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Reglan 10 mg (50 tablets)

$7.70

f566350044d4

Description

The instruction for medical use

of Tserukal® medicine

the Trade name
of Tserukal®

the International unlicensed

name Metoclopramidum Dosage Form
of the Tablet of 10 mg

Structure
One tablet contains
active agent – hydrochloride Metoclopramidum monohydrate of 10.54 mg,
excipients: potato starch, lactoses monohydrate, gelatin, magnesium stearate, silicon dioxide.

The description
of the Tablet of white color, round shape, with a flat surface, with slanted edges, with risky on one party, and smooth with not measured edges on the other hand.

Pharmacotherapeutic group
Drugs for treatment of functional disorders of digestive tract. Stimulators of motility of digestive tract. Metoclopramidum.
The ATX A03FA01 code

the Pharmacological

Pharmacokinetics Later properties of intake is quickly soaked up, time of achievement of the maximum concentration in blood (TCmax) after intake is 30-120 min. The bioavailability is 60-80%. Easily gets through a blood-brain barrier and it is allocated with breast milk.
It is metabolized in a liver. Elimination half-life makes from 3rd to 5 hours, in renal failures can increase till 14 o’clock. It is removed by kidneys within the first 24 hours in not changed look and in the form of metabolites (about 80% of the accepted dose).
The pharmacodynamics
Metoclopramidum — the central antagonist of dopamine receptors, also has peripheral cholinergic activity. Note two main effects: antiemetic effect and effect of acceleration of gastric emptying and small intestine. The antiemetic effect is caused by action on the central receptors of a trunk of a brain (chemoceptors — the activating zone of the emetic center) probably by braking of dopaminergic neurons. Strengthening of a vermicular movement is also partially controlled by the central nervous system centers, but also the mechanism of peripheral action along with activation of postganglionic cholinergic receptors and, perhaps, oppression of dopaminergic receptors of a stomach and small intestine can be partially involved.
Indications
– vomiting and nausea of various genesis
– an atony and hypotonia of a stomach and intestines (in particular postoperative)
– stomach paresis in diabetes
– for strengthening of a vermicular movement when carrying out X-ray contrast researches of digestive tract
– as the means facilitating duodenal sounding (for acceleration of gastric emptying and advance of food on a small intestine.
A route of administration and doses
Inside on 1 tablet (10 mg of Metoclopramidum) in 30 minutes prior to meal, washing down with water 3 times a day.
Duration of treatment is 5 days.

Side effects
Often
– diarrhea
– an asthenia
– extrapyramidal disorders, parkinsonism
– an akathisia
– a depression
– hypotonia
Infrequently
– bradycardia
– an amenorrhea
– a giperprolaktinemiya
– hypersensitivity
– dystonia
– dyskinesia
– decrease in level of consciousness
– a hallucination
is rare
– a galactorrhoea
– spasms
– confusion of consciousness
It is unknown (it is impossible to estimate on the available data)
– a methemoglobinemia
– a sulfhemoglobinemia
– tachycardia
– a gynecomastia
– anaphylactic reactions
of the Contraindication
– hypersensitivity to Metoclopramidum and excipients
– a concomitant use with anticholinergic drugs
– hereditary intolerance of a lactose/galactose, deficiency of lactase, a lactose/galactose sprue, a glyukozemiya, a galactosemia
– glaucoma
– a pheochromocytoma (t. to it can cause the sharp hypertensive answer)
– arterial hypotension or hypertensia
– prolaktinzavisimy tumors
– mechanical intestinal impassability
– gastrointestinal bleedings
– a stomach pyloric stenosis
– perforation of a stomach or intestines
– epilepsy
– Parkinson’s disease
– extrapyramidal disturbances
– the I trimester of pregnancy and the period of a lactation
– children’s age up to 18 years
Medicinal interactions
Anticholinergics can weaken effect of Metoclopramidum.
Metoclopramidum strengthens absorption of antibiotics (tetracycline, ampicillin), paracetamol, a levodopa, lithium and alcohol.
Metoclopramidum reduces absorption of digoxin and Cimetidinum.
Metoclopramidum strengthens effect of alcohol and the medicines oppressing central nervous system, can influence effect of tricyclic

