Pharmacy No. 84. Delivery of medicines to your home and office.

Delivery on Sundays and holidays does not work!

Medicines

my basket

Apteka84.kz is an online pharmacy that offers its customers medicines, medicinal and decorative cosmetics, dietary supplements, vitamins, baby food, intimate products for adults, medical equipment and thousands of other medical and cosmetic products at low prices. All data presented on the Apteka84.kz website is for informational purposes only and is not a substitute for professional medical care. Apteka84.kz strongly recommends that you carefully read the instructions for use contained in each package of medicines and other products. If you currently have any symptoms of the disease, you should seek help from a doctor. You should always tell your doctor or pharmacist about all the medicines you take. If you feel you need further help, please consult your local pharmacist or contact our GP online or by telephone.

Motinorm syrup 5 mg/5 ml 30 ml x1

Motinorm syrup 5 mg/5 ml 30 ml x1, ATX code: A03FA03 (Domperidone) Active substance: domperidone Rec.INN registered by WHO

Dosage form

MOTINORM

syrup 5 mg/5 ml: fl. 30 mlreg. No.: LSR-004219/09 from 05/28/09 - Indefinitely

Release form, composition and packaging

Syrup 5 ml

domperidone 5 mg, Clinical and pharmacological group: Antiemetic drug of central action, blocking dopamine receptors Pharmacotherapeutic group: Antiemetic drug - central dopamine receptor antagonist The scientific information provided is general and cannot be used to make a decision about the possibility of using a specific drug.

pharmachologic effect

Antiemetic. It has an antiemetic effect, soothes hiccups and eliminates nausea in some cases. The action is due to the blockade of central dopamine receptors. Thanks to this, the inhibitory effect of dopamine on the motor function of the gastrointestinal tract is eliminated and the evacuation and motor activity of the stomach increases.

Pharmacokinetics Absorption after oral administration, on an empty stomach is rapid (taking after meals, reduced acidity of gastric juice slows down and reduces absorption). Cmax is reached after 1 hour. Bioavailability is 15% (first pass effect through the liver). Plasma protein binding - 90%. Penetrates into various tissues and does not pass through the blood-brain barrier. Metabolized in the liver and in the intestinal wall (by hydroxylation and N-dealkylation). 66% is excreted through the intestines, 33% by the kidneys, incl. unchanged - 10% and 1%, respectively. T1/2 - 7-9 hours, with severe chronic renal failure - lengthens.

Indications Nausea, vomiting, hiccups of various origins (with toxemia, radiation therapy, diet disorders, taking certain medications (morphine), endoscopic and radiopaque studies, in the postoperative period). Postoperative hypotension and atony of the stomach and intestines, biliary dyskinesia, flatulence, reflux esophagitis, cholecystitis, cholangitis, various types of dyspepsia. Nausea and vomiting caused by dopaminomimetics. ICD-10 codes

Dosage regimen: Adults and children over 5 years old: 10 mg 3 times a day 15-30 minutes before meals, and if necessary, an additional 10 mg before bedtime. In acute cases of nausea and vomiting, severe dyspepsia - 20 mg 3-4 times a day. In case of renal failure, the frequency of use should be reduced.

Side effect

From the side of the central nervous system: rarely - increased excitability and/or extrapyramidal disorders, headache.

From the digestive system: spasms of smooth muscles of the gastrointestinal tract, dry mouth, thirst.

Allergic reactions: itching, rash, urticaria.

Other: increased plasma prolactin levels, galactorrhea, gynecomastia.

Contraindications for use Gastrointestinal bleeding, mechanical intestinal obstruction, perforation of the stomach or intestines, prolactinoma, children under 1 year of age (up to 5 years and children weighing up to 20 kg - for tablets), hypersensitivity to domperidone, pregnancy, lactation period (breastfeeding).

Use during pregnancy and breastfeeding

Domperidone is contraindicated for use during pregnancy and lactation.

Use for liver dysfunction Use with caution in liver dysfunction.

Use for impaired renal function Use with caution in case of impaired renal function. In case of renal failure, the frequency of use should be reduced.

Use in children Contraindicated in children under 1 year of age (under 5 years and children weighing up to 20 kg - for tablets).

Special instructions: Use with caution in case of impaired liver and kidney function.

Drug interactions

When used simultaneously with antacids, antisecretory drugs (including cimetidine, sodium bicarbonate), the bioavailability of domperidone decreases.

When used simultaneously with anticholinergic drugs, the effect of domperidone is inhibited.

