INDOMETHACIN- indomethacin capsule

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956)

Saatavilla:

REMEDYREPACK INC.

INN (Kansainvälinen yleisnimi):

INDOMETHACIN

Koostumus:

INDOMETHACIN 50 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

REMEDYREPACK INC.
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SPL MEDGUIDE
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 acoronary 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 calledcorticosteroidsandanticoagulants
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 be used by pregnant
women late in their pregnancy.
if you are breastfeeding. Talk to

Valmisteyhteenveto

INDOMETHACIN - INDOMETHACIN CAPSULE
REMEDYREPACK INC.
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BOXED WARNING
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 A GREATER RISK. (SEE WARNINGS.)
INDOMETHACIN IS 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 EVENTS. (SEE
WARNINGS.)
DESCRIPTION
Indomethacin Capsules, USP for oral administration contain either 25
mg or 50 mg of indomethacin and
the following inactive ingredients: D & C Red #28, FD&C Blue #1, FD&C
Red #3, gelatin, lactose
monohydrate, magnesium stearate, povidone, pregelatinized starch,
silicon dioxide, sodium lauryl
sulfate, starch and titanium dioxide. Indomethacin is a non-steroidal
anti-inflammatory indole derivative
designated chemically as
1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid.
Indomethacin 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. The structural formula is:
C19H16ClNO4 M.W. 357.79
CLINICAL PHARMACOLOGY
Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits antipyretic and analgesic
properties. Its mode of action, like that of other anti-inflammatory
drugs, is not known. However, its
therapeutic action is not due to pituitary-adrenal stimulation.
Indomethacin is a potent inhibitor of prostaglandin synthesis in
vitro. Concentrations are reached during
the