reuptake inhibitors.

DosageView

1 capsule 3 times daily or as advised by the physician

Side effectsView

Anxiety states, elevated blood pressure, exanthema, nausea, insomnia, tachycardia, tremor, mania and vomiting.

ContraindicationsView

The drug should not be used by patients with liver and kidney diseases, chronic inflammation of the sexual organs or prostate gland or with a history of gastric or duodenal ulcers

PrecautionsView

Patients taking Yohimbe should avoid alcohol ingestion

InteractionsView

Theoretically, Yohimbe may counteract the hypotensive effect of antihypertensive medications, resulting inadequate blood pressure control. It may potentiate pharmaceutical MAO-inhibitors

StorageView

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Meganor

Megestrol Acetate

Tablet 160 mg Allopathic

Indication detailsView

Megestrol Tablet is indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used instead of currently accepted procedures such as surgery, radiation, or chemotherapy.

Megestrol Oral Suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of Acquired Immunodeficiency Syndrome (AIDS) & cancer.

PharmacologyView

Megestrol Acetate is a synthetic, antineoplastic and progestational drug. While the precise mechanism by which Megestrol Acetate produces its antineoplastic effects against endometrial carcinoma is unknown at the present time, inhibition of pituitary gonadotrophin production and resultant decrease in estrogen secretion may be factors. The antineoplastic action of megestrol acetate on carcinoma of the breast is effected by modifying the action of other steroid hormones and by exerting a direct cytotoxic effect on tumor cells. In metastatic cancer, hormone receptors may be present in some tissues but not others. The receptor mechanism is a cyclic process whereby estrogen produced by the ovaries enters the target cell, forms a complex with cytoplasmic receptor and is transported into the cell nucleus. There it induces gene transcription and leads to the alteration of normal cell functions. Pharmacologic doses of megestrol acetate not only decrease the number of hormone-dependent human breast cancer cells but also are capable of modifying and abolishing the stimulatory effects of estrogen on these cells.

Estimates of plasma levels of Megestrol Acetate are dependent on the measurement method used. Peak plasma concentrations occur 2 to 3 hours after a single oral dose 160 mg tablets. The plasma half-life of Megestrol Acetate is 33 to 38 hours. Approximately 66% of an administered dose is excreted in the urine and approximately 20% in the faeces.

DosageView

Tablet:

Breast cancer: 160 mg/day
Endometrial carcinoma: 40-320 mg/day in divided doses.
At least 2 months of continuous treatment is considered an adequate period for determining the efficacy of Megestrol.

Oral Suspension: The recommended adult initial dosage of Megestrol Oral Suspension is 800 mg/day (20 ml/day).

Side effectsView

Weight Gain: Weight gain is a frequent side effect of Megestrol Acetate. This gain has been associated with increased appetite and is not necessarily associated with fluid retention.

Thromboembolic Phenomena: Thromboembolic phenomena including thrombophlebitis and pulmonary embolism (in some cases fatal) have been reported.

Glucocorticoid Effects: The glucocorticoid activity of Megestrol Acetate has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and overt Cushing’s syndrome have been reported in association with the chronic use of Megestrol Acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic Megestrol Acetate therapy in the stressed and non-stressed state.

Other: Nausea, dyspnea, tumor flare, hyperglycemia, glucose intolerance, alopecia, hypertension, carpal tunnel syndrome, mood changes, hot flashes, malaise, asthenia, lethargy, sweating and rash.

ContraindicationsView

History of hypersensitivity to Megestrol Acetate or any component of the formulation. Known or suspected pregnancy.

PrecautionsView

General: Close surveillance is indicated for any patient treated for recurrent or metastatic cancer. Use with caution in patients with a history of thromboembolic disease.

Use in Diabetics: Exacerbation of preexisting diabetes with increased insulin requirements has been reported in association with the use of Megestrol Acetate.

InteractionsView

Pharmacokinetic studies show that there are no significant alterations in pharmacokinetics parameters of Zidovudine or Rifabutin to warrant dosage adjustment when Megestrol Acetate is administered with these drugs. The effects of Zidovudine or Rifabutin on the pharmacokinetics of Megestrol Acetate were not studied.

