Lansoprazole ................... 30 mg
Excipients q.s.............. 1 capsule
Box of 3 blisters x 10 capsules.
Lastro contains lansoprazole which is a substituted benzimidazole gastric acid antisecretory agent. It belongs to proton pump inhibitors. Lansoprazole irreversibly binds to H+/K+ ATPase enzyme system at the surface of the gastric parietal cell and therefore suppressing the transport of hydrogen ions into the stomach.
Lansoprazole is used for short-term treatment of gastroduodenal ulcers and for long-term treatment of pathological hypersecretory conditions (including Zollinger-Ellison syndrome, polyendocrine adenomatosis, and elevated mast cell counts). The degree of inhibition of gastric acid secretion is related to the dose and duration of therapy, but lansoprazole is a more potent inhibitor of such secretion than are H2-receptor antagonists.
Lansoprazole can suppress Helicobacter pylori in patients with gastric or duodenal ulcers infected with the organism. Combined therapy with lansoprazole and one or more appropriate anti-infectives (e.g., amoxicillin, clarithromycin) can effectively eradicate H. pylori gastric infection.
Absorption of lansoprazole is rapid, with the mean Cmax occurring approximately 1.7 hours after oral dosing, and the absolute bioavailability is over 80%. In healthy subjects, the mean plasma half-life was 1.5 (±1.0) hours. Both the Cmax and AUC are diminished by about 50% if lansoprazole is given 30 minutes after food. Lansoprazole is 97% bound to plasma proteins. Approximately 20% of the dose is excreted via bile and urine.
Lansoprazole elimination is significantly prolonged in patients with severe hepatic disease, but does not change in patients with severe renal impairment. Therefore, dose reduction should be applied to patients with severe hepatic disease.
Cautions should be taken during driving and operating machinery since the drug may cause headache, dizziness.
Dose reduction should be practiced in patients with hepatic disease. Pregnant women and breast-feeding mothers should be used with cautions.
It is not known that whether lansoprazole goes through the fetus. However, a prolonged use with high doses caused tumorigenicity in animal experiments. So, the drug should not be given to pregnant women, particularly during the first trimester of pregnancy; or it is better not to use lansoprazole in any period of pregnancy.
Lansoprazole or its metabolites may be excreted in human milk. Because of the potential for tumorigenicity shown for lansoprazole in animal, lansoprazole should not be indicated to nursing mothers.
Lansoprazole is metabolized through the cytochrome P450 enzyme system. Concomitant administration of lansoprazole with drugs whose metabolism via this enzyme should not be recommended. Lansoprazole decreases the effects of ketoconazole, itraconazole and other drugs which their absorption requires acid medium. Concomitant administration of lansoprazole with sucralfate resulted in delayed and decreased absorption (by 30%).
Frequently: Body as a whole: headache, dizziness; Gastrointestinal disorders: diarrhea, colic, nausea, vomiting, constipation, dyspepsia; Skin disorders: rash.
Rarely: fatigue.
Paraclinically: increased levels of plasma gastrin, liver enzyme, hematocrit, hemoglobin, uric acid and urine protein.
Inform a physician about any adverse effects occur during the treatment.
Symptoms: low body temperature, sedation, convulsions, decreased respiratory frequency.
Supportive treatment: Lansoprazole is not removed from the circulation by hemodialysis.
Store in dry places, not exceeding 30°C, protect from light.
Short-term and maintenance treatment of erosive esophagitis in patients with gastroesophageal reflux disease (up for 8 weeks).
Treatment of acute gastric - duodenal ulcers.
Treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome, polyendocrine adenomatosis.
Hypersensitivity to lansoprazole or any components of the drug. During the first trimester of pregnancy.
* Erosive esophagitis: The adult recommended dose should be 30 mg (1 capsule) once daily for 4 - 8 weeks. In patients not fully healed within this time, an additional 8-week course of lansoprazole may be given.
* Gastric ulcer: The recommended dose should be 30 mg (1 capsule) once daily for 4 - 8 weeks, preferably taken in the morning before breakfast.
Combination with amoxicillin and clarithromycin for treatment of H. pylori infection in patients with active duodenal ulcer is as follows:
Triple therapy: 30 mg (1 capsule) lansoprazole + 1 g amoxicillin + 500 mg clarithromycin, given twice daily for 10 - 14 days, before meals.
Dual therapy: 30 mg (1 capsule) lansoprazole + 1 g amoxicillin, given three times daily for 14 days before meals.
* Others acid hypersecretory conditions (Zollinger-Ellison syndrome):
The adult initial dose should be 60 mg (2 capsules) once daily, preferably taken in the morning before a meal.
Dose reduction should be practiced in patients with severe hepatic disease, normally given not more than 30 mg daily.
Lansoprazole is not stable in gastric acid; so it should be taken before meals and the capsules should be swallowed whole.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
This drug is for prescription only.
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