TOLMETIN SODIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Pharma Holdings, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of tolmetin sodium tablets, USP 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 sodium tablets are indicated in the treatment of acute flares and the long-term management of the chronic disease. Tolmetin sodium tablets are also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of tolmetin sodium tablets have not been established in pediatric patients under 2 years of age (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION). Tolmetin sodium tablets are contraindicated in patients with known hypersensitivity to tolmetin sodium. Tolmetin should not be given to patients who have experienced asthma, urticaria or allergic-type re

Product summary:

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 600 mg tablets are a beige, film-coated, oval-shaped, biconvex, beveled-edge tablet debossed with “R 25” on one side of the tablet and plain on the other side. They are available as follows: Bottles of 30 Tablets    NDC 16571-825-03 Bottles of 90 Tablets    NDC 16571-825-09 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Issued: 04/2023 200607 PIR82501-00 PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TOLMETIN SODIUM - TOLMETIN SODIUM TABLET, FILM COATED
Rising Pharma Holdings, Inc.
----------
SPL MEDGUIDE
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
• Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
° with increasing doses of NSAIDs
° with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft (CABG).”
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
• Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the mouth
to the stomach), stomach and intestines:
° anytime during use
° without warning symptoms
° that may cause death
The risk of getting an ulcer or bleeding increases with:
° past history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
° taking medicines called “corticosteroids”,
“anticoagulants”, “SSRIs”, or “SNRIs”
° increasing doses of NSAIDs
° older age
° poor health
° advanced liver disease
° bleeding problems
° longer use of NSAID
° smoking
° drinking alcohol
NSAIDs should only be used:
° exactly as prescribed
° at the lowest dose possible for your treatment
° for the shortest time needed
What are NSAIDs?
NSAIDs 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 NSAIDs?
Do not take NSAIDs:
•
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs.
•
right before or after heart bypass surgery.
Before taking NSAIDs, te

Summary of Product characteristics

TOLMETIN SODIUM - TOLMETIN SODIUM TABLET, FILM COATED
RISING PHARMA HOLDINGS, INC.
----------
TOLMETIN SODIUM TABLETS, USP 600 MG
RX ONLY
BOXED WARNING
CARDIOVASCULAR THROMBOTIC EVENTS
• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased
risk of serious
cardiovascular thrombotic events, including myocardial infarction and
stroke, which
can be fatal. This risk may occur early in treatment and may increase
with duration
of use (see WARNINGS and PRECAUTIONS).
• Tolmetin sodium tablets are contraindicated 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
(maize), 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, soluble in methanol and
slightly soluble in
alcohol. Tolmetin sodium is a nonselective nonsteroidal
anti-inflammatory agent. The
structural formula is:
(C
H
NNaO • 2H O)
M.W. 315.30
Sodium 1-methyl-5 _p_-toluoylpyrrole-2-acetate dihydrate.
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 inflamm