ETODOLAC capsule 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:

Aphena Pharma Solutions - Tennessee, LLC

INN (Mezinárodní Name):

Etodolac

Složení:

Etodolac 200 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: - For acute and long-term use in the management of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis - Osteoarthritis - Rheumatoid arthritis - For the management of acute pain 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,

Přehled produktů:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Etodolac Capsules, USP 200 mg capsules (dark pink gelatin capsule, with black imprint "ETO 200 MG" on cap and body, white to off-white powder filling) - in bottles of 100, NDC 60429-243-01 300 mg capsules (light pink gelatin capsule, with black imprint "ETO 300 MG" on cap and body, white to off-white powder filling) - in bottles of 100, NDC 60429-244-01 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] protected from moisture . Etodolac Tablets, USP 400 mg tablets (peach, oval shaped, film coated tablet engraved with "T88" on one side and other side plain) - in bottles of 100, NDC 60429-311-01 500 mg tablets (blue, oval shaped, film coated tablet engraved with "TARO" on one side and "89." engraved on the other side) - in bottles of 100, NDC 60429-312-01 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. Etodolac extended-release tablets, USP are available as: 400 mg tablets (pink, round, bi-convex, film coated tablet engraved with "T400" on one side and plain on the other side). - in bottles of 100, NDC 60429-313-01 500 mg tablets (green, oblong, normal convex, film coated tablet engraved with "T500" on one side and plain on the other side). - in bottles of 100, NDC 60429-314-01 600 mg tablets (grey, oval, bi-convex, film coated tablet engraved with "T600" on one side and plain on the other side). - in bottles of 100, NDC 60429-315-01 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature.] Protect from excessive heat and humidity. Store tablets in original container until ready to use. Dispense in light-resistant container.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

ETODOLAC- ETODOLAC TABLET, FILM COATED
Aphena Pharma Solutions - Tennessee, LLC
----------
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 pharmaci

Charakteristika produktu

ETODOLAC- ETODOLAC CAPSULE
ETODOLAC- ETODOLAC TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
ETODOLAC
CAPSULES, TABLETS AND ER TABLETS, USP
RX ONLY
Cardiovascular Risk
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).
Gastrointestinal Risk
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 without warning symptoms. Elderly
patients are at greater risk
for serious gastrointestinal (GI) events. (See WARNINGS).
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 N