Tiniba (Tablets) Instructions for Use

Marketing Authorization Holder

Cadila Healthcare Ltd. (India)

ATC Code

P01AB02 (Tinidazole)

Active Substance

Tinidazole (Rec.INN registered by WHO)

Dosage Forms

	Tiniba	Film-coated tablets, 300 mg: 10 pcs.
		Film-coated tablets, 500 mg: 4 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow in color, smooth, round, flat on both sides.

Excipients: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, hydroxypropylcellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, dye, purified water.

10 pcs. – blisters (1) – cardboard packs.

Film-coated tablets yellow in color, smooth, capsule-shaped, flat on both sides.

Excipients: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, hydroxypropylcellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, dye, purified water.

4 pcs. – blisters (1) – cardboard packs.

Clinical-Pharmacological Group

Antiprotozoal drug with antibacterial activity

Pharmacotherapeutic Group

Antimicrobial and antiprotozoal agent

Pharmacological Action

Antimicrobial and antiprotozoal agent. Tinidazole is active against Trichomonas vaginalis, Entamoeba hystolitica, Lamblia; causative agents of anaerobic infections – Bacteroides spp. (including Bacteroides fragilis, Bacteroides melaninogenicus), Clostridium spp., Eubacterium spp., Fusobacterium spp., Peptococcus spp., Peptostreptococcus spp. Being a highly lipophilic compound, it penetrates into trichomonads and anaerobic microorganisms, where it is reduced by nitroreductase, inhibits the synthesis and damages the structure of DNA.

Pharmacokinetics

Absorption

Absorption is high, bioavailability is about 100%. C_max after oral administration of 2 g is 40-51 µg/ml, after 24 hours – 11-19 µg/ml, after 72 hours – 1 µg/ml. Time to reach C_max is 2 hours.

Distribution

Plasma protein binding is 12%. V_d is 50 L. It penetrates the blood-brain barrier and the placental barrier. It is excreted in breast milk within 72 hours after administration.

Metabolism

It is metabolized in the liver to form pharmacologically active hydroxylated metabolites, which suppress the growth of anaerobic microorganisms and may enhance the effect of tinidazole.

Elimination

T_1/2 is 12-14 hours. It is excreted in bile – 50%, by the kidneys – 25% (unchanged) and 12% (as metabolites) due to reabsorption in the renal tubules.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug

• Trichomoniasis, giardiasis, amebiasis (including hepatic form and amoebic dysentery);
• Acute ulcerative gingivitis;
• Nonspecific vaginitis;
• Cutaneous leishmaniasis;
• Infections of various locations caused by anaerobic bacteria: peritonitis, abscess, endometritis, endomyometritis, pyosalpinx; sepsis, wound infections (including prevention of postoperative anaerobic infections), skin and soft tissue infections, pneumonia, empyema, lung abscess;
• Mixed aerobic-anaerobic infections (in combination with antibiotics);
• Eradication of Helicobacter pylori (in combination with bismuth preparations and antibiotics).

ICD codes

Dosage Regimen

Take orally during or immediately after meals.

For giardiasisadults are prescribed 2 g as a single dose; children – 50-75 mg/kg of body weight (not more than 2 g). If ineffective (presence of Giardia in the contents of the duodenum or in feces, starting from the 7-10th day after the end of therapy), treatment is repeated in the same dose. It is recommended to treat all family members simultaneously.

For urogenital trichomoniasisadults are prescribed 2 g as a single dose. Alternative dosing regimen: 150 mg 3 times/day for 5 days or 150 mg 2 times/day for 7 days. Children – 50-75 mg/kg of body weight; if necessary, repeated administration in the same dose is possible. When treating vaginal trichomoniasis, additional local treatment is recommended.

Intestinal amebiasisadults – 2 g/day in one dose for 2-3 days or 600 mg 2 times/day for 5 days. If the 5-day course is ineffective, treatment can be continued for up to 10 days. Children – 50-60 mg/kg/day in one dose for 3 days.

Hepatic amebiasis:adults – 1.5-2 g/day in one dose for 3 days; if necessary, treatment is continued with the same doses for up to 5-6 days. Alternative option: 600 mg 2 times/day for 5-10 days. Children – 50-60 mg/kg/day in one dose for 5 days.

Acute ulcerative gingivitis – 2 g as a single dose.

For nonspecific vaginitis – 2 g as a single dose or 2 g sequentially for 2 days.

For anaerobic infections (Bacteroides spp., Fusobacterii spp., Clostridium spp.) the course of treatment is 5-6 days; on the first day of treatment – 2 g/day, then 1 g once/day or 500 mg 2 times/day.

For the prevention of postoperative anaerobic infections the drug is prescribed at a dose of 2 g 12 hours before surgery.

Adverse Reactions

From the digestive system anorexia, dry oral mucosa, metallic taste in the mouth, nausea, vomiting, diarrhea.

From the central and peripheral nervous system headache, dizziness, fatigue, impaired coordination of movements (including locomotor ataxia), dysarthria, peripheral neuropathy; rarely – convulsions, weakness.

Allergic reactions urticaria, skin itching, skin rash, angioedema.

Other transient leukopenia.

Contraindications

• Organic diseases of the central nervous system;
• Blood disorders;
• First trimester of pregnancy;
• Lactation period (breastfeeding);
• Children under 12 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of Tiniba is contraindicated in the first trimester of pregnancy and during lactation (breastfeeding).

Pediatric Use

The drug is contraindicated in children under 12 years of age.

Special Precautions

For trichomoniasis, simultaneous treatment of both partners should be carried out.

During treatment, one should refrain from consuming ethanol (possibility of developing disulfiram-like reactions).

When treating for more than 6 days, monitoring of the peripheral blood picture is necessary.

The drug causes dark discoloration of urine.

Use in pediatrics

The safety and efficacy of Tiniba for the treatment and prevention of anaerobic infections in children under 12 years of age have not been established.

Effect on the ability to drive vehicles and mechanisms

During the treatment period, it is necessary to refrain from engaging in potentially hazardous activities that require concentration and speed of psychomotor reactions.

Overdose

Symptoms possible intensification of side effects.

Treatment symptomatic therapy. There is no specific antidote. It is removed by dialysis.

Drug Interactions

It enhances the effect of indirect anticoagulants (to reduce the risk of bleeding, the dose is reduced by 50%).

It is compatible with sulfonamides and antibiotics (aminoglycosides, erythromycin, rifampicin, cephalosporins).

It is not recommended to prescribe simultaneously with ethionamide.

Phenobarbital accelerates the metabolism of tinidazole.

In patients receiving Tinidazole, ethanol may cause a disulfiram-like effect.

Storage Conditions

List B. The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life is 4 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.