Allergolan (Gel, Drops) Instructions for Use

ATC Code

D04AA13 (Dimetindene)

Active Substance

Dimetindene (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Histamine H₁-receptor blocker. Antiallergic drug

Pharmacotherapeutic Group

Antiallergic agent – H₁-histamine receptor blocker

Pharmacological Action

Histamine H₁-receptor blocker, an alkylamine derivative. It has antiallergic, antipruritic, and a slight anticholinergic effect. It also has a pronounced local anesthetic effect. It causes a weakly expressed sedative effect of central origin.

Pharmacokinetics

It is raply and sufficiently completely absorbed after oral administration. Bioavailability is about 70%. Plasma protein binding is 90%. It penetrates well into tissues and passes through the blood-brain barrier. It is metabolized in the liver by hydroxylation and methoxylation. It is excreted in bile and urine ( 90% as a metabolite and 10% unchanged).

With topical application, Dimetindene rapidly penetrates the skin; systemic bioavailability is 10%.

Indications

For oral administration: urticaria, hay fever, vasomotor rhinitis, food and drug allergy, angioedema; as an adjuvant in the treatment of anaphylactic reactions and serum sickness; pruritus from insect bites, eczema, dermatoses of allergic and non-allergic origin, in measles, rubella, chickenpox. Prophylactic hyposensitizing therapy in patients prone to allergic reactions.

For topical application: pruritic skin lesions in dermatoses, urticaria, insect bites, as well as in mild burns.

ICD codes

Dosage Regimen

Gel, Drops

Orally. For adults and children over 12 years of age, the recommended daily dose is 3-6 mg, divided into 3 doses. For children aged from 1 month to 12 years, it is prescribed in a daily dose based on 0.1 mg/kg of body weight. The daily dose must be divided into 3 doses.

Topically. Apply to the affected area of skin 2-4 times/day.

In cases of severe itching or widespread skin lesions, simultaneous use of oral forms is recommended.

Adverse Reactions

From the immune system: with oral administration, very rarely – anaphylactoid reactions, including facial edema, pharyngeal edema, rash, muscle spasms, and shortness of breath.

From the nervous system with oral administration – fatigue, drowsiness (especially at the beginning of treatment), nervousness, excitement, muscle spasm; rarely – headache, dizziness, anxiety.

From the digestive system with oral administration, nausea, dry mouth or throat may occur.

Other with oral administration – edema; rarely – skin rash; in isolated cases – disorders of the respiratory system.

With topical application rarely – dryness and burning sensation at the application site, allergic skin reactions.

Contraindications

Hypersensitivity to dimetindene; angle-closure glaucoma, urination disorders (including with prostatic hyperplasia), children under 1 month of age (especially in case of premature birth).

For oral administration: bronchial asthma; first trimester of pregnancy; breastfeeding period.

Use in Pregnancy and Lactation

Oral administration. Dimetindene is contraindicated for oral administration in the first trimester of pregnancy. Use in the second and third trimesters of pregnancy is possible under medical supervision, only if the expected benefit to the mother outweighs the potential risk to the fetus. Use during breastfeeding is contraindicated.

Topical application. Use in the first trimester of pregnancy is possible only after consultation with a doctor. In the second and third trimesters of pregnancy, as well as during breastfeeding, it should not be applied to large areas of the skin, especially in the presence of inflammation or bleeding. Nursing mothers should not apply the product to the nipples of the mammary glands.

Pediatric Use

Oral administration. Contraindicated for use in children under 1 month of age (especially in case of premature birth). In children aged from 1 month to 1 year, the product should be used only as prescribed by a doctor and if there are indications for the use of H1-histamine receptor blockers, and exceeding the recommended doses should be avoided.

Topical application. In children from 1 month to 2 years, Dimetindene is used only after consultation with a doctor.
In infants and young children, the product should not be applied to large areas of the skin (especially with weeping and inflammation).

Geriatric Use

Use in elderly patients is permitted according to indications in recommended doses.

Special Precautions

Oral administration. In children aged from 1 month to 1 year, the product should be used only as prescribed by a doctor and if there are indications for the use of H1-histamine receptor blockers, and exceeding the recommended doses should be avoided.

Effect on ability to drive vehicles and machinery

During treatment, one should not engage in activities requiring increased attention and quick psychomotor reactions.

Topical application. In children from 1 month to 2 years, Dimetindene is used only after consultation with a doctor.
In infants and young children, the product should not be applied to large areas of the skin (especially with weeping and inflammation). In cases of severe itching or extensive skin lesions, Dimetindene should be used only after consultation with a doctor. When applying dimetindene topically to large areas of the skin, sun exposure should be avoided.
It is not effective for itching associated with cholestasis.

Drug Interactions

With simultaneous use with agents that have a depressant effect on the myocardium, it is possible to enhance the effect of the latter.

With simultaneous use with tricyclic antidepressants or anticholinergic agents, the risk of increased intraocular pressure increases.

MAO inhibitors may cause enhancement of the anticholinergic and sedative effects of dimetindene.

With simultaneous use, Dimetindene enhances the effect of anxiolytics, hypnotics.

With simultaneous consumption of ethanol, a slowing of reaction speed is observed.

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.