DICLOFENAC SODIUM AND MISOPROSTOL tablet, delayed release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

BluePoint Laboratories

DCI (Denominação Comum Internacional):

DICLOFENAC SODIUM

Composição:

DICLOFENAC SODIUM 50 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.3)]. Diclofenac sodium and misoprostol delayed-Release tablets are contraindicated in the following patients: - Pregnancy. Use of misoprostol, a component of diclofenac sodium and misoprostol delayed-release tablets, during pregnancy can result in maternal and fetal harm, including uterine rupture, abortion, premature birth, or birth defects [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] - In the setting of coronary artery bypa

Resumo do produto:

Diclofenac sodium and misoprostol delayed-release tablets, USP are supplied as: The dosage strengths are supplied in:   Strength   NDC Number   Size  50 mg/0.2 mg  68001-231-06  bottle of 60     75 mg/0.2 mg  68001-232-06  bottle of 60 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

BluePoint Laboratories
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MEDICATION GUIDE for
Diclofenac Sodium (dye kloe' fen ak soe' dee um) and Misoprostol
(mye'' soe pros' tol)
Delayed-Release Tablets for oral use.
1.
What is the most important information I should know about diclofenac
sodium and misoprostol
delayed-release tablets?
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids”, “antiplatelet
drugs”, “anticoagulants”, “SSRIs”, or
“SNRIs”
•
increasing doses of NSAIDs
•
older age
•
longer use of NSAIDs
•
poor health
•
smoking
•
advanced liver disease
•
drinking alcohol
•
bleeding problems
1.
NSAID containing medicines should only be used:
1.
What is diclofenac sodium and misoprostol delayed-release tablets?
It is not known if diclofenac sodium and misoprostol delayed-release
tablets are safe and effective for use
in children.
1.
What are NSAIDs?
Who should not take diclofenac sodium and misoprostol delayed-release
tablets?
Do not take diclofenac sodium and misoprostol delayed-release tablets:
•
If you are pregnant.
•
Right before or after heart bypass surgery.
•
If you currently have bleeding in your stomach (gastrointestinal
bleeding).
•
If you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs.
•
If you are allergic to diclofenac sodium and misoprostol, other
prostaglandins or any other
ingredients in diclofenac sodium and misoprostol delayed-release
tablets. See the end of this
Medication Guide for a list of ingredients in diclofenac sodium and
misoprostol delayed-release
tablets.
Before taking diclofenac sodium and misoprostol delayed-release
tablets, tell your healthcare provider
about all of your medical conditions, including if you:
•
have liver or kidney problems.
•
have high blood pressure.
•
have heart problems, including a history of heart failure or heart
attack.
•
have asthma.
•
are pregnant or plan to become pregnant. See “Who should not take
diclo

Características técnicas

DICLOFENAC SODIUM AND MISOPROSTOL- DICLOFENAC SODIUM AND
MISOPROSTOL TABLET, DELAYED RELEASE
BLUEPOINT LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC SODIUM
AND MISOPROSTOL DELAYED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE
TABLETS.
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 1997
WARNING: RISK OF UTERINE RUPTURE, ABORTION, PREMATURE BIRTH, BIRTH
DEFECTS;
SERIOUS CARDIOVASCULAR EVENTS ; AND SERIOUS GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ADMINISTRATION OF MISOPROSTOL, A COMPONENT OF DICLOFENAC SODIUM AND
MISOPROSTOL
DELAYED-RELEASE TABLETS, TO PREGNANT WOMEN CAN CAUSE UTERINE RUPTURE,
ABORTION,
PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS OCCURRED WHEN
MISOPROSTOL
WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR AN ABORTION ( 4,
5.1, 8.1)
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS ARE
CONTRAINDICATED IN
PREGNANCY AND NOT RECOMMENDED IN WOMEN OF CHILDBEARING POTENTIAL.
PATIENTS MUST
BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE
DRUG TO OTHERS (
5.1, 8.3)
INCREASED RISK OF SERIOUS CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING
MYOCARDIAL
INFARCTION AND STROKE, WHICH CAN BE FATAL. ( 5.2)
DICLOFENAC SODIUM AND MISOPROSTOL DELAYED-RELEASE TABLETS ARE
CONTRAINDICATED IN
THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. ( 4, 5.2)
INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI) ADVERSE EVENTS
INCLUDING BLEEDING,
ULCERATION, AND PERFORATION OF THE STOMACH OR INTESTINES, WHICH CAN BE
FATAL AND CAN
OCCUR AT ANY TIME AND WITHOUT WARNING SYMPTOMS. ELDERLY PATIENTS AND
PATIENTS WITH
A PRIOR HISTORY OF PEPTIC ULCER DISEASE AND/OR GI BLEEDING ARE AT
GREATER RISK. ( 5.3)
INDICATIONS AND USAGE
Diclofenac sodium and misoprostol delayed-release tablets are a
combination of diclofenac sodium, a
non-steroida