INDOMETHACIN capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Proficient Rx LP

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 Capsule, USP has been found effective in active stages of the following: Indomethacin Capsule, USP is contraindicated in patients with known hypersensitivity to indomethacin or the excipients (see DESCRIPTION). Indomethacin Capsule, USP 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 PRECAUTIONS:General:Preexisting Asthma). Indomethacin Capsule, USP is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

ملخص المنتج:

Indomethacin Capsules, USP are available containing either 25 mg of Indomethacin, USP. The 25 mg capsules are size ‘3’ hard gelatin capsules, with opaque light green cap imprinted with ‘H’ and opaque light green body imprinted with ‘103’, containing white to off-white powder. Bottles of 20 capsules NDC 71205-215-20 Bottles of 30 capsules NDC 71205-215-30 Bottles of 60 capsules NDC 71205-215-60 Bottles of 90 capsules NDC 71205-215-90 Store at 20° to 25°C (68° to 77°F) [see USP 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. Manufactured for: Camber Pharmaceuticals, Inc                                              2012729 Piscataway, NJ 08854 By: Hetero Labs Limited Jeedimetla, Hyderabad-500 055, India. Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

INDOMETHACIN- INDOMETHACIN CAPSULE
Proficient Rx LP
----------
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

خصائص المنتج

INDOMETHACIN- INDOMETHACIN CAPSULE
PROFICIENT RX LP
----------
INDOMETHACIN CAPSULE, USP
RX ONLY
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
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:
C19H16CLNO4 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
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).
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).
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 o