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Cefzon

Ceftazidime Pentahydrate

IM/IV Injection 1 gm/vial Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Ceftazidime Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:

Lower Respiratory Tract Infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp., Haemophilus influenzae, including ampicillin-resistant strains; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae; and Staphylococcus aureus (methicillin susceptible strains).

Skin and Skin Structure Infections caused by Pseudomonas aeruginosa; Klebsiella spp.; Escherichia coli; Proteus spp., including Proteus mirabilis and indole-positive Proteus, Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin susceptible strains); and Streptococcus pyogenes (group A beta-hemolytic streptococci).

Urinary Tract Infections, both complicated and uncomplicated, caused by Pseudomonas aeruginosa; Enterobacter spp.; Proteus spp., including Proteus mirabilis and indole-positive Proteus, Klebsiella spp.; and Escherichia coli.

Bacterial Septicemia caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae and Staphylococcus aureus (methicillin susceptible strains).

Bone and Joint Infections caused by Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., and Staphylococcus aureus (methicillin susceptible strains).

Gynecologic Infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli.

Intraabdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella spp., and Staphylococcus aureus (methicillin susceptible strains) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp.

Central Nervous System Infections, including meningitis, caused by Haemophilus influenzae and Neisseria meningitidis, Pseudomonas aeruginosa and Streptococcus pneumoniae.

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. Ceftazidime is bactericidal in action exerting its effect by inhibition of enzymes responsible for cell-wall synthesis. A wide range of gram-negative organisms is susceptible to ceftazidime in vitro, including strains resistant to gentamicin and other aminoglycosides. In addition, ceftazidime has been shown to be active against gram-positive organisms. It is highly stable to most clinically important beta-lactamases, plasmid or chromosomal, which are produced by both gram-negative and gram-positive organisms and, consequently, is active against many strains resistant to ampicillin and other cephalosporins.

DosageView

The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection and the condition, and renal function of the patient.

Ceftazidime is to be used by the parenteral route, the dosage depending upon the severity, sensitivity & type of infections and the age, weight & renal function of the patient.

Adults: The adult dosage range for ceftazidime is 1 to 6 gm per day 8 or 12 hourly (IM/IV) in the majority of infections, 1 gm 8 hourly or 2 gm 12 hourly should be given.

In urinary tract infections and many less serious infections: 500 mg or 1 gm 12 hourly is usually adequate.
In severe infections, especially immunocompromised patients, including those with neutropenia: 2 gm 8 or 12 hourly should be administered. When used as a prophylactic agent in prostatic surgery 1 gm should be given at the induction of anesthesia. A second dose should be considered at the time of catheter removal.

Elderly: In view of the reduced clearance of Ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 gm, especially in those over 80 years of age.

Cystic fibrosis: In fibrocystic adults with normal renal function who have pseudomonal lung infections, high doses of 100 to 150 mg/kg/day as three divided doses should be used.

Infants and Children: The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided doses. Doses up to 150 mg/kg/day (maximum 6 gm daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.

Neonates and Children up to 2 months of age: The usual dosage range is 25 to 60 mg/kg/day as two divided doses.

AdministrationView

Ceftazidime may be given intravenously or by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral proof of the thigh. Intra-arterial administration should be avoided. For IV/IM administration, Ceftazidime should be reconstituted with the supplied Sterile Water for Injection.

Side effectsView

The most common side-effects are local reactions following IV injection and allergic and gastrointestinal reactions. Hypersensitivity reactions are pruritus, rash, and fever. Angioedema and anaphylaxis have been reported very rarely. Gastrointestinal symptoms are diarrhea, nausea, vomiting, and abdominal pain. Central nervous system reactions included headache, dizziness, and paresthesia.

ContraindicationsView

Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.

PrecautionsView

The total daily dosage should be reduced when Ceftazidime is administered to patients with renal insufficiency. Ceftazidime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Pregnancy & lactationView

Pregnancy: No adequate and well-controlled studies in pregnant women have been conducted with Ceftazidime. Because animal reproduction studies are not always predictive of human response this drug should be used during pregnancy only if clearly needed.

Lactation: Ceftazidime is excreted in human milk in low concentrations. Because many drugs are excreted in human milk and because the safety of the component of the injections in nursing infants has not been established, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric usageView

Impaired Renal Function: Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate <50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of Ceftazidime may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage.

Dosage in peritoneal dialysis: Ceftazidime may also be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD). As well as using Ceftazidime intravenously, it can be incorporated into the dialysis fluid (usually 125 to 250 mg for 2L of dialysis fluid).

Impaired Hepatic Function: No adjustment in dosage is required for patients with hepatic dysfunction.

Overdose effectsView

Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients who receive an acute overdosage should be carefully observed and given supportive treatment.

ReconstitutionView

Single-dose vial Administration Amount of WFI to be added: 250 mg IM in 1.5 ml, 250 mg IV in 5 ml, 500 mg IM in 1.5 ml, 500 mg IV in 5 ml and 1 g IM in 3 ml, 1 g IV in 10 ml.

StorageView

Store below 25°C, protected from light and moisture. Reconstituted solutions are stable for up to 24 h if stored between 2°-8°C.

Cefzon

Ceftazidime Pentahydrate

IM/IV Injection 250 mg/vial Allopathic Third generation Cephalosporins

Indications

Urinary tract infection

Indication detailsView

Ceftazidime Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases:

Lower Respiratory Tract Infections, including pneumonia, caused by Pseudomonas aeruginosa and other Pseudomonas spp., Haemophilus influenzae, including ampicillin-resistant strains; Klebsiella spp.; Enterobacter spp.; Proteus mirabilis; Escherichia coli; Serratia spp.; Citrobacter spp.; Streptococcus pneumoniae; and Staphylococcus aureus (methicillin susceptible strains).

Skin and Skin Structure Infections caused by Pseudomonas aeruginosa; Klebsiella spp.; Escherichia coli; Proteus spp., including Proteus mirabilis and indole-positive Proteus, Enterobacter spp.; Serratia spp.; Staphylococcus aureus (methicillin susceptible strains); and Streptococcus pyogenes (group A beta-hemolytic streptococci).

Urinary Tract Infections, both complicated and uncomplicated, caused by Pseudomonas aeruginosa; Enterobacter spp.; Proteus spp., including Proteus mirabilis and indole-positive Proteus, Klebsiella spp.; and Escherichia coli.

Bacterial Septicemia caused by Pseudomonas aeruginosa, Klebsiella spp., Haemophilus influenzae, Escherichia coli, Serratia spp., Streptococcus pneumoniae and Staphylococcus aureus (methicillin susceptible strains).

Bone and Joint Infections caused by Pseudomonas aeruginosa, Klebsiella spp., Enterobacter spp., and Staphylococcus aureus (methicillin susceptible strains).

Gynecologic Infections, including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by Escherichia coli.

Intraabdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella spp., and Staphylococcus aureus (methicillin susceptible strains) and polymicrobial infections caused by aerobic and anaerobic organisms and Bacteroides spp.

Central Nervous System Infections, including meningitis, caused by Haemophilus influenzae and Neisseria meningitidis, Pseudomonas aeruginosa and Streptococcus pneumoniae.

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. Ceftazidime is bactericidal in action exerting its effect by inhibition of enzymes responsible for cell-wall synthesis. A wide range of gram-negative organisms is susceptible to ceftazidime in vitro, including strains resistant to gentamicin and other aminoglycosides. In addition, ceftazidime has been shown to be active against gram-positive organisms. It is highly stable to most clinically important beta-lactamases, plasmid or chromosomal, which are produced by both gram-negative and gram-positive organisms and, consequently, is active against many strains resistant to ampicillin and other cephalosporins.

DosageView

The usual adult dosage is 1 gram administered intravenously or intramuscularly every 8 to 12 hours. The dosage and route should be determined by the susceptibility of the causative organisms, the severity of infection and the condition, and renal function of the patient.

Ceftazidime is to be used by the parenteral route, the dosage depending upon the severity, sensitivity & type of infections and the age, weight & renal function of the patient.

Adults: The adult dosage range for ceftazidime is 1 to 6 gm per day 8 or 12 hourly (IM/IV) in the majority of infections, 1 gm 8 hourly or 2 gm 12 hourly should be given.

In urinary tract infections and many less serious infections: 500 mg or 1 gm 12 hourly is usually adequate.
In severe infections, especially immunocompromised patients, including those with neutropenia: 2 gm 8 or 12 hourly should be administered. When used as a prophylactic agent in prostatic surgery 1 gm should be given at the induction of anesthesia. A second dose should be considered at the time of catheter removal.

Elderly: In view of the reduced clearance of Ceftazidime in acutely ill elderly patients, the daily dosage should not normally exceed 3 gm, especially in those over 80 years of age.

Cystic fibrosis: In fibrocystic adults with normal renal function who have pseudomonal lung infections, high doses of 100 to 150 mg/kg/day as three divided doses should be used.

