INDOMETHACIN- indomethacin capsule

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

Indomethacin (UNII: XXE1CET956) (Indomethacin - UNII:XXE1CET956)

Disponibbli minn:

Contract Pharmacy Services-PA

INN (Isem Internazzjonali):

Indomethacin

Kompożizzjoni:

Indomethacin 25 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin has been found effective in active stages of the following: - Moderate to severe rheumatoid arthritis including acute flares of chronic disease. - Moderate to severe ankylosing spondylitis. - Moderate to severe osteoarthritis. - Acute painful shoulder (bursitis and/or tendinitis). - Acute gouty arthritis. Indomethacin is contraindicated in patients with known hypersensitivity to indomethacin or the excipients (see DESCRIPTION). Indomethacin should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic/anaphylactoid reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactic/Anaphylactoid Reactions, and PR

Sommarju tal-prodott:

Indomethacin Capsules, USP are available containing either 25 mg or 50 mg of Indomethacin, USP. The 25 mg capsule is a hard-shell gelatin capsule with a light green opaque cap and a light green opaque body axially printed with MYLAN over 143 in black ink on both the cap and body. The capsule is filled with a white powder blend. They are available as follows: NDC 67046-330-30 blister of 30 capsules The 50 mg capsule is a hard-shell gelatin capsule with a light green opaque cap and a light green opaque body axially printed with MYLAN over 147 in black ink on both the cap and body. The capsule is filled with a white powder blend. They are available as follows: NDC 67046-331-30 blister of 30 capsules Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Fuljett ta 'informazzjoni

Contract Pharmacy Services-PA
----------
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:
•
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:
•
The chance of a person getting an ulcer or bleeding increases with:
•
NSAID medicines should only be used:
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 be used by pregnant
women late in their
pregnancy.
•
if you are breastfeeding. Talk to your doctor.
What are the possible side effects of Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs)?
Serious side effects include:
Other side effects include:
•
heart attack
•
stroke
•
high blood pressure
•
heart failure from body
swelling (fluid retention)
•
kidney problem

Karatteristiċi tal-prodott

INDOMETHACIN- INDOMETHACIN CAPSULE
CONTRACT PHARMACY SERVICES-PA
----------
INDOMETHACIN CAPSULES, USP
RX ONLY
25 MG AND 50 MG
Cardiovascular Risk
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, 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).
Indomethacin is contraindicated for the treatment of perioperative
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 events (see WARNINGS).
DESCRIPTION
Indomethacin Capsules, USP for oral administration are provided in two
dosage strengths which contain
either 25 mg or 50 mg of indomethacin. Indomethacin is a non-steroidal
anti-inflammatory indole
derivative designated chemically as
1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1_H_-indole-3-acetic acid.
The structural formula is:
C H CLNO M.W. 357.79
Indomethacin, USP is practically insoluble in water and sparingly
soluble in alcohol. It has a pKa of 4.5
and is stable in neutral or slightly acidic media and decomposes in
strong alkali.
Each capsule for oral administration contains 25 mg or 50 mg of
indomethacin and the following
inactive ingredients: colloidal silicon dioxide, gelatin, FD&C Green
No. 3, magnesium stearate,
microcrystalline cellulose, powdered cellulose, sodium lauryl sulfate,
sodium starch glycolate,
titanium dioxide and D&C Yellow No. 10.
The imprinting ink contains the following: black iron oxide, D&C
Yellow No. 10 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red
No. 40 Aluminum
19
16
4
Lake, pharmaceutical glaze a