The instruction for medical use
of MUKOGEN medicine
the Trade name
Mukogen
Mezhdunarodnoye the unlicensed
name Rebamipid Lekarstvennaya
the Tablet form coated, 100 mg
Structure
One tablet contains
active agent - rebamipid 100 mg,
excipients: sodium lauryl sulfate, Mannitolum, sodium of a kroskarmelloz, starch prezhelatinizirovanny, anhydrous citric acid, talc, magnesium stearate,
structure of a cover: gipromelloza (5 cps), talc, propylene glycol, titan dioxide (E 171).
Description
White or almost white round biconvex tablets, coated, smooth on both sides.
Pharmacotherapeutic group
Drugs for treatment of the diseases connected with disturbance of acidity. Other antiulcerous drugs and drugs for treatment of a gastroezofagalny reflux.
The ATX A02BX code
the Pharmacological
Pharmacokinetics Absorption Later properties of intake of a single dose of 100 mg concentration of a rebamipid in plasma reached peak (340 ng/ml) approximately in 2 hours. Linking with proteins of plasma of 98.4-98.6%. Plasma elimination half-life – 1.5 hours. Drug does not collect in a human body.
Metabolism
In urine after reception of a single dose of 600 mg inside is found a metabolite of a rebamipid with hydroxyl group in the 8th position.
Excretion
the Most part drug is removed in not changed look.
About 10% of the entered dose are removed with urine.
The pharmacodynamics
Rebamipid is the gastroprotektorny means derivative 2(1H) - hino-bosoms. This connection stimulates production of prostaglandin in mucous a stomach, reduces terms and improves quality of epithelization of stomach ulcer and also reduces ulcer recurrence probability in the future. Rebamipid protects mucous a stomach from the damages caused by toxic and ulcerogenic substances. Clinical and basic researches revealed pharmacological properties of a rebamipid to which it is possible to refer:
- increase in level of prostaglandins
- increase in amount of surface and soluble slime in a stomach by means of strengthening of activity of the enzymes accelerating biosynthesis of high-molecular glycoproteins
- increase in excretion of an epithelial growth factor and increase in number of receptors to it in normal and ulcerated mucous a stomach, and as a result - stimulation of proliferation of epithelial cells of the damaged site mucous
- suppression of activity of neutrophils and production of cytokines of inflammation, stimulated intake of non-steroidal anti-inflammatory drugs or H. pylori. Moreover, rebamipid promotes an eradikation of H. pylori at a combination with means of standard antiulcerous therapy as interferes with adhesion of bacteria to epithelial cells of a stomach.
- improvement of a blood-groove and hemodynamics in mucous a stomach
- increase in secretion of alkali in a stomach
- lack of influence on gastric secretion: rebamipid does not influence neither basal secretion of gastric juice, nor secretion of acid owing to stimulation.
Indications
- a peptic ulcer of a stomach
- acute gastritis, chronic gastritis in an aggravation phase
- an eradikation of H. pylori at treatment of gastritis and peptic ulcer of a stomach.
Adult
to Accept a route of administration and doses inside on 1 tablet (100 mg) 3 times a day, washing down with a small amount of liquid. The course of treatment makes 2 - 4 weeks, can be in case of need prolonged up to 8 weeks.
Side effects
- an itching, skin rash, eczema and other symptoms of hypersensitivity
- change of flavoring feelings, heartburn, an eructation, nausea, vomiting, an abdominal pain, a meteorism, a constipation, diarrhea
- abnormal liver functions: increase in activity of hepatic transaminases in blood serum
- a leukopenia, a granulocytopenia
- disturbances of a menstrual cycle
-
Contraindication hypostases
- hypersensitivity to a rebamipid and/or auxiliary components of drug
- malignant diseases of a stomach
Medicinal interactions
Is considered that interaction of drug with enzymes of P450 cytochrome does not break either Mukogen's metabolism, or metabolism of other drugs which take along with Mukogen.
It is supposed that only CYP3A4 is involved in process of hydroxylation of Mukogen. It is shown that Mukogen does not suppress the metabolism which is carried out by means of CYP 1A2-, 2C9-, 2C19-, 2D6-, 2E1 - 3A4-of enzymes.
The cytoprotective effect of Mukogen is weakened under the influence of cycloheximide or Actinomycinum D.
Special instructions
With care to apply at elderly to minimize risk of gastrointestinal disorders as these patients can be more sensitive to a rebamipid, than young people.
Use in pediatrics
Safety and efficiency of a rebamipid at children and teenagers is not studied.
Pregnancy and the period of a lactation
Safety of use Mukogena at pregnancy is not established. In case of need prescribing of drug in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination.
There Is no feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms data
Overdose
Symptoms: strengthening of side effects is possible.
Treatment: symptomatic. There is no specific antidote.
A form of release and packing
On 10 tablets in planimetric bezjyacheykovy packing from aluminum foil.
On 3 packs together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry, protected from light place, at a temperature not above 25 °C to Store out of children's reach!
2 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
Macleods Pharmaceutical Limited Producer, India
304, Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai – 400,059, India.
