INDOMETHACIN- indomethacin capsule

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Mylan Pharmaceuticals Inc.

INN (Међународно име):

INDOMETHACIN

Састав:

INDOMETHACIN 25 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Indomethacin capsules are indicated for: Indomethacin capsules are contraindicated in the following patients: Use of NSAIDs, including indomethacin capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including indomethacin capsules, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of indomethacin capsules in pregnant women. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. In animal reproduction studies, retarded fetal ossification was observed with administration of indomethacin to mice and rats during organogenesis at doses 0.1 and 0.2 times, respective

Резиме производа:

Indomethacin Capsules, USP are available containing 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 0378-0143-01 bottles of 100 capsules NDC 0378-0143-10 bottles of 1000 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 0378-0147-01 bottles of 100 capsules NDC 0378-0147-05 bottles of 500 capsules Storage and Handling 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.

Статус ауторизације:

New Drug Application

Информативни летак

Mylan Pharmaceuticals Inc.
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MEDICATION GUIDE FOR NONSTEROIDAL ANTI-
INFLAMMATORY DRUGS (NSAIDS)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft
(CABG).”
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You
may have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
•
anytime during use
•
without warning symptoms
•
that may cause death
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
•
older age
•
poor health
•
advanced liver disease
•
drinking alcohol
bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are NSAIDs?
NSAIDs 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 NSAIDs?
Do not take NSAIDs:
•
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other
NSAIDs.
•
right before or after heart bypass surgery.
Before taking NSAIDs, tell your healthcare provider about all of your
med

Карактеристике производа

INDOMETHACIN- INDOMETHACIN CAPSULE
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INDOMETHACIN CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INDOMETHACIN
CAPSULES.
INDOMETHACIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1965
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
RECENT MAJOR CHANGES
Boxed Warning 5/2016
Warnings and Precautions, Cardiovascular Thrombotic Events (5.1)
5/2016
Warnings and Precautions, Heart Failure and Edema (5.5) 5/2016
INDICATIONS AND USAGE
Indomethacin capsules are a nonsteroidal anti-inflammatory drug
indicated for:
•
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Indomethacin capsules: 25 mg and 50 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED RISK
OF SERIOUS CARDIOVASCULAR
THROMBOTIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND STROKE, WHICH
CAN BE FATAL. THIS RISK MAY
OCCUR EARLY IN TREATMENT AND MAY INCREASE WITH DURATION OF USE (5.1)
INDOMETHACIN CAPSULES ARE CONTRAINDICATED IN THE SETTING OF CORONARY
ARTERY BYPASS GRAFT (CABG)
SURGERY (4, 5.1)
NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
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
AND PATIENTS WITH A PRIOR
HISTORY OF PEPTIC ULCER DISEASE AND/OR GI BLEEDING ARE AT GREATER RISK
FOR SERIOUS GI EVENTS (5.2)
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 (1)
Use the lowest effective dosage for shortest duration consistent with
individual pa