Since domperidone is metabolized mainly with the participation of the CYP3A4 isoenzyme, it is believed that with the simultaneous use of domperidone and inhibitors of this isoenzyme (including antifungals of the azole group, macrolide antibiotics, HIV protease inhibitors, nefazodone), an increase in the level of domperidone in the blood plasma is possible .

Motinorm

Motinorm tablet 10 mg x10, ATX code: A03FA03 (Domperidone) Active substance: domperidone Rec.INN registered by WHO

Dosage form

MOTINORM

tab. 10 mg: 20, 30, 50 or 100 pcs.reg. No.: LSR-001276/09 dated 02/20/09 - Valid

Release form, composition and packaging

Tablets 1 tab.

domperidone 10 mg, Clinical and pharmacological group: Antiemetic drug of central action, blocking dopamine receptors Pharmacotherapeutic group: Antiemetic drug - central dopamine receptor antagonist The scientific information provided is general and cannot be used to make a decision about the possibility of using a specific drug.

pharmachologic effect

Side effect

From the side of the central nervous system: rarely - increased excitability and/or extrapyramidal disorders, headache.

From the digestive system: spasms of smooth muscles of the gastrointestinal tract, dry mouth, thirst.

Allergic reactions: itching, rash, urticaria.

Other: increased plasma prolactin levels, galactorrhea, gynecomastia.

Use during pregnancy and breastfeeding

Domperidone is contraindicated for use during pregnancy and lactation.

Use for liver dysfunction Use with caution in liver dysfunction.

Use for impaired renal function Use with caution in case of impaired renal function. In case of renal failure, the frequency of use should be reduced.

Use in children Contraindicated in children under 1 year of age (under 5 years and children weighing up to 20 kg - for tablets).

Special instructions: Use with caution in case of impaired liver and kidney function.

Drug interactions

When used simultaneously with antacids, antisecretory drugs (including cimetidine, sodium bicarbonate), the bioavailability of domperidone decreases.

When used simultaneously with anticholinergic drugs, the effect of domperidone is inhibited.

