Clarithromycin (Clarithromycin)

Trade Name : Clarithromycin

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 250 mg/1

CLARITHROMYCIN Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Clarithromycin (Clarithromycin) which is also known as Clarithromycin and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 250 mg/1 per ml. Read more

Clarithromycin (Clarithromycin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets USP and other antibacterial drugs, clarithromycin tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
  • Clarithromycin, USP is a semi-synthetic macrolide antibiotic. Chemically, it is 6--methylerythromycin. The structural formula is:
  • CHNO M.W. 747.96
  • Clarithromycin, USP is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water.
  • Clarithromycin is available as immediate-release tablets.
  • Each yellow, film-coated, oval-shaped clarithromycin tablet USP for oral administration contains 250 mg of clarithromycin, USP and each light-yellow, film-coated, oval-shaped clarithromycin tablet for oral administration contains 500 mg of clarithromycin, USP. Each tablet of both strengths contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow #10 aluminum lake, FD&C blue #2 indigo carmine aluminum lake, FD&C red #40 allura red AC aluminum lake, hypromellose, magnesium hydroxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, titanium dioxide, and vanillin.
  • No data
  • Clarithromycin tablets USP are indicated for the treatment of mild to moderate infections caused by susceptible isolates of the designated bacteria in the conditions as listed below:
  • Clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics.
  • Clarithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin.
  • Concomitant administration of clarithromycin and any of the following drugs is contraindicated: cisapride, pimozide, astemizole, terfenadine, and ergotamine or dihydroergotamine (see ). There have been postmarketing reports of drug interactions when clarithromycin and/or erythromycin are coadministered with cisapride, pimozide, astemizole, or terfenadine resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and) most likely due to inhibition of metabolism of these drugs by erythromycin and clarithromycin. Fatalities have been reported.
  • Concomitant administration of clarithromycin and colchicine is contraindicated in patients with renal or hepatic impairment.
  • Clarithromycin should not be given to patients with history of QT prolongation or ventricular cardiac arrhythmia, including .
  • Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis (see ).
  • For information about contraindications of other drugs indicated in combination with clarithromycin, refer to the section of their package inserts.
  • No data
  • No data
  • The most frequent and common adverse reactions related to clarithromycin therapy for both adult and pediatric populations are abdominal pain, diarrhea, nausea, vomiting and dysgeusia. These adverse reactions are consistent with the known safety profile of macrolide antibiotics.
  • There was no significant difference in the incidence of these gastrointestinal adverse reactions during clinical trials between the patient population with or without preexisting mycobacterial infections.
  • Adverse Reactions Observed During Clinical Trials of Clarithromycin
  • The following adverse reactions were observed in clinical trials with clarithromycin at a rate greater than or equal to 1%:
  • Gastrointestinal Disorders
  • Diarrhea, vomiting, dyspepsia, nausea, abdominal pain
  • Hepatobiliary Disorders
  • Liver function test abnormal
  • Immune System Disorders
  • Anaphylactoid reaction
  • Infection and Infestations
  • Candidiasis
  • Nervous System Disorders
  • Dysgeusia, headache
  • Psychiatric Disorders
  • Insomnia
  • Skin and Subcutaneous Tissue Disorders
  • Rash
  • Other Adverse Reactions Observed During Clinical Trials of Clarithromycin
  • The following adverse reactions were observed in clinical trials with clarithromycin at a rate less than 1%:
  • Blood and Lymphatic System Disorders
  • Leukopenia, neutropenia, thrombocythemia, eosinophilia
  • Cardiac Disorders
  • Electrocardiogram QT prolonged, cardiac arrest, atrial fibrillation, extrasystoles, palpitations
  • Ear and Labyrinth Disorders
  • Vertigo, tinnitus, hearing impaired
  • Gastrointestinal Disorders
  • Stomatitis, glossitis, esophagitis, gastroesophageal reflux disease, gastritis, proctalgia, abdominal distension, constipation, dry mouth, eructation, flatulence
  • General Disorders and Administration Site Conditions
  • Malaise, pyrexia, asthenia, chest pain, chills, fatigue
  • Hepatobiliary Disorders
  • Cholestasis, hepatitis
  • Immune System Disorders
  • Hypersensitivity
  • Infections and Infestations
  • Cellulitis, gastroenteritis, infection, vaginal infection
  • Investigations
  • Blood bilirubin increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, albumin globulin ratio abnormal
  • Metabolism and Nutrition Disorders
  • Anorexia, decreased appetite
  • Musculoskeletal and Connective Tissue Disorders
  • Myalgia, muscle spasms, nuchal rigidity
  • Nervous System Disorders
  • Dizziness, tremor, loss of consciousness, dyskinesia, somnolence
  • Psychiatric Disorders
  • Anxiety, nervousness
  • Renal and Urinary Disorders
  • Blood creatinine increased, blood urea increased
  • Respiratory, Thoracic and Mediastinal Disorders
  • Asthma, epistaxis, pulmonary embolism
  • Skin and Subcutaneous Tissue Disorders
  • Urticaria, dermatitis bullous, pruritus, hyperhidrosis, rash maculo-papular
  • In the acute exacerbation of chronic bronchitis and acute maxillary sinusitis studies overall gastrointestinal adverse events were reported by a similar proportion of patients taking either clarithromycin tablets or clarithromycin extended-release tablets; however, patients taking clarithromycin extended-release tablets reported significantly less severe gastrointestinal symptoms compared to patients taking clarithromycin tablets. In addition, patients taking clarithromycin extended-release tablets had significantly fewer premature discontinuations for drug-related gastrointestinal or abnormal taste adverse events compared to clarithromycin tablets.
