LIDOVIX DELAYED RELEASE- lidocaine, diclofenac sodium

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Primary Pharmaceuticals, Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac is 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 ). - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSA

Ürün özeti:

75 mg -– white to off-white, biconvex, round shaped, unscored (imprinted on one side), supplied in bottles of 60 Bottles of 60 ..................................................................NDC 61442-103-60 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. Dispense in tight container (USP). Manufactured by: Carlsbad Tech Carlsbad, CA 92008 USA Revised: 05/2016 Lidocaine patch 5% is available as the following: Carton of 30 patches, packaged into individual child-resistant envelopes. NDC 0591-3525-30 Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature]. For more information, call Actavis at 1-800-272-5525. Manufactured by: Actavis Laboratories UT, Inc. Salt Lake City, UT 84108 USA

Yetkilendirme durumu:

unapproved drug other

Bilgilendirme broşürü

LIDOVIX DELAYED RELEASE- LIDOCAINE, DICLOFENAC SODIUM
Primary Pharmaceuticals, Inc.
Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been
approved by FDA. For further information about unapproved drugs, click
here.
----------
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 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 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:
•

Ürün özellikleri

LIDOVIX DELAYED RELEASE- LIDOCAINE, DICLOFENAC SODIUM
PRIMARY PHARMACEUTICALS, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
LIDOVIX
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 is a benzene-acetic acid
derivative. Diclofenac sodium is a
white or slightly yellowish 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
318.14. Its molecular formula is C
H
Cl
NNaO
, and it has the following structural formula
The inactive ingredients in diclofenac sodium delayed-release tablets
include: hydroxypropyl
methylcellulose, lactose monohydrate, magnesium stearate, methacrylic
acid copolymer,
microcrystalline cellulose, polyethylene glycol, povidone, propylene
glycol, sodium starch glycolate,
talc, titanium dio