PIROXICAM capsule

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

PIROXICAM (UNII: 13T4O6VMAM) (PIROXICAM - UNII:13T4O6VMAM)

זמין מ:

AvKARE

INN (שם בינלאומי):

PIROXICAM

הרכב:

PIROXICAM 20 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Piroxicam capsules are indicated: - For relief of the signs and symptoms of osteoarthritis. - For relief of the signs and symptoms of rheumatoid arthritis. Piroxicam is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam 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 prior to 30 weeks gestation; Category D starting at 30 weeks gestation. Risk Summary Use of NSAIDs, including piroxicam, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including piroxicam, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of piroxicam 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 in rats and rabbits, there was no evidence of teratogenicity at exposures up to 5 and 10 times the MRHD, respectively. In rat studies with piroxicam, fetotoxicity (postimplantation loss) was observed at exposures 2 times the MRHD, and delayed parturition and an increased incidence of stillbirth were noted at doses equivalent to the MRHD of piroxicam. 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 piroxicam, resulted in increased pre- and post-implantation loss. Clinical Considerations Labor or Delivery There are no studies on the effects of piroxicam during labor or delivery. In animal studies, NSAIDS, including piroxicam inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Animal data Pregnant rats administered piroxicam at 2, 5, or 10 mg/kg/day during the period of organogenesis (Gestation Days 6 to 15) demonstrated increased post-implantation losses with 5 and 10 mg/kg/day of piroxicam (equivalent to 2 and 5 times the maximum recommended human dose [MRHD], of 20 mg respectively, based on a mg/m 2 body surface area [BSA]). There were no drug-related developmental abnormalities noted in offspring. Gastrointestinal tract toxicity was increased in pregnant rats in the last trimester of pregnancy compared to non-pregnant rats or rats in earlier trimesters of pregnancy. Pregnant rabbits administered piroxicam at 2, 5, or 10 mg/kg/day during the period of organogenesis (Gestation Days 7 to 18) demonstrated no drug-related developmental abnormalities in offspring (up to 10 times the MRHD based on a mg/m 2 BSA). In a pre- and post-natal development study in which pregnant rats were administered piroxicam at 2, 5, or 10 mg/kg/day on Gestation Day 15 through delivery and weaning of offspring, reduced weight gain and death were observed in dams at 10 mg/kg/day (5 times the MRHD based on a mg/m 2 BSA) starting on Gestation Day 20. Treated dams revealed peritonitis, adhesions, gastric bleeding, hemorrhagic enteritis and dead fetuses in utero . Parturition was delayed and there was an increased incidence of stillbirth in all piroxicam-treated groups (at doses equivalent to the MRHD). Postnatal development could not be reliably assessed due to the absence of maternal care secondary to severe maternal toxicity. Risk Summary Limited data from 2 published reports that included a total of 6 breastfeeding women and 2 infants showed piroxicam is excreted in human milk at approximately 1% to 3% of the maternal concentration. No accumulation of piroxicam occurred in milk relative to that in maternal plasma during treatment. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for piroxicam and any potential adverse effects on the breastfed infant from the piroxicam or from the underlying maternal condition. Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including piroxicam, 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 piroxicam, in women who have difficulties conceiving or who are undergoing investigation of infertility. Piroxicam has not been investigated in pediatric patients. The safety and effectiveness of piroxicam have not been established. 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, 5.13)].

leaflet_short:

Piroxicam capsules USP, 10 mg are a #2 capsule with a dark green cap and an olive body imprinted "93" "756" on the cap and body. They are available in bottles of 100 (NDC 42291-674-01). Piroxicam capsules USP, 20 mg are a #2 capsule with a dark green cap and a dark green body imprinted "93" "757" on the cap and body. They are available in bottles of 100 (NDC 42291-677-01) and 500 (NDC 42291-677-50). Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).

מצב אישור:

Abbreviated New Drug Application

עלון מידע

AvKARE
----------
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
•
drinking alcohol
•
older age
•
poor health
•
advanced liver
disease
•
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
medical conditions,
inclu

מאפייני מוצר

PIROXICAM- PIROXICAM CAPSULE
AVKARE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
PIROXICAM CAPSULES USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PIROXICAM CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PIROXICAM
CAPSULES.
PIROXICAM 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._
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)
PIROXICAM 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)
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
Piroxicam capsules are a nonsteroidal anti-inflammatory drug indicated
for (1)
Relief of the signs and symptoms of osteoarthritis (OA)
Relief of the signs and symptoms of rheumatoid arthritis (RA)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals
(2)
OA and RA: 20 mg once daily
DOSAGE FORMS AND STRENGTHS
Piroxicam capsules USP: 10 mg and 20 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to piroxicam or any components of the drug
product (4)
History of asthma, urticaria, or other allergic-type reactions after
taking aspirin or oth