Infants and Children: The usual dosage range for children aged over two months is 30 to 100 mg/kg/day, given as two or three divided doses. Doses up to 150 mg/kg/day (maximum 6 gm daily) in three divided doses may be given to infected immunocompromised or fibrocystic children or children with meningitis.

Neonates and Children up to 2 months of age: The usual dosage range is 25 to 60 mg/kg/day as two divided doses.

AdministrationView

Ceftazidime may be given intravenously or by deep IM injection into a large muscle mass such as the upper outer quadrant of the gluteus maximus or lateral proof of the thigh. Intra-arterial administration should be avoided. For IV/IM administration, Ceftazidime should be reconstituted with the supplied Sterile Water for Injection.

Side effectsView

The most common side-effects are local reactions following IV injection and allergic and gastrointestinal reactions. Hypersensitivity reactions are pruritus, rash, and fever. Angioedema and anaphylaxis have been reported very rarely. Gastrointestinal symptoms are diarrhea, nausea, vomiting, and abdominal pain. Central nervous system reactions included headache, dizziness, and paresthesia.

ContraindicationsView

Ceftazidime is contraindicated in patients who have shown hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.

PrecautionsView

The total daily dosage should be reduced when Ceftazidime is administered to patients with renal insufficiency. Ceftazidime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.

Pregnancy & lactationView

Pregnancy: No adequate and well-controlled studies in pregnant women have been conducted with Ceftazidime. Because animal reproduction studies are not always predictive of human response this drug should be used during pregnancy only if clearly needed.

Lactation: Ceftazidime is excreted in human milk in low concentrations. Because many drugs are excreted in human milk and because the safety of the component of the injections in nursing infants has not been established, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric usageView

Impaired Renal Function: Ceftazidime is excreted by the kidneys, almost exclusively by glomerular filtration. Therefore, in patients with impaired renal function (glomerular filtration rate <50 mL/min), it is recommended that the dosage of ceftazidime be reduced to compensate for its slower excretion. In patients with suspected renal insufficiency, an initial loading dose of 1 gram of Ceftazidime may be given. An estimate of GFR should be made to determine the appropriate maintenance dosage.

Dosage in peritoneal dialysis: Ceftazidime may also be used in peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD). As well as using Ceftazidime intravenously, it can be incorporated into the dialysis fluid (usually 125 to 250 mg for 2L of dialysis fluid).

Impaired Hepatic Function: No adjustment in dosage is required for patients with hepatic dysfunction.

Overdose effectsView

Ceftazidime overdosage has occurred in patients with renal failure. Reactions have included seizure activity, encephalopathy, asterixis, neuromuscular excitability, and coma. Patients who receive an acute overdosage should be carefully observed and given supportive treatment.

ReconstitutionView

Single-dose vial Administration Amount of WFI to be added: 250 mg IM in 1.5 ml, 250 mg IV in 5 ml, 500 mg IM in 1.5 ml, 500 mg IV in 5 ml and 1 g IM in 3 ml, 1 g IV in 10 ml.

StorageView

Store below 25°C, protected from light and moisture. Reconstituted solutions are stable for up to 24 h if stored between 2°-8°C.

Celbarin

Ribavirin

Capsule 200 mg Allopathic Hepatic viral infections (Hepatitis C)

Indications

Chronic hepatitis C

Indication detailsView

Ribavirin is indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with other antiviral drugs in patients with compensated liver disease not previously treated with interferon alpha and in adult CHC patients coinfected with HIV. Ribavirin should not be used alone.

Therapeutic classView

Hepatic viral infections (Hepatitis C)

PharmacologyView

Ribavirin is a synthetic nucleoside which has inhibitory action against respiratory syncytial virus, influenza virus and herpes simplex virus. The mechanism of action is not clear. It may act at several sites including cellular enzymes to interfere with viral nucleic acid synthesis. The mono- and triphosphate derivatives are known to be responsible for the antiviral action of the compound.

DosageView

The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. After 24 weeks of treatment virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population. In patients who relapse following interferon therapy, the recommended duration of treatment is 24 weeks. There are no safety and efficacy data on treatment for longer than 24 weeks in the relapse patient populations.

Ribavirin + Interferon: Genotype Ribavirin Daily Interferon alpha-2a Duration or interferon alpha-2b.

All <75 kg: (400+600) mg 3 MIU 3 times weekly 48 weeks Genotypes subcutaneously (Genotype1&4)
>75 kg: (600+600) mg 24 weeks (Genotype2&3)

Ribavirin + Peg-Interferon: Genotype Ribavirin Daily Peg-Interferon alpha-2a Duration or Peg-interferon alpha-2b:

1 & 4 < 75 kg: (400+600) mg 180 gm once weekly 48 weeks
> 75 kg: (600+600) mg subcutaneously 2 & 3 (400+400) mg 24 weeks

Ribavirin may be administered without regard to food, but should be administered in a consistent manner. Drink plenty of water while being treated with this medication; drinking water will decrease the risk of serious side effects.

Side effectsView

The most common adverse reactions in adults receiving combination therapy are psychiatric and central nervous system effects, severe ocular disorder, dental and periodontal disorders & growth inhibition in children and adolescents that may be irreversible in some patients. The most common adverse reactions in pediatric subjects were similar to those seen in adults.

ContraindicationsView

Women who are pregnant. Ribavirin may cause fetal harm when administered to a pregnant woman. Ribavirin is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia). In combination with didanosine. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials.

PrecautionsView

Birth defects and fetal death with ribavirin: Do not use in pregnancy and for 6 months after treatment. Patients must have a negative pregnancy test prior to therapy, use at least 2 forms of contraception and undergo monthly pregnancy tests. For a male patient, it is very important for his female partner to avoid becoming pregnant during treatment and during the 7 months after treatment and do not have sex with a pregnant women.

InteractionsView

Nucleoside reverse transcriptase inhibitors or reduce dose or discontinue interferon, ribavirin or both with worsening toxicities

Azathioprine: Concomitant use of azathioprine with ribavirin has been reported to induce severe pancytopenia and may increase the risk of azathioprine-related myelotoxicity.

Pregnancy & lactationView

Pregnancy Category X. Ribavirin produced significant embryocidal and/or teratogenic effects in all animal species in which adequate studies have been conducted. Malformations of the skull, palate, eye, jaw, limbs, skeleton and gastrointestinal tract were noted. The incidence and severity of teratogenic effects increased with escalation of the drug dose. Survival of fetuses and offspring was reduced.

Nursing Mothers: It is not known whether Ribavirin is excreted in human milk. Because many drugs are excreted in human milk and to avoid any potential for serious adverse reactions in nursing infants from ribavirin, a decision should be made either to discontinue nursing or therapy with Ribavirin, based on the importance of the therapy to the mother.

Pediatric usageView

Pediatric Use: Safety and effectiveness of Ribavirin in combination with Peginterferon has not been established in pediatric patients below the age of 3 years.

Geriatric Use: The risk of toxic reactions to this drug may be greater in patients with impaired renal function. The dose of Ribavirin should be reduced in patients with creatinine clearance less than or equal to 50 ml/min; and the dose of Interferon should be reduced in patients with creatinine clearance less than 30 ml/min.

StorageView

Keep out of the reach of children. Keep in a cool & dry place. Protect from light.

Celeco

Celecoxib

Capsule 100 mg Allopathic Drugs for Osteoarthritis

Indications

Spondylitis

Indication detailsView

Celecoxib is indicated-

For the relief of the signs and symptoms of osteoarthritis.
For the relief of the signs and symptoms of rheumatoid arthritis.
For the regression and prevention of colorectal adenomatous polyps in patients with familial adenomatous polyposis (FAP).

Therapeutic classView

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

PharmacologyView

Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor, non-steroidal anti-inflammatory drug (NSAID). It exhibits anti-inflammatory, analgesic and antipyretic properties. The mechanism of action of Celecoxib is believed to be due to the inhibition of prostaglandin synthesis, via the inhibition of cyclooxygenase-2 (COX-2) enzyme. At therapeutic concentration, Celecoxib does not inhibit cyclooxygenase-1 (COX-1) isoenzyme.

DosageView

Osteoarthritis: The recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.

Rheumatoid arthritis: The recommended oral dose is 100 to 200 mg twice daily.

Familial adenomatous polyposis (FAP): Usual medical care for FAP patients should be continued while on Celecoxib. To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg (2x200 mg capsules) twice daily to be taken with food.