Motinorm 60 ml syrup for oral administration

Instructions for medical use of the drug MOTINORM® ▼ This drug is subject to additional monitoring. This will allow new safety information to be quickly identified. We encourage healthcare professionals to report any suspected adverse reactions. Trade name MOTINORM® International nonproprietary name Domperidone Dosage form Syrup Composition 5 ml of syrup contain the active substance - domperidone 5 mg, excipients: lactic acid, sorbitol solution 70% glycerin, caramel (E150a), sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, strawberry flavoring , purified water Description Golden yellow syrup with strawberry scent. Pharmacotherapeutic group Drugs for the treatment of functional disorders of the gastrointestinal tract. Stimulants of gastrointestinal motility. Domperidone. ATC code A03FA03 Pharmacological properties Pharmacokinetics Domperidone is rapidly absorbed when taken orally on an empty stomach, the maximum plasma concentration (Cmax) is reached after approximately 60 minutes. The low absolute bioavailability of oral domperidone (approximately 15%) is due to extensive metabolism in the intestinal wall and liver. Although in healthy people the bioavailability of domperidone increases when taken after meals, patients with gastrointestinal complaints should take domperidone 15-30 minutes before meals. Reduced gastric acidity reduces the absorption of domperidone. The bioavailability of the drug when taken orally is reduced after prior administration of cimetidine or sodium bicarbonate. When the drug is taken orally after a meal, maximum absorption slows down slightly and the area under the curve (AUC) increases slightly. When taken orally, domperidone does not accumulate and does not induce its own metabolism; the maximum plasma level at 90 minutes (21 ng/mL) after two weeks of oral dosing at 30 mg per day was almost the same as after the first dose (18 ng/mL). Domperidone is 91–93% bound to plasma proteins. Domperidone slightly penetrates the blood-brain barrier. Domperidone is metabolized quickly and extensively in the liver by hydroxylation and N-dealkylation. In-vitro metabolism studies have shown that CYP3A4 is the main isoenzyme of cytochrome P-450, which is involved in the N-dealkylation of domperidone, and CYP3A4, together with CYP1A2 and CYP2E1, are involved in the aromatic hydroxylation of domperidone. Excretion in urine and feces is 31% and 66% of the oral dose, respectively. Excretion of the drug unchanged is a small percentage (10% in feces and approximately 1% in urine). The plasma half-life after taking a single dose is 7–9 hours in healthy people, but prolonged in patients with severe renal failure. Liver failure In patients with moderate liver failure (Child-Pugh score 7-9 or class B), the AUC and C max of domperidone are 2.9 and 1.5 times higher, respectively, than in healthy individuals. The level of unbound fraction increases by 25%, and the terminal half-life is extended from 15 to 23 hours. Patients with moderate hepatic impairment have slightly less systemic exposure than healthy subjects based on Cmax and AUC, with no changes in protein binding or half-life. The pharmacokinetics of domperidone in patients with severe hepatic impairment have not been studied. Motinorm® is contraindicated in patients with moderate or severe liver failure. Renal failure In patients with severe renal failure (creatinine clearance <30 ml/min/1.73 m2), the half-life of domperidone is increased from 7.4 to 20.8 hours, but plasma drug levels are lower than in healthy volunteers. Since very little unchanged drug (about 1%) is excreted through the kidneys, the need for dose adjustment with a single dose in patients with renal failure is unlikely. However, upon repeated administration, the frequency of use of the drug should be reduced to once or twice a day depending on the severity of the disorder, and a dose reduction may be necessary. Pharmacodynamics Domperidone is a dopamine antagonist that has an antiemetic effect. Its antiemetic effect may be due to a combination of peripheral (gastrokinetic) action and antagonism of dopamine receptors in the chemoreceptor trigger zone, which is located behind the blood-brain barrier in the zone postrema. Domperidone is rarely associated with extrapyramidal side effects, especially in adults, but domperidone stimulates the release of prolactin by the pituitary gland. In animal studies, domperidone was found in low concentrations in the brain, indicating a predominantly peripheral effect of domperidone on dopamine receptors. Human studies have shown that oral administration of domperidone increases pressure in the lower esophageal resting zone, improves antroduodenal motility and accelerates gastric emptying, while domperidone does not affect gastric secretion. The effect of domperidone on QT was studied in two active-control and placebo studies in healthy subjects receiving up to 80 mg per day (10 or 20 mg x 4 times daily) of domperidone for 4 days. It was found that the maximum difference in the QTc interval when taking domperidone 20 mg x 4 times a day and placebo with an average initial value of 3.4 ms (from 1.0 to 5.9 ms) does not exceed 10 ms. Clinically significant QTc effects were not observed when domperidone was used at a dose of 80 mg/day (i.e., more than twice the maximum recommended daily dose). However, two studies showed some evidence of QTc prolongation with domperidone monotherapy (10 mg 4 times daily). The mean maximum QTcF difference between domperidone and placebo was 5.4 ms (95% CI: -1.7 to 12. 