Perinorm
Perinorm: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Perinorm
ATX code: A03FA01
Active ingredient: metoclopramide (Metoclopramide)
Manufacturer: Ipka Laboratories, Ltd. (Ipca Laboratories, Ltd.) (India)
Description and photo update: 2019-18-11
Perinorm is an antiemetic drug, a central dopamine receptor blocker.
Release form and composition
Dosage forms of Perinorm:
- tablets: white or almost white, round, flat, engraved "PERINORM" on one side, dividing lines on the other (10 pcs. in blisters, in a cardboard box 2, 10 or 20 blisters);
- oral solution (1 mg / ml): clear green liquid with the smell of assorted fruits with a hint of vanilla (30 ml or 100 ml each in dark glass bottles, in a cardboard box 1 bottle complete with a dosage pipette packed in a plastic bag);
- solution for intravenous (i / v) and intramuscular (i / m) administration (5 mg / ml): clear, colorless liquid (2 ml in amber glass ampoules, in a cardboard box of 10 ampoules).
Each pack also contains instructions for the use of Perinorm.
1 tablet contains:
- active substance: anhydrous metoclopramide hydrochloride (in the form of metoclopramide hydrochloride monohydrate) - 10 mg;
- auxiliary components: corn starch, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, purified talc, purified water.
5 ml of oral solution contains:
- active substance: anhydrous metoclopramide hydrochloride (in the form of metoclopramide hydrochloride monohydrate) - 5 mg;
- auxiliary components: sorbitol, glycerin, propylparaben, methylparaben, citric acid monohydrate, sodium metabisulfite, assorted fruit essence, vanilla essence, brilliant blue dye, soluble quinoline yellow dye, purified water.
1 ml of solution for intravenous and intramuscular administration contains:
- active substance: anhydrous metoclopramide hydrochloride (in the form of metoclopramide hydrochloride monohydrate) - 5 mg;
- auxiliary components: glacial acetic acid, disodium salt of ethylenediaminetetraacetic acid, sodium acetate, sodium chloride, water for injection.
Pharmacological properties
Pharmacodynamics
Perinorm is an antiemetic drug that stimulates the motility of the gastrointestinal tract (GIT). Its active ingredient, metoclopramide, is a specific blocker of dopamine (D2) and serotonin (5-NTZ) receptors. Metoclopramide, by inhibiting the chemoreceptors of the trigger zone of the brainstem, helps to weaken the sensitivity of the visceral nerves, which transmit impulses to the vomiting center from the pylorus and duodenum. As a result of innervation of the gastrointestinal tract through the hypothalamus and the parasympathetic nervous system, it exerts a regulatory and coordinating effect on the tone of the upper gastrointestinal tract (including the tone of the lower esophageal sphincter at rest) and its motor activity. By increasing the tone of the stomach and intestines, metoclopramide accelerates the process of gastric emptying, stimulates intestinal peristalsis. Reduces hyperacid stasis,prevents pyloric and esophageal reflux. Metoclopramide helps to normalize the secretion of bile and reduce the spasm of the sphincter of Oddi. Eliminates dyskinesia of the gallbladder without changing its tone.
Perinorm does not affect the tone of the blood vessels in the brain, blood pressure (BP), hematopoiesis, gastric and pancreatic secretion, respiratory, kidney and liver function. It potentiates the secretion of prolactin and aldosterone, increasing the retention of sodium ions and the excretion of potassium ions. Increases tissue sensitivity to acetylcholine, this action is eliminated by anticholinergics and does not depend on vagal innervation.
With vomiting of vestibular genesis, the use of metoclopramide is not effective.
Pharmacokinetics
After taking Perinorm inside, metoclopramide is rapidly absorbed from the gastrointestinal tract. Bioavailability is 75%. The maximum concentration (C max) in the blood is reached after 1–2 hours, the C max value is proportional to the dose taken.
Regardless of the route of administration, plasma protein binding is 13-30%, the volume of distribution is 3.5 l / kg.
The substance crosses the blood-brain and placental barrier, enters breast milk.
Metoclopramide is metabolized in the liver.
The half-life (T 1/2) is 2.5–6 hours, with impaired renal function, it increases to 14 hours. It is excreted mainly through the kidneys unchanged and in the form of conjugates within 24–72 hours.
