Somol Drug Information [ Maver Laboratorios ]

Table of content

Somol category:

• Human
• Sleep Aids
• Ethanolamine Derivatives

Active ingredients:

• Diphenhydramine Hydrochloride

Somol companies and manufacturers:

• Maver Laboratorios

General Information

Somol forms, composition and dosages:

• Tablet; Oral; Diphenhydramine Hydrochloride 25 mg

Indications, usages and classification codes:

• R06AA02 - Diphenhydramine

There is an additional general information about this medication active ingredient diphenhydramine:

Pharmacological action

This is a blocker of histamine H1-receptors. It has antiallergic activity, has a local anesthetic, antispasmodic and mild ganglion blocking action.
When administered orally diphenhydramine has a sedative and hypnotic effects, has a moderate antiemetic effect and has a central holinoliticheskoy activity.
When applied externally it has antiallergic effect.

Pharmacokinetics

Rapidly absorbed from the gastrointestinal tract. Bioavailability is 50%. C_max is achieved after 20-40 min (in the greatest concentration is determined in the lungs, spleen, kidneys, liver, brain and muscles). Binding to plasma proteins - 98-99%. Penetrates through the BBB. Metabolised mainly in the liver, partly - in the lungs and kidneys. T1/2 is 4-10 hours. Within one day completely removed kidneys as metabolites conjugated to glucuronic acid. Significant quantities are derived from milk and can cause sedation in infants (may be a paradoxical reaction characterized by hyperexcitability).

Why is Somol prescribed?

Allergic reactions (urticaria, hay fever, angioedema), allergic conjunctivitis, vasomotor rhinitis, Henoch-Schonlein purpura, serum sickness, itchy dermatitis, sleep disorders (monotherapy or in combination with drugs), chorea, sea and air sickness, vomiting in pregnancy, Meniere's syndrome, premedication.

Dosage and administration

Oral, IV, IM, rectal, topical, intranasal, in the conjunctival sac. Oral for adults - at 30-50 mg 1-3 times / day. The treatment course is 10-15 days. As soporific - 50 mg at bedtime. IM in doses of 50-250 mg; IV in drip - 20-50 mg. When oral administered single dose for children under 1 year - 2-5 mg; from 2 to 5 years - 5-15 mg; of 6 to 12 years - 15-30 mg. Externally applied 1-2 times / day.

Somol side effects

Possible: a short-term numbness in the oral mucosa, drowsiness, weakness, decrease in psychomotor speed of reaction in children may be a paradoxical development of insomnia, irritability, and euphoria.
Rarely: dizziness, headache, dry mouth, nausea, photosensitivity, paresis of accommodation, poor coordination of movements, tremor.

Contraindications

Closure glaucoma, prostatic hypertrophy, stenosing peptic ulcer, stenosis of the bladder neck, bronchial asthma, epilepsy, hypersensitivity to diphenhydramine.

Using during pregnancy and breastfeeding

During pregnancy and lactation (breastfeeding), diphenhydramine used with caution, according to strict indications, when the expected therapeutic effect for the mother outweighs the potential risk to the fetus or infant.

Special instructions

With careful use diphenhydramine during pregnancy and lactation.
During the period of treatment should not be exposed to solar radiation should be avoided alcohol.
Used with caution in patients involved in potentially dangerous activities requiring attention and rapid psychomotor reactions.

Precautionary measures

Not recommended for SC injection. Since diphenhydramine has atropinopodobnym action should be cautious in its use: patients with recent respiratory infection in history (including asthma), increased intraocular pressure in hyperthyroidism, cardiovascular system, hypotension. Antihistamines drugs can reduce mental alertness as well as in adults and children and also cause agitation and hallucinations, convulsions and death in infants and children, especially in overdose. Precautions apply at age 60 and older because more likely to develop dizziness, sedation and hypotension. During treatment with diphenhydramine should avoid sun exposure. Should not be used during the drivers of vehicles and people, trade is connected with increased concentration. In the period of treatment should avoid drinking alcoholic beverages.

Somol drug interactions

When applied simultaneously increases the effects of ethanol and drugs that depress the central nervous system.
With simultaneous use of MAO inhibitors increase the anticholinergic activity of diphenhydramine.
The antagonistic interaction observed with a joint appointment with psychostimulants.
Reduces the effectiveness of apomorphine as an emetic in the treatment of poisoning. Intensifies anticholinergic effects of drugs with anticholinergic activity.

Somol in case of emergency / overdose

Symptoms: dry mouth, difficulty breathing, persistent mydriasis, flushing, depression or excitement (more common in children), CNS confusion; children - the development of convulsions and death.
Treatment: induction of vomiting, gastric lavage, the prescription of activated charcoal, symptomatic and supportive therapy on a background of careful monitoring of respiration and blood pressure levels.

• Somol analogs
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