DICLOFENAC SODIUM tablet, delayed release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

Disponible des:

Golden State Medical Supply, Inc.

Designació comuna internacional (DCI):

DICLOFENAC SODIUM

Composición:

DICLOFENAC SODIUM 50 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation) . Diclofenac sodium delayed-release tablets are indicated: - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis - for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis Diclofenac sodium delayed-release tablets are contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see WARNINGS; Anaphylactic Reactions, Serious Skin Reactions)

Resumen del producto:

Diclofenac sodium delayed-release tablets, USP are available as follows: 50 mg — Each white, round, enteric-coated tablet printed with on one side and 550 on the other side with black ink contains 50 mg of diclofenac sodium, USP. Tablets are supplied in bottles of 100 (NDC 60429-421-01), 180 (NDC 60429-421-18) and 1000 (NDC 60429-421-10). 75 mg — Each white, round, enteric-coated tablet printed with on one side and 551 on the other side with black ink contains 75 mg of diclofenac sodium, USP. Tablets are supplied in bottles of 60 (NDC 60429-422-60), 100 (NDC 60429-422-01), 180 (NDC 60429-422-18) and 1000 (NDC 60429-422-10). Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. C 8/2021 Marketed/Packaged by: GSMS, Inc. Camarillo, CA USA 93012

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Golden State Medical Supply, Inc.
----------
Dispense with Medication Guide available at:
www.tevausa.com/medguides
Medication Guide for Nonsteroidal Anti-Inflammatory Drugs
(NSAIDs)
What is the most important information I should know about medicines
called Non-Steroidal 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:
•
any time 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 had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAIDs.
•
right before or after heart bypass surgery.

Fitxa tècnica

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP
RX ONLY
PRESCRIBING INFORMATION
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS
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).
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS ARE CONTRAINDICATED IN THE
SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY (SEE
CONTRAINDICATIONS, WARNINGS).
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
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
AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC ULCER DISEASE AND/OR GI
BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS (SEE WARNINGS).
DESCRIPTION
Diclofenac sodium delayed-release tablets, USP are a benzene-acetic
acid derivative.
Diclofenac sodium, USP is a white to almost white crystalline powder
and is sparingly
soluble in water at 25°C. The chemical name is
2-[(2,6-dichlorophenyl)amino]
benzeneacetic acid, monosodium salt. The molecular weight is 318.13
g/mol. Its
molecular formula is C
H
Cl
NNaO
, and it has the following structural formula
Each enteric-coated tablet for oral administration contains 50 mg or
75 mg of diclofenac
14
10
2
2
sodium, USP. In addition, each tablet contains the following inactive
ingredients:
aluminum hydrate, colloidal silicon dioxide, hypromellose, lactose
monohydrate,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
polysorbate 80,
polyvinyl acetate phthalate, propylene glycol, silica, sodium
alginate, sodium starch
glycolate (Type A)