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Emidom (Domperidone)

Pharmacology:

EMIDOM (Domperidone) is a dopamine antagonist. Since it can't readily enter the central nervous system due to blood-brain barrier, its effects are confined to the periphery and acts principally at the receptor in the chemoreceptor trigger zone.

COMPOSITION:

EMIDOM Tablet                    : Each film coated tablet contains Domperidone Maleate BP which is equivalent to 10 mg of Domperidone.

EMIDOM Suspension            : Each 5 ml suspension contains Domperidone BP 5 mg.

EMIDOM Paediatric Drops     : Each ml drop contains Domperidone BP 5 mg.

INDICATION:

  1. Stimulation of gut mobility :

                a) Non-ulcer dyspepsia      b) Esophageal reflux, reflux esophagitis and gastritis c) Diabetic gastroparesis d) Functional dyspepsia

                e) Speeding barium transit in 'follow-through' radiological studies

  1. Prevention and symptomatic relief of acute nausea and vomiting from any cause including cytotoxic therapy, radio therapy and anti-parkinsonism therapy
  2. In the prophylactic treatment of migraine

DOSAGE AND ADMINISTRATION:

EMIDOM tablet should be taken 15-30 minutes before meal In case of acute nausea and vomiting the recommended oral dose

Adults: 10-20 mg (1-2 EMIDOM Tablet or 10-20 ml EMIDOM Suspension) every 4-8 hours daily.

Children: 2- 4 ml EMIDOM Suspension/10 kg or 0.4- 0.8 ml EMIDOM Drops / 10 kg body weight every 4-8 hours daily. In case of functional  dyspepsia

Adults: 10-20 mg (1-2 EMIDOM Tablet or 10-20 ml EMIDOM Suspension) 3 times daily orally before meal and at night.

Children: Not recommended. For acute nausea, vomiting and functional dyspepsia, maximum period of treatment is 12 weeks.

CONTRAINDICATION:

Domperidone is contraindicated in patients having known hypersensitivity to this drug and in case of neonates.

PRECAUTION:

Domperidone should be used with absolute caution in case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood-brain barrier. Since Domperidone is highly metabolized in liver, it should be used with caution in patient with hepatic impairment.

SIDE EFFECT:

Domperidone may produce hyperprolactinemia (1.3%). This may result in galactorrhea, gynaecomastia (breast enlargement), soreness and reduced libido. Dry mouth (1.9%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhoea (0.2%), skin rash and itching (0.1%) may occur during treatment with Domperidone. Extra-pyramidal reactions are seen in 0.25% of patients in clinical studies.

USE IN PREGNANCY & LACTATION:

Pregnant women: The safety of Domperidone has not been proven and it is therefore not recommended during pregnancy. Animal studies have not demonstrated teratogenic effects on the fetus.

Lactating mother : Domperidone may precipitate galactorrhea and improve post-natal location. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.

DRUG-INTERACTION:

Domperidone may reduce the risk of hypoprolactinemic effect of bromocriptine and cabergoline. The action of Domperidone on GI function may be antagonized by antimuscarinics and opioid analgesics.

OVERDOSAGE:

There are no reported cases of overdosage.

PACKAGING:

EMIDOM Tablet                :  Each box contains 10x10 tablets in blister pack.

EMIDOM Suspension        :  Each glass bottle contains 60 ml/100 ml suspension.

EMIDOM Paediatric Drops : Each glass bottle contains 15 ml Paediatric Drops.

 

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