  • In community-acquired pneumonia studies conducted in adults comparing clarithromycin to erythromycin base or erythromycin stearate, there were fewer adverse events involving the digestive system in clarithromycin-treated patients compared to erythromycin-treated patients (13% vs. 32%; p < 0.01). Twenty percent of erythromycin-treated patients discontinued therapy due to adverse events compared to 4% of clarithromycin-treated patients.
  • In two U.S. studies of acute otitis media comparing clarithromycin to amoxicillin/potassium clavulanate in pediatric patients, there were fewer adverse events involving the digestive system in clarithromycin-treated patients compared to amoxicillin/potassium clavulanate-treated patients (21% vs. 40%, p < 0.001). One-third as many clarithromycin-treated patients reported diarrhea as did amoxicillin/potassium clavulanate-treated patients.
  • The following adverse reactions have been identified during post approval use of clarithromycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Blood and Lymphatic System Disorders
  • Thrombocytopenia, agranulocytosis
  • Cardiac Disorders
  • Torsades de pointes
  • Ear and Labyrinth Disorders
  • Deafness was reported chiefly in elderly women and was usually reversible.
  • Gastrointestinal Disorders
  • Pancreatitis acute, tongue discoloration, tooth discoloration was reported and was usually reversible with professional cleaning upon discontinuation of the drug.
  • Hepatobiliary Disorders
  • Hepatic failure, jaundice hepatocellular. Adverse reactions related to hepatic dysfunction have been reported with clarithromycin (see ).
  • Immune System Disorders
  • Anaphylactic reaction
  • Infections and Infestations
  • Pseudomembranous colitis
  • Investigations
  • Prothrombin time prolonged, white blood cell count decreased, international normalized ratio increased. Abnormal urine color has been reported, associated with hepatic failure.
  • Metabolism and Nutrition Disorders
  • Hypoglycemia has been reported in patients taking oral hypoglycemic agents or insulin.
  • Musculoskeletal and Connective Tissue Disorders
  • Myopathy, rhabdomyolysis was reported and in some of the reports, clarithromycin was administered concomitantly with statins, fibrates, colchicine or allopurinol (see and ).
  • Nervous System Disorders
  • Convulsion, ageusia, parosmia, anosmia, paraesthesia
  • Psychiatric Disorders
  • Psychotic disorder, confusional state, depersonalization, depression, disorientation, manic behavior, hallucination, abnormal behavior, abnormal dreams. These disorders usually resolve upon discontinuation of the drug.
  • There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should be taken into account before patients drive or use machines.
  • Renal and Urinary Disorders
  • Nephritis interstitial, renal failure
  • Skin and Subcutaneous Tissue Disorders
  • Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, acne
  • Vascular Disorders
  • Hemorrhage
  • There have been reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients (see and ).
  • Overdosage of clarithromycin can cause gastrointestinal symptoms such as abdominal pain, vomiting, nausea, and diarrhea.
  • Adverse reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum concentrations are not expected to be appreciably affected by hemodialysis or peritoneal dialysis.
  • Clarithromycin tablets may be given with or without food.
  • Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CL < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CL of 30 to 60 mL/min or < 30 mL/min, respectively.
  • Clarithromycin tablets USP are available as follows:
  • 250 mg u2013 yellow, film-coated, oval-shaped tablets, debossed with u201c93u201d on one side and u201c7157u201d on the other side in bottles of 60 (NDC 0093-7528-06).
  • 500 mg u2013 light-yellow, film-coated, oval-shaped tablets, debossed with u201c93u201d on one side and u201c7158u201d on the other side in bottles of 60 (NDC 0093-7529-06).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • No data
  • Clarithromycin is rapidly and well-absorbed with dose-linear kinetics, low protein binding, and a high volume of distribution. Plasma half-life ranged from 1 to 6 hours and was species dependent. High tissue concentrations were achieved, but negligible accumulation was observed. Fecal clearance predominated. Hepatotoxicity occurred in all species tested (i.e., in rats and monkeys at doses 2 times greater than and in dogs at doses comparable to the maximum human daily dose, based on mg/m). Renal tubular degeneration (calculated on a mg/m basis) occurred in rats at doses 2 times, in monkeys at doses 8 times, and in dogs at doses 12 times greater than the maximum human daily dose. Testicular atrophy (on a mg/m basis) occurred in rats at doses 7 times, in dogs at doses 3 times, and in monkeys at doses 8 times greater than the maximum human daily dose. Corneal opacity (on a mg/m basis) occurred in dogs at doses 12 times and in monkeys at doses 8 times greater than the maximum human daily dose. Lymphoid depletion (on a mg/m basis) occurred in dogs at doses 3 times greater than and in monkeys at doses 2 times greater than the maximum human daily dose. These adverse events were absent during clinical trials.
  • 1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically u2013 9th edition. Approved Standard. CLSI Document M07-A9, CLSI. 950 West Valley Rd, Suite 2500, Wayne, PA 19087, 2012.
  • 2. CLSI. Performance Standards for Antimicrobial Susceptibility Testing, 23 Informational Supplement, CLSI Document M100-S23, 2013.
  • 3. CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests, 11th edition. Approved Standard CLSI Document M02-A11, 2012.
  • 4. CLSI. Methods for Antimicrobial Dilution and Disk Diffusion Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria u2013 2 edition. CLSI document M45-A2, 2010.
  • 5. Chaisson RE, et al. Clarithromycin and Ethambutol with or without Clofazimine for the Treatment of Bacteremic Complex Disease in Patients with HIV Infection. AIDS. 1997;11:311-317.
  • 6. Kemper CA, et al. Treatment of Complex Bacteremia in AIDS with a Four-Drug Oral Regimen. . 1992;116:466-472.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
  • Manufactured For:n n North Wales, PA 19454
  • Rev. Q 1/2015
  • No data

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