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Composition |
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Each tablet of DROVERA 40 / 80 contains: |
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Drotaverine HCl . . . 40 / 80 mg |
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Each 2 ml DROVERA Inj contains:
Drotaverine HCl . . . 40 mg |
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Therapeutic indications & Usage |
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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. |
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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. |
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Contraindications |
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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. |
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Precaution |
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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 |
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Warnings |
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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. |
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Adverse Reactions |
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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. |
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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. |
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Recommended Dosage & Administration |
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Adults
ORAL: 1 DROVERA 40 / 80 Tab tid, or as prescribed. |
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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. |
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PREMEDICATION before Procedures: 2 DROVERA Inj Amps IV 30 mins before investigation, and 1
DROVERA Inj Amp IV immediately before procedure. |
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INDUCTION OF LABOR: Inj DROVERA 1 Amp IM every 2 hours for a maximum of 3 doses, or as prescribed. |
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Children
1-6 years: ½ DROVERA 40 Tab tid, or as prescribed.
6-12 years: 1 DROVERA 80 Tab tid, or as prescribed. |
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DROVERA Tab could be maximally continued for 10-14 days. |
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Presentations |
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DROVERA 40 Tablets: Blisters of 10s.
DROVERA 80 Tablets: Blisters of 10s.
DROVERA Injections: 10 ampoules of 2ml
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