Vitamin A (Retinol palmitate)

INN: Retinol

Код АТХ: A11CA 1

Composition:

5 ml oily solution contain 200 000 IU retinol palmitate (40 000 IU/ml). 1 ml = 30 drops

Indications:

For prevention and treatment of proved hypovitaminosis A, when parenteral application is not necessary in: keratomalacia; hemeralopia (day-blindness); vitamin A deficiency; prevention of malabsorption syndrome.

In the complex therapy of different dyskeratosis (hyperkeratosis, follicular keratosis), seborrheic eczema, burns, cold injuries, decubital ulcers and other states accompanied by weak epithelization; in oto-rhino-laryngology in dry chronic rhinopharyngitis; as adjunct to the immune system in infections and stress; gastrointestinal diseases (gastrectomy, celiac disease, regional enteritis, steatorrhea of various origin, persistent diarrhea, malabsorption syndrome with pancreatic insufficiency, chronic pancreatitis); pregnancy and lactation.

Dosage and administration:

For prophylaxis and treatment of vitamin A deficiency without xerophthalmia:

• children over 8 years of age and adults - 80 000 IU daily for 3 days, followed by a 14-day course at a dose of 50 000 IU daily
• children 1-8 years of age - 5 000 to 10 000 IU/kg body mass for 5 days, followed by 17 000 to 35 000 IU daily for a period of 10 days
• children under 1 year of age - 10 000 IU/kg body mass daily for 5 days, followed by a 10-day course of treatment at a dose of 5 000 to 7 500 IU daily

For treatment of vitamin A deficiency with xerophthalmia:

• children over 8 years of age and adults - 200 000 IU daily for 3 days, followed by a 14-day course at a dose of 50 000 IU/day, followed by a 2-month period of treatment at a dose of 20 000 IU daily
• children 1-8 years of age - 5 000 to 10 000 IU/kg body mass daily but not more than 200 000 IU for 5 days or until improvement is achieved

For prophylaxis of malabsorption syndrome: children over 8 years of age and adults - 10 000 to 50 000 IU daily.

In the complex therapy of different dyskeratosis: adult females - 4 000 IU daily;

• adult males - 5 000 IU daily; children over 10 years of age - 4 000 to 5000 IU daily
• children between the age of 7 and 10 years - 3 300 to 3 500 IU daily
• children between the age of 4 and 6 years - 2500 IU daily; children between the age of 6 months and 3 years - 1 500 to 2000 IU daily

Recommended daily doses in states of higher needs: pregnant women – 5000 IU daily; breastfeeding women – 6 000 IU daily. There are data of teratogenic effect at a daily dose exceeding 10 000 IU.

Contraindications:

Hypersensitivity to the product, hypervitaminosis A, severe hepatic and renal diseases.

Drug interactions:

Alcohol and retinoids increase the toxicity of vi−tamin A. Oral contraceptives increase the serum vitamin A level, and nitrites and cholestyramine disturb its resorption.

The combination of vitamin A and vitamin E has shown very good results in the therapy of gynecologic, dermatological and geriatric diseases. Its combination with riboflavin and nicotinic acid is suitable in treatment of hemeralopia.

Adverse reactions:

The following adverse reactions may be observed during administration of the product: somnolence, headache, increased intracranial pressure, rhagades, higher body temperature. Vomiting, itching, swelling of the optic nerve papilla, diplopia, and skin hyperplasia.

Supplied:

Vial of 5 ml solution and a dropper.

Dispensing:

On doctor’s prescription.

Manufactured by Sopharma AD: www.sopharma.com