Lansobel 14s 30 mg capsules
- $12.10
The instruction for use
of medicine for experts
ЛАНСОБЕЛ®
Trade name
ЛАНСОБЕЛ®
the International unlicensed
name Lansoprazol Lekarstvennaya a form
of the Capsule of 30 mg
Structure
One capsule contains
active agent – a lansoprazola of a micropellet of 377.40 mg
30 mg of a lansoprazol,
structure of a cover of the capsule are equivalent: titan E 171 dioxide, ferrous oxide yellow E 172,
ferrous oxide red E 172, patent
blue V E 131.
The description
Solid gelatin capsules with the opaque body of light orange color and an opaque lid of dark green color. Contents of capsules – spherical micropellets of white or almost white color.
Pharmacotherapeutic group
Antiulcerous means and the drugs used at a gastroesophageal reflux. Inhibitors of the protonew
pump Code of Automatic Telephone Exchange A02BC03 Pharmacological Pharmacokinetics Absorption Properties of a lansoprazol occurs in intestines. Лансобел® it is quickly soaked up and reaches average maximum concentration in plasma approximately in 1.7 hours, after intake, bioavailability higher than 80%. Peak plasma concentration and area under a curve of plasma concentration (AUC) of a lansoprazol is approximately proportional in doses from 15 mg to 60 mg after single oral administration. Лансобел® does not accumulate and its pharmacokinetics does not change at repeated use.
Time of semi-removal from blood plasma is 1.5 (±1.0) hours. The maximum concentration in plasma and area indicators under a curve concentration - time decreases to 50% if the drug is taken in 30 minutes after a meal unlike reception on an empty stomach. 97% of a lansoprazol contact proteins of plasma. Linking with plasma proteins is invariable at concentration ranging from 0.05 up to 5.0 mkg/ml., lansoprazol is extensively metabolized in a liver. In the measured quantities in plasma two metabolites were revealed (hydroxylated sulfinit also sulfonic derivatives of a lansoprazol). These metabolites have practically no anti-secretory activity. Lansoprazol is transformed to two active views which suppress acid secretion inhibiting (N + - K+) – ATP-ase in tubules of covering cells, but have no effect in a big circle of blood circulation. Elimination half-life of a lansoprazol makes about 2 hours and does not influence duration of suppression of hydrochloric acid in a stomach. At elderly the clearance (clearing coefficient) of a lansoprazol with lengthening of elimination half-life approximately decreases by 50% and 100%. Repeated single dose in day does not lead to cumulation at elderly people. Peak plasma concentration at elderly do not increase.
The pharmacodynamics
of Lansobel® - anti-secretory drug, the substituted benzimidazole, specifically inhibits a fermental system (N +-K+) ATP-ases on the secretory surface of covering cells of a stomach. Being inhibitor of the protonew pump, Lansobel® suppresses a final stage of secretion of hydrochloric acid. The developing dose-dependent effect provides inhibition of basal and stimulated secretion. At treatment lansoprazoly the gipergastrinemiya coming to initial within 1-2 weeks after drug withdrawal is observed. After oral purpose of a lansoprazol value rn a stomach between 3 and 4. Лансобел® considerably reduces development and volume of hydrochloric acid, stimulated both meal, and Pentagastrinum. Patients with the raised hypersecretion have acids, Lansobel® considerably reduces basal and stimulated Pentagastrinum secretion, slows down normal increase in volume of secretion of acidity and the production of acid induced by insulin.
Suppression of acidity can strengthen action of antimicrobial means at an eradikation of Helicobacter pylori (H. pylori).
The small decrease in bleeding in antral and peloric departments of a stomach and a bulb of a duodenum caused by the normal physiological activity caused by oppression of secretion of gastric acid was observed. Лансобел® shows activity against the majority of strains of Helicobacter pylori.
Indications
- a peptic ulcer of a stomach and duodenum in an aggravation stage
- a gastroesophageal reflux disease (GERD)
- the gastropathies caused by non-steroidal anti-inflammatory drugs
(NPVS - gastropathies)
- an eradikation of H. pylori
- Zollingera-Ellison's syndrome
the Route of administration and doses
Exacerbation of stomach ulcer and a duodenum
the Recommended oral dose for adult 30 mg of drug (1 capsule) once a day to food within 8 weeks.
