Prescription Drugs

CLINICAL PHARMACOLOGY Isometheptene Mucate, a sympathomimetic amine, acts by constricting dilated cranial and cerebral arterioles, thus reducing the stimuli that lead to vascular headaches. Dichloralphenazone, a mild sedative, reduces the patient's emotional reaction to the pain of both vascular and tension headaches. Acetaminophen raises the threshold to painful stimuli, thus exerting an analgesic effect against all types of headaches.

MIDRIN® (isometheptene mucate, dichloralphenazone and acetaminophen) DESCRIPTION Each red capsule contains Isometheptene Mucate USP, 65 mg, Dichloralphenazone USP, 100 mg, and Acetaminophen USP, 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. Dichloralphenazone is a white, microcrystalline powder, with slight odor and tastes saline at first, becoming acrid. It is a mild sedative. Acetaminophen, a non-salicylate, occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Midrin (acetaminophen, isometheptene and dichloralphenazone) capsules contain FD&C Yellow No. 6 as a color additive.

INDICATIONS For relief of tension and vascular headaches*. *Based on a review of this drug (isometheptene mucate) by 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 the less-than-effective indication requires further investigation. DOSAGE AND ADMINISTRATION FOR RELIEF OF MIGRAINE HEADACHE: The usual adult dosage is two capsules at once, followed by one capsule every hour until relieved, up to 5 capsules within a twelve hour period. FOR RELIEF OF TENSION HEADACHE: The usual adult dosage is one or two capsules every four hours up to 8 capsules a day. HOW SUPPLIED Red capsules imprinted with the word MIDRIN (acetaminophen, isometheptene and dichloralphenazone) in pink letters. Bottles of 100 capsules, NDC 14508-304-08. Store at controlled room temperature 15°-30°C (59°-86° F) in a dry place. Manufactured and distributed by: CARACO PHARMACEUTICAL LABORATORIES, LTD. DETROIT, MI 48202 Under license from: Sun Pharmaceutical Industries. FDA Rev date: n/a

PATIENT INFORMATION No information provided. Please refer to the PRECAUTIONS section.

OVERDOSE No information provided. CONTRAINDICATIONS Midrin® (acetaminophen, isometheptene and dichloralphenazone) is contraindicated in glaucoma and/or severe cases of renal disease, hypertension, organic heart disease, hepatic disease and in those patients who are on monoamine-oxidase (MAO) inhibitor therapy.

SIDE EFFECTS Transient dizziness and skin rash may appear in hypersensitive patients. This can usually be eliminated by reducing the dose. DRUG INTERACTIONS No information provided.

WARNINGS No information provided. PRECAUTIONS Caution should be observed in hypertension, peripheral vascular disease and after recent cardio-vascular attacks.