Each tablet contains:
DROTALON Tablet is a combination of Drotaverine HCL and Mefanamic Acid.
Drotaverine is classified as selective phosphodiesterase inhibitor and acts as antispasmodic prescribed for pain and dysfunction caused by smooth muscle spasm.
Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) that alleviates pain symptoms by inhibition of pain mediators associated with both isoforms of COX and prevents formation of prostaglandins and is used to treat mild to moderate pain, including menstrual pain, and is sometimes used to prevent migraines associated with menstruation.
DROTALON is indicated mainly for the treatment of biliary tract spasm, gastrointestinal spasm, urinary tract spasm, and pain due to primary dysmenorrhea.
The adult oral dose of DROTALON is one tablet taken every 6-8 hours for more than 2-3 days. The dose for children more than 14 years is same as adult dose. The formula is best taken with a full glass of water or with food.
DROTALON should not be administered in the following cases:
Caution should be exercised when DROTALON is prescribed at the same time with Magnesium hydroxide cause increase in drug absorption.
Caution should be exercised when prescribing DROTALON to patients with lithium toxicity as it increases lithium toxicity which can be fatal.
DROTALON contains drotaverine for which dosage adjustments may be required in patients with renal impairment since drotaverine and its metabolites are excreted by kidneys.
Drotaverin has the potential to decrease the antiparkinsonian effect of levodopa resulting in increase in rigidity and tremor. In patients of parkinson DROTALON is not recommended.
The most frequently reported adverse reactions associated with the use of mefenamic acid (in DROTALON) 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 DROTALON). Oral drotaverine has very less adverse event incidence reported.
DROTALON should not to be used in pregnancy. The use of mefenamic acid in late pregnancy is not recommended because of the effects on the fetal cardiovascular system of drugs of this class. There are no controlled data in human pregnancy. Mefenamic acid is only recommended for use during pregnancy when benefit outweighs risk.
DROTALON tablets are available in a 10X10s blister packing
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