Sumatriptan Succinate

SUMATRIPTAN SUCCINATE- sumatriptan succinate tablet, film coated
Preferred Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

Sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:

Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks.
Sumatriptan succinate tablets are not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

The recommended dose of sumatriptan succinate tablets is 25 mg, 50 mg, or 100 mg. Doses of 50 mg and 100 mg may provide a greater effect than the 25 mg dose, but doses of 100 mg may not provide a greater effect than the 50 mg dose. Higher doses may have a greater risk of adverse reactions [see Clinical Studies (14)].
If the migraine has not resolved by 2 hours after taking sumatriptan succinate tablets, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 200 mg in a 24-hour period.
Use after sumatriptan injection
If the migraine returns following an initial treatment with sumatriptan injection, additional single sumatriptan succinate tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses.
The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

2.2 Dosing in Patients with Hepatic Impairment

If treatment is deemed advisable in the presence of mild to moderate hepatic impairment, the maximum single dose should not exceed 50 mg [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Sumatriptan succinate tablets, 25 mg are white, triangular-shaped, film-coated tablets debossed with “S” on one side and “I” on the other side.
Sumatriptan succinate tablets, 50 mg are white, triangular-shaped, film-coated tablets debossed with “S” on one side and “50″ on the other side.
Sumatriptan succinate tablets, 100 mg are pink, triangular-shaped, film-coated tablets debossed with “S” on one side and “100″ on the other side.

4 CONTRAINDICATIONS

Sumatriptan succinate tablets are contraindicated in patients with:

Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions (5.1)]
Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2)]
History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [s ee Warnings and Precautions (5.4)]
Peripheral vascular disease [see Warnings and Precautions (5.5)]
Ischemic bowel disease [see Warnings and Precautions (5.5)]
Uncontrolled hypertension [see Warnings and Precautions (5.8)]
Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine1 (5-HT1 ) agonist [see Drug Interactions (7.1, 7.3)]
Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions (7.2), Clinical Pharmacology (12.3)]
Hypersensitivity to sumatriptan succinate tablets (angioedema and anaphylaxis seen) [see Warnings and Precautions (5.9)]
Severe hepatic impairment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]

5 WARNINGS AND PRECAUTIONS

5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina

The use of sumatriptan succinate tablets is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan succinate tablets. Some of these reactions occurred in patients without known CAD. Sumatriptan succinate tablets may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.
Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving sumatriptan succinate tablets. If there is evidence of CAD or coronary artery vasospasm, sumatriptan succinate tablets are contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of sumatriptan succinate tablets in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of sumatriptan succinate tablets. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of sumatriptan succinate tablets.

5.2 Arrhythmias

Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue sumatriptan succinate tablets if these disturbances occur. Sumatriptan succinate tablets are contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.

5.3 Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure

Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan succinate tablets and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. The use of sumatriptan succinate tablets is contraindicated in patients with CAD and those with Prinzmetal’s variant angina.

5.4 Cerebrovascular Events

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA). Discontinue sumatriptan succinate tablets if a cerebrovascular event occurs. Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions. Sumatriptan succinate tablets are contraindicated in patients with a history of stroke or TIA.

5.5 Other Vasospasm Reactions

Sumatriptan succinate tablets may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud’s syndrome. In patients who experience symptoms or signs suggestive of non-coronary vasospasm reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before receiving additional sumatriptan succinate tablets.
Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT1 agonists has not been clearly established.

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