ISOMETHEPTENE MUCATE, CAFFEINE, AND ACETAMINOPHEN- isometheptene mucate, caffeine and acetaminophen tablet
Xspire Pharma
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Rx Only
WARNING
Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often in combination with other acetaminophen-containing products.
DESCRIPTION
Each Isometheptene Mucate, Caffeine, and Acetaminophen Caplet contains:
Isometheptene Mucate �������������.. 65 mg
Caffeine ��������������������� 20 mg
Acetaminophen ����������������.. 325 mg
Isometheptene Mucate is a white crystalline powder having a characteristic aromatic odor and bitter taste. It is an unsaturated aliphatic amine with sympathomimetic properties. Isometheptene mucate has the following structural formula:
chemical structure-01
(click image for full-size original)
Caffeine is 1H-Purine-2,6-dione, 3,7-dyhydro-1,3,7-trimethyl-. It has the following structural formula:
chemical structure-02
Acetaminophen, a non-salicylate, occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Acetaminophen is Acetamide, N-(4-hydroxyphenyl)-. It has the following structural formula:
chemical structure-03chemical structure-01chemical structure-02chemical structure-03
Inactive ingredients include colloidal silicon dioxide, crospovidone polyplasdone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.
CLINICAL PHARMACOLOGY
Isometheptene mucate, a sympathomimetic amine, acts by constricting dilated cranial and cerebral arterioles, thus reducing the stimuli that lead to vascular headaches. It is particularly desirable in patients predisposed to nausea and vomiting, and where ergotamines are precluded. Its action is similar to ergotamine but possesses a low order of toxicity.
Caffeine, also a cranial vasoconstrictor, is added to further enhance the vasoconstrictor effect. It is also used as a central stimulant for relief of headache.
Acetaminophen, an effective non-narcotic analgesic, reduces the perception of pain impulses originating from dilated cerebral vessels; no hyperacidity of stomach and less allergies than aspirin.
INDICATIONS
For relief of tension and vascular headaches.*
*Based on a review of this drug (isometheptene mucate), the National Academy of Sciences- National Research Council and/or other information, FDA has classified the other indication as �Possibly" effective in the treatment of migraine headache. Final classification of less than effective indication requires further investigation.
