PIROXICAM capsule

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Bryant Ranch Prepack

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Piroxicam capsules are indicated: Piroxicam capsules are contraindicated in the following patients: Use of NSAIDs, including piroxicam capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including piroxicam capsules, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of piroxicam capsules 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 maximum recommended human dose (MRHD), respectively. In rat studies with

পণ্য সারাংশ:

Piroxicam Capsules, USP are available containing 20 mg of piroxicam, USP. The 20 mg capsules are hard gelatin capsules with a swedish orange opaque cap and swedish orange opaque body containing white to off-white powder. The capsules are imprinted with NP above 20 in black ink on the cap. They are available as follows: NDC 63629-9150-1 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

Bryant Ranch Prepack
----------
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”, “antiplatelet
drugs”, “anticoagulants”, “SSRIs” or
“SNRIs”
o
increasing doses of NSAIDs
o
longer use of NSAIDs
o
smoking
o
o
older age
o
poor health
o
advanced liver disease
o
drinking alcohol
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 about all of your
medical conditions, i

পণ্য বৈশিষ্ট্য

PIROXICAM- PIROXICAM CAPSULE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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._
•
•
•
RECENT MAJOR CHANGES
Warnings and Precautions,
Gastrointestinal Bleeding, Ulceration, and Perforation (5.2) 05/2019
INDICATIONS AND USAGE
Piroxicam capsules are a nonsteroidal anti-inflammatory drug indicated
for
•Relief of the signs and symptoms of osteoarthritis (OA)
(1)•Relief of the signs and symptoms of
rheumatoid arthritis (RA) (1)
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Piroxicam capsules: 10 mg and 20 mg (3)
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
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)
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment
goals (2)
OA and RA: 20 mg once daily (2)
Known hypersensitivity to piroxicam or any components of the drug
product (4)
History of asthma, urticaria, or other allergic-type reactions after
taki