Side effectsView

Adverse events occurring in ≥2% of patients at recommended doses - Abdominal pain 4.1%, diarrhoea 5.6%, dyspepsia 8.8%, flatulence 2.2%, nausea 3.5%, back pain 2.8%, peripheral oedema 2.1%, accidental injury 2.9%, dizziness 2.0%, headache 15.8%, insomnia 2.3%, pharyngitis 2.3%, rhinitis 2.0%, sinusitis 5.0%, upper respiratory tract infections 8.1%, rash 2.2%. The following adverse events occurred in 0.1-1.9% of patients-

General: Allergy aggravated, allergic reaction, asthenia, chest pain, oedema generalised, face oedema, fatigue, fever, hot flushes, influenza like symptoms, pain, peripheral pain.
Gastrointestinal: Constipation, diverticulitis, dysphagia, oesophagitis, gastritis, gastroenteritis, gastro-oesophageal reflux disease, haemorrhoids, hiatal hernia, melaena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting.
Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disease, myocardial infarction.
Nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo. Female reproductive system : Breast fibroadenosis, breast neoplasm, breast pain, dysmenorrhoea, menstrual disorder, menorrhagia, vaginitis.
Male reproductive system: Prostatic disorder.
Resistance mechanism disorders: Herpes simplex, herpes zoster, bacterial infection, fungal infection, infection of soft tissue, viral infection, moniliasis, moniliasis genital, otitis media.
Hearing and vestibular: Deafness, ear abnormality, earache, tinnitus.
Heart rate and rhythm: Palpitation, tachycardia.
Respiratory: Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnoea, laryngitis, pneumonia.
Liver and biliary system: Peptic function abnormal, increased AST and ALT.
Musculoskeletal: Arthralgia, arthrosis, accidental fracture, myalgia, neck stiffness, synovitis, tendinitis.
Urinary system: Albuminuria, cystitis, dysuria, haematuria, micturition frequency, renal calculus, urinary incontinence, urinary tract infection.
Metabolic and nutritional: Blood urea nitrogen (BUN), CPK, creatinine, alkaline phosphatase, are increased. Hypercholesterolaemia, hyperglycaemia, hypokalaemia. Bodyweight is also increased.
Psychiatric: Anorexia, anxiety, increased appetite, depression, nervousness, somnolence.
Haemic: Anaemia, ecchymosis, epistaxis, thrombocythaemia.
Skin and appendages: Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, dry skin, increased sweating, urticaria.
Application site disorders: Cellulitis, contact dermatitis, skin nodule.
Special senses: Taste perversion.
Vision: Blurred vision, cataract, conjunctivitis, eye pain, glaucoma.

ContraindicationsView

Celecoxib is contraindicated in patients with known hypersensitivity to Celecoxib. It should not be given to patients who have demonstrated allergic type reactions to Sulphonamides (Celecoxib contains a sulphonamide side chain). Celecoxib should not be given to patients who have demonstrated asthma, urticaria or allergic type reactions after taking Aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic like reactions to NSAIDs have been reported in such patients.

PrecautionsView

Celecoxib, at doses up to 200 mg bid, can be administered without regard to timing of meal. Higher doses (400 mg bid) should be administered with food.

InteractionsView

ACE inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given into consideration in patients taking Celecoxib concomitantly with ACE inhibitors.

Frusemide: NSAIDs can reduce the natriuretic effect of Frusemide and thiazides in some patients.

Aspirin: Celecoxib can be used with low dose Aspirin. However, concomitant administration of Aspirin with Celecoxib may result in an increased rate of gastrointestinal ulceration or similar complications, compared to the use of Celecoxib alone.

Fluconazole: Concomitant administration of Fluconazole at 200 mg qid resulted in a two fold increase in Celecoxib plasma concentration. Celecoxib should be introduced at the lowest recommended dose in patients receiving Fluconazole.

Lithium: Patients on Lithium treatment should be closely monitored when Celecoxib is introduced or withdrawn.

Warfarin: Caution should be used when administering Celecoxib with Warfarin since these patients are at increased risk of bleeding complications.

Co-administration of Celecoxib with aluminium and magnesium-containing antacid should be avoided, because they may reduce the amount of Celecoxib that the body absorbs.

Pregnancy & lactationView

Celecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to fetus. But in late pregnancy Celecoxib should be avoided because it may cause premature closure of ductus arteriosus. It is not known whether Celecoxib is excreted in human milk. Because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from Celecoxib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric usageView

Geriatric: Dose adjustment in the elderly is not generally necessary. However, for patients of less than 50 kg in body weight, initiate therapy at the lowest recommended dose.

Paediatric: The safety and efficacy of Celecoxib is not established in pediatric patients.

Hepatic insufficiency: Celecoxib capsules should be introduced at a reduced dose in patients with moderate hepatic impairment. The use of Celecoxib in patients with severe hepatic impairment is not recommended.

Overdose effectsView

Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. No information is available regarding the removal of Celecoxib by hemodialysis but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose. Emesis and/or activated charcoal and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding.

StorageView

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

Celeco

Celecoxib

Capsule 200 mg Allopathic Drugs for Osteoarthritis

Indications

Spondylitis

Indication detailsView

Celecoxib is indicated-

For the relief of the signs and symptoms of osteoarthritis.
For the relief of the signs and symptoms of rheumatoid arthritis.
For the regression and prevention of colorectal adenomatous polyps in patients with familial adenomatous polyposis (FAP).

Therapeutic classView

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

PharmacologyView

Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor, non-steroidal anti-inflammatory drug (NSAID). It exhibits anti-inflammatory, analgesic and antipyretic properties. The mechanism of action of Celecoxib is believed to be due to the inhibition of prostaglandin synthesis, via the inhibition of cyclooxygenase-2 (COX-2) enzyme. At therapeutic concentration, Celecoxib does not inhibit cyclooxygenase-1 (COX-1) isoenzyme.

DosageView

Osteoarthritis: The recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.

Rheumatoid arthritis: The recommended oral dose is 100 to 200 mg twice daily.

Familial adenomatous polyposis (FAP): Usual medical care for FAP patients should be continued while on Celecoxib. To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg (2x200 mg capsules) twice daily to be taken with food.

Side effectsView

Adverse events occurring in ≥2% of patients at recommended doses - Abdominal pain 4.1%, diarrhoea 5.6%, dyspepsia 8.8%, flatulence 2.2%, nausea 3.5%, back pain 2.8%, peripheral oedema 2.1%, accidental injury 2.9%, dizziness 2.0%, headache 15.8%, insomnia 2.3%, pharyngitis 2.3%, rhinitis 2.0%, sinusitis 5.0%, upper respiratory tract infections 8.1%, rash 2.2%. The following adverse events occurred in 0.1-1.9% of patients-

General: Allergy aggravated, allergic reaction, asthenia, chest pain, oedema generalised, face oedema, fatigue, fever, hot flushes, influenza like symptoms, pain, peripheral pain.
Gastrointestinal: Constipation, diverticulitis, dysphagia, oesophagitis, gastritis, gastroenteritis, gastro-oesophageal reflux disease, haemorrhoids, hiatal hernia, melaena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting.
Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disease, myocardial infarction.
Nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo. Female reproductive system : Breast fibroadenosis, breast neoplasm, breast pain, dysmenorrhoea, menstrual disorder, menorrhagia, vaginitis.
Male reproductive system: Prostatic disorder.
Resistance mechanism disorders: Herpes simplex, herpes zoster, bacterial infection, fungal infection, infection of soft tissue, viral infection, moniliasis, moniliasis genital, otitis media.
Hearing and vestibular: Deafness, ear abnormality, earache, tinnitus.
Heart rate and rhythm: Palpitation, tachycardia.
Respiratory: Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnoea, laryngitis, pneumonia.
Liver and biliary system: Peptic function abnormal, increased AST and ALT.
Musculoskeletal: Arthralgia, arthrosis, accidental fracture, myalgia, neck stiffness, synovitis, tendinitis.
Urinary system: Albuminuria, cystitis, dysuria, haematuria, micturition frequency, renal calculus, urinary incontinence, urinary tract infection.
Metabolic and nutritional: Blood urea nitrogen (BUN), CPK, creatinine, alkaline phosphatase, are increased. Hypercholesterolaemia, hyperglycaemia, hypokalaemia. Bodyweight is also increased.
Psychiatric: Anorexia, anxiety, increased appetite, depression, nervousness, somnolence.
Haemic: Anaemia, ecchymosis, epistaxis, thrombocythaemia.
Skin and appendages: Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, dry skin, increased sweating, urticaria.
Application site disorders: Cellulitis, contact dermatitis, skin nodule.
Special senses: Taste perversion.
Vision: Blurred vision, cataract, conjunctivitis, eye pain, glaucoma.

ContraindicationsView

Celecoxib is contraindicated in patients with known hypersensitivity to Celecoxib. It should not be given to patients who have demonstrated allergic type reactions to Sulphonamides (Celecoxib contains a sulphonamide side chain). Celecoxib should not be given to patients who have demonstrated asthma, urticaria or allergic type reactions after taking Aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic like reactions to NSAIDs have been reported in such patients.

PrecautionsView

Celecoxib, at doses up to 200 mg bid, can be administered without regard to timing of meal. Higher doses (400 mg bid) should be administered with food.

InteractionsView

ACE inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given into consideration in patients taking Celecoxib concomitantly with ACE inhibitors.

