Doprokin (Domperidone)
COMPOSITION
Each tablet contains domperidone 10 mg.
THERAPEUTIC INDICATIONS
I. Dyspeptic symptoms complex, which often
associated with bradyperistalsis, gastro esophageal reflux, esophagitis:
- The sense of overfilling in epigastria, abdominal distension, pain in upper
part of a stomach.
- Eructation.
- Nausea, vomiting.
- Pyrosis.
II. Nausea and vomiting of functional, organic an infectious etiology caused by
radiotherapy, drug therapy or deviation from diet. Nausea and vomiting caused by
agonists of dopamine (L-dopa and bromocriptin) in case of their application for
treatment of Parkinsonism are specific indications.
III. Pediatric practice: regurgitation syndrome, cyclic vomiting,
gastroesophageal reflux and other disturbances of stomach motility.
CONTRAINDICATIONS
Doprokin is contraindicated for patients with
known hypersensitivity to domperidone. Doprokin should not be administered when
stimulation of gastric motor activity can be dangerous (i.e. in case of
gastrointestinal bleeding, mechanical ileus or perforation).
Doprokin is contraindicated for patients with prolactin-secreting pituitary
tumor (prolactinoma).
ADVERSE EFFECTS
Adverse effects are seldom observed.
Effects from GIT: extraordinary cases – temporary intestinal colic (completely
reversible and spontaneously disappear after treatment cessation).
Effects from CNS: extrapyramidal events in children and in single cases in
adults. As hypophysis is out of blood brain barrier Doprokin can induce
increasing of prolactin plasma level. In rare cases this hyperprolactinemia can
stimulate the appearance of neuroendocrinal events.
Allergic reactions: seldom – rash and urticaria.
DOSAGE AND ADMINISTRATION
1. Chronic dyspepsia
Adults: 10 mg (1 tablet) 3 times a day 15-30 minutes before meal and if
necessary before sleep.
Children: 2.5 mg/10 kg of body weight 3 times a day 15-30 minutes before meal
and if necessary before sleep.
If necessary the indicated dose can be doubled (except for children younger one
year).
2. Acute and subacute states (primarily nausea and vomiting).
Adults: 20 mg (2 tablets) 3-4 times a day before meal and sleep.
Children: 5 mg/10 kg of body weight 3-4 times a day before meal and sleep.
Notes:
- Peroral administration of Doprokin before meal is recommended. Absorption is
slow down following administration after meal.
- Doprokin tablets are indicated only for adults and for children older 5 years.
- Reducing of frequency of Doprokin administration is recommended in case of
renal insufficiency.
DRUG INTERACTIONS
Anticholinergic drugs can neutralize
antidyspeptic action of Doprokin. Antacid and antisecretory agents should not be
co-administered with Doprokin as they reduce bioavailability of domperidone
following oral administration.
PREGNANCY AND LACTATION
Doprokin should be prescribed during the first
trimester of pregnancy only if its application is justified by the expected
therapeutic benefit. If nursering mother takes Doprokin breast-feeding is not
recommended except for cases when expected benefit justifies potential risk.
MANUFACTURED FORM
Tablets for oral use 10 mg.
10 tablets are in PVC and aluminum foil blisters. 2 blisters with a leaflet are
in a carton box.
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