Drug Facts
Composition & Profile
Identifiers & Packaging
Sumatriptan succinate tablets, 25 mg, 50 mg, and 100 mg of sumatriptan (base) as the succinate. Sumatriptan succinate tablets, 25 mg are white, triangular-shaped, film-coated tablets debossed with "S" on one side and "I" on the other side. Bottles of 30 (Child Resistant Cap).........................................NDC 62756-520-83 Bottles of 100 (Child Resistant Cap).........................................NDC 62756-520-88 Bottles of 100 ..................................................................................NDC 62756-520-08 Bottles of 1000 ..................................................................................NDC 62756-520-18 Unit-of-use blister pack of 9 (1x9) tablets...................................NDC 72189-432-09 Unit-of-use blister pack of 9 (3x3) tablets....................................NDC 62756-520-93 Unit-of-use blister pack of 27 (3x9) tablets……………….…..NDC 62756-520-01 Sumatriptan succinate tablets, 50 mg are white, triangular-shaped, film-coated tablets debossed with "S" on one side and "50" on the other side. Bottles of 30 (Child Resistant Cap)......................................... NDC 62756-521-83 Bottles of 100 (Child Resistant Cap).........................................NDC 62756-521-88 Bottles of 100 .................................................................................NDC 62756-521-08 Bottles of 1000 ..................................................................................NDC 62756-521-18 Unit-of-use blister pack of 9 (1x9) tablets.........................................NDC 62756-521-69 Unit-of-use blister pack of 9 (3x3) tablets.........................................NDC 62756-521-93 Unit-of-use blister pack of 27 (3x9) tablets……………….…...NDC 62756-521-01 Sumatriptan succinate tablets, 100 mg are pink, triangular-shaped, film-coated tablets debossed with "S" on one side and "100" on the other side. Bottles of 30 (Child Resistant Cap) .........................................NDC 62756-522-83 Bottles of 100 (Child Resistant Cap).........................................NDC 62756-522-88 Bottles of 100 ..................................................................................NDC 62756-522-08 Bottles of 1000 .................................................................................. NDC 62756-522-18 Unit-of-use blister pack of 9 (1x9) tablets........................NDC 62756-522-69 Unit-of-use blister pack of 9 (3x3) tablets...............................NDC 62756-522-93 Unit-of-use blister pack of 27 (3x9) tablets..............................NDC 62756-522-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP controlled Room Temperature.); 72189-432-09
- Sumatriptan succinate tablets, 25 mg, 50 mg, and 100 mg of sumatriptan (base) as the succinate. Sumatriptan succinate tablets, 25 mg are white, triangular-shaped, film-coated tablets debossed with "S" on one side and "I" on the other side. Bottles of 30 (Child Resistant Cap).........................................NDC 62756-520-83 Bottles of 100 (Child Resistant Cap).........................................NDC 62756-520-88 Bottles of 100 ..................................................................................NDC 62756-520-08 Bottles of 1000 ..................................................................................NDC 62756-520-18 Unit-of-use blister pack of 9 (1x9) tablets...................................NDC 72189-432-09 Unit-of-use blister pack of 9 (3x3) tablets....................................NDC 62756-520-93 Unit-of-use blister pack of 27 (3x9) tablets……………….…..NDC 62756-520-01 Sumatriptan succinate tablets, 50 mg are white, triangular-shaped, film-coated tablets debossed with "S" on one side and "50" on the other side. Bottles of 30 (Child Resistant Cap)......................................... NDC 62756-521-83 Bottles of 100 (Child Resistant Cap).........................................NDC 62756-521-88 Bottles of 100 .................................................................................NDC 62756-521-08 Bottles of 1000 ..................................................................................NDC 62756-521-18 Unit-of-use blister pack of 9 (1x9) tablets.........................................NDC 62756-521-69 Unit-of-use blister pack of 9 (3x3) tablets.........................................NDC 62756-521-93 Unit-of-use blister pack of 27 (3x9) tablets……………….…...NDC 62756-521-01 Sumatriptan succinate tablets, 100 mg are pink, triangular-shaped, film-coated tablets debossed with "S" on one side and "100" on the other side. Bottles of 30 (Child Resistant Cap) .........................................NDC 62756-522-83 Bottles of 100 (Child Resistant Cap).........................................NDC 62756-522-88 Bottles of 100 ..................................................................................NDC 62756-522-08 Bottles of 1000 .................................................................................. NDC 62756-522-18 Unit-of-use blister pack of 9 (1x9) tablets........................NDC 62756-522-69 Unit-of-use blister pack of 9 (3x3) tablets...............................NDC 62756-522-93 Unit-of-use blister pack of 27 (3x9) tablets..............................NDC 62756-522-01 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP controlled Room Temperature.)