Frusemide: NSAIDs can reduce the natriuretic effect of Frusemide and thiazides in some patients.

Aspirin: Celecoxib can be used with low dose Aspirin. However, concomitant administration of Aspirin with Celecoxib may result in an increased rate of gastrointestinal ulceration or similar complications, compared to the use of Celecoxib alone.

Fluconazole: Concomitant administration of Fluconazole at 200 mg qid resulted in a two fold increase in Celecoxib plasma concentration. Celecoxib should be introduced at the lowest recommended dose in patients receiving Fluconazole.

Lithium: Patients on Lithium treatment should be closely monitored when Celecoxib is introduced or withdrawn.

Warfarin: Caution should be used when administering Celecoxib with Warfarin since these patients are at increased risk of bleeding complications.

Co-administration of Celecoxib with aluminium and magnesium-containing antacid should be avoided, because they may reduce the amount of Celecoxib that the body absorbs.

Pregnancy & lactationView

Celecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to fetus. But in late pregnancy Celecoxib should be avoided because it may cause premature closure of ductus arteriosus. It is not known whether Celecoxib is excreted in human milk. Because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from Celecoxib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric usageView

Geriatric: Dose adjustment in the elderly is not generally necessary. However, for patients of less than 50 kg in body weight, initiate therapy at the lowest recommended dose.

Paediatric: The safety and efficacy of Celecoxib is not established in pediatric patients.

Hepatic insufficiency: Celecoxib capsules should be introduced at a reduced dose in patients with moderate hepatic impairment. The use of Celecoxib in patients with severe hepatic impairment is not recommended.

Overdose effectsView

Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. No information is available regarding the removal of Celecoxib by hemodialysis but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose. Emesis and/or activated charcoal and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding.

StorageView

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

Celenta

Celecoxib

Capsule 100 mg Allopathic Drugs for Osteoarthritis

Indications

Spondylitis

Indication detailsView

Celecoxib is indicated-

For the relief of the signs and symptoms of osteoarthritis.
For the relief of the signs and symptoms of rheumatoid arthritis.
For the regression and prevention of colorectal adenomatous polyps in patients with familial adenomatous polyposis (FAP).

Therapeutic classView

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

PharmacologyView

Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor, non-steroidal anti-inflammatory drug (NSAID). It exhibits anti-inflammatory, analgesic and antipyretic properties. The mechanism of action of Celecoxib is believed to be due to the inhibition of prostaglandin synthesis, via the inhibition of cyclooxygenase-2 (COX-2) enzyme. At therapeutic concentration, Celecoxib does not inhibit cyclooxygenase-1 (COX-1) isoenzyme.

DosageView

Osteoarthritis: The recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.

Rheumatoid arthritis: The recommended oral dose is 100 to 200 mg twice daily.

Familial adenomatous polyposis (FAP): Usual medical care for FAP patients should be continued while on Celecoxib. To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg (2x200 mg capsules) twice daily to be taken with food.

Side effectsView

Adverse events occurring in ≥2% of patients at recommended doses - Abdominal pain 4.1%, diarrhoea 5.6%, dyspepsia 8.8%, flatulence 2.2%, nausea 3.5%, back pain 2.8%, peripheral oedema 2.1%, accidental injury 2.9%, dizziness 2.0%, headache 15.8%, insomnia 2.3%, pharyngitis 2.3%, rhinitis 2.0%, sinusitis 5.0%, upper respiratory tract infections 8.1%, rash 2.2%. The following adverse events occurred in 0.1-1.9% of patients-

General: Allergy aggravated, allergic reaction, asthenia, chest pain, oedema generalised, face oedema, fatigue, fever, hot flushes, influenza like symptoms, pain, peripheral pain.
Gastrointestinal: Constipation, diverticulitis, dysphagia, oesophagitis, gastritis, gastroenteritis, gastro-oesophageal reflux disease, haemorrhoids, hiatal hernia, melaena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting.
Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disease, myocardial infarction.
Nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo. Female reproductive system : Breast fibroadenosis, breast neoplasm, breast pain, dysmenorrhoea, menstrual disorder, menorrhagia, vaginitis.
Male reproductive system: Prostatic disorder.
Resistance mechanism disorders: Herpes simplex, herpes zoster, bacterial infection, fungal infection, infection of soft tissue, viral infection, moniliasis, moniliasis genital, otitis media.
Hearing and vestibular: Deafness, ear abnormality, earache, tinnitus.
Heart rate and rhythm: Palpitation, tachycardia.
Respiratory: Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnoea, laryngitis, pneumonia.
Liver and biliary system: Peptic function abnormal, increased AST and ALT.
Musculoskeletal: Arthralgia, arthrosis, accidental fracture, myalgia, neck stiffness, synovitis, tendinitis.
Urinary system: Albuminuria, cystitis, dysuria, haematuria, micturition frequency, renal calculus, urinary incontinence, urinary tract infection.
Metabolic and nutritional: Blood urea nitrogen (BUN), CPK, creatinine, alkaline phosphatase, are increased. Hypercholesterolaemia, hyperglycaemia, hypokalaemia. Bodyweight is also increased.
Psychiatric: Anorexia, anxiety, increased appetite, depression, nervousness, somnolence.
Haemic: Anaemia, ecchymosis, epistaxis, thrombocythaemia.
Skin and appendages: Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, dry skin, increased sweating, urticaria.
Application site disorders: Cellulitis, contact dermatitis, skin nodule.
Special senses: Taste perversion.
Vision: Blurred vision, cataract, conjunctivitis, eye pain, glaucoma.

ContraindicationsView

Celecoxib is contraindicated in patients with known hypersensitivity to Celecoxib. It should not be given to patients who have demonstrated allergic type reactions to Sulphonamides (Celecoxib contains a sulphonamide side chain). Celecoxib should not be given to patients who have demonstrated asthma, urticaria or allergic type reactions after taking Aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic like reactions to NSAIDs have been reported in such patients.

PrecautionsView

Celecoxib, at doses up to 200 mg bid, can be administered without regard to timing of meal. Higher doses (400 mg bid) should be administered with food.

InteractionsView

ACE inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given into consideration in patients taking Celecoxib concomitantly with ACE inhibitors.

Frusemide: NSAIDs can reduce the natriuretic effect of Frusemide and thiazides in some patients.

Aspirin: Celecoxib can be used with low dose Aspirin. However, concomitant administration of Aspirin with Celecoxib may result in an increased rate of gastrointestinal ulceration or similar complications, compared to the use of Celecoxib alone.

Fluconazole: Concomitant administration of Fluconazole at 200 mg qid resulted in a two fold increase in Celecoxib plasma concentration. Celecoxib should be introduced at the lowest recommended dose in patients receiving Fluconazole.

Lithium: Patients on Lithium treatment should be closely monitored when Celecoxib is introduced or withdrawn.

Warfarin: Caution should be used when administering Celecoxib with Warfarin since these patients are at increased risk of bleeding complications.

Co-administration of Celecoxib with aluminium and magnesium-containing antacid should be avoided, because they may reduce the amount of Celecoxib that the body absorbs.

Pregnancy & lactationView

Celecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to fetus. But in late pregnancy Celecoxib should be avoided because it may cause premature closure of ductus arteriosus. It is not known whether Celecoxib is excreted in human milk. Because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from Celecoxib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric usageView

Geriatric: Dose adjustment in the elderly is not generally necessary. However, for patients of less than 50 kg in body weight, initiate therapy at the lowest recommended dose.

Paediatric: The safety and efficacy of Celecoxib is not established in pediatric patients.

Hepatic insufficiency: Celecoxib capsules should be introduced at a reduced dose in patients with moderate hepatic impairment. The use of Celecoxib in patients with severe hepatic impairment is not recommended.

Overdose effectsView

Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. No information is available regarding the removal of Celecoxib by hemodialysis but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose. Emesis and/or activated charcoal and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding.

StorageView

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

Celenta

Celecoxib

Capsule 200 mg Allopathic Drugs for Osteoarthritis

Indications

Spondylitis

Indication detailsView

Celecoxib is indicated-

For the relief of the signs and symptoms of osteoarthritis.
For the relief of the signs and symptoms of rheumatoid arthritis.
For the regression and prevention of colorectal adenomatous polyps in patients with familial adenomatous polyposis (FAP).

Therapeutic classView

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

PharmacologyView

Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor, non-steroidal anti-inflammatory drug (NSAID). It exhibits anti-inflammatory, analgesic and antipyretic properties. The mechanism of action of Celecoxib is believed to be due to the inhibition of prostaglandin synthesis, via the inhibition of cyclooxygenase-2 (COX-2) enzyme. At therapeutic concentration, Celecoxib does not inhibit cyclooxygenase-1 (COX-1) isoenzyme.

DosageView

Osteoarthritis: The recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.

Rheumatoid arthritis: The recommended oral dose is 100 to 200 mg twice daily.

