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

Composition:Each ml of solution for injection contains:
active substance: metoclopramide hydrochloride monohydrate (in terms of anhydrous metoclopramide hydrochloride) - 5.00 mg;
Excipients: diatrium EDTA salt - 0.100 mg, sodium chloride - 7.90 mg, sodium acetate - 0.100 mg, glacial acetic acid - 0.00025 mg, water for injection - up to 1 ml.

Description:A clear, colorless solution.

Pharmacotherapeutic group:Antiemetics - dopamine receptors blocker central.

ATX: & nbsp

A.03.F.A Motility stimulators GIT

A.03.F.A.01 Metoclopramide

Pharmacodynamics:The specific blocker of dopamine (D2) and serotonin (5-HTZ) receptors, depresses the chemoreceptors of the trigger zone of the brainstem, weakens the sensitivity of the visceral nerves that transmit pulses from the pyloric and duodenum to the vomiting center. Through the hypothalamus and the parasympathetic nervous system (the innervation of the gastrointestinal tract) has a regulating and coordinating effect on the tone and motor activity of the upper gastrointestinal tract (including the tone of the lower sphincter of the esophagus at rest). Increases the tone of the stomach and intestines, accelerates the emptying of the stomach, reduces the hyperacid stasis, prevents pyloric and esophageal reflux, stimulates intestinal peristalsis. Normalizes the separation of bile, reduces the spasm of the sphincter of Oddi. Without changing its tone, it eliminates dyskinesia of the gallbladder. Does not affect the tone of the blood vessels of the brain, blood pressure, respiratory function, as well as kidney and liver, on hematopoiesis, gastric and pancreatic secretion. Stimulates the secretion of prolactin. Increases the sensitivity of tissues to acetylcholine (the action does not depend on vagal innervation,but eliminated holinoblokatorami). Stimulating the secretion of aldosterone, enhances the retention of sodium ions and eliminated potassium ions.

Pharmacokinetics:Connection with plasma proteins - 13-30%. It is metabolized in the liver. The half-life period is from 2.5 to 6 hours, with kidney failure - up to 14 hours. Removal of the drug occurs mainly through the kidneys for 24-72 hours in unchanged form and in the form of conjugates. Passes through the placental and blood-brain barrier and penetrates into the mother's milk.

Indications:Adults:
Prevention of postoperative nausea and vomiting.
Symptomatic treatment of nausea and vomiting, including acute migraine.
Prevention of nausea and vomiting caused by radiation therapy and
chemotherapy.
To enhance peristalsis in radiocontrast studies of the gastrointestinal tract.
Children
The second line of treatment for postoperative nausea and vomiting.
The second line of prevention of delayed nausea and vomiting caused by chemotherapy.

Contraindications:- hypersensitivity to metoclopramide and to the components of the drug;
- gastrointestinal bleeding, mechanical intestinal obstruction,Perforation of the wall of the stomach and intestines, the conditions under which the stimulation of the peristalsis of the gastrointestinal tract represents a risk;
- confirmed or suspected pheochromocytoma in connection with the risk of developing severe arterial hypertension;
- tardive dyskinesia, which developed after treatment with neuroleptics or chlorpromide in the anamnesis;
- Epilepsy (increased frequency and severity of seizures);
- Parkinson's disease;
- simultaneous use with levodopa and agonists dopamine fluors;
- Methemoglobinemia due to metoclopramide or nicotinamide deficiency of dinucleotide (NADH) cytochrome b5 in history;
- Prolactinoma or prolactin-dependent tumor;
- Children's age up to 1 year;
- the period of breastfeeding.

Carefully:When used in elderly patients, cardiac conduction disorder (including prolongation of QT interval), disturbance of water-electrolyte balance, bradycardia, with the use of other drugs that extend the QT interval, arterial hypertension, concomitant neurological diseases, when taking drugs affecting the central nervous system, depression (in the anamnesis),renal failure of moderate and severe severity (QC 15-60 ml / min), hepatic failure of severe severity, pregnancy.

Pregnancy and lactation:Metoclopramide can be used during pregnancy (I-II trimesters) only if the potential benefit to the mother exceeds the potential risk to the fetus. In connection with the pharmacological features (like other neuroleptics), the use of metoclopramide at the end of pregnancy can not exclude the possibility of developing extrapyramidal symptoms in a newborn. Metoclopramide Do not use at the end of pregnancy (during the third trimester).
If metoclopramide is needed, the condition of the newborn should be monitored.
Metoclopramide in small amounts excreted in breast milk.
It is impossible to exclude the possibility of developing adverse reactions in the child. The use of metoclopramide during breastfeeding is contraindicated. If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:Intravenously (intravenously) and intramuscularly (in / m).
Intravenous (iv) drug should be administered bolusio slowly (at least 3 minutes). To avoid an overdose, a minimum interval of 6 hours between administration of the drug should be observed.
Adults.
Prevention of postoperative nausea and vomiting.
The recommended single dose is 10 mg.
Symptomatic treatment of nausea and vomiting, including acute migraine. Prevention of nausea and vomiting caused by radiation therapy and chemotherapy.
The recommended single dose of 10 mg is administered up to three times a day.
To enhance peristalsis in radiocontrast studies of the gastrointestinal tract.
Recommended IV bolus slow administration of 10-20 mg for 10 minutes before the start of the study.
The maximum daily dose is 30 mg or 0.5 mg / kg.
The period of administration of the drug in the form of injections should be as short as possible, followed by a transition to a dosage form for oral administration.
Children age from 1 year to 18 years.
It is recommended IV bolus slow administration at a dose of 0.1-0.15 mg / kg up to 3 times a day.
The maximum daily dose of 0.5 mg / kg / day.
The maximum duration of metoclopramide for the prevention of postoperative nausea and vomiting is 2 days. To prevent nausea and vomiting caused by chemotherapy - 5 days.
Elderly patients may need to reduce the dose due to a decrease in kidney and liver function.
In patients with terminal stage of renal failure (CC less than 1 ml / min), the daily dose should be reduced by 75%. In patients with moderate or severe renal insufficiency (KK 15-60 ml / min), the dose should be reduced by 50%.
In patients with hepatic insufficiency of severe severity, the dose should be reduced by 50%.

