Ozolex Capsules (Hard Gelatin)
Omeprazole
40mg
Nexgen Pharma FZ LLC
| Pack size | 28's (7's Blister x 4) |
|---|---|
| Dispensing mode | POM |
| Source | UAE |
| Agent | ARABIAN ETHICALS CO. |
| Retail Price | 193.00 AED |
Available as:
Indications
Ozolex Capsules (Hard Gelatin) 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
Capsules: should be taken with food, immediately before a meal.
Tablets (MUPS): can be taken with or without food.
Powder for oral suspension: should be taken on an empty stomach, at least 1 hour before a meal.
Delayed-release capsules: should be taken on an empty stomach, at least 1 hour before meals. Should be swallowed whole, and not crushed or chewed.
For patients who have difficulty swallowing capsules, they can be carefully opened and the contents can be sprinkled on a spoonful of applesauce. The mixture should be swallowed immediately without chewing and should not be stored for future use.
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
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
Pregnancy-Lactation
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.
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
Ozolex 40mg Capsules (Hard Gelatin) manufactured by Nexgen Pharma FZ LLC. Its generic name is Omeprazole. Ozolex is availble in United Arab Emirates.
Farmaco UAE drug index information on Ozolex Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.