DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE- diclofenac sodium and misoprostol tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Diclofenac sodium (UNII: QTG126297Q) (Diclofenac - UNII:144O8QL0L1), Misoprostol (UNII: 0E43V0BB57) (Misoprostol - UNII:0E43V0BB57)

Available from:

Eagle Pharmaceuticals, Inc.

INN (International Name):

Diclofenac sodium

Composition:

Diclofenac sodium 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Diclofenac sodium and misoprostol delayed-release tablets (diclofenac sodium/misoprostol) are 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 white circular, biconvex tablets with off white circular enteric coated inlay tablets on one side and debossed “DM2” on other side. The 75 mg/200 mcg dosage strength is a white circular, biconvex tablets with off white circular enteric coated inlay tablets on one side and debossed “DM1” on other side. The dosage strengths are supplied in: Store at or below 25°C (77°F), in a dry area. Rx only Manufactured by: Cipla Ltd., India For: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA Revised April 2013 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MISOPROSTOL TABLET, DELAYED RELEASE
Eagle Pharmaceuticals, Inc.
----------
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 inter

Summary of Product characteristics

DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE - DICLOFENAC SODIUM
AND MISOPROSTOL TABLET, DELAYED RELEASE
EAGLE PHARMACEUTICALS, INC.
----------
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS
CONTRAINDICATIONS AND WARNINGS
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE 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 AND MISOPROSTOL DELAYED-RELEASE 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 AND MISOPROSTOL
DELAYED-RELEASE 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 and misoprostol delayed-release 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 and misoprostol delayed-release 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 durati