Vomino®
Domperidone

COMPOSITION
Vomino® tablet: Each film coated tablet contains Domperidone Maleate BP equivalent to 10mg Domperidone. Vomino® suspension: Each 5ml suspension contains Domperidone BP 5mg.

PHARMACOLOGICAL INFORMATION

Pharmacological Action
Vomino® (Domperidone) is a peripheral dopamine D2 - receptor antagonist with gastroprokinetic and anti-emetic properties. It is used in the treatment of symptoms of nausea and vomiting of variable origin. Vomino effectively increases esophageal peristalsis and lower esophageal sphincter pressure (LESP), increases gastric motility and peristalsis, enhances gastroduodenal coordination and consequently facilitates gastric emptying and decreases small bowel transit time.

Mechanism of Action
The gastroprokinetic properties of Domperidone are related to its peripheral dopamine receptor blocking properties. Domperidone facilitates gastric emptying and decreases small bowel transit time by increasing esophageal and gastric peristalsis. The antiemetic properties of domperidone are related to its dopamine receptor blocking activity at both the chemoreceptor trigger zone and at the gastric level.

Pharmacokinetics
The systemic bioavailability of domperidone is only about 15% in fasting subjects given a dose by mouth, although this is increased when domperidone is given after food. The low bioavailability is thought to be due to first-pass hepatic and intestinal metabolism.
Domperidone is more than 90% bound to plasma proteins, and has a terminal elimination half-life of about 7.5 hours. It is chiefly cleared from the blood by extensive metabolism. About 30% of an oral dose is excreted in urine within 24 hours, almost entirely as metabolites; the remainder of a dose is excreted in feces over several days, about 10% as unchanged drug. It does not readily cross the blood-brain barrier.
Small amounts of domperidone are distributed into breast milk, reaching concentrations about one-quarter of those in maternal serum.

CLINICAL INFORMATION
Therapeutic Indications

• Prevention and symptomatic relief of acute nausea and vomiting adults from any cause
• Non-ulcer dyspepsia
• Functional dyspepsia
• Diabetic gastroparesis
• Heartburn
• Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
• Gastro-esophageal reflux diseases
• Stimulation of gut mobility
• Relieves nausea associated with migraine attack

Dosage and Administration
The recommended oral dose for
Adults: 10-20 mg every 4-8 hours daily.
Children: 0.2-0.4 mg/kg body weight every 4-8 hours daily.
Vomino® (Domperidone) should be taken 15-30 minutes before a meal. For acute vomiting and nausea, maximum period of treatment is 12 weeks. Use in children is restricted to nausea and vomiting following cytotoxics or radiotherapy.

Use in Pregnancy and 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 effect in the fetus.
Lactating mother: Vomino® (Domperidone) may precipitate galactorrhea and improve post-natal lactation. It is secreted in breast milk but in very small quantities insufficient to be considered harmful.

Use in Patient with Impaired Hepatic Function
Vomino® (Domperidone) is highly metabolized in the liver, Vomino should be used with caution in patients with hepatic impairment.

Use in Patient with Impaired Renal Function
It is unlikely that the dose needs to be adjusted for single administration in patients with renal insufficiency. However, on repeated administration the dosing frequency will need to be reduced to once or twice daily depending on the severity of the impairment. The dose may also need to be reduced. Generally, patients on prolonged therapy should be reviewed regularly.

Side Effects
Vomino® (Domperidone) may produce hyperprolactinemia (1.3%). This may result in galactorrhea, breast enlargement, and soreness and reduced libido.

Contraindications
Vomino® (Domperidone) is contraindicated to patients having known hypersensitivity to this drug and in case of neonates. It is also contraindicated in patients with prolactin releasing pituitary tumor (prolactinoma).

Precautions
Vomino® (Domperidone) should be used with caution in case of children because there may be 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.

Drug Interactions
Vomino® (Domperidone) may antagonise the hypoprolactinaemic effect of drugs such as bromocriptine. In addition Opioid analgesics and antimuscarinics may antagonise the prokinetic effects of domperidone.

PHARMACEUTICAL INFORMATION
Storage Conditions
Store in a cool (below 30oC)and dry place and protect from light and moisture. Keep this medication out of the reach of children.

Presentation & Packaging
Vomino® tablet: Each commercial box contains 10 X 10's tablets in Alu-PVC blister pack.
Vomino® suspension: Each bottle contains 60ml suspension.