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Tinidazole (Tindamax)

Trade Name : Tindamax

Mission Pharmacal Company

TABLET, FILM COATED

Strength 250 mg/1

TINIDAZOLE Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]

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Product information is meant for

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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 (Tindamax) which is also known as Tindamax and Manufactured by Mission Pharmacal Company. It is available in strength of 250 mg/1 per ml. Read more

Tinidazole (Tindamax) 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.

Read more
  • No data
  • Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent (n n n n n n ). Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. n n n n n n 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 (n n n n n n ). Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Use should be limited to approved indications only.n n n n n n
  • Indications and Usage, Bacterial Vaginosis (n n n n n n ) u00a0u00a0u00a0u00a0u00a0u00a0u00a05/2007n nn n nn
  • Dosage and Administration, Bacterial Vaginosis (n n n n n n ) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 5/2007n nn n nn
  • Tindamax is a nitroimidazole antimicrobial indicated for:
  • Trichomoniasis (n n n n n n )n n n n n n
  • Giardiasis: in patients age 3 and older (n n n n n n )n n n n n n
  • Amebiasis: in patients age 3 and older (n n n n n n )n n n n n n
  • Bacterial Vaginosis: in non-pregnant, adult women (n n n n n n n )n n n n n n
  • No data
  • Trichomoniasis: a single 2 g oral dose taken with food. Treat sexual partners with the same dose and at the same time (n n n n n n )n n n n n n
  • Giardiasis: Adults: a single 2 g dose taken with food. Pediatric patients older than three years of age: a single dose of 50 mg/kg (up to 2 g) with food (n n n n n n )n n n n n n
  • Amebiasis, n n n n n n Adults: 2 g per day for 3 days with food. Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3 days with food (n n n n n n ). n n n n n n Adults: 2 g per day for 3-5 days with food. Pediatric patients older than three years of age: 50 mg/kg/day (up to 2 g per day) for 3-5 days with food (n n n n n n )n n n n n n
  • Bacterial vaginosis: Non-pregnant, adult women: 2 g once daily for 2 days taken with food, or 1 g once daily for 5 days taken with food (n n n n n n )n n n n n n
  • Tablets: 250 mg and 500 mg (n n n n n n )n nn n nn
  • The use of tinidazole is contraindicated:
  • Prior history of hypersensitivity to tinidazole or other nitroimidazole derivatives (n n n n n n n n )n n n n n n
  • First trimester of pregnancy (n n n n n n n )n n n n n n
  • Nursing mothers, unless breast-feeding is interrupted during tinidazole therapy and for 3 days following the last dose (n n n n n n n )n n n n n n
  • No data
  • Seizures and neuropathy have been reported. Discontinue Tindamax if abnormal neurologic signs develop (n n n n n n )n n n n n n
  • Vaginal candidiasis may develop with Tindamax and require treatment with an antifungal agent (n n n n n n )n n n n n n
  • Use Tindamax with caution in patients with blood dyscrasias. Tindamax may produce transient leukopenia and neutropenia (n n n n n n n )n n n n n n
  • 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 (n n n n n n )n nn n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal Company at 1-855-778-0177or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • 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:
  • Warfarin and other oral coumarin anticoagulants: Anticoagulant dosage may need adjustment during and up to 8 days after tinidazole therapy (n n n n n n )n n n n n n
  • Alcohol-containing beverages/preparations: Avoid during and up to 3 days after tinidazole therapy (n n n n n n )n n n n n n
  • Lithium: Monitor serum lithium concentrations (n n n n n n )n n n n n n
  • Cyclosporine, tacrolimus: Monitor for toxicities of these immunosuppressive drugs (n n n n n n )n n n n n n
  • Fluorouracil: Monitor for fluorouracil-associated toxicities (n n n n n n )n n n n n n
  • Phenytoin, fosphenytoin: Adjustment of anticonvulsant and/or tinidazole dose(s) may be needed (n n n n n n n )n n n n n n
  • CYP3A4 inducers/inhibitors: Monitor for decreased tinidazole effect or increased adverse reactions (n n n n n n )n n n n n n
  • See n n n n n n for PATIENT COUNSELING INFORMATIONn n n n n n
  • Revised: 5/2007
  • Pediatric Use: Data on tinidazole use in children is limited to treatment of giardiasis and amebiasis in patients age 3 and older (n n n n n n )n n n n n n
  • Hemodialysis patients: If tinidazole is administered the same day and prior to hemodialysis, administer an additional u00bd dose after end of hemodialysis (n n n n n n n )n n n n n n
  • There are no reported overdoses with tinidazole in humans.
  • Treatment of Overdosage:
  • Tinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has the following chemical structure:
  • Tindamax pink oral tablets contain 250 mg or 500 mg of tinidazole. Inactive ingredients include croscarmellose sodium, FD&C Red 40 lake, FD&C Yellow 6 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized corn starch, titanium dioxide, and triacetin.
  • No data
  • No data
  • No data
  • Tindamax 250 mg tablets are pink, round, scored tablets, with TM debossed on one side and 250 on the other, supplied in bottles with child-resistant caps as:
  • NDC 0178-8250-40u00a0u00a0u00a0u00a0Bottle of 40
  • Tindamax 500 mg tablets are pink, oval, scored tablets, with TM debossed on one side and 500 on the other, supplied in bottles with child-resistant caps as:
  • NDC 0178-8500-60u00a0u00a0u00a0u00a0Bottle of 60n n n n n n NDC 0178-8500-20u00a0u00a0u00a0u00a0Bottle of 20n nn n nn
  • Professional Samples:
  • NDC 0178-8500-04u00a0u00a0u00a0u00a0Bottle of 4
  • Storage:
  • No data
  • Tindamax Labeln n n n n n 0178-8500-20n nn n nn
  • Tindamax Labeln n n n n n NDC: 0178-8250-40n nn n nn
  • Tindamax Labeln n n n n n 0178-8500-60n nn n nn

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

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Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

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Clinical Trials Supply

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