TIVORBEX- indomethacin capsule

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Iroko Pharmaceuticals, LLC

INN (International Adı):

INDOMETHACIN

Kompozisyon:

INDOMETHACIN 40 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

TIVORBEX is indicated for treatment of mild to moderate acute pain in adults. TIVORBEX is contraindicated in the following patients:  - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [see Warnings and Precautions ( 5.7 , 5.9 ) ] - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ( 5.7 ,   5.8 ) ]  - In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions ( 5.1 ) ] Pregnancy Category C in the first and second trimesters of pregnancy; Category D in the third trimester. Risk Summary Use of NSAIDs, including TIVORBEX, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including TIVORBEX, in pregnant women starting at 30 weeks of ge

Ürün özeti:

TIVORBEX (indomethacin) are supplied as: Storage Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in the original container and keep the bottle tightly closed to protect from moisture and light.  Dispense in a tight container if package is subdivided.

Yetkilendirme durumu:

New Drug Application

Bilgilendirme broşürü

Iroko Pharmaceuticals, LLC
----------
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
○ older age
○ longer use of NSAIDs
○ poor health
○ smoking
○ 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
medica

Ürün özellikleri

TIVORBEX- INDOMETHACIN CAPSULE
IROKO PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TIVORBEX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TIVORBEX.
TIVORBEX (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._
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)
TIVORBEX IS 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)
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
TIVORBEX is a nonsteroidal anti-inflammatory drug indicated for
treatment of mild to moderate acute pain in adults (1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals (2.1)
The dosage is 20 mg orally three times daily or 40 mg orally two or
three times daily. (2.1)
TIVORBEX capsules are not interchangeable with other formulations of
oral indomethacin (2.2)
DOSAGE FORMS AND STRENGTHS
TIVORBEX (indomethacin) Capsules: 20 mg and 40 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to indomethacin or any components of the drug
product (4)
History of