Adults
To stop or prevent feeling sick (nausea) or being sick (vomiting).
Children
To stop or prevent children feeling sick (nausea) or being sick (vomiting)

It is recommended to take the tablets 15 to 30 minutes before a meal and, if needed, before
you go to bed.
Adults and teenagers (over 12 years and who weigh more than 35 kg) Take one Dompy
tablet (10 mg) up to 3 times daily.
Dose shall not exceed 1 tablet (10 mg) 3 times daily orally for a period of one week.

• Children
Do not give Dompy tablets to children under 12 years of age and weighing less than 35kg.

Dompy is contraindicated in the following situations: Patients with certain heart conditions including heart failure, previous heart attack, Angina (chest pains), and heart arrhythmia disorders. • Known hypersensitivity to domperidone or any of the excipients • Prolactin-releasing pituitary tumour (prolactinoma). Dompy should not be used when stimulation of the gastric motility could be harmful: gastro-intestinal haemorrhage, mechanical obstruction or perforation.

Precautions for use
The tablets contain lactose and may be unsuitable for patients with lactose intolerance,
galactosaemia or glucose/galactose malabsorption.
Use during lactation:
The total amount of domperidone excreted in human breast milk is expected to be less than
7μg per day at the highest recommended dosing regimen. It is not known whether this is
harmful to the newborn. Therefore breast-feeding is not recommended for mothers who are
taking Dompy.
Use in liver disorders:
Since domperidone is highly metabolised in the liver, Dompy should be not be used in
patients with hepatic impairment.
Renal insufficiency:

In patients with severe renal insufficiency (serum creatinine > 6 mg/100 ml, i.e. > 0.6 m
mol/l) the elimination half-life of domperidone was increased from 7.4 to 20.8 hours, but
plasma drug levels were lower than in healthy volunteers. Since very little unchanged drug is
excreted via the kidneys, it is unlikely that the dose of a single administration needs to be
adjusted in patients with renal insufficiency. However, on repeated administration, the dosing
frequency should be reduced to once or twice daily depending on the severity of the
impairment, and the dose may need to be reduced. Such patients on prolonged therapy should
be reviewed regularly.

Use with Potent CYP3A4 Inhibitors:

Co-administration with oral ketoconazole, erythromycin or other potent CYP3A4 inhibitors
that prolong the QTc interval should be avoided (see section 4.5 Interaction with other
medicinal products and other forms of interaction).

The main metabolic pathway of domperidone is through CYP3A4. In vitro data suggest that
the concomitant use of drugs that significantly inhibit this enzyme may result in increased
plasma levels of domperidone.

Separate in vivo pharmacokinetic/pharmacodynamic interaction studies with oral
ketoconazole or oral erythromycin in healthy subjects confirmed a marked inhibition of
domperidone's CYP3A4 mediated first pass metabolism by these drugs.

With the combination of oral domperidone 10mg four times daily and ketoconazole 200mg
twice daily, a mean QTc prolongation of 9.8 msec was seen over the observation period, with
changes at individual time points ranging from 1.2 to 17.5 msec. With the combination of
domperidone 10mg four times daily and oral erythromycin 500mg three times daily, mean
QTc over the observation period was prolonged by 9.9 msec, with changes at individual time
points ranging from 1.6 to 14.3 msec. Both the Cmax and AUC of domperidone at steady
state were increased approximately three-fold in each of these interaction studies. In these
studies domperidone monotherapy at 10mg given orally four times daily resulted in increases
in mean QTc of 1.6 msec (ketoconazole study) and 2.5 msec (erythromycin study), while
ketoconazole monotherapy (200mg twice daily) led to increases in QTc of 3.8 and 4.9 msec,
respectively, over the observation period.

There are limited post-marketing data on the use of domperidone in pregnant women. A
study in rats has shown reproductive toxicity at a high, maternally toxic dose. The potential
risk for humans is unknown. Therefore, Dompy should only be used during pregnancy when
justified by the anticipated therapeutic benefit.

The drug is excreted in breast milk of lactating rats (mostly as metabolites: peak
concentration of 40 and 800 ng/ml after oral and i.v. administration of 2.5 mg/kg
respectively). Domperidone concentrations in breast milk of lactating women are 10 to 50%

of the corresponding plasma concentrations and expected not to exceed 10ng/ml. The total
amount of domperidone excreted in human breast milk is expected to be less than 7μg per
day at the highest recommended dosing regimen. It is not known whether this is harmful to
the newborn. Therefore breast-feeding is not recommended for mothers who are taking
Dompy.

Dompy has no or negligible influence on the ability to drive and use machines.

The following frequencies are used for the description of the occurrence of adverse reactions:
Very common ( 1/10); common ( 1/100 to <1/10); uncommon ( 1/1,000 to <1/100); rare
( 1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the
available data).
Immune System Disorder:
Very rare; anaphylactic reactions including anaphylactic shock, angioedema, allergic
reaction
Endocrine disorder:
Rare; increased prolactin levels
Psychiatric System Disorder:
Very rare; agitation, nervousness
Gastrointestinal disorders:
Rare; gastro-intestinal disorders, including very rare transient intestinal cramps
Skin and subcutaneous tissue disorders:
Very rare; urticaria, pruritus, rash
Reproductive system and breast disorders:
Rare; galactorrhoea, gynaecomastia, amenorrhoea.
Cardiac disorders:
Very rare; ventricular arrhythmias,

Frequency not known; QTc prolongation
Investigations:

Very rare; liver function test abnormal
As the hypophysis is outside the blood brain barrier, domperidone may cause an increase in
prolactin levels. In rare cases this hyperprolactinaemia may lead to neuro-endocrinological
side effects such as galactorrhoea, gynaecomastia and amenorrhoea.

