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

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




ClarithromycinTabletsInfection
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



Based on Body WeightDosing Calculated on 7.5 mg/kg q12hWeightDoseKglbs(q12h)125 mg/5 mL250 mg/5 mL

Mycobacterial Infections

Prophylaxis


Treatment



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Clarithromycin



Clarithromycin



Clarithromycin

Clarithromycin TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-195(NDC:60505-2615)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CLARITHROMYCIN CLARITHROMYCIN 500 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2208 (100 MPA.S)
MAGNESIUM STEARATE
cellulose, microcrystalline
PEG-12 DILAURATE
polysorbate 80
povidone
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
yellow 21 mm APO;CLA500 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-195-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065384 2011-04-20


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Be sure to consult your doctor before taking any medication!
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