Universal reference book for medicines
Product name: LANZOPTOL (LANSOPTOL ® )

Active substance: lansoprazole

Type: H + -K + -ATPase inhibitor.
Antiulcer drug
Manufacturer: KRKA (Slovenia)
Composition, form of production and packaging
Capsules of
white color;
the contents of the capsule - pellets from white to white with a creamy or yellowish hue of color.
1 caps.

lansoprazole 30 mg

Excipients: sugar beads, hydroxypropylcellulose, magnesium carbonate, sucrose, corn starch, sodium lauryl sulfate, hydroxypropylmethylcellulose, methacrylic acid, talc, macrogol 600, titanium dioxide.

The composition of the capsule shell: titanium dioxide, gelatin.

7 pcs.
- blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

An anti-ulcer drug, a specific proton pump inhibitor (H + -K + -ATPase).
Metabolized in parietal cells of the stomach to active sulfonamide derivatives that inactivate the sulfhydryl groups of H + -K + -ATPase. It blocks the final stage of synthesis of hydrochloric acid, 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. Inhibitory effect increases in the first 4 days of admission. After discontinuation of the intake, the acidity remains below 50% basal level for 30 hours, there is no ricochetial increase in secretion. Secretory activity is restored 3-4 days after the end of the drug. In patients with Zollinger-Ellison syndrome, it is more prolonged.
PHARMACOKINETICS

Suction

After ingestion, absorption is high.
Eating lowers absorption and bioavailability, but the inhibitory effect on gastric secretion remains the same, regardless of food intake. When administered orally at a dose of 30 mg C max in blood plasma is achieved through 1.5-2.2. h and is 0.75-1.15 mg / l.
Distribution

Binding to plasma proteins - 97.7-99.4%.

Metabolism

It is actively metabolized by the "first pass" through the liver.

Excretion

T 1/2 is 1.3-1.7 hours.

It is excreted by the kidneys in the form of metabolites (14-23%) and through the intestines.

Pharmacokinetics in special clinical cases

With hepatic insufficiency and in elderly patients, excretion slows down.

INDICATIONS

- Stomach ulcer and duodenal ulcer;

- reflux-esophagitis, erosive-ulcerative esophagitis;

- erosive and ulcerative lesions of the stomach and duodenum associated with the administration of NSAIDs, stress ulcers;

- erosive and ulcerative lesions of the stomach and duodenum, associated with Helicobacter pylori (as part of complex therapy);

- Zollinger-Ellison syndrome.

DOSING MODE

The drug is taken orally.

With duodenal ulcer in the phase of exacerbation appoint 30 mg / day for 2-4 weeks, in resistant cases - up to 60 mg / day.

With peptic ulcer in the phase of exacerbation and erosive-ulcerative esophagitis - 30-60 mg / day for 4-8 weeks.

With erosive and ulcerative lesions of the gastrointestinal tract caused by the intake of NSAIDs - 30 mg / day for 4-8 weeks.

To eradicate Helicobacter pylori - 30 mg 2 times / day for 10-14 days in combination with antibacterial agents.

For anti-relapse treatment of peptic ulcer of the stomach and duodenum - 30 mg / day.

For the anti-relapse treatment of reflux esophagitis - 30 mg / day for a long time (up to 6 months).

With Zollinger-Ellison syndrome, the dose is set individually until the level of basal secretion is less than 10 mmol / h.

Capsules should be swallowed whole, not liquid.

SIDE EFFECT

From the digestive system: increased or decreased appetite, nausea, abdominal pain;
rarely diarrhea or constipation; in some cases - ulcerative colitis, candidiasis of the gastrointestinal tract, an increase in the activity of liver enzymes, an increase in the content of bilirubin in the blood.
From the side of the central nervous system: headache;
rarely - malaise, dizziness, drowsiness, depression, anxiety.
On the part of the respiratory system: rarely - cough, pharyngitis, rhinitis, upper respiratory infections, flu-like syndrome.

From the hemopoietic system: rarely - thrombocytopenia (with hemorrhagic manifestations);
in some cases - anemia.
Allergic reactions: skin rash;
in some cases, erythema multiforme.
Dermatological reactions : rarely - alopecia;
in some cases - photosensitivity.
Other: rarely - myalgia.

CONTRAINDICATIONS

- malignant neoplasms in the digestive tract;

- I trimester of pregnancy;

- lactation period;

- age up to 18 years;

- Hypersensitivity to the components of the drug.

With caution should prescribe the drug for hepatic and / or renal failure, pregnancy (II and III trimesters), elderly patients.

PREGNANCY AND LACTATION

The drug is contraindicated for use in the first trimester of pregnancy and lactation (breastfeeding).

Caution should be given to the drug during pregnancy (II and III trimesters).

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution should prescribe the drug for kidney failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should prescribe the drug for liver failure.

APPLICATION FOR CHILDREN

Contraindication: age to 18 years .

APPLICATION IN ELDERLY PATIENTS

Caution should be given to elderly patients.

SPECIAL INSTRUCTIONS

Before the beginning of treatment it is necessary to exclude the presence of malignant process in the upper GI tract, tk.
The drug may mask symptoms and make diagnosis difficult.
DRUG INTERACTION

With the simultaneous use of lansoprazole slows the excretion of drugs metabolized in the liver by microsomal oxidation (including diazepam, phenytoin, indirect anticoagulants).

Reduces the clearance of theophylline by 10%.

Lansoprazole 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 min).

Antacids slow down and reduce the absorption of lansoprazole (antacids should be prescribed for 1 hour or 1-2 hours after taking lansoprazole).

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, protected from moisture at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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