The clearance of metoclopramide depends on the state of renal function. The consequence of a decrease in creatinine clearance (CC) with varying degrees of renal failure is a decrease in the rate of blood plasma clearance, renal and chain clearance and an increase in T 1/2. In renal failure with CC 10-50 ml / min T 1/2 is approximately 10 hours, with CC less than 10 ml / min - 15 hours.
In patients with renal insufficiency, the kinetics of metoclopramide remains linear, and therefore, in order to avoid accumulation of Perinorm, a reduction in the maintenance dose is necessary.
Indications for use
The use of Perinorm in adults is indicated in the following cases:
- symptomatic treatment of nausea and vomiting, including acute migraine;
- prevention of nausea and vomiting caused by radiation therapy and chemotherapy.
In addition, additional indications for certain dosage forms of Perinorm:
- tablets: as a second-line therapy in adolescents 15–18 years old to prevent nausea and vomiting caused by chemotherapy;
- oral solution: prevention of postoperative nausea and vomiting;
- solution for intravenous and intramuscular administration: adults - prevention of postoperative nausea and vomiting, in order to enhance peristalsis during X-ray contrast studies of the gastrointestinal tract; children - as a second-line therapy in the treatment of postoperative nausea and vomiting and the prevention of delayed nausea and vomiting after chemotherapy.
Contraindications
Absolute:
- bleeding from the gastrointestinal tract;
- pyloric stenosis;
- mechanical intestinal obstruction;
- perforation of the stomach or intestines;
- the period after operations on the gastrointestinal tract (including pyloroplasty, intestinal anastomosis) and other conditions for which stimulation of the gastrointestinal tract peristalsis poses a risk;
- pheochromocytoma (including presumed);
- epilepsy;
- extrapyramidal disorders, Parkinson's disease;
- prolactinoma or prolactin-dependent tumors;
- Methemoglobinemia due to the use of metoclopramide or a deficiency of nicotinamide adenine dinucleotide (NADH) of cytochrome-b5 in the anamnesis;
- simultaneous use with levodopa or dopaminergic receptor agonists;
- third trimester of pregnancy;
- breast-feeding;
- age restrictions: tablets, oral solution - children and adolescents up to 15 years old; solution for intravenous and intramuscular administration - children under 1 year of age;
- hypersensitivity to the components of Perinorm.
In addition, additional absolute contraindications for certain forms of the drug:
- tablets: vomiting for breast cancer or during treatment and overdose with antipsychotics, glaucoma;
- oral solution, solution for intravenous and intramuscular administration: a history of tardive dyskinesia, developing after treatment with neuroleptics or clopramide.
Perinorm should be used with caution to treat patients with impaired water and electrolyte balance, renal or hepatic insufficiency, bronchial asthma, arterial hypertension, impaired cardiac conduction, bradycardia, concomitant neurological diseases, a history of depression, with concomitant therapy with drugs that lengthen the QT interval or affect on the central nervous system (CNS), during the I and II trimester of pregnancy, in old age.
Perinorm, instructions for use: method and dosage
Pills
Perinorm tablets are taken orally 0.5 hours before meals with a small amount of water.
The recommended dosage for adults and adolescents weighing more than 61 kg: 1 pc. 3 times a day with an interval between doses of 6 hours (including vomiting and incomplete absorption of the previous dose).
The maximum daily dose is 30 mg. The maximum course of therapy is 5 days.
For elderly patients, it is possible to reduce the dose, taking into account their general condition, renal and liver function.
In patients with severe hepatic impairment, the dose should be reduced by 50%.
In end-stage renal failure (CC less than 10 ml / min), the daily dose of metoclopramide should be 10 mg (1 tablet of Perinorm), with moderate to severe renal failure (CC 11-60 ml / min) - 50% of the usual dose.
Oral solution
Perynorm solution is taken orally.
Recommended dosage based on patient's age and weight:
- adults, adolescents over 15 years old with a body weight of more than 60 kg: 10 ml (10 mg) 1-3 times a day. The maximum daily dose is 30 mg, it should not exceed 0.5 mg per 1 kg of the patient's body weight;
- teenagers over 15 years old with body weight less than 60 kg: 5 ml 1-3 times a day. The maximum daily dose should not exceed 0.5 mg / kg of the patient's body weight.
The minimum interval between doses should be 6 hours. The duration of the course of treatment is no more than 5 days.
