Lanzoptol - instructions for use, doses, side effects, contraindications

Composition:1 capsule contains:
Active substance: lansoprazole 30 mg
Excipients: sugar granule (sucrose, starch treacle), giprolose, magnesium carbonate, heavy, sucrose, corn starch, sodium lauryl sulfate, hypromellose, methacrylic acid and ethyl acrylate copolymer (1: 1), 30% dispersion, sodium hydroxide, talc, macrogol 6000, titanium dioxide.
Composition of gelatin capsule shell:
Capsule body: titanium dioxide E171, gelatin
Capsule cap: titanium dioxide E171, gelatin.

Description:Capsules №1 of white color. The contents of the capsules are pellets from white to white with a slightly yellowish or slightly pinkish hue of color.

Pharmacotherapeutic group:Reducing secretion of the gastric glands means - a proton pump inhibitor.

ATX: & nbsp

A.02.B.C Proton pump inhibitors

A.02.B.C.03 Lansoprazole

Pharmacodynamics:Antiulcer. Specific proton pump inhibitor (H + / K + ATPase); metabolized in parietal cells of the stomach to active sulfonamide derivatives, which inactivate the sulfhydryl groups of H + / K + ATPase. It blocks the final stage of hydrochloric acid secretion, reducing basal and stimulated secretion, regardless of the nature of the stimulus. The inhibition of production of hydrochloric acid at a dose of 30 mg - 80-97%. Does not affect the motility of the gastrointestinal tract (GIT). Inhibitory effect increases in the first four days of admission. After stopping the intake, the acidity for 39 hours remains below 50% basal level, "ricochet" increase in secretion is not noted. Secretory activity is restored 3-4 days after the end of the drug. In patients with Zollinger-Ellison syndrome, it is more prolonged.

Pharmacokinetics:Absorption is high (eating intake reduces absorption and bioavailability, but the inhibitory effect on gastric secretion remains the same, regardless of food intake). The time of maximum concentration (TC_max) on average after oral administration of 30 mg - 1.7 hours, the maximum concentration (C_max) - 0,75-1,15 mg / l. The maximum plasma concentrations and the area under the curve (AUC) are approximately proportional to the single dose taken. Pharmacokinetics in the dose range from 15 to 60 mg is linear, i.e. concentrations are proportional to the dose received, the parameters are constant, there is no cumulation. The connection with plasma proteins is 97%. Actively metabolized by "primary passage" through the liver. The half-life (T_1/2) - 1,3-1,7 hours Excretion by the kidneys (in the form of active metabolites: lansoprazole sulfone and hydroxylansoprazole) - 14-23% (renal failure for speed and clearance is not significantly affected) and bile (2/3). With hepatic failure and in elderly patients excretion slows down. T_1/2 (with hepatic insufficiency) - 3.2-7.2 h and T_1/2 (in the elderly) 1.9-2.9 h.

Indications:- Treatment and prevention of exacerbations of peptic ulcer of the stomach and duodenum;
- Treatment and prevention of erosive and ulcerative lesions of the stomach and duodenum associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) (NSAIDs-gastropathy);
- Gastroesophageal reflux disease (GERD), including erosive-ulcerative reflux esophagitis and non-erosive forms of reflux disease (NERD);
- Eradication of Helicobacter pylori in combination with two antibiotics;
- Zollinger-Ellison syndrome and other pathological conditions, accompanied by increased acid secretion in the stomach.

Contraindications:- Hypersensitivity to lansoprazole or other components of the drug;
- Pregnancy (I trimester) and lactation period;
- Children under 18 years of age (due to lack of data on use in children).

Carefully:Hepatic insufficiency, pregnancy (II-III trimesters), advanced age, malignant neoplasms of the gastrointestinal tract, hereditary fructose intolerance, glucose malabsorption syndrome and / or galactose, or a deficiency of sucrose isomaltase.

Pregnancy and lactation:The experience with lansoprazole in pregnant women is limited. When pregnancy can be used with caution only if the positive effect for the mother justifies the possible risk to the fetus and the baby. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped, since lansoprazole penetrates into breast milk.

Dosing and Administration:Inside. Capsules should be swallowed whole, not liquid.
Preferably with a single admission per day, the drug should be taken in the morning, before breakfast, but perhaps in the evening, before supper. If necessary, double reception: appoint before breakfast and dinner. If you can not swallow the whole capsule, its contents can be mixed with a small amount of apple juice (about 1 full tablespoon) and immediately swallowed without chewing. You can also enter through the gastric tube.
The maximum daily dose - 60 mg, in the case of Zollinger-Ellison syndrome - may be higher.
With liver failure and in elderly patients, treatment starts with half the doses, gradually increasing them to the recommended, but not more than 30 mg / day.
Peptic ulcer of duodenum in the phase of exacerbation: at 30 mg per day for 2-4 weeks (in resistant cases up to 60 mg per day).
Stomach ulcer in the phase of exacerbation: 30 mg once a day for 4-8 weeks.
Erosive-ulcerative lesions of the stomach and duodenum associated with the administration of NSAIDs (NSAIDs): at 30 mg per day for 4-8 weeks.
GERD, including reflux esophagitis and NERD: 30 mg per day for 4-8 weeks.In case of erosive esophagitis, if necessary, the duration of therapy can be doubled.
Helicobacter pylori eradication: 30 mg twice a day for 7-14 days in combination with two antibacterial agents.
Anti-relapse treatment of peptic ulcer of stomach and duodenum: 30 mg per day. The efficacy and safety of 12-month therapy with lansoprazole has been proven.
Preventive maintenance of relapses of erosive esophagitis: 30 mg per day. The efficacy and safety of 12-month therapy with lansoprazole has been proven.
Prevention of ulcers and erosions of the stomach and duodenum, as well as dyspeptic symptoms when taking NSAIDs: 30 mg 1 time per knock.
Zollinger-Ellison Syndrome: the dose is selected individually until the level of basal secretion is less than 10 mmol / h. A starting dose of 60 mg once a day is recommended. If you need a daily dose of 120 mg, it is recommended to appoint in two divided doses. The duration of therapy is determined by the doctor.

