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Protobit
Indo-Bangla Pharmaceuticals Ltd.
Generic: Omeprazole
Safety Advices
বাংলা
English
CAUTION
Caution is advised when consuming alcohol with Protobit. Please consult your doctor.
CONSULT YOUR DOCTOR
Protobit 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
Protobit 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 Protobit alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.
SAFE IF PRESCRIBED
Protobit is safe to use in patients with kidney disease. No dose adjustment of Protobit is recommended.
CAUTION
Protobit should be used with caution in patients with severe liver disease. Dose adjustment of Protobit may be needed. Please consult your doctor.
A lower dose may be advised in patients with liver disease and who have to take this medicine for a long time.
Medicine Overview of Protobit 20mg Capsule
Introduction
Protobit 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. Protobit 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 condition and...
... Show moreUses of Protobit
- Gastroesophageal reflux disease (Acid reflux)
- Peptic ulcer disease
Side effects of Protobit
Common
- Diarrhea
- Flatulence
- Headache
- Nausea
- Stomach pain
- Vomiting
How to use Protobit
Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Protobit is to be taken empty stomach.
How Protobit works
Protobit 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 Protobit?
If you miss a dose of Protobit, 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.
- 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 Protobit 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.
- 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.
Brief Description
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...
... Show moreChild 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...
... Show moreInteraction
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.
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