INDOMETHACIN capsule

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Hetero Drugs Ltd.,

INN (Међународно име):

INDOMETHACIN

Састав:

INDOMETHACIN 25 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

C19 H16 ClNO4        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: lactose monohydrate, sodium lauryl sulphate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. The hard gelatin shell consists of gelatin, titanium dioxide USP, FD & C Blue 1, D & C Yellow 10. The capsules are printed with black ink containing black iron oxide E172 dye. 

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

Hetero Drugs Ltd.,
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SPL MEDGUIDE
INDOMETHACIN CAPSULES USP
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 pre

Карактеристике производа

INDOMETHACIN - INDOMETHACIN CAPSULE
HETERO DRUGS LTD.,
----------
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 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-1H-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: lactose monohydrate, sodium lauryl sulphate,
sodium starch glycolate, colloidal
silicon dioxide, magnesium stearate. The hard gelatin shell consists
of gelatin, titanium dioxide USP,
FD & C Blue 1, D & C Yellow 10. The capsules are printed with black
ink containing black iron oxide
E172 dye.
CLINICAL PHARMACOLOGY
Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits antipyretic and analgesic
properties. Its mode of action, like that of ot