TIME Pharmaceuticals : Touching Lives, Delivering Promises
"स्वस्थ नेपाल हाम्रो अभियान; गुणस्तरीय औषधि हाम्रो पहिचान"
TIME Pharmaceuticals: Thrive For Effectiveness
Generic Name
Composition
Therapeutic Category
Division
Omeprazole
Omeprazole 20mg Capsules
Proton Pump Inhibitor
TIME
| BRAND | COMPOSITION | DESCRIPTION |
|---|---|---|
| ULSEF |
Each capsule contains: Omeprazole BP (As enteric coated pellets) 20mg |
Cream coloured pellets filled in Plain Hard Gelatin Capsule (size 2) having yellow body and yellow cap. |
PATIENT INFORMATION |
|---|
|
PATIENT INFORMATION Food Interaction: Absorption may be delayed. St John's wort decreases omeprazole levels. Ethanol may cause gastric mucosal irritation. Administration: Should be taken before meal. Pregnancy:Category C Omeprazole can pass into the breast milk and harm the nursing baby. Do not breast feed while taking omeprazole. Storage: Store capsules between 15-30°C protected from light. Missed dose:Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose |
PHARMACOLOGY
Pharmacotherapeutic Group:Proton Pump Inhibitor
Pharmacodynamic Properties:Omeprazole is a substituted benzimidazole gastric antisecretory agent and is also known as PPI. It blocks the final step in gastric acid secretion by specific inhibition of H+/K+ ATPase enzyme system present on the secretory surface of the gastric parietal cell. Both basal and stimulated acid are inhibited.
Pharmacokinetic Properties:
Absorption: Rapid but variably absorbed (oral). Bioavailability: Oral: Approx 30-40%. Time to peak plasma concentration: Approx 1-2 hr.Onset: Approximately 1 hour. Duration: Upto 72 hour.
Distribution:Plasma protein binding: Approximately 95%
Metabolism: Hepatic metabolism via CYP2C19 isoenzyme to form hydroxyl-omeprazole and CYP3A4 to form omeprazole sulfone.
Excretion: Mainly via urine (approx 77%), the remainder in faeces (via the bile). Elimination half-life: 0.5-3 hr
INDICATIONS
Gastroesophageal reflux disease (GERD), acid related dyspepsia, H. pylori infection, drug induced gastric ulceration, Zollinger Ellison syndrome
DOSAGE & ADMINISTRATION
Peptic Ulcer: 20 or 40 mg/day in severe cases for 4 weekk (duodenal ulcer) or for 8 week (gastric ulcer). NSAID associated ulceration: 20 mg once in the morning.Gastro-esophageal reflux disease: 20 mg/day for 4 week may continue for another 4-8 week if necessary.
ADVERSE DRUG REACTIONS
Diarrhoea, nausea, constipation, abdominal pain, vomiting, headache, flatulence.
PRECAUTIONS
Gastric malignancy should be ruled out. Pregnancy, lactation, children <1 yr.
DRUG INTERACTIONS
Increased risk of hypomagnesaemia with diuretics. May increase International Normalized Ratio (INR) and prothrombin time with warfarin. May reduce the antiplatelet effect of clopidogrel. Increased risk of digoxin-induced cardiotoxic effects. May increase plasma concentration benzodiazepines (e.g. diazepam), clarithromycin and methotrexate. Decreased absorption of itraconazole, ketoconazole, posaconazole, dasatinib, iron salts. May decrease plasma concentration and pharmacological effects of rilpivirine, nelfinavir and atazanavir.
CONTRAINDICATIONS
Known hypersensitivity to omeprazole, any ingredient in the formulation, or esomeprazole or other substituted benzimidazoles.
PRESENTATION
ULSEF: Each box contains 20 Strips of 10 Tablets per strip
