NUDROXIPAK E-400- etodolac,methyl salicylate/menthol/capsaicin kit

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Commercializzato da:

NuCare Pharmaceuticals,Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac tablets, USP are indicated: - For acute and long-term use in the management of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis - Osteoarthritis - Rheumatoid arthritis - For the management of acute pain Etodolac is contraindicated in patients with known hypersensitivity to etodolac. Etodolac should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions and PRECAUTIONS, Pre-existing Asthma ). - Etodolac tablets are contraindicated in the setting of coronary arter

Dettagli prodotto:

400 mg Tablets (White to off-white, oval, unscored, film-coated tablets, imprinted APO 041 on one side and 400 on the other side.) -in bottles of 100, NDC 60505-0041-1 Store at 20° to 25°C (68° to 77°F); excursions permitted from 15°C to 30° (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. Manufactured By Manufactured for Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 Revised: July 2016 Rev. 4

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

NUDROXIPAK E-400- ETODOLAC,METHYL SALICYLATE/MENTHOL/CAPSAICIN
NuCare Pharmaceuticals,Inc.
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Medication Guide for Non-Steroidal 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
•
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 have had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAIDs.
•
right before or after heart bypass surgery.
Before ta

Scheda tecnica

NUDROXIPAK E-400- ETODOLAC,METHYL SALICYLATE/MENTHOL/CAPSAICIN
NUCARE PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
NUDROXIPAK E-400
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NUDROXIPAK E-400, SEE
FULL PRESCRIBING INFORMATION FOR NUDROXIPAK E-400.
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. (16)
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. (21)
STORE BELOW (90°F/32°C) (21)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 11/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
DESCRIPTION
CLINICAL PHARMACOLOGY
Pharmacodynamics
Pharmacokinetics
Special Populations
CLINICAL TRIALS
ANALGESIA
OSTEOARTHRITIS
RHEUMATOID ARTHRITIS
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
GENERAL
INFORMATION FOR PATIENTS
LABORATORY TESTS
DRUG INTERACTIONS
Drug/Laboratory Test Interactions
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Pregnancy
Labor and Delivery
Nursing Mothers
Pediatric Use
Geriatric Use
ADVERSE REACTIONS
Incidence Greater Than Or Equal To 1% - Probably Causally Related
Incidence Less Than 1% - Probably Causally Related
Incidence Less Than 1% - Causal Relationship Unknown
Additional Adverse Reactions Reported with NSAIDS
OVERDOSAGE
DOSAGE AND ADMINISTRATION
Analgesia
Osteoarthritis and Rheumatoid Arthritis
HOW SUPPLIED
*
FULL PRESCRIBING INFORMATION
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
increas