Composition:
Orbidon Tablet: Each film-coated tablet contains Domperidone Maleate BP equivalent to Domperidone 10 mg.

Pharmacology
Domperidone is a dopamine receptor (D2) antagonist. Domperidone is a selective peripheral dopamine antagonist at the D2 Dopamine receptor in the Chemoreceptor Trigger Zone (CTZ) and stomach. Domperidone does not readily enter the central nervous system. Domperidone increases spontaneous gastric activity and antagonizes dopamine inhibition of gastric emptying. Domperidone has been shown to lower esophageal sphincter pressure and promotes esophageal and antral peristalsis and also increases pyloric dilation. Domperidone increases the frequency, amplitude, duration of duodenal contraction and reduces the small bowel transit time. Domperidone has no acetylcholine-like effect.

Indication

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

   • Cytotoxic therapy
   • Radiotherapy
   • Nausea and vomiting associated with L-dopa and bromocriptine treatment for parkinsonian patients
   • Nausea associated with migraine attacks.

2. Stimulation of gut motility:

   • Non-ulcer dyspepsia
   • Esophageal reflux
   • Reflux esophagitis
   • Gastritis
   • Speeding barium transit in “Follow-through” radiological studies
   • Diabetic gastroparesis

3. Functional Dyspepsia

Dosage & Administration
Orbidon Tablet: Should be taken 15-30 minutes before a meal. The usual recommended oral dose is as follows:

• Adult (12 years & older): One 10 mg tablet up to three times per day. Maximum dose is 30 mg per day.
• Elderly: Same as for adults.
• Child: Due to the need for accurate dosing, Domperidone 10 mg tablet is unsuitable for use in children and adolescents weighing less than 35 kg or as directed by a physician.

Contraindications:
Domperidone is contraindicated in patients having known hypersensitivity to this drug and in neonates. Domperidone should not be used when gastrointestinal stimulation might be dangerous, i.e., gastrointestinal hemorrhage, obstruction, perforation, or immediately after surgery.

Side Effects:
Domperidone may produce hyperprolactinemia. This may result in galactorrhea, breast enlargement, soreness, and reduced libido. Dry mouth, thirst, headache, nervousness, drowsiness, diarrhea, skin rash, and itching may occur during treatment with domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.

Precautions and Precautions:
Domperidone should be used with absolute caution in children because there may be an increased risk of extrapyramidal reactions in young children due to an incompletely developed blood-brain barrier.

Use in special population group

• Pregnancy & Lactation: The safety of Domperidone has not been proven, and it is therefore not recommended during pregnancy. Animal studies have not demonstrated a teratogenic effect on the fetus. Domperidone may precipitate galactorrhea and improve postnatal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.
• Patients with renal or hepatic insufficiency: Since Domperidone is highly metabolized in the liver, it should not be used in patients with moderate to severe hepatic impairment. In patients with renal insufficiency, the dosing frequency should be reduced.

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

Over Dosage
There are no reported cases of overdose.

Storage
Store below 30°C in a cool & dry place, protected from light. Keep all medicines out of reach of children.

Pack Size:
Orbidon Tablet: Each box contains 10 X 10 tablets Alu-PVC in a blister strip.