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:

Blenheim Pharmacal, Inc.

INN (International Name):

DICLOFENAC SODIUM

Composition:

DICLOFENAC SODIUM 75 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. Dic

Product summary:

Diclofenac sodium and misoprostol delayed-release tablets are supplied in dosage strengths of either 50 mg diclofenac sodium/0.2 mg misoprostol or 75 mg diclofenac sodium/0.2 mg misoprostol.  The 50 mg/0.2 mg dosage strength are white to off white, round, biconvex tablets, plain on one side and debossed with “ 0397 ” on the other side. The 75 mg/0.2 mg dosage strength are white to off white, round, biconvex tablets, plain on one side and debossed with “ 0398 ” on the other side. The dosage strengths are supplied in:  Strength                    NDC Number                Size 50 mg /0.2 mg    0591-0397-60             bottle of 60 50 mg /0.2 mg    0591-0397-19             bottle of 90  75 mg /0.2 mg    0591-0398-60             bottle of 60 75 mg /0.2 mg    0591-0398-19             bottle of 90 Store at 20°-25°C (68°-77°F), in a dry area.  [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Blenheim Pharmacal, 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 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

Summary of Product characteristics

DICLOFENAC SODIUM AND MISOPROSTOL- DICLOFENAC SODIUM AND MISOPROSTOL
TABLET,
DELAYED RELEASE
BLENHEIM PHARMACAL, INC.
----------
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS
Diclofenac Sodium and Misoprostol Delayed-Release Tablets
CONTRAINDICATIONS AND WARNINGS
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS
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). 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 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 dura