TREXIMET- sumatriptan succinate and naproxen sodium tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO), NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)

Disponível em:

Rebel Distributors Corp

DCI (Denominação Comum Internacional):

SUMATRIPTAN SUCCINATE

Composição:

SUMATRIPTAN SUCCINATE 85 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

TREXIMET is indicated for the acute treatment of migraine attacks with or without aura in adults. Carefully consider the potential benefits and risks of TREXIMET and other treatment options when deciding to use TREXIMET. TREXIMET is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of TREXIMET have not been established for cluster headache. TREXIMET should not be given to patients with history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes. In addition, patients with other significant underlying cardiovascular diseases should not receive TREXIMET, nor should patients who have had coronary artery bypass graft (CABG) surgery. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort and vasospastic forms of angina, such as the Prinzmetal variant), all forms of myocardial infarction, and silent

Resumo do produto:

TREXIMET contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium and is supplied as blue film-coated tablets debossed on one side with TREXIMET in compact containers of 9 tablets with a specially formulated, non-removable desiccant (NDC 21695-954-09). Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Do not repackage; dispense and store in original container.

Status de autorização:

New Drug Application

Folheto informativo - Bula

TREXIMET- SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM TABLET, FILM
COATED
Rebel Distributors Corp
----------
MEDICATION GUIDE
TREXIMET®[trex' i-met] Tablets
(sumatriptan and naproxen sodium)
What is the most important information I should know about TREXIMET?
TREXIMET, which contains sumatriptan and naproxen sodium [a
nonsteroidal anti-inflammatory drug
(NSAID)], may increase the chance of a heart attack or stroke that can
lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease.
NSAID-containing medicines, such as TREXIMET, should never be used
right before or after a heart
surgery called a coronary artery bypass graft (CABG).
NSAID-containing medicines, such as TREXIMET, can cause ulcers and
bleeding in the stomach and
intestines at any time during treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death.
The chance of a person getting an ulcer or bleeding increases with:
•
the use of medicines called steroid hormones (corticosteroids) and
blood thinners (anticoagulants)
•
longer use
•
more frequent use
•
smoking
•
drinking alcohol
•
older age
•
having poor health.
TREXIMET is not recommended for people with risk factors for heart
disease unless a heart exam is done
and shows no problems.
The risk factors for heart disease include:
•
high blood pressure
•
high cholesterol levels
•
smoking
•
obesity
•
diabetes
•
family history of heart disease
•
female who has gone through menopause
•
male over age 40.
“Serotonin syndrome” is a serious and life-threatening problem
that may occur with TREXIMET,
especially if used with antidepressant medicines called selective
serotonin reuptake inhibitors (SSRIs) or
selective norepinephrine reuptake inhibitors (SNRIs).
Commonly used SSRIs are:
•
CELEXA® (citalopram HBr)
•
LEXAPRO® (escitalopram oxalate)
•
PAXIL® (paroxetine)
•
PROZAC®/SARAFEM® (fluoxetine)
•
SYMBYAX® (olanzapine/fluoxetine)
•
ZOLOFT® (sertraline)
•
LUVOX® (fluvoxamine)

Características técnicas

TREXIMET- SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM TABLET, FILM
COATED
REBEL DISTRIBUTORS CORP
----------
TREXIMET
(SUMATRIPTAN AND NAPROXEN SODIUM)
TABLETS
WARNINGS
CARDIOVASCULAR RISK: TREXIMET MAY CAUSE AN INCREASED RISK OF SERIOUS
CARDIOVASCULAR
THROMBOTIC EVENTS, MYOCARDIAL INFARCTION, AND STROKE, WHICH CAN BE
FATAL. THIS RISK MAY
INCREASE WITH DURATION OF USE. PATIENTS WITH CARDIOVASCULAR DISEASE OR
RISK FACTORS FOR
CARDIOVASCULAR DISEASE MAY BE AT GREATER RISK (SEE WARNINGS:
CARDIOVASCULAR EFFECTS).
GASTROINTESTINAL RISK: TREXIMET CONTAINS A NONSTEROIDAL
ANTI-INFLAMMATORY DRUG
(NSAID). NSAID-CONTAINING PRODUCTS CAUSE AN INCREASED RISK OF SERIOUS
GASTROINTESTINAL
ADVERSE EVENTS INCLUDING BLEEDING, ULCERATION, AND PERFORATION OF THE
STOMACH OR INTESTINES,
WHICH CAN BE FATAL. THESE EVENTS CAN OCCUR AT ANY TIME DURING USE AND
WITHOUT WARNING
SYMPTOMS. ELDERLY PATIENTS ARE AT GREATER RISK FOR SERIOUS
GASTROINTESTINAL EVENTS (SEE
WARNINGS: RISK OF GASTROINTESTINAL ULCERATION, BLEEDING, AND
PERFORATION WITH
NONSTEROIDAL ANTI-INFLAMMATORY DRUG THERAPY).
DESCRIPTION
TREXIMET contains sumatriptan (as the succinate), a selective
5-hydroxytryptamine (5-HT ) receptor
subtype agonist, and naproxen sodium, a member of the arylacetic acid
group of nonsteroidal anti-
inflammatory drugs (NSAIDs).
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
H N O S•C H O , 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.
Naproxen sodium is chemically designated as
(S)-6-methoxy-α-methyl-2-naphthaleneacetic acid,
sodium salt, and it has the following structure:
®
1
1
14
21
3
2
4
6
4
The empirical formula is C
H NaO , representing a molecular weight of 252.23. Naproxen sodium is
a white-to-creamy white crystalline solid, freely soluble in water at
neutral pH.
Each TREXIMET Tablet for oral administr