Drug Catalog - Product Detail
SUMATRIPTAN PREFILLED SYRINGE INJECT. 6MG/0.5ML SD 2X0.5ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 55111-0693-12 | DR.REDDY'S LABORATORIES, INC. | 0 | 6MG/0.5ML | SOLUTION |
PACKAGE FILES
Generic Name
SUMATRIPTAN SUCCINATE
Substance Name
SUMATRIPTAN SUCCINATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
SUBCUTANEOUS
Application Number
ANDA090495
Description
11 DESCRIPTION Sumatriptan injection USP contains sumatriptan succinate, USP a selective 5-HT 1B/1D receptor agonist. Sumatriptan succinate, USP is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The molecular 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 USP is a white or almost white powder and is freely soluble in water, sparingly soluble in methanol, practically insoluble in methylene chloride. Sumatriptan injection USP is a clear, colorless to pale yellow, free from visible particulate matter, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of sumatriptan injection solution contains 8.4 mg of sumatriptan succinate, USP equivalent to 6 mg of sumatriptan, USP and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range of the solutions is approximately 4.2 to 5.3. The osmolality of the injection is between 275 and 315 mOsm/kg.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Sumatriptan injection USP contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: NDC 55111-693-12 Sumatriptan Injection USP Autoinjector System includes 2 Autoinjectors, each with an associated single-dose prefilled syringe which contains 6 mg of sumatriptan (as the succinate salt) and 3.5 mg of sodium chloride in 0.5 mL of solution. Store at 25°C (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.
Indications & Usage
1 INDICATIONS AND USAGE Sumatriptan 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 injection, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks. Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks. Sumatriptan 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) 2.1 Dosing Information The maximum single recommended adult dose of sumatriptan 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, the lower dose of 4 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 Sumatriptan Autoinjector An autoinjector device (sumatriptan autoinjector) is available for use with 6 mg prefilled syringe to facilitate self-administration in patients using the 6 mg dose. 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 sumatriptan autoinjector and direct them to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle.