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APULDON

Domperidone

 

Description:

Domperidone is dopamine receptor (D2) antagonist which is a selective peripheral dopamine antagonist at the D2 dopamine receptor and acts principally at receptor in the chemoreceptor trigger zone (CTZ) and also at receptors in the stomach. Domperidone does not readily enter the central nervous system or cross the blood-brain barrier. Domperidone increases spontaneosus gastric activity and antagonises dopamine inhibition of gastric emptying. Domperidone also exerts effects at some points of CNS that do not possess blood-brain barrier and thus controls emesis. Thus domperidone acts as an antiemetic and gastroprokinetic agent.

Composition:

Apuldon Tablet: Each tablet contains Domperidone Maleate BP equivalent to Domperidone 10 mg.

Apuldon Suspension: Each 5 ml contains Domperidone BP 5 mg.

Apuldon Paediatric Drops: Each ml contains Domperidone BP 5 mg.

Indications:

1. Stimulation of gut mobility:

• Non-ulcer dyspepsia

• Esophageal reflux, reflux esophagitis & gastritis

• Speeding barium transit in 'follow-through' radioloigical studies.

• Diabetic gastroparesis.

2. Prevention and symptomatic relief from acute nausea & vomiting in adults from any cause but specially:

• Cytotoxic therapy & radiotherapy

• Nausea & vomiting associated with migraine attacks (in combination with analgesics)

• L-dopa and bromocriptine treatment for Parkinsonian patients

3. Functional dyspepsia.

Dosage & Administration:

The recommended oral dose for:

Adults: 10-20 mg every 4-8 hours daily.

Children (2-12 years): 0.2-0.4 mg/kg body weight (0.4-0.8 ml paediatric drops/10 Kg) every 4-8 hours daily.

Note: Both tablet & suspension should be taken 15-30 minutes before a meal. For acute nausea & vomiting maximum period of treatment is 12 weeks.

Contraindications:

Patients with a known allergy to Domperidone or Domperidone Maleate or any inactive ingredient of the product and neonates.

Side-effects:

Apuldon may produce hyperprolactinemia which may cause galactorrhoea & breast enlargement. It may rarely cause dry mouth (1.9%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhoea (0.2%), skin rash & itching (0.1%).

Precautions:

In case of children, treatment with Apuldon should be continued with caution because there may be increased risk of extra-pyrimidal reactions in young children.

Use in pregnancy and Lactation:

The safety of this drug has not been established for pregnant women. So it is not recommended during pregnancy. Apuldon may precipitate galactorrhoea and improve postnatal lactation, which is secreted in breast milk but in very small quantities insufficient to be considered harmful.

Drug Interaction:

The hypoprolactinemic effect of bromocriptine may be reduced by Apuldon. The effect of antimuscarinics & opioid analgesics may antagonize Apuldon on GI function.

Packing:

Apuldon Tablet: Box containing 10x10's tablets in blister pack.

Apuldon Suspension: Bottle containing 60 ml suspension.

Apuldon Paediatric Drops:  Bottle containing 15 ml drops alongwith a dropper.

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