NUDROXIPAK DSDR-75- diclofenac sodium, methyl salicylate/menthol/capsaicin kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, USP 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 Reaction

Product summary:

Diclofenac Sodium Delayed-Release Tablets, USP are available as follows: 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 0228-2551-06) 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. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9184 Revised — October 2017

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NUDROXIPAK DSDR-75- DICLOFENAC SODIUM, METHYL
SALICYLATE/MENTHOL/CAPSAICIN
NuCare Pharmaceuticals,Inc.
----------
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:
•
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.
B

Summary of Product characteristics

NUDROXIPAK DSDR-75- DICLOFENAC SODIUM, METHYL
SALICYLATE/MENTHOL/CAPSAICIN
NUCARE PHARMACEUTICALS,INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
NUDROXIPAK DSDR-75
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC SOD DR . SEE
FULL PRESCRIBING INFORMATION FOR DICLOFENAC SOD DR .
INITIAL U.S. APPROVAL
INDICATIONS AND USAGE
Use for the temporary relief of minor aches and muscle pains
associated with arthritis, simple backache,
strains, muscle soreness and stiffness. (15)
DOSAGE AND ADMINISTRATION
Shake before each use. Prior to first use rub small amount to check
for sensitivity. Apply product directly
to affected area. Dry before contact with clothes or bedding to avoid
staining. Wash hands after use.
Product may be used as necessary, but should not be used more than
four times per day. (20)
STORE BELOW (90°F/32°C) (20)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 10/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
DESCRIPTION
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
PHARMACOKINETICS
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS
CARDIOVASCULAR THROMBOTIC EVENTS
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
HEPATOTOXICITY
HYPERTENSION
HEART FAILURE AND EDEMA
RENAL TOXICITY AND HYPERKALEMIA
ANAPHYLACTIC REACTIONS
EXACERBATION OF ASTHMA RELATED TO ASPIRIN SENSITIVITY
SERIOUS SKIN REACTIONS
Premature Closure of Fetal Ductus Arteriosus
Hematologic Toxicity
PRECAUTIONS
GENERAL
INFORMATION FOR PATIENTS
LABORATORY MONITORING
DRUG INTERACTIONS
Carcinogenesis, Mutagenesis, Impairment of Fertility
PREGNANCY
LABOR OR DELIVERY
NURSING MOTHERS
PEDIATRIC USE
GERIATRIC USE
ADVERSE REACTIONS
OVERDOSAGE
DOSAGE AND ADMINISTRATION
HOW SUPPLIED
*
FULL 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