tinidazole

Therapeutic Classification: antiprotozoals

Pharmacologic Classification: imidazoles

Interaction with protozoa results in release of a free nitro radical that has antiprotozoal activity.

Therapeutic effects:

Resolution of protozoal infections.

Spectrum:

Active against Bacteroides spp., Entamoeba histolytica, Gardnerella vaginalis, Giardia duodenalis (also known as Giardia lamblia), Prevotella spp., and , Trichomonas vaginalis.

Absorption: Rapidly and completely absorbed following oral administration.

Distribution: Extensively distributed; crosses placenta and blood-brain barrier, enters breast milk.

Metabolism/Excretion: Mostly metabolized (CYP3A4 enzyme system); 20–25% excreted unchanged in urine, 12% excreted in feces.

Half-Life: 12–14 hr.

(blood levels)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	2 hr	24 hr

Contraindicated in:

Hypersensitivity; cross sensitivity with other imidazoles may occur;
Lactation: Lactation.

Use Cautiously in:

CNS pathology;
History of blood dyscrasias;
Hemodialysis (removes significant amount of tinidazole; supplement post-dialysis with additional 50% of dose);
Hepatic impairment;
Unrecognized candidiasis (requires concurrent antifungal therapy);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Pedi: Children <3 yr (safety and effectiveness not established).

GI: constipation, dyspepsia, metallic/bitter taste, vomiting

GU: ↓fertility (males)

Hemat: transient leukopenia/neutropenia

Neuro: dizziness, headache, malaise

Drug-drug:

↑risk of bleeding with warfarin.
Disulfiram-like reaction may occur with alcohol or propylene glycol; disulfiram should be avoided for at least 2 wk before tinidazole.
May ↑ levels of lithium, cyclosporine, tacrolimus, fluorouracil, and fosphenytoin (observe/monitor for toxicity if administered concurrently).
Drugs that induce the CYP450 liver enzyme system (phenobarbital, rifampin, phenytoin or fosphenytoin) may ↓ levels and effectiveness.
Drugs that inhibit the CYP450 liver enzyme system (cimetidine or ketoconazole) may ↑ levels.
Absorption is ↓ by cholestyramine; separate dosing.

PO (Adults ): Bacterial vaginosis—1 g once daily for 5 days or 2 g once daily for 2 days; Trichomoniasis and Giardiasis—2 g single dose; Intestinal amebiasis—2 g once daily for 3 days; Amebic liver abscess—2 g once daily for 3–5 days.
PO (Children >3 yr): Giardiasis—50 mg/kg (up to 2 g) single dose; Intestinal amebiasis—50 mg/kg once daily for 3 days; Amebic liver abscess—50 mg/kg once daily for 3–5 days.

(Generic available)

Tablets: 250 mg; 500 mg

Assess patient for symptoms of infection (discharge, itching) prior to and during therapy.
Monitor neurologic status during and after IV infusions. Inform health care professional if numbness, paresthesia, weakness, ataxia, or convulsions occur.
Giardiasis: Monitor three stool samples taken several days apart, beginning 3–4 wk after treatment.

Lab Test Considerations:

May cause transient leukopenia and neutropenia. Monitor total and differential leukocyte counts if retreatment is necessary.
- May interfere with certain tests of serum chemistry values such as AST, ALT, LDH, and triglycerides.

Symptoms of known or previously unrecognized candidiasis may become worse during therapy and require treatment with an antifungal agent.
PO: Administer with food to decrease GI upset. May be crushed and prepared as a suspension in cherry syrup by pharmacist for patients unable to swallow tablets. Shake well before administering.

Instruct patient to take medication as directed, even if feeling better. Do not skip doses or double up on missed doses. If a dose is missed, take as soon as remembered if not almost time for next dose.
Advise patients treated for trichomoniasis that sexual partners may be asymptomatic sources of reinfection and should be treated concurrently. Patient should also refrain from intercourse or use a condom to prevent reinfection.
Caution patient to avoid intake of alcoholic beverages or preparations containing alcohol during and for at least 3 days after treatment with tinidazole. May cause a disulfiram-like reaction (flushing, nausea, vomiting, headache, abdominal cramps).
May cause dizziness or drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Inform patient that medication may cause an unpleasant metallic taste.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise female patients of reproductive potential to inform health care professional if pregnancy is planned or suspected and to avoid breastfeeding during and for 72 hr after taking tinidazole. .

