Motinorm - instructions for use, dose, side effects, contraindications

Excipients: lactic acid, sorbitol (70% solution, non-crystallizing), glycerol (glycerin), sucrose (sucrose), methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, dye sunset yellow FCF, aromatizer mint-anise, purified water.

Description:

Transparent, syrupy liquid of light orange color, with the smell of anise and mint.

Pharmacotherapeutic group:Antiemetics - dopamine receptor blocker central

ATX: & nbsp

A.03.F.A.03 Domperidone

Pharmacodynamics:

Increases the duration of peristaltic contractions of the antral part of the stomach and duodenum, accelerates the emptying of the stomach in case of slowing of this process, increases the tone of the lower esophageal sphincter, eliminates the development of nausea and vomiting.

Stimulates the release of prolactin from the pituitary gland. Antiemetic action may be due to a combination of peripheral (gastrokinetic) action and antagonism to dopamine receptors in the chemoreceptor trigger zone. Domperidone has no effect on gastric secretion.

Domperidone poorly penetrates the blood-brain barrier, so the use of domperidone is rarely accompanied by the development of extrapyramidal side effects.

Pharmacokinetics:

Suction

After oral administration domperidone quickly absorbed. It has low bioavailability (about 15%). Eating and lowering the acidity of the gastric contents reduces the absorption of domperidone. The maximum concentration in the plasma is reached in 30-60 minutes.

Distribution

Domperidone is distributed in various tissues, in the brain tissues its concentration is low. Binding to plasma proteins is 91-93%.

Metabolism

It is subjected to intensive metabolism in the wall of the intestine and liver.

Excretion

It is excreted through the intestine (66%) and kidneys (33%), in unchanged form, respectively, 10% and 1% of the dose. The half-life (T_1/2) - 7-9 h, with pronounced renal failure, it lengthens. In patients with severe renal failure (serum creatinine> 0.6 mmol / L) T_1/2domperidone increased from 7.4 to 20.8 h, but the drug concentration in the plasma were lower than in healthy volunteers.

Indications:

Dyspepsia (a feeling of overfilling in the epigastrium, a sensation of bloating, pain in the upper abdomen, belching, flatulence, heartburn);

Nausea and vomiting of a functional, organic, infectious origin, and also caused by radiotherapy, drug therapy (including dopamine agonists - levodopa and bromocriptine) or a violation of diet.

Contraindications:

Hypersensitivity, gastrointestinal bleeding, mechanical intestinal obstruction, perforation of the stomach or intestine, prolactinoma.

Carefully:

Hepatic / kidney failure, child age.

Pregnancy and lactation:

Reception during pregnancy and lactation is possible only if the intended benefit to the mother exceeds the possible risk to the fetus or child.

Dosing and Administration:

Inside.

It is recommended to take the drug before meals.

Adults and children over 5 years of age: with chronic dyspeptic phenomena - 10 mg 3-4 times a day and, if necessary, additionally before bedtime. At the expressed nausea and vomiting - on 20 mg 3-4 times a day and before a dream.

Children under 5 years: for chronic dyspeptic phenomena - 2.5 mg / 10 kg of body weight 3 times a day and, if necessary, additionally before bedtime.With severe nausea and vomiting - 5 mg / 10 kg body weight 3-4 times a day and before bedtime. If necessary, the dose can be doubled.

With renal insufficiency it is recommended to reduce the frequency of taking the drug (see section "Special instructions").

Side effects:

From the digestive system: transient intestinal spasms.

From the nervous system: extrapyramidal disorders (in children and people with increased permeability of the blood-brain barrier).

Mental disorders: very rarely - agitation, nervousness, cramps, drowsiness.

Allergic reactions: skin rash, hives.

Other: hyperprolactinemia (galactorrhea, gynecomastia).

Such side effects as convulsions, drowsiness and agitation are very rare and occur mainly in children and newborns.

Overdose:

Symptoms: drowsiness, disorientation and extrapyramidal reactions.

Treatment: reception of activated carbon, when extrapyramidal reactions occur - anticholinergic, anti-Parkinsonian, antihistamines.

Interaction:

Cimetidine, sodium hydrogen carbonate, other antacid and antisecretory drugs reduce the bioavailability of domperidone.

Anticholinergic drugs neutralize the action of domperidone.

Increase the concentration of domperidone in plasma: antifungal agents of the azole series, antibiotics from the macrolide group, HIV protease inhibitors, nefazodone.

Compatible with the use of antipsychotic drugs (neuroleptics), dopaminergic receptor agonists (bromocriptine, levodopa).

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

Special instructions:

In patients with severe renal failure (serum creatinine> 0.6 mmol / L) T_1/2domperidone increased from 7.4 to 20.8 h, but the concentration of the drug in the plasma was lower than in healthy volunteers. Since a very small percentage of the drug is excreted by the kidneys unchanged, no single dose adjustment is necessary in patients with renal insufficiency, but if repeated administration is necessary, the frequency of intake should be reduced 1-2 times during the day, depending on the severity of liver failure. In severe renal failure, it may be necessary to reduce the dose.

With prolonged therapy, patients should be under regular supervision.

The drug contains sucrose, which must be taken into account in patients with concomitant diabetes mellitus, as well as patients with rare hereditary diseases (fructose intolerance and glucose / galactose malabsorption insufficiency or sucrose / isomaltase insufficiency).

Form release / dosage:

Syrup, 5 mg / 5 ml.

Packaging:

To 30 ml, 60 ml and 100 ml of the preparation into a bottle of dark glass with a screw cap.

Each bottle, together with the instruction for use and a measuring cup of polypropylene, is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C, in a dry place.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-004219/09

Date of registration:28.05.2009 / 23.10.2009

Expiration Date:Unlimited

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

Manufacturer: & nbsp

MEDLEY PHARMACEUTICALS, Ltd. India

Information update date: & nbsp31.05.2018

Illustrated instructions

Instructions

Motinorm (Motinorm)