ETODOLAC tablet, film coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Etodolac (UNII: 2M36281008) (Etodolac - UNII:2M36281008)

Dostupné s:

Blenheim Pharmacal, Inc.

INN (Mezinárodní Name):

Etodolac

Složení:

Etodolac 400 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac Capsules and Tablets, USP are indicated: Etodolac Capsules and Tablets, USP are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac. Etodolac Capsules and Tablets, USP 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 and PRECAUTIONS, Pre-existing Asthma ). Etodolac capsules and tablets, USP are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Přehled produktů:

Etodolac Capsules and Tablets, USP are available as: 400 mg tablets (peach, oval shaped, film coated tablet engraved with "T88" on one side and other side plain) - in bottles of 30, NDC 10544-862-30 - in bottles of 30, NDC 10544-862-60 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Store tablets in original container until ready to use. Dispense in light-resistant container.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

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 should not

Charakteristika produktu

ETODOLAC- ETODOLAC TABLET, FILM COATED
BLENHEIM PHARMACAL, INC.
----------
ETODOLAC TABLETS, USP
RX ONLY
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Etodolac capsules and tablets, USP are members of the pyranocarboxylic
acid group of nonsteroidal
anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains
etodolac for oral administration.
Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac
is a white crystalline compound,
insoluble in water but soluble in alcohols, chloroform, dimethyl
sulfoxide, and aqueous polyethylene
glycol.
The chemical name is (±)
1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The
molecular weight of the base is 287.37. It has a pKa of 4.65 and an
n-octanol: water partition coefficient
of 11.4 at pH 7.4. The molecular formula for etodolac is C
H NO , and it has the following
structural formula:
_Each Capsule, for oral administration, contains 200 or 300 mg of
Etodolac. In addition, each capsule_
_contains the following inactive ingredients: _Ammonium Hydroxide USP,
Black Iron Oxide USP, Colloidal
Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP,
Gelatin, Isopropyl Alcohol USP,
Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline
Cellulose NF, N-Butyl Alcohol
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events,
myocardial infarction (MI), and stroke, which can be fatal. This risk
may increase with
duration of use. Patients with cardiovascular disease or risk factors
for cardiovascular
disease may be at greater risk. (See WARNINGS).
Etodolac capsules USP, 200 mg and 300 mg, and Etodolac tablets USP,
400 mg and 500 mg
are contraindicated for the treatment of peri-operative pain in the
setting of coronary artery
bypass graft (CABG) surgery (See WARNINGS).
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including
bleeding, ulceration, and perforation of the stomach or intestines,
which can be fatal. These
events can occur at any time during use and wi