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Vitamin A (Capsules) Instructions for Use

ATC Code

A11CA01 (Retinol (vitamin A))

Active Substance

Retinol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Vitamin preparation

Pharmacotherapeutic Group

Vitamins; vitamins A and D, including their combinations; vitamin A

Pharmacological Action

Vitamin A is a fat-soluble vitamin. It has a diverse effect on the body’s vital activities.

It plays an important role in redox processes (due to a large number of unsaturated bonds), participates in the synthesis of mucopolysaccharides, proteins, and lipids. Retinol plays an important role in maintaining the normal condition of the skin and epithelium of mucous membranes, ensuring normal differentiation of epithelial tissue, and in the processes of photoreception (promotes human adaptation to darkness).

Retinol participates in mineral metabolism, cholesterol formation processes, enhances the production of lipase and trypsin, enhances myelopoiesis, and cell division processes. The local action is mediated by the presence of specific retinol-binding receptors on the surface of epithelial cells.

It inhibits keratinization processes, enhances the proliferation of epithelial cells, rejuvenates cell populations, and reduces the number of cells that follow the path of terminal differentiation.

It is believed that Retinol has an antitumor effect, which, however, does not extend to non-epithelial tumors.

Indications

Hypovitaminosis and avitaminosis A. Eye diseases (pigmentary retinitis, nyctalopia, xerophthalmia, keratomalacia, eczematous lesions of the eyelids), skin diseases and lesions (frostbite, burns, wounds, ichthyosis, hyperkeratosis, psoriasis, some forms of eczema and other inflammatory and degenerative pathological processes).

Complex therapy of rickets, hypotrophy, acute respiratory infections, chronic bronchopulmonary diseases, erosive-ulcerative and inflammatory lesions of the gastrointestinal tract, liver cirrhosis.

Epithelial tumors and leukemias (to increase the resistance of hematopoietic tissue to the action of cytostatics during complex chemotherapy). Mastopathy (as part of a complex of non-hormonal agents).

