DICLOFENAC SODIUM tablet, film coated, extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

זמין מ:

Direct RX

INN (שם בינלאומי):

DICLOFENAC SODIUM

הרכב:

DICLOFENAC SODIUM 100 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

- Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium extended-release tablets are indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets, USP and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium extended-release tablets are indicated: - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis - Diclofenac sodium extend

leaflet_short:

Diclofenac Sodium Extended-release Tablets, USP 100 mg- Pink round convex film coated tablet debossed with DX 41 on one side. Bottle of 100 Watson NDC 0591-0676-01. Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in tight container (USP). Manufactured for: Watson Laboratories Inc. Corona, CA 92880 USA Manufactured by: Dexcel ® Ltd. 1 Dexcel Street Or-Akiva 30600, Israel

מצב אישור:

Abbreviated New Drug Application

עלון מידע

Direct RX
----------
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 should n

מאפייני מוצר

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
DIRECT RX
----------
DICLOFENAC SODIUM
BOXED WARNING
SPL UNCLASSIFIED SECTION
Diclofenac Sodium Extended-release Tablets,
USP, Tablets of 100 mg
Prescribing Information Rx only
DESCRIPTION
Diclofenac sodium extended-release tablets, USP are benzeneacetic acid
derivative. Diclofenac
sodium extended-release tablets of 100 mg (pink) are available for
oral administration. The chemical
name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium
salt. The molecular weight
is 318.14. Its molecular formula is C14H10Cl2NNaO2 and it has the
following structural formula:
The inactive ingredients in diclofenac sodium extended-release tablets
include: carnauba wax,
cetostearyl alcohol, colloidal silicon dioxide, compressible sugar,
copovidone, gum acacia,
hydroxypropyl methylcellulose, iron oxide red, magnesium stearate,
polyethylene glycol, povidone,
sugar, talc, titanium dioxide.
Meets USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
Pharmacodynamics
Diclofenac sodium extended-release tablets, USP are a non-steroidal
anti-inflammatory drug
(NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic
activities in animal models. The
mechanism of action of diclofenac sodium extended-release tablets,
like that of other NSAIDs, is
not completely understood but may be related to prostaglandin
synthetase inhibition.
Pharmacokinetics
Absorption
Diclofenac is 100% absorbed after oral administration compared to IV
administration as measured
by urine recovery. However, due to first-pass metabolism, only about
50% of the absorbed dose is
systemically available (see Table 1). When diclofenac sodium
extended-release tablet is taken with
food, there is a delay of 1 to 2 hours in the Tmax and a two-fold
increase in Cmax values. The extent
of absorption of diclofenac, however, is not significantly affected by
food intake.
TABLE 1. PHARMACOKINETIC PARAMETERS FOR DICLOFENAC
PK Parameter
Normal Healthy
Adults
(18 - 48 yrs.)
Mean
Coefficient of Variation
(%