TOLMETIN SODIUM- tolmetin sodium capsule TOLMETIN SODIUM- tolmetin sodium tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

tolmetin sodium (UNII: 02N1TZF99F) (tolmetin - UNII:D8K2JPN18B)

Disponível em:

Mutual Pharmaceutical Company, Inc.

DCI (Denominação Comum Internacional):

tolmetin sodium

Composição:

tolmetin 400 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Carefully consider the potential benefits and risks of tolmetin sodium and other treatment options before deciding to use tolmetin sodium. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Tolmetin sodium is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin sodium is indicated in the treatment of acute flares and the long-term management of the chronic disease. Tolmetin sodium is also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of tolmetin sodium have not been established in pediatric patients under 2 years of age (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION ). Tolmetin sodium is contraindicated in patients with known hypersensitivity to tolmetin sodium. Tolmetin sodium should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, an

Resumo do produto:

Tolmetin sodium capsules and tablets are supplied as follows: Tolmetin sodium capsules equivalent to 400 mg tolmetin, orange/orange imprinted: Mutual   179 Tolmetin sodium tablets equivalent to 200 mg tolmetin, off white, round scored, debossed: MP 50 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

TOLMETIN SODIUM- TOLMETIN SODIUM TABLET
Mutual Pharmaceutical Company, Inc.
----------
MEDICATION GUIDE FOR NON-STEROIDAL ANTI-
INFLAMMATORY DRUGS (NSAIDS)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 medicines should never be used right before or after a heart
surgery called a "coronary artery
bypass graft (CABG)."
NSAID medicines 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:
•
taking medicines called "corticosteroids" and "anticoagulants"
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines are used to treat pain and redness, swelling, and heat
(inflammation) from medical
conditions such as:
•
different types of arthritis
•
menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.

Características técnicas

TOLMETIN SODIUM- TOLMETIN SODIUM CAPSULE
TOLMETIN SODIUM- TOLMETIN SODIUM TABLET
MUTUAL PHARMACEUTICAL COMPANY, INC.
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TOLMETIN SODIUM CAPSULES USP
TOLMETIN SODIUM TABLETS USP
RX ONLY
CARDIOVASCULAR RISK
NSAIDs 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).
Tolmetin sodium is contraindicated for the treatment of peri-operative
pain in the setting of
coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and
WARNINGS).
GASTROINTESTINAL RISK
NSAIDs 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 anytime during use and without warning symptoms. Elderly
patients are at greater risk
for serious gastrointestinal events (See WARNINGS).
DESCRIPTION
Each tolmetin sodium capsule, for oral administration, contains 492 mg
of tolmetin sodium (as the
dihydrate), equivalent to 400 mg of tolmetin. Each capsule contains 36
mg (1.568 mEq) of sodium and
the following inactive ingredients: FD&C Red No. 3, FD&C Yellow No. 6,
gelatin, magnesium
stearate, pregelatinized starch, talc and titanium dioxide.
Each tolmetin sodium tablet, for oral administration, contains 246 mg
of tolmetin sodium (as the
dihydrate), equivalent to 200 mg of tolmetin (scored for 100 mg). Each
tablet contains 18 mg (0.784
mEq) of sodium and the following inactive ingredients: magnesium
stearate, microcrystalline cellulose,
pregelatinized starch, sodium starch glycolate and talc.
The pKa of tolmetin is 3.5 and tolmetin sodium is freely soluble in
water.
Tolmetin sodium is a nonselective nonsteroidal anti-inflammatory
agent.
The structural formula is:
Sodium 1-methyl-5-(4-methylbenzoyl)-1_H_-pyrrole-2-acetate dihydrate.
CLINICAL PHARMACOLOGY
Studies in animals