Dimethinden, gel 0.1% 30 g

Pharmacodynamics

Antihistamine, anti-allergic and antipruritic agent. Blocker of H1-histamine receptors, is a competitive histamine antagonist.

The drug reduces increased capillary permeability associated with allergic reactions. When applied to the skin the drug reduces itching and irritation caused by skin allergic reactions. It also has a strong local anesthetic effect.

It has also antikinin and weak anticholinergic effect.

When used externally the gel base allows for a quick onset of action (in a few minutes) and a mild cooling effect. Maximal effect occurs after 1-4 hours.

Pharmacokinetics

When used externally it penetrates into the skin well, systemic bioavailability is 10%.

Indications

Skin itching of various origins (except those associated with cholestasis), for example: itchy dermatoses, eczema, urticaria, insect bites.
Sunburn, household and industrial burns (mild).

Pharmacological effect

Pharmacodynamics

Antihistamine, antiallergic and antipruritic agent. H1-histamine receptor blocker, is a competitive histamine antagonist.

The drug reduces 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 used externally, thanks to the gel base, it has a quick onset of action (within a few minutes) and a slight cooling effect. Maximum effect – after 1-4 hours.

Pharmacokinetics

When used externally, it penetrates well into the skin, systemic bioavailability is 10%.

Special instructions

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

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

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

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 and machinery

No effect.

Active ingredient

Dimetinden

Composition

Active ingredient:
Dimetindene maleate – 0.1 g.
Excipients:
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.

Pregnancy

Before using Dimetindene, if you are pregnant, or think you might be pregnant, or are planning a pregnancy, you should consult your doctor.

The 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 in the presence of inflammation or bleeding. Nursing mothers should not apply the drug to the nipples of the mammary glands.

Contraindications

Hypersensitivity to dimethindene and other components included in the drug, angle-closure glaucoma, prostatic hyperplasia, children under 1 month of age, especially premature infants.

With caution

Pregnancy 1st trimester, breastfeeding period.

Side Effects

The frequency of adverse reactions that may occur during therapy is given in the following gradation: very often (≥1/10); often (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (< 1/10000), including isolated reports and reactions of unknown frequency (cannot be calculated from available data).Skin and subcutaneous tissue disorders:
Uncommon: dry, burning skin.
Very rare: allergic dermatitis, including skin rash, itching.

If any of the side effects indicated in the instructions get worse or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

There are no known drug interactions for the drug.

Overdose

If a large amount of the drug is accidentally ingested, symptoms characteristic of an overdose of H1-histamine receptor blocker drugs may occur, including depression of the functions of the central nervous system (CNS), drowsiness (mainly in adults), stimulation of CNS functions, 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:

A specific antidote is unknown. The usual emergency measures should be taken: if taken orally, take 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.
In case of accidental overdose, tell your doctor immediately.

Storage conditions

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

Shelf life

3 years.

Manufacturer

Tula pharmaceutical factory, Russia