Nodolor Capsules

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.

Nodolor™ Capsules 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

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.

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 Nodolor™ Capsules. 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. Nodolor™ Capsules 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.

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.

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 1-877-622-6836.

To report SUSPECTED ADVERSE REACTIONS, contact Macoven Pharmaceuticals at 1-800-793-2145.

NDC 44183-442-01

CIV

Nodolor™
Capsules
65 mg/100 mg/325 mg

Rx Only
100 CAPSULES

MACOVEN
PHARMACEUTICALS