|Company:||Beacon Pharmaceuticals Ltd.|
Xelopes 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. Xelopes 20 is also used to prevent stomach ulcers and acidity that may be seen with the prolonged use of painkillers. 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 condition and how you respond to the medicine. You should keep on taking it as prescribed even if your symptoms disappear quickly. You can increase the efficiency of the treatment by eating smaller meals more often and avoiding caffeinated drinks (like tea and coffee), and spicy or fatty foods.
The most common side effects observed with this medicine include nausea, vomiting, headache, flatulence, diarrhea, and stomach pain. These symptoms are generally mild but if they bother you or do not go away, consult your doctor. Long-term use of this medicine may lead to an increased risk of side effects. For instance, using this medicine for more than 1 year may increase your risk for bone fractures, especially with higher doses. Talk to your doctor about ways to prevent bone loss (osteoporosis), like taking calcium and vitamin D supplements. Before taking this medicine, you need to tell your doctor if you have severe liver problems or allergic reactions to similar medicines in the past or suffer from bone loss (osteoporosis). Many other medicines may affect, or be affected by, this medicine so let your doctor know about all other medicines you are taking, to make sure it is safe. This is particularly important if you are taking medicines for HIV, fungal infections, tuberculosis, epilepsy (fits), or some types of blood thinners. Pregnant or breastfeeding women should also consult their doctor before taking it.
Uses of Xelopes 20
- Gastroesophageal reflux disease (Acid reflux)
- Peptic ulcer disease
Side effects of Xelopes 20
- Stomach pain
How to use Xelopes 20
Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Xelopes 20 is to be taken empty stomach.
How Xelopes 20 Works
Xelopes 20 is a proton pump inhibitor (PPI). It works by reducing the amount of acid in the stomach which helps in the relief of acid-related indigestion and heartburn.
What if you forget to take Xelopes 20?
If you miss a dose of Xelopes 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.
- It is a well-tolerated medicine and provides relief for a long time.
- Avoid eating late at night or before bedtime.
- Inform your doctor if you get watery diarrhea, fever or stomach pain that does not go away.
- Inform your doctor if you do not feel better after taking it for 14 days as you may be suffering from some other problem that needs attention.
- Long-term use of Xelopes 20 can cause weak bones and a deficiency of minerals such as magnesium. Take adequate dietary intake of calcium and magnesium or supplements as prescribed by your doctor.
- Do not stop taking medication without talking to your doctor.
- Consult your doctor right away if you develop decreased urination, edema (swelling due to fluid retention), lower back pain, nausea, fatigue, and rash or fever. These could be signs of a kidney problem.
Peptic ulcer, H. pylori infection, Gastro-oesophageal reflux disease, Zollinger-Ellison syndrome, Oesophagitis, Acid-related dyspepsia, NSAID-associated ulceration
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, the 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 it immediately before a meal.
Oral Peptic ulcer Adult: 20 or 40 mg/day in severe cases for 4 wk (duodenal ulcer) or 8 wk (gastric ulcer). Maintenance: 10-20 mg/day. All doses are 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 are 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 mg/day. Doses >80 mg are administered in 2 divided doses.
Prophylaxis of acid aspiration during general anesthesia Adult: 40 mg given in the evening and another 40 mg 2-6 hr pre-op. Acid-related dyspepsia Adult: 10 or 20 mg once in the morning for 2-4 wk. Erosive oesophagitis Adult: 20 mg/day for 4-8 wk. Maintenance of healing: 20 mg/day for up to 12 mth. All doses are to be taken once in the morning. H.pylori infection Adult: As triple therapy: 20 mg bid or 40 mg once daily combined w/ amoxicillin 500 mg and metronidazole 400 mg both tid or combined w/ clarithromycin 250 mg and metronidazole 400 mg (or tinidazole 500 mg) both bid or combined w/ amoxicillin 1 g and clarithromycin 500 mg both bid. Duration: 7 or 10 days. As 2-wk dual therapy: 20 mg bid or 40 mg/day combined w/ either amoxicillin 750 mg to 1 g bid or w/ clarithromycin 500 mg tid.
Intravenous Gastro-oesophageal reflux disease; Gastric and duodenal ulcers; NSAID-associated ulceration Adult: 40 mg once daily infused over 20-30 min or slow inj over 5 min until an oral admin is possible. Zollinger-Ellison syndrome Adult: Initially, 60 mg/day, adjust according to response. Daily doses >60 mg/day should be given in 2 divided doses. Elderly: No dosage adjustment is needed. Hepatic impairment: 10-20 mg/day.
Oral GERD Indicated for the treatment of GERD <1 year: Safety and efficacy not established > 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 <1 month: Safety and efficacy not established Aged 1 month to <1 year 3 to <5 kg: 2.5 mg qDay 5 to <10 kg: 5 mg qDay >10 kg: 10 mg qDay May treat for up to 6 weeks Aged 1-16 years 5 to <10 kg: 5 mg PO qDay 10 to <20 kg: 10 mg PO qDay >20 kg: 20 mg PO qDay May treat for 4-8 weeks
Renal impairment: No dosage adjustment is needed.
Known hypersensitivity to any of its components.
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 the H+/K+ ATPase enzyme system present on the secretory surface of the gastric parietal cell. Both basal and stimulated acids are inhibited.
Gastric malignancy should be ruled out. Pregnancy, lactation, child <1 yr. Monitoring Parameters Monitor Mg concentrations before initiation and periodically thereafter. Lactation Risk Summary Limited data suggest omeprazole may be present in human milk; there are no clinical data on the effects of omeprazole on breastfed infants or milk production; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from treatment or the underlying maternal condition
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 doses about 68 times and 42 times, respectively, an oral human dose of 40 mg esomeprazole or 40 mg omeprazole (based on body surface area for a 60 kg person).
Changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole. When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age.
Increased risk of hypomagnesemia w/ diuretics. May increase INR and prothrombin time w/ warfarin. Increased risk of digoxin-induced cardiotoxic effects. May increase the plasma concentration of 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.