NAFITHROMYCIN (MIKNAF) 350 mg, 6 tablets

NAFITHROMYCIN (MIKNAF) 350 mg, 6 tablets

1. Brand Name

Nafithromycin (Miqnaf)

2. International Nonproprietary Name (INN)

Nafithromycin

3. Dosage Form

Film-coated tablets, 350 mg

4. Composition

• One tablet contains:
  • Active substance: nafithromycin calcium trihydrate — 385.0 mg, equivalent to 350.0 mg of nafithromycin.
• Excipients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate.
• Coating composition: Opadry II white.

5. Description

White or almost white, round, biconvex tablets, engraved with "N" on one side.

6. Pharmacotherapeutic Group

Antimicrobial for systemic use. A macrolide antibiotic.

7. Indications for Use

The drug is used to treat bacterial infections caused by susceptible microorganisms:

• Community-acquired pneumonia (acquired outside of a hospital setting).
• Acute bacterial bronchitis.

Important: The decision to prescribe the drug is made by a doctor based on data about the infectious agent and its susceptibility to antibiotics.

8. Contraindications

• Hypersensitivity to nafithromycin, other macrolide antibiotics, or any excipients of the drug.
• Severe hepatic impairment.
• Concurrent use with drugs known to cause serious cardiac arrhythmias (prolongation of the QT interval): terfenadine, astemizole, cisapride, pimozide.
• Children under 18 years of age (due to insufficient data on efficacy and safety).

9. Special Cautions

Use with caution in patients with:

• Mild to moderate hepatic impairment.
• Conditions predisposing to arrhythmias (prolongation of the QT interval on ECG).
• Pregnancy and breastfeeding (use only if the potential benefit to the mother justifies the potential risk to the fetus or infant).

10. Dosage and Administration

• Dosage Regimen: The drug is taken once daily.
• Recommended dose for adults (including the elderly): 1 tablet (350 mg) once a day.
• Course of Treatment: 6 days. The package contains a full course of treatment — 6 tablets.
• How to Take: The tablet should be swallowed whole, without chewing, with a glass of water. It can be taken with or without food, but it is recommended to take it at the same time each day to maintain a constant blood concentration.

The duration of the course is determined by the doctor. Do not stop the course of treatment on your own, even if you start to feel better.

11. Side Effects

Like all medicines, Nafithromycin can cause side effects, although not everybody gets them.

Most Common:

• Gastrointestinal disorders: abdominal pain, diarrhea, nausea, vomiting.
• Headache.

Other Possible Effects:

• Allergic reactions (rash, itching, hives).
• Changes in laboratory parameters: increased activity of liver enzymes (ALT, AST).
• Candidiasis (thrush) of mucous membranes.

A full list of side effects is provided in the official package insert. If you experience any adverse reactions, stop taking the drug and consult your doctor.

12. Overdose

Symptoms: Intensification of side effects (especially gastrointestinal).
Treatment: Immediate gastric lavage and symptomatic therapy. There is no specific antidote.

13. Drug Interactions

Inform your doctor about all the medicines you are taking, including over-the-counter and herbal preparations.

• Do not take concurrently with: terfenadine, astemizole, cisapride, pimozide (risk of severe arrhythmias).
• Use with caution with: drugs metabolized in the liver by the CYP3A4 enzyme (their concentration in the blood may increase).
• Antacids (for heartburn) may reduce the absorption of nafithromycin. Take them at least 2 hours apart.

14. Special Precautions

• If your condition does not improve or worsens after a few days of treatment, you must consult a doctor immediately.
• As with other antibiotics, antibiotic-associated diarrhea, including pseudomembranous colitis, may develop during treatment.
• The drug does not affect the ability to drive vehicles or operate machinery.

15. Storage Conditions

Store in the original package, in a place protected from light, at a temperature not exceeding 25°C. Keep out of reach of children.

16. Shelf Life

2 years. Do not use after the expiration date printed on the packaging.

17. Marketing Authorization Holder & Manufacturer

JSC "Pharmstandard-Leksredstva", Russia.

18. Legal Classification

For medical prescription use only.

Manufacturer: WOCKHARDT (India)