FENOPROFEN CALCIUM capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

FENOPROFEN CALCIUM (UNII: 0X2CW1QABJ) (FENOPROFEN - UNII:RA33EAC7KY)

Доступна з:

Proficient Rx LP

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Fenoprofen calcium is indicated for: Fenoprofen calcium is contraindicated in the following patients: Risk Summary Use of NSAIDs, including fenoprofen calcium, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of fenoprofen calcium use between about 20 and 30 weeks of gestation, and avoid fenoprofen calcium use at about 30 weeks of gestation and later in pregnancy (see Clinical Considerations, Data)       Premature Closure of Fetal Ductus Arteriosus       Use of NSAIDs, including fenoprofen calcium, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.      Oligohydramnios/Neonatal Renal Impairment       Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, ne

Огляд продуктів:

Fenoprofen calcium capsules, USP are for oral administration, and are supplied as following: NDC 71205-828-30 Bottles of 30 NDC 71205-828-60 Bottles of 60 NDC 71205-828-90 Bottles of 90 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]. Preserve in well-closed containers.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

FENOPROFEN CALCIUM- FENOPROFEN CALCIUM CAPSULE
Proficient Rx LP
----------
MEDICATION GUIDE FOR NON-STEROIDAL
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:
o
with increasing doses of NSAIDs
o
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:
o
anytime during use
o
without warning symptoms
o
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 provi

Характеристики продукта

FENOPROFEN CALCIUM- FENOPROFEN CALCIUM CAPSULE
PROFICIENT RX LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FENOPROFEN CALCIUM
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FENOPROFEN
CALCIUM CAPSULES.
FENOPROFEN CALCIUM CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1982
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS)
(5.10) 04/2021
Warnings and Precautions, Fetal Toxicity
(5.11) 04/2021
INDICATIONS AND USAGE
Fenoprofen calcium is a nonsteroidal anti-inflammatory drug indicated
for:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Fenoprofen calcium capsules: 400 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
NON-STEROIDAL 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)
FENOPROFEN 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 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)
Relief of mild to moderate pain in adults. (1)
Relief of the signs and symptoms of rheumatoid arthritis. (1)
Relief of the signs and symptoms of osteoarthritis. (1)
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment
goals (2.1)
Analgesia: For the treatment of mild to moderate pain, the