Side effects:On the part of the hematopoiesis system: Very rarely: leukopenia, thrombocytopenia (with hemorrhagic manifestations), eosinophilia, pancytopenia, agranulocytosis; in some cases - anemia.
From the digestive system: often: constipation; infrequently: abdominal pain, diarrhea, nausea, dry mouth, indigestion, taste perversion, flatulence; rarely: jaundice, hepatitis; very rarely: ulcerative colitis, candidiasis of the gastrointestinal tract, increased activity of "liver" enzymes, hyperbilirubinemia.
From the central and peripheral nervous system: often: headache; infrequently: malaise, dizziness, agitation, fear, confusion, depression, drowsiness, anxiety.
From the sense organs: often: pain in the eyes, visual impairment; very rarely: tinnitus.
From the skin and subcutaneous tissue: rarely: itchy skin, purpura, petechiae and hair loss are very rare: toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme.
From the side of skeletal-muscular and connective tissues: rarely: pain in the joints, muscles and bones.
From the genitourinary system: very rarely: interstitial nephritis, renal insufficiency, creatininemia; very rarely: urogenital disorders, impotence, enlargement of the mammary glands or gynecomastia.
From the respiratory system: rarely - cough, pharyngitis, rhinitis, upper respiratory tract infection, flu-like syndrome.
Allergic reactions: rarely: urticaria, angioedema, photosession, skin rash; very rarely: anaphylactic reactions, multiforme exudative erythema.
Metabolic and nutritional disorders: rarely: anorexia, increased appetite.
Other: alopecia, weakness.

Overdose:There is one report of an overdose: the patient took 600 mg of lansoprazole without any adverse effects.
Treatment: symptomatic, the patient must be under medical supervision. Hemodialysis is ineffective.

Interaction:Lansoprazole reduces the acidity of gastric juice, which can affect the absorption of certain drugs. For example, it decreases the bioavailability of ketoconazole, ampicillin esters and iron salts.
The bioavailability of digoxin is increased by 10%, which is clinically insignificant for most patients.
Slows down the elimination of drugs metabolized in the liver by microsomal oxidation (including diazepam, ibuprofen, indomethacin, clarithromycin, prednisolone, propranolol, terfenadine or warfarin, phenytoin).
Reduces the clearance of theophylline by 10%, the effect is clinically insignificant.
Changes the pH-dependent absorption of drugs belonging to weak acid groups (deceleration) and bases (acceleration).
Sucralfate reduces the bioavailability of lansoprazole by 30% (the interval between taking these drugs should be 30-40 minutes)
Antacids slow down and reduce the absorption of lansoprazole (they should be prescribed for 1 hour or 1 -2 hours after taking lansoprazole).

Special instructions:Before the start of therapy, it is necessary to exclude the presence of malignant process (especially in case of gastric ulcer), because treatment, "masking" the symptomatology, can delay the formulation of the correct diagnosis. Therefore, mandatory endoscopic control is recommended before and after treatment.
With caution, it is necessary to take Lanzoptol in patients with severe liver disease and in the elderly; with a maximum daily dose of 30 mg.
Dose changes for patients with kidney disease are not required.
Lanzoptol contains sucrose, so the drug is not recommended for patients with hereditary intolerance to fructose, glucose malabsorption syndrome and / or galactose, or a deficiency of sucrose isomaltase.

Effect on the ability to drive transp. cf. and fur:in recommended doses, the drug does not affect the speed of psychomotor reactions and concentration of attention.

Form release / dosage:Capsules of 30 mg.

Packaging:When manufacturing in Krka, dd, Novo mesto, Slovenia:
Capsules of 30 mg. For 7 capsules in a blister (contour squamous packaging). For 2 blisters (a contour cell package) is placed in a cardboard box together with an instruction for use.
When manufactured at OOO Krka-Rus:
Capsules of 30 mg. 7 or 14 capsules in a contour cell package. 2 contour packs of 7 capsules together with instructions for use are placed in a pack of cardboard. 1 contour pack of 14 capsules together with the instructions for use are placed in a pack of cardboard.

Storage conditions:List B.
Store in a dry place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:3 years.
Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N 015744/01

Date of registration:25.11.2008

Expiration Date:Unlimited

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, d.d. Slovenia

KRKA-RUS, LLC Russia

Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Information update date: & nbsp2016-11-03

Illustrated instructions

Instructions

Lansoptol (Lansoptol)