RITEMED Domperidone 10mg Tablet 1's
RXDRUG-DRP-2007-03-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Domperidone is used as an antiemetic for the short-term treatment of nausea and vomiting of various aetiologies.
Domperidone is also used for its prokinetic actions in dyspepsia and in diabetic gastroparesis. It is given with paracetamol in the symptomatic treatment of migraine.
Domperidone is also used for its prokinetic actions in dyspepsia and in diabetic gastroparesis. It is given with paracetamol in the symptomatic treatment of migraine.
Dosage/Direction for Use
For the treatment of Nausea and Vomiting: 10 to 20 mg 3 or 4 times daily up to a maximum daily dose of 80 mg.
For the symptomatic treatment of non-ulcer dyspepsia: Adult: 10 mg, 3 times daily before meals and last dose to be taken at night.
In Migraine: 20 mg up to every 4 hours, in combination with paracetamol, as required up to a maximum of 4 doses in 24 hours.
Or as prescribed by a physician.
For the symptomatic treatment of non-ulcer dyspepsia: Adult: 10 mg, 3 times daily before meals and last dose to be taken at night.
In Migraine: 20 mg up to every 4 hours, in combination with paracetamol, as required up to a maximum of 4 doses in 24 hours.
Or as prescribed by a physician.
Administration
Should be taken on an empty stomach.
Contraindications
Known hypersensitivity to the active substance or to any of the excipients.
Warnings
Not considered suitable for chronic nausea and vomiting, nor for the routine prophylaxis of post operative vomiting.
Parenteral administration has caused fatal ventricular arrhythmia especially in patients with hypokalemia.
Tartrazine may cause allergic type reactions (including bronchial asthma) in certain susceptible individuals.
Parenteral administration has caused fatal ventricular arrhythmia especially in patients with hypokalemia.
Tartrazine may cause allergic type reactions (including bronchial asthma) in certain susceptible individuals.
Special Precautions
Domperidone is not recommended for chronic use or for the routine prophylaxis of postoperative nausea and vomiting. Domperidone should be used with great caution if given intravenously, because of the risk of arrhythmias, especially in patients predisposed to cardiac arrhythmias or hypokalaemia.
Use in Pregnancy: Domperidone should only be used during pregnancy when justified by the anticipated therapeutic benefit.
Use in Lactation: The drug is excreted in breast milk, the use of Domperidone during lactation is therefore not recommended.
Use in Pregnancy: Domperidone should only be used during pregnancy when justified by the anticipated therapeutic benefit.
Use in Lactation: The drug is excreted in breast milk, the use of Domperidone during lactation is therefore not recommended.
Use In Pregnancy & Lactation
Use in Pregnancy: Domperidone should only be used during pregnancy when justified by the anticipated therapeutic benefit.
Use in Lactation: The drug is excreted in breast milk, the use of Domperidone during lactation is therefore not recommended.
Use in Lactation: The drug is excreted in breast milk, the use of Domperidone during lactation is therefore not recommended.
Adverse Reactions
Plasma-prolactin concentration may be increased, which may lead to galactorrhoea or gynaecomastia. There have been reports of reduced libido and rashes and other allergic reactions.
Domperidone does not readily cross the blood-brain barrier and the incidence of central effect such as extrapyramidal reaction or drowsiness may be lower than with metoclopramide; however there have been reports of dystonic reactions.
Domperidone does not readily cross the blood-brain barrier and the incidence of central effect such as extrapyramidal reaction or drowsiness may be lower than with metoclopramide; however there have been reports of dystonic reactions.
Drug Interactions
Effect on GIT activity is antagonized by opioid analgesics and anti-muscarinic agents; antagonizes the hypoprolactinemic effect of bromocriptine. Azole antifungals and macrolide antibiotics can block metabolism of domperidone resulting in the increased plasma concentration.
Storage
Store in a dry and dark place at a temperature not exceeding 30°C.
Action
Pharmacology: Pharmacokinetics: Although absorption is rapid, the systemic bioavailability of Domperidone is only about 15% in fasting subjects given an oral dose; this is increased when Domperidone is given after food. The low bioavailability is thought to be due to first-pass hepatic and intestinal metabolism. The bioavailability of rectal Domperidone is similar to that after oral doses, although peak plasma concentrations are only about one-third that of an oral dose and are achieved after about an hour, compared with 30 minutes after an oral dose.
Domperidone is more than 90% bound to plasma proteins, and has a terminal elimination half-life of about 7.5 hours. It undergoes rapid and extensive hepatic metabolism. The main metabolic pathways are N-dealkylation by cytochrome P450 isoenzyme CYP3A4, and aromatic hydroxylation by CYP3A4, CYP1A2, and CYP2E1. 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 faeces 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; concentrations are 10 to 50% of those in maternal serum.
Domperidone is more than 90% bound to plasma proteins, and has a terminal elimination half-life of about 7.5 hours. It undergoes rapid and extensive hepatic metabolism. The main metabolic pathways are N-dealkylation by cytochrome P450 isoenzyme CYP3A4, and aromatic hydroxylation by CYP3A4, CYP1A2, and CYP2E1. 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 faeces 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; concentrations are 10 to 50% of those in maternal serum.
MedsGo Class
GIT Regulators, Antiflatulents & Anti-Inflammatories
Features
Brand
RiteMed
Full Details
Dosage Strength
10mg
Drug Ingredients
- Domperidone
Drug Packaging
Tablet 1's
Generic Name
Domperidone
Dosage Form
Tablet
Registration Number
DRP-2007-03
Drug Classification
Prescription Drug (RX)
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