ZEMBRACE SymTouch

×

Overview

What is ZEMBRACE SymTouch?

ZEMBRACE SymTouch injection contains sumatriptan succinate, a selective 5-HT 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 CHNOS•CHO, 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).

What does ZEMBRACE SymTouch look like?

What are the available doses of ZEMBRACE SymTouch?

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

What should I talk to my health care provider before I take ZEMBRACE SymTouch?

How should I use ZEMBRACE SymTouch?

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

Limitations of Use:

The recommended dose of ZEMBRACE SymTouch is 3 mg injected subcutaneously.

The maximum cumulative injected dose that may be given in 24 hours is 12 mg, with doses of ZEMBRACE SymTouch separated by at least 1 hour. ZEMBRACE SymTouch may also be given at least 1 hour following a dose of another sumatriptan product.

What interacts with ZEMBRACE SymTouch?

Sorry No Records found

What are the warnings of ZEMBRACE SymTouch?

Sorry No Records found

What are the precautions of ZEMBRACE SymTouch?

Sorry No Records found

What are the side effects of ZEMBRACE SymTouch?

Sorry No records found

What should I look out for while using ZEMBRACE SymTouch?

ZEMBRACE SymTouch injection is contraindicated in patients with:

What might happen if I take too much ZEMBRACE SymTouch?

Coronary vasospasm was observed after intravenous administration of sumatriptan injection . 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 , 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.

How should I store and handle ZEMBRACE SymTouch?

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.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.Cyclobenzaprine hydrochloride tablets USP are available in 5 mg and 10 mg dosage strengths. The 5 mg tablets are beige colored, film coated, round, biconvex tablets debossed with on one side and on other. The 10 mg tablets are yellow colored, film coated, round, biconvex tablets debossed with on one side and on other. The two dosage strengths are supplied as follows: 5 mg – 100 count bottle NDC 69097-845-075 mg – 1000 count bottle NDC 69097-845-1510 mg – 100 count bottle NDC 69097-846-0710 mg – 1000 count bottle NDC 69097-846-15Cyclobenzaprine hydrochloride tablets USP are available in 5 mg and 10 mg dosage strengths. The 5 mg tablets are beige colored, film coated, round, biconvex tablets debossed with on one side and on other. The 10 mg tablets are yellow colored, film coated, round, biconvex tablets debossed with on one side and on other. The two dosage strengths are supplied as follows: 5 mg – 100 count bottle NDC 69097-845-075 mg – 1000 count bottle NDC 69097-845-1510 mg – 100 count bottle NDC 69097-846-0710 mg – 1000 count bottle NDC 69097-846-15Cyclobenzaprine hydrochloride tablets USP are available in 5 mg and 10 mg dosage strengths. The 5 mg tablets are beige colored, film coated, round, biconvex tablets debossed with on one side and on other. The 10 mg tablets are yellow colored, film coated, round, biconvex tablets debossed with on one side and on other. The two dosage strengths are supplied as follows: 5 mg – 100 count bottle NDC 69097-845-075 mg – 1000 count bottle NDC 69097-845-1510 mg – 100 count bottle NDC 69097-846-0710 mg – 1000 count bottle NDC 69097-846-15Cyclobenzaprine hydrochloride tablets USP are available in 5 mg and 10 mg dosage strengths. The 5 mg tablets are beige colored, film coated, round, biconvex tablets debossed with on one side and on other. The 10 mg tablets are yellow colored, film coated, round, biconvex tablets debossed with on one side and on other. The two dosage strengths are supplied as follows: 5 mg – 100 count bottle NDC 69097-845-075 mg – 1000 count bottle NDC 69097-845-1510 mg – 100 count bottle NDC 69097-846-0710 mg – 1000 count bottle NDC 69097-846-15Cyclobenzaprine hydrochloride tablets USP are available in 5 mg and 10 mg dosage strengths. The 5 mg tablets are beige colored, film coated, round, biconvex tablets debossed with on one side and on other. The 10 mg tablets are yellow colored, film coated, round, biconvex tablets debossed with on one side and on other. The two dosage strengths are supplied as follows: 5 mg – 100 count bottle NDC 69097-845-075 mg – 1000 count bottle NDC 69097-845-1510 mg – 100 count bottle NDC 69097-846-0710 mg – 1000 count bottle NDC 69097-846-15

×

Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Sumatriptan binds with high affinity to human cloned 5-HT receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

Non-Clinical Toxicology

ZEMBRACE SymTouch injection is contraindicated in patients with:

Cyclobenzaprine HCl may have life-threatening interactions with MAO inhibitors. (See .) Postmarketing cases of serotonin syndrome have been reported during combined use of Cyclobenzaprine Hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. If concomitant treatment with Cyclobenzaprine Hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see ).

Cyclobenzaprine HCl may enhance the effects of alcohol, barbiturates, and other CNS depressants.

Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.

Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.

† ULTRAM (tramadol hydrochloride tablets, Ortho-McNeil Pharmaceutical)

† ULTRACET (tramadol hydrochloride and acetaminophen tablets, Ortho-McNeil Pharmaceutical)

The use of ZEMBRACE SymTouch injection 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 injection. Some of these reactions occurred in patients without known CAD. 5-HT agonists, including ZEMBRACE SymTouch injection, 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 ZEMBRACE SymTouch injection. If there is evidence of CAD or coronary artery vasospasm, ZEMBRACE SymTouch injection is contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of ZEMBRACE SymTouch injection in a medically supervised setting and performing an electrocardiogram (ECG) immediately following ZEMBRACE SymTouch injection. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of ZEMBRACE SymTouch injection.

The following serious adverse reactions are described below and elsewhere in the labeling:

×

Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

×

Review

×

Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

×

Tips

×

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

Disclaimer: