Isometheptene Mucate, Caffeine, and Acetaminophen description, usages, side effects, indications, overdosage, supplying and lots more!

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Isometheptene Mucate, Caffeine, and Acetaminophen

Womens Choice Pharmaceuticals, LLC
Womens Choice Pharmaceuticals, LLC

Isometheptene, Caffeine, and Acetaminophen Tablets




FULL PRESCRIBING INFORMATION

WARNING HepatotoxicityIsometheptene, Caffeine, and Acetaminophen Tablets contain acetaminophen, isometheptene mucate and caffeine. 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.

Each Isometheptene, Caffeine, and Acetaminophen Tablet contains:

Isometheptene Mucate ...................................... 130 mg

Caffeine ............................................................... 20 mg

Acetaminophen .................................................. 500 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:

Figure 1: Isometheptene mucate

Isometheptene Mucate, Caffeine, and Acetaminophen
(C9H19N)2•C6H10O8 M.W. 492.65 Caffeine is 1H-Purine-2,6-dione, 3,7-dyhydro-1,3,7-trimethyl-. It has the following structural formula: Figure 2: Caffeine C8H10N4O2 M.W. 194.19 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: Figure 3: Acetaminophen C8H9NO2 M.W. 151.16

Inactive ingredients include calcium phosphate, colloidal silicone dioxide, crospovidone polyplasdone, magnesium stearate, microcrystalline cellulose, Povidone, Prosolv, and stearic acid.

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.

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.

This Product 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 inhibitor (MAOI) therapy.

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 involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products. The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.

Hypersensitivity/Anaphylaxis – There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Isometheptene, Caffeine, and Acetaminophen Tablets immediately and seek medical care if they experience these symptoms. Do not prescribe Isometheptene, Caffeine, and Acetaminophen Tablets for patients with acetaminophen allergy.

Hypersensitive patients have shown rash and transient dizziness, this can be eliminated by reducing dosage.

Caution should be observed in hypertension, peripheral vascular disease and after recent cardiovascular attacks.

Do not take this product if you are allergic to any of its ingredients. If you develop signs of allergy such as rash or difficulty breathing stop taking this product and contact your healthcare provider immediately.

Do not take more than 4,000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.

Following an acute overdosage, toxicity may result.

Acetaminophen – In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

FOR RELIEF OF MIGRAINE HEADACHE: The usual adult dosage is two tablets at once, followed by one tablet every hour until relieved, up to 5 tablets within a twelve hour period.

FOR RELIEF OF TENSION HEADACHE: The usual adult dosage is one or two tablets every four hours up to 8 tablets a day.

Isometheptene, Caffeine, and Acetaminophen Tablets are supplied as white tablets debossed “130” on one side, and scored on the opposite side. Available in bottles of 50 tablets, NDC 50967-620-50.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, CALL A DOCTOR OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Avoid exposure to heat.

Dispense in a tight, light-resistant container as defined in USP/NF with a child-resistant closure.

Manufactured for:

Women’s Choice Pharmaceuticals

Gilbert, AZ 85233

(877) 774-4949

500421 Rev. 09/2011

Figure 4: Bottle Label

Isometheptene Mucate, Caffeine, and Acetaminophen

Isometheptene Mucate, Caffeine, and Acetaminophen

Isometheptene Mucate, Caffeine, and Acetaminophen TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:50967-620
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
CAFFEINE 20 mg
ISOMETHEPTENE MUCATE ISOMETHEPTENE 130 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
CROSPOVIDONE
MAGNESIUM STEARATE
cellulose, microcrystalline
POVIDONE K30
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE 19 mm 130 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50967-620-50 50 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-10-12


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