Rebambid Macleodz - instructions for use, dose, side effects, contraindications

Active substanceRebambidRebambid

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Rebambid Macleodz

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McLeodz Pharmaceuticals Co., Ltd. India

Dosage form: & nbspfilm coated tablets

Composition:

Each tablet contains:

Active substance:

Rebambid 100 mg

Excipients: mannitol (35.70 mg), croscarmellose sodium (14.0 mg), pregelatinized starch (80.70 mg), sodium lauryl sulfate (2.00 mg), citric acid (2.30 mg), purified talc (3.10 mg), magnesium stearate (2.20 mg).

Film Sheath: hypimellose (2.77 mg), talc purified (0.57 mg), titanium dioxide (1.11 mg), propylene glycol (0.55 mg)

Description:

Round, biconvex tablets, covered with a film shell of white or almost white color.

Pharmacotherapeutic group:gastroprotective agent

ATX: & nbsp

A.02.B.X Other antiulcer drugs

Pharmacodynamics:

Rebambid increases the content of prostaglandin E2 (PGE2) in the gastric mucosa and increases the content of PGE2 and GI2 in the contents of gastric juice. Has a cytoprotective effect against the gastric mucosa with the damaging effects of ethanol, acids and alkalis, acetylsalicylic acid. Promotes the activation of enzymes that accelerate the biosynthesis of high-molecular glycoproteins, and increases the mucus content on the surface of the stomach wall.It improves the blood supply to the gastric mucosa, activates its barrier function, activates the alkaline gastric secretion, enhances the proliferation and exchange of epithelial cells of the stomach, cleans mucosa from hydroxyl radicals and suppresses superoxides produced by polymorphonuclear leukocytes and neutrophils in the presence Helicobacter pylori, protects the gastric mucosa from damage by bacteria, has a gastroprotective effect when exposed to mucous non-steroidal anti-inflammatory drugs (NSAIDs).

Pharmacokinetics:

Absorption when ingested - high. After taking a dose of 100 mg peak concentration in the blood plasma (Cmax) is reached after approximately 2 hours and is 340 ng / ml. The half-life (T 1/2) is approximately 1.0 h. Repeated drug administration does not lead to its cumulation in the body. Approximately 10% of the drug is excreted by the kidneys, mostly unchanged. When administered at a dose of 600 mg, it is possible to isolate traces of a hydroxylated metabolite.

In the experiments in vitro it is shown that from 98.4 % up to 98.6% of the drug is bound by plasma proteins.

Indications:

Stomach ulcer.Chronic gastritis with increased acid-forming function of the stomach in the stage of exacerbation, erosive gastritis. Prevention of mucosal lesions on the background of non-steroidal anti-inflammatory drugs. Can be used in combination therapy.

Contraindications:

Individual intolerance to ribabipide or other components of the drug. Pregnancy.

Lactation period.

Children under the age of 18 years.

Carefully:

It is advisable to use caution when first prescribing rebamipid to patients with advanced age due to the possibility of hypersensitivity to the drug.

Pregnancy and lactation:

The safety of the use of rebamipide during pregnancy is not proven. Do not use during pregnancy. Because the rebamipide penetrates into breast milk, breastfeeding should be discontinued, or the issue of infant feeding should be resolved if a mother of rebamipid is to be given during breastfeeding.

Dosing and Administration:

Inside, 1 tablet 3 times a day, squeezed a small amount of liquid. The course of treatment is 2-4 weeks, if necessary, can be extended to 8 weeks. The drug does not have the features of the action at the first reception or upon its cancellation.

If you miss a dose, you need to take the next dose of the drug at the set time, do not take twice the dose of the drug.

Side effects:

From the gastrointestinal tract: constipation, flatulence, diarrhea, nausea, vomiting, pain in the abdomen, a violation of taste, heartburn.

From the side of the liver: signs of liver dysfunction, increased serum

glutamic alanine aminotransferase (ALT) and serum glutamic aspartate aminotransferase (ACT).

On the part of the hematopoiesis system: leukopenia, granulocytopenia.

Allergic reactions: itching, skin rash, eczematous rashes.

Other: violation of the menstrual cycle.

Overdose:

Symptoms of an overdose with rebamipide are not described, until today information about cases of deliberate overdose has not been reported. There may be nausea, vomiting, abdominal pain, diarrhea or constipation, headache.

Measures to assist: the specific antidote is unknown. In case of an overdose, wash the stomach and perform symptomatic therapy.

Interaction:

With the use of rebamipide in the traditional regimens of therapy of patients with infection Helicobacter pylori, the effectiveness of eradication therapy significantly increases.

Reactions with other drugs have not been studied.

Effect on the ability to drive transp. cf. and fur:

The effect of the drug on the rate of psychomotor reactions and / or the ability to control vehicles or mechanisms has not been studied. In case of taking the drug should be cautious about driving the car and other activities that require increased concentration of attention.

Form release / dosage:

Tablets, film-coated, 100 mg.

10 tablets per blister of aluminum foil. For 3 blisters together with instructions for use in a pack of cardboard.

Packaging:10 tablets per blister of aluminum foil. For 3 blisters together with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Special precautions for the destruction of an unused medicinal product or a drug with an expired shelf life is not required.

Terms of leave from pharmacies:On prescription

Registration number:LP-001831

Date of registration:12.09.2012

The owner of the registration certificate:McLeodz Pharmaceuticals Co., Ltd. McLeodz Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

MACLEODS PHARMACEUTICALS, Ltd. India

Representation: & nbspAdvansd Trading, OOOAdvansd Trading, OOO

Information update date: & nbsp12.09.2012

Illustrated instructions

Instructions

Rebambid Macleodz (Rebamipide Macleods)