TOLMETIN SODIUM capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Rising Pharma Holdings, Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Carefully consider the potential benefits and risks of tolmetin sodium capsules, USP and other treatment options before deciding to use tolmetin sodium capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Tolmetin sodium capsules are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin sodium capsules are indicated in the treatment of acute flares and the long-term management of the chronic disease. Tolmetin sodium capsules are also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of tolmetin sodium capsules have not been established in pediatric patients under 2 years of age (see PRECAUTIONS: Pediatric Use and DOSAGE AND ADMINISTRATION). Tolmetin sodium capsules 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 reactions

Каталог на резюме:

Tolmetin Sodium Capsules, USP are available containing 492 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 400 mg of tolmetin. The 400 mg capsules are size “0”, hard-shell gelatin capsule with light blue opaque cap and light blue opaque body imprinted with “R26” on body with black ink containing off-white powder. They are available as follows: Bottles of 30 capsules  NDC 16571-826-03 Bottles of 90 capsules  NDC 16571-826-09 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: 02/2023 200606 PIR82601-00 PHARMACIST: Dispense a Medication Guide with each prescription.

Статус Оторизация:

Abbreviated New Drug Application

Листовка

TOLMETIN SODIUM - TOLMETIN SODIUM CAPSULE
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
•
longer use of NSAIDs
•
poor health
•
smoking
•
advanced liver disease
•
drinking alcohol
•
bleeding problems
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 NSA

Данни за продукта

TOLMETIN SODIUM - TOLMETIN SODIUM CAPSULE
RISING PHARMA HOLDINGS, INC.
----------
TOLMETIN SODIUM CAPSULES, USP
400 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 capsules 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 capsule for oral administration contains 492 mg of tolmetin
sodium, USP as the
dihydrate in an amount equivalent to 400 mg of tolmetin. Each capsule
contains 36 mg
(1.568 mEq) of sodium and the following inactive ingredients:
colloidal silicon dioxide,
croscarmellose sodium, magnesium stearate, microcrystalline cellulose,
and sodium
lauryl sulfate. The empty gelatin capsule shells contain FD&C Blue No.
1, gelatin, and
titanium dioxide. In addition, the imprinting ink contains black iron
oxide, D&C Yellow No.
10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2
Aluminum Lake,
FD&C Red No. 40 Aluminum Lake, propylene glycol, and shellac glaze.
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:
Sodium 1-methyl-5_ p_-toluoylpyrrole-2-acetate dihydrate.
CLINICAL PHARMACOLOGY
Studies in animals have shown tolmetin sodium to possess
anti-inflammatory, analgesic,
and antip