Domstal - instructions for use, doses, side effects, contraindications

Domperidone is a dopamine antagonist that possesses antiemetic properties similar to metoclopramide and some neuroleptics. However, in contrast to these drugs, domperidone poorly penetrates the blood-brain barrier. The use of domperidone is rarely accompanied by extrapyramidal side effects, especially in adults, but domperidone stimulates the release of prolactin from the pituitary gland. Its antiemetic effect may be due to a combination of peripheral (gastrokinetic) action and antagonism to dopamine receptors in the trigger zone of the brain.

When administered orally domperidone prolongs the duration of antral and duodenal contractions, accelerates the emptying of the stomach - the yield of liquid and semi-solid fractions in healthy people and solid fractions in patients in whom this process has been slowed,and increases the pressure of the sphincter of the lower esophagus in healthy people. Domperidone has no effect on gastric secretion.

Pharmacokinetics:

After oral administration of bioavailability of the drug - from 13 to 17% (the effect of "first passage" through the liver). The half-life is 7.5 hours, with renal failure may increase to 20.8 hours. Domperidone is subject to rapid and extensive metabolism. Output through the intestine 66%, kidneys - 33%, incl. in unchanged form - 10 and 1% respectively.

Indications:

- A complex of dyspeptic symptoms, often associated with delayed emptying of the stomach, gastroesophageal reflux, esophagitis (feeling overflow in the epigastrium, a sensation of bloating, pain in the upper abdomen; eructation, flatulence; nausea, vomiting; heartburn);

- nausea and vomiting of a functional, organic, infectious origin, caused by radiotherapy, drug therapy, or a violation of the diet;

- nausea and vomiting caused by dopamine agonists if used in Parkinson's disease (such as levodopa and bromocriptine).

Contraindications:

- Fgastrointestinal bleeding;

- mechanical intestinal obstruction, perforation of the stomach or intestines, in which stimulation of the motor function of the stomach can be dangerous;

- prolactin-secreting pituitary tumor (prolactinoma);

- hypersensitivity to the components of the drug;

- children under 5 years old and weighing up to 20 kg;

- hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Carefully:Pronounced renal and / or hepatic insufficiency.

Pregnancy and lactation:

Data on the use of the drug Domstal® in pregnancy is not enough.

To date, there is no evidence of an increased risk of human developmental malformations. Nevertheless, the use of the drug in pregnancy is possible only in cases where the expected benefit of therapy for the mother exceeds the potential risk to the fetus.

In women, concentrations of domperidone in breast milk are 4 times lower than the corresponding concentrations in plasma. It is not known whether this level has a negative effect on newborns. Therefore, if it is necessary to use Domstal® in a nursing mother, breastfeeding should be discontinued.

Dosing and Administration:

The drug is prescribed by mouth 15-30 minutes before meals.

When chronic dyspeptic symptoms adults prescribe 10 mg (1 tab) 3-4 times within the day and, if necessary, additionally before bedtime.

In case of insufficient effect, this dose is doubled.

Children over 5 years appoint 2.5 mg / 10 kg of body weight 3 times during the day and, if necessary, additionally before bed.

When acute and subacute conditions, especially with nausea and vomiting, adults appoint 20 mg (2 tab) 3-4 times during the day and, if necessary, additionally before bedtime.

Children over 5 years prescribe 5 mg per 10 kg of body weight 3-4 times during the day and, if necessary, additionally before bedtime.

When renal failure depending on the degree of severity, it is recommended to reduce the frequency of taking the drug to 1-2 times / day.

Side effects:

From the digestive system: transient intestinal spasms (completely reversible and disappear after discontinuation of treatment).

From the central nervous system: extrapyramidal disorders in children and in persons with increased permeability of the blood-brain barrier (completely reversible and disappear after discontinuation of treatment).With insufficient development of the blood-brain barrier (for example, in children) or increased permeability, the possibility of neurological side effects can not be ruled out completely.

Allergic reactions: rash and hives.

Other: hyperprolactinemia (galactorrhea, gynecomastia).

Overdose:

Symptoms: drowsiness, disorientation and extrapyramidal disorders, especially in children.

Treatment: the use of activated carbon and careful observation. Anticholinergics, drugs used to treat parkinsonism, or antihistamines with anticholinergic properties may be effective in the occurrence of extrapyramidal reactions.

Interaction:

Anticholinergic drugs can neutralize the effect of the drug.

Bioavailability at ingestion decreases after the previous intake of cimetidine or sodium bicarbonate.

It is not recommended the simultaneous use of antacid and antisecretory medicines, t. they reduce the bioavailability of domperidone after ingestion.

It can also be combined with neuroleptics, the effect of which it does not increase; agonists of dopaminergic receptors (bromocriptine,levodopa), undesirable peripheral effects of which, such as digestive disorders, nausea, vomiting, it suppresses without neutralizing their basic properties.

Antifungal azole agents, antibiotics from the macrolide group, HIV protease inhibitors, nefazodone (antidepressant) increase the concentration of domperidone in plasma.

Simultaneous administration with paracetamol and digoxin had no effect on the concentration of these drugs in the blood.

Special instructions:

With the combined use of the drug Domstal® with antacid or antisecretory drugs, the latter must be taken after meals, and not before meals, i.e. they should not be taken concurrently with Domstal®.

When taking the drug after a meal, absorption is somewhat slowed down.

Form release / dosage:Tablets, 10 mg.

Packaging:

10 tablets in a blister of aluminum foil and PVC film.

1 or 3 blisters with instructions for use in a cardboard box

Storage conditions:

In the dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:4 years.

Do not use later than the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015954 / 01

Date of registration:15.09.2009 / 29.04.2013

The owner of the registration certificate:Torrent Pharmaceuticals Co., Ltd.Torrent Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

TORRENT PHARMACEUTICALS, Ltd. India

Representation: & nbspTORRENT PHARMACEUTICALS LTD. TORRENT PHARMACEUTICALS LTD. India

Information update date: & nbsp18.01.2016

Illustrated instructions

Instructions

Domstal® (Domstal®)