Tinimark (Tinidazole Intravenous Infusion 200 mg/100 mL)

Tinidazole Tablet is a nitroimidazole antimicrobial indicated for: Trichomoniasis ( 1.1 ) Giardiasis: in patients age 3 and older ( 1.2 ) Amebiasis: in patients age 3 and older ( 1.3 ) Bacterial Vaginosis: in adult women ( 1.4, 8.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tinidazole Tablets and other antibacterial drugs, Tinidazole Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.5) . 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. …

• Trichomoniasis: a single 2 g oral dose taken with food
• Treat sexual partners with the same dose and at the same time 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 Amebiasis, Intestinal: 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
• Amebic liver abscess: 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 Bacterial vaginosis: Adult women: 2 g once daily for 2 days taken with food, or 1 g once daily for 5 days taken with food Dosing Instructions It is advisable to take tinidazole with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects
• Food does not affect the oral bioavailability of tinidazole [see Clinical Pharmacology ]
• Alcoholic beverages should be avoided when taking tinidazole and for 3 days afterwards [see Drug Interactions ]
• Compounding of the Oral Suspension For those unable to
• Swallow tablets, tinidazole tablets may be crushed in artificial cherry syrup to be taken with food
• Procedure for Extemporaneous Pharmacy Compounding of the Oral Suspension: Pulverize four 500 mg oral tablets with a mortar and pestle
• Add approximately 10 mL of cherry syrup to the powder and mix until smooth
• Transfer the suspension to a graduated amber container. …

250 mg tablets are pink color, circular shaped film coated scored tablets with "250" debossed on one side and " T│P" on the other side 500 mg tablets are pink color, capsule shaped film coated scored tablets with "500" debossed on one side and " T│P" on the other side Tablets: 250 mg and 500 mg, scored ( 3 )

• Other than for use in the treatment of giardiasis and amebiasis
• Pediatric patients older than three years of age, safety and effectiveness of tinidazole
• Pediatric patients have not been established
• Pediatric Administration: For those unable to
• Swallow tablets, tinidazole tablets may be crushed in artificial cherry syrup, to be taken with food [see Dosage and Administration ]

Clinical studies of tinidazole did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• 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 Tablets 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 Tablets and to discontinue breastfeeding for 72 hours following the administration of Tinidazole Tablets. …

• The use of tinidazole is contraindicated: In patients with a previous history of hypersensitivity to tinidazole or other nitroimidazole derivatives
• Reported reactions have ranged in severity from urticaria to Stevens-Johnson syndrome [see Adverse Reactions ]
• In patients with Cockayne syndrome. …

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 ( 7.1 ) Alcohol-containing beverages/preparations: Avoid during and up to 3 days after tinidazole therapy ( 7.1 ) Lithium: Monitor serum lithium concentrations ( 7.1 ) Cyclosporine, tacrolim …

Seizures and neuropathy have been reported. Discontinue Tinidazole Tablets if abnormal neurologic signs develop ( 5.1 ) Vaginal candidiasis may develop with Tinidazole Tablets and require treatment with an antifungal agent ( 5.2 ) Use Tinidazole Tablets with caution in patients with blood dyscrasias. Tinidazole Tablets may produce transient leukopenia and neutropenia ( 5.3, 7.3 ) 5.1 Potential for Genotoxicity and Carcinogenicity Carcinogenicity has been seen in mice and rats treated chronically with nitroimidazole derivatives, which are structurally related to tinidazole [see Nonclinical Toxicology ( 13.1 )] . …

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 ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Risk Summary Available published data from a case-control study and case report with Tinidazole Tablets use in pregnant women are insufficient to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks associated with untreated lower genital tract infections during pregnancy (see Clinical Considerations) . …

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.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.