antidepressants, inhibitors of a monoaminooxidase (MAO) and sympathomimetic means.
Antipsychotic drugs at co-administration with Metoclopramidum can increase risk of developing extrapyramidal disorders.
Metoclopramidum reduces efficiency of therapy H2-gistaminoblokatorami.
Metoclopramidum increases risk of development of hepatotoxicity at a combination with gepatotoksichny means.
Metoclopramidum reduces efficiency of a pergolid, levodopa.
Metoclopramidum increases bioavailability of cyclosporine that can demand control of its kontsetration.
Metoclopramidum raises Bromocriptinum kontsetration in plasma.
At co-administration of Metoclopramidum with thiamine (B1 Vitamin) the last quickly breaks up.

Special instructions
to Children and teenagers from 2nd to 18 years for the purpose of the correct dosing drug is appointed only in the form of injections.
In the course of treatment it is necessary to abstain from alcohol intake.
Patients with heavy renal failures have an increased risk of development of by-effects.
Against the background of use of Metoclopramidum, distortions of these laboratory indicators of function of a liver and definition of a kontsetration of Aldosteronum and prolactin in plasma are possible.
It is necessary to be careful when assigning Tserukala® to teenagers because of risk of emergence of side effects, in particular diskineziya, to patients aged up to 30 years having big tendency to emergence dystonic – diskinetichesky disturbances at treatment by Metoclopramidum and to patients of advanced age in connection with high risk of developing parkinsonism.
Pregnancy and the period of a lactation
Drug is contraindicated in the I trimester. To women in II and III trimester of Tserukal® appoint only according to strict vital indications.
During treatment of Tserukalom® it is necessary to refuse breastfeeding.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering side effects to the patients accepting Tserukal® it is necessary to abstain from potentially dangerous types of activity requiring special attention and speed of psychomotor reactions.

Overdose
Symptoms: drowsiness, confusion of consciousness, irritability, concern, spasms, extrapyramidal motive disorders, dysfunctions of a cardiovascular system with bradycardia, decrease or increase in arterial blood pressure.
At easy forms of poisonings the symptoms disappear in 24 hours after medicine cancellation. Depending on weight of symptomatology it is recommended to establish observation of the vital functions of the patient. Fatal cases at overdose of drug are not revealed.
Treatment: symptomatic. Extrapyramidal disorders eliminate with slow administration of Biperidinum (doses for adults – 2.5 – 5 mg). Bipereden enter only in the conditions of a hospital, under control of the doctor. It is possible to apply diazepam to calm of the patient. At hit in an organism bolshiz doses of Metoclopramidum do gastric lavage, use activated carbon and sodium sulfate.

A form of release and packing
On 50 tablets in a bottle of brown glass, with a stopper of white color from polyethylene of low density with the relief inscription AWD. On 1 bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.

To Store storage conditions at a temperature not above 30ºС, in the place protected from light.
To store out of children’s reach!

Not to apply a period of storage of 5 years after expiry date.

Prescription status
According to the prescription

the Producer
Pliva Hrvatsk of of the lake of the lake.
Prilaz Filippovich’s 25 baruna,
10 000 Zagreb, Republic of Croatia

the Owner of the registration certificate
of Teva Pharmaceutical Industries Ltd, Israel

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):

050000, Republic of Kazakhstan Almaty, Al-Farabi Avenue 19,
Nurla Tau’s Business center 1B of office
603,604 Phone number, fax (727) 311-09-15, 311-07-34
E-mail of teva@teva.co.il

to Develop ratiofarm Kazakhstan LLP

Additional information

Ingredient

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