Minolexin^® (Capsules) Instructions for Use

Marketing Authorization Holder

Avva Rus, JSC (Russia)

ATC Code

J01AA08 (Minocycline)

Active Substance

Minocycline (Rec.INN registered by WHO)

Dosage Forms

	Minolexin®	Capsules 50 mg: 20 or 30 pcs.
		Capsules 100 mg: 20 or 30 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size #2, with a yellow body and cap; capsule contents – yellow powder.

Excipients: microcrystalline cellulose 102 – 73.5 mg, povidone K-17 – 8.75 mg, potato starch – 7 mg, magnesium stearate – 1.75 mg, lactose monohydrate – up to the capsule contents mass of 175 mg.

Composition of the hard gelatin capsule water – 13%-16%, titanium dioxide – 0.974%-2%, quinoline yellow dye – 0.5833%-0.75%, sunset yellow FCF (E110) – 0.0025%-0.0059%, gelatin – up to 100%.

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.

Capsules hard gelatin, size #0, with a white body and cap; capsule contents – yellow powder.

Excipients: microcrystalline cellulose 102 – 147 mg, povidone K-17 – 17.5 mg, potato starch – 14 mg, magnesium stearate – 3.5 mg, lactose monohydrate – up to the capsule contents mass of 350 mg.

Composition of the hard gelatin capsule water – 13%-16%, titanium dioxide – 2%-2.1118%, gelatin – up to 100%.

10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.

Clinical-Pharmacological Group

Antibiotic of the tetracycline group

Pharmacotherapeutic Group

Systemic antibacterial agents; tetracyclines

Pharmacological Action

An antibiotic of the tetracycline group. It has a bacteriostatic effect by inhibiting protein synthesis through reversible binding to the 30S ribosomal subunit of susceptible microorganisms.

Active against gram-positive bacteria: Staphyloccocus aureus, Streptococcus spp., Nocardia spp., Listeria spp., Bacillus anthracis; gram-negative bacteria: Neisseria meningitidis, Bartonella bacilliformis, Vibrio cholerae, Escherichia coli, Klebsiella spp., Shigella spp., Acinetobacter spp., Haemophilus spp.; anaerobic bacteria: Clostridium spp., Bacteroides spp.

Minocycline is also active against Mycobacterium spp. (including Mycobacterium leprae), Chlamydia spp., Ureaplasma urealyticum, Treponema pallidum.

Indications

Acne, nocardiosis, leprosy (as part of combination therapy); infectious and inflammatory diseases caused by pathogens susceptible to minocycline (including pneumonia, bronchitis, pleural empyema, tonsillitis, cholecystitis, pyelonephritis, intestinal infections, endocarditis, endometritis, prostatitis, syphilis, gonorrhea, brucellosis, rickettsioses, purulent soft tissue infections, osteomyelitis, trachoma).

ICD codes

Dosage Regimen

For adults, administer an initial dose of 200 mg, followed by a maintenance dose of 100 mg every 12 hours.

Alternatively, use a dosage of 100 mg or 200 mg initially, then 50 mg every 6 hours.

Do not exceed a maximum daily dose of 400 mg.

For the treatment of uncomplicated gonorrhea, administer a single 200 mg dose, then 100 mg every 12 hours for a minimum of 4 days.

For the treatment of syphilis, administer a total daily dose of 200 mg for 10-15 days.

For the treatment of meningococcal carrier state, administer 100 mg every 12 hours for 5 days.

For the treatment of acne vulgaris, administer 50 mg once daily or 100 mg once daily.

For children over 8 years of age, administer an initial dose of 4 mg/kg body weight.

Follow with a maintenance dose of 2 mg/kg every 12 hours.

Swallow capsules whole with a full glass of water.

Administer capsules while in an upright position to reduce the risk of esophageal irritation.

Take at least 1 hour before or 2 hours after meals.

Avoid concurrent administration with antacids, dairy products, or iron preparations.

Continue therapy for at least 24-48 hours after symptoms and fever have subsided.

Adverse Reactions

Possible vestibular disorders (dizziness, unsteadiness), pigmentation of the skin and mucous membranes, hepatotoxic effect, nausea, vomiting, candidiasis.

Contraindications

Impaired liver function, children under 8 years of age, hypersensitivity to tetracyclines.

Use in Pregnancy and Lactation

Minocycline crosses the placental barrier and is excreted in breast milk.

It is not used in the second half of pregnancy and during lactation, because Minocycline causes discoloration of teeth, enamel hypoplasia, and impaired growth of the skeletal bones of the fetus and child.

Use in Hepatic Impairment

Contraindicated in impaired liver function.

Pediatric Use

Minocycline causes discoloration of teeth, enamel hypoplasia, and impaired growth of the skeletal bones of the fetus and child, therefore Minocycline is not used in children under 8 years of age.

Special Precautions

When taken with milk and dairy products, the absorption of minocycline is impaired.

Minocycline causes discoloration of teeth, enamel hypoplasia, and impaired growth of the skeletal bones of the fetus and child, therefore Minocycline is not used in children under 8 years of age.

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.