Roles D

Uses

Stimulation of gut motility in-

• Non-ulcer dyspepsia
• Oesophageal reflux, reflux oesophagitis and gastritis
• Diabetic gastroparesis
• Functional dyspepsia
• Speeding barium transit in follow through radiological studies

Prevention and symptomatic relief of acute nausea and vomiting from any cause including cytotoxic therapy, radiotherapy and antiparkinsonism therapy.

In the prophylactic treatment of migraine.

Roles D is also used to associated treatment for these conditions: Diabetic Gastroparesis, Dyspepsia, Erosive Esophagitis, Gastrointestinal Symptoms, Non-erosive Reflux Esophagitis Disease (NERD), Upper gastrointestinal motility disorders

How Roles D works

Roles D acts as a gastrointestinal emptying (delayed) adjunct and peristaltic stimulant. The gastroprokinetic properties of domperidone are related to its peripheral dopamine receptor blocking properties. Roles D facilitates gastric emptying and decreases small bowel transit time by increasing esophageal and gastric peristalsis and by lowering esophageal sphincter pressure. Antiemetic: The antiemetic properties of domperidone are related to its dopamine receptor blocking activity at both the chemoreceptor trigger zone and at the gastric level. It has strong affinities for the D2 and D3 dopamine receptors, which are found in the chemoreceptor trigger zone, located just outside the blood brain barrier, which - among others - regulates nausea and vomiting

Dosage

Roles D dosage

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

Children: 0.2 - 0.4 mg/kg every 4 - 8 hours daily.

Roles D tablet and suspension should be taken 15 - 30 minutes before a meal. For acute nausea and vomiting, maximum period of treatment is 12 weeks.

Side Effects

Roles D may produce hyperprolactinemia which may cause galactorrhea & breast enlargement, soreness and reduced libido. It may rarely cause dry mouth, thirst, headache, nervousness, drowsiness, diarrhea, skin rash and itching.

Toxicity

Side effects include galactorrhea, gynecomastia, or menstrual irregularities.

Precaution

Roles D 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.

Interaction

Roles D may reduce the hypoprolactinaemic effect of bromocriptine. Anti-muscarinics and opioid analgesics may antagonize the action of Roles D on gastrointestinal function.

Food Interaction

• Take before a meal. Take 15-30 minutes before meals.

Half Life

7 hours

Pregnancy & Breastfeeding use

Use in pregnancy: The safety of this drug has not been established for pregnant women. So it is not recommended during pregnancy.

Use in lactation: Roles D may precipitate galactorrhea and improve postnatal lactation, which is secreted in breast milk but in very small quantities insufficient to be considered harmful.

Contraindication

Roles D is contraindicated to the patients who have hypersensitivity to this drug and in case of neonates.

Acute Overdose

Overdose has been reported primarily in infants and children. Symptoms of overdosage may include disorientation, somnolence and extrapyramidal reactions. There is no specific antidote to domperidone, but in the event of overdose, the administration of activated charcoal may be useful. Anticholinergics, antiparkinson drugs may be useful in controlling extrapyramidal reactions. The patient should be observed closely and supportive measures employed.

Storage Condition

Store in a cool dry place protected from light. Keep out of reach of children.

Innovators Monograph

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