Isometheptene Mucate/Dichloralphenazone/Acetaminophen

ECI Pharmaceuticals LLC

Isometheptene Mucate/Dichloralphenazone/ Acetaminophen Capsules

FULL PRESCRIBING INFORMATION: CONTENTS*

• ISOMETHEPTENE MUCATE/DICHLORALPHENAZONE/ACETAMINOPHEN DESCRIPTION
• CLINICAL PHARMACOLOGY
• ISOMETHEPTENE MUCATE/DICHLORALPHENAZONE/ACETAMINOPHEN INDICATIONS AND USAGE
• ISOMETHEPTENE MUCATE/DICHLORALPHENAZONE/ACETAMINOPHEN CONTRAINDICATIONS
• PRECAUTIONS
  • Drug Interactions
  • Pregnancy
  • Nursing mothers
  • Pediatric use
  • Geriatric
• ISOMETHEPTENE MUCATE/DICHLORALPHENAZONE/ACETAMINOPHEN ADVERSE REACTIONS
• OVERDOSAGE
• ISOMETHEPTENE MUCATE/DICHLORALPHENAZONE/ACETAMINOPHEN DOSAGE AND ADMINISTRATION
  • FOR RELIEF OF MIGRAINE HEADACHE
  • FOR RELIEF OF TENSION HEADACHE
• HOW SUPPLIED
  • STORAGE
• PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

FULL PRESCRIBING INFORMATION

CIV

CAUTION: Federal law prohibits dispensing without prescription.

ISOMETHEPTENE MUCATE/DICHLORALPHENAZONE/ACETAMINOPHEN DESCRIPTION

Taken orally, each capsule contains Isometheptene Mucate USP, 65 mg, Dichloralphenazone USP, 100 mg, and Acetaminophen USP, 325 mg. Each capsule also contains Citric Acid, FD&C Blue #1, FD&C Red #40, Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid, Talc, and Titanium Dioxide.

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 is a sympathomimetic amine and its chemical name is 6-Methylamino-2-methylheptene, tetrahydroxyadipic acid. Isometheptene Mucate has the following structural formula.

Dichloralphenazone is a white, microcrystalline powder, with slight odor and tastes saline at first, becoming acrid. Dichloralphenazone is a sedative and its chemical name is 1,2-Dihydro-1,5-dimethyl-2-phenyl-3H-pyrazol-3-one, compound with 2,2,2-trichloro-1, 1-ethanediol (1:2). Dichloralphenazone has the following structural formula.

Acetaminophen, a non-salicylate, occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Acetaminophen is an analgesic and antipyretic and its chemical name is N-(4-hydroxyphenyl)-. It has the following structural formula:

CLINICAL PHARMACOLOGY

Isometheptene Mucate is a sympathomimetic amine, acts by constricting dilated cranial and cerebral arterioles, thus reducing the stimuli that lead to vascular headaches.

Dichloralphenazone is 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/ACETAMINOPHEN INDICATIONS AND USAGE

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.

ISOMETHEPTENE MUCATE/DICHLORALPHENAZONE/ACETAMINOPHEN CONTRAINDICATIONS

Isometheptene Mucate/Dichloralphenazone/Acetaminophen is contraindicated in:

• Hypersensitivity or intolerance to any component of this product
• Cardiovascular or cerebrovascular insufficiency, including recent myocardial infarction or stroke
• Glaucoma, not optimally controlled
• Severe cases of renal disease
• Hypertension, not optimally controlled
• Organic heart disease
• Peripheral vascular disease
• Hepatic disease
• Those patients who are on monoamine-oxidase (mao) inhibitor therapy

PRECAUTIONS

Caution should be observed in hypertension, 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.

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. Acetaminophen/ dichloralphenazone/isometheptene should only be given during pregnancy when need has been clearly established.

Nursing mothers

Acetaminophen is excreted into human milk in small concentrations. Metabolites of dichloralphenazone are excreted into human milk. There are no data on the excretion of isometheptene into human milk. Problems in humans have not been documented.

Pediatric use

Studies with this medicine have been done only in adult patients, and there is no specific information about its use in children.

Geriatric

There is no specific published information comparing use of this combination medicine in the elderly with use in other age groups. Geriatric patients are more likely to have peripheral vascular disease, and are therefore more likely to be adversely affected by peripheral vasoconstriction, than are younger adults. However, isometheptene may be safer for elderly patients than the ergot derivatives used to abort acute vascular headaches. Also, elderly patients are more likely to have age related renal function impairment, which may require caution in patients receiving acetaminophen and isometheptene.

ISOMETHEPTENE MUCATE/DICHLORALPHENAZONE/ACETAMINOPHEN ADVERSE REACTIONS

There is a potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash). A very serious allergic reaction, called anaphylaxis, to this drug is unlikely, but if it occurs, discontinue the drug and seek immediate medical attention if it occurs.

Transient dizziness, drowsiness, and nausea may occur. This can usually be eliminated by reducing the dose. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

To report SUSPECTED ADVERSE REACTIONS, contact ECI Pharmaceuticals, LLC at 954-486-8181 X-109

OVERDOSAGE

If overdose is suspected, contact your local poison control center or emergency room immediately. U.S. residents can call the U.S. national poison hotline at 1-800-222-1222. Symptoms of overdose may include: restlessness, severe drowsiness/dizziness, low body temperature, fast/slow breathing, fast/slow/irregular heartbeat, unresponsiveness.

ISOMETHEPTENE MUCATE/DICHLORALPHENAZONE/ACETAMINOPHEN DOSAGE AND ADMINISTRATION

Take this medication by mouth with or without food as directed by your doctor.

FOR RELIEF OF MIGRAINE HEADACHE

The usual adult dosage is two capsules at the first sign of the headache as directed by your doctor, 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

Size '0' Red Capsules with '617' printed in black ink on the cap and body in the following configurations:

50 capsules NDC: 51293-617-67
100 capsules NDC: 51293-617-01
250 capsules NDC: 51293-617-66

STORAGE

Store at controlled room temperature 15°-30°C (59°-86°F) in a dry place in well-closed container. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Manufactured by:
ECI Pharmaceuticals, LLC
5311 NW 35^th Terrace
Fort Lauderdale, FL 33309
954-486-8181

The most recent revision of this labeling is 10/2012.

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

NDC 51293-617-01

ECI Pharmaceuticals

Isometheptene Mucate,
Dichloralphenazone,
and Acetaminophen
Capsules

Rx only
100 CAPSULES

65 mg/
100 mg/325 mg