DICLOFENAC SODIUM AND MISOPROSTOL tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

MISOPROSTOL (UNII: 0E43V0BB57) (MISOPROSTOL - UNII:0E43V0BB57), DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

Mevcut itibaren:

DIRECT RX

INN (International Adı):

DICLOFENAC SODIUM

Kompozisyon:

DICLOFENAC SODIUM 75 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Carefully consider the potential benefits and risks of diclofenac sodium/misoprostol tablets and other treatment options before deciding to use diclofenac sodium/misoprostol tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium/misoprostol tablets are 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. Diclofenac sodium/misoprostol tablets should not be taken by pregnant women. Diclofenac sodium/misoprostol tablets are contraindicated in patients with hypersensitivity

Ürün özeti:

Diclofenac sodium/misoprostol tablets are supplied as film-coated tablets 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 a "50" in the middle on one side and "G" and "0028" on the other. The 75 mg/200 mcg dosage strength is a round, biconvex, white to off-white tablet imprinted with a "75" in the middle on one side and "G" and "0029" on the other. The dosage strengths are supplied in: Store at or below 25°C (77°F), in a dry area.

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

DIRECT RX
----------
SPL MEDGUIDE SECTION
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 and pharmacist.
•
if you are pregnant. NSAID medicines shou

Ürün özellikleri

DICLOFENAC SODIUM AND MISOPROSTOL- DICLOFENAC SODIUM AND MISOPROSTOL
TABLET, FILM
COATED
DIRECT RX
----------
DICLOFENAC SODIUM AND MISOPROSTOL
BOXED WARNING SECTION
CONTRAINDICATIONS AND WARNINGS
DICLOFENAC SODIUM/MISOPROSTOL TABLETS CONTAIN 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).
DICLOFENAC SODIUM/MISOPROSTOL TABLETS 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. Diclofenac sodium/misoprostol tablets
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, diclofenac sodium/misoprostol
tablets 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 diclofenac sodium/misoprostol tablets 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).
Diclofenac