Drug Catalog - Product Detail
Sumatriptan Succinate Inj 6 MG/0.5ML 0.5 ML x 5 UD
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 64679-0728-01 | WOCKHARDT USA | 0 | 6MG/0.5ML | SOLUTION |
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Description
DESCRIPTION Sumatriptan succinate injection is a selective 5-hydroxytryptamine1 receptor subtype 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 molecular formula is C 14 H 21 N 3 O 2 SC 4 H 6 O 4 , representing a molecular weight of 413.5. Sumatriptan succinate is a white or almost 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 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 solution is approximately 4.2 to 5.3. The osmolality of injection is in between 270 to 330 mOsmol. Structure
How Supplied
HOW SUPPLIED Sumatriptan succinate injection 6 mg / 0.5 mL containing sumatriptan 6 mg (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: NDC 64679-728-01 sumatriptan succinate injection single-dose vial (6 mg/0.5 mL) in cartons containing 5 vials. Store between 2° and 25°C (36° and 77°F). Protect from light.
Indications & Usage
INDICATIONS AND USAGE Sumatriptan succinate injection is indicated for 1) the acute treatment of migraine attacks with or without aura and 2) the acute treatment of cluster headache episodes. Sumatriptan succinate injection is not for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS ).
Dosage and Administration
DOSAGE AND ADMINISTRATION The maximum single recommended adult dose of sumatriptan succinate injection is 6 mg injected subcutaneously. If side effects are dose limiting, then lower doses may be used (see Table 1). The maximum recommended dose that may be given in 24 hours is two 6-mg injections separated by at least 1 hour. Controlled clinical trials have failed to show that clear benefit is associated with the administration of a second 6-mg dose in patients who have failed to respond to a first injection. In patients receiving MAO inhibitors, decreased doses of sumatriptan should be considered (see WARNINGS: Concomitant Drug Use and CLINICAL PHARMACOLOGY: Drug Interactions: Monoamine Oxidase Inhibitors ). Since the injection is intended to be given subcutaneously, intramuscular or intravascular delivery should be avoided. Patients should be directed to use injection sites with an adequate skin and subcutaneous thickness to accommodate the length of the needle. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.