Sumatriptan

SUMATRIPTAN- sumatriptan spray
Florida Pharmaceutical Products, LLC.

1 INDICATIONS AND USAGE

Sumatriptan nasal spray is 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 nasal spray, reconsider the diagnosis of migraine before Sumatriptan nasal spray is administered to treat any subsequent attacks.
• Sumatriptan is not indicated for the prevention of migraine attacks.
• Safety and effectiveness of sumatriptan nasal spray have not been established for cluster headache.

2 DOSAGE AND ADMINISTRATION

The recommended adult dose of sumatriptan nasal spray for the acute treatment of migraine is 5 mg, 10 mg, or 20 mg. The 20 mg dose may provide a greater effect than the 5 mg and 10 mg doses, but may have a greater risk of adverse reactions [see Clinical Studies (14)] .

The 5 mg and 20 mg doses are given as a single spray in 1 nostril. The 10 mg dose may be achieved by the administration of a single 5 mg dose in each nostril.

If the migraine has not resolved by 2 hours after taking sumatriptan nasal spray or returns after a transient improvement, 1 additional dose may be administered at least 2 hours after the first dose. The maximum daily dose is 40 mg in a 24 hour period.

The safety of treating an average of more than 4 headaches in a 30 day period has not been established.

3 DOSAGE FORMS AND STRENGTHS

Unit dose nasal spray devices containing 20 mg sumatriptan.

4 CONTRAINDICATIONS

Sumatriptan nasal spray is 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, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see 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-hydroxytryptamine ₁ (5-HT ₁ ) 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) and Clinical Pharmacology (12.3)]
• Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) [see Warnings and Precautions (5.10)]
• Severe hepatic impairment [see Clinical Pharmacology (12.3)]

5 WARNINGS AND PRECAUTIONS

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

The use of sumatriptan nasal spray 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 nasal spray. Some of these reactions occurred in patients without known CAD. Sumatriptan nasal spray 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 nasal spray. If there is evidence of CAD or coronary artery vasospasm, sumatriptan nasal spray is contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of sumatriptan nasal spray in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of sumatriptan nasal spray. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of sumatriptan nasal spray.

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-HT ₁ agonists. Discontinue sumatriptan nasal spray if these disturbances occur. Sumatriptan nasal spray is 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 may occur after treatment with sumatriptan nasal spray and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. The use of sumatriptan nasal spray 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-HT ₁ agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT ₁ 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 nasal spray 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 nasal spray is contraindicated in patients with a history of stroke or TIA.

5.5 Other Vasospasm Reactions

Sumatriptan nasal spray 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-HT ₁ agonist, rule out a vasospastic reaction before using additional sumatriptan nasal spray.

Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5‑HT ₁ agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT ₁ agonists have not been clearly established.

5.6 Medication Overuse Headache

Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache).

Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.