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Composition |
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Each tablet of DROVERA MF contains:
Drotaverine HCl . . . 80 mg
Mefenamic Acid . . . 250 mg |
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Therapeutic indications & Usage |
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DROVERA MF is indicated for symptomatic relief of colics such as intestinal, biliary and ureteric, as well
as for spasmodic dysmenorrhea.
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Contraindications |
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DROVERA MF should not be used in patients who have previously exhibited hypersensitivity to its
ingredients, or another NSAID. It is contraindicated in presence of active ulceration or chronic
inflammation of either the upper or lower gastrointestinal tract, preexisting renal disease due to
mefenamic acid. |
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DROVERA MF is contraindicated in pregnancy especially in the third trimester; it is strictly not advocated
for small children less than 6 months, and during lactation. |
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Precaution |
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DROVERA MF should be administered during the first 6 months of pregnancy only if strictly required. |
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Warnings |
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Mefenamic acid (in DROVERA MF) can cause reduced renal blood flow in presence of impaired renal function, heart failure, liver dysfunction, in those taking concomitant diuretics, and in the elderly.
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It is unknown whether drotaverine is excreted in human breast milk, and hence the use of
DROVERA MF during lactation must be if only strictly required. |
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Mefenamic acid (in DROVERA MF) should be co-administered with caution along with oral anticoagulants. |
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Adverse Reactions |
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The most frequently reported adverse reactions associated with the use of mefenamic acid (in
DROVERA MF) are diarrhea, nausea with or without vomiting, and abdominal pain. Other GI
reactions less frequently reported include anorexia, pyrosis, flatulence and constipation. GI
ulceration with and without hemorrhage can also occur with mefenamic acid (in DROVERA MF).
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Mefenamic acid (in DROVERA MF) can cause hypersensitivity reactions; central nervous disturbances
like drowsiness, dizziness, nervousness, headache, blurred vision, insomnia and hematopoietic disturbances.
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As with other NSAIDs, renal failure, including papillary necrosis, is a possibility with mefenamic acid (in
DROVERA MF) administration. Eye complaints, mild hepatic toxicity, perspiration, and an increased need
for insulin in diabetics are possible consequences of mefenamic acid (in DROVERA MF) administration. |
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The adverse reactions incidence due to drotaverine is 3%, but these mainly occur following IV administration. Oral drotaverine (in DROVERA MF) has only 0.9% adverse event incidence. Since, it is a direct
spasmolytic, drotaverine (in ROVERA MF) does not have any anticholinergics side effect. 96% of those
administered drotaverine (as DROVERA MF) tolerate the drug very well. |
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Hypotonia, hypotension, headache, vertigo, nausea, tachycardia, palpitations and porphyria are other reactions
reported due to drotaverine (in DROVERA MF). |
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Recommended Dosage & Administration |
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ADULTS: 1 DROVERA MF Tab tid, or as prescribed.
ELDERLY CHILDREN: ½-1 DROVERA MF Tab tid, or as prescribed.
Therapy should not exceed one week. |
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Presentations |
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DROVERA MF Tablets: Blisters of 10s.
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