ANSO Package Insert - Shaigan

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ANSO Package Insert Short-Term Treatment of Active Duodenal Ulcer Lansoprazole is indicated for short-term treatment (up to 4 weeks) for healing and symptom relief of active duodenal ulcer. H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole/amoxicillin/clarithromycin Lansoprazole in combination with amoxicillin plus clarithromycin as triple therapy is indicated for thetreatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.) Dual Therapy: Lansoprazole/amoxicillin Lansoprazole in combination with amoxicillin as dual therapy is indicated for the treatment of patientswith H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin isknown or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradicationof H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICALSTUDIES and DOSAGE AND ADMINISTRATION.) Maintenance of Healed Duodenal Ulcers Lansoprazole is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months. Short-Term Treatment of Active Benign Gastric Ulcer Lansoprazole is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer. Healing of NSAID-Associated Gastric Ulcer Lansoprazole is indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks. Risk Reduction of NSAID-Associated Gastric Ulcer Lansoprazole is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks. Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD Lansoprazole is indicated for the treatment of heartburn and other symptoms associated with GERD.Short-Term Treatment of Erosive Esophagitis Lansoprazole is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with Lansoprazole for 8 weeks (5-10%), it may be helpful to give an additional 8 weeks of treatment.If there is a recurrence of erosive esophagitis an additional 8-week course of Lansoprzole refer to full prescribing information for amoxicillin before prescribing.) Clarithromycin is contraindicated in patients with a known hypersensitivity to any macrolide antibiotic, and in patients receiving terfenadine therapy who have preexisting cardiac abnormalities or electrolyte disturbances. (Please refer to full prescribing information for clarithromycin before prescribing.) WARNINGS CLARITHROMYCIN SHOULD NOT BE USED IN PREGNANT WOMEN EXCEPT IN CLINICAL CIRCUMSTANCES WHERE NO ALTERNATIVE THERAPY OCCURS WHILE TAKING CLARITHROMYCIN, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. (SEE WARNINGS IN PRESCRIBING INFORMATION FOR CLARITHROMYCIN.) Drug Interactions Lansoprazole is metabolized through the cytochrome P450 system, specifically through the CYP3A and CYP2C19 isozymes. Studies have shown that lansoprazole does not have clinically significant interactions with other drugs metabolized by the cytochrome P450 system, such as warfarin, antipyrine,indomethacin, ibuprofen, phenytoin, propranolol, prednisone, diazepam, or clarithromycin in healthy subjects. These compounds are metabolized through various cytochrome P450 isozymes including CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A. When lansoprazole was administered concomitantly with theophylline (CYP1A2, CYP3A), a minor increase (10%) in the clearance of theophylline was seen. Nursing Mothers Lansoprazole or its metabolites are excreted in the milk of rats. It is not known whether lansoprazole is excreted in human milk. Because many drugs are excreted in human milk, because of the potential for serious adverse reactions in nursing infants from lansoprazole, and because of the potential for tumorigenicity shown for lansoprazole in rat carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The safety and effectiveness of Lansoprazole have been established in the age group 1 year to 11 years for short-term treatment of symptomatic GERD and erosive esophagitis. Safety and effectiveness have not been established in patients < 1 year or 12-17 years of age.Use of Lansoprazole in the age group 1 year to 11 years is supported by evidence from adequate and well controlled studies of lansoprazole in adults with additional clinical, pharmacokinetic, pharmacodynamic, and safety studies performed in pediatric patients. In an uncontrolled, open-label, U.S. multicenter study, 66 pediatric patients (1 to 11 years of age) with GERD were assigned, based on body weight, to receive an initial dose of either lansoprazole 15 mg q.d. if < 30 kg or lansoprazole 30 mg q.d. if > 30 kg administered for 8 to 12 weeks. DOSAGE AND ADMINISTRATION
ANSO Package Insert Lansoprazole Delayed-Release Capsules should be taken before eating. In the clinical trials, antacids were used concomitantly with Lansoprazole. No dosage adjustment is necessary in patients with renal insufficiency or the elderly. For patients with severe liver disease, dosage adjustment should be considered. OVERDOSAGE Oral doses up to 5000 mg/kg in rats (approximately 1300 times the recommended human dose based on body surface area) and mice (about 675.7 times the recommended human dose based on body surface area) did not produce deaths or any clinical signs. Lansoprazole is not removed from the circulation by hemodialysis. In one reported case of overdose,the patient consumed 600 mg of lansoprazole with no adverse reaction. DOSAGE AND ADMINISTRATION PEDIATRIC USE Maintenance of Healing of Erosive Esophagitis 15 mg Once daily CLINICAL STUDIES Pathological Hypersecretory Conditions Including Zollinger-Ellision Syndrome 60 mg Once daily*** CLINICAL STUDIES . Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.* Controlled studies did not extend beyond indicated duration. ** For patients who do not heal with Lansoprazole for 8 weeks (5.10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8week course of Lansoprazole may be considered Lansoprazole should be taken before eating. Lansoprazole Capsules-Oral Administration Lansoprazole Delayed-Release Capsules should be swallowed whole. The capsule should not be chewed or crushed.Lansoprazole is not known to effect ability to drive or operate machine. Presentation: ANSO 15mg in Alu-Alu Blister pack of 10’ capsules (2x5’s) ANSO 30mg in Alu-Alu Blister packs of 14 capsules (2x7’s) Storage:Protect from moisture,freezing,excessive heat and sunlight. keep out of the reach of children. Manufactured by: Shaigan Pharmaceauticals (pvt) Ltd 14km,Adyala Road,P.O,Dahgal,Rawalpindi-Pakistan
Page 1: ANSO Package Insert ANSO TM Capsule

ANSO Package Insert - Shaigan

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