Adult Dosing

Intestinal amebiasis

• 2 g PO daily x 3 days

Amebic liver abscess

• 2 g PO daily x 3-5 days

Giardiasis

• 2 g PO x 1 day

Trichomoniasis

• 2 g PO x 1 day

Bacterial vaginosis (non-pregnant females)

• 2 g PO daily x 2 days or 1 g PO daily x 5 days

Pediatric Dosing

Intestinal amebiasis

• Child >3 yrs: 50 mg/kg PO daily x 3 days
• Max: 2 g/dose

Amebic liver abscess

• Child >3 yrs: 50 mg/kg PO daily x 3-5 days
• Max: 2 g/dose
• Note: Monitor closely when treatment duration exceeds 3 days

Giardiasis

• Child >3 yrs: 50 mg/kg PO x 1 day
• Max: 2 g/dose

[Outline]

• Adult Dosing
• Pediatric Dosing

• Intestinal amebiasis
• Amebic liver abscess
• Giardiasis
• Trichomoniasis
• Bacterial vaginosis (non-pregnant females)

• Hypersensitivity to any of the ingredients of the product
• Pregnancy 1st trimester
• Breastfeeding during treatment and for 3 days following the last dose
• Disulfiram use
• Alcohol use

• Carcinogenicity has been observed in mice and rats receiving chronic metronidazole, another agent of nitroimidazole class; no similar data available for tinidazole but avoid unnecessary use
• Administer therapy for approved indications only

Renal Dose Adjustment

• Renal impairment: No dose adjustments
• Hemodialysis: Supplement post-dialysis with additional 50% of recommended dose

Hepatic Dose Adjustment

• Hepatic impairment: Caution advised; dose adjustments not defined

See Supplemental Patient Information

• Seizures and neuropathy have been reported. Discontinue tinidazole if abnormal neurologic signs develop
• Candida vaginitis/vaginal fungal infections may occur with therapy in bacterial vaginosis
• Administer cautiously in patients with evidence of or history of blood dyscrasias; tinidazole may produce transient leukopenia and neutropenia
• It may increases the risk of the development of drug-resistant bacteria in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication
• Alcoholic beverages should be avoided during therapy and for 3 days afterwards
• It is advisable to take tinidazole with food to minimize the incidence of epigastric discomfort and other gastrointestinal side-effects
• Monitor leukocytes before and after therapy

Cautions: Use cautiously in

• Hepatic impairment
• Concomitant use with warfarin, lithium, phenytion, immunosuppressive drugs
• CNS pathology
• History of blood dyscrasia
• Hemodialysis
• Unrecognized candidiasis
• Children (except to treat giardiasis and amebiasis in children older than age 3)
• Elderly patient

Supplemental Patient Information

• Advise patient to take drug with food
• Caution patient or caregiver to stop therapy and call prescriber immediately if seizures or numbness or tingling in extremities occurs
• Instruct patient to avoid alcohol use during therapy
• Advise female patient to avoid pregnancy during therapy
• Instruct female patient to avoid breastfeeding during therapy and for 3 days after last dose

Pregnancy Category:C

Breastfeeding: Unsafe. Effect on nursing infant is unknown but may be of concern. Hence discontinuation of breastfeeding temporarily after maternal treatment is recommended based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776).Amount of tinidazole excreted in breast milk is less than the dose given to infants. Due to possibility of mutagenicity and carcinogenicity as per another drug in nitroimidazole class (Metronidazole) the interruption of breast-feeding is recommended during therapy and for 3 days following the last dose based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 16 November 2010).Manufacturer recommends interruption of breast-feeding during tinidazole therapy and for 3 days following the last dose.

• CNS: Seizures, peripheral neuropathy, dizziness, headache, ataxia, convulsions, drowsiness, giddiness, insomnia, numbness, paresthesias, vertigo
• CV: Angioedema, palpitations
• HEMAT: Thrombocytopenia, transient leukopenia, transient neutropenia
• RESP: Bronchospasm, URI
• DERM: Stevens-Johnson syndrome, erythema multiforme, pruritus, rash
• GI: Metallic taste, nausea, vomiting, anorexia, flatulence, dyspepsia, cramps, epigastric discomfort, constipation, diarrhea, oral candidiasis, stomatitis, tongue discoloration, hepatic abnormalities, including elevated transaminase levels
• GU: Candida vaginitis, menorrhagia, painful urination, pelvic pain, urine abnormality, UTI, vaginal odor, vulvovaginal discomfort, dark urine, increased vaginal discharge
• MUSC: Arthralgia, arthritis, myalgia
• HYPERSENSITIVITY: Angioedema, salivation, sweating, thirst, urticaria, burning sensation, dryness of mouth, flushing
• MISC: Candida overgrowth

• Antiprotozoal; free nitro radical (generated from tinidazole reduction by Trichomonas cell extracts) may explain activity against Trichomonas species; activity against Giardia and Entamoeba species is unknown
• Mostly metabolized by liver; CYP450: 3A4 (substrate)
• Renally excreted: 20-25% (primarily unchanged), feces: 12%
• Half-Life: 12-14 hrs

US Trade Name(s)

• Tindamax

US Availability

tinidazole (generic)

• TABS: 250, 500 mg

Tindamax

• TABS: 250, 500 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Fasigyn

UK Availability

Fasigyn

• TABS: 500 mg

Australian Trade Name(s)

• Fasigyn
• Simplotan

Australian Availability

Fasigyn, Simplotan

• TABS: 500 mg

[Outline]

Antimicrobials

Antiparasitics

Amebicides

Infectious Disease

Antiparasitics

Amebicides

Pricing data from www.DrugStore.com in U.S.A.

• Tindamax 500 MG TABS [Bottle] (MISSION)
  20 mg = $223.29
  60 mg = $634.22

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: TINDAMAX 250 MG Oral Tablet

Ingredient(s): Tinidazole

Imprint: TM;250

Color(s): Pink

Shape: Round

Size (mm): 10.00

Score: 2

Inactive Ingredient(s): 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 / triacetin

Drug Label Author:
Mission Pharmacal Company

DEA Schedule:
Non-Scheduled

Drug Name: TINDAMAX 500 MG Oral Tablet

Ingredient(s): Tinidazole

Imprint: TM;500

Color(s): Pink

Shape: Oval

Size (mm): 16.00

Score: 2

Inactive Ingredient(s): 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 / triacetin

Drug Label Author:
Mission Pharmacal Company

DEA Schedule:
Non-Scheduled