Isometheptene Mucate

Isometheptene Mucate

Isometheptene Mucate Recall

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Questions & Answers

Side Effects & Adverse Reactions

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

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

2fda2720-figure-01

(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

2fda2720-figure-02

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

2fda2720-figure-03

C8H9NO2 M.W. 151.16

Isometheptene Mucate Manufacturers


  • Womens Choice Pharmaceuticals, Llc
    Isometheptene Mucate, Caffeine, And Acetaminophen Tablet [Womens Choice Pharmaceuticals, Llc]
  • Macoven Pharmaceuticals
    Isometheptene Mucate, Dichloralphenazone, And Acetaminophen Capsule [Macoven Pharmaceuticals]
  • Xspire Pharma
    Isometheptene Mucate, Caffeine, And Acetaminophen (Isometheptene Mucate, Caffeine And Acetaminophen) Tablet [Xspire Pharma]

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