Risek/Risek Insta

Risek/Risek Insta

omeprazole

Manufacturer:

Getz Pharma

Distributor:

Getz Bros
Concise Prescribing Info
Contents
Risek Omeprazole. Risek Insta Per 20 mg/1,680 mg powd for oral susp Omeprazole 20 mg, Na bicarbonate 1,680 mg. Per 40 mg/1,680 mg powd for oral susp Omeprazole 40 mg, Na bicarbonate 1,680 mg
Indications/Uses
Risek Treatment of duodenal ulcer, gastric ulcer, H. pylori-associated PUD, reflux esophagitis & Zollinger-Ellison syndrome. GERD, maintenance of healed erosive esophagitis, NSAID-associated ulcer, acid aspiration. Risek Insta Treatment of duodenal & gastric ulcers, GERD (symptomatic GERD, erosive esophagitis & maintenance of erosive esophagitis healing).
Dosage/Direction for Use
Risek cap Duodenal ulcer 20 mg once daily for 2-4 wk. Gastric ulcer & reflux esophagitis 20 mg once daily w/ amoxicillin 1.5-3 g daily in divided doses for 2 wk. Zollinger-Ellison syndrome 60 mg once daily. Doses >80 mg should be divided & administered bid. Risek inj GERD, PUD, NSAID-associated ulcer 40 mg IV once daily. Zollinger-Ellison syndrome Initially 60 mg IV daily & dose adjusted individually. Dose >60 mg given bid. Prophylaxis of acid aspiration 40 mg IV completed 1 hr pre-op. Eradication of H. pylori 40 mg daily combined w/ antibacterials in dual therapy or omeprazole 20 mg bid w/ antibacterials in triple therapy. Risek Insta Adult & childn (≥18 yr) Short-term treatment of active duodenal ulcer 20 mg for 4 wk. Benign gastric ulcer 40 mg for 4-8 wk. Reduction of risk of upper GI bleeding in critically ill patient Initially 40 mg (oral susp only) followed by 40 mg 6-8 hr later; 40 mg daily thereafter for 14 days. May require additional 4 wk therapy. GERD: Symptomatic GERD (w/ no esophageal erosions) 20 mg for 4 wk. Erosive esophagitis 20 mg for 4-8 wk. May give an additional 4 wk of therapy; if there is recurrence consider 4-8 wk treatment. Maintenance of healing of erosive esophagitis 20 mg. All doses to be taken once daily.
Administration
Should be taken on an empty stomach: Take 30 min-1 hr before meals. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to substituted benzimidazoles. Risek Insta Patients w/ metabolic alkalosis & hypercalcemia. Lactation.
Special Precautions
Symptomatic response to therapy does not preclude presence of gastric malignancy. Pregnancy. Risek Hepatic impairment. Lactation. Risek Insta Omeprazole: Atropic gastritis in long-term therapy. Patient in Na-restricted diet. Na bicarbonate: Patients w/ Bartter's syndrome, hypokalemia, resp alkalosis, acid-base imbalance. Long-term use may cause milk-alkali syndrome w/ Ca or milk.
Adverse Reactions
Rash, vertigo. Risek Headache, diarrhea, constipation, abdominal pain, nausea/vomiting & flatulence. Increased liver enzymes, urticaria &/or pruritus, dizziness, paresthesia, somnolence, insomnia & malaise. Risek Insta Chest pain or angina, tachycardia, bradycardia, palpitation, elevated BP, peripheral edema; pancreatitis, anorexia, irritable colon, flatulence, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, dry mouth, stomatitis; hyponatremia, hypoglycemia, wt gain; muscle cramps, myalgia, muscle weakness, joint & leg pain; (depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, tremors, apathy, somnolence, anxiety, dream abnormalities, paresthesia, hemifacial dysesthesia) psychic disturbances; epistaxis, pharyngeal pain; tinnitus, taste perversion; blurred vision, ocular irritation, dry eye syndrome, optic atrophy, anterior ischemic neuropathy, optic neuritis, double vision; interstitial nephritis, UTI, microscopic pyuria, urinary frequency, elevated serum creatinine, proteinuria, hematuria, glycosuria, testicular pain, gynecomastia.
Drug Interactions
Omeprazole: Prolong elimination of diazepam, warfarin & phenytoin. Increased INR & prothrombin w/ warfarin. Risek Clarithromycin; ketoconazole, itraconazole, citalopram, imipramine, clomipramine. Risek Insta Omeprazole: Other drugs metabolized via CYP450 system (eg, cyclosporine, disulfiram, benzodiazepines). May interfere absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, ampicillin esters & Fe salts). Reduced plasma levels of atazanavir. Increased serum levels of tacrolimus; plasma levels w/ clarithromycin & 14-hydroxy-clarithromycin.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
Risek cap 20 mg
Packing/Price
14's (P539/pack)
Form
Risek cap 40 mg
Packing/Price
14's (P762.3/pack)
Form
Risek powd for inj 40 mg
Packing/Price
1's (P756.8/vial)
Form
Risek Insta 20 mg/1,680 mg powd for oral susp
Packing/Price
4 g x 10 × 1's (P363/box)
Form
Risek Insta 40 mg/1,680 mg powd for oral susp
Packing/Price
4 g x 10 × 1's (P484/box)
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