TOLMETIN SODIUM tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

TOLMETIN SODIUM (UNII: 02N1TZF99F) (TOLMETIN - UNII:D8K2JPN18B)

Dostupné s:

STAT RX USA LLC

INN (Mezinárodní Name):

TOLMETIN SODIUM

Složení:

TOLMETIN SODIUM 600 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Tolmetin Sodium Tablets, USP are available containing 738 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 600 mg of tolmetin. The tablet is a beige film-coated, oval-shaped, unscored tablet debossed with M 313 on one side and blank on the other side. They are available as follows: NDC 0378-0313-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED MAY 2008 TLNT:R1mc

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

TOLMETIN SODIUM - TOLMETIN SODIUM TABLET, FILM COATED
STAT RX USA LLC
----------
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction (MI) 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 perioperative
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 any time during use and without warning symptoms. Elderly
patients are at greater risk
for serious gastrointestinal events (see WARNINGS)
DESCRIPTION
Each tablet for oral administration contains 738 mg of tolmetin
sodium, USP as the dihydrate in an
amount equivalent to 600 mg of tolmetin. Each tablet contains 54 mg
(2.35 mEq) of sodium and the
following inactive ingredients: black iron oxide, crospovidone,
hypromellose, magnesium stearate,
microcrystalline cellulose, polydextrose, polyethylene glycol,
povidone, pregelatinized starch, sodium
lauryl sulfate, titanium dioxide, triacetin and yellow iron oxide.
The pKa of tolmetin is 3.5 and tolmetin sodium is freely soluble in
water.
Tolmetin sodium is a nonselective non-steroidal anti-inflammatory
agent. The structural formula is:
SODIUM 1-METHYL-5 P-TOLUOYLPYRROLE-2-ACETATE DIHYDRATE MOLECULAR
FORMULA:
C H NNAO •2H M.W. 315.30
CLINICAL PHARMACOLOGY
Studies in animals have shown tolmetin sodium to possess
anti-inflammatory, analgesic and antipyretic
activity. In the rat, tolmetin prevents the development of
experimentally induced polyarthritis and also
decreases established inflammation.
The mode of action of tolmetin is not known. However, studies in
laboratory animals and man ha