DICLOFENAC SODIUM tablet, delayed release

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

Diclofenac Sodium (UNII: QTG126297Q) (diclofenac - UNII:144O8QL0L1)

Доступна з:

Stat Rx USA

ІПН (Міжнародна Ім'я):

Diclofenac Sodium

Склад:

Diclofenac Sodium 50 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diclofenac sodium delayed-release tablets, are indicated: - For relief of signs and symptoms of osteoarthritis - For relief of signs and symptoms of rheumatoid arthritis - For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis Diclofenac sodium delayed-release tablets, are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac sodium delayed-release tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions

Огляд продуктів:

Diclofenac sodium delayed-release tablets, USP, for oral administration, are available as: 25 mg: round, yellow, enteric-coated tablets imprinted GG 737 on one side in black ink and plain on the reverse side are supplied as: NDC 0781-1785-60 bottles of 60 tablets NDC 0781-1785-01 bottles of 100 tablets NDC 0781-1785-10 bottles of 1000 tablets NDC 0781-1785-13 unit dose packages of 100 tablets 50 mg: round, brown, enteric-coated tablets imprinted GG 738 on one side in black ink and plain on the reverse side are supplied as: NDC 0781-1787-60 bottles of 60 tablets NDC 0781-1787-01 bottles of 100 tablets NDC 0781-1787-10 bottles of 1000 tablets NDC 0781-1787-13 unit dose packages of 100 tablets 75 mg: round, pink, enteric-coated tablets imprinted GG 739 on one side in black ink and plain on the reverse side are supplied as: NDC 0781-1789-60 bottles of 60 tablets NDC 0781-1789-01 bottles of 100 tablets NDC 0781-1789-10 bottles of 1000 tablets Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

DICLOFENAC SODIUM - DICLOFENAC SODIUM TABLET, DELAYED RELEASE
Stat Rx USA
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DICLOFENAC SODIUM - diclofenac sodium tablet
Sandoz Inc.
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Diclofenac Sodium Delayed-release Tablets, USPMEDICATION 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 your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with eac

Характеристики продукта

DICLOFENAC SODIUM - DICLOFENAC SODIUM TABLET, DELAYED RELEASE
STAT RX USA
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DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET
DESCRIPTION
Diclofenac sodium is a benzeneacetic acid derivative, designated
chemically as 2-[(2,6-
dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The
structural formula is:
soluble in methanol, soluble in ethanol, sparingly soluble in water
and practically insoluble in
chloroform and in dilute acid. The n-octanol/water partition
coefficient is 13.4 at pH 7.4 and 1545 at pH
5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2
at 25°C in water.
Each enteric-coated tablet for oral administration contains 25 mg, 50
mg, or 75 mg of diclofenac
sodium. In addition, each tablet contains the following inactive
ingredients. Inactive ingredients: Black
iron oxide, croscarmellose sodium, hydroxypropyl cellulose,
hydroxypropyl methylcellulose, lactose
(monohydrate), magnesium stearate, methacrylic acid copolymer,
microcrystalline cellulose,
polyethylene glycol, povidone, red iron oxide, and titanium dioxide.
The 25 MG also contains: D and C
Yellow #10 Aluminum Lake and pharmaceutical glaze shellac. The 50 MG
also contains: Pharmaceutical
glaze shellac and yellow iron oxide. The 75 MG also contains: carnauba
wax, glycerol monostearate,
shellac, and yellow iron oxide.
CLINICAL PHARMACOLOGYPharmacodynamics
Diclofenac sodium delayed-release tablets are a nonsteroidal
anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic, and antipyretic activities in
animal models. The mechanism of
action of diclofenac sodium delayed-release tablets, like that of
other NSAIDs, is not completely
understood but may be related to prostaglandin synthetase inhibition.
PharmacokineticsAbsorption
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. Food has no significant effect on the extent
of diclofenac absorpt