Domperidone-Teva, pills 10mg 30pcs

Composition

1 tablet contains:

Active ingredient:

domperidone 10 mg;

Auxiliary substances:  

microcrystalline cellulose-60.00 mg,

pregelatinized starch-19.46 mg,

colloidal silicon dioxide (aerosil) – 0.09 mg,

magnesium stearate-0.45 mg,

polyvinyl alcohol-1.44 mg,

macrogol (polyethylene glycol) – 0.73 mg,

talc-0.53 mg,

titanium dioxide-0.90 mg

Pharmacological action

Domperidone is a dopamine receptor blocker with an antiemetic effect.

The effect is due to a combination of peripheral (gastrokinetic) action and inhibition of dopamine receptors in the trigger zone of brain chemoreceptors located outside the blood-brain barrier in the areapostrema region.

When taken orally, domperidone increases reduced pressure in the esophagus, improves antroduodenal motility and accelerates gastric emptying, without affecting gastric secretion.

Domperidone increases the secretion of prolactin in the pituitary gland.

Pharmacokinetics

When taken orally on an empty stomach, domperidone is rapidly absorbed, its Cmax in plasma is reached within 30-60 minutes. The low absolute bioavailability after oral use (about 15%) is due to the “first pass” effect through the liver. Although the bioavailability of domperidone increases in healthy volunteers when taken after meals, patients with gastrointestinal complaints should take domperidone 15-30 minutes before meals. With a decrease in the acidity of gastric juice, there is a violation of the absorption of domperidone. Pre-use of cimetidine and sodium bicarbonate reduces the bioavailability of domperidone. When taken orally after a meal, a slightly longer time is required to achieve maximum absorption.

When taken orally, domperidone does not accumulate or induce its own metabolism. Domperidone is 91-93% bound to plasma proteins. Domperidone is distributed in various tissues of the body, is found in breast milk, but does not penetrate the blood-brain barrier. The concentration of domperidone in breast milk is 10-50% of the concentration in blood plasma.

Domperidone is metabolized in the liver and in the intestinal wall by hydroxylation and N-dealkylation involving the isoenzymes CYP3A4, CYP1A2, and CYP2E1.

Domperidone is excreted by the intestines (66%) and kidneys (33%), including unchanged (10% and 1%, respectively). T1 / 2 is 7-9 h

. Pharmacokinetics in special clinical cases

In patients with a serum creatinine concentration of more than 0.6 mmol/l, T1 / 2 ranges from 7.4 to 20.8 hours, while the concentration of domperidone in blood plasma is reduced.

Indications

Dyspeptic symptoms, such as:

• Nausea, vomiting.
• Feeling of fullness in the epigastric region.
• Discomfort in the upper abdomen.
• Regurgitation of gastric contents.

Use during pregnancy and lactation

Domperidone-Teva is contraindicated in pregnancy, breast-feeding and children under 1 year of age.

Contraindications

• Hypersensitivity to domperidone or any other component of the drug.
• Prolactin-secreting pituitary tumor (prolactinoma).
• Gastrointestinal bleeding.
• Perforation of the gastrointestinal tract.
• Mechanical bowel obstruction.
• Hereditary lactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
• Breast-feeding period.
• Children weighing less than 35 kg.

With caution:

• Pregnancy.
• Liver failure.
• Kidney failure.

Side effects

From the digestive system:  gastrointestinal disorders (transient intestinal spasms).

Nervous system disorders:  extrapyramidal disorders (in children and individuals with increased BBB permeability, in adults-isolated cases); these phenomena are completely reversible and disappear after discontinuation of the drug.

Allergic reactions:  skin rash, urticaria.

Other services:  hyperprolactinemia (galactorrhea, gynecomastia, amenorrhea).

Interaction

of Cimetidine, sodium bicarbonate reduces the bioavailability of domperidone.

M-holinoblockers and antacid drugs neutralize the effect of domperidone.

The concentration of domperidone in plasma is increased by inhibitors of the CYP3A4 isoenzyme: azole-type antifungal drugs, macrolide antibiotics, HIV protease inhibitors, nefazodone (an antidepressant). When co-administered with ketoconazole, an approximately three-fold increase in the maximum concentration of domperidone is achieved.

Concomitant use with paracetamol and digoxin did not affect the concentration of these drugs in the blood.

It is compatible with antipsychotic drugs (neuroleptics) and dopaminergic receptor agonists (bromocriptine, levodopa).

How to take, course of use and dosage

Inside before eating, with a sufficient amount of water.

• Adults and children with a body weight of more than 35 kg 1-2 tablets 3-4 times a day. The maximum dose is 80 mg per day. The duration of admission is 4 weeks. Further use of the drug is possible after consulting a doctor.

Patients with renal insufficiency are recommended to reduce the frequency of taking the drug to 1-2 times a day.

Overdose

Symptoms: drowsiness, disorientation, extrapyramidal disorders (especially in children).

Treatment: taking activated charcoal, with extrapyramidal disorders –m-holinoblockers, antiparkinsonian drugs or antihistamines with anticholinergic properties.

Special instructions

Cimetidine, sodium bicarbonate reduce the bioavailability of domperidone.

M-holinoblockers and antacid drugs neutralize the effect of domperidone.

The concentration of domperidone in plasma is increased by inhibitors of the CYP3A4 isoenzyme: azole-type antifungal drugs, macrolide antibiotics, HIV protease inhibitors, nefazodone (an antidepressant). When co-administered with ketoconazole, an approximately three-fold increase in the maximum concentration of domperidone is achieved.

Concomitant use with paracetamol and digoxin did not affect the concentration of these drugs in the blood.

It is compatible with antipsychotic drugs (neuroleptics) and dopaminergic receptor agonists (bromocriptine, levodopa).

Form of production

Domperidon-Teva. Film-coated tablets.

Storage conditions

Store in a dry place, protected from light, at temperatures below 25 °C

Shelf life

4 years

Active ingredient

Domperidone

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

Pregnant women as prescribed by a doctor, Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Flatulence, Intestinal infections, Reflux Esophagitis