Clinical Drug Profile Omeprazol

1. MUHAMMAD USAMA
45-E 7TH SEMESTER
IPS-UVAS LAHORE
DRUG PROFILE OF
OMEPRAZOLE

2. General Detail
Generic: Omeprazole
Drug category: Prescription only drug
Included in WHO Essential Drug List: Yes

3. Product Description
Popular Brands

4. Manufacturer name:
GETZ PHARMA
 Dosage form available:
Infusion,Capsules
Strength: 20mg,40mg
Price: Rs.260
Risek

5. Manufacturer name:
SAMI PHARMACEUTICAL
 Dosage form available:
Infusion,Capsules
Strength: 20mg,40mg
Price: Rs.258
Teph

6. Manufacturer name:
FEROZSONS lABORTRIES
 Dosage form available:
Infusion,Capsules
Strength: 20mg,40mg
Price: Rs.258
Omega

7. Storage Conditions/Considerations
Store below 30℃
protect from sun light

8. Pharmacokinetics of the Drug

9. Absorption
Absorbed at Small intestine(weakly basic)
Bioavailability:
35% At first dose
60% After Repeated once daily Dose
Protein Binding : 95%
Cross Placental Barrier
Do not cross Blood Brain Barrier
Secreted in Breast milk

10. Distribution
Distributed in (Vd): 0.3 l/kg
Time for onset of action: 1Hr
Duration of Action: 73 hr

11. Metabolism
Half Life: 0.5- 3 Hr
Site of Metabolism: Liver
Liver Enzymes Used:
CYP2C19 (Primarily)
CYP3A4 (Small extent)

12. Excretion
77% through Urine
To a lesser extent through Bile

13. Pharmacology
Pharmacological Class Anti ulcer
Indications Gastric and Duodenal ulcer,GERD,NSAID associated Ulcer,H.pylori`
infection,Zollinger-Ellison syndrome,Prophylaxis of acid aspiration
Mechanism of Action Omeprazole is a selective and irreversible proton pump inhibitor.
It suppresses stomach acid secretion by specific inhibition of the
H+/K+-ATPase system found at the secretory surface of gastric
parietal cells.
Contraindications In renal failure,Hypersensitivity to any component of drug
Precautions/warning Atrophic gastritis has been noted occasionally in gastric corpus
biopsies from patients treated long-term with omeprazole
Avoid use in pregnancy
Avoid use in liver failure
FDA Pregnancy Class C

14. Recommended Dosage Regimen
For which
Indication
Route of Administration Recommended
Dose
Duration of Treatment
Duodenal Ulcer Oral
20mg
4-8 weeks
H.Pylori Infection
(Triplet therapy)
Oral
20mg
10 Days
Gastric Ulcer Oral
40mg
8 weeks

15. For which
Indication
Route of Administration Recommended
Dose
Duration of Treatment
Errosive esophagitis Oral
20mg
4-8 weeks
Oral
20mg
10 Days
Oral
40mg
8 weeks