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DROVERA:

 
 
 
   
   
   
 
 



 
   
 
     
     
 
  Composition
   
  Each tablet of DROVERA 80 contains:
Drotaverine HCl....80 mg
   
  Each 2 ml DROVERA Inj contains:
Drotaverine HCl....40 mg
   
   
  Therapeutic Indications & Usage
   
  DROVERA is indicated for symptomatic relief of spasm in intestinal colic, biliary colic, ureteric colic and dysmenorrhea. For biliary smooth muscle spasm, drotaverine (DROVERA) is the drug of choice.
   
  DROVERA is advocated to prevent premature labor at term, and also to augment labor whilst lowering the incidence of cervical rupture. It is also useful as premedication for esophagoscopy, gastroscopy and distention procedures of esophageal strictures, and for hysterosalpingography.
   
   
  Contraindications
   
  DROVERA is not advocated in presence of known hypersensitivity to its ingredients. Its use in pregnancy, particularly in the first and second trimesters, is to be avoided.
   
   
  Precautions
   
  In order to minimize postpartum hemorrhage, the use of a second DROVERA injection within 2 hours of anticipated labor must be avoided in those being administered the drug for augmenting labor
   
   
  Warnings
   
  DROVERA must be advocated with due precaution in third trimester of pregnancy. It is unknown whether drotaverine is excreted in human breast milk, and hence the use of DROVERA during lactation must be if only strictly required.
   
   
  Adverse Reactions
   
  The adverse reactions incidence due to drotaverine is 3%, and these mainly occur following IV administration. Oral drotaverine (DROVERA) has only 0.9% adverse event incidence. Since, it is a direct spasmolytic, DROVERA does not have any anticholinergic side effect. 96% of those administered drotaverine tolerate the drug very well.
   
  Hypotonia, hypotension, headache, vertigo, nausea, tachycardia, palpitations and porphyria are the common reactions reported. However these are common after rapid parenteral drotaverine (DROVERA Inj) administration. Cervical tearing can occur following drotaverine (DROVERA) use in labor especially when cervical dilatation progresses at a rate greater than 5 cms/hour. Even Enhanced postpartum hemorrhage incidence has been reported following drotaverine (DROVERA) use in augmentation of labor.
   
   
  Recommended Dosage & Administration
   
  Adults
  PARENTERAL: Inj DROVERA1-2 Amps IV / IM bid / tid, or as prescribed. There is direct dose response relationship upto 120 mg drotaverine administered as DROVERA Inj IV. DROVERA Inj IV must be administered slowly to patient in supine position to prevent hypotension.
   
  PREMEDICATION before Procedures: 2 DROVERA Inj Amps IV 30 mins before investigation, and 1 DROVERA Inj Amp IV immediately before procedure.
   
  INDUCTION OF LABOR: Inj DROVERA 1 Amp IM every 2 hours for a maximum of 3 doses, or as prescribed.
   
  Children
  6-12 years: 1 DROVERA 80 Tab tid, or as prescribed.
DROVERA Tab could be maximally continued for 10-14 days.
   
   
  Presentations
   
  DROVERA 80 Tablets: Blisters of 10s.
DROVERA Injections: 10 ampoules of 2ml.
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
   
 
         
 
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