Sumatriptan

Sumatriptan Injection, USP is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: • Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine attack treated with Sumatriptan Injection reconsider the diagnosis before Sumatriptan Injection is administered to treat any subsequent attacks. • Sumatriptan Injection is not indicated for the prevention of migraine attacks or cluster headache attacks. …

• For subcutaneous use only • Acute treatment of migraine: single dose of 1 to 6 mg • Acute treatment of cluster headache: single dose of 6 mg • Maximum dose in a 24-hour period: 12 mg, separate doses by at least 1 hour • Patients receiving doses other than 4 or 6 mg: Use the 6-mg single-dose vial Dosing Information The maximum single recommended adult dose of Sumatriptan injection, USP for the acute treatment of migraine or cluster headache is 6 mg injected subcutaneously
• For the treatment of migraine, if side effects are dose limiting, lower doses (1 mg to 5 mg) may be used [see Clinical Studies ]
• For the treatment of cluster headache, the efficacy of lower doses has not been established
• The maximum cumulative dose that may be given in 24 hours is 12 mg, two 6 mg injections separated by at least 1 hour
• A second 6-mg dose should only be considered if some response to a first injection was observed
• Administration of Doses of Sumatriptan Other than 4 or 6 mg In patients receiving doses other than 4mg or 6 mg, use the 6-mg single-dose vial; Visually inspect the vial for particulate matter and discoloration before administration
• Do not use if particulates and discolorations are noted

Injection: 6 mg single-dose vial. Each 0.5 mL injection contains 8.4 mg of sumatriptan succinate equivalent to 6 mg of sumatriptan. Injection: 6 mg single-dose vial

• Safety and effectiveness
• In pediatric patients have not been established. sumatriptan injection is not recommended for use in patients younger than 18 years of age
• Two controlled clinical trials evaluated sumatriptan nasal spray (5 to 20 mg) in 1,248 pediatric migraineurs aged 12 to 17 years who treated a single attack
• The trials did not establish the efficacy of sumatriptan nasal spray compared with placebo in the treatment of migraine
• In pediatric patients
• Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials
• In adults. …

Clinical trials of sumatriptan injection did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
• Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events Inform patients that sumatriptan injection may cause serious cardiovascular side effects such as myocardial infarction or stroke. …

Sumatriptan Injection 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)]. …

7.1 Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and sumatriptan injection within 24 hours of each other is contraindicated. 7.2 Monoamine Oxidase-A Inhibitors MAO-A inhibitors increase systemic exposure by 2-fold. Therefore, the use of Sumatriptan injection in patients receiving MAO-A inhibitors is contraindicated [see Clinical Pharmacology (12.3)]. …

• Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors (5.1) • Arrhythmias: Discontinue Sumatriptan Injection if occurs (5.2) • Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk (5.3) • Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue Sumatriptan Injection if occurs (5.4) • Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue Sumatriptan Injection if occurs (5.5) • Medication overuse headache: Detoxification may be necessary (5.6) • …

The following serious adverse reactions are described below and elsewhere in the labeling: · Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1)] · Arrhythmias [see Warnings and Precautions (5.2)] · Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3)] · Cerebrovascular events [see Warnings and Precautions (5.4)] · Other vasospasm reactions [see Warnings and Precautions (5.5)] · Medication overuse headache [see Warnings and Precautions (5.6)] · Serotonin syndrome [see Warnings and Precautions (5.7)] · Increase in blood pressure [see Warnings and Precautions (5.8)] · Hypersensitivity reactions [see Cont …

8.1 Pregnancy Risk Summary Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see Data). …

Coronary vasospasm was observed after intravenous administration of sumatriptan injection [see Contraindications (4)]. Overdoses would be expected from animal data (dogs at 0.1 g/kg, rats at 2 g/kg) to possibly cause convulsions, tremor, inactivity, erythema of the extremities, reduced respiratory rate, cyanosis, ataxia, mydriasis, injection site reactions (desquamation, hair loss, and scab formation), and paralysis. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.