Efodio 10

Generic of Efodio 10

Domperidone Maleate

 

Indication of Efodio 10 mg Tablet

1. Stimulation of gut motility in Dyspeptic symptom complex

• Non-ulcer dyspepsia
• Delayed gastric emptying, gastro- esophageal reflux, reflux esophagitis and gastritis
• Epigastric sense of fullness, feeling of abdominal distension, upper abdominal pain
• Eructation, flatulence, early satiety
• Nausea and vomiting
• Heartburn with or without regurgitations of gastric contents in the mouth
• Diabetic gastroparesis
• Functional dyspepsia
• Speeding Barium transit in ‘follow-through’ radiological studies

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

 

Pharmacology

Domperidone is a selective peripheral dopamine D2 receptor antagonist that principally blocks the dopamine receptors located in the Chemoreceptor Trigger Zone (CTZ) and stomach. Its gastroprokinetic action is based on its blocking effect of dopamine receptors that have an influence on the motility of gastro-intestinal tract. Due to its weak penetration across the blood-brain-barrier, Domperidone has almost no effect on the dopaminergic receptors in the brain, therefore excluding psychotropic and neurologic side effects. Domperidone restores normal motility and tone of the upper gastro-intestinal tract, facilitates gastric emptying, enhances antral and duodenal peristalsis and regulates contraction of the pylorus. Domperidone also increases esophageal peristalsis and lower esophageal sphincter pressure and thus prevents regurgitation of gastric content.

 

Dosage & Administration

Efodio 10 mg tablet should be taken 15-30 minutes before meals and, if necessary, before retiring.

The usual recommended oral dose of Domperidone is as follows:

• Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily. The maximum dose of Domperidone is 80 mg daily.
• Children: 2-4 ml suspension/10 kg body weight or 0.4-0.8 ml paediatric drops/10 kg body weight, every 6-8 hours daily.

In dyspeptic symptom:

• Adults: 10-20 mg (1-2 tablet or 10-20 ml suspension), every 6-8 hours daily.
• Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily.

In acute and sub-acute conditions (mainly in acute nausea and vomiting):

• Adults: 20 mg (2 tablets or 20 ml suspension), every 6-8 hours daily
• Children: 0.2-0.4 mg/kg (2-4 ml suspension/10 kg or 0.4-0.8 ml paediatric drops/10 kg) body weight, every 6-8 hours daily. (In acute nausea and vomiting maximum period of treatment is 12 weeks).

By rectum in suppositories:

• Adults (including elderly): 30-60 mg every 4-8 hours.
• Children: The maximum daily dose rectally in children's is 30 mg for those weighting 10 to 25 kg. The dose may be divided throughout day if necessary.
• The maximum period of treatment is 12 weeks.

 

Interaction

Bromocriptine's hypoprolactemic impact may be reduced by domperidone. Antimuscarinics and opioid analgesics may counteract Domperidone's effect on Gl function. When domperidone is used with MAO (monoamine oxidase) inhibitors, caution should be exercised.

 

Contraindications

Efodio 10 mg is contraindicated to patients having known hypersensitivity to this drug and in the case of neonates. Domperidone should not be used whenever gastro-intestinal stimulation might be dangerous, like in the case of gastrointestinal hemorrhage, mechanical obstruction, or perforation. It is also contraindicated in patients with prolactin releasing pituitary tumors (prolactinoma).

 

Side Effects of Efodio 10

Efodio 10 mg may produce hyperprolactinemia (1.3% frequency). This may result in galactorrhea, breast enlargement and soreness, and reduced libido. Dry mouth (1.9%), thirst, headache (1.2%), nervousness, drowsiness (0.4%), diarrhea (0.2%), skin rash and itching (0.1%) may occur during treatment with Domperidone. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.

 

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 effects on the fetus.

Lactating mother: 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. Drug Interactions: Domperidone may reduce the hypoprolactinemic effect of Bromocriptine. Anti-muscarinics and opioid analgesics may antagonize the action of Domperidone on GI function. Care should be taken when Domperidone is administered in combination with MAO (Monoamine oxidase) inhibitors.

 

Precautions & Warnings

Efodio 10 mg should be used with absolute caution in the 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 the liver, it should be used with caution in patients with hepatic impairment.

 

Therapeutic Class

Prokinetic medicines, Motility stimulants/Dopamine antagonists, Motility stimulants/Dopamine antagonists

 

Storage Conditions

Store in a cool & dry place below 30ºC, protect from light & moisture. Keep out of reach of children.

 

Pharmaceutical Name of Efodio 10

Radiant Pharmaceutical Ltd

 

Related Products of Efodio 10

• Domiren 10
• Vave 10
• Domilin 10
• Dysnov
• Omidon 10