Clarithromycin description, usages, side effects, indications, overdosage, supplying and lots more!

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Clarithromycin

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

CLARITHROMYCIN DESCRIPTION



DESCRIPTION


Clarithromycin








CLINICAL PHARMACOLOGY

Pharmacokinetics











Microbiology
























Pretreatment Resistance



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Amoxicillin Susceptibility Test Results and Clinical/Bacteriological Outcomes

















Susceptibility Testing Excluding Mycobacteria and Helicobacter

Dilution Techniques




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Diffusion Techniques





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In Vitro Activity of Clarithromycin Against Mycobacteria





Susceptibility Testing for Mycobacterium avium Complex (MAC)


Susceptibility Test for Helicobacter pylori


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INDICATIONS & USAGE



Adults










Children








Prophylaxis



CLARITHROMYCIN CONTRAINDICATIONS





WARNINGS








PRECAUTIONS



General







INFORMATION FOR PATIENTS





DRUG INTERACTIONS






























CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
















PREGNANCY

Teratogenic Effects

Pregnancy category C



NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE



CLARITHROMYCIN ADVERSE REACTIONS





Postmarketing Experience








Changes in Laboratory Values






OVERDOSAGE




DOSAGE & ADMINISTRATION





H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy: Clarithromycin/Lansoprazole/Amoxicillin


Triple Therapy: Clarithromycin/Omeprazole/Amoxicillin


Dual Therapy: Clarithromycin/Omeprazole


Dual Therapy: Clarithromycin/Ranitidine Bismuth Citrate


Children





Mycobacterial Infections

Prophylaxis


Treatment



HOW SUPPLIED







INACTIVE INGREDIENT

COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 5
HYPROMELLOSE
MAGNESIUM HYDROXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TITANIUM DIOXIDE
VANILLIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

















Clarithromycin


Clarithromycin










Clarithromycin

Clarithromycin TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-679(NDC:0093-7157)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CLARITHROMYCIN CLARITHROMYCIN 250 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 5
HYPROMELLOSES
magnesium hydroxide
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol
povidone
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
titanium dioxide
VANILLIN

Product Characteristics

Color Size Imprint Code Shape
yellow 17 mm 93;7157 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-679-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065155 2011-05-12


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Be sure to consult your doctor before taking any medication!
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