Resolution of signs and symptoms of infection.

NDC Code

0178- Mission Pharmacal Company
- 0178-8250- Tindamax
  - 0178-8250-40- 40 TABLET, FILM COATED in 1 BOTTLE (0178-8250-40)

0178- Mission Pharmacal Company
- 0178-8500- Tindamax
  - 0178-8500-20- 20 TABLET, FILM COATED in 1 BOTTLE (0178-8500-20)

0178- Mission Pharmacal Company
- 0178-8500- Tindamax
  - 0178-8500-60- 60 TABLET, FILM COATED in 1 BOTTLE (0178-8500-60)

14799- Zhejiang Supor Pharmaceuticals Co., Ltd
- 14799-2005-
  - 14799-2005-1- 25 kg in 1 DRUM (14799-2005-1)

14799- Zhejiang Supor Pharmaceuticals Co., Ltd
- 14799-2005-
  - 14799-2005-2- 10 kg in 1 DRUM (14799-2005-2)

14799- Zhejiang Supor Pharmaceuticals Co., Ltd
- 14799-2005-
  - 14799-2005-3- 5 kg in 1 CAN (14799-2005-3)

14799- Zhejiang Supor Pharmaceuticals Co., Ltd
- 14799-2005-
  14799-2005-4- 1 kg in 1 CAN (14799-2005-4)

14799- Zhejiang Supor Pharmaceuticals Co., Ltd
- 14799-2005-
  14799-2005-5- 1 kg in 1 DRUM (14799-2005-5)

38779- Medisca Inc.
- 38779-2957-
  38779-2957-4- 25 g in 1 JAR (38779-2957-4)

38779- Medisca Inc.
- 38779-2957-
  38779-2957-5- 100 g in 1 JAR (38779-2957-5)

38779- Medisca Inc.
- 38779-2957-
  38779-2957-8- 500 g in 1 JAR (38779-2957-8)

38779- Medisca Inc.
- 38779-2957-
  38779-2957-9- 1000 g in 1 JAR (38779-2957-9)

42799- Edenbridge Pharmaceuticals LLC.
- 42799-207- Tinidazole
  42799-207-01- 40 TABLET in 1 BOTTLE (42799-207-01)

42799- Edenbridge Pharmaceuticals LLC.
- 42799-208- Tinidazole
  - 42799-208-01- 20 TABLET in 1 BOTTLE (42799-208-01)

42799- Edenbridge Pharmaceuticals LLC.
- 42799-208- Tinidazole
  - 42799-208-02- 60 TABLET in 1 BOTTLE (42799-208-02)

43386- Lupin Pharmaceuticals,Inc.
- 43386-550- Tinidazole
  - 43386-550-04- 40 TABLET in 1 BOTTLE (43386-550-04)

43386- Lupin Pharmaceuticals,Inc.
- 43386-551- Tinidazole
  - 43386-551-02- 20 TABLET in 1 BOTTLE (43386-551-02)

43386- Lupin Pharmaceuticals,Inc.
- 43386-551- Tinidazole
  - 43386-551-06- 60 TABLET in 1 BOTTLE (43386-551-06)

44523- BioComp Pharma, Inc.
- 44523-450- Tinidazole
  - 44523-450-12- 12 TABLET, FILM COATED in 1 BOTTLE (44523-450-12)

44523- BioComp Pharma, Inc.
- 44523-450- Tinidazole
  - 44523-450-20- 20 TABLET, FILM COATED in 1 BOTTLE (44523-450-20)

62135- Chartwell RX, LLC
- 62135-834- Tinidazole
  - 62135-834-20- 20 TABLET, FILM COATED in 1 BOTTLE (62135-834-20)

62135- Chartwell RX, LLC
- 62135-835- Tinidazole
  - 62135-835-20- 20 TABLET, FILM COATED in 1 BOTTLE (62135-835-20)

64980- Rising Pharma Holdings, Inc.
- 64980-426- Tindazole
  - 64980-426-02- 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-426-02)

64980- Rising Pharma Holdings, Inc.
- 64980-427- Tindazole
  - 64980-427-12- 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-427-12)

67296- Redpharm Drug, Inc.
- 67296-1836- Tindazole
  - 67296-1836-8- 8 TABLET, FILM COATED in 1 BOTTLE (67296-1836-8)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Pot. Nursing Diagnoses ⬆ ⬇

Code ⬆