For the treatment of elderly patients, it may be necessary to reduce the dose of Perinorm depending on the general condition, the indicator of renal and liver function.
In end-stage renal failure (CC less than 15 ml / min), the daily dose of Perinorm should be reduced by 75%, moderate or severe renal failure (CC 15-60 ml / min) - by 50%.
In severe hepatic impairment, the dose should be 50% of the standard recommended.
Solution for i / v and i / m administration
The solution is used by intramuscular or slow intravenous bolus (at least 3 minutes) administration.
The minimum interval between injections of Perinorm should be 6 hours.
In the form of intramuscular and intravenous administration, metoclopramide must be used for the shortest possible course, followed by a switch to oral forms of the drug.
Recommended dosage of Perinorm for adults:
- prevention of postoperative nausea and vomiting: 10 mg once a day. The course of treatment is 2 days;
- symptomatic therapy of nausea and vomiting (including those caused by acute migraine), prevention of nausea and vomiting caused by chemotherapy or radiation therapy: 10 mg 1-3 times a day. The duration of the use of metoclopramide for the prevention of nausea and vomiting caused by chemotherapy is 5 days;
- carrying out X-ray contrast studies of the gastrointestinal tract (in order to enhance peristalsis): 10 minutes before the start of the study, 10–20 mg of the solution is injected in a bolus bolus.
The maximum daily dose is 30 mg or at the rate of 0.5 mg / kg of the patient's weight.
For children aged 1 to 18 years, Perinorm is recommended to be used as an intravenous bolus injection at a dose of 0.1-0.15 mg / kg of the child's body weight 1-3 times a day. The maximum daily dose for children is 0.5 mg / kg.
For elderly patients, dose adjustment is made taking into account the state of renal and liver function.
In end-stage renal failure, the daily dose should be reduced by 75%, with moderate or severe degree - by 50% of the usual dose.
In severe hepatic impairment, the usual dose of Perinorm should be reduced by 50%.
Side effects
Possible negative side reactions in systemic organ classes caused by the use of Perinorm:
- on the part of the cardiovascular system: impaired blood pressure, bradycardia, sinus blockade, atrioventricular block, lengthening of the QT interval on the electrocardiogram, arrhythmia of the "pirouette" type, cardiac arrest, cardiogenic shock;
- from the nervous system: drowsiness, fatigue, headache, anxiety, confusion, hallucinations, depression, confusion, tinnitus; extrapyramidal disorders (including bulbar type of speech, rhythmic protrusion of the tongue, spasm of the facial muscles, trismus, spasm of extraocular muscles, oculogyric crisis, spastic torticollis, muscle hypertonicity, opisthotonus); parkinsonism (muscle rigidity, hyperkinesis); in elderly patients, with chronic renal failure - dyskinesia; isolated cases - the development of a malignant neuroleptic syndrome (increased blood pressure, fever, changes in consciousness and muscle contracture);
- from the digestive system: constipation or diarrhea;
- from the endocrine system: with prolonged use of high doses - galactorrhea, gynecomastia, amenorrhea or menstrual irregularities, hyperprolactinemia;
- from the hematopoietic system and lymphatic system: agranulocytosis, methemoglobinemia, sulfhemoglobinemia;
- from the immune system: hypersensitivity, allergic reactions, urticaria, anaphylactic reactions, up to anaphylactic shock.
In addition, against the background of the use of certain forms of Perinorm, the following undesirable phenomena may develop:
- tablets: dry mouth, supraventricular tachycardia; when using high doses - hyperemia of the nasal mucosa;
- oral solution, solution for intravenous and intramuscular administration: nausea, polyuria, urinary incontinence, sexual dysfunction, priapism, maculopapular rash, leukopenia, neutropenia, akathisia.
Overdose
Symptoms of a metoclopramide overdose: abdominal pain, drowsiness, hypersomnia, confusion, irritability, anxiety, convulsions, hallucinations, extrapyramidal disorders, dizziness, changes in blood pressure, bradycardia and other disorders of the cardiovascular system, cardiac arrest and respiratory arrest. Symptoms usually disappear 24 hours after stopping treatment with Perinorm.
