Acezin DHG

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Barcode: 8935206003697
Description

COMPOSITION:

Alimemazine tartrate .................................................... 5 mg

Excipients q.s............................................................1 tablet

(Aerosil, tapioca starch, lactose, refined sugar, talc, magnesium stearate, ospray R110).

DOSAGE FORM: Film coated tablets.

PRESENTATION: Box of 2 blisters x 25 film coated tablets.

ACTIONS: Alimemazine is a phenothiazine derivative which is a potent antihistamine and antiserotonin. Alimemazine also acts as sedative, antitussive, antiemetic.

Alimemazine is competitive with histamine at the histamine H1-receptors, thus it is resistant to histamine H1, and antagonistic with most of pharmacological actions of histamine including urticaria, pruritus. Alimemazine is a sedative due to histamine N-methyltransferase enzyme inhibition and due to blocking central receptors secreting histamine and concomitantly acting on other receptors, especially serotoninergic receptor. Besides, Alimemazine is antiemetic by a direct effect on the chemical sensitive central area of spinal cord and maybe by blocking dopaminergic receptors at this area.

Alimemazine is rapidly absorbed by the gastrointestinal tract. After taking drug for 15 - 20 minutes, the drug's effect lasts for 6 - 8 hours. Elimination half-life is 3.5 - 4 hrs; 20 - 30% bound to plasma protein. Alimemazine is excreted via kidney under sulfoxide metabolites (70 - 80% after 48 hours)

INDICATIONS:

Symptomatic treatment of various cases:

Respiratory allergies (rhinitis, sneezing, coryza) and skin rashes (urticaria, pruritus).

Dry cough (due to allergy or irritation).

Insomnia (occasional or temporary) in adults and children.

Frequent vomiting in children.

CONTRAINDICATIONS:

Hypersensitivity to alimemazine or phenothiazine derivatives.

Children aged < 2 years. Pregnant women or nursing mothers.

Impaired hepatic, renal function, epilepsy, Parkinson's disease, hypothyroidism, myasthenia, prostatauxe.

Known granulocytopenia, closed-angle glaucoma.

PRECAUTIONS:

Caution should be taken in the elderly, especially in so cold or hot wheather (a risk of hypothermia or hyperthermia); the elderly who is easy to suffer from orthostatic hypotension.

Patients with angiocardiophathy.

Drivers and machinery operators are warned of the possibility of drowsiness.

INTERACTIONS: Alcohol may increase the sedation effect of alimemazine, so alcohol should be avoided during the therapy.

Concomitant administration with barbituric soporific and other sedatives is reported to increase the effect of CNS inhibition, respiratory depression of alimemazine. Concurrent administration with other anticholinergics may enhance anticholinergic effect of alimemazine. Antacids, Parkinson-treatment drugs, lithium prevent the absorption of alimemazine.

ADVERSE EFFECTS: Drowsiness, headache, lassitude, dizziness, dryness of mouth, increased viscidity of bronchial secretion, optical accomodation disorders, constipation, urinary retention.

Rarely: agranulocytosis, hypoleukemia, hypotention, tachycardia, jaundice hepatitis caused by cholestatic, extrapyramidal symptom, Parkinson tremor, anxiety, acute dystonia, decrease in convulsant threshold in epilepsy.

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE: Symptoms of overdosage includes drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Extra-pyramidal reactions may occur.

Treatment of overdosage:

Gastric lavage should be carried out especially if the overdose was taken within the previous 6 hours. Pharmacological induction of emesis is unlikely to be of any use. Activated charcoal should be given. There is no specific antidote. Treatment should be supportive in cases of cardiovascular collapse, arrhythmias, severe central nervous inhibition.

DOSAGE & ADMINISTRATION: Short-term treatment of

* Allergy and cough:

Adults: oral dose of 1 - 2 tablets x 2 - 4 times daily.

Children aged > 2 years: oral dose of 0.5 -1 mg/ kg body-weight daily, in divided doses.

* Insomnia:

Adults: oral dose of 1 - 4 tablets before bedtime.

Children aged > 2 years: oral dose of 0.25 - 0.5 mg / kg body-weight daily before bedtime.

Or as directed by the physician.

Read the directions carefully before use.

Consult the physician for more information.

Shelf-life: 36 months from the manufacturing date.

Storage conditions: Store in dry places, temperature not exceeding 300C.

Specifications: Manufacturer's.

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