Sumatriptan Succinate Subcutaneous Injection, USP

ZEMBRACE SymTouch injection contains 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:

The empirical 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.

ZEMBRACE SymTouch is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of ZEMBRACE SymTouch contains 4.2 mg of sumatriptan succinate equivalent to 3-mg of sumatriptan (base) and 4.15 mg of sodium chloride, USP in Water for Injection, USP.

The pH range of solution is approximately 4.2 to 5.3 and the osmolality of injection is approximately 291 mOsmol (275 to 315 mOsmol).

ZEMBRACE SymTouch is indicated for the acute treatment of migraine with or without aura in adults.

Limitations Of Use

Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with ZEMBRACE SymTouch, reconsider the diagnosis before ZEMBRACE SymTouch is administered to treat any subsequent attacks.

ZEMBRACE SymTouch injection is not indicated for the prevention of migraine attacks.

Dosage Forms And Strengths

Injection: 3 mg sumatriptan in 0.5 mL prefilled, ready-to-use, single dose, disposable auto-injector.

ZEMBRACE SymTouch 3 mg/0.5 mL Injection contains sumatriptan as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution in a prefilled, ready-to-use, single dose, disposable auto-injector unit (NDC # 67857-809-37).

Each carton contains 4 units (NDC # 67857-809-38) and a Patient Information and Instructions for Use leaflet.

Storage And Handling

Store between 20°C and 25°C (68°F and 77°F) Excursions permitted between 15°C and 30°C (59°F and 86°F).

Protect from light.

Manufactured for: Dr. Reddy's Laboratories Limited; by Ajinomoto Althea, Inc., San Diego, CA 92121 Distributed by: Promius Pharma, LLC., Princeton, NJ 08540. Revised: Mar 2017

Coronary vasospasm was observed after intravenous administration of sumatriptan injection [see CONTRAINDICATIONS]. 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.

The elimination half-life of sumatriptan is about 2 hours [see CLINICAL PHARMACOLOGY], and therefore monitoring of patients after overdose with ZEMBRACE SymTouch injection should continue for at least 10 hours or while symptoms or signs persist.

It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.

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© Zembrace SymTouch Patient Information is supplied by Cerner Multum, Inc. and Zembrace SymTouch Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.