NAPROXEN tablet NAPROXEN SODIUM tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Glenmark Pharmaceuticals Inc., USA

ІПН (Міжнародна Ім'я):

NAPROXEN

Склад:

NAPROXEN 250 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: Naproxen tablets and naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: the management of: Naproxen tablets and naproxen sodium tablets are contraindicated in the following patients: Risk Summary Use of NSAIDs, including naproxen tablets and naproxen sodium tablets, 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 naproxen tablets or naproxen sodium tablets use between about 20 and 30 weeks of gestation, and avoid naproxen tablets and naproxen sodium tablets 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 naproxen tablets and naproxen sodium tablets, 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, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies in rats, rabbits, and mice no evidence of teratogenicity or fetal harm when naproxen was administered during the period of organogenesis at doses 0.13, 0.26, and 0.6 times the maximum recommended human daily dose of 1500 mg/day, respectively [see Data ]. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as naproxen, resulted in increased pre-and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including naproxen tablets and naproxen sodium tablets, can cause premature closure of the fetal ductus arteriosus (see Data ). Oligohydramnios/Neonatal Renal Impairment: If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If naproxen tablets or naproxen sodium tablets treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue naproxen tablets and naproxen sodium tablets, and follow up according to clinical practice (see Data ). Labor or Delivery There are no studies on the effects of naproxen tablets or naproxen sodium tablets during labor or delivery. In animal studies, NSAIDS, including naproxen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Human Data There is some evidence to suggest that when inhibitors of prostaglandin synthesis are used to delay preterm labor, there is an increased risk of neonatal complications such as necrotizing enterocolitis, patent ductus arteriosus, and intracranial hemorrhage. Naproxen treatment given in late pregnancy to delay parturition has been associated with persistent pulmonary hypertension, renal dysfunction, and abnormal prostaglandin E levels in preterm infants. Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly starting at 30-weeks of gestation, or third trimester) should be avoided. Premature Closure of Fetal Ductus Arteriosus: Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment: Published studies and postmarketing reports describe maternal NSAID use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. In many cases, but not all, the decrease in amniotic fluid was transient and reversible with cessation of the drug. There have been a limited number of case reports of maternal NSAID use and neonatal renal dysfunction without oligohydramnios, some of which were irreversible. Some cases of neonatal renal dysfunction required treatment with invasive procedures, such as exchange transfusion or dialysis. Methodological limitations of these postmarketing studies and reports include lack of a control group; limited information regarding dose, duration, and timing of drug exposure; and concomitant use of other medications. These limitations preclude establishing a reliable estimate of the risk of adverse fetal and neonatal outcomes with maternal NSAID use. Because the published safety data on neonatal outcomes involved mostly preterm infants, the generalizability of certain reported risks to the full-term infant exposed to NSAIDs through maternal use is uncertain. Animal Data Reproduction studies have been performed in rats at 20 mg/kg/day (0.13 times the maximum recommended human daily dose of 1500 mg/day based on body surface area comparison), rabbits at 20 mg/kg/day (0.26 times the maximum recommended human daily dose, based on body surface area comparison), and mice at 170 mg/kg/day (0.6 times the maximum recommended human daily dose based on body surface area comparison) with no evidence of impaired fertility or harm to the fetus due to the drug. Risk Summary The naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for naproxen tablets or naproxen sodium tablets and any potential adverse effects on the breastfed infant from the naproxen tablets or naproxen sodium tablets or from the underlying maternal condition. Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including naproxen tablets and naproxen sodium tablets, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation. Consider withdrawal of NSAIDs, including naproxen tablets and naproxen sodium tablets, in women who have difficulties conceiving or who are undergoing investigation of infertility. Safety and effectiveness in pediatric patients below the age of 2 years have not been established. Pediatric dosing recommendations for polyarticular juvenile idiopathic arthritis are based on well-controlled studies [see Dosage and Administration (2) ]. There are no adequate effectiveness or dose-response data for other pediatric conditions, but the experience in polyarticular juvenile idiopathic arthritis and other use experience have established that single doses of 2.5 to 5 mg/kg as naproxen suspension, with total daily dose not exceeding 15 mg/kg/day, are well tolerated in pediatric patients over 2 years of age. The hepatic and renal tolerability of long-term naproxen administration was studied in two double-blind clinical trials involving 586 patients. Of the patients studied, 98 patients were age 65 and older and 10 of the 98 patients were age 75 and older. NAPROXEN was administered at doses of 375 mg twice daily or 750 mg twice daily for up to 6 months. Transient abnormalities of laboratory tests assessing hepatic and renal function were noted in some patients, although there were no differences noted in the occurrence of abnormal values among different age groups. Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see Warnings and Precautions (5.1, 5.2, 5.3, 5.6, 5.14) ]. Studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. The clinical significance of this finding is unclear, although it is possible that the increase in free naproxen concentration could be associated with an increase in the rate of adverse events per a given dosage in some elderly patients. Caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. As with other drugs used in the elderly, it is prudent to use the lowest effective dose. Experience indicates that geriatric patients may be particularly sensitive to certain adverse effects of nonsteroidal anti- inflammatory drugs. Elderly or debilitated patients seem to tolerate peptic ulceration or bleeding less well when these events do occur. Most spontaneous reports of fatal GI events are in the geriatric population [see Warnings and Precautions (5.2) ]. Naproxen is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Clinical Pharmacology ( Error! Hyperlink reference not valid. ) ]. Geriatric patients may be at a greater risk for the development of a form of renal toxicity precipitated by reduced prostaglandin formation during administration of nonsteroidal anti-inflammatory drugs [see Warnings and Precautions (5.6) ]. Caution is advised when high doses are required and some adjustment of dosage may be required in these patients. It is prudent to use the lowest effective dose [see Clinical Pharmacology ( Error! Hyperlink reference not valid. ) ]. Naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 mL/min) [see Warnings and Precautions (5.6), Clinical Pharmacology ( Error! Hyperlink reference not valid. ) ].

