DON-A
®\
(Domperidone)
Tablet/ Suspension/ Paediatric Suspension/ Paediatric
Drops/ Suppository
DESCRIPTION
DON-A (Domperidone) is a dopamine receptor (D2) antagonist. DON-A
(Domperidone) is a selective peripheral dopamine antagonist at the D2
dopamine receptor in the Chemo-receptor Trigger Zone (CTZ) and
stomach. DON-A (Domperidone) does not readily enter the central
nervous system (the chemoreceptor trigger zone is considered to lie
outside the blood brain barrier). DON-A (Domperidone) increases
spontaneous gastric activity and antagonizes dopamine inhibition of
gastric emptying. DON-A (Domperidone) has been shown to increase
lower esophageal sphincter pressure and promotes esophageal and antral
peristalsis and also increases pyloric dilatation. DON-A (Domperidone)
increases the frequency, amplitude, duration of duodenal contraction and
reduces the small bowel transit time. DON-A (Domperidone) has no
acetylcholine like effect.
COMPOSITION
DON-A Tablet: Each film-coated tablet contains Domperidone Maleate
BP equivalent to Domperidone 10 mg.
DON-A Suspension: Each 5 ml suspension contains Domperidone BP 5
mg.
DON-A Paediatric Suspension: Each ml suspension contains
Domperidone BP 1 mg.
DON-A Paediatric Drops: Each ml contains Domperidone BP 5 mg.
DON-A 15 Suppository : Each suppository contains Domperidone BP 15
mg.
DON-A 30 Suppository : Each suppository contains Domperidone BP 30
mg.
INDICATIONS
1. Prevention and symptomatic relief of acute nausea and
vomiting in adults from any cause but specially-
Cytotoxic – therapy
Radio – therapy
Nausea and vomiting associated with L-dopa and
bromocriptine treatment for parkinsonian patients
Nausea associated with migraine attacks
2. Stimulation of gut mobility
Non-ulcer dyspepsia
Esophageal reflux
Reflux esophagitis
Gastritis
Speeding barium transit in "follow- through" radiological studies
Diabetic gastroparesis
3. Functional dyspepsia.
DOSAGE AND ADMINISTRATION
DON-A (Domperidone) should be taken 15-30 minutes before a meal. The
usual recommended oral dose is as follows:
Tablet/ Suspension/ Paediatric drops :
Adult: 10-20 mg (1-2 DON-A tablet or 10-20 ml DON-A suspension) every
4-8 hours.
Elderly : Same as for adults.
Children: 0.2-0.4 mg/kg body weight (2-4 ml suspension or 0.4-0.8 ml
Paediatric drops/ 10 kg body weight) every 4-8 hours.
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. Dose may be divided throughout day if
necessary.
Maximum period of treatment is 12 weeks.
OR AS DIRECTED BY THE PHYSICIAN.
SIDE EFFECTS
Extrapyramidal reactions are seen in 0.05% of patients in clinical studies.
Domperidone may produce hyperprolactinemia (1.3%). This may result in
galactorrhea, breast enlargement, soreness and reduced libido. Dry
mouth (1.9%), thirst, headache (1.2%), nervousness, drowsiness (0.4%),
diarrhea (0.2%), skin rash and itch (0.1%) may all follow treatment with
Domperidone.
CONTRAINDICATIONS
Domperidone is contraindicated to patients having known hypersensitivity
to this drug and in case of neonates. Domperidone should not be used
when gastrointestinal stimulation might be dangerous i.e. gastrointestinal
haemorrhage, obstruction, perforation or immediately after surgery.
PRECAUTIONS
Domperidone should be used with absolute caution in case of children
because there may be an increased risk of extrapyramidal reactions in
young children because of an incompletely developed blood brain barrier.
The safety of Domperidone has not been proven and it is, therefore, not
recommended during pregnancy. Animal studies have not demonstrated
teratogenic effect on the fetus. Domperidone may precipitate galactorrhea
and improve postnatal lactation. It is secreted in breast milk but in very
small quantities insufficient to be considered harmful.
DRUG INTERACTIONS
Domperidone may reduce the risk of hypoprolactinemic effect of
bromocriptine. The action of Domperidone on Gl function may be
antagonized by antimuscarinics and opioid analgesics.
OVERDOSAGE
There are no reported cases of over dosage.
SUPPLY
DON-A Tablet: Each box contains 10 X 10 tablets in blister strip.
DON-A Suspension: Bottle containing 60 ml suspension.
DON-A Paediatric Suspension: Bottle containing 30 ml suspension with
a dropper.
DON-A Paediatric Drops: Bottle containing 15 ml drops with a dropper.
DON-A 15 Suppository : Each Box contains 2 X 5 suppositories in blister
strips.
DON-A 30 Suppository : Each Box contains 2 X 5 suppositories in blister
strips.
Store in a cool and dry place, protected from light.
Keep all medicines out of reach of children.
Further information is available on request.
FOR HEALTH, VIGOUR AND HAPPINESS
.
Dhamrai, Dhaka, Bangladesh.
07 1035
Brand: The ACME Laboratories Ltd