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Clarithromycin (Clarithromycin)

Trade Name : Clarithromycin

West-Ward Pharmaceuticals Corp.

TABLET, COATED

Strength 500 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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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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 West-Ward Pharmaceuticals Corp.. It is available in strength of 500 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

Packaging and Delivery

Validated Cold Chain Shipment

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.

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About GNH

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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  • Clarithromycin is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following:
  • Limitations of Use:
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin and other antibacterial drugs, clarithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ()
  • Helicobacter pylori
  • No data
  • H. pylori
  • Clarithromycin Tablets, USP are available as 250 mg and 500 mg tablets for oral administration.
  • u2022
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  • Severe Acute Hypersensitivity Reactions
  • QT Prolongationn- torsades de pointes
  • Hepatotoxicity
  • Arrayn- Clostridium difficile
  • Embryo-Fetal Toxicity
  • The following serious adverse reactions are described below and elsewhere in the labeling:
  • Most frequent adverse reactions for both adult and pediatric populations in clinical trials: abdominal pain, diarrhea, nausea, vomiting, dysgeusia ()
  • Co-administration of clarithromycin 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 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.
  • Co-administration of clarithromycin can alter the concentrations of other drugs. The potential for drug-drug interactions must be considered prior to and during therapy. (, , , )
  • Geriatric: Increased risk of ()
  • Overdosage of clarithromycin can cause gastrointestinal symptoms such as abdominal pain, vomiting, nausea, and diarrhea.
  • Treat adverse reactions accompanying overdosage 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 is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6-O-methylerythromycin A. The molecular formula is CHNO, and the molecular weight is 747.96. The structural formula is:
  • Figure 1: Structure of Clarithromycin
  • 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 Tablets, USP are available for oral administration as immediate-release tablets containing either 250 mg or 500 mg of clarithromycin, USP.
  • Each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry II (White), povidone, stearic acid, and talc. Opadry II (White) contains hypromellose, polyethylene glycol, polydextrose, titanium dioxide and triacetin.
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  • Clarithromycin Tablets USP
  • 250 mg tablets are supplied as a round, white, film coated beveled edged, standard biconvex tablet, debossed with product identification u201c54 271u201d on one side and plain on the other side.
  • NDC 0054-0036-21: Bottle of 60 Tablets
  • 500 mg tablets are supplied as a white, film coated, standard biconvex, capsule shaped tablet, debossed with product identification u201c54 312u201d on one side and plain on the other side.
  • NDC 0054-0037-21: Bottle of 60 Tablets
  • Storage:
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF.
  • Provide the following instructions or information about clarithromycin to patients:
  • Important Administration Instructions:
  • Advise patients that clarithromycin can be taken with or without food and can be taken with milk.
  • Drug Interactions:
  • Advise patients that clarithromycin may interact with some drugs; therefore, advise patients to report to their healthcare provider the use of any other medications.
  • Diarrhea:
  • Advise patients that diarrhea is a common problem caused by antibacterials including clarithromycin which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial. If this occurs, instruct patients to contact their healthcare provider as soon as possible.
  • Embryo-Fetal Toxicity:
  • Advise females of reproductive potential that that if pregnancy occurs while taking this drug, there is a potential hazard to the fetus [see Warnings and Precautions () and Use in Specific Populations ()].
  • Antibacterial Resistance:
  • Counsel patients that antibacterial drugs including clarithromycin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When clarithromycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by clarithromycin or other antibacterial drugs in the future.
  • Potential for Dizziness, Vertigo and Confusion:
  • There are no data on the effect of clarithromycin on the ability to drive or use machines. However, counsel patients regarding the potential for dizziness, vertigo, confusion and disorientation, which may occur with the clarithromycin. The potential for these adverse reactions should be taken into account before patients drive or use machines.
  • Risk of Mortality in Patients with Coronary Disease Years After Clarithromycin Treatment:
  • Advise patients who have coronary artery disease to continue medications and lifestyle modifications for their coronary artery disease because clarithromycin may be associated with increased risk for mortality years after the end of clarithromycin treatment.
  • Distr. by: Eatontown, NJ 07724
  • 10002870/17
  • Revised September 2019
  • Clarithromycin Tablets USP 250 mg Bottle of 60
  • NDC: 0054--21
  • Clarithromycin Tablets USP 500 mg Bottle of 60
  • NDC: 0054--21

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Validated Cold Chain Shipment

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