- 72189-432-09
Overview
Sumatriptan succinate tablets contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: [chemical-structure] The molecular formula is C14H21N3O2S·C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan succinate tablet for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate, USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C Red # 27 aluminum lake (100 mg only), dibasic calcium phosphate, hypromellose, iron oxide red (100 mg only), magnesium stearate, microcrystalline cellulose, polyethylene glycol (25 mg & 50 mg only), polysorbate 80 (25 mg & 50 mg only) propylene glycol (100 mg only), talc and titanium dioxide.
Indications & 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.
Dosage & Administration
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)].
Warnings & Precautions
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. 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. 5.7 Serotonin Syndrome Serotonin syndrome may occur with sumatriptan succinate tablets, particularly during coadministration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors [see Drug Interactions (7.4)]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue sumatriptan succinate tablets if serotonin syndrome is suspected. 5.8 Increase in Blood Pressure Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with sumatriptan succinate. Sumatriptan succinate tablets are contraindicated in patients with uncontrolled hypertension. 5.9 Anaphylactic/Anaphylactoid Reactions Anaphylactic/anaphylactoid reactions have occurred in patients receiving sumatriptan succinate. Such reactions can be life-threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. Sumatriptan succinate tablets are contraindicated in patients with a history of hypersensitivity reaction to sumatriptan succinate. 5.10 Seizures Seizures have been reported following administration of sumatriptan succinate. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. There are also reports in patients where no such predisposing factors are apparent. Sumatriptan succinate tablets should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.
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 [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-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)]
Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the prescribing information: 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 Contraindications (4), Warnings and Precautions (5.9)] Seizures [see Warnings and Precautions (5.10)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Table 1 lists adverse reactions that occurred in placebo-controlled clinical trials in patients who took at least 1 dose of study drug. Only treatment-emergent adverse reactions that occurred at a frequency of 2% or more in any group treated with sumatriptan succinate tablets and that occurred at a frequency greater than the placebo group are included in Table 1. Table 1. Adverse Reactions Reported by at Least 2% of Patients Treated with Sumatriptan Succinate Tablets and at a Greater Frequency than Placebo Adverse Reaction Percent of Patients Reporting Sumatriptan Succinate Tablets 25 mg (n = 417) Sumatriptan Succinate Tablets 50 mg (n = 771) Sumatriptan Succinate Tablets 100 mg (n = 437) Placebo (n = 309) Atypical sensations 5 6 6 4 Paresthesia (all types) 3 5 3 2 Sensation warm/cold 3 2 3 2 Pain and other pressure sensations 6 6 8 4 Chest - pain/tightness/ pressure and/or heaviness 1 2 2 1 Neck/throat/jaw - pain/ tightness/pressure <1 2 3 <1 Pain - location specified 2 1 1 1 Other - pressure/tightness/ heaviness 1 1 3 2 Neurological Vertigo <1 <1 2 <1 Other Malaise/fatigue 2 2 3 <1 The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients. There were insufficient data to assess the impact of race on the incidence of adverse reactions. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of sumatriptan succinate tablets, sumatriptan nasal spray, and sumatriptan injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to sumatriptan succinate or a combination of these factors. Cardiovascular Hypotension, palpitations. Neurological Dystonia, tremor.
Drug Interactions
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 succinate tablets within 24 hours of each other is contraindicated. 7.2 Monoamine Oxidase-A Inhibitors MAO-A inhibitors increase systemic exposure by 7-fold. Therefore, the use of sumatriptan succinate tablets in patients receiving MAO-A inhibitors is contraindicated [see Clinical Pharmacology (12.3)]. 7.3 Other 5-HT1 Agonists Because their vasospastic effects may be additive, coadministration of sumatriptan succinate tablets and other 5-HT1 agonists (e.g., triptans) within 24 hours of each other is contraindicated. 7.4 Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome Cases of serotonin syndrome have been reported during coadministration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7)].
Storage & Handling
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP controlled Room Temperature.)
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