Metronidazole500 Mg 500 Mg (Page 5 of 5)

Dosage Adjustments

Patients with Severe Hepatic Impairment
For patients with severe hepatic impairment (Child-Pugh C), the dose of metronidazole tablets should be reduced by 50% (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

Patients Undergoing Hemodialysis:
Hemodialysis removes significant amounts of metronidazole and its metabolites from systemic circulation. The clearance of metronidazole will depend on the type of dialysis membrane used, the duration of the dialysis session, and other factors. If the administration of metronidazole cannot be separated from the hemodialysis session, supplementation of metronidazole dosage following the hemodialysis session should be considered, depending on the patient’s clinical situation (see CLINICAL PHARMACOLOGY).

HOW SUPPLIED

Metronidazole tablets USP, 500 mg are white, capsule shaped, film coated tablets, debossed with “H569” on one side and plain on the other side.
They are supplied as follows:

NDC 70882-131-14, Unit of Use Bottles of 14 Tablets

Storage and Stability: Store below 77°F (25°C) and protect from light.

REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard -Eighth Edition. CLSI document M11-A8. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA, 2012.

2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement , CLSI document M100-S25. CLSI, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

Manufactured By:
Vivimed Labs (Alathur) Private Limited
Plot No.101, 102, 107 & 108,
SIDCO Pharmaceutical Complex,
Alathur, Kanchipuram Dist – 603 110,
Tamilnadu, India.

For more information, contact Cambridge Therapeutic Technologies at 1-844-810-0004.

Distributed by Cambridge Therapeutic Technologies, LLC
Teaneck, NJ 07666

Packaged by Legacy Pharmaceutical Packaging, LLCEarth City, MO 63045

Revised: 08/2017

20729

Metronidazole Tablets, USP 500 mg

Metronidazole Tablets, USP 500 mg
(click image for full-size original)

METRONIDAZOLE500 MG 500 MG metronidazole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70882-131(NDC:23155-569)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METRONIDAZOLE (METRONIDAZOLE) METRONIDAZOLE 500 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE (TYPE E)
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
STEARIC ACID
HYPROMELLOSE 2910 (15 MPA.S)
HYDROXYPROPYL CELLULOSE (TYPE L)
TITANIUM DIOXIDE
ETHYLCELLULOSE (10 MPA.S)
SHELLAC
DIACETYLATED MONOGLYCERIDES
PROPYLENE GLYCOL
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code H569
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70882-131-14 14 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070039 06/13/2016
Labeler — Cambridge Therapeutics Technologies, LLC (080072003)

Revised: 09/2017 Cambridge Therapeutics Technologies, LLC

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