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

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Rifampin

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

RIFAMPIN DESCRIPTION



DESCRIPTION


Rifampin



CLINICAL PHARMACOLOGY

Oral Administration


WARNINGS


Pediatrics

Oral Administration


Microbiology


INDICATIONS AND USAGE

INDICATIONS AND USAGE















Susceptibility Tests










CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
Microorganism MIC (mcg/mL)
Staphylococcus aureus ATCC 29213 0.008 - 0.06
Enterococcus faecalis ATCC 29212 1 - 4
Escherichia coli ATCC 25922 8 - 32
Pseudomonas aeruginosa ATCC 27853 32 - 64
Haemophilus influenzae ATCC 49247 0.25 - 1

Diffusion Techniques: Quantitative methods that require measurement of zone diameters provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure3,4 that has been recommended for use with disks to test the susceptibility of microorganisms to rifampin uses the 5 mcg rifampin disk. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for rifampin.
Reports from the laboratory providing results of the standard single-disk susceptibility test with a 5 mcg rifampin disk should be interpreted according to the following criteria for Neisseria meningitidis.

Zone Diameter (mm)Interpretation20(S) Susceptible17-19(I) Intermediate16(R) ResistantInterpretation should be as stated above for results using dilution techniques.
As with standard dilution techniques, diffusion methods require the use of laboratory control microorganisms. The use of these microorganisms does not imply clinical efficacy (seeINDICATIONS AND USAGE

MicroorganismZone Diameter (mm)S. aureusATCC 2592326 - 34E. coliATCC 259228 - 10H. influenzaeATCC 4924722 - 30


INDICATIONS & USAGE



Tuberculosis




Meningococcal Carriers
WARNINGS



RIFAMPIN CONTRAINDICATIONS

CONTRAINDICATIONS
WARNINGS

WARNINGS

WARNINGS





PRECAUTIONS

General





INFORMATION FOR PATIENTS








LABORATORY TESTS




DRUG INTERACTIONS

Enzyme Induction













DRUG & OR LABORATORY TEST INTERACTIONS

Drug/Laboratory Interactions



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis, Mutagenesis, Impairment of Fertility




PREGNANCY

Pregnancy-Teratogenic Effects


Pregnancy-Non-Teratogenic Effects


NURSING MOTHERS

Nursing Mothers


PEDIATRIC USE

Pediatric Use
CLINICAL PHARMACOLOGYPediatricsDOSAGE AND ADMINISTRATION.

GERIATRIC USE

Geriatric Use
WARNINGS

RIFAMPIN ADVERSE REACTIONS

Gastrointestinal


Hematologic





Central Nervous System



Ocular


Endocrine



Renal


Dermatologic



Hypersensitivity Reactions



Miscellaneous



OVERDOSAGE

Signs and Symptoms



Acute Toxicity



Treatment



DOSAGE & ADMINISTRATION

INDICATIONS AND USAGECLINICAL PHARMACOLOGY

Tuberculosis






Incompatibilities:


Meningococcal Carriers




Preparation of Extemporaneous Oral Suspension









HOW SUPPLIED




Storage:




REFERENCES













INACTIVE INGREDIENT

INACTIVE INGREDIENTS:
SILICON DIOXIDE

STARCH, CORN
DOCUSATE SODIUM
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM BENZOATE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE

TALC
TITANIUM DIOXIDE
D&C YELLOW NO. 10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Rifampin

Rifampin

Rifampin

Rifampin CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-250(NDC:0185-0799)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
rifampin RIFAMPIN 300 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
DOCUSATE SODIUM
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM BENZOATE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
talc
titanium dioxide
D&C YELLOW NO. 10

Product Characteristics

Color Size Imprint Code Shape
red 18 mm E799 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-250-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064150 2011-03-28


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