ICD codes

ICD-10 code Indication
C80 Malignant neoplasm without specification of site
C95.9 Leukemia, unspecified
E46 Unspecified protein-energy malnutrition
E50 Vitamin A deficiency
E55.0 Active rickets
H01.1 Noninfectious dermatoses of eyelid
H04.1 Other disorders of lacrimal gland (dry eye syndrome)
H18.0 Corneal pigmentations and deposits
H18.4 Corneal degeneration
H35.5 Hereditary retinal dystrophies
H53.1 Subjective visual disturbances
J06.9 Acute upper respiratory infection, unspecified
J42 Unspecified chronic bronchitis
J44 Other chronic obstructive pulmonary disease
K25 Gastric ulcer
K26 Duodenal ulcer
K27 Peptic ulcer
K29 Gastritis and duodenitis
K52.9 Noninfective gastroenteritis and colitis, unspecified
K74 Fibrosis and cirrhosis of liver
L20.8 Other atopic dermatitis (neurodermatitis, eczema)
L30.0 Nummular eczema
L30.9 Dermatitis, unspecified
L40 Psoriasis
L85.0 Acquired ichthyosis
L85.1 Acquired keratosis [keratoderma] palmaris et plantaris
L85.2 Punctate keratosis (palmar-plantar)
N60 Benign mammary dysplasia (including fibrocystic mastopathy)
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T14.1 Open wound of unspecified body region
T30 Burns and corrosions of unspecified body region
T33 Superficial frostbite
ICD-11 code Indication
2B33.4 Leukemia, unspecified
2D4Z Unspecified malignant neoplasms of ill-defined or unspecified sites
5B50 Deficiency of weight in infants, children and adolescents
5B51 Exhaustion in infants, children and adolescents
5B52 Acute protein-energy malnutrition in infants, children and adolescents
5B53 Growth delay in infants, children and adolescents
5B54 Underweight in adults
5B55.Z Vitamin A deficiency, unspecified
5B57.0 Vitamin D-dependent rickets
5B71 Protein deficiency
9A06 Certain specified disorders of the eyelids
9A06.70 Atopic eczema of the eyelids
9A1Z Diseases of the lacrimal system, unspecified
9A78.1 Corneal pigmentation or deposits
9A78.4 Corneal degeneration
9B70 Hereditary retinal dystrophies
9D51 Transient vision loss
9D5Z Subjective visual disturbances, unspecified
9E1Y Other specified diseases of the visual system
CA07.0 Acute upper respiratory tract infection of unspecified site
CA20.1Z Chronic bronchitis, unspecified
CA22.Z Chronic obstructive pulmonary disease, unspecified
DA42.Z Gastritis, unspecified
DA51.Z Duodenitis, unspecified
DA60.Z Gastric ulcer, unspecified
DA61 Peptic ulcer of unspecified site
DA63.Z Duodenal ulcer, unspecified
DA7Z Diseases of stomach or duodenum, unspecified
DA90.0 Syndromic diarrhea
DB93 Fibrosis or cirrhosis of liver
DE2Z Diseases of the digestive system, unspecified
EA80.0 Infantile atopic eczema
EA80.1 Childhood atopic eczema
EA80.2 Adult atopic eczema
EA80.Z Atopic eczema, unspecified
EA82 Nummular dermatitis
EA85.20 Atopic hand eczema
EA85.2Z Hand dermatitis, unspecified
EA85.3 Foot dermatitis
EA89 Generalized eczematous dermatitis of unspecified type
EA8Z Dermatitis or eczema, unspecified
EA90.Z Psoriasis, unspecified
EC20.32 Papular palmoplantar keratodermas
ED50.0 Acquired ichthyosis
ED55.0 Acquired palmoplantar keratodermas
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
GB20.Z Benign breast disease, unspecified
ND56.0 Superficial injury of unspecified body region
ND56.1 Open wound of unspecified body region
NE11 Burn of unspecified body region
NE40 Superficial frostbite

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Take capsules orally with a meal to enhance absorption.

For severe vitamin A deficiency in adults, administer up to 100,000 IU daily for 3 days, followed by 50,000 IU daily for 2 weeks.

For maintenance therapy in adults, use 10,000 to 20,000 IU daily for 2 months.

For skin diseases like psoriasis or eczema, prescribe 100,000 to 300,000 IU daily.

For pediatric patients over 7 years old, administer 1,000 to 5,000 IU daily based on body weight and severity of deficiency.

Adjust the daily dosage and treatment duration individually according to clinical response and serum retinol levels.

Limit the treatment course to avoid hypervitaminosis; do not exceed 6,000 IU/kg body weight.

For prophylactic use in populations at risk, a single dose of 200,000 IU is acceptable.

In cases of malabsorption, consider a higher dosage or parenteral administration under strict medical supervision.

Monitor patients for signs of toxicity, especially with long-term use exceeding 4,000 IU daily.

Adverse Reactions

Hypervitaminosis A in adults – drowsiness, lethargy, headache, facial flushing, nausea, vomiting, gait disturbances, pain in the bones of the lower extremities; in children, fever, drowsiness, sweating, vomiting, skin rashes are possible.

Possible increase in cerebrospinal fluid pressure (in infants, hydrocephalus and bulging of the fontanelle may develop).

Contraindications

Cholelithiasis, chronic pancreatitis (exacerbation of the disease is possible), acute inflammatory skin diseases, pregnancy, breastfeeding period, children under 7 years of age.

With caution

Nephritis, heart failure of II-III degree, chronic alcoholism, liver cirrhosis, viral hepatitis, renal failure.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use is contraindicated in cholelithiasis.

With caution: liver cirrhosis, viral hepatitis.

Use in Renal Impairment

Use with caution in acute and chronic nephritis, renal failure.

Pediatric Use

Use is contraindicated in children under 7 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Use with caution in acute and chronic nephritis, in decompensation of cardiac activity.