Familial adenomatous polyposis (FAP): Usual medical care for FAP patients should be continued while on Celecoxib. To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg (2x200 mg capsules) twice daily to be taken with food.

Side effectsView

Adverse events occurring in ≥2% of patients at recommended doses - Abdominal pain 4.1%, diarrhoea 5.6%, dyspepsia 8.8%, flatulence 2.2%, nausea 3.5%, back pain 2.8%, peripheral oedema 2.1%, accidental injury 2.9%, dizziness 2.0%, headache 15.8%, insomnia 2.3%, pharyngitis 2.3%, rhinitis 2.0%, sinusitis 5.0%, upper respiratory tract infections 8.1%, rash 2.2%. The following adverse events occurred in 0.1-1.9% of patients-

General: Allergy aggravated, allergic reaction, asthenia, chest pain, oedema generalised, face oedema, fatigue, fever, hot flushes, influenza like symptoms, pain, peripheral pain.
Gastrointestinal: Constipation, diverticulitis, dysphagia, oesophagitis, gastritis, gastroenteritis, gastro-oesophageal reflux disease, haemorrhoids, hiatal hernia, melaena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting.
Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disease, myocardial infarction.
Nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo. Female reproductive system : Breast fibroadenosis, breast neoplasm, breast pain, dysmenorrhoea, menstrual disorder, menorrhagia, vaginitis.
Male reproductive system: Prostatic disorder.
Resistance mechanism disorders: Herpes simplex, herpes zoster, bacterial infection, fungal infection, infection of soft tissue, viral infection, moniliasis, moniliasis genital, otitis media.
Hearing and vestibular: Deafness, ear abnormality, earache, tinnitus.
Heart rate and rhythm: Palpitation, tachycardia.
Respiratory: Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnoea, laryngitis, pneumonia.
Liver and biliary system: Peptic function abnormal, increased AST and ALT.
Musculoskeletal: Arthralgia, arthrosis, accidental fracture, myalgia, neck stiffness, synovitis, tendinitis.
Urinary system: Albuminuria, cystitis, dysuria, haematuria, micturition frequency, renal calculus, urinary incontinence, urinary tract infection.
Metabolic and nutritional: Blood urea nitrogen (BUN), CPK, creatinine, alkaline phosphatase, are increased. Hypercholesterolaemia, hyperglycaemia, hypokalaemia. Bodyweight is also increased.
Psychiatric: Anorexia, anxiety, increased appetite, depression, nervousness, somnolence.
Haemic: Anaemia, ecchymosis, epistaxis, thrombocythaemia.
Skin and appendages: Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, dry skin, increased sweating, urticaria.
Application site disorders: Cellulitis, contact dermatitis, skin nodule.
Special senses: Taste perversion.
Vision: Blurred vision, cataract, conjunctivitis, eye pain, glaucoma.

ContraindicationsView

Celecoxib is contraindicated in patients with known hypersensitivity to Celecoxib. It should not be given to patients who have demonstrated allergic type reactions to Sulphonamides (Celecoxib contains a sulphonamide side chain). Celecoxib should not be given to patients who have demonstrated asthma, urticaria or allergic type reactions after taking Aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic like reactions to NSAIDs have been reported in such patients.

PrecautionsView

Celecoxib, at doses up to 200 mg bid, can be administered without regard to timing of meal. Higher doses (400 mg bid) should be administered with food.

InteractionsView

ACE inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given into consideration in patients taking Celecoxib concomitantly with ACE inhibitors.

Frusemide: NSAIDs can reduce the natriuretic effect of Frusemide and thiazides in some patients.

Aspirin: Celecoxib can be used with low dose Aspirin. However, concomitant administration of Aspirin with Celecoxib may result in an increased rate of gastrointestinal ulceration or similar complications, compared to the use of Celecoxib alone.

Fluconazole: Concomitant administration of Fluconazole at 200 mg qid resulted in a two fold increase in Celecoxib plasma concentration. Celecoxib should be introduced at the lowest recommended dose in patients receiving Fluconazole.

Lithium: Patients on Lithium treatment should be closely monitored when Celecoxib is introduced or withdrawn.

Warfarin: Caution should be used when administering Celecoxib with Warfarin since these patients are at increased risk of bleeding complications.

Co-administration of Celecoxib with aluminium and magnesium-containing antacid should be avoided, because they may reduce the amount of Celecoxib that the body absorbs.

Pregnancy & lactationView

Celecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to fetus. But in late pregnancy Celecoxib should be avoided because it may cause premature closure of ductus arteriosus. It is not known whether Celecoxib is excreted in human milk. Because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from Celecoxib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric usageView

Geriatric: Dose adjustment in the elderly is not generally necessary. However, for patients of less than 50 kg in body weight, initiate therapy at the lowest recommended dose.

Paediatric: The safety and efficacy of Celecoxib is not established in pediatric patients.

Hepatic insufficiency: Celecoxib capsules should be introduced at a reduced dose in patients with moderate hepatic impairment. The use of Celecoxib in patients with severe hepatic impairment is not recommended.

Overdose effectsView

Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. No information is available regarding the removal of Celecoxib by hemodialysis but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose. Emesis and/or activated charcoal and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding.

StorageView

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

Celeste

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.

Celipress

Celiprolol Hydrochloride

Tablet 200 mg Allopathic Beta-blockers

Indications

Lower the blood pressure

Indication detailsView

Celiprolol Hydrochloride belongs to a group of medicines called beta-blockers. It works by slowing your heart rate or lowering your blood pressure. It is used to treat high blood pressure (hypertension).

Therapeutic classView

Beta-blockers

PharmacologyView

Celiprolol is a vasoactive beta-1 selective adrenoceptor antagonist with partial beta-2 agonist activity. The beta-2 agonist activity is thought to account for its mild vasodilating properties. It lowers blood pressure in hypertensive patients at rest and on exercise. The effects on heart rate and cardiac output are dependent on the pre-existing background level of sympathetic tone. Under conditions of stress such as exercise, celiprolol attenuates chronotropic and inotropic responses to sympathetic stimulation. However, at rest minimal impairment of cardiac function is seen.

DosageView

Adults including the elderly: the recommended starting dose is 200 mg of Celiprolol Hydrochloride once a day. If needed after 2 to 4 weeks, your doctor will increase your dose to 400 mg once a day. The maximum dose is 400 mg once a day. If you have the impression that the effect of Celiprolol Hydrochloride tablets is too strong or too weak, talk to your doctor or pharmacist.

Adults with liver or kidney problems: if you have kidney problems, your doctor may give you a lower dose than stated above and increase it as needed. A reduction in dosage by half may be appropriate in patients with moderate impairment of kidney function (creatinine clearance in the range of 15-40 ml per minute). Celiprolol Hydrochloride is not recommended for patients with severely impaired kidney function (creatinine clearance less than 15 ml per minute). Use of low doses of Celiprolol Hydrochloride is recommended in patients with liver problems.

AdministrationView

Always take this medicine exactly as your doctor has told you. Swallow the tablets whole with a glass of water. Take the tablets preferably first thing in the morning, one hour before food or two hours after food. To help you remember to take your medicine, try to get into the habit of taking it at the same time each day, preferably first thing in the morning.

Side effectsView

Serious side effects: Allergic reaction: a rash, swallowing or breathing problems, swelling of your face, lips, throat or tongue. You get flu like symptoms, swollen or painful joints, increased sensitivity to sunlight, hair loss, abdominal pain, anaemia. This may mean you have a condition called Systemic Lupus Erythematosus (SLE). These symptoms will usually go away after Celiprolol Hydrochloride has been stopped. These are very serious side effects. If you have them you may have had a serious allergic reaction to Celiprolol Hydrochloride. You may need urgent medical attention or hospitalization.

Common side effects (may affect up to 1 in 10 people): Dizziness or light headedness, weakness, or fainting especially when standing up from a lying position. These could be signs of low blood pressure. Skin rashes, excessive itching

ContraindicationsView

Do not take Celiprolol Hydrochloride if you:

are allergic to celiprolol hydrochloride or any of the ingredients of this medicine. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
have suffered an allergic reaction to a beta-blocker (propranolol, sotalol, timolol etc.) in the past
suffer from an irregular/very slow heartbeat (known as bradycardia) or low blood pressure (hypotension)
suffer from heart failure which is not under control (heart failure is a condition in which your heart is not pumping blood as well as it should), have an abnormal heart rhythm, difficulty breathing and swollen ankles
suffer from missed heart beats (heart block) or other heart problems or you suffer from hardened arteries
have severe kidney problems
have, or have had, episodes of asthma, wheezing or other severe breathing problems
have a rare tumour called a phaeochromocytoma that is not being treated
have abnormal levels of acid in your blood (metabolic acidosis), usually as a result of severe illness
are already taking theophylline (an anti-asthma medicine).
have late stage peripheral arterial occlusive disease or Raynaud’s syndrome.

