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Last Edit: 15 August 2006
Domperidone/Motilium: A Summary of Facts
This information has been compiled from the original manufacturer's facts sheet, (Janssen-Cilag Pty Ltd, New Zealand), and other reliable sources.
Description:
- Domperidone/Motilium manufactured by, or licensed for manufacture by, Janssen-Cilag Pty Ltd are circular, white, film-coated, biconvex, 10 mg tablets with m/10 imprinted on one side, and JANSSEN on the other.
- Domperidone/Motilium is a dopamine inhibiting medication, with vomit inhibiting properties similar to those of Reglan, (Metoclopramide), and certain other neuroleptic medicines. Unlike Reglan, Domperidone does not readily cross the blood-brain barrier, and does not normally cause depression. Side effects seldom cause interference with physical motor control, (extrapyramidal), but does cause a rise in Prolactin levels.
Common Uses:
- Designed and manufactured for the treatment and relief of Dyspeptic Symptom Complex, (sometimes know as Acid Reflux Disease). Dyspeptic Symptom Complex is a condition often associated with delayed stomach emptying, food returning to the esophagus from the stomach, upper abdominal pain, feeling of abdominal fullness, abnormal belching, flatulence and heartburn.
- Treatment of nausea and vomiting of various origins including functional, organic, infectious, dietetic, radiotherapy, medicine therapy.
- Because Domperidone elevates Prolactin levels in some women, it is often used as an aid to inducing lactation.
Dosage:
- General: For Dyspeptic Symptom Complex, (Acid Reflux), Domperidone/Motilium should be taken 15-30 minutes before meals and, if necessary, before retiring. As an aid to inducing lactation only, it is often taken 15-30 minutes after meals.
- Adults: For treatment of Dyspeptic Symptom Complex - One, 10 mg tablet, three to four times daily. If necessary this dose may be doubled after two weeks if an adequate therapeutic response is not attained.
For acute and subacute conditions (e.g. nausea and vomiting) 20 mg three to four times daily.
- Inducing Lactation: Up to two, 10 mg tablets, four times daily are often used by women to aid with inducing lactation. Increasing dosage beyond 80 mg per day does not seem to increase results accordingly.
- Testing For Side Effects: Begin dosage with one, 10 mg tablet, three to four times daily. If side effects appear, (such as headache), reduce, or discontinue dosage until side effects disappear.
Side Effects:
- The most frequent reactions to Domperidone/Motilium are those related to elevated Prolactin levels: which include breast tenderness, spontaneous lactation, increase in breast size, and abnormal suppression or absence of menstruation. These effects are dose-related and gradually resolve after lowering dosage or discontinuing treatment.
- Other rare adverse reactions may include headache, diarrhea, dizziness, mild and transient abdominal cramps, dry mouth and drowsiness. Rare allergic reactions, such as rash and urticaria (itching, burning, stinging), have also been reported.
- Extrapyramidal reactions, (loss of motor control), occur rarely in young children, and very rarely in adults. Extrapyramidal reactions are usually resolved completely and spontaneously after cessation of treatment.
Additional Ingredients:
- Domperidone/Motilium tablets manufactured by, or licensed for manufacture by, Janssen-Cilag Pty Ltd also contain lactose, maize starch, microcrystalline cellulose, pregelatinized potato starch, polyvidone, magnesium stearate, hydrogenated vegetable oil, sodium lauryl sulfate and hypromellose.
- Counterfeit, or unlicensed Domperidone/Motilium tablets may contain unknown ingredients, and often appear different in color and markings.
Additional Information and Precautions:
- Domperidone/Motilium causes an increase in plasma Prolactin. An elevated level of Prolactin persists with continued use, but falls to normal upon discontinuing the medicine. During continued oral administration of 30 mg daily for two weeks, the plasma Prolactin level measured 90 minutes after medicine intake increased in females to 117 ng/mL after the first dose, but decreased to 56 ng/mL after 14 doses. (normal pretreatment value was 9 ng/mL) Prolactin levels remained fairly constant at 25 ng/mL in males (normal value was 5 ng/mL).
- Tissue culture experiments indicate that approximately one-third of human breast cancers are Prolactin-dependent in vitro, a factor of potential importance if the administration of Domperidone is contemplated in a patient with a past history of breast cancer. Although occurrences such as spontaneous lactation, increase in breast size, abnormal suppression or absence of menstruation and impotence have been reported with other Prolactin-elevating medicines, the clinical significance of elevated serum Prolactin levels is unknown. An increase in mammary neoplasms, (tumor, abnormal new growth of tissue in animals), have been found in rodents after chronic administration of Domperidone and other Prolactin-stimulating medicines.
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