Pregnancy & lactationView

Pregnancy Category D. The use of progestational agents during the first four months of pregnancy is not recommended. Very small amounts (approximately 0.1%) are excreted in mother's milk. It is however, not known whether these amounts exert any harmful effect on the newborn. Because of the potential for adverse effects on the new born, nursing should be discontinued during treatment with Megestrol Acetate.

Pediatric usageView

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: In the dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Overdose effectsView

No serious unexpected side effects have resulted from studies involving Megestrol Acetate administered in dosages as high as 1600 mg/day.

StorageView

Store at or below 25°C. Protect from heat, light & moisture.

Megapime

Cefepime Hydrochloride

IV Injection 2 gm/vial Allopathic Fourth generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Cefepime is indicated for the treatment of the following infections caused by susceptible strains of the microorganisms:

Pneumonia (moderate to severe): caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
Febrile Neutropenia: Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients.
Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis): caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.
Uncomplicated Skin and Skin Structure Infections: caused by Staphylococcus aureus (methicillin- susceptible strains only) or Streptococcus pyogenes.
Complicated Intra-abdominal Infections (used in combination with metronidazole): caused by Escherichia coli, viridians group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.

Therapeutic classView

Fourth generation Cephalosporins

PharmacologyView

Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).

DosageView

Cefepime should be administered intravenously over approximately 30 minutes.

Moderate to Severe Pneumonia due to S. pneumoniae, *P. aeruginosa, K. pneumoniae, or Enterobacter species: 1-2 gm IV 12 hourly for 10 days.
Empiric therapy for febrile neutropenic patients: 2 gm IV 8 hourly for 7** days.
Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis*: 0.5-1 gm IV/IM*** 12 hourly for 7-10 days.
Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae*: 2 gm IV 12 hourly for 10 days.
Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes: 2 gm IV 12 hourly for 10 days.
Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis: 2 gm IV 12 hourly for 7-10 days.

Note:
*including cases associated with concurrent bacteremia.
**or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re evaluated frequently.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.

Side effectsView

Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.

ContraindicationsView

Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.

PrecautionsView

Prescribing Cefepime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
As with other antimicrobials, prolonged use of Cefepime may result in overgrowth of non susceptible microorganisms. Repeated evaluation of the patient's condition is essential.
Many cephalosporins, including cefepime, have been associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk.
Cefepime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Arginine has been shown to alter glucose metabolism and elevate serum potassium transiently when administered at 33 times the amount provided by the maximum recommended human dose of Cefepime. The effect of lower doses is not presently known.

InteractionsView

Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.

Pregnancy & lactationView

Pregnancy Category B. There are, however, no adequate and well-controlled studies of cefepime use 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. Cefepime is excreted in human breast milk in very low concentrations (0.5 pg/ml). Caution should be exercised when cefepime is administered to a nursing woman.

Pediatric usageView

Pediatric Use (2 months up to 16 years): The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg/kg/dose, administered every 12 hours (50 mg/kg/dose, every 8 hours for febrile neutropenic patients), for durations as given above.

Geriatric Use: Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.

Impaired Hepatic Function: No adjustment is necessary for patients with impaired hepatic function.

Impaired Renal Function: In patients with impaired renal function (creatinine clearance<60 ml/min), the dose of Cefepime should be adjusted to compensate for the slower rate of renal elimination.

Overdose effectsView

Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.

ReconstitutionView

For IV the resulting solution should be injected directly into the vein over a period of three to five minutes or injected into the tubing of an administration set while the patient is receiving a compatible IV fluid.

Intravenous: Cefepime is compatible with Sterile Water for Injection. It is also compatible at concentrations between 1 mg/ml and 40 mg/ml with the following IV infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection.

Intramuscular: Cefepime is compatible with the following diluent such as: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol or 0.5% or 1% Lidocaine Hydrochloride.

500 mg (IV) vials for intravenous administration:

Amount of WFI to be added: 5 ml
Approximate available volume: 5.6 ml

500 mg (IM) vials for intramuscular administration:

Amount of WFI to be added: 1.3 ml
Approximate available volume: 1.8 ml

1 gm (IV) vials for Intravenous administration:

Amount of WFI to be added: 10 ml
Approximate available volume: 11.3 ml

1 gm (IM) vials for intramuscular administration:

Amount of WFI to be added: 2.4 ml
Approximate available volume: 3.6 ml

2 gm (IV) vials for Intravenous administration:

Amount of WFI to be added: 10 ml
Approximate available volume: 12.5 ml

StorageView

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.