PrecautionsView

Take special care and consult your doctor before taking Celiprolol Hydrochloride if you:

have liver or kidney problems
have Prinzmetal’s angina (chest pain while resting)
have poor blood circulation e.g. Raynaud’s, Burger’s Disease. Symptoms of Raynaud’s disease include fingers and toes changing colour when cold and tingling or painful on warming up. Your doctor will closely monitor you while taking this medicine.
have inadequate circulation of blood through the coronary arteries.
have ever had a skin condition known as psoriasis. Your doctor will stop this medicine if you have.
have asthma or breathing problems due to long term lung problems (called bronchitis or emphysema)
have a thyroid problem as the effects of an overactive thyroid gland (thyrotoxicosis) may be hidden by beta blocker medicine
have a history of severe allergies, particularly to other medicines, including anaphylactic reactions
need anti-allergic treatment eg. following a wasp or bee sting; your doctor may wish to interupt your Celiprolol Hydrochloride treatment to prevent a possible allergic reaction.
are diabetic. Patients with diabetes should be aware that the symptoms of low blood pressure (hypoglycaemia) may be hidden by beta blocker medicines
have any heart failure that is under control with medication. Your doctor will give this medicine under strict medical surveillance
have a slow or irregular heartbeat.

Pregnancy & lactationView

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advise before taking this medicine. If your doctor cannot find any safer alternative you may be given Celiprolol Hydrochloride. If you take Celiprolol Hydrochloride during pregnancy, you should tell your midwife. In the new born of the treated mother, activity of these kind of medicines remains for several days. The effects can include slow heart beat, heart failure or having trouble breathing. Therefore close monitoring of the neonate is recommended for the first 3 to 5 days of life. If you are already taking Celiprolol Hydrochloride and have just found out you are pregnant, you should talk to your doctor immediately. You should not breast-feed if you are taking Celiprolol Hydrochloride. If you are breast-feeding or planning to breast-feed you should talk to your doctor or pharmacist before taking this medicine.

Pediatric usageView

Use in children: Celiprolol Hydrochloride is not recommended for use in children.

Use in elderly: Your doctor may decide to lower your dose of Celiprolol Hydrochloride if necessary.

Overdose effectsView

You may have symptoms such as slow heart beats, low blood pressure, feeling dizzy or weak, difficulty in breathing, wheezing or heart problems. Contact your doctor or go to the nearest hospital causalty department immediately. Take this leaflet or some tablets with you so your doctor will know what you have taken.

StorageView

Keep container in the outer carton. Do not store above 25°C. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Celipress

Celiprolol Hydrochloride

Tablet 400 mg Allopathic Beta-blockers

Indications

Lower the blood pressure

Indication detailsView

Celiprolol Hydrochloride belongs to a group of medicines called beta-blockers. It works by slowing your heart rate or lowering your blood pressure. It is used to treat high blood pressure (hypertension).

Therapeutic classView

Beta-blockers

PharmacologyView

Celiprolol is a vasoactive beta-1 selective adrenoceptor antagonist with partial beta-2 agonist activity. The beta-2 agonist activity is thought to account for its mild vasodilating properties. It lowers blood pressure in hypertensive patients at rest and on exercise. The effects on heart rate and cardiac output are dependent on the pre-existing background level of sympathetic tone. Under conditions of stress such as exercise, celiprolol attenuates chronotropic and inotropic responses to sympathetic stimulation. However, at rest minimal impairment of cardiac function is seen.

DosageView

Adults including the elderly: the recommended starting dose is 200 mg of Celiprolol Hydrochloride once a day. If needed after 2 to 4 weeks, your doctor will increase your dose to 400 mg once a day. The maximum dose is 400 mg once a day. If you have the impression that the effect of Celiprolol Hydrochloride tablets is too strong or too weak, talk to your doctor or pharmacist.

Adults with liver or kidney problems: if you have kidney problems, your doctor may give you a lower dose than stated above and increase it as needed. A reduction in dosage by half may be appropriate in patients with moderate impairment of kidney function (creatinine clearance in the range of 15-40 ml per minute). Celiprolol Hydrochloride is not recommended for patients with severely impaired kidney function (creatinine clearance less than 15 ml per minute). Use of low doses of Celiprolol Hydrochloride is recommended in patients with liver problems.

AdministrationView

Always take this medicine exactly as your doctor has told you. Swallow the tablets whole with a glass of water. Take the tablets preferably first thing in the morning, one hour before food or two hours after food. To help you remember to take your medicine, try to get into the habit of taking it at the same time each day, preferably first thing in the morning.

Side effectsView

Serious side effects: Allergic reaction: a rash, swallowing or breathing problems, swelling of your face, lips, throat or tongue. You get flu like symptoms, swollen or painful joints, increased sensitivity to sunlight, hair loss, abdominal pain, anaemia. This may mean you have a condition called Systemic Lupus Erythematosus (SLE). These symptoms will usually go away after Celiprolol Hydrochloride has been stopped. These are very serious side effects. If you have them you may have had a serious allergic reaction to Celiprolol Hydrochloride. You may need urgent medical attention or hospitalization.

Common side effects (may affect up to 1 in 10 people): Dizziness or light headedness, weakness, or fainting especially when standing up from a lying position. These could be signs of low blood pressure. Skin rashes, excessive itching

ContraindicationsView

Do not take Celiprolol Hydrochloride if you:

are allergic to celiprolol hydrochloride or any of the ingredients of this medicine. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
have suffered an allergic reaction to a beta-blocker (propranolol, sotalol, timolol etc.) in the past
suffer from an irregular/very slow heartbeat (known as bradycardia) or low blood pressure (hypotension)
suffer from heart failure which is not under control (heart failure is a condition in which your heart is not pumping blood as well as it should), have an abnormal heart rhythm, difficulty breathing and swollen ankles
suffer from missed heart beats (heart block) or other heart problems or you suffer from hardened arteries
have severe kidney problems
have, or have had, episodes of asthma, wheezing or other severe breathing problems
have a rare tumour called a phaeochromocytoma that is not being treated
have abnormal levels of acid in your blood (metabolic acidosis), usually as a result of severe illness
are already taking theophylline (an anti-asthma medicine).
have late stage peripheral arterial occlusive disease or Raynaud’s syndrome.

PrecautionsView

Take special care and consult your doctor before taking Celiprolol Hydrochloride if you:

have liver or kidney problems
have Prinzmetal’s angina (chest pain while resting)
have poor blood circulation e.g. Raynaud’s, Burger’s Disease. Symptoms of Raynaud’s disease include fingers and toes changing colour when cold and tingling or painful on warming up. Your doctor will closely monitor you while taking this medicine.
have inadequate circulation of blood through the coronary arteries.
have ever had a skin condition known as psoriasis. Your doctor will stop this medicine if you have.
have asthma or breathing problems due to long term lung problems (called bronchitis or emphysema)
have a thyroid problem as the effects of an overactive thyroid gland (thyrotoxicosis) may be hidden by beta blocker medicine
have a history of severe allergies, particularly to other medicines, including anaphylactic reactions
need anti-allergic treatment eg. following a wasp or bee sting; your doctor may wish to interupt your Celiprolol Hydrochloride treatment to prevent a possible allergic reaction.
are diabetic. Patients with diabetes should be aware that the symptoms of low blood pressure (hypoglycaemia) may be hidden by beta blocker medicines
have any heart failure that is under control with medication. Your doctor will give this medicine under strict medical surveillance
have a slow or irregular heartbeat.

Pregnancy & lactationView

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advise before taking this medicine. If your doctor cannot find any safer alternative you may be given Celiprolol Hydrochloride. If you take Celiprolol Hydrochloride during pregnancy, you should tell your midwife. In the new born of the treated mother, activity of these kind of medicines remains for several days. The effects can include slow heart beat, heart failure or having trouble breathing. Therefore close monitoring of the neonate is recommended for the first 3 to 5 days of life. If you are already taking Celiprolol Hydrochloride and have just found out you are pregnant, you should talk to your doctor immediately. You should not breast-feed if you are taking Celiprolol Hydrochloride. If you are breast-feeding or planning to breast-feed you should talk to your doctor or pharmacist before taking this medicine.

Pediatric usageView

Use in children: Celiprolol Hydrochloride is not recommended for use in children.

Use in elderly: Your doctor may decide to lower your dose of Celiprolol Hydrochloride if necessary.

Overdose effectsView

You may have symptoms such as slow heart beats, low blood pressure, feeling dizzy or weak, difficulty in breathing, wheezing or heart problems. Contact your doctor or go to the nearest hospital causalty department immediately. Take this leaflet or some tablets with you so your doctor will know what you have taken.

