Presentation

Opaque white/ opaque white coloured size '1' vegetable capsule containing white to off white pellets.

Each capsule contains Lansoprazole 30mg.

Pharmacodynamic

Lansoprazole is a proton pump inhibitor. It suppresses the activity of (H⁺-K⁺)-ATPase existing in the parietal cells of the gastric mucosa which plays an important role as the proton pump. As a result, the gastric acid secretion will be reduced. Clinical efficacy of lansoprazole as proton pump inhibitor with high healing rate in gastric ulcer and duodenal ulcer has been proven. Moreover, its effectiveness can be observed in treatments in stomal ulcer, reflux esophagitis and Zollinger-Ellison syndrome.

Pharmacokinetic

Lansoprazole is unstable at acidic condition and must be administered in enteric-coated form. After oral administration, lansoprazole is rapidly absorbed and achieves peak plasma concentration in about 1.5 hours. The bioavailability of lansoprazole exceeds 80% even after the first dose. In the liver, it is metabolized extensively by cytochrome P450 isoenzyme CYP2C19 to form 5-hydroxyl-lansoprazole and by CYP3A to form lansoprazole sulfone. Most of the metabolites will be excreted in faeces via the bile and only around 15-30% of a dose will be excreted in urine. Almost all lansoprazole (97%) will bind to protein. Lansoprazole has long duration of action even though its plasma half-life is only about 1-2 hours. Elderly and patients with liver disease will have a slower rate of clearance.

Indication

Lansoprazole is indicated for gastric ulcer, duodenal ulcer, reflux esophagitis and Zollinger-Ellison syndrome. When administered with suitable antibiotics, it is also indicated for treatment of eradication of Helicobacter pylori from the upper gastrointestinal tract in patients with peptic ulcer (duodenal or benign gastric ulcer).

Dosage and administration

Adult: One capsule daily. Duodenal Ulcer One capsule daily for 4 weeks. Gastric ulcer and stoma/ ulcer. One capsule once daily for 8 weeks. Reflux esophagitis: One capsule daily for 4-8 weeks. Zollinger-Ellison syndrome: Dosage should be adjusted according to patient's signs and symptoms. Eradication of H. pylori: One Lazol capsule twice daily plus two antibiotics (amoxicillin 1 g twice daily or metronidazole 400mg twice daily and clarithromycin 200-500mg twice daily). Combination of clarithromycin with either amoxicillin or metronidazole gives best eradication results (up to 90%). The safety and efficacy of lansoprazole in children has not been established.

Contraindication

Lazol is contraindicated in patients with known hypersensitivity to lansoprazole.

Precautions/ Warning

Full prescribing information of antibiotic should be studied before antibiotics are prescribed together with lansoprazole in treatment of eradication of H. pylori. The course of disease should be observed closely and carefully during the period of treatment. Dosage allocation should be adjusted according to disease condition and minimum therapeutic dose should be given. Long term usage of this drug as maintenance treatment is not recommended due to lack of experience on prolonged use. Lansoprazole should be administered with care in patients with past history of drug hypersensitivity, patients with hepatic disorders and in elderly patients. For elderly patients, lansoprazole should also be administered with caution because their gastric secretion and other physiological functions are decreased. The symptoms of gastric ulcer may be masked by administration of lansoprazole. Before starting treatment, the presence of gastric malignancy should be excluded.

Interaction with other medicaments

In omeprazole (a drug that is similar to lansoprazole), retardation of metabolism and excretion of diazepam and phenytoin has been reported.

Usage during Pregnancy and Lactation

The serum concentration of lansoprazole in rat fetus is higher compared with the mother rat. On the other hand, an increased fetal death is observed in rabbits (p.o., 30 mg/kg). Thus, the usage of lansoprazole in pregnant women or women suspected of being pregnant must be weighed against the possible hazards to the mother and fetus. In animal studies, lansoprazole can be found in milk. Therefore, administration of lansoprazole should be avoided in nursing mother. Nursing should be stopped if the treatment of lansoprazole is mandatory.

Side effects/ Adverse reactions

Hypersensitivity

Rash and pruritus rarely occur. Discontinue treatment if these signs are observed.

Hepatic

Close observation should be given to patients because elevation of GOT, GPT, alkaline-P, LDH or V-GTP might happen occasionally. When any abnormalities are observed, treatment should be discontinued if necessary.

Blood

Occurrence of diseases like anemia, leukopenia, or eosinophilia is infrequent while thrombocytopenia is rare.

Gastrointestinal

Diarrhea, constipation, abdominal distension and dry mouth can be observed.

Psychoneurotic

Headache and sleepiness occur infrequently while insomnia and dizziness rarely happens.

Other Side Effects

Fever as well as elevation of total cholesterol and uric acid might be observed.

Overdosage and Treatment

Information on the effect of overdosage is not available. Appropriate symptomatic and supportive therapy should be given if overdosage occurred.

Storage

Store in a dry place (below 30°C). Protect from light.

Shelf-life

2 years

Package quantities

Strip pack of 1x10's, 3x10's, 5x10's and 10x10's.