Tinidazole is an antibiotic medicine that is used to treat protozoal infections.

It is used to treat the following disorders:

• Amebiasis:

  • It is used in the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in patients older than 3 years.

  • It is not indicated for the treatment of asymptomatic cyst passage.

• Bacterial vaginosis:

  • It is used in the treatment of bacterial vaginosis (previously referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in adult women.

• Giardiasis:

  • It is used in the treatment of giardiasis caused by Giardia duodenalis (also termed Giardia lamblia) in patients older than 3 years.

• Trichomoniasis:

  • It is used for treating trichomoniasis caused by Trichomonas vaginalis;

  • Partners of infected patients should be treated simultaneously to prevent reinfection.

• Off Label Usage of Tinidazole in Adults:

  • It is used for Helicobacter pylori eradication;

  • It is used for prophylaxis against sexually transmitted diseases following sexual assault;

  • It is used for urethritis, nongonococcal (persistent and recurrent)

Tinidazole Dose in Adults

Dosage in the treatment of intestinal Amebiasis:

• 3 days of taking 2 g orally once a day.

Dosage for treating Amebic liver abscess:

• Orally 2 g once daily for 3 to 5 days

Dosage in the treatment of bacterial vaginosis:

• 1 g once daily for 5 days, or 2 g once day for 2 days, administered orally

Off label dosage in the treatment of recurrent bacterial vaginosis:

• Oral administration of 500 mg twice daily for seven days, followed by intravaginal treatment with boric acid and metronidazole suppressive therapy.

Dosage in the treatment of Giardiasis:

• 2 g taken orally in a single dosage

Off label dosage in the treatment of Helicobacter pylori eradication:

• Concomitant regimen:

  • 500 mg is administered in conjunction with 500 mg twice daily of clarithromycin, 1 g twice daily of amoxicillin, and a standard-dose proton pump inhibitor twice daily.
  • for 10 to 14 days continue this regimen

• Sequential regimen:

  • Clarithromycin 500 mg twice daily, tinidazole 500 mg twice daily, and a standard-dose proton pump inhibitor daily for 5 to 7 days should be given after amoxicillin 1 g twice daily and a standard-dose proton pump inhibitor twice daily for 5 to 7 days.

• Hybrid regimen:

  • Following a course of amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, tinidazole 500 mg twice daily, and a standard-dose proton pump inhibitor twice daily for 7 days, the next course of treatment is amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and a standard-dose proton pump inhibitor twice daily.

Off label dosage in the treatment of Prophylaxis against sexually transmitted diseases following sexual assault:

• 2 g taken orally in a single dosage along with ceftriaxone and azithromycin

Dosage in the treatment of Trichomoniasis:

• 2 g taken orally in one dose;
• sexual partners should be treated at the same time

Off Label dosage in the treatment of Trichomoniasis, persistent or recurrent (ie, treatment failure of nitroimidazole [eg, metronidazole]):

• Orally 2 g once daily for 7 days

Off Label dosage in the treatment of Urethritis, nongonococcal (recurrent or persistent urethritis in men who have sex with women and who live in regions where T. vaginalis is prevalent):

• Orally 2 g as a single dose.
• Compliance with the initial regimen and lack of reexposure to an untreated sex partner has to be excluded prior to use

Tinidazole Dose in Children

Dosage the treatment of intestinal Amebiasis:

• Children >3 years and Adolescents:

  • Orally 50 mg/kg/day for 3 days is given
  • 2000 mg/day is maximum daily dose
  • for patients with the severe and extraintestinal disease, give for 5 days

Dose in the treatment of Amebic liver abscess:

• Children >3 years and Adolescents:

  • 50 mg/kg/day for 3–5 days when taken orally
  • The daily dose cap is 2000 mg.

Dosage in the treatment of bacterial vaginosis:

• Adolescents:

  • 2000 mg are administered orally once daily for two days or once daily for five days.

Dosage in the treatment of Giardiasis:

• Children >3 years and Adolescents:

  • 50 mg/kg taken orally in a single dosage
  • 2000 mg is the maximum dose.

Dosage in the treatment of Helicobacter pylori infection: 

• Children >3 years and Adolescents:

  • 20 mg/kg/day administered orally in 1 to 2 divided doses for 5 to 7 days while taking additional medications; some experts recommend a longer course of 2 to 6 weeks.
  • The daily dosing cap is 1000 mg.

Dose in the treatment of recurrent, persistent, Nongonococcal urethritis:

• Adolescents:

  • A single oral dose of 2000 mg of azithromycin is administered.

Dose in the treatment of Trichomoniasis:

• Children >3 years:

  • 50 mg/kg taken orally in a single dosage
  • 2000 mg is the maximum dose.

• Adolescents:

  • Orally 2000 mg as a single dose is given
  • sexual partners should be treated at the same time
  • if treatment failure, then consider extended regimen of 2000 mg once daily for 5 days

Pregnancy Risk Factor: C

• Tinidazole crosses into the fetal circulation and enters the human placenta.
• Tinidazole's safety for treatment of bacterial vignanosis or trichomoniasis in pregnant women is not well understood.
• Pregnancy is best served by other agents.