GERD
the Recommended oral dose for adult 30 mg of drug (1 capsule) once a day to food within 8 weeks. If necessary the course can be repeated.
Gastropathy NPVS-
the Recommended oral dose for adult 30 mg of drug (1 capsule) once a day to food within 8 weeks.
Eradikation H. pylori
On 30 mg of drug (1 capsule) 2 times a day (in 12 hours) within 7-14 days or 3 times a day (in 8 hours) within 14 days.
The drug should be taken before food. The granules which are contained in capsules cannot be chewed or pounded.
Side effects
- anafilakticheky reactions
- hepatotoxicity
- vomiting
- an agranulocytosis, aplastic anemia, a leukopenia, a neutropenia,
a pancytopenia, and a Werlhof's disease
- a speech disorder
-
the Contraindication ischuria
- hypersensitivity to one of drug components
- a renal failure
- a liver failure
- the first trimester of pregnancy
- the lactation period
Medicinal interaction
of Lansobel® is metabolized through a fermental system P450 cytochrome, especially through CYP3A and CYP2C19 isoenzymes. Лансобел® has no considerable clinical interactions with other drugs which are metabolized by means of a system P450 cytochrome, such as warfarin, antipyrine, indometacin, ibuprofen, Phenytoinum, propranolol, Prednisonum, diazepam, klaritromitsin or terfenadin. At combined use of a lansoprazol with theophylline (CYP1A2, CYP3A), slight increase (10%) of clearance of theophylline was observed. At joint intake of these drugs it is necessary to modify a theophylline dose.
Лансобел® it is necessary to accept in 30 minutes prior to reception of the sukralfat.
Due to the suppression of secretion of hydrochloric acid the bioavailability of drugs for which rn a stomach is important can be reduced (ketokanazol, ampicillin, iron salts, digoxin).
Special instructions
At use of combination therapy lansoprazol amoxicillin klaritromitsin and lansoprazol amoxicillin no specific side reactions to this combination of drugs were observed.
Pseudomembranous colitis can be observed at use of a klaritromitsin and amoxicillin. Before an initiation of treatment any penicillin, it is necessary to conduct attentive survey of rather previous reactions of hypersensitivity to penicillin, cephalosporins and other allergens. Heavy anaphylactic reactions demand immediate and urgent use of adrenaline. It is also necessary to appoint oxygen, intravenously steroids and control of breath, including an intubation.
Side reactions of a vremenna also do not demand the treatment termination. At patients with a heavy renal failure, linking with plasma proteins decreases by 1.0% - 1.5%.
At patients with different degrees of a liver failure the average plasma elimination half-life of medicine is extended from 1.5 to 3.2 - 7.2 o'clock. Increase in average AUC (the area under a concentration curve) up to 500% was observed with steady constancy, at patients from the liver broken by function in comparison with healthy faces. At patients with a serious illness of a liver it is necessary to consider reduction of a dosage.
In the presence of any disturbing symptoms (for example, considerable spontaneous degrowth of a body, frequent vomiting, a dysphagy, vomiting with impurity of blood or a melena) and also in the presence of stomach ulcer (or suspicion of stomach ulcer) it is necessary to exclude a possibility of a malignant new growth therefore in these cases before an initiation of treatment the endoscopic control since treatment lansoprazoly can disguise symptomatology is obligatory and delay the correct diagnostics.
At use at advanced age the correction of a dosage is not required.
Use in pediatrics
the Efficiency and safety of use of drug for children are not established
Pregnancy and a lactation
it is not necessary to apply lansoprazol in the I trimester of pregnancy, in the II-III trimesters the use is possible only in emergency cases.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not affect ability to run the vehicle and work with potentially dangerous mechanisms
Overdose
Symptoms: are not described. The overdose case without side reactions is known.
Treatment: drug has no known antidote. In case of overdose it is necessary to carry out symptomatic and maintenance therapy. Gastric lavage and use of activated carbon is effective. Drug is not removed from an organism by means of dialysis.
A form of release and packing
of the Capsule of 30 mg, in the blister on 7 capsules, 2 or 4 blisters in a cardboard pack together with the instruction for use.
To Store storage conditions at a temperature of 15 °C - 30º C in the dry, protected from light place.
To store out of children's reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer
Republic of Kazakhstan. Almaty, Shevchenko St. 162 E.
