FELDENE- piroxicam capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Piroxicam (UNII: 13T4O6VMAM) (Piroxicam - UNII:13T4O6VMAM)

Available from:

Keltman Pharmaceuticals Inc.

INN (International Name):

Piroxicam

Composition:

Piroxicam 20 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: - For relief of the signs and symptoms of osteoarthritis. - For relief of the signs and symptoms of rheumatoid arthritis. 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 USP, 20 mg are a #2 capsule with a dark green cap and a dark green body imprinted "93" "756" on the cap and body. They are available in bottles of 15. 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). Manufactured for: Keltman Pharmaceuticals Inc. 1 Lakeland Square, Suite A Flowood, Ms 39232 R4

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Keltman Pharmaceuticals Inc.
----------
Medication GuideforNon-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Rx only
(Seetheendof this MedicationGuide for a listof
prescriptionNSAIDmedicines.)
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 are pregnant. NSAID medic

Summary of Product characteristics

FELDENE- PIROXICAM CAPSULE
KELTMAN PHARMACEUTICALS INC.
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PIROXICAM CAPSULES USP
CARDIOVASCULAR RISK
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).
GASTROINTESTINAL RISK
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).
DESCRIPTION
Piroxicam capsules contain piroxicam which is a member of the oxicam
group of non-steroidal anti-
inflammatory drugs (NSAIDs). Each dark green capsule contains 20 mg
piroxicam for oral
administration. The chemical name for piroxicam is
4-hydroxy-2-methyl-_N_-2-pyridinyl-2_H_-1,2-
benzothiazine-3- carboxamide 1,1-dioxide. Members of the oxicam family
are not carboxylic acids, but
they are acidic by virtue of the enolic 4-hydroxy substituent.
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 alkaline solutions. It exhibits a weakly acidic
4-hydroxy proton (pKa 5.1) and a weakly
basic pyridyl nitrogen (pKa 1.8). It has the following structural
formula:
C
H N O S M.W. 331.35
Each capsule, for oral administration, 20 mg piroxicam. In addition,
each capsule contains the following
inactive ingredients: colloidal silicon dioxide, corn starch, D&C
Yellow No. 10, FD&C Green No. 3,
gelatin, lactose, magnesium stearate, povidone, sodium lauryl sulfate,
and titanium dioxide.
CLINICAL PHARMACOLOG