DICLOFENAC POTASSIUM- diclofenac potassium tablets tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

DICLOFENAC POTASSIUM (UNII: L4D5UA6CB4) (DICLOFENAC - UNII:144O8QL0L1)

थमां उपलब्ध:

Zydus Pharmaceuticals (USA) Inc.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Carefully consider the potential benefits and risks of diclofenac potassium immediate-release tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: - For treatment of primary dysmenorrhea - For relief of mild to moderate pain - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis Diclofenac potassium 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). - History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients ( see WARNINGS; Anaphylactic Reactions, Exacerbation of Asthma Related to Aspirin Sensitivity). - In the setting of coronary artery bypass graft (CABG) surgery ( see WARNINGS; Cardiovascular Thrombotic Events).

उत्पाद समीक्षा:

Diclofenac Potassium Tablets, USP are available containing 50 mg of diclofenac potassium, USP. The 50 mg tablets are white to off-white, round, biconvex, film coated tablets debossed with 'DP' on one side and '50' on other side. NDC 70710-1832-1 in HDPE Bottle of 100 tablets with child-resistant closure NDC 70710-1832-5 in HDPE Bottle of 500 tablets NDC 70710-1832-0 in HDPE Bottle of 1000 tablets Store and dispense in tight, light- resistant container as defined in the USP. Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779. Manufactured by: Umedica Laboratories Pvt. Ltd. Plot No. 221 and 221/1, GIDC, IInd Phase, Vapi, Gujarat 396195, INDIA (IND). Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev: 06/23

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

Zydus Pharmaceuticals (USA) Inc.
----------
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.
•
Increasedrisk 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
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age,
•
poor health
•
advanced liver disease
•
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.
Before taking NSAIDs, tell your healthcare provider about all of your
med

उत्पाद विशेषताएं

DICLOFENAC POTASSIUM - DICLOFENAC POTASSIUM TABLETS TABLET, FILM
COATED
ZYDUS PHARMACEUTICALS (USA) INC.
----------
DICLOFENAC POTASSIUM 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 POTASSIUM 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 potassium tablets, USP are a benzeneacetic acid derivative.
Diclofenac
potassium tablets are available as immediate-release tablets of 50 mg
(white to off-white)
for oral administration. Diclofenac potassium, USP is a White to
off-white or slightly
yellowish crystalline powder, slightly hygroscopic and is freely
soluble in methanol;
soluble in alcohol; sparingly soluble in water; slightly soluble in
acetone. The chemical
name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid,
monopotassium salt. The
molecular weight is 334.25. Its molecular formula is C
H
Cl
NKO
, and it has the
following structural formula.
14
10
2
2
The inactive ingredients in diclofenac potassium tablets include:
lactose monohydrate,
microcrystalline cellulose, sodium lauryl sulphate, colloidal silicon
dioxide, magnesium
stearate, hypromellose, talc & titanium dioxid