Indications & Dose:
Adults:
Active Dudenal Ulcer:
20mg/1100mg per day for 4-8 weeks.
Active GastricUlcer:
40mg/1100mg per day for 4-8 weeks.
Symptomaic GRED:
20mg/1100mg per day for 4 weeks.
Active Errosive esophagitis:
20mg/1100mg per day for 4-8 weeks.; maintanance healing ; 20/1100mg per day upto 12 months
Contraindications:
Hypersensitivity (anaphylaxis, anaphylacticshock, angioadema & urticaria)” to any components of the formulation.
Side Effects:
Cautions:
Precautions:
General:Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole.
Patients on Sodium restricted diet:Patients of sodium restricted diet or at risk of developing congestive heart failure (CHF) should be informed of the sodium content of Omeprazole + Sodium bi carbonate
Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia.
Sodium bicarbonate should be used with caution in patients with Barter’s J syndrome, hypokalemia, respiratory alkalosis, and problems with acid-1 base balance. Long-term administration of bicarbonate with c or milk can cause milk-alkali syndrome.
Pregnancy:Pregnancy Category C:
There are no adequate and well-controlled studies on the use of omeprazole in pregnant women.
Nursing Mothers: should be used with caution in nursing mothers.
Pediatric Use: no adequate and well-controlled studies in pediatric patients with omeprazole and sodium Bicrbonate combination.
Geriatric Use: no dosage adjustment is necessary in the elderly.
Interaction:
See under Omeprazole and Sodium bi carbonate
Warnings:
Adverse Effects:
Lactations:
Special Precautions:
Counselling:
Side Effects Or Adverse Reactions:
Body As a Whole: Allergic reactions, including, rarely, anaphylaxis (see also Skin below), fever, pain, fatigue, malaise, abdominal swelling.
Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitation, elevated blood pressure, and peripheral edema.
Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, flatulence, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, dry mouth, stomatitis. During treatment with omeprazolei gastric fundic gland polyps have been noted rarely These polyps are benign and appear to be reversible when treatment is discontinued. Gastroduodenal carcinoids have been reported in patients with Zollinger-Ellison syndrome on long-term treatment with omeprazole. This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors.
Hepatic: Mild and, rarely, marked elevations of liver function tests [ALT (SGPT), AST (SGOT), v-glutamyl transpeptidase, alkaline phosphatase, and bilirubin (jaundice)]. In rare instances, overt liver disease has occurred, including hepatocellular, cholestatic, or mixed hepatitis, liver necrosis (some fatal), hepatic failure (some fatal), and hepatic encephalopathy.
Metabolic/Nutritional: Hyponatremia, hypoglycemia, and weight gain.
Musculoskeletal: Muscle cramps, myalgia, muscle weakness, joint pain, and leg pain.
Nervous System/Psychiatric: Psychic disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, tremors, apathy, somnolence, anxiety, dream abnormalities; vertigo; paresthesia; and hemifacial dysesthesia.
Respiratory: Epistaxis, pharyngeal pain.
Skin: Rash and rarely, cases of severe generalized skin reactions including toxic epidermal necrolysis (TEN; some fatal), Stevens-Johnson syndrome, and erythema multiforme (some severe); purpura and/or petechiae (some with rechallenge); skin inflammation, urticaria, angioedema, pruritus, photosensitivity, alopecia, dry skin, and hyperhidrosis.
Special Senses: Tinnitus, taste perversion.
Ocular: Blurred vision, ocular irritation, dry eye syndrome, optic atrophy, anterior ischemic optic neuropathy, optic neuritis and double vision.
Urogenital: Interstitial nephritis (some with positive rechallenge), urinary tract infection, microscopic pyuna,urinary frequency, elevated serum creatinine, proteinuria, hematuria, glycosuria, testicular pain, and gynecomastia.
Hematologic: Rare instances of pancytopenia, agranulocytosis (some fatal), thrombocytopenia, neutropenia, leukopenia, anemia, leucocytosis, and hemolytic anemia have been reported.
The incidence of clinical adverse Experiences in patients greater than 65 years of age was similar to that in patients 65 years of age or less. Additional adverse reactions that could be caused by sodium bicarbonate, include metabolic alkalosis, seizures, and tetany.
Patient And Carer Advice:
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