PURPAL (ESOMAPRAZOLE ) ///// CAPSULES USES

                             
                                              {{..PURPAL..}}

                             [ESOMEPRAZOLE MAGNESIUM]

                                                 [CAPSULE]

                           

COMPOSITION: Purpal 40 mg:    Each capsule equaivalent to Esomeprazole 40 mg

               purple 20 mg:    Each capsule equaivalent to Esomeprazole 20 mg

                                                           
                                                                 


PHARMACOLOGICAL CLASSIFICATION: Proton pump inhibitor






DESCRIPTION:
The active ingredients in puple /DELAYED RELEASE CAPSULE/ is bis [(S)-[(4-methoxy-3, 5-dimethyle-2-pyridinyl)
     




1 CLINICAL PHARMACOLOGY:

ABSORPTION:
purple delayed release capsules contain in enteric-coated pellet formulation of esomeprazole.so that absorption of esomaprazole begins only after the granules leave the stomach.After oral administration, peak plasma levels occure at approximately 1.5 houres.The increase proportionally when the dose is increased and there is a three fold increase in the area under the plasma concentration time corve from 20 40 mg.

       

DISTRIBUTION PURPAL:    
Distribution purpal is 97% bound to plasma protiens.Plasma orotien binding over the  concentration range 2 to 20 mol/L.The apparent volum of distribution at steady state in healthy volunteers is approximatly 16L.

     
     

EXCRETION:
The plasma elimination half-life of purpal is approximatlly 1.5 hours.Less then 1 % of parent drugs is excreted in the urine. Approximatelly 80 % of an oral dose of pupale is excreted  is inactive metabolites in the urine and the remainder is found as inactive metabolites
in the faces,


 .

2 PHARMACODYNAMICS:


MECHANISM OF ACTION:
Esomeprazole is a proton  pump inhibitor that suppress gastric acid secretion by specific inhibition of the  H/K-ATPASE in the gastric parietal cell. The  S and R isomers of omeprazole are protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor the achiral sulphenamide. By acting specifically on the proton punp.Eromeprazole blocks the final step in acidic production thus reducing gastric acidity.





3 INDICATIONS AND USAGE



HEALING OF EROSIVE ESOPHAGITIS: Purpal is indicated for the short-time treatment (4 to 8 weeks) in healing and symptomatic resolution of  diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 weeks course of purpal may be considered

        .

HEARTBURN AND OTHER SYMPTOMS:
Pupal delayed release capsules are indicated for the treatment of heartburn and other symptoms associated with GERD
        .

MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS:
Purpal delayed release capsules are indicated to maintain symptoms resolution andhealing of erosive esophagitis. Controlled studies do no extend beyond  6 months
.

CONTRAINDICATIONS:
Purpal  capsules are contraindicated in patients with know                                                                        hypersensitivity to any component of the formulation.







                                                                  WARNINGS:




CLARITHROMYCIN: it should not be use in pregnant women except in clinical circumstances where no alternative therapy is appropriate If pregnancy occurs while taking clarithromycin. The patient should be apprised of the potential hazard to the fetus..
     

AMOXICILLIN:
Serious and occasionally fatal hypersensitivity reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur  in individuals with a history of penicillin hypersensitivity and/or a  history of sensitivity to multiple allergens.
                           
                                           

MANUFACTURED BY:
DYSON RESEARCH              
                                                                                                     LABORATORIES (PVT.)LTD
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