ARTHROTEC- diclofenac sodium and misoprostol tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

diclofenac sodium (UNII: QTG126297Q) (diclofenac - UNII:144O8QL0L1), misoprostol (UNII: 0E43V0BB57) (misoprostol - UNII:0E43V0BB57)

可用日期:

Rebel Distributors Corp.

INN（国际名称）:

diclofenac sodium

组成:

diclofenac sodium 75 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Carefully consider the potential benefits and risks of ARTHROTEC and other treatment options before deciding to use ARTHROTEC. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). ARTHROTEC is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. See WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding and Perforation for a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications. See boxed CONTRAINDICATIONS AND WARNINGS related to misoprostol. ARTHROTEC should not be taken by pregnant women. ARTHROTEC is contraindicated in patients with hypersensitivity to diclofenac or to misoprostol or other prostaglandins. ARTHROTEC should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after

產品總結:

ARTHROTEC (diclofenac sodium/misoprostol) is supplied as a film-coated tablet in dosage strengths of either 50 mg diclofenac sodium/200 mcg misoprostol or 75 mg diclofenac sodium/200 mcg misoprostol. The 50 mg/200 mcg dosage strength is a round, biconvex, white to off-white tablet imprinted with four "A's" encircling a "50" in the middle on one side and "SEARLE" and "1411" on the other. The 75 mg/200 mcg dosage strength is a round, biconvex, white to off-white tablet imprinted with four "A's" encircling a "75" in the middle on one side and "SEARLE" and "1421" on the other. The dosage strengths are supplied in: Store at or below 25°C (77°F), in a dry area.

授权状态:

New Drug Application

资料单张

ARTHROTEC - DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED
Rebel Distributors Corp.
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MEDICATION GUIDE FOR NON-STEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This
chance increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a "coronary artery
bypass graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called "corticosteroids" and "anticoagulants"
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider a

产品特点

ARTHROTEC - DICLOFENAC SODIUM AND MISOPROSTOL TABLET, FILM COATED
REBEL DISTRIBUTORS CORP.
----------
ARTHROTEC
(DICLOFENAC SODIUM/MISOPROSTOL) TABLETS
CONTRAINDICATIONS AND WARNINGS
ARTHROTEC CONTAINS DICLOFENAC SODIUM AND MISOPROSTOL.
ADMINISTRATION OF MISOPROSTOL TO WOMEN WHO ARE PREGNANT CAN CAUSE
ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS
BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT
WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK
OF PREGNANCY (see also PRECAUTIONS). ARTHROTEC SHOULD NOT BE TAKEN BY
PREGNANT WOMEN (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED
NOT TO GIVE THE DRUG TO OTHERS.ARTHROTEC should not be used in women
of
childbearing potential unless the patient requires nonsteroidal
anti-inflammatory drug (NSAID)
therapy and is at high risk of developing gastric or duodenal
ulceration or for developing
complications from gastric or duodenal ulcers associated with the use
of the NSAID (see
WARNINGS). In such patients, ARTHROTEC may be prescribed if the
patient:
has had a negative serum pregnancy test within 2 weeks prior to
beginning therapy.
is capable of complying with effective contraceptive measures.
has received both oral and written warnings of the hazards of
misoprostol, the risk of possible
contraception failure, and the danger to other women of childbearing
potential should the drug
be taken by mistake.
will begin ARTHROTEC only on the second or third day of the next
normal menstrual period.
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk
(see WARNINGS).
ARTHROTEC is contraindicated for treatment of peri-operative pain in
the setting of
coronary artery bypass graft (CABG) surgery (see WARNINGS).
GASTROINTESTINAL RISK