PHARMACOLOGICAL PROPERTIES:
Lansoprazole is a member of class of drugs belonging to proton pump inhibitors, Wezol suppresses the secretion of gastric acid by the irreversible inhibition of the enzyme system H+ / K + ATPase( also called proton pump), of the parietal cells in the stomach, the final step in the acid production thus reducing gastric acidity, a key requirement for healing of acid related disorders. WEZOL (Lansoprazole) has a prolonged pharmacological action providing effective acid suppression over 24 hours thereby promoting rapid healing and symptoms relief.
Pharmacokinetic properties:
WEZOL (Lansoprazole) provides high (60% to 90%) bioavailability with a single or multiple doses. Peak plasma levels are obtained within 1.5 to 2 hours. The plasma half-life ranges from 1 to 2 hours following Single or multiple doses.
WEZOL is 97% bound to plasma protein.
WEZOL (Lansoprazole) is excreted by renal and biliary route in approximately equal quantities.
Description | Wt/Vol |
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Wezol 30 mg Cap |
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Each Capsule Contains: | |
Lansoprazole USP | 30 mg |
Short terms treatment of active duodenal ulcer Active benign Gastric Ulcer Gastroesophageal Reflux Disease Pathological Hyper-secretory conditions e.g., Zollinger Ellison syndrome Eradication of H:pylori in patients with peptic ulcer when used in combination with antibiotics like Clarithromycin, Amoxicillin and Metronidazole |
Gastroesophageal Reflux Disease (GERD) Usual dosage of WEZOL capsule is 30mg once daily for 4 weeks. A further 4 week treatment at the same dosage may be continued in poorly responsive patients. Maintenance dose: 15 - 30mg once daily. DUODENAL ULCER WEZOL Cap 30mg daily for 4 weeks. For prevention of relapse, the recommended maintenance dose is 15mg once daily. GASTRIC ULCER: WEZOL 30mg daily for 8 weeks. Maintenance dose: 15 - 30mg once daily. Maintenance treatment should not be continued for more than one year unless considered essential by the prescribing physician. ZOLLINGER-ELLISON SYNDROME WEZOL 60mg once daily, and then dosage should be adjusted individually. For patients who require 120mg or more per day the dose should be divided and given twice daily. H. PYLORI ERADICATION The following combinations have been shown to be effective: WEZOL (Lansoprazole) 30mg plus CLARIWEB (Clarithromycin) 500mg and Amoxicillin 1gm all given twice daily or WEZOL (LANSOPRAZOLE) 30mg plus, CLARIWEB (Clarithromycin) 250mg and Metronidazole 400mg all given twice daily for 7-14 days. ADMINISTRATION WEZOL should be taken once daily, except when used in combination to eradicate H. pylori. For optimal inhibitory effects WEZOL should be administered in the morning before meal. Elderly: Dose adjustment not required in the elderly. IMPAIRED HEPATIC AND RENAL FUNCTION: Lansoprazole is metabolized substantially by the liver. Clinical trials in patients with liver disease indicate that metabolism of Lansoprazole is prolonged however no dose adjustment is necessary but dose should not exceed the recommended dose. There is no need to alter the dosage in patients with impaired renal function. Children: There is no experience with WEZOL (Lansoprazole) in children. |
The possibility of malignancy should be excluded before initiating WEZOL therapy, since the drug may alleviate.the symptoms and delays the diagnosis. When prescribing WEZOL for eradication of H. pylori, possible drug interactions with other components of regimen should be considered. WEZOL (Lansoprazole) should be used with caution in patients with severe hepatic impairment |
Generally WEZOL (Lansoprazole) is well tolerated and adverse events are usually of mild and transient nature. The most common side effects reported are headache, dizziness, fatigue and malaise. Gastrointestinal effects include diarrhea, constipation, abdominal pain dyspepsia, nausea, vomiting, flatulence and dry or sore mouth and throat. Dermatological reactions includes skin rashes, urticaria and pruritis. Other hypersensitivity reactions include angioedema, wheezing and very rarely anaphylaxis. Hematological effects like thrombocytopenia, eosinophilia, leucopenia and pancytopenia have occurred rarely. Bruising, purpura and petechiae have also been reported. Other reactions include arthralgia, myalgia, depression, peripheral edema and rarely paraesthesia, visual disturbance, vertigo, confusion. Gynaecomastia and impotence have been reported rarely. |
Generally WEZOL (Lansoprazole) is well tolerated and adverse events are usually of mild and transient nature. The most common side effects reported are headache, dizziness, fatigue and malaise. Gastrointestinal effects include diarrhea, constipation, abdominal pain dyspepsia, nausea, vomiting, flatulence and dry or sore mouth and throat. Dermatological reactions includes skin rashes, urticaria and pruritis. Other hypersensitivity reactions include angioedema, wheezing and very rarely anaphylaxis. Hematological effects like thrombocytopenia, eosinophilia, leucopenia and pancytopenia have occurred rarely. Bruising, purpura and petechiae have also been reported. Other reactions include arthralgia, myalgia, depression, peripheral edema and rarely paraesthesia, visual disturbance, vertigo, confusion. Gynaecomastia and impotence have been reported rarely. |
Wezol affects the metabolism of the drugs metabolized via P 450 system. It therefore increases plasma concentration of the drugs metabolized through this system, e.g. diazepam, phenytoin, warfarin, theophyllin, etc. The concomitant use of Wezol with these drugs should be avoided. Antacid and Sucralfate may reduce the bioavailability of Lansoprazole and should be taken one hour before or after the administration of WEZOL |
Wezol is contraindicated in patients with a known history of hypersensitivity to the drug or any ingredient of the formulation. |
There is no information on the effect of over-dosage, however, 120mg/day in divided dosage has no adverse effects. |
WEZOL 30mg capsules are available in 2x7 blister pack. |
There is insufficient experience with Lansoprazole in pregnancy however animal studies do not reveal any teratogenic effect. Animal studies indicate that Lansoprazole is excreted in breast milk. The use of WEZOL (Lansoprazole) should be avoided unless considered essential. |