Clarithromycin 500 mg/1
Clarithromycin · TABLET · A-S Medication Solutions
Clarithromycin is a tablet containing clarithromycin at 500 mg/1, taken oral. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- Clarithromycin
- Generic Name
- Clarithromycin
- NDC Code (Product)
50090-5282- Manufacturer
- A-S Medication Solutions
- Strength
- 500 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA065136
- Drug Class
- Macrolide Antimicrobial [EPC]
- Marketing Start
- 08/25/2005
Recall History
American Health Packaging
CGMP Deviations: Firm did not adequately investigate customer complaints.
Wockhardt Usa Inc.
CGMP Deviations: Firm did not adequately investigate customer complaints.
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Blenheim Pharmacal, Inc.
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Clarithromycin is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1.1 ) Acute Maxillary Sinusitis ( 1.2 ) Community-Acquired Pneumonia ( 1.3 ) Pharyngitis/Tonsillitis ( 1.4 ) Uncomplicated Skin and Skin Structure Infections ( 1.5 ) Acute Otitis Media in Pediatric Patients ( 1.6 ) Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1.7 ) Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults ( 1.8 ) Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.9 ) 1.1 Acute Bacterial Exacerbation of Chronic Bronchitis Clarithromycin tablets are indicated in adults for the treatment of mild to moderate infections caused by susceptible isolates due to Haemophilus influenzae , Haemophilus parainfluenzae , Moraxella catarrhalis , or Streptococcus pneumoniae …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adults : clarithromycin tablets 250 mg or 500 mg every 12 hours for 7 to 14 days ( 2.2 ) H. pylori eradication (in combination with lansoprazole/amoxicillin, omeprazole/amoxicillin, or omeprazole): clarithromycin tablets 500 mg every 8 or 12 hours for 10 to 14 days. See full prescribing information (FPI) for additional information. ( 2.3 ) Pediatric Patients : clarithromycin 15 mg/kg/day divided every 12 hours for 10 days ( 2.4 ) Mycobacterial Infections : clarithromycin tablets 500 mg every 12 hours; clarithromycin tablets 7.5 mg/kg up to 500 mg every 12 hours in pediatric patients ( 2.5 ) Reduce dose in moderate renal impairment with concomitant atazanavir or ritonavir-containing regimens and in severe renal impairment ( 2.6 ) 2.1 Important Administration Instructions Clarithromycin tablets may be given with or without food. 2.2 Adult Dosage The recommended dosages of clarithromycin tablets for the treatment of mild to moderate infections in adults are listed in Table 1 . Table 1. Adult Dosage Guidelines Infection Clarithromycin Tablets Dosage (every 12 hours) Duration (days) Acute bacterial exacerbation of chronic bronchitis 250 to 500 mg 7 † -14 Acut…
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to clarithromycin or any macrolide drug ( 4.1 ) Cisapride and pimozide ( 4.2 ) History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin ( 4.3 ) Colchicine in renal or hepatic impairment ( 4.4 ) Lomitapide, lovastatin, and simvastatin ( 4.5 ) Ergot alkaloids (ergotamine or dihydroergotamine) ( 4.6 ) Lurasidone ( 4.7 ) 4.1 Hypersensitivity Clarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs [see Warnings and Precautions ( 5.1 )] . 4.2 Cisapride and Pimozide Concomitant administration of clarithromycin tablets with cisapride and pimozide is contraindicated [see Drug Interactions ( 7 )] . There have been postmarketing reports of drug interactions when clarithromycin is co‑administered with cisapride or pimozide, resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes ) most likely due to inhibition of metabolism of these drugs by clarithromycin tablets. Fatalities have been reported. 4.3 Cholestatic Jaundice/Hepatic Dysfunction Clarithromycin tablets …
Drug Interactions
7 DRUG INTERACTIONS Co-administration of clarithromycin tablets is known to inhibit CYP3A, and a drug primarily metabolized by CYP3A may be associated with elevations in drug concentrations that could increase or prolong both therapeutic and adverse effects of the concomitant drug. Clarithromycin tablets should be used with caution in patients receiving treatment with other drugs known to be CYP3A enzyme substrates, especially if the CYP3A substrate has a narrow safety margin (e.g., carbamazepine) and/or the substrate is extensively metabolized by this enzyme. Adjust dosage when appropriate and monitor serum concentrations of drugs primarily metabolized by CYP3A closely in patients concurrently receiving clarithromycin. Table 8. Clinically Significant Drug Interactions with Clarithromycin Tablets Drugs That Are Affected By Clarithromycin Tablets Drug(s) with Pharmacokinetics Affected by Clarithromycin Tablets Recommendation Comments Antiarrhythmics: Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Not Recommended Disopyramide, Quinidine: There have been postmarketing reports of torsades de pointes occurring with concurrent use of clarithromycin and quinidine or dis…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Acute Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] QT Prolongation [see Warnings and Precautions ( 5.2 )] Hepatotoxicity [see Warnings and Precautions ( 5.3 )] Serious Adverse Reactions Due to Concomitant Use with Other Drugs [see Warnings and Precautions ( 5.4 )] Clostridium difficile Associated Diarrhea [see Warnings and Precautions ( 5.6 )] Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.8 )] Most frequent adverse reactions for both adult and pediatric populations in clinical trials: abdominal pain, diarrhea, nausea, vomiting, dysgeusia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Based on pooled data across all indications, the most frequent advers…
Frequently Asked Questions
What is Clarithromycin used for?
Clarithromycin contains Clarithromycin. It is a tablet taken oral. Consult your doctor for specific uses.
Is Clarithromycin a controlled substance?
Clarithromycin is not classified as a controlled substance by the DEA.
What is the generic name for Clarithromycin?
The generic name for Clarithromycin is Clarithromycin. There are 1 other brand versions of Clarithromycin.
What is the NDC code for Clarithromycin 500 mg/1?
The NDC (National Drug Code) for Clarithromycin 500 mg/1 is 50090-5282, listed by A-S Medication Solutions.
Other Clarithromycin Dosages
- Clarithromycin500 mg/185766-198
- Clarithromycin500 mg/143063-752
- Clarithromycin250 mg/146708-344
- Clarithromycin500 mg/150090-1830
- Clarithromycin500 mg/168002-104
- Clarithromycin500 mg/168071-5045
- Clarithromycin500 mg/10527-1930
- Clarithromycin500 mg/10527-1932
- Clarithromycin500 mg/173473-911
- Clarithromycin500 mg/10781-1962
Other Clarithromycin Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)