Dimethindene gel for external use 0.1%, 50g

Composition

Active ingredient:  

• Dimethindenee maleate – 0.1 g.

Auxiliary substances:  

• disodium edetate-0.05 g,
• carbomer-0.9 g,
• sodium hydroxide-0.3 g,
• benzalkonium chloride-0.005 g,
• propylene glycol-15.0 g,
• purified water – up to 100 g.

Pharmacological action

pharmacodynamicantigistamine, anti-allergic and antipruritic agent. H1 – histamine receptor blocker, is a competitive histamine antagonist. The drug reduces the increased capillary permeability associated with allergic reactions. When applied to the skin, the drug reduces itching and irritation caused by allergic skin reactions. The drug also has a pronounced local anesthetic effect. It also has antikinin and weak anticholinergic effects. When applied externally, thanks to the gel base, it has a quick onset of action (in a few minutes) and a slight cooling effect. The maximum effect is after 1-4 hours. Pharmacokineticapri external application penetrates well into the skin, systemic bioavailability-10%.

Indications

• Skin pruritus of various origins (other than those associated with cholestasis), for example: itchy dermatoses, eczema, hives, insect bites.
• Sunburn, domestic and industrial burns (mild).

Use during pregnancy and lactation

Before using Dimethindenee, if you are pregnant, or believe that you might be pregnant, or are planning to become pregnant, you should consult your doctor. Use of the drug in the first trimester of pregnancy is possible only after consultation with a doctor. In the second and third trimesters, as well as during breastfeeding, the drug should not be used on large areas of the skin, especially if there are signs of inflammation or bleeding. Nursing mothers should not apply the drug to the nipples of the mammary glands.

Contraindications

Hypersensitivity to Dimethindenee and other components of the drug, angle-closure glaucoma, prostatic hyperplasia, children under 1 month of age, especially premature babies.

With caution

Pregnancy I trimester, the period of breastfeeding.

Side effects

The frequency of adverse reactions that may occur during therapy is given in the following gradation: very common (≥1/10); common (≥1/100 to <1/10); infrequent (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (Skin and subcutaneous tissue disorders: Infrequently: dry, burning skin. Very rare: allergic dermatitis, including skin rash, pruritus. If any of the side effects listed in the instructions get worse or you notice any other side effects that are not listed in the instructions, tell your doctor.

Interaction

Any drug interactions for the drug are unknown.

How to take, course of use and dosage

Externally. The gel is applied to the affected area of the skin 2-4 times a day. In cases of severe pruritus or common skin lesions, the simultaneous use of oral forms of Dimethindenee is recommended.

Overdose

If a large amount of the drug is accidentally ingested, symptoms characteristic of an overdose of H1-histamine receptor blockers may occur, including central nervous system (CNS) depression, drowsiness (mainly in adults), CNS stimulation, antimuscarinic effects (especially in children), including increased excitability, ataxia, hallucinations, tonic-clonic seizures, mydriasis, dry mouth, flushes of blood to the face, urinary retention and fever. This may be followed by a drop in blood pressure. Treatment: The specific antidote is unknown. You should take the usual emergency measures: when ingested-taking activated charcoal, saline laxatives; if necessary, take measures to maintain the functions of the cardiovascular and respiratory systems. Vasoconstrictors can be used to treat arterial hypotension. Do not exceed the recommended dose of the drug. If you accidentally overdose, tell your doctor immediately.

Special instructions

In children from 1 month to 2 years, the drug is used after consultation with a doctor. In children and young children, the drug should not be used on large areas of the skin, especially if there are signs of inflammation or bleeding.

In case of severe itching or if large areas of the skin are affected, the drug can only be used after consulting a doctor. When using the drug on large areas of the skin, avoid exposure to sunlight.

If the severity of the symptoms of the disease does not decrease or, on the contrary, increases during the use of the drug, you should consult a doctor.

It is ineffective for itching associated with cholestasis.

The drug contains propylene glycol and benzalkonium chloride, which can cause local allergic reactions.

Effect of the drug on the ability to drive vehicles, mechanisms

It doesn’t affect you.

Form of production

Gel for external use 0.1%. By 5,10,15,20,25,30,35,40,50,60,70,80,90,100 d in orange glass jars with a triangular whisk with a tensioned lid with a sealing element. By 5,10,15,20,25,30,35,40,50,60,70,80,90,100 d in polymer cans complete with lids or in polyethylene terephthalate cans with capping agents. By 20,25,30,35,40,50,60,70,80,100 d in aluminum tubes coated with BF-2 varnish, with caps made of high-pressure polyethylene or in polymer tubes with polyethylene screw caps. Each jar and tube together with the instructions for use is placed in a pack of cardboard.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 3 years.

Active ingredient

Dimethindenee

Dosage form

gel for external use