4) and 7.5 ms (95% CI: 0.6 to 14.4), respectively. Indications for use - symptomatic treatment of nausea and vomiting Method of administration and dosage Domperidone should be used in the minimum effective dose for the shortest time necessary to combat nausea and vomiting. Domperidone is recommended to be taken before meals. If taken after a meal, absorption of the drug occurs with some delay. Patients should take each additional dose at the prescribed time. If the dosage time is missed, then the next dose is taken according to the usual dosing schedule, without compensating for the missed dose in order to avoid double dosing. The maximum duration of treatment should not exceed one week. Motinorm in syrup form is recommended for use in pediatric practice (especially for children under 5 years of age). The drug is prescribed orally over 15-30 minutes. before meals. The bottle of syrup should be shaken before use. Children over 12 years of age and with a body weight of 35 kg or more: 10 mg up to 3 times daily, max. 30 mg per day - 10 mg (1 ml/ml oral substance) up to three times daily, with a maximum dosage of 30 mg per day. Infants and children up to 12 years: 250 micrograms/kg up to 3 times daily, max. 30 mg per day: max. 750 micrograms/kg over 24 hours. For children weighing 10 kg, the dosage is 2.5 ml, i.e. 2.5 mg, which can be taken three times daily with a maximum dosage of 7.5 ml (7.5 mg) per day. In case of renal failure, it is recommended to increase the interval between taking the drug. In patients with severe renal impairment (serum creatinine > 6 mg/100 ml, i.e. > 0.6 mmol/l), the half-life of domperidone increased from 7.4 to 20.8 hours. The frequency of dosing should be reduced to once or twice daily, and it may be necessary to reduce the dose. Side effects Based on clinical studies Adverse reactions observed in ≥ 1% of patients: depression, anxiety, decreased or absent libido, headache, drowsiness, akathisia, dry mouth, diarrhea, rash, itching, galactorrhea, gynecomastia, pain and tenderness in the area of the mammary glands, menstrual irregularities and amenorrhea, lactation disorders, asthenia. Adverse reactions observed in <1% of patients: hypersensitivity, urticaria, swelling and discharge from the mammary glands. Based on spontaneous reports of adverse events, side effects are given with a distribution by frequency and organ system. The frequency of side effects was classified as follows: very common (>1/10), common (>1/100, <1/10) and uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rarely (<1/10,000, including isolated cases). Rarely: - gastrointestinal disorders - increased plasma prolactin levels due to the fact that the pituitary gland is located outside the blood-brain barrier, in rare cases this hyperprolactinemia can stimulate the appearance of neuro-endocrine phenomena such as galactorrhea, gynecomastia and amenorrhea very rarely: - transient spasms intestines - itching, rash - extrapyramidal syndrome (very rarely occur in children and in isolated cases in adults, they are completely reversible and disappear immediately after stopping the drug), convulsions, drowsiness, headache. - prolongation of the QT interval, sudden cardiac death*, serious ventricular arrhythmias*. - agitation, nervousness. Side effects such as convulsions, drowsiness and agitation are very rare and occur mainly in children and newborns. - anaphylactic reactions, including anaphylactic shock, angioedema, allergic reactions, urticaria. *Some epidemiological studies have suggested that domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden death. The risk of these events is more likely in patients over 60 years of age and in patients taking the drug in a daily dose of more than 30 mg. It is recommended to use domperidone in the lowest effective dose in adults and children. Contraindications - hypersensitivity to the components of the drug - gastrointestinal bleeding - mechanical obstruction or perforation, in which stimulation of the motor function of the stomach can be dangerous - prolactin-secreting tumor of the pituitary gland (prolactinoma) simultaneous use of oral forms of ketoconazole, erythromycin and other powerful inhibitors of the CYP3A4 isoenzyme, causing QT prolongation, such as fluconazole, voriconazole, clarithromycin, amiodarone, and telithromycin - patients with current or history of conduction disturbances, particularly QT prolongation on ECG - patients with severe electrolyte disturbances or serious heart disease (eg, congestive heart disease) heart failure) - pregnancy and lactation. With caution - renal dysfunction. Drug interactions. Increased risk of developing QT interval prolongation as a result of pharmacodynamic and / or pharmacokinetic interactions. Simultaneous use of Motinorm® with QTc-prolonging drugs is contraindicated. QTc-prolonging drugs: - Class IA antiarrhythmics (eg, disopyramide, hydroxyquinidine, quinidine) - Class III antiarrhythmics (eg, amiodarone, dofetilide dronedarone, ibutilide, sotalol) - some antipsychotics (eg, haloperidol, pimozide, sertindole) - some antidepressants (for example, citalopram, escitalopram) - some antibiotics (for example, erythromycin, levofloxacin, moxifloxacin, spiramycin) - some antifungals (for example, pentamidine) - some antimalarials (for example, halofantrine, lumefantrine) - some drugs used for gastrointestinal diseases (eg, cisapride, dolasetron, prucalopride) - some antihistamines (eg, mequitazine, mizolastine) - cancer drugs (eg, toremifene, vandetanib, vincamine) - some other drugs (eg, bepridil, difemanil , methadone). The main role in the metabolism of domperidone is played by the CYP3A4 isoenzyme. In vitro studies and clinical experience indicate that concomitant use of drugs that significantly inhibit this isoenzyme may cause increased plasma concentrations of domperidone. Motinorm® is contraindicated for use with strong inhibitors of the CYP3A4 isoenzyme (regardless of their QT effects): azole antifungals (imidazoles), macrolide antibiotics (erythromycin, clarithromycin, telithromycin), HIV protease inhibitors, antidepressants (nefazodone) because they can block the metabolism of domperidone, which leads to increased plasma concentrations. Concomitant use with moderate CYP3A4 inhibitors (diltiazem, verapamil and some macrolides) is not recommended. Concomitant use with the following substances requires caution - drugs that induce bradycardia and hypokalemia; - macrolides that prolong the QT