StorageView

Keep container in the outer carton. Do not store above 25°C. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Cellcept

Mycophenolate Mofetil

Tablet 500 mg Allopathic Immunosuppressant

Indications

Vasculitis

Indication detailsView

Mycophenolate Mofetil in combination with corticosteroids and either ciclosporin or tacrolimus is indicated for-

Prophylaxis of acute organ rejection and treatment of first or refractory organ rejection in patients receiving allogeneic renal transplants.
Prophylaxis of acute organ rejection in patients receiving allogeneic cardiac transplants.
Prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplants.
Mycophenolate Mofetil is indicated for induction and maintenance therapy of patients with Class III-V lupus nephritis (diagnosed according to International Society of Nephrology/Renal Pathology Society classification.

Therapeutic classView

Immunological Chemotherapy, Immunosuppressant

PharmacologyView

Mechanism of Action: Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA). MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis. The mechanism by which MPA inhibits the enzymatic activity of IMPDH appears to be related to the ability of MPA to structurally mimic both nicotinamide adenine dinucleotide cofactor and a catalytic water molecule. This prevents the oxidation of IMP to xanthose-5’-monophosphate which is the committed step in de novo guanosine nucleotide biosynthesis. MPA has more potent cytostatic effects on lymphocytes than on other cells because T- and B lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilize salvage pathways.

Pharmacodynamics: Mycophenolic acid, the active metabolite of mycophenolate mofetil, is a non-competitive, reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). Inhibition of IMPDH blocks the de novo synthesis of guanosine nucleotides which are necessary substrates for DNA and RNA synthesis. Unlike other cell types which can use the salvage pathway, B and T lymphocytes are dependent upon the de novo pathway for the generation of guanosine. Data from in vitro studies indicate that mycophenolic acid and/or mycophenolate mofetil inhibit mixed lymphocyte responses and human peripheral blood lymphocyte proliferation induced by a variety of mitogens and antigens. Mycophenolic acid decreases intracellular pools of guanosine triphosphate (GTP) and deoxyguanosine triphosphate (dGTP) in mitogen-stimulated human peripheral blood monocytes or T lymphocytic cell lines but has no effect on GTP concentrations in human neutrophils.

DosageView

Transplant patients:
Standard dosage for prophylaxis of renal rejection

Adults: A dose of 1 g administered orally twice a day (daily dose of 2 g) is recommended for use in renal transplant patients.
Children (aged 3 months to 18 years): Patients with a body surface area of 1.25 to 1.5 m² may be prescribed Mycophenolate Mofetil Tablets at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area >1.5 m² may be prescribed Mycophenolate Mofetil tablets at a dose of 1 gm twice daily (2 g daily dose).

Standard dosage for prophylaxis of cardiac rejection-

Adults: A dose of 1.5 g administered orally (over not less than 2 hour) twice a day (daily dose of 3 g) is recommended for use in cardiac transplant patients.
Children: no data are available for pediatric cardiac transplant patients.

Standard dosage for prophylaxis of hepatic rejection-

Adults: A dose of 1.5 g orally twice a day (daily dose of 3 g) is recommended for use in hepatic transplant patients
Children: no data are available for pediatric hepatic transplant patients.

Standard dosage for treatment of first or refractory renal rejection-

Adults: A dose of 1.5 g administered orally twice a day (daily dose of 3 g) is recommended for management of first or refractory rejection.
Children: no data are available for the treatment of first or refractory renal rejection in pediatric renal transplant patients.

Lupus nephritis patients:
Standard Dosage for Induction Therapy-

Adults: A dose of 750 mg-1.5 g administered orally twice a day (daily dose of up to 3 g) is recommended
Children: A dose of 600 mg/m² administered orally twice a day (up to a maximum of 2 g daily) is recommended

Standard Dosage for Maintenance Therapy-

Adults: A dose of 500 mg-1 g administered orally twice a day is recommended
Children: A dose of 300 mg/m² administered orally twice a day is recommended

Mycophenolate Mofetil should be used in combination with corticosteroids. Doses should be introduced gradually and adjusted according to clinical response. Therapeutic drug monitoring could help prevent sub-therapeutic exposure (Cmin≥3.0 mg/L or inter-dose AUC ≥35 h*mg/L).

Side effectsView

The principal adverse reactions associated with the administration of Mycophenolate Mofetil includes diarrhea, leukopenia, sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, vomiting and there is evidence of a higher frequency of certain types of infections eg. opportunistic infections.

ContraindicationsView

Mycophenolic acid is contraindicated in patients with a hypersensitivity to mycophenolic acid, or to any of its excipients. Mycophenolic acid is contraindicated during pregnancy due to its mutagenic and teratogenic potential. Mycophenolic acid is contraindicated in women who are breastfeeding.

PrecautionsView

Mycophenolic acid tablets are used with caution because it-

Can increase new or reactive viral infections. Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation, or infections caused by polyomaviruses.
Can cause blood dyscrasias including pure red cell aplasia (PRCA).
Can cause serious GI tract complications (gastrointestinal bleeding, perforations and ulcers).
May increase the risk of developing lymphomas and other malignancies, particularly of the skin.
Use of live vaccines should be avoided during treatment with Mycophenolic acid.
Patients should not donate blood during therapy.

InteractionsView

Caution should be exercised with concomitant administration of Antacids, Azathioprine, Cyclosporin, Rifampin, Sevelamer, Cholestyramine, Acyclovir, Metronidazole, Hormonal contraceptives as these medicines may decrease Mycophenolic acid concentration.

Pregnancy & lactationView

Mycophenolate Mofetil is contraindicated in pregnancy and during breastfeeding. The safe use of Mycophenolate Mofetil during labor and delivery has not been established.

Pediatric usageView

Geriatric population: Geriatric patients may be at an increased risk of adverse events such as certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal hemorrhage and pulmonary edema, compared with younger individuals.

Overdose effectsView

In many of these cases no adverse events were reported. It is expected that an overdose of mycophenolate mofetil could possibly result in over suppression of the immune system and increase susceptibility to infections and bone marrow suppression. If neutropenia develops, dosing with Mycophenolate Mofetil should be interrupted or the dose reduced.

StorageView

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

Celofen

Aceclofenac

Tablet 100 mg Allopathic Drugs for Osteoarthritis

Indications

Spondylitis

Indication detailsView

Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.

Therapeutic classView

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

PharmacologyView

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

DosageView

Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.

Side effectsView

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

ContraindicationsView

Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.

PrecautionsView

Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.

InteractionsView

No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:

Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
Diuretics: may interact the activity of diuretics.
Anticoagulants: may enhance the activity of anticoagulant.
Methotrexate: may increase the plasma level of methotrexate.

Pregnancy & lactationView

The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Pediatric usageView

There are no clinical data on the use of Aceclofenac in children.

StorageView

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

Celozin

Cetirizine Hydrochloride

Tablet 10 mg Allopathic Sedating Anti-histamine

Indications

Urticaria

Indication detailsView

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Therapeutic classView

Sedating Anti-histamine

PharmacologyView

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

DosageView

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

Side effectsView

The most common side effects that occurred more frequently on Cetirizine is somnolence.

ContraindicationsView

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

PrecautionsView

Caution should be exercised when driving a car or operating a heavy machinery.

InteractionsView

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

Pregnancy & lactationView

US FDA Pregnancy Category of Cetirizine Hydrochloride is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

StorageView

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

Celozin

Cetirizine Hydrochloride

Syrup 5 mg/5 ml Allopathic Sedating Anti-histamine

Indications

Urticaria

Indication detailsView

It is indicated for the relief of symptoms associated with seasonal & perennial allergic rhinitis. It is also indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria and allergen induced asthma.

Therapeutic classView

Sedating Anti-histamine

PharmacologyView

Cetirizine Hydrochloride is a potent H1 receptor antagonist without any significant anticholinergic and antiserotonic effects. At pharmacologically active dose levels, it has almost no drowsiness effect and does not cause behavioral changes. It inhibits the histamine-mediated early phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the late phase of the allergic reaction.

Pharmacokinetics: Cetirizine 10 mg achieves peak plasma concentrations of 257 mcg/L within one hour of administration (980 mcg/L in children). Food does not affect the extent of absorption, but it may slightly reduce the rate. Peak blood levels 0.3 micrograms/ml are reached between thirty & sixty minutes after administration of 10 mg dose of Cetirizine. Its plasma half-life is approximately 11 hours. Absorption is very consistent from one subject to the next. Its renal clearance is 30 ml/minute and the excretion half-life is approximately nine hours.

DosageView

Adults and Children 6 years and older: 1 tablet or 2 teaspoonfuls daily (or 1 teaspoonful twice daily).

Children 2-6 years: 1 teaspoonful once daily or 1/2 teaspoonful twice daily.

Children 6 months to 2 years : 1/2 teaspoonful once daily. The dose in children 12-23 months of age can be increased to a maximum dose as 1/2 teaspoonful every 12 hours.

Side effectsView

The most common side effects that occurred more frequently on Cetirizine is somnolence.

ContraindicationsView

It is contraindicated in patients with a history of hypersensitivity to Cetirizine or hydroxyzine.

PrecautionsView

Caution should be exercised when driving a car or operating a heavy machinery.