To develop
of medicine for experts
ЛАНСОБЕЛ®
Trade name
ЛАНСОБЕЛ®
the International unlicensed
name Lansoprazol Lekarstvennaya a form
of the Capsule of 30 mg
Structure
One capsule contains
active agent – a lansoprazola of a micropellet of 377.40 mg
30 mg of a lansoprazol,
structure of a cover of the capsule are equivalent: titan E 171 dioxide, ferrous oxide yellow E 172,
ferrous oxide red E 172, patent
blue V E 131.
The description
Solid gelatin capsules with the opaque body of light orange color and an opaque lid of dark green color. Contents of capsules – spherical micropellets of white or almost white color.
Pharmacotherapeutic group
Antiulcerous means and the drugs used at a gastroesophageal reflux. Inhibitors of the protonew
pump Code of Automatic Telephone Exchange A02BC03 Pharmacological Pharmacokinetics Absorption Properties of a lansoprazol occurs in intestines. Лансобел® it is quickly soaked up and reaches average maximum concentration in plasma approximately in 1.7 hours, after intake, bioavailability higher than 80%. Peak plasma concentration and area under a curve of plasma concentration (AUC) of a lansoprazol is approximately proportional in doses from 15 mg to 60 mg after single oral administration. Лансобел® does not accumulate and its pharmacokinetics does not change at repeated use.
Time of semi-removal from blood plasma is 1.5 (±1.0) hours. The maximum concentration in plasma and area indicators under a curve concentration - time decreases to 50% if the drug is taken in 30 minutes after a meal unlike reception on an empty stomach. 97% of a lansoprazol contact proteins of plasma. Linking with plasma proteins is invariable at concentration ranging from 0.05 up to 5.0 mkg/ml., lansoprazol is extensively metabolized in a liver. In the measured quantities in plasma two metabolites were revealed (hydroxylated sulfinit also sulfonic derivatives of a lansoprazol). These metabolites have practically no anti-secretory activity. Lansoprazol is transformed to two active views which suppress acid secretion inhibiting (N + - K+) – ATP-ase in tubules of covering cells, but have no effect in a big circle of blood circulation. Elimination half-life of a lansoprazol makes about 2 hours and does not influence duration of suppression of hydrochloric acid in a stomach. At elderly the clearance (clearing coefficient) of a lansoprazol with lengthening of elimination half-life approximately decreases by 50% and 100%. Repeated single dose in day does not lead to cumulation at elderly people. Peak plasma concentration at elderly do not increase.
The pharmacodynamics
of Lansobel® - anti-secretory drug, the substituted benzimidazole, specifically inhibits a fermental system (N +-K+) ATP-ases on the secretory surface of covering cells of a stomach. Being inhibitor of the protonew pump, Lansobel® suppresses a final stage of secretion of hydrochloric acid. The developing dose-dependent effect provides inhibition of basal and stimulated secretion. At treatment lansoprazoly the gipergastrinemiya coming to initial within 1-2 weeks after drug withdrawal is observed. After oral purpose of a lansoprazol value rn a stomach between 3 and 4. Лансобел® considerably reduces development and volume of hydrochloric acid, stimulated both meal, and Pentagastrinum. Patients with the raised hypersecretion have acids, Lansobel® considerably reduces basal and stimulated Pentagastrinum secretion, slows down normal increase in volume of secretion of acidity and the production of acid induced by insulin.
Suppression of acidity can strengthen action of antimicrobial means at an eradikation of Helicobacter pylori (H. pylori).
The small decrease in bleeding in antral and peloric departments of a stomach and a bulb of a duodenum caused by the normal physiological activity caused by oppression of secretion of gastric acid was observed. Лансобел® shows activity against the majority of strains of Helicobacter pylori.
Indications
- a peptic ulcer of a stomach and duodenum in an aggravation stage
- a gastroesophageal reflux disease (GERD)
- the gastropathies caused by non-steroidal anti-inflammatory drugs
(NPVS - gastropathies)
- an eradikation of H. pylori
- Zollingera-Ellison's syndrome
the Route of administration and doses
Exacerbation of stomach ulcer and a duodenum
the Recommended oral dose for adult 30 mg of drug (1 capsule) once a day to food within 8 weeks.