The owner of the registration certificate
of Macleods Pharmaceutical Limited, India
the Name and the country of the organization of the packer
of Macleods Pharmaceuticals Limited, India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims of consumers on quality of products (goods): Branch KOO Macleods Pharmaceuticals Limited, Republic Kazakhstang. Almaty, Tulebayev St. 38, floor 5, Ph./fax. +7 727 2734593, E-mail: danielt@macleodspharma.com.
of MUKOGEN medicine
the Trade name
Mukogen
Mezhdunarodnoye the unlicensed
name Rebamipid Lekarstvennaya
the Tablet form coated, 100 mg
Structure
One tablet contains
active agent - rebamipid 100 mg,
excipients: sodium lauryl sulfate, Mannitolum, sodium of a kroskarmelloz, starch prezhelatinizirovanny, anhydrous citric acid, talc, magnesium stearate,
structure of a cover: gipromelloza (5 cps), talc, propylene glycol, titan dioxide (E 171).
Description
White or almost white round biconvex tablets, coated, smooth on both sides.
Pharmacotherapeutic group
Drugs for treatment of the diseases connected with disturbance of acidity. Other antiulcerous drugs and drugs for treatment of a gastroezofagalny reflux.
The ATX A02BX code
the Pharmacological
Pharmacokinetics Absorption Later properties of intake of a single dose of 100 mg concentration of a rebamipid in plasma reached peak (340 ng/ml) approximately in 2 hours. Linking with proteins of plasma of 98.4-98.6%. Plasma elimination half-life – 1.5 hours. Drug does not collect in a human body.
Metabolism
In urine after reception of a single dose of 600 mg inside is found a metabolite of a rebamipid with hydroxyl group in the 8th position.
Excretion
the Most part drug is removed in not changed look.
About 10% of the entered dose are removed with urine.
The pharmacodynamics
Rebamipid is the gastroprotektorny means derivative 2(1H) - hino-bosoms. This connection stimulates production of prostaglandin in mucous a stomach, reduces terms and improves quality of epithelization of stomach ulcer and also reduces ulcer recurrence probability in the future. Rebamipid protects mucous a stomach from the damages caused by toxic and ulcerogenic substances. Clinical and basic researches revealed pharmacological properties of a rebamipid to which it is possible to refer:
- increase in level of prostaglandins
- increase in amount of surface and soluble slime in a stomach by means of strengthening of activity of the enzymes accelerating biosynthesis of high-molecular glycoproteins
- increase in excretion of an epithelial growth factor and increase in number of receptors to it in normal and ulcerated mucous a stomach, and as a result - stimulation of proliferation of epithelial cells of the damaged site mucous
- suppression of activity of neutrophils and production of cytokines of inflammation, stimulated intake of non-steroidal anti-inflammatory drugs or H. pylori. Moreover, rebamipid promotes an eradikation of H. pylori at a combination with means of standard antiulcerous therapy as interferes with adhesion of bacteria to epithelial cells of a stomach.
- improvement of a blood-groove and hemodynamics in mucous a stomach
- increase in secretion of alkali in a stomach
- lack of influence on gastric secretion: rebamipid does not influence neither basal secretion of gastric juice, nor secretion of acid owing to stimulation.
Indications
- a peptic ulcer of a stomach
- acute gastritis, chronic gastritis in an aggravation phase
- an eradikation of H. pylori at treatment of gastritis and peptic ulcer of a stomach.
Adult
to Accept a route of administration and doses inside on 1 tablet (100 mg) 3 times a day, washing down with a small amount of liquid. The course of treatment makes 2 - 4 weeks, can be in case of need prolonged up to 8 weeks.
Side effects
- an itching, skin rash, eczema and other symptoms of hypersensitivity
- change of flavoring feelings, heartburn, an eructation, nausea, vomiting, an abdominal pain, a meteorism, a constipation, diarrhea
- abnormal liver functions: increase in activity of hepatic transaminases in blood serum
- a leukopenia, a granulocytopenia
- disturbances of a menstrual cycle
-
Contraindication hypostases
- hypersensitivity to a rebamipid and/or auxiliary components of drug
- malignant diseases of a stomach
Medicinal interactions
Is considered that interaction of drug with enzymes of P450 cytochrome does not break either Mukogen's metabolism, or metabolism of other drugs which take along with Mukogen.
It is supposed that only CYP3A4 is involved in process of hydroxylation of Mukogen. It is shown that Mukogen does not suppress the metabolism which is carried out by means of CYP 1A2-, 2C9-, 2C19-, 2D6-, 2E1 - 3A4-of enzymes.
The cytoprotective effect of Mukogen is weakened under the influence of cycloheximide or Actinomycinum D.
Special instructions
With care to apply at elderly to minimize risk of gastrointestinal disorders as these patients can be more sensitive to a rebamipid, than young people.
Use in pediatrics
Safety and efficiency of a rebamipid at children and teenagers is not studied.
Pregnancy and the period of a lactation
Safety of use Mukogena at pregnancy is not established. In case of need prescribing of drug in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination.
There Is no feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms data
Overdose
Symptoms: strengthening of side effects is possible.
Treatment: symptomatic. There is no specific antidote.
A form of release and packing
On 10 tablets in planimetric bezjyacheykovy packing from aluminum foil.
On 3 packs together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry, protected from light place, at a temperature not above 25 °C to Store out of children's reach!
2 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
Macleods Pharmaceutical Limited Producer, India
304, Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai – 400,059, India.
The owner of the registration certificate
of Macleods Pharmaceutical Limited, India
the Name and the country of the organization of the packer
of Macleods Pharmaceuticals Limited, India
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims of consumers on quality of products (goods): Branch KOO Macleods Pharmaceuticals Limited, Republic Kazakhstang. Almaty, Tulebayev St. 38, floor 5, Ph./fax. +7 727 2734593, E-mail: danielt@macleodspharma.com.
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