Side effects:Nausea, diarrhea, constipation, methemoglobinemia, sulfgemoglobinemia, leukoia, neutropenia, agranulocytosis, bradycardia, cardiac arrest, atrioventricular olocada, sinocad nodule, QT interval prolongation on the electrocardiogram, pirouette arrhythmia, lowering of arterial pressure, cardiogeocyst shock, pressure in patients with pheochromocytoma, amenorrhea, hyperprolactinaemia, galactorrhea, gynecomastia, polyuria, urinary incontinence, sexual dysfunction, priapism, anaphylactic reactions (including anaphylaxis active shock), allergic reactions (urticaria, maculopapular rash), drowsiness, asthenia, pyramidal extremes, parkinsonism, acacia,dystonia, impaired consciousness, convulsions, tardive dyskinesia, neuroleptic malignant syndrome, depression, hallucinations, confusion.

Overdose:There may be hypersomnia, disorientation and extrapyramidal disorders, drowsiness, confusion, hallucinations, irritability, dizziness, bradycardia, changes in blood pressure, cardiac and respiratory arrest, abdominal pain. As a rule, simgfmatika disappears after discontinuation of the drug within 24 hours. If necessary, treatment with holinoblokagorami and antiparkinsonian means. There is no special antidote.

Interaction:Contraindicated simultaneous use of metoclopramide with levodopa or dopamine receptor agonists in connection with the existing mutual antagonism.
Alcohol increases the sedative effect of metoclopramide.
In connection with the prokinetic effect of metoclopramide, absorption of certain drugs may be impaired. M-holinoblokatory and derivatives of morphine have a mutual antagonism with metoclopramide in relation to the effect on peristalsis of the gastrointestinal tract.Drugs of the CNS (morphine derivatives, tranquilizers, H blockers₁ -gistahin receptors, antidepressants with sedative effect, barbiturates, clonidine and other drugs of these groups) may enhance the sedation effect of metoclopramide.
Metoclopramide enhances the effect of neuroleptics on pyramidal symptoms. With the concomitant use of metoclopramide and tetrabenazine, there is a possibility of a deficiency of dopamine, which can be accompanied by muscle spasm, difficulty in speaking and swallowing, anxiety, tremor, involuntary movements of muscles, including facial muscles. The use of metoclopramide with serotonergic drugs, for example, with selective serotonin reuptake inhibitors, increases the risk of developing serotonin syndrome (serotonin intoxication). Metoclopramide reduces the bioavailability of digoxin, increases the bioavailability of cyclosporine. The exposure of metoclopramide increases with simultaneous use with potent inhibitors of the CYP2D6 isoenzyme, for example, fluoxetine and paroxetine.With the simultaneous use of metoclopramide with atovahona significantly reduced the concentration of atovahona in blood plasma (about 50%). Metoclopramide increases the concentration of bromocriptine in the blood plasma, enhances the absorption of tetracycline, mexiletine and lithium, reduces the absorption of cimetidine.

Special instructions:Metoclopramide is not effective in vomiting of vestibular genesis.
Against the background of the use of metoclopramide, there are possible distortions of these laboratory parameters of liver function and determination of the concentration of aldosterone and prolactin in plasma.
Most side effects occur within 36 hours of the start of treatment and take place within 24 hours after cancellation. Treatment should be as short as possible.
During the treatment with the drug, alcohol is not recommended.

Effect on the ability to drive transp. cf. and fur:During the use of the drug should be avoided potentially dangerous activities that require increased concentration of attention, rapid mental and motor reaction (driving vehicles, etc.).

Form release / dosage:Solution for intravenous and intramuscular injection 5 mg / ml.

Packaging:2 ml of the drug in a ampoule amber neutral glass (type I BP), with a fault line in the form of a marking ring.
For 10 ampoules on a paper tray, along with instructions for use, they are placed in a cardboard box.

Storage conditions:In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:3 years.
Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N015834 / 01

Date of registration:22.10.2009 / 07.08.2015

Expiration Date:Unlimited

The owner of the registration certificate:Ipka Laboratories Ltd.Ipka Laboratories Ltd. India

Manufacturer: & nbsp

IPCA LABORATORIES, Ltd. India

Information update date: & nbsp2016-09-02

Illustrated instructions

Instructions

Perinorm (Perinorm)