Carolin (Solution) Instructions for Use

Marketing Authorization Holder

Roscarpharm, CJSC (Russia)

ATC Code

A11CA02 (Betacarotene)

Active Substance

Betacarotene (Rec.INN registered by WHO)

Dosage Form

Carolin

Oral and external solution 1 mg/1 ml: fl. 30 ml, 50 ml or 100 ml

Dosage Form, Packaging, and Composition

30 ml – dark glass bottles (1) – cardboard packs.
50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Vitamin preparation

Pharmacotherapeutic Group

Vitamin

Pharmacological Action

A carotenoid, a precursor of vitamin A. It has an antioxidant effect and has the ability to inactivate free radicals under hypoxic conditions.

It protects the skin from the harmful effects of ultraviolet rays and has an antixerophthalmic effect.

Betacarotene has an immunomodulatory effect, apparently by stimulating the differentiation of B- and T-lymphocytes.

It participates in the processes of regeneration of epithelial tissues and increases their resistance to infections.

Pharmacokinetics

Absorption when taken orally is rapid and complete.

It is metabolized in the liver to form active forms of vitamin A, which bind to the retinol-transporting protein and are delivered to various organs and tissues. In the presence of Zn²⁺, inactive products are formed in the liver.

It is excreted by the kidneys and with bile.

Indications

Prevention and treatment of vitamin A deficiency.

To increase the body’s nonspecific resistance during exposure to low doses of radiation, X-ray examination, during radiation and chemotherapy in oncology, laser therapy, immunodeficiency states, contact with pesticides.

Age-related macular degeneration.

As part of complex therapy: gastric and duodenal ulcers, erosive gastritis, duodenitis, ulcerative colitis, dysbiosis; nonspecific diseases of the lungs and upper respiratory tract; wounds, burns, frostbite, trophic ulcers; polymorphic photodermatosis, vitiligo, local skin pigmentation, hyperpigmentation.

ICD codes

Dosage Regimen

Administer orally or apply externally. Determine the dose and duration individually based on the clinical indication and patient condition.

For oral administration, use the provided graduated dropper. Take the solution during or immediately after a meal to enhance absorption.

For adults and children over 12 years, the typical prophylactic dose is 1-2 mg (1-2 ml) once daily. For therapeutic purposes, increase the dose to 4-6 mg (4-6 ml) once daily or as a divided dose.

For children aged 7 to 12 years, administer 1-2 mg (1-2 ml) once daily. For children aged 3 to 6 years, administer 1 mg (1 ml) once daily. Do not administer to children under 3 years of age without medical supervision.

For external use in treating wounds, burns, or trophic ulcers, apply the solution directly to cleansed affected areas 1-2 times daily. Apply a thin layer and cover with a sterile dressing if indicated.

For conditions like vitiligo or photodermatosis, combine oral administration with topical application to depigmented or affected skin areas as directed.

The maximum daily oral dose for adults should not exceed 10 mg (10 ml). The duration of treatment is determined by the therapeutic response; prolonged courses may be necessary for chronic conditions.

Monitor for yellow discoloration of the skin (carotenoderma), which is a dose-related and reversible effect. Discontinue use if severe or adverse reactions occur.

Adverse Reactions

Possible yellow coloration of the skin, constipation.

Rarely arthralgia.

Contraindications

Hypersensitivity to vitamin A.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding with caution, under medical supervision.

Pediatric Use

It is possible to use in children according to indications in age-appropriate recommended doses.

Special Precautions

Betacarotene is used as a colorant in the food industry.

Drug Interactions

Calcium preparations, cholestyramine, mineral oils, neomycin, tocopherol (vitamin E) reduce the absorption of betacarotene.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.