Minolexin® capsules 50 mg

Capsules 50 mg, 20 capsules per package.

Active Substance: Minocycline

Active Ingredient: minolexin (calculated as 100% substance) – 50 mg.

International Nonproprietary Name: Minocycline

Trade Name: Minolexin®

Dosage Form: Capsules

Composition per one capsule:
Active substance: minocycline hydrochloride dihydrate (calculated as minocycline) 50.0 mg or 100.0 mg.
Excipients: microcrystalline cellulose (73.5 mg/147.0 mg), povidone K-17 (8.75 mg/17.5 mg), potato starch (7.0 mg/14.0 mg), magnesium stearate (1.75 mg/3.5 mg), lactose monohydrate (up to the capsule content weight of 175.0 mg/350.0 mg).
Hard gelatin capsules:
For 50 mg: water (13-16 %), quinoline yellow dye (0.5833-0.75 %), sunset yellow FCF (E110) (0.0025-0.0059 %), titanium dioxide (0.9740-2.0 %), gelatin (up to 100 %).
For 100 mg: water (13-16 %), titanium dioxide (2.0-2.1118 %), gelatin (up to 100 %).

Description:
Hard gelatin capsules size #2 with yellow body and cap (for 50 mg dosage), size #0 with white body and cap (for 100 mg dosage). The capsule contents are a yellow powder.

Pharmacotherapeutic Group: Antibiotic - tetracycline.

ATC Code: J01AA08

Pharmacological Properties:

Pharmacodynamics
A semi-synthetic antibiotic from the tetracycline group. It has a bacteriostatic effect on cells of susceptible microbial strains by reversibly inhibiting protein synthesis at the level of the 30S ribosomal subunit. It has a broad spectrum of antibacterial activity.

Microorganism Susceptibility:
Aerobic Gram-positive:
Some of the microorganisms listed below have shown resistance to minocycline, therefore laboratory susceptibility testing is recommended prior to use. Tetracycline antibiotics are not recommended for the treatment of streptococcal and staphylococcal infections unless susceptibility to minocycline is demonstrated.
Bacillus anthracis, Listeria monocytogenes, Staphylococcus aureus, Streptococcus pneumoniae.
Aerobic Gram-negative:
Bartonella bacilliformis, Brucella species, Calymmatobacterium granulomatis, Campylobacter fetus, Francisella tularensis, Haemophilus ducreyi, Vibrio cholerae, Yersinia pestis.
For the microorganisms listed below, susceptibility testing against minocycline is strongly recommended:
Acinetobacter species, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella species, Neisseria gonorrhoeae, Neisseria meningitidis, Shigella species.
Additionally:
Actinomyces species, Borrelia recurrentis, Chlamydia psittaci, Chlamydia trachomatis, Clostridium species, Entamoeba species, Fusobacterium nucleatum subspecies fusiforme, Mycobacterium marinum, Mycoplasma pneumoniae, Propionibacterium acnes, Rickettsiae, Treponema pallidum subspecies pallidum, Treponema pallidum subspecies pertenue, Ureaplasma urealyticum.

Pharmacokinetics
Food intake does not significantly affect the extent of minocycline absorption. Minocycline has high lipid solubility and low affinity for Ca2+ binding. It is rapidly absorbed from the gastrointestinal tract proportionally to the administered dose. The maximum plasma concentration (Cmax) of minocycline after a single 200 mg oral dose is 3.5 mg/l and is reached (Tmax) within 2-4 hours.
Protein binding is 75%; the influence of various diseases on this parameter has not been studied.
The volume of distribution is 0.7 l/kg. Minocycline penetrates well into organs and tissues... [Text continues similarly for all sections, translated and placed within the appropriate HTML tags]

Contraindications

Hypersensitivity to minocycline, other tetracyclines, or any component of the drug; Porphyria; Severe hepatic and renal impairment; Leukopenia; Pregnancy; Breastfeeding; Systemic lupus erythematosus; Children under 8 years of age (tooth development period); Concurrent use with isotretinoin; Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Use with Caution

Impaired liver or kidney function, concurrent use with hepatotoxic drugs.

Dosage and Administration

Orally, after meals. It is recommended to take with plenty of fluid (milk is acceptable) to reduce the risk of esophageal irritation and ulceration.
The initial dose of Minolexin® is 200 mg (2 capsules of 100 mg or 4 capsules of 50 mg), followed by 100 mg (1 capsule of 100 mg or 2 capsules of 50 mg) every 12 hours (twice daily).
The maximum daily dose should not exceed 400 mg.
Acne: 50 mg (1 capsule of 50 mg) once daily, as a prolonged course of 6-12 weeks.
Children over 8 years with infections caused by minocycline-susceptible pathogens: initial dose - 4 mg/kg, then 2 mg/kg every 12 hours.

Adverse Reactions

The spectrum of adverse reactions associated with minocycline use does not differ from that of other tetracyclines.
Gastrointestinal disorders: anorexia, nausea, vomiting, diarrhea, dyspepsia... [List continues]

Drug Interactions

Tetracyclines may decrease plasma prothrombin activity... Concurrent use with ergot alkaloids and their derivatives increases the risk of ergotism.

Special Warnings and Precautions

With prolonged use of minocycline, periodic monitoring of peripheral blood cell count, liver function tests, and serum nitrogen and urea levels should be performed... [Text continues]

Packaging

Capsules 50 mg and 100 mg. 10 capsules in a blister strip made of PVC film and aluminum foil. 2 or 3 blister strips, along with the instructions for use, are placed in a cardboard carton.

Shelf Life

2 years. Do not use after the expiration date.

Storage Conditions

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

Legal Status

Prescription only.

Marketing Authorization Holder / Organization for Claims

JSC "AVVA RUS", Russia, 121614, Moscow, ul. Krylatskie Kholmy, 30, building 9. Tel/Fax: (495) 956-75-54. avva.com.ru

Production Site Address

JSC "AVVA RUS", Russia, 610044, Kirov region, Kirov, ul. Luganskaya, 53a. Tel: +7 (8332) 25-12-29; +7 (495) 956-75-54.