REGLAN

Active material: Metoclopramide
When ATH: A03FA01
CCF: Antiemetic drugs of the central action, blocking dopamine receptors
ICD-10 codes (testimony): K21.0, K31.3, (K) 19.8, K56, K82.8, K91.3, R11
When CSF: 11.06.02
Manufacturer: AWD.pharma GmbH & Co.KG (Germany)

Pharmaceutical form, composition and packaging

Pills white, round, flat, with Valium on one side, with a smooth surface and solid beveled edges.

Excipients: potato starch, lactose monohydrate, gelatin, magnesium stearate, precipitated silicon dioxide.
50 PC. – vials of dark glass (1) – packs cardboard.

Solution for in / and the / m clear, colorless.

Excipients: sodium sulphite, disodium эdetat (disodium ètilendiamintetraacetat), sodium chloride, water d / and.

2 ml – colorless glass vials (5) – contour cell package (2) – packs cardboard.

Pharmacological action

Antiemetics. Specific blocker dopaminovykh receptors, weakens the sensitivity of visceral nerves, transmit impulses from the pyloric Department of a stomach and duodenal intestine to rvotnomu Center. Through the hypothalamus and the parasympathetic nervous system provides regulating and coordinating effects on tone and motor activity of the upper section of the gastrointestinal tract (incl. tone lower digestive sphincter alone).

Improves muscle tone of the stomach and intestines, accelerates gastric emptying, reduces giperatidnyi Staz, lets piloričeskomu and èzofageal′nomu reflux. Stimulates the intestinal peristalsis.

Pharmacokinetics

Absorption

After intake of rapidly absorbed, the time to reach C_max plasma 30-120 m.

Bioavailability is 60-80%.

Distribution

Penetrates the blood-brain and placental barriers. Provided with breast milk.

Metabolism

It is metabolized in the liver.

Deduction

T_1/2 – 3-5 no. Report the news in the first 24 h, unedited, and in the form of metabolites (about 80% from once the dose).

Pharmacokinetics in special clinical situations

In human kidney function (T)_1/2 may increase to 14 no.

Testimony

is vomiting and nausea of various Genesis;

— atony and hypotension of stomach and intestines (incl. Postoperative);

-biliary dyskinesia;

-reflux esophagitis;

-functional stenosis of pylorus;

— for enhancing peristalsis in rentgencontrastnykh studies of gastrointestinal tract;

— gastric paresis in diabetes;

— as a means of, facilitate duodenal sounding (to speed up gastric emptying and move food to the small intestine).

Dosage regimen

Set individually depending on the clinical symptoms and the age of the patient.

Adults and adolescents aged 14 and older appointed interior 10 mg 3-4 times / day.

If necessary, you can enter Reglan in/m or/in the dose 10 mg. The frequency – 3-4 times / day.

The average duration of treatment – 4-6 weeks; in some cases – to 6 Months.

To children 2-14 years the maximum single dose of both for intake, and for parenteral use is 0.1 mg / kg body weight; the maximum daily dose – 0.5 mg / kg.

Inside the drug should be taken for 30 minutes before meals.

Patients with impaired renal function requires correction mode.

Side effect

CNS: in some cases there may be a feeling of fatigue, headache, dizziness, a sense of fear, anxiety, depression, drowsiness, noise in ears; in some cases (mainly in children) can develop diskineticeski syndrome (knee-jerk tikoobraznye twitching facial muscles, neck or shoulders); the emergence of extrapiramidale disorders – spasm of the facial muscles, Trizm, rhythmic protrusion of tongue, bulbar type of speech, spasm of the extraocular muscles (incl. okulohyrnыy crisis), spasmodic torticollis, opisthotonus, Muscle hypertonicity, symptoms of Parkinson's disease (the risk of children and adolescents increased by overdose 0.5 mg / kg / day) and later diskinesia (in elderly patients with chronic renal insufficiency); in a few cases may develop severe Neuroleptic Malignant Syndrome.