Treatment: there is no specific antidote. Careful constant monitoring of the function of the cardiac and respiratory system is required. Depending on the clinical condition of the patient, symptomatic therapy is prescribed. In case of an overdose in children, the use of benzodiazepines is indicated, in adults - anticholinergics and antiparkinsonian drugs.
special instructions
The duration of treatment should be as short as possible. Most of the adverse events occur within the first 36 hours and disappear within 24 hours after discontinuation of Perinorm.
It should be borne in mind that the results of laboratory studies to determine the indicators of liver function, the concentration of aldosterone and prolactin in plasma, carried out during the period of therapy with metoclopramide, may be distorted.
It is not recommended to drink alcohol during the period of treatment with Perinorm.
If adverse reactions occur, immediate discontinuation of the drug is required.
Influence on the ability to drive vehicles and complex mechanisms
During the period of treatment with Perinorm, patients should not engage in potentially hazardous activities, the implementation of which requires a high concentration of attention and a speed of psychomotor reaction, including driving.
Application during pregnancy and lactation
The use of Perinorm is contraindicated in the third trimester of gestation and during breastfeeding.
It should be borne in mind that treatment with metoclopramide at the end of pregnancy increases the risk of developing extrapyramidal symptoms in a newborn.
In the first and second trimester of pregnancy, the drug can be prescribed only if the potential effect for the mother is higher than the likely risk for the fetus.
If it is necessary to use Perinorm during lactation, breastfeeding should be stopped.
Pediatric use
It is contraindicated to prescribe Perinorm in the form of tablets and oral solution for the treatment of children under the age of 15 years, in the form of a solution for intravenous and intramuscular administration - for infants under 1 year of age.
With impaired renal function
Perinorm should be used with caution to treat patients with moderate, severe and end-stage renal failure.
The dosage regimen should be set taking into account QC.
For violations of liver function
Perinorm should be used with caution to treat patients with severe hepatic insufficiency.
Use in the elderly
With caution, given the state of renal and liver function, Perinorm should be prescribed to elderly patients.
Prolonged use of high doses of the drug can cause the development of parkinsonism, tardive dyskinesia and other extrapyramidal disorders.
Drug interactions
With the simultaneous use of Perinorm:
- levodopa, dopamine receptor agonists: these agents show mutual antagonism with metoclopramide, therefore their combination is contraindicated;
- ethanol: the use of alcohol and ethanol-containing drugs enhances the sedative effect of metoclopramide;
- morphine derivatives, m-anticholinergics: it should be borne in mind that concomitant therapy with each of these drugs causes mutual antagonism in relation to the effect on gastrointestinal motility, and be careful;
- antidepressants with a sedative effect, tranquilizers, morphine derivatives, blockers of H1-histamine receptors, clonidine, barbiturates: it is possible to increase the sedative effect of drugs that depress the central nervous system;
- antipsychotics: there is a risk of increasing the action of antipsychotics in relation to extrapyramidal symptoms;
- tetrabenazine: combination with tetrabenazine increases the risk of dopamine deficiency, which can lead to involuntary muscle movements, increased muscle stiffness and spasm, difficulty speaking or swallowing, anxiety, tremor
- serotonergic drugs: increase the risk of developing serotonin syndrome (serotonin intoxication);
- digoxin, cyclosporin: reduce their bioavailability, therefore, it is necessary to control their concentration in blood plasma;
- fluoxetine, paroxetine and other powerful inhibitors of the isoenzyme CYP2D6: these drugs increase the exposure of metoclopramide;
- atovahone: there is a clinically significant (up to 50%) decrease in the level of atovahone in blood plasma;
- bromocriptine: metoclopramide increases its concentration in blood plasma;
- tetracycline, mexiletine, lithium preparations: the absorption of the listed funds is enhanced;
- cimetidine: a decrease in its absorption should be considered.
Analogs
The analogues of Perinorm are Metoclopramide, Metoclopramide Velpharm, Metoclopramide-Acri, Metoclopramide-Vial, Metoclopramide-Promed, Metoclopramide-ESCOM, Ceruglan, Cerucal, etc.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C, protected from moisture and light.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Perinorm
In isolated reviews of Perinorm, patients point to its effectiveness, but complain about adverse reactions from the nervous system. At the same time, according to the results of private surveys, the drug is assigned the second place among drugs that suppress the gag reflex and reduce the unpleasant feeling of nausea.
Price for Perinorm in pharmacies
The price of Perinorm in the form of a solution for oral administration for a package containing 100 ml can range from 224 rubles.
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
