Seclotil 20 - capsule Omeprazole - 20mg 10 Capsule(s) / Strip Pristine Pharmaceuticals Ltd Introduction: Seclotil 20 is a medicine that reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine such as heartburn, acid reflux, peptic ulcer disease, and some other stomach conditions associated with excessive acid production. Seclotil 20 is also used to prevent stomach ulcers and acidity that may be seen with the prolonged use of pain-killers. It belongs to a class of medicines known as proton pump inhibitors (PPIs). This medicine should be taken one hour before a meal, preferably in the morning. The dose will depend on your underlying... Uses of Seclotil 20: Gastroesophageal reflux disease (Acid reflux)Peptic ulcer disease Side effects of Seclotil 20: DiarrheaFlatulenceHeadacheNauseaStomach painVomiting How to use Seclotil 20: Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Seclotil 20 is to be taken empty stomach. How Seclotil 20 works: Seclotil 20 is a proton pump inhibitor (PPI). It works by reducing the amount of acid in the stomach which helps in relief of acid related indigestion and heartburn. What if you forget to take Seclotil 20?: If you miss a dose of Seclotil 20, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose. Indication: Peptic ulcer, H. pylori infection, Gastro-oesophageal reflux disease, Zollinger-Ellison syndrome, Oesophagitis, Acid-related dyspepsia, NSAID-associated ulceration Administration: Delayed-release cap: Should be taken on an empty stomach. Take at least 1 hr before meals. Swallow whole, do not chew/crush. For patients w/ difficulty swallowing, cap may be carefully opened & entire contents sprinkled in a spoonful of applesauce. Swallow drug/food mixt w/o chewing immediately after prep. Drug/food mixt should not be stored for future use. Powd for oral susp: Should be taken on an empty stomach. Take on an empty stomach at least 1 hr before a meal. MUPS tab: May be taken with or without food. Cap: Should be taken with food. Take immediately before a meal. Adult Dose: Oral Peptic ulcer Adult: 20 or 40 mg/day in severe cases for 4 wk (duodenal ulcer) or for 8 wk (gastric ulcer). Maintenance: 10-20 mg/day. All doses to be taken once in the morning. NSAID-associated ulceration Adult: 20 mg once in the morning. Gastro-oesophageal reflux disease Adult: 20 mg/day for 4 wk may continue for another 4-8 wk if necessary. Refractory oesophagitis: 40 mg/day. Maintenance: 20 mg/day (after healing of oesophagitis); 10 mg/day (acid reflux). All doses to be taken once in the morning. Zollinger-Ellison syndrome Adult: Initially, 60 mg once in the morning, adjust as required. Dose Range: 20-120... Child Dose: Oral GERD Indicated for treatment of GERD 1 year 5-10 kg: 5 mg PO qDay 10-20 kg: 10 mg PO qDay >20 kg: 20 mg PO qDay Erosive Esophagitis Indicated for treatment and to maintain healing of erosive esophagitis caused by acid-mediated GERD 10 kg: 10 mg qDay May treat for up to 6 weeks Aged 1-16 years 5 to 20 kg: 20 mg PO qDay May treat for 4-8 weeks Renal Dose: Renal impairment: No dosage adjustment needed. Contraindication: Known hypersensitivity to any of its component. Mode of Action: 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. Precaution: Gastric malignancy should be ruled out. Pregnancy, lactation, childn <1 yr. Monitoring Parameters Monitor Mg concentrations prior to initiation and periodically thereafter. Lactation Risk Summary Limited data suggest omeprazole may be present in human milk; there are no clinical data on effects of omeprazole on breastfed infant or on milk production; developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition Side Effect: 1-10% Headache (7%),Abdominal pain (5%),Diarrhea (4%),Nausea (4%),Vomiting (3%),Flatulence (3%),Dizziness (2%),Upper respiratory infection (2%),Acid regurgitation (2%),Constipation (2%),Rash (2%),Cough (1%) Frequency Not Defined Fracture of bone, osteoporosis-related,Hepatotoxicity (rare),Agranulocytosis,Anorexia,Gastric polyps,Hip fracture,Alopecia,Atrophic gastritis,Interstitial nephritis (rare),Pancreatitis (rare),Rhabdomyolysis,Taste perversion,Abnormal dreams,Toxic epidermal necrolysis (rare) Potentially Fatal: Anaphylaxis. Pregnancy Category Note: Risk Summary There are no adequate and well-controlled studies with Omeprazole in pregnant women. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole (an enantiomer of omeprazole) magnesium in rats and rabbits during organogenesis with... Interaction: Increased risk of hypomagnesaemia w/ diuretics. May increase INR and prothrombin time w/ warfarin. 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 prolong elimination of diazepam, cilostazol, phenytoin and ciclosporin. May reduce the antiplatelet effect of clopidogrel. Potentially Fatal: May decrease plasma concentrations and pharmacological effects of rilpivirine, nelfinavir and atazanavir.