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Lanpro

COMPOSITION
Each capsule contains: Lansoprazole enteric coated pellets 344.825 mg equivalent to Lansoprazole 30 mg. Colours used in capsule shell: Brilliant Blue &Titanium Dioxide.

PRODUCT DESCRIPTION

White to off-white spherical pellets in size '1' capsule with light blue cap and opaque white body with LANPRO printed in black on body and cap.

DESCRIPTION
Lansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that do not exhibit anticholinergic or histamine H2 receptor antagonist properties, but that suppress gastric acid secretion by specific inhibition of the H+- K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.

Following oral administration of lansoprazole 15 mg or 30 mg, inhibition of gastric acid secretion is observed in 2-3 or 1 -2 hours, respectively. The inhibition of gastric acid secretion is dose dependent.

Following discontinuation of therapy gastric acid secretion returns to baseline over a 2 to 4 day period without rebound gastric acidity. When combined with appropriate anti-infectives, lansoprazole may be effective in eradicating H.pylori in patients with this infection.

PHARMACOKINETICS
Absorption of lansoprazole following oral administration of Lanpro capsules begins only after the granules leave the stomach. Absorption is rapid with peak plasma levels of lansoprazole occurring after approximately 1.7 hours. The estimated bioavailability of lansoprazole from enteric coated granules is over 80%.

In healthy subjects the mean plasma half-life is 1.5 hours. Food interferes with absorption of lansoprazole.

Lansoprazole is 97% bound to plasma proteins. It is extensively metabolised in the liver and the metabolites are pharmacologically inactive. Biliary excretion of metabolites is the major elimination pathway for lansoprazole. The elimination half life of lansoprazole increases in the elderly and in patients with various degree of hepatic dysfunction. The half-life and protein binding are decreased in patients with renal insufficiency.

INDICATIONS
Lansoprazole is indicated in the treatment of duodenal ulcer, benign gastric ulcer, reflux oesophagitis and Zollinger Ellison Syndrome.

CONTRAINDICATION
Lanpro (Lansoprazole) is contra-indicated in patients with known hypersensitivity to any component of this formulation.

WARNING AND PRECAUTIONS
- In common with other anti-ulcer therapies, the possibility of malignant gastric tumour should be excluded when treating a gastric ulcer with lansoprazole because lansoprazole can mask the symptoms and delay the diagnosis.

- Lansoprazole should be used with caution in patients with moderate and severe hepatic dysfunction.

- Decreased gastric acidity due to lansoprazole might be expected to increase gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with lansoprazole may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.

- In patients suffering from gastro-duodenal ulcers, the possibility of H. pylori infection as an etiological factor should be considered.

- If lansoprazole is used in combination with antibiotics for eradication therapy of H.pylori, then the instructions for the use of these antibiotics should also be followed.

- Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough risk/benefit assessment should regularly be performed in these patients.

- Very rarely cases of colitis have been reported in patients taking lansoprazole. Therefore, in the case of severe and/or persistent diarrhea, discontinuation of therapy should be considered.

- The treatment for the prevention of peptic ulceration of patients in need of continuous NSAID treatment should be restricted to high risk patients (e.g. previous gastrointestinal bleeding, perforation or ulcer, advanced age, concomitant use of medication known to increase the likelihood of upper GI adverse events [e.g. corticosteroids or anticoagulants], the presence of a serious co-morbidity factor or the prolonged use of NSAID maximum recommended doses).

- Effects on ability to drive and use machines Adverse drug reactions such as dizziness, vertigo, visual disturbances and somnolence may occur. Under these conditions the ability to react may be decreased.

DRUG INTERACTIONS
Drugs with pH-Dependent Absorption Kinetics:
Lanpro causes long-lasting inhibition of gastric acid secretion. Lanpro and other PPIs are likely to substantially decrease the systemic concentrations of the HIV protease inhibitor atazanavir, which is dependent upon the presence of gastric acid for absorption, and may result in a loss of therapeutic effect of atazanavir and the development of HIV resistance. Therefore, Lanpro and other PPIs should not be co-administered with atazanavir.

It is theoretically possible that Lanpro and other PPIs may interfere with the absorption of other drugs where gastric pH is an important determinant of oral bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole).

Warfarin:
In a study of healthy subjects, co-administration of single or multiple 60 mg doses of Lanpro and warfarin did not affect the pharmacokinetics of warfarin nor prothrombin time. However, there have been reports of increased IN R and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.

Theophylline:
A minor increase (10%) in the clearance of theophylline was observed following the administration of Lanpro concomitantly with theophylline. Although the magnitude of the effect on theophylline clearance is small, individual patients may require additional titration of their theophylline dosage when Lanpro is started or stopped to ensure clinically effective blood levels.

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