Fasigyn^® (Tablets) Instructions for Use

Marketing Authorization Holder

Pfizer (Belgium)

ATC Code

P01AB02 (Tinidazole)

Active Substance

Tinidazole (Rec.INN registered by WHO)

Dosage Form

Fasigyn®

Film-coated tablets, 500 mg: 4 pcs.

Dosage Form, Packaging, and Composition

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

Clinical-Pharmacological Group

Antiprotozoal drug with antibacterial activity

Pharmacotherapeutic Group

Antimicrobial and antiprotozoal agent

Pharmacological Action

Antiprotozoal agent with antibacterial action. The mechanism of action is due to the inhibition of synthesis and damage to the DNA structure of pathogens.

It is active against Trichomonas vaginalis, Entamoeba histolytica, Lamblia intestinalis. It has a bactericidal effect against the following anaerobic bacteria: Bacteroides spp. (including Bacteroides fragilis, Bacteroides melaninogenicus), Clostridium spp., Eubacterium spp., Fusobacterium spp., Peptococcus spp., Peptostreptococcus spp., Veillonella spp.

Pharmacokinetics

Tinidazole has a high degree of absorption, bioavailability is about 100%. Plasma protein binding is 12%. C_max after oral administration of a 2 g dose is achieved after 2 hours and is 40-51 µg/ml, after 24 hours it is 11-19 µg/ml, after 72 hours – 1 µg/ml. V_d – 50 L. It penetrates the blood-brain barrier and the placental barrier. It is excreted in breast milk within 72 hours after administration.

It is metabolized in the liver with the formation of pharmacologically active hydroxylated derivatives, which suppress the growth of anaerobic microorganisms and may enhance the effect of tinidazole. T_1/2 – 12-14 hours. 50% is excreted in the bile, 25% is excreted by the kidneys (unchanged) and 12% (as metabolites) due to reabsorption in the renal tubules.

Indications

Trichomoniasis, giardiasis, amebiasis (including hepatic form), infections caused by anaerobic bacteria, mixed aerobic-anaerobic infections (in combination with antibiotics), eradication of Helicobacter pylori (in combination with bismuth preparations and antibiotics).

Prophylaxis of postoperative anaerobic infections.

ICD codes

Dosage Regimen

Administer the dose orally, during or immediately after a meal. Swallow the tablet whole with water.

For trichomoniasis, administer a single 2 g dose (four 500 mg tablets). Alternatively, administer 150 mg twice daily for 7 days. Ensure simultaneous treatment of the sexual partner.

For giardiasis, administer a single 2 g dose (four 500 mg tablets). For amebiasis, administer 2 g daily for 2-3 days. For amebic liver abscess, administer 2 g daily for 3-6 days.

For anaerobic bacterial infections, administer an initial loading dose of 2 g, followed by 1 g daily for 5-6 days.

For postoperative infection prophylaxis, administer a single 2 g dose 12 hours before surgery, or a 2 g dose during the operation.

For Helicobacter pylori eradication, administer 500 mg twice daily for 7 days, as part of a combination therapy regimen.

In patients with severe hepatic impairment, reduce the dose or increase the dosing interval. Monitor plasma concentrations. No dosage adjustment is required for renal impairment.

The maximum daily dose for adults is 4 g. The maximum treatment duration is typically 7-10 days.

Adverse Reactions

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

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

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

Other: transient leukopenia, weakness.

Contraindications

Hypersensitivity to tinidazole or other derivatives of 5-nitroimidazole; organic diseases of the CNS, hematopoietic disorders; first trimester of pregnancy, lactation period (breastfeeding); children under 12 years of age.

Use in Pregnancy and Lactation

Contraindicated for use in the first trimester of pregnancy. Use in the second and third trimesters is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided. Tinidazole is detected in breast milk within 72 hours after administration.

Pediatric Use

Contraindicated for use in children under 12 years of age.

Special Precautions

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

If adverse reactions from the CNS appear, Tinidazole should be discontinued.

During the use of tinidazole, abstain from consuming alcohol.

When using tinidazole, dark discoloration of urine is observed.

If treatment continues for more than 6 days, regular monitoring of the peripheral blood picture should be performed.

Influence on the ability to drive vehicles and mechanisms

During treatment with tinidazole, patients should refrain from engaging in potentially hazardous activities that require increased attention and high speed of psychomotor reactions.

Drug Interactions

With simultaneous use, Tinidazole enhances the effect of indirect anticoagulants.

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

With simultaneous use with ethanol, the development of a disulfiram-like effect cannot be excluded.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.