The document summarizes a generic combination drug containing omeprazole and ketorolac tromethamine. Omeprazole is in an immediate release layer to inhibit stomach acid production before ketorolac, which is in a sustained release layer to take effect over 15 minutes. This combination aims to reduce ketorolac's gastrointestinal side effects by inhibiting stomach acid. Comparative studies showed the ketorolac-omeprazole combination had the fastest onset of action and highest efficacy with the fewest side effects compared to other NSAID-PPI combinations.

3. Generic:
Omeprazole 20mg
+
Ketorolac Tromethamine 10mg
Brand Name: Keto Plus

4. Pharmacology of generic :
 Ketorolac is a acetic acid derivative related to
the carboxylic acid group of NSAIDs. Ketorolac
is an anti-inflammatory agent with analgesic
and antipyretic properties . It also used to treat
osteoarthritis and control acute pain.
 Omeprazole is a PPI used to inhibit the
secretion of excess HCL from the parietal cell of
stomach.

5. Tablet type :
Bilayer tablet
Omeprazole - immediate release layer
Ketorolac Tromethamine - sustained
release layer

6. Why omeprazole is in immediate release
layer and Ketorolac Tromethamine is in
sustained release layer ?

7. After administration of omeprazole it takes minimum
5 minutes to enter into the MEC level and Ketorolac
Tromethamine takes minimum 15 minutes to reach
MEC level.
It is advised to take omeprazole at lest 15-20 minutes
before the administration of Ketorolac Tromethamine
Due to maintain this phenomenon omeprazole is in
immediate release layer and Ketorolac Tromethamine
is in sustained release layer.

8. Reasons of combination:
Ketorolac tromethamine is a potent NSAID drug but it
produce some severe adverse reaction inside the
body, because ketorolac is acidic in nature. Stomach
produce strong HCl acid from the parietal cell of the
stomach.So acetic nature of ketorolac and secreted
HCl produce severe side effects inside the body.Such
as GIT irritation,peptic ulcer,perforation,renal failure
etc.
Following the above side effects of ketorolac can be
minimize by combining ketorolac with omeprazole.

9. Comparative studies with other
combinations :
Onset of action
Ketorolac+Omeprazole Naproxen+Omeprazole
Diclofenac+Omeprazol

10. Efficacy
Ketorolac+Omeprazole Naproxen+Omeprazole
Diclofenac+Omeprazol

11. Side effects
Diclofenac+Omeprazole Naproxen+Omeprazole
Ketorolac+Omeprazole