interval: azithromycin and roxithromycin (clarithromycin is contraindicated as a potent inhibitor of CYP3A4). The above list of substances with which use or prescription with caution is not recommended is approximate and not completely exhaustive. Separate pharmacokinetic/pharmacodynamic studies of the interaction of domperidone with oral ketoconazole or erythromycin in healthy subjects confirmed the marked inhibition of CYP3A4-mediated first pass metabolism of domperidone by these drugs. With simultaneous administration of 10 mg of domperidone 4 times a day and 200 mg of ketoconazole 2 times a day, a prolongation of the QT interval was observed by an average of 9.8 ms during the entire observation period, at certain points the changes varied from 1.2 to 17.5 ms. With simultaneous administration of 10 mg of domperidone 4 times a day and 500 mg of erythromycin 3 times a day, there was an increase in the QT interval by an average of 9.9 ms during the entire observation period, at certain points the changes varied from 1.6 to 14.3 ms. In each of these studies, the Cmax and AUC of domperidone were increased approximately threefold (see Contraindications section). It is currently unknown how elevated plasma concentrations of domperidone contribute to changes in the QT interval. In these studies, domperidone monotherapy (10 mg four times daily) prolonged the QT interval by 1.6 ms (ketoconazole study) and 2.5 ms (erythromycin study), whereas ketoconazole monotherapy (200 mg twice daily) and erythromycin (500 mg three times daily) led to a prolongation of the QT interval by 3.8 and 4.9 ms, respectively, during the entire observation period. Special instructions Antacids or antisecretory agents, anticholinergic drugs together with Motinorm® are not recommended. Epidemiological studies have shown that use of domperidone was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death. A higher risk was observed in patients over 60 years of age, in patients taking daily doses greater than 30 mg, and in patients concomitantly taking drugs that prolong the QT interval or CYP3A4 inhibitors. Domperidone should be used at the minimum effective dose in adults and children. Domperidone is contraindicated in patients with known existing cardiac impairment, particularly QT prolongation, and in patients with significant electrolyte imbalance (hypokalemia, hyperkalemia, hypomagnesemia) or bradycardia, or in patients with underlying cardiac disease such as congestive heart failure from - for an increased risk of ventricular arrhythmia. Electrolyte disturbances (hypokalemia, hyperkalemia, hypomagnesemia) or bradycardia are known to increase the risk of abnormal heart rhythms. Domperidone treatment should be discontinued if signs or symptoms that may be related to cardiac arrhythmias occur. Patients should be advised to promptly report any heart symptoms to their physician. Use for liver diseases Considering the high degree of metabolism of domperidone in the liver, Motinorm® should be prescribed with caution to patients with mild liver failure. Use for kidney diseases Since a very small percentage of the drug is excreted unchanged by the kidneys, there is hardly any need to adjust the single dose in patients with renal failure. However, when re-prescribed, the frequency of administration should be reduced to 1-2 times a day, depending on the severity of renal failure, and a dose reduction may also be required. In patients with diabetes mellitus, it is necessary to adjust insulin doses when using Motinorm®. The drug contains sorbitol, so it should not be taken by patients with sorbitol intolerance. Use of Motinorm® in pediatrics in rare cases may cause neurological side effects. In children in the first months of life, metabolic functions and the blood-brain barrier are not fully developed, and therefore they have an increased risk of unwanted neurological effects in the form of extrapyramidal disorders and seizures. In this regard, it is not recommended to prescribe dosperidon to newborns, babies up to 1 year old, and you should also very accurately calculate the dose of Motinorm® for early preschool children and strictly adhere to this dose. Neurological undesirable effects can be caused in children an overdose of the drug, but it is necessary to take into account other possible causes of such effects. Features of influence on the ability to drive vehicles and potentially dangerous mechanisms. Caution should be exercised. An overdose symptoms: drowsiness, disorientation, extrapyramidal disorders. Treatment: taking activated coal; With extrapyramidal disorders - anticholinergic drugs, anti -parquinsonical or antihistamines with anticholinergic properties. The release form and packaging of 30 ml or 60 ml of the drug is placed in an orange glass bottle, deceived by a screwed aluminum cover with a laying and control of the first opening. 1 bottle along with a measured cup and instructions for use in the state and Russian languages are placed in a cardboard box. Storage conditions Store at a temperature not exceeding 25ºС. Keep out of the reach of children! The shelf life of 3 years does not use the drug after the expiration date. Conditions of vacation from pharmacies according to the recipe, manufacturer of the meshuticals Ltd, India Meply House, D2, Mids Eria, Anderi (E), Mumbai-400 093, India. Telephone, e-mail91-22-56959800/28204453 The owner of the registration certificate of the Mashamasyutyutikals LTD, India name, address and contact details (telephone, fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, receiving claims (proposals) on the quality of medicines From consumers: Representation in the Republic of Kazakhstan in the person of the proxy of Amita Srivastava, Almaty, st. Kurmangazy 48a Email Tel./Fax: 261-51-41 Name, address and contact details (telephone, fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, responsible for post-passing monitoring of the safety of the drug: LLP Consultasia st. Shevchenko 165B tel./Fax: +77051708876/ +77051708825 E-mail