Amintax (Suppositories) Instructions for Use

Marketing Authorization Holder

Patent-Pharm, JSC (Russia)

Manufactured By

Altpharm LLC (Russia)

ATC Code

G01AA51 (Nystatin in combination with other drugs)

Active Substances

Nystatin (Rec.INN registered by WHO)

Neomycin (Rec.INN registered by WHO)

Polymyxin B (Rec.INN registered by WHO)

Dosage Form

Amintax

Vaginal suppositories 35000 IU+100000 IU+35000 IU: 6, 10, 12, or 15 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories yellow in color, torpedo-shaped; the presence of an air core and/or a funnel-shaped depression is allowed.

Excipients: macrogol 400 and macrogol 1500 in a ratio of (5:95) – to obtain a suppository of 2400 mg.

5 pcs. – contour cell packs (2) – cardboard boxes.
5 pcs. – contour cell packs (3) – cardboard boxes.
6 pcs. – contour cell packs (1) – cardboard boxes.
6 pcs. – contour cell packs (2) – cardboard boxes.

Clinical-Pharmacological Group

A drug with antibacterial and antifungal action for topical use in gynecology

Pharmacotherapeutic Group

Combined antibiotic (antibiotics: aminoglycoside + polyene + cyclic polypeptide)

Pharmacological Action

Combined medicinal product. It has antibacterial, bactericidal, and antifungal action.

It exerts a bactericidal effect on gram-positive ( Staphylococcus aureus, corynebacteria, etc.) and gram-negative microorganisms ( Enterococcus faccium, Enterobacter aerogenes, Escherichia coli, Hemophilus influenzae, Proteus vulgaris, Klebsiella pneumoniae, Mycobacterium tuberculosis, Pseudomonas aeruginosa, Ureaplasma urealyticum).

It has a fungicidal effect on pathogenic fungi, especially yeast-like fungi of the genus Candida albicans, Cryptococcus, Hystoplasma. It improves trophic processes in the mucosa.

Pharmacokinetics

It is evenly distributed over the mucous membrane, exerting a local bactericidal and fungicidal effect; it is practically not absorbed from the surface of the mucous membrane.

Indications

Cervicitis; vaginitis (of bacterial, fungal, or mixed origin); preoperative prevention of infectious complications in gynecological interventions, before childbirth, during the insertion of a contraceptive intrauterine device, during intraurethral examinations.

ICD codes

Dosage Regimen

Administer intravaginally.

Insert one suppository once or twice daily, as directed by a physician.

For treatment of infections, the typical duration is 10 to 14 days.

For preoperative prophylaxis and other preventive measures, use as prescribed, typically for a shorter duration.

Perform thorough hand hygiene before and after handling the suppository.

Insert the suppository deeply into the vagina, preferably while lying down.

Use sanitary napkins to protect clothing from potential staining, as the suppository base may melt at body temperature.

Complete the full prescribed course of treatment, even if symptoms improve earlier.

Discontinue use and consult a physician immediately if severe local irritation, burning, or itching occurs.

Do not use concurrently with spermicidal products, as this may reduce the drug’s efficacy.

Adverse Reactions

Local reactions: burning, itching, irritation, contact eczema.

Contraindications

Hypersensitivity; first trimester of pregnancy; lactation period.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy and during lactation (breastfeeding). It is used in the second and third trimesters of pregnancy only if the intended benefit to the mother outweighs the potential risk to the fetus.

Special Precautions

Before using the drug, it is necessary to preliminarily take a smear and conduct a bacteriological analysis.

Drug Interactions

It is not recommended to use drugs with this combination simultaneously with spermicides, as a decrease in the activity of the components is possible.

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.