NAPROXEN suspension

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)

Доступно од:

Palmetto Pharmaceuticals

INN (Међународно име):

NAPROXEN

Састав:

NAPROXEN 125 mg in 5 mL

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Naproxen oral suspension is indicated for: the relief of the signs and symptoms of: the management of: Naproxen oral suspension is contraindicated in the following patients: Risk Summary: Use of NSAIDs, including naproxen oral suspension, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including naproxen oral suspension, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of naproxen oral suspension 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 2-4% for major malformations, and 15-20% for pregnancy loss. In animal reproduction studies in rats, rabbits, and mice no evidence of teratogenicity or fetal harm wh

Резиме производа:

Naproxen Oral Suspension USP The 125 mg per 5 mL oral suspension is supplied as a (pineapple-orange-flavored) light-orange suspension which readily resuspends on shaking. Sodium content: 39.3 mg/5 mL, 1.71 mEq/5 mL. NDC 68134-201-16: Bottle of 500 mL Store at 20˚ to 25˚C (68˚ to 77˚F). [See USP Controlled Room Temperature.] Avoid excessive heat above 40°C (104°F). Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF. SHAKE GENTLY BEFORE USING.

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

Palmetto Pharmaceuticals
----------
MEDICATION GUIDE
Naproxen Oral Suspension USP
(na prox’ en)
Rx only
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:
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:
o
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
o
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o
increasing doses of NSAIDs
o
o
older age
longer use of NSAIDs
o
smoking
o
drinking alcohol
o
poor health
o
advanced liver disease
o
bleeding problems
NSAIDs should only be used:
o
exactly as prescribed
o
at the lowest dose possible for your treatment
o
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.
How should I take naproxenoral suspension?

Карактеристике производа

NAPROXEN- NAPROXEN SUSPENSION
PALMETTO PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR NAPROXEN ORAL
SUSPENSION.
NAPROXEN ORAL SUSPENSION
INITIAL U.S. APPROVAL: 1976
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
INDICATIONS AND USAGE
Naproxen oral suspension is a non-steroidal anti-inflammatory drug
indicated for: (1)
the relief of the signs and symptoms of: (1)
•
•
•
•
•
•
•
the management of: (1)
•
•
DOSAGE AND ADMINISTRATION
Use the lowest effective dose for shortest duration consistent with
individual patient treatment goals. (2)
Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis
Naproxen Oral Suspension
250 mg (10 mL)
or 375 mg (15 mL)
or 500 mg (20 mL)
twice daily
twice daily
twice daily
The dose may be adjusted up or down depending on the clinical response
of the patient. In patients who
tolerate lower doses well, the dose may be increased to naproxen 1500
mg/day for up to 6 months.
Polyarticular Juvenile Idiopathic Arthritis
Recommended total daily dose of naproxen is approximately 10 mg/kg
given in 2 divided doses.
The following table may be used as a guide for dosing of naproxen
suspension:
PATIENT’S WEIGHT
DOSE
ADMINISTERED AS
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)
NAPROXEN ORAL SUSPENSION 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 D