Tinidazole use during breastfeeding:

• Breast milk contains Tinidazole.
• Breast milk tinidazole concentrations are identical to maternal serum levels and decline 72 hours after the last maternal dosage.
• The manufacturer doesn't recommend breastfeeding during therapy, or 72 hours after last tinidazole dosage.

Dose in kidney disease:

• No dosage adjustment required

Hemodialysis:

• An additional dose equal to ½ the usual dose should be given at the end of hemodialysis if tinidazole is administered prior to hemodialysis on a dialysis day.

Dose in liver disease:

• The manufacturer's labelling does not mention dosage changes (has not been researched);
• use with caution.

Less Common Side Effects of Tinidazole Include:

• Central Nervous System:

  • Fatigue
  • Malaise
  • Dizziness
  • Headache

• Dermatologic:

  • Body Odor

• Endocrine & Metabolic:

  • Hypermenorrhea

• Gastrointestinal:

  • Dysgeusia
  • Nausea
  • Anorexia
  • Decreased Appetite
  • Flatulence
  • Dyspepsia
  • Abdominal Cramps
  • Epigastric Distress
  • Vomiting
  • Constipation

• Genitourinary:

  • Vulvovaginal Candidiasis
  • Dysuria
  • Pelvic Pain
  • Urine Abnormality
  • Vulvovaginal Disease

• Neuromuscular & Skeletal:

  • Weakness

• Renal:

  • Urinary Tract Infection

• Respiratory:

  • Upper Respiratory Tract Infection

Frequency of side effects not defined:

• Cardiovascular:

  • Flushing
  • Palpitations

• Central Nervous System:

  • Ataxia
  • Burning Sensation
  • Drowsiness
  • Insomnia
  • Peripheral Neuropathy
  • Seizure
  • Vertigo

• Dermatologic:

  • Diaphoresis
  • Pruritus
  • Skin Rash
  • Urticaria

• Endocrine & Metabolic:

  • Increased Thirst

• Gastrointestinal:

  • Abdominal Pain
  • Diarrhea
  • Oral Candidiasis
  • Salivation
  • Stomatitis
  • Tongue Discoloration
  • Xerostomia

• Genitourinary:

  • Dark Urine
  • Vaginal Discharge

• Hematologic & Oncologic:

  • Leukopenia
  • Neutropenia

• Hepatic:

  • Increased Serum Transaminases

• Hypersensitivity:

  • Angioedema

• Infection:

  • Candidiasis

• Neuromuscular & Skeletal:

  • Arthralgia
  • Arthritis
  • Myalgia

• Miscellaneous:

  • Fever

Contraindication to Tinidazole Include:

• Hypersensitivity to tinidazole derivatives and nitroimidazole derivatives or any component of the formulation

Warnings and precautions

• Carcinogenic: [US Boxed Warning]

  • In animal studies, carcinogenicity was observed with another nitroimidazole derivative, metronidazole.
  • Only approved indications should be used.
  • Avoid prolonged use

• CNS effects

  • With tinidazole or other nitroimidazole derivatives, seizures and peripheral neuropathy (eg extremity numbness or paresthesia) have been reported.
  • If you notice abnormal neurological signs or symptoms, stop treating them.

• Superinfection

  • The antibiotic's prolonged use can result in fungal and bacterial superinfections, including diarrhoea caused by Clostridium difficile, pseudomembranous collitis, and/or vaginal candidiasis.
  • CDAD was observed for more than two months after antibiotic treatment.

• Blood dyscrasias:

  • Patients with a history or current blood disorder should be cautious.

• Hepatic impairment

  • Hepatic patients need to exercise caution.

Tinidazole: Drug Interaction

Monoitor:

Monitor Liver functions, Blood CBC, and clinical features of neuropathy.

How to administer Tinidazole?

• Use with food.

Mechanism of action of Tinidazole:

• Tinidazole can cause cytotoxicity in the organism by damaging DNA and stopping further DNA synthesis after it has been absorbed.

Absorption:

• It is Rapid and complete

Distribution:

• V : almost 50 L; distributes to tissues and fluids of body and crosses the blood-brain barrier

Protein binding:

• 12%

Metabolism:

• Mainly Hepatic via CYP3A4 ; undergoes oxidation, hydroxylation and conjugation; forms a metabolite

Half-life elimination:

• 13.2 hours

Time to peak, plasma:

• 1.6 hours (fasting, delayed ~2 hours when given with food)

Excretion:

• From Urine (~20% to 25%) & feces (~12%) [/bg_collapse]

International Brands of Tinidazole:

• Amibiol
• Asgin
• Astiba
• Cachtin
• Dyzole
• Estovit-T
• Fasdol
• Fasigin
• Fasigyn
• Fasigyne
• Induken
• Jie Li
• Protocide
• Protogyn
• Protozole
• Simplotan
• Su
• T-Zol
• Tindol
• Tiniba
• Tinidan
• Tinidazine
• Tinidol
• Tinirem
• Tinizol
• Tinoral
• Tiprogyn
• Tricolam
• Tricor 500
• Trinigyn
• Troxxil

Tinidazole Brands in Pakistan: