omeprazole, clarithromycin, amoxicillin (Omeclamox-Pak)

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Trade Name: Omeclamox-Pak

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Cumberland Pharmaceuticals Inc.

Presentation: KIT, HUMAN PRESCRIPTION DRUG

Storage and handling

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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OMECLAMOX-PAK, a co-packaged product containing omeprazole, a proton pump inhibitor, clarithromycin, a macrolide antimicrobial, and amoxicillin, a penicillin class antibacterial, is indicated for the treatment of patients with infection and duodenal ulcer disease (active or up to one-year history) to eradicate . ()n
To reduce the development of drug-resistant bacteria and maintain the effectiveness of OMECLAMOX-PAK and other antibacterial drugs, OMECLAMOX-PAK should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ()n

The recommended adult oral dose and regimen is omeprazole delayed-release capsules 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg, each given twice daily, for 10 days, in the morning and evening before eating a meal. Inform patients that omeprazole, clarithromycin, and amoxicillin should not be crushed or chewed, and should be swallowed whole.n
In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.n

Adult regimen: omeprazole 20 mg plus clarithromycin 500 mg plus amoxicillin 1000 mg, each given twice daily for 10 days in the morning and evening before eating a meal. ()n
Advise patients to swallow all tablets and capsules whole. ()n
In patients with an ulcer present at initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended. ()n

OMECLAMOX-PAK is supplied in a carton containing ten individual daily administration cards. Each card contains:n
Two opaque, hard gelatin lavender and grey capsules, with u2018R 158u2019 and u2018OMEPRAZOLE 20 mgu2019 imprinted on the capsules in black ink, containing off-white to pale-yellow, elliptical spherical pellets.n
Two white, biconvex beveled-edge capsule-shaped coated tablets debossed with u201854 312u2019 on one side and plain on the other side.n
Four opaque hard gelatin yellow capsules, marked u2018GG849u2019.n
Pack of 10 daily administration cards for morning and evening dosing, each containing ():n

Two omeprazole delayed-release capsules, USP, 20 mg.n
Two clarithromycin tablets, USP, 500 mg.n
Four amoxicillin capsules, USP, 500 mg.n

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Known hypersensitivity to omeprazole, any macrolide antibiotic, any penicillin, or any component of the formulations. ()n
Coadministration with pimozide, ergotamine or dihydroergotamine. (, , )n

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Embryo-Fetal Toxicity: Based on animal findings for omeprazole and clarithromycin, OMECLAMOX-PAK may cause fetal harm. OMECLAMOX-PAK is not recommended for use in pregnant women except in clinical circumstances when there is no appropriate alternative therapy. ()n
Colchicine interaction: Concomitant use of clarithromycin and colchicine has resulted in deaths, especially in the elderly with renal insufficiency. Monitor patients for clinical symptoms of colchicine toxicity. (, )n
Myasthenia gravis: Exacerbation of symptoms and new onset of symptoms reported with clarithromycin. Monitor patients for symptoms. ()n
Clostridioides difficile
Risk of gastric malignancy: Symptomatic response does not preclude concomitant underlying malignancy. ()n
otAcute Tubulointerstitial Nephritis: has been observed in patients taking proton pump inhibitors (PPIs), including omeprazole. Discontinue OMECLAMOX-PAK and evaluate patients ()n
Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue OMECLAMOX- PAK and evaluate ()n

The following serious adverse reactions are described elsewhere in the labeling:n
Most frequent adverse reactions (> 7%) with triple therapy were diarrhea, taste perversion, and headache. ()n
To report SUSPECTED ADVERSE REACTIONS, contact Cumberland Pharmaceuticals Inc. at 1-877-484-2700 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Antiarrhythmics: Risk of torsades de pointes and other arrhythmias with concurrent use of clarithromycin and quinidine, disopyramide, and digoxin. Monitor ECGs and serum digoxin concentrations. ()n
Oral anticoagulants: Concomitant administration of omeprazole or clarithromycin may potentiate the anticoagulant effects of warfarin and other oral anticoagulants. Monitor prothrombin times and INR. ()n
Atazanavir and nelfinavir: Omeprazole reduces plasma concentrations of atazanavir and nelfinavir. Concomitant use is not recommended. ()n
Saquinavir: Omeprazole increases plasma concentrations of saquinavir. Monitor for toxicity and consider dose reduction of saquinavir. ()n
Cilostazol: Omeprazole increases systemic exposure of cilostazol and one of its active metabolites. Consider dose reduction of cilostazol. ()n
Tacrolimus: Omeprazole may increase serum concentrations of tacrolimus. Frequently monitor whole blood trough concentrations of tacrolimus. ()n
Theophylline: Clarithromycin may increase serum concentrations of theophylline. Monitor serum theophylline concentrations. ()n
Carbamazepine: Clarithromycin may increase plasma concentrations of carbamazepine. Monitor blood concentrations of carbamazepine. ()n
Sildenafil: Clarithromycin may increase systemic exposure of sildenafil. Consider dose reduction of sildenafil. ()n
HMG-CoA reductase inhibitors (statins): Clarithromycin may alter the effect of HMG-CoA reductase inhibitors (statins). ()n
Drugs metabolized by cytochrome P450 (e.g., diazepam, warfarin, phenytoin, cyclosporine, disulfiram, benzodiazepines): Omeprazole can prolong their elimination. Monitor and determine need for dose adjustments. (, )n
Probenecid: Probenecid may increase blood concentrations of the amoxicillin. ()n
Omeprazole may interfere with drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, ampicillin esters, digoxin, and mycophenolate mofetil). ()n

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Hepatic Impairment: Avoid use ()n
Asian Patients: Avoid use unless it is deemed that the benefits outweigh the risks. ()n

In case of an overdose, patients should contact a physician, poison control center, or emergency room. There is neither a pharmacologic basis nor data suggesting an increased toxicity of the combination compared to individual components.n
As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose, contact your local Poison Control Center at 1-800-222-1222.n

OMECLAMOX-PAK consists of a pack of ten individual daily administration cards, each card containing two omeprazole delayed-release 20 mg capsules, USP, two clarithromycin 500 mg tablets, USP, and four amoxicillin 500 mg capsules, USP, for oral administration.n

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Three U.S., randomized, double-blind clinical studies in patients with infection and duodenal ulcer disease (n = 558) compared omeprazole plus clarithromycin plus amoxicillin with clarithromycin plus amoxicillin. Two studies (1 and 2) were conducted in patients with an active duodenal ulcer, and the other study () was conducted in patients with a history of a duodenal ulcer in the past 5 years but without an ulcer present at the time of enrollment. The dose regimen in the studies was omeprazole 20 mg twice daily plus clarithromycin 500 mg twice daily plus amoxicillin 1 g twice daily for 10 days; or clarithromycin 500 mg twice daily plus amoxicillin 1 g twice daily for 10 days. In studies 1 and 2, patients who took the omeprazole regimen also received an additional 18 days of omeprazole 20 mg once daily. Endpoints studied were eradication of and duodenal ulcer healing (studies 1 and 2 only). status was determined by CLOtest, histology and culture in all three studies. For a given patient, was considered eradicated if at least two of these tests were negative and none was positive.n
The combination of omeprazole plus clarithromycin plus amoxicillin, was effective in eradicating n

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OMECLAMOX-PAK is supplied in a carton containing ten individual daily administration cards. Each card contains the morning dose and the evening dose of the following three drugs:n
Omeprazole Delayed-Release Capsules, USP, 20 mgn
Clarithromycin Tablets, USP, 500 mgn
Amoxicillin Capsules, USP, 500 mgn
Store at controlled room temperature between 20u00b0C and 25u00b0C (68u00b0F and 77u00b0F). Protect from light and moisture.n

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of omeprazole, clarithromycin, amoxicillin (Omeclamox-Pak) which is also known as Omeclamox-Pak and Manufactured by Cumberland Pharmaceuticals Inc.. It is available in strength of .

omeprazole, clarithromycin, amoxicillin (Omeclamox-Pak) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.