Isometheptene Mucate, Dichloralphenazone, and Acetaminophen

ISOMETHEPTENE MUCATE, DICHLORALPHENAZONE, AND ACETAMINOPHEN- isometheptene mucate, dichloralphenazone and acetaminophen capsule, gelatin coated
Vilvet Pharmaceuticals Inc

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.

CAUTION

This product contains acetaminophen. Severe liver damage may occur if a person takes:

  • More than 4,000 mg of acetaminophen in 24 hours
  • With other drugs containing acetaminophen
  • With 3 or more alcoholic drinks everyday while using this product.

DESCRIPTION

Each Isometheptene Mucate, Dichloralphenazone, and Acetaminophen Capsule contains:

Isometheptene Mucate65 mg
Dichloralphenazone100 mg
Acetaminophen325 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. Its molecular weight is 492.65 and it has the following structural formula:

Chemical Structure
(click image for full-size original)

Dichloralphenazone is a white, microcrystalline powder, with slight odor and tastes saline at first, becoming acrid. It is a mild sedative. Its molecular weight is 519.07 and it has the following structural formula:

Chemical Structure

Acetaminophen , a non-salicylate, occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Its molecular weight is 151.16 and it has the following structural formula:

Chemical Structure

The inactive ingredients are: gelatin, lactose anhydrous, silicon dioxide, magnesium stearate, FD&C Blue #1, FD&C yellow 5, carmine and titanium dioxide.

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.

Isometheptene Mucate, Dichloralphenazone, and Acetaminophen Indications and Usage

For relief of tension and vascular headaches.1


1
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.

CONTRAINDICATIONS

Isometheptene Mucate, Dichloralphenazone and Acetaminophen is contraindicated in:

  • Hypersensitivity or intolerance to any component of this product
  • Cardiovascular or cerebrovascular insufficiency, including recent myocardial infarction or stroke
  • Glaucoma
  • Severe cases of renal disease
  • Hypertension
  • Organic heart disease
  • Peripheral vascular disease
  • Hepatic disease
  • Those patients who are on monoamine-oxidase (mao) inhibitor therapy

WARNINGS

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.

Serious Skin Reactions

Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN) which can be fatal. Patients should be informed about the signs of severe skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

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 Mucate, Dichloralphenazone, and Acetaminophen Capsules immediately and seek medical care if they experience these symptoms. Do not prescribe Isometheptene Mucate, Dichloralphenazone, and Acetaminophen Capsules for patients with acetaminophen allergy.

PRECAUTIONS

Caution should be observed in hypertension, peripheral vascular disease and after recent cardiovascular attacks. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Remember that alcohol may be a cause of headaches.

INFORMATION FOR PATIENTS

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.

DRUG INTERACTIONS

This drug should not be used with the following medications because very serious interactions may occur:

  • Sodium oxybate.
  • Avoid MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur.
  • Consider drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine, phenytoin), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants (e.g., cyclobenzaprine), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone).
  • This medication may interfere with certain laboratory tests (including certain urine glucose tests, urine catecholamine levels, urine 5-HIAA levels), possibly causing false test results.

PREGNANCY

FDA has not assigned a pregnancy category for acetaminophen, dichloralphenazone, or isometheptene. Acetaminophen is routinely used for short-term pain relief and fever in all stages of pregnancy.

Acetaminophen crosses the placenta and is believed to be safe in pregnancy when used intermittently for short durations. No controlled studies have been done to establish the safety of dichloralphenazone or isometheptene or of their combination with acetaminophen. Isometheptene Mucate, Dichloralphenazone and Acetaminophen Capsules, USP should only be given during pregnancy when need has been clearly established.

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