InteractionsView

No clinically significant drug interactions have been found with Theophylline, Azithromycin, Pseudoephedrine, Ketoconazole or Erythromycin and with other drugs.

Pregnancy & lactationView

US FDA Pregnancy Category of Cetirizine Hydrochloride is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cetirizine Hydrochloride has been shown to be excreted in human milk. So, caution should be exercised when Cetirizine Hydrochloride is administered to a nursing woman.

StorageView

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

Celudex

Betamethasone Sodium Phosphate

Ophthalmic Solution 0.10% Allopathic Corticosteroid

Indications

Ocular infections

Indication detailsView

Short-term treatment of steroid responsive in inflammatory conditions of the eye after clinical exclusion of bacterial, viral or fungal infections. Non-infected inflammatory conditions of the ear or nose.

Therapeutic classView

Corticosteroid

PharmacologyView

Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Betamethasone phosphate has a short duration of action as it is rapidly hydrolyzed to betamethasone. Corticosteroids have a wide therapeutic window as patients may require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.

DosageView

Eye: 1 or 2 drops to each affected eye every 1 or 2 hours until control is achieved, then the frequency may be reduced.
Ear: 2 or 3 drops to each affected ear every 2 or 3 hours until control is achieved, then the frequency may be reduced.
Nose: 2 or 3 drops instilled into each nostril 2 or 3 times daily.

Side effectsView

Hypersensitivity reactions may occur leading to irritation, burning, stinging, itching and dermatitis. Topical corticosteroid use may result in corneal ulceration, increased intraocular pressure leading to optic nerve damage, reduced visual acuity. Intensive or prolonged use of topical corticosteroids may lead to formation of posterior subcapsular cataracts. In those diseases causing thinning of the cornea or sclera, corticosteroid therapy may result in thinning of the globe leading to perforation. Mydriasis, ptosis and epithelial punctate keratitis have also been reported following ophthalmic use of corticosteroids.

PrecautionsView

Topical corticosteroids should never be given for an undiagnosed red eye. Ophthalmic treatment with corticosteroid preparations should not be repeated or prolonged without regular review to exclude raised intraocular pressure, cataract formation or unsuspected infections.

InteractionsView

Specific drug interaction studies have not been conducted.

Pregnancy & lactationView

There are no adequate and well controlled studies for pregnant woman. It should not be used extensively in pregnant woman. There is no information available whether it is secreted in the milk or not.

Overdose effectsView

Long-term intensive topical use may lead to systemic effects.

StorageView

This should be protected from light, store below 25°C. Keep out of reach of children. Do not use more than 4 weeks after opening.

Celutis

Tedizolid Phosphate

Tablet 200 mg Allopathic

Indications

Complicated skin and skin structure infections

Indication detailsView

Tedizolid is an oxazolidinone-class antibacterial drug indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tedizolid and other antibacterial drugs, Tedizolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria

Therapeutic classView

Other antibiotic

PharmacologyView

After conversion to its active form by phosphatases, tedizolid exerts its antibacterial activity through inhibition of protein synthesis by binding to the 50S ribosomal subunit of susceptible Gram-positive bacteria. Cross-resistance between other non-oxazolidinone antibacterial drugs is unlikely as it inhibits bacterial protein synthesis through a different mechanism.

DosageView

Acute Bacterial Skin and Skin Structure Infection (ABSSSI):

Intravenous: 200 mg Once daily 1 hour (Infusion Time) for 6 days
Oral: 200 mg Once daily for 6 days

No dose adjustment is necessary when changing from intravenous to oral Tedizolid. If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.

Side effectsView

The most common adverse reactions (>2%) are nausea, headache, diarrhea, vomiting, and dizziness

ContraindicationsView

None

PrecautionsView

Patients with neutropenia: The safety and efficacy of Tedizolid in patients with neutropenia (neutrophil counts <1000 cells/mm3) have not been adequately evaluated. In an animal model of infection, the antibacterial activity of Tedizolid was reduced in the absence of granulocytes. Consider alternative therapies in neutropenic patients.

Clostridium difficile-associated diarrhea: Evaluate if diarrhea occurs.

InteractionsView

Tedizolid (when administered orally) can increase the plasma concentrations of orally administered Breast Cancer Resistance Protein BCRP substrates. Monitor for adverse reactions related to the concomitant BCRP substrates if coadministration cannot be avoided

Pregnancy & lactationView

Pregnancy category C. There are no adequate and well-controlled studies of Tedizolid in pregnant women. Tedizolid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Tedizolid is excreted in the breast milk of rats. It is not known whether tedizolid is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tedizolid is administered to a nursing woman.

Pediatric usageView

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

Geriatric Use: Clinical studies of Tedizolid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No overall differences in pharmacokinetics were observed between elderly subjects and younger subjects

Overdose effectsView

In the event of overdosage, Tedizolid should be discontinued and general supportive treatment given. Hemodialysis does not result in meaningful removal of tedizolid from systemic circulation

StorageView

Tablets and injection should be stored at 20°C to 25°C

Cemaxi

Cefixime Trihydrate

Capsule 200 mg Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView

Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:

Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

DosageView

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

½-1 year: 75 mg daily.
1-4 years: 100 mg daily.
5-10 years: 200 mg daily.
11-12 years: 300 mg daily
In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

Side effectsView

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

ContraindicationsView

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

PrecautionsView

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

InteractionsView

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

Pregnancy & lactationView

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Overdose effectsView

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

StorageView

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Cemaxi

Cefixime Trihydrate

Powder for Suspension 100 mg/5 ml Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView

Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:

Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

DosageView

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

½-1 year: 75 mg daily.
1-4 years: 100 mg daily.
5-10 years: 200 mg daily.
11-12 years: 300 mg daily
In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

Side effectsView

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

ContraindicationsView

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

PrecautionsView

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

InteractionsView

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

Pregnancy & lactationView

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Overdose effectsView

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

StorageView

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Cemix-3

Cefixime Trihydrate

Powder for Suspension 100 mg/5 ml Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView

Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:

Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

DosageView

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

½-1 year: 75 mg daily.
1-4 years: 100 mg daily.
5-10 years: 200 mg daily.
11-12 years: 300 mg daily
In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

Side effectsView

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

ContraindicationsView

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

PrecautionsView

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

InteractionsView

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

Pregnancy & lactationView

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Overdose effectsView

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

StorageView

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.

Cemix-3

Cefixime Trihydrate

Capsule 200 mg Allopathic Third generation Cephalosporins

Indications

Urethritis

Indication detailsView

Cefixime is indicated in the treatment of the following infections when caused by the susceptible strains of the designated microorganisms:

Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
Otitis Media caused by Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.
Uncomplicated gonorrhoea (cervical/urethral) caused by Neisseria gonorrhoeae.

Therapeutic classView

Third generation Cephalosporins

PharmacologyView

Cefixime is a third generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of gram positive and gram negative bacteria at easily achievable plasma concentrations. It kills bacteria by interfering in the synthesis of bacterial cell wall. It is highly stable in the presence of Beta-lactamase enzyme. As a result, many organisms resistant to penicillins and some cephalsporins due to the presence of beta-lactamases, may be susceptible to Cefixime. Absorption of it is about 40% to 50% whether administered with or without food.

DosageView

The usual course of treatment is 7 days. This may be continued for up to 14 days depending on the severity of the infection.

Adult and children over 12 years: The recommended adult dose is 200-400 mg (1 to 2 capsules) daily, given either as a single dose or in two divided doses. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of Cefixime 400 mg is recommended.

Children (6 month or older): Usually 8 mg/kg/day given as a single dose or in two divided doses or may be given as following

½-1 year: 75 mg daily.
1-4 years: 100 mg daily.
5-10 years: 200 mg daily.
11-12 years: 300 mg daily
In typhoid fever, dosage should be 10 mg/kg/day for 14 days.

Children (under 6 month): The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

Side effectsView

The drug is generally well tolerated. The most frequent side effects are diarrhoea and stool changes; that have been more commonly associated with higher doses. Other side effects are nausea, abdominal pain, dyspepsia, vomiting, flatulence, headache and dizziness. Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been reported. These reactions usually subsided upon dicontinuation of therapy.

ContraindicationsView

It is contraindicated in hypersensitivity to Cefixime or other cephalosporins.

PrecautionsView

The drug should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. The drug should be given with caution in patients with marked impaired renal function as well as those undergoing continuous ambulatory peritoneal dialysis and hemodialysis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min), in that case a dose of 200 mg once daily should not be exceeded.

InteractionsView

Carbamazepine: Concomitant use elevates the carbamazepine level. Warfarin and other anticoagulants: Concomitant use increases prothrombin time.

Pregnancy & lactationView

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known that Cefixime is excreted in human milk. So, caution should be exercised when Cefixime is administered to a nursing woman.

Overdose effectsView

Gastric Lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

StorageView

Keep below 30ºC temperature, protected from light & moisture. Keep out of the reach of children.