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Tinidazole (Tinidazole)

Trade Name : Tinidazole

West-Ward Pharmaceuticals Corp.

TABLET, FILM COATED

Strength 250 mg/1

TINIDAZOLE Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]

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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 Tinidazole (Tinidazole) which is also known as Tinidazole and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 250 mg/1 per ml. Read more

Tinidazole (Tinidazole) 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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  • No data
  • No data
  • Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of tinidazole to approved indications only Avoid chronic use n
  • WARNING: POTENTIAL RISK FOR CARCINOGENICITY
  • See full prescribing information for complete boxed warning
  • Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent (). Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Limit use of tinidazole tablets to approved indications only (, , ). Avoid chronic use. ()
  • Tinidazole is a nitroimidazole antimicrobial indicated for:
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of tinidazole and other antibacterial drugs, tinidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ()
  • (
  • 1.4n- 8.1
  • No data
  • Intestinaln- Amebic liver abscess
  • 2.5n- 2.5
  • Tablets: 250 mg and 500 mg ()
  • The use of tinidazole is contraindicated:
  • u2022
  • No data
  • 5.3n- 7.3
  • Most common adverse reactions for a single 2 g dose of tinidazole (incidence >1%) are metallic/bitter taste, nausea, weakness/fatigue/malaise, dyspepsia/cramps/epigastric discomfort, vomiting, anorexia, headache, dizziness and constipation ()
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or .
  • Although not specifically identified in studies with tinidazole, the following drug interactions were reported for metronidazole, a chemically-related nitroimidazole. Therefore, these drug interactions may occur with tinidazole.
  • The following drug interactions were reported for metronidazole, a chemically-related nitroimidazole and may therefore occur with tinidazole:
  • 7.1n- 7.2
  • No data
  • 8.6n- 12.3
  • There are no reported overdoses with tinidazole in humans.
  • Treatment of Overdosage:
  • There is no specific antidote for the treatment of overdosage with tinidazole; therefore, treatment should be symptomatic and supportive. Gastric lavage may be helpful. Hemodialysis can be considered because approximately 43% of the amount present in the body is eliminated during a 6-hour hemodialysis session.
  • Tinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulphonyl)ethyl]-2-methyl-5-nitroimidazole, which has a molecular weight of 247.27 and the following chemical structure:
  • Tinidazole Tablets contain either 250 mg or 500 mg of tinidazole USP. Each film-coated tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, magnesium stearate, Opadry II (White) and silicified microcrystalline cellulose. Opadry II (White) contains: polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
  • No data
  • Metronidazole, a chemically-related nitroimidazole, has been reported to be carcinogenic in mice and rats but not hamsters. In several studies metronidazole showed evidence of pulmonary, hepatic, and lymphatic tumorigenesis in mice and mammary and hepatic tumors in female rats. Tinidazole carcinogenicity studies in rats, mice or hamsters have not been reported.
  • Tinidazole was mutagenic in the TA 100, tester strain both with and without the metabolic activation system and was negative for mutagenicity in the TA 98 strain. Mutagenicity results were mixed (positive and negative) in the TA 1535, 1537, and 1538 strains. Tinidazole was also mutagenic in a tester strain of . Tinidazole was negative for mutagenicity in a mammalian cell culture system utilizing Chinese hamster lung V79 cells (HGPRT test system) and negative for genotoxicity in the Chinese hamster ovary (CHO) sister chromatid exchange assay. Tinidazole was positive for genotoxicity in the mouse micronucleus assay.
  • In a 60-day male rat fertility study, oral doses of 600 mg/kg (approximately 3-fold the highest human therapeutic dose based on body surface area conversions) reduced fertility and produced testicular histopathology, including tubular degeneration, vacuolation of the seminiferous epithelium in the testis, and hypospermia in the epididymis. At 300 and 600 mg/kg dose levels, significant effects on sperm parameters were observed, including dose-related reduction in sperm motility, epididymal sperm numbers, percentage of normal sperm, retention of spermatids, and decreased epididymal weights. No effects on sperm parameters were observed at 100 mg/kg (approximately 0.5-fold the highest human therapeutic dose based upon body surface area conversions). This effect is characteristic of agents in the 5-nitroimidazole class.
  • No data
  • Tinidazole Tablets
  • 250 mg tablet is supplied as an off-white to pale yellow, round, biconvex, film-coated tablet debossed with product identification u201c54u201d over u201c524u201d on one side and scored on the other side.
  • NDC 0054-0347-16: Bottle of 40 Tablets
  • 500 mg tablet is supplied as an off-white to pale yellow, modified oval, film-coated tablet debossed with product identification u201c54 455u201d on one side and scored on the other side.
  • NDC 0054-0348-07: Bottle of 20 Tablets
  • NDC 0054-0348-21: Bottle of 60 Tablets
  • Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • PROTECT FROM LIGHT.
  • Administration of Drug:
  • Patients should be told to take tinidazole tablets with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects. Food does not affect the oral bioavailability of tinidazole.
  • Alcohol Avoidance:
  • Patients should be told to avoid alcoholic beverages and preparations containing ethanol or propylene glycol during tinidazole therapy and for 3 days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur.
  • Lactation:
  • Advise women not to breastfeed during treatment with tinidazole and to discontinue breastfeeding for 72 hours following the administration of tinidazole. Also, advise a nursing mother that she may choose to pump and discard her milk for 72 hours after administration of tinidazole n
  • Infertility:
  • Advise males of reproductive potential that tinidazole may impair fertility n
  • Drug Resistance:
  • Patients should be counseled that antibacterial drugs including tinidazole should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When tinidazole 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 tinidazole or other antibacterial drugs in the future.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10006626/03
  • Revised June 2019
  • No data
  • No data

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