Dimethinden, drops 1 mg/ml 20 ml

< section>Pharmacokinetics:

It is rapidly and quite completely absorbed when taken orally. Bioavailability is about 70%. Antihistamine effect begins to appear 30 min after oral administration, reaching maximum intensity after 5 h. Time of reaching maximum concentration of dimethinden in blood plasma after oral administration is 2 hours. Binding with plasma proteins is 90%. It penetrates well into the tissues.

Metabolized in the liver by hydroxylation and methoxylation. Half-life is 6 hours. It is excreted with bile and urine (90% as metabolite and 10% unchanged).

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Indications

Allergic diseases: urticaria, hay fever, year-round allergic rhinitis, angioedema; food and drug allergies.

The skin itching of various origins (eczema, itchy dermatosis: including atopic dermatitis; measles, rubella, varicella, insect bites).

Prevention of allergic reactions during hypersensitization therapy.

Active ingredient

Composition

Per 1 ml:

Active ingredient:

dimethindene maleate-1.0 mg.

Auxiliary substances:

sodium hydrophosphate dodecahydrate-16.0 mg,

citric acid monohydrate-5.0 mg,

benzoic acid-1.0 mg,

dinatrium edetate – 1.0 mg,

sodium saccharinate – 0.5 mg,

propylene glycol – 100.0 mg,

purified water – up to 1 ml.

How to take, the dosage

Ingestion.

Children from 1 month to 12 years of age: Recommended daily dose is 0.1 mg/kg body weight, equivalent to 2 drops per kg body weight. The daily dose should be divided into 3 doses.

In children from 1 month to 1 year of age the drug should only be taken when prescribed by a physician and when indicated for use of H1-histamine receptor blockers.

Children over 12 years of age and adults: the recommended daily dose is 3-6 mg dimethindene (60-120 drops) divided into 3 doses, that is 20-40 drops 3 times a day.

20 drops = 1 ml = 1 mg dimethinden.

Dose adjustment is not required for elderly patients (over 65 years of age).

Patients who are prone to sleepiness are recommended to use 40 drops before going to bed and 20 drops in the morning.

Interaction

It enhances the effect of anxiolytics, hypnotics and other drugs that depress CNS function (opioid analgesics, anticonvulsants, tricyclic antidepressants, MAO inhibitors, antihistamines, antiemetics, neuroleptics, scopolamine, ethanol).

Tricyclic antidepressants and m-cholinoblockers (bronchodilators, gastrointestinal antispasmodics, etc.) increase the risk of increased intraocular pressure or urinary retention.

The combined use of antihistamines and procarbazine should also be avoided.

Special Instructions

In young children, particularly those under 6 years of age, antihistamines may cause increased excitability.

The drug should not be exposed to high temperatures; when prescribed for infants, they should be added to a bottle with warm baby food just before feeding. If the baby is already being spoon-fed, the drops can be given undiluted. The drops have a pleasant taste.

Do not exceed the recommended dose.

Ineffective in itching associated with cholestasis.

Like other antihistamines, dimethindene may impair attention, so it should be taken with caution when driving, operating machinery, or other jobs that require increased attention.

Contraindications

Hypersensitivity to dimethindene and other ingredients of the drug, closed-angle glaucoma, bronchial asthma, prostatic hyperplasia, children under 1 month of age, pregnancy I trimester, breast-feeding period.

In chronic obstructive pulmonary diseases, epilepsy.

In children aged 1 month to 1 year, because the sedative effect may be accompanied by episodes of nocturnal apnea.

Side effects

The frequency of adverse reactions that may occur during therapy is given as the following grading: very common (≥ 3/10); common (≥ 1/100 to < 1/10); infrequent (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1 /10000), including individual reports and reactions of unknown frequency.

Disorders of the immune system:

Very rare: Anaphylactoid reactions including facial edema, pharyngeal edema, rash, muscle cramps, and shortness of breath.

Mental disorders:

Rarely: restlessness.

Nervous system disorders:

Very common: fatigue;

Often: drowsiness, nervousness;

Rare: headache, dizziness.

Gastrointestinal disorders:

Rarely: gastrointestinal disturbances, nausea, dry mouth, dry throat.

If any of the side effects listed in the instructions worsen or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms: central nervous system (CNS) depression and drowsiness (mainly in adults), CNS stimulation and m-cholin-blocking effects (especially in children), including agitation, ataxia, tachycardia, hallucinations, tonic-clonic seizures, mydriasis, dry mouth, blood “flushes” to face, urine retention and fever; BP decrease, collapse.

Treatment: activated charcoal, saline laxatives, drugs to support cardiovascular and respiratory system activity (analeptic drugs should not be used).

Pregnancy use

The use of the drug during pregnancy (II-III trimester) is possible under medical supervision only if the expected benefits to the mother exceed the potential risk to the fetus.

The use of the drug during breastfeeding is contraindicated.

Similarities