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Roxenole
Cosmic Pharma Ltd.
Generic: Esomeprazole Magnesium Trihydrate
Safety Advices
বাংলা
English
CAUTION
Caution is advised when consuming alcohol with Roxenole. Please consult your doctor.
CONSULT YOUR DOCTOR
Roxenole may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
CONSULT YOUR DOCTOR
Roxenole is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
CONSULT YOUR DOCTOR
It is not known whether Roxenole alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.
SAFE IF PRESCRIBED
Roxenole is safe to use in patients with kidney disease. No dose adjustment of Roxenole is recommended.
However, inform your doctor if you have any kidney disease.
CAUTION
Roxenole should be used with caution in patients with severe liver disease. Dose adjustment of Roxenole may be needed. Please consult your doctor.
Medicine Overview of Roxenole 20mg+500mg Tablet
Introduction
Roxenole is a medicine which reduces the amount of acid produced in your stomach. It is used to treat heartburn, acid reflux and problems in your food pipe. It is also used to prevent and treat stomach ulcers. You should take Roxenole as your doctor advises. The dose will depend on what you are being treated for, but it should be the lowest dose for the shortest amount of time needed to treat your condition. Normally it should be swallowed whole about an hour before a meal and at the same time each day. It may take up to a...
... Show moreUses of Roxenole
- Gastroesophageal reflux disease (Acid reflux)
- Peptic ulcer disease
Side effects of Roxenole
Common
- Headache
- Dizziness
- Dryness in mouth
- Nausea
- Abdominal pain
- Constipation
- Flatulence
- Diarrhea
How to use Roxenole
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Roxenole is to be taken empty stomach.
How Roxenole works
Roxenole 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 Roxenole?
If you miss a dose of Roxenole, 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.
Quick Tips
- 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.
- Long-term use of Roxenole can cause weak bones and a deficiency of minerals such as magnesium. Take adequate dietary intake of calcium and magnesium or their supplements as prescribed by 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.
Brief Description
Indication
Heartburn, Acid Related Dyspepsia, Peptic ulcer disease, Zollinger-Ellison syndrome, Gastroesophageal reflux disease (GERD), Helicobacter pylori infection, Erosive Esophagitis, Gouty arthritis, Duodenal and Gastric Ulcer.
Administration
Delayed-release cap: Should be taken on an empty stomach. Take on an empty stomach 1 hr before meals.
Tab: May be taken with or without food.
Adult Dose
GERD Without Erosive Esophagitis 20 mg PO qDay for 4 weeks; consider an additional 4 weeks of treatment if symptoms do not resolve completely in the first 4 weeks GERD With Erosive Esophagitis 20-40 mg PO qDay for 4-8 weeks If oral therapy inappropriate or not possible: 20-40 mg qDay IV up to 10 days; switch to PO once patient able to swallow Maintenance: 20 mg PO qDay for up to 6 months Risk Reduction of NSAID-Associated Gastric Ulcer 20-40 mg PO qDay for up to 6 months NSAID-Induced Gastric Ulcer 20 mg PO qDay for 4-8 weeks Zollinger-Ellison Syndrome...
... Show moreChild Dose
GERD Without Erosive Esophagitis
Oral
12 years: 20-40 mg PO qDay for up to 8 weeks
GERD With Erosive Esophagitis (Healing)
3.5-7.5 kg: 5 mg PO qDay for up to 6 weeks
>7.5 kg: 10 mg PO qDay for up to 6 weeks
1-12 years
20 kg: 10-20 mg qDay for 8 weeks
>12 years
20-40 mg PO qDay for 4-8 weeks
Maintenance: 20 mg PO qDay up to 6 months
Renal Dose
Renal impairment: No dosage adjustment needed.
Contraindication
Esomeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted Benzimidazoles.
Mode of Action
Esomeprazole is a PPI that suppresses gastric acid secretion by inhibiting H+/K+ ATPase in the gastric parietal cell. It is the S-isomer of omeprazole.
Precaution
Paediatric; pregnancy, lactation. Malignancy and hepatic impairment. Increased risk of developing certain infections such as community-acquired pneumonia. For patients with severe liver impairment, a dose of 20 mg should not be exceeded. Lactation Risk Summary Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk. There are no clinical data on the effects of esomeprazole on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Esomeprazole and any potential adverse effects on the breastfed infant from Esomeprazole...
... Show moreSide Effect
>10%
Headache (2-11%)
1-10%
Flatulence (10%),Indigestion (6%),Nausea (6%),Abdominal pain (1-6%),Diarrhea (2-4%),Xerostomia (3-4%),Dizziness (2-3%),Constipation (2-3%),Somnolence (1-2%),Pruritus (1%)
<1%
Blood and lymphatic system disorders: Agranulocytosis, pancytopenia
Blurred vision,
GI disorders: Pancreatitis, stomatitis, microscopic colitis
Hepatobiliary disorders: Hepatic failure, hepatitis with or without jaundice
Anaphylactic reaction/shock
GI candidiasis
Hypomagnesemia
Musculoskeletal disorders: Muscular weakness, myalgia, bone fracture
Nervous system disorders: Hepatic encephalopathy, taste disturbance
Psychiatric disorders: Aggression, agitation, depression, hallucination
Interstitial nephritis
Gynecomastia
Bronchospasm
Skin and subcutaneous tissue disorders: Alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (sometimes fatal fatal)
Pregnancy Category Note
Pregnancy There are no adequate and well-controlled studies in pregnant women; esomeprazole is the S-isomer of omeprazole; 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) Lactation Esomeprazole is the S-isomer of omeprazole and limited data suggest that omeprazole may be present in human milk; there are no...
... Show moreInteraction
Increased risk of digoxin-induced cardiotoxic effects. Increased risk of hypomagnesaemia w/ diuretics. May increase INR and prothrombin time w/ warfarin. May increase serum concentration of tacrolimus, saquinavir, methotrexate. May interfere the elimination of drugs metabolised by CYP2C19 (e.g. diazepam). May decrease the bioavailability of ketoconazole, erlotinib and Fe salts.
Potentially Fatal: May decrease serum concentration and pharmacological effects of rilpivirine, atazanavir and nelfinavir. May decrease the antiplatelet effects of clopidogrel.
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