Prazol Capsule
Omeprazole
20mg
CTL Pharmaceuticals Pvt. Ltd.
| Pack size | 200's |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 4.00 NPR |
Indications
Prazol Capsule is used for:
Peptic ulcer, H. pylori infection, Gastro-oesophageal reflux disease, Zollinger-Ellison syndrome, Oesophagitis, Acid-related dyspepsia, NSAID-associated ulceration
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 mg/day.
Doses >80 mg are administered in 2 divided doses.
Prophylaxis of acid aspiration during general anaesthesia
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 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 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 needed.
Hepatic impairment: 10-20 mg/day.
Child Dose
Oral
GERD
Indicated for 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 Dose
Renal impairment: No dosage adjustment needed.
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.
Contra Indications
Known hypersensitivity to any of its component.
Precautions
Gastric malignancy should be ruled out. Pregnancy, lactation, childn <1 yr. Monitoring Parameters Monitor Mg concentrations prior to initiation and periodically thereafter.
Lactation: Distributes into human breast milk; use caution
Pregnancy-Lactation
Interactions
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.
Adverse Effects
Side effects of Omeprazole :
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.
Mechanism 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.
Note
Prazol 20mg Capsule manufactured by CTL Pharmaceuticals Pvt. Ltd.. Its generic name is Omeprazole. Prazol is availble in Nepal.
Farmaco Nepal drug index information on Prazol Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.