Огляд продуктів:

Naproxen Tablets, USP 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of a break line on one side and ‘250’ on the other side. Packaged in light-resistant bottles of 100 and 500. Bottles of 100, NDC 68462-188-01 Bottles of 500, NDC 68462-188-05 Naproxen Tablets, USP 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. Packaged in light-resistant bottles of 100 and 500. Bottles of 100, NDC 68462-189-01 Bottles of 500, NDC 68462-189-05 Naproxen Tablets, USP 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of a break line on one side and ‘500’ on the other side. Packaged in light-resistant bottles of 30, 50, 100 and 500. Bottles of 30, NDC 68462-190-30 Bottles of 50, NDC 68462-190-50 Bottles of 100, NDC 68462-190-01 Bottles of 500, NDC 68462-190-05 Store at 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]. Dispense in well-closed containers. Naproxen Sodium Tablets, USP 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ on the other side. Packaged in bottles of 100 and 500. Bottles of 100, NDC 68462-178-01 Bottles of 500, NDC 68462-178-05 Naproxen Sodium Tablets, USP 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of a break line and a break line on the other side. Packaged in bottles of 100 and 500. Bottles of 100, NDC 68462-179-01 Bottles of 500, NDC 68462-179-05 Store at 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]. Dispense in well-closed containers.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

NAPROXEN SODIUM- naproxen sodium tablet
Glenmark Pharmaceuticals Limited Inc., USA
----------
Medication Guide for Nonsteroidal
Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Non-Steroidal 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
older age
o
o
longer use of NSAIDs
poor health
o
smoking
o
advanced liver disease
o
drinking alcohol
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.
Before taking NSAIDS, tell your healthcare provider a

Характеристики продукта

NAPROXEN- NAPROXEN TABLET
NAPROXEN SODIUM- NAPROXEN SODIUM TABLET
GLENMARK PHARMACEUTICALS LIMITED INC., USA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN TABLETS AND NAPROXEN SODIUM TABLETS SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR
NAPROXEN TABLETS AND NAPROXEN SODIUM TABLETS.
NAPROXEN TABLETS AND NAPROXEN SODIUM TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1976
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.10, 5.11) 04/2021
INDICATIONS AND USAGE
Naproxen tablets and naproxen sodium tablets are non-steroidal
anti-inflammatory drugs indicated for: (1)
the relief of the signs and symptoms of: (1)
•
•
•
•
Naproxen tablets and naproxen sodium tablets are also indicated for:
(1)
the relief of signs and symptoms of: (1)
•
•
•
the management of: (1)
•
•
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals.
(2.1)
Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis
Naproxen tablets
250 mg (one-half
tablet) 500 mg
twice daily
Naproxen sodium
275 mg (one-half
twice daily
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 tablets and naproxen sodium tablets 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 d