In long-term care Cerukalom in elderly patients may develop symptoms of Parkinsonism and later dyskinesias.

From the hematopoietic system: agranulocytosis.

Cardio-vascular system: supraventricular tachycardia, arterial hypotension or hypertension.

From the digestive system: constipation, diarrhea, dry mouth.

On the part of the endocrine system: rarely – with long-term use drugs may experience gynecomastia, galactorrhea or menstrual irregularities (in developing these phenomena metoclopramide overturned).

Contraindications

-pheochromocytoma;

-intestinal obstruction;

is bleeding from the digestive tract;

-GASTROINTESTINAL perforation;

— prolaktinzawisimaya tumor;

-Epilepsy;

-extrapyramidal movement disorders;

— I trimester of pregnancy;

-lactation (breast-feeding);

-Children Under the age of 2 years;

-hypersensitivity to metoklopramidu;

-hypersensitivity to sodium sulfitu, especially in patients with bronchial asthma and other allergic diseases (for injection mold Cerukala).

FROM caution should designate product in hypertension, asthma, hepatic dysfunction, hypersensitivity to prokainu and prokainamidu, children aged 2 to 14 years.

Pregnancy and lactation

Reglan is contraindicated for use in the first trimester of pregnancy.

Application of Cerukala in II and III trimestrah pregnancy only on strict conditions.

If necessary, the use of Cerukala during lactation should decide on the termination of breastfeeding.

Cautions

Caution must be exercised in the appointment Cerukala children, adolescents and patients with the human kidney. The number of patients increased risk of side effects. In the case of side effects of the drug should immediately cancel.

Reglan is not effective for vomit vestibular Genesis.

Against the backdrop of metoclopramide distortions laboratory indicators of liver function and for determining the concentration of aldosterone and prolactin in plasma.

During treatment patients are prohibited from drinking alcohol.

Effects on ability to drive vehicles and management mechanisms

Patients, host Reglan, It should refrain from potentially hazardous activities, require increased attention and psychomotor speed reactions (driving machines, working with moving mechanisms).

Overdose

Symptoms: drowsiness, confusion, irritability, anxiety, convulsions, extrapyramidal movement disorders, human cardiovascular system with bradikardiei and arterial hypo- or hypertension.

In light forms of poisoning symptoms disappear after 24 h after drug withdrawal. Depending on the severity of the symptoms, we recommend that you install monitoring vital functions of the patient. Fatal cases of poisoning in overdose not identified.

Treatment: symptomatic therapy. Ekstrapiramidnye disorders eliminate slow in/with the introduction of biperiden (dose for adults – 2.5-5 mg). It is possible to use diazepam.

Drug Interactions

Together with the use of Reglan lowers antiholinesteraznah drugs action.

While applying Cerukala and doses may increase extrapiramidale symptoms.

If you are applying to Cerukala with cimetidine and digoxin may decrease absorption of the past.

If you are applying to Cerukala with some antibiotics (tetracycline, regimen of ampicillin), lithium preparations, paracetamol, levodopa, pour, ethanol intake is amplified past.

Reglan increases the effects of ethanol and medicines, CNS depressants.

While applying Cerukala and tricyclic antidepressants, MAO inhibitors and simpatomimeticakih funds may change their effects.

Reglan lowers the effects of H₂ -Histamine receptors.

Reglan increases the risk of Hepatotoxicity in combination with hepatotoxic means.

Reglan lowers efficiency pergolida, levodopa.

Reglan increases the bioavailability of Cyclosporine, that may require monitoring its concentration in blood plasma.

Reglan increases concentration bromokriptina.

Pharmaceutical interaction

When mixing solutions of Cerukala and vitamin B₁ destruction occurs vitamin.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored in the dark, inaccessible to children at temperature not exceeding 30 ° C. Shelf life – 5 years.