Each capsule contains: Lansoprazole enteric coated pellets 344.825 mg
equivalent to Lansoprazole 30 mg. Colours used in capsule shell: Brilliant
Blue &Titanium Dioxide.
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.
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
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.
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
Lansoprazole is indicated in the treatment of duodenal ulcer, benign gastric
ulcer, reflux oesophagitis and Zollinger Ellison Syndrome.
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
- 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
- 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
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
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
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
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