No more than one preparation containing Retinol should be used simultaneously to avoid overdose.

Drug Interactions

With simultaneous use with cholestyramine, colestipol, neomycin, a decrease in the absorption of retinol is possible.

During long-term therapy with tetracyclines, vitamin A is not recommended to be prescribed due to the risk of intracranial hypertension.

Oral contraceptives increase the plasma concentration of retinol.

Isotretinoin increases the risk of adverse effects.

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

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Meligen FP, CJS (Russia)

Dosage Form

Bottle OTC Icon Vitamin A Capsules 33,000 IU

Dosage Form, Packaging, and Composition

Capsules

1 caps.
Retinol palmitate (Vitamin A) calculated as 100% vitamin A 18.2 mg (33000 IU)

10 pcs. – blister packs – cardboard packs (10 pcs.) – Over-the-Counter
10 pcs. – blister packs (10 pcs.) – cardboard packs (100 pcs.) – Over-the-Counter
10 pcs. – blister packs (100 pcs.) – cardboard boxes (1000 pcs.) – for hospitals
10 pcs. – blister packs (100 pcs.) – polyethylene bags (1000 pcs.) – for hospitals
10 pcs. – blister packs (1000 pcs.) – cardboard boxes (10000 pcs.) – for hospitals
10 pcs. – blister packs (2 pcs.) – cardboard packs (20 pcs.) – Over-the-Counter
10 pcs. – blister packs (200 pcs.) – cardboard boxes (2000 pcs.) – for hospitals
10 pcs. – blister packs (200 pcs.) – polyethylene bags (2000 pcs.) – for hospitals
10 pcs. – blister packs (2000 pcs.) – cardboard boxes (20000 pcs.) – for hospitals
10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – Over-the-Counter
10 pcs. – blister packs (4 pcs.) – cardboard packs (40 pcs.) – Over-the-Counter
10 pcs. – blister packs (400 pcs.) – cardboard boxes (4000 pcs.) – for hospitals
10 pcs. – blister packs (400 pcs.) – polyethylene bags (4000 pcs.) – for hospitals
10 pcs. – blister packs (4000 pcs.) – cardboard boxes (40000 pcs.) – for hospitals
10 pcs. – blister packs (50 pcs.) – cardboard boxes (500 pcs.) – for hospitals
10 pcs. – blister packs (50 pcs.) – polyethylene bags (500 pcs.) – for hospitals
10 pcs. – blister packs (6 pcs.) – cardboard packs (60 pcs.) – Over-the-Counter
10 pcs. – blister packs (600 pcs.) – cardboard boxes (6000 pcs.) – for hospitals
10 pcs. – blister packs (600 pcs.) – polyethylene bags (6000 pcs.) – for hospitals
10 pcs. – blister packs (6000 pcs.) – cardboard boxes (60000 pcs.) – for hospitals

Marketing Authorization Holder

Meligen FP, CJS (Russia)

Dosage Form

Bottle OTC Icon Vitamin A (Retinol acetate) Capsules 33 thousand IU: 10, 20, 30, 40, 100, 500, 1000, 2000, 4000, 6000 pcs.

Dosage Form, Packaging, and Composition

Capsules from light yellow to dark yellow, soft, gelatinous, spherical in shape; filled with an oily liquid from light yellow to dark yellow, without a rancid odor.

1 caps.
Retinol acetate (calculated as 100% vitamin A) 33000 IU (11.35 mg)

Excipients : soybean oil up to 150 mg.
Capsule shell gelatin 31.04 mg, glycerol 9.76 mg, methylparahydroxybenzoate 0.2 mg

10 pcs. – blister packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
10 pcs. – blister packs (50) – cardboard boxes.
10 pcs. – blister packs (100) – cardboard boxes.
10 pcs. – blister packs (200) – cardboard boxes.
10 pcs. – blister packs (400) – cardboard boxes.
10 pcs. – blister packs (600) – cardboard boxes.

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