PIROXICAM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

PIROXICAM

Composition:

PIROXICAM 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of piroxicam capsules and other treatment options before deciding to use piroxicam capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Piroxicam capsules are indicated: Piroxicam capsules are contraindicated in patients with known hypersensitivity to piroxicam. Piroxicam capsules should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions and PRECAUTIONS: Preexisting Asthma ). Piroxicam capsules are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Product summary:

Piroxicam capsules are available as follows: Piroxicam capsules, 10 mg lavender/white, Imprinted: MUTUAL                                                                                        165 Bottles of 100 CRC NDC 57664-657-88 Piroxicam capsules, 20 mg lavender/lavender, Imprinted: MUTUAL                                                                                           166 Bottles of 100 CRC NDC 57664-658-88 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

PIROXICAM- PIROXICAM CAPSULE
Sun Pharmaceutical Industries, Inc.
----------
Medication Guide
for
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death.
This chance increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a "coronary artery bypass
graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during treatment.
Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called "corticosteroids" and "anticoagulants"
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each other
and cause serious side effects. Keep a list of your medicines to show
to your healthcare provider and
pharmacist.
•
if you

Summary of Product characteristics

PIROXICAM- PIROXICAM CAPSULE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
PIROXICAM
CAPSULES USP
RX ONLY
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Piroxicam capsules USP contain piroxicam which is a member of the
oxicam group of nonsteroidal anti-
inflammatory drugs (NSAIDs). The chemical name for piroxicam is
4-hydroxyl-2-methyl- _N_-2-
pyridinyl-2 _H_-1,2,-benzothiazine-3-carboxamide 1,1-dioxide.
Piroxicam occurs as a white crystalline
solid, sparingly soluble in water, dilute acid, and most organic
solvents. It is slightly soluble in alcohol
and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton
(pKa 5.1) and a weakly basic
pyridyl nitrogen (pKa 1.8). The molecular weight of piroxicam is
331.35. Its molecular formula is C
H
N
O
S and it has the following structural formula:
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may
increase with duration of
use. Patients with cardiovascular disease or risk factors for
cardiovascular disease may be
at greater risk (see WARNINGS).
Piroxicam capsules are contraindicated for the treatment of
peri-operative pain in the setting
of coronary artery bypass graft (CABG) surgery (see WARNINGS).
NSAIDs cause an increased risk of serious gastrointestinal 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 are
at greater risk for serious gastrointestinal events (see WARNINGS).
15
13
3
4
Inactive ingredients: corn starch, D&C Red #28, FD&C Blue #1, FD&C Red
#40, gelatin, lactose,
magnesium stearate, sodium lauryl sulfate, sodium starch glycolate,
and titanium dioxide. Imprinting ink
Black S-1-8114/S-1-8115 contains: black iron oxide, D&C Yellow #10,
FD&C Blue #1, FD&C Blue
#2, FD&C Red #40, propylene glycol, and shellac glaze.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Piroxicam capsules are a nons