Drug Catalog - Product Detail
SUMATRIPTAN FOR INJECTION KIT INJECT. 6MG/0.5ML 1X6MG VL
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00781-3172-07 | SANDOZ | 0 | 6MG/0.5ML | SOLUTION |
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Description
11 DESCRIPTION Sumatriptan Succinate Injection contains sumatriptan succinate, a selective 5-HT 1B/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: The empirical formula is C 14 H 21 N 3 O 2 S•C 4 H 6 O 4 , 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. Sumatriptan Succinate Injection is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of Sumatriptan Succinate Injection 8-mg/mL solution contains 4 mg of sumatriptan (base) as the succinate salt and 3.8 mg of sodium chloride, USP in Water for Injection, USP. Each 0.5 mL of Sumatriptan Succinate Injection 12-mg/mL solution contains 6 mg of sumatriptan (base) as the succinate salt and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range of both solutions is approximately 4.2 to 5.3. The osmolality of both injections is 291 mOsmol. chemical structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Sumatriptan Succinate Injection contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: Prefilled Syringe and/or Autoinjector Pen: The needle shield of the prefilled syringe contains dry natural rubber (a latex derivative) that has the potential to cause allergic reactions in latex-sensitive individuals. Each pack contains a Patient Information and Instructions for Use leaflet. • Sumatriptan Succinate Injection Kit, 4 mg, containing 1 autoinjector pen, 2 prefilled single-dose syringe cartridges, and 1 carrying case (NDC 0781-3169-07). • Sumatriptan Succinate Injection Kit, 6 mg, containing 1 autoinjector pen, 2 prefilled single-dose syringe cartridges, and 1 carrying case (NDC 0781-3172-07). • Two 4-mg single-dose prefilled syringe cartridges for use with Sumatriptan Succinate Injection Kit (NDC 0781-3170-07). • Two 6-mg single-dose prefilled syringe cartridges for use with Sumatriptan Succinate Injection Kit (NDC 0781-3173-07). Single-Dose Vial: • Sumatriptan Succinate Injection single-dose vial (6 mg/0.5 mL) in cartons containing 5 vials (NDC 0781-3174-14). Store between 2° and 30°C (36° and 86°F). Protect from light.
Indications & Usage
1 INDICATIONS AND USAGE Sumatriptan Succinate Injection 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 or cluster headache attack treated with Sumatriptan Succinate Injection, reconsider the diagnosis before Sumatriptan Succinate Injection is administered to treat any subsequent attacks. • Sumatriptan Succinate Injection is not indicated for the prevention of migraine or cluster headache attacks. Sumatriptan Succinate Injection is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for: • Acute treatment of migraine with or without aura in adults ( 1 ) • Acute treatment of cluster headache in adults ( 1 ) Limitations of Use: • Use only if a clear diagnosis of migraine or cluster headache has been established ( 1 ) • Not indicated for the prophylactic therapy of migraine or cluster headache attacks ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • For subcutaneous use only ( 2.1 ) • Acute treatment of migraine: single dose of 1 to 6 mg ( 2.1 ) • Acute treatment of cluster headache: single dose of 6 mg ( 2.1 ) • Maximum dose in a 24-hour period: 12 mg, separate doses by at least 1 hour ( 2.1 ) • The needle shield of the prefilled syringe contains dry natural rubber (a latex derivative) which may cause allergic reactions in latex sensitive patients ( 2.2 ) • Patients receiving doses other than 4 or 6 mg: Use the 6-mg single-dose vial ( 2.3 ) 2.1 Dosing Information The maximum single recommended adult dose of Sumatriptan Succinate Injection 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 ( 14.1 )] . 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. 2.2 Administration Using the Autoinjector Pen An autoinjector device is available for use with 4-mg and 6-mg prefilled syringe cartridges. With this device, the needle penetrates approximately 1/4 inch (5 to 6 mm). The injection is intended to be given subcutaneously, and intramuscular or intravascular delivery must be avoided. Instruct patients on the proper use of the autoinjector pen and direct them to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle. The needle shield of the prefilled syringe contains dry natural rubber (a latex derivative) [see Warnings and Precautions ( 5.9 )]. 2.3 Administration of Doses of Sumatriptan Succinate Other than 4 or 6 mg In patients receiving doses other than 4 mg or 6 mg, use the 6-mg single-dose vial; do not use the autoinjector pen. Visually inspect the vial for particulate matter and discoloration before administration. Do not use if particulates and discolorations are noted.