GERD
the Recommended oral dose for adult 30 mg of drug (1 capsule) once a day to food within 8 weeks. If necessary the course can be repeated.
Gastropathy NPVS-
the Recommended oral dose for adult 30 mg of drug (1 capsule) once a day to food within 8 weeks.
Eradikation H. pylori
On 30 mg of drug (1 capsule) 2 times a day (in 12 hours) within 7-14 days or 3 times a day (in 8 hours) within 14 days.
The drug should be taken before food. The granules which are contained in capsules cannot be chewed or pounded.
Side effects
- anafilakticheky reactions
- hepatotoxicity
- vomiting
- an agranulocytosis, aplastic anemia, a leukopenia, a neutropenia,
a pancytopenia, and a Werlhof's disease
- a speech disorder
-
the Contraindication ischuria
- hypersensitivity to one of drug components
- a renal failure
- a liver failure
- the first trimester of pregnancy
- the lactation period
Medicinal interaction
of Lansobel® is metabolized through a fermental system P450 cytochrome, especially through CYP3A and CYP2C19 isoenzymes. Лансобел® has no considerable clinical interactions with other drugs which are metabolized by means of a system P450 cytochrome, such as warfarin, antipyrine, indometacin, ibuprofen, Phenytoinum, propranolol, Prednisonum, diazepam, klaritromitsin or terfenadin. At combined use of a lansoprazol with theophylline (CYP1A2, CYP3A), slight increase (10%) of clearance of theophylline was observed. At joint intake of these drugs it is necessary to modify a theophylline dose.
Лансобел® it is necessary to accept in 30 minutes prior to reception of the sukralfat.
Due to the suppression of secretion of hydrochloric acid the bioavailability of drugs for which rn a stomach is important can be reduced (ketokanazol, ampicillin, iron salts, digoxin).
Special instructions
At use of combination therapy lansoprazol amoxicillin klaritromitsin and lansoprazol amoxicillin no specific side reactions to this combination of drugs were observed.
Pseudomembranous colitis can be observed at use of a klaritromitsin and amoxicillin. Before an initiation of treatment any penicillin, it is necessary to conduct attentive survey of rather previous reactions of hypersensitivity to penicillin, cephalosporins and other allergens. Heavy anaphylactic reactions demand immediate and urgent use of adrenaline. It is also necessary to appoint oxygen, intravenously steroids and control of breath, including an intubation.
Side reactions of a vremenna also do not demand the treatment termination. At patients with a heavy renal failure, linking with plasma proteins decreases by 1.0% - 1.5%.
At patients with different degrees of a liver failure the average plasma elimination half-life of medicine is extended from 1.5 to 3.2 - 7.2 o'clock. Increase in average AUC (the area under a concentration curve) up to 500% was observed with steady constancy, at patients from the liver broken by function in comparison with healthy faces. At patients with a serious illness of a liver it is necessary to consider reduction of a dosage.
In the presence of any disturbing symptoms (for example, considerable spontaneous degrowth of a body, frequent vomiting, a dysphagy, vomiting with impurity of blood or a melena) and also in the presence of stomach ulcer (or suspicion of stomach ulcer) it is necessary to exclude a possibility of a malignant new growth therefore in these cases before an initiation of treatment the endoscopic control since treatment lansoprazoly can disguise symptomatology is obligatory and delay the correct diagnostics.
At use at advanced age the correction of a dosage is not required.
Use in pediatrics
the Efficiency and safety of use of drug for children are not established
Pregnancy and a lactation
it is not necessary to apply lansoprazol in the I trimester of pregnancy, in the II-III trimesters the use is possible only in emergency cases.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not affect ability to run the vehicle and work with potentially dangerous mechanisms
Overdose
Symptoms: are not described. The overdose case without side reactions is known.
Treatment: drug has no known antidote. In case of overdose it is necessary to carry out symptomatic and maintenance therapy. Gastric lavage and use of activated carbon is effective. Drug is not removed from an organism by means of dialysis.
A form of release and packing
of the Capsule of 30 mg, in the blister on 7 capsules, 2 or 4 blisters in a cardboard pack together with the instruction for use.
To Store storage conditions at a temperature of 15 °C - 30º C in the dry, protected from light place.
To store out of children's reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer
Republic of Kazakhstan. Almaty, Shevchenko St. 162 E.
To develop
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