To reports any side effect(s):
Saudi arabia
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

There is no specific antidote to domperidone, but in the event of overdose, gastric lavage as
well as the administration of activated charcoal, may be useful. Close medical supervision
and supportive therapy is recommended.
Anticholinergic, anti-parkinson drugs may be helpful in controlling the extrapyramidal
reactions.

Pharmacotherapeutic group:
Propulsives, ATC code: A03F A 03
Domperidone is a dopamine antagonist with anti-emetic properties, Domperidone does not
readily cross the blood-brain barrier. In domperidone users, especially in adults,
extrapyramidal side effects are very rare, but domperidone promotes the release of prolactin
from the pituitary. Its anti-emetic effect may be due to a combination of peripheral
(gastrokinetic) effects and antagonism of dopamine receptors in the chemoreceptor trigger
zone, which lies outside the blood-brain barrier in the area postrema. Animal studies,

together with the low concentrations found in the brain, indicate a predominantly peripheral
effect of domperidone on dopamine receptors.
Studies in man have shown oral domperidone to increase lower oesophaegeal pressure,
improve antroduodenal motility and accelerate gastric emptying. There is no effect on gastric
secretion.

Absorption
In fasting subjects, domperidone is rapidly absorbed after oral administration, with peak
plasma concentrations at 30 to 60 minutes. The low absolute bioavailability of oral
domperidone (approximately 15%) is due to an extensive first-pass metabolism in the gut wall
and liver. Although domperidone's bioavailability is enhanced in normal subjects when taken
after a meal, patients with gastro-intestinal complaints should take domperidone 15-30
minutes before a meal. Reduced gastric acidity impairs the absorption of domperidone. Oral
bioavailability is decreased by prior concomitant administration of cimetidine and sodium
bicarbonate. The time of peak absorption is slightly delayed and the AUC somewhat increased
when the oral drug is taken after a meal.

Distribution
Oral domperidone does not appear to accumulate or induce its own metabolism; a peak plasma
level after 90 minutes of 21 ng/ml after two weeks oral administration of 30 mg per day was
almost the same as that of 18 ng/ml after the first dose. Domperidone is 91-93% bound to
plasma proteins. Distribution studies with radiolabelled drug in animals have shown wide
tissue distribution, but low brain concentration. Small amounts of drug cross the placenta in
rats.

Metabolism
Domperidone undergoes rapid and extensive hepatic metabolism by hydroxylation and Ndealkylation.
In vitro metabolism experiments with diagnostic inhibitors revealed that
CYP3A4 is a major form of cytochrome P-450 involved in the N-dealkylation of
domperidone, whereas CYP3A4, CYP1A2 and CYP2E1 are involved in domperidone
aromatic hydroxylation.

Excretion
Urinary and faecal excretions amount to 31 and 66% of the oral dose respectively. The
proportion of the drug excreted unchanged is small (10% of faecal excretion and
approximately 1% of urinary excretion). The plasma half-life after a single oral dose is 7-9
hours in healthy subjects but is prolonged in patients with severe renal insufficiency.

Electrophysiological in vitro and in vivo studies indicate an overall moderate risk of
domperidone to prolong the QT interval in humans. In in vitro experiments on isolated cells
transfected with HERG and on isolated guinea pig myocytes, exposure ratios ranged between
5 and 30-fold, based on IC50 values inhibiting currents through IKr ion channels in
comparison to the free plasma concentrations in humans after administration of the
maximum daily dose of 20mg (q.i.d.). Exposure margins for prolongation of action potential
duration in in vitro experiments on isolated cardiac tissues exceeded the free plasma
concentrations in humans at maximum daily dose (20mg q.i.d) by 17-fold. However, safety
margins in in vitro pro-arrhythmic models (isolated Langendorff perfused heart) and in in
vivo models (dog, guinea pig, rabbits sensitised for torsades de pointes) exceeded the free
plasma concentrations in humans at maximum daily dose (20mg q.i.d.) by more than 17-fold.
In the presence of inhibition of the metabolism via CYP3A4 free plasma concentrations of
domperidone can rise up to 10-fold.

At a high, maternally toxic dose (more than 40 times the recommended human dose),
teratogenic effects were seen in the rat. No teratogenicity was observed in mice and rabbits.

Core Tablet:
- Ludipress
- Microcrystalline Cellulose
- Crospovidone
- Silicon Dioxide Colloidal
- Magnesium Stearate

Coating materials:
- Opadry white
- Propylene Glycol
- Purified Water

Not applicable.

36 Months

Do not store above 30°C.

Immediate Container: Alu- PVC/PVDC blister with Aluminum foil, 
Outer Individual Carton
PIL/Leaflet
 

No special requirements.