Details for: APO PIROXICAM CAP
Company: APOTEX INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
00642886 | APO PIROXICAM CAP 10MG | PIROXICAM | 10 MG | CAPSULE | ORAL |
00642894 | APO PIROXICAM CAP 20MG | PIROXICAM | 20 MG | CAPSULE | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Your health care provider has prescribed APOPIROXICAM Capsules for you for symptomatic relief of one or more of the following medical conditions:
- rheumatoid arthritis;
- osteoarthritis (degenerative joint disease);
- ankylosing spondylitis.
What it does
APO-PIROXICAM (piroxicam) Capsules, as a
nonsteroidal anti-inflammatory drug (NSAID), can
reduce the chemicals produced by your body, which
cause pain and swelling.
APO-PIROXICAM Capsules does NOT cure your
illness or prevent it from getting worse. APOPIROXICAM
can only relieve the pain and reduce
swelling as long as you continue to take it.
When it should not be used
DO NOT TAKE APO-PIROXICAM if you have
any of the following medical conditions:
Patients who took a drug in the same class as
APO-PIROXICAM after a type of heart surgery
(coronary artery bypass grafting (CABG)) were
more likely to have heart attacks, strokes, blood
clots in the leg(s) or lung(s), and infections or
other complications than those who did NOT take
that drug.
APO-PIROXICAM should NOT be used in patients
under 16 years of age since the safety and
effectiveness have NOT been established.
What the medicinal ingredient is
Piroxicam
What the non-medicinal ingredients are
Non-medicinal ingredients include: D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, lactose, microcrystalline cellulose, sodium lauryl sulfate, sorbitan monolaurate, starch, stearic acid, talc and titanium dioxide.
What dosage form it comes in
APO-PIROXICAM is available as capsules of 10 mg and 20 mg.
Warnings and precautions
Serious Warnings and Precautions
If you have, or previously had, any of the following
medical conditions, see your health care provider to
discuss treatment options other than APOPIROXICAM:
Before taking this medication, tell your health care provider if you have any of the following:
- High blood pressure
- High cholesterol
- Diabetes mellitus or on a low sugar diet
- Atherosclerosis
- Poor circulation to your extremities
- Smoker or ex-smoker
- Kidney disease or urine problems
- Previous ulcer or bleeding from the stomach or gut
- Previous bleeding in the brain
- Bleeding problems
- Family history of allergy to NSAIDs, such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic acid, tolmetin, or valdecoxib (NOT a complete list)
- Family history of asthma, nasal polyps, longterm swelling of the sinus (chronic sinusitis) or hives
- Any other medical problem.
While taking this medication:
- tell any other doctor, dentist, pharmacist or other health care professional that you see, that you are taking this medication, especially if you are planning to have heart surgery;
- do NOT drink alcoholic beverages while taking this medication because you would be more likely to develop stomach problems;
- fertility may be decreased. The use of APOPIROXICAM is not recommended in women trying to get pregnant. In women who have difficulty conceiving, stopping APOPIROXICAM should be considered;
- Check with your doctor if you are not getting any relief or if any problems develop;
- Your regular medical checkups are essential.
Interactions with this medication
Talk to your health care provider and pharmacist if you are taking any other medication (prescription or non-prescription) such as any of the following (NOT a complete list):
- Acetylsalicylic Acid (ASA) or other NSAIDs
- e.g. ASA, celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen
- Antacids
- Antidepressants
- Selective Serotonin Reuptake Inhibitors
(SSRIs)
- e.g. citalopram, fluoxetine, paroxetine, sertraline
- Selective Serotonin Reuptake Inhibitors
(SSRIs)
- Blood pressure medications
- ACE (angiotensin converting enzyme)
inhibitors
- e.g. enalapril, lisinopril, perindopril, ramipril
- ARBs (angiotensin II receptor blockers)
- e.g. candesartan, irbesartan, losartan, valsartan
- Beta-adrenergic blockers
- e.g. propranolol
- ACE (angiotensin converting enzyme)
inhibitors
- Blood thinners
- e.g. warfarin, ASA, clopidogrel
- Cholestyramine
- Cimetidine
- Corticosteroids (including glucocorticoids)
- e.g. prednisone
- Cyclosporin
- Diuretics
- e.g. furosemide, hydrochlorothiazide
- Lithium
- Methotrexate
- Oral contraceptives
- Oral hypoglycemics (diabetes medications)
- Tacrolimus
Proper use of this medication
Usual Dose
Medical Condition | Starting Dose | Maximum Dose (per day) |
---|---|---|
Rheumatoid Arthritis, | 20 mg once daily or 10 mg twice daily. According to therapeutic response, the dose may be reduced to 10 mg once daily. | 20 mg |
Ankylosing Spondylitis | 20 mg once daily or 10 mg twice daily. According to therapeutic response, the dose may be reduced to 10 mg once daily. | 20 mg |
Osteoarthritis | 20 mg once daily or 10 mg twice daily. According to therapeutic response, the dose may be reduced to 10 mg once daily. | 20 mg |
Take APO-PIROXICAM only as directed by your
health care provider. Do NOT take more of it, do
NOT take it more often and do NOT take it for a
longer period of time than your health care
provider recommended. If possible, you should
take the lowest dose of this medication for the
shortest time period. Taking too much APOPIROXICAM
may increase your chances of
unwanted and sometimes dangerous side effects,
especially if you are elderly, have other diseases or
take other medications.
See your health care provider regularly to discuss
whether this medicine is working for you and if it is
causing you any unwanted effects.
This medication has been prescribed specifically
for you. Do NOT give it to anyone else. It may
harm them, even if their symptoms seem to be
similar to yours.
APO-PIROXICAM is NOT recommended for use
in patients under 16 years of age since safety and
effectiveness have NOT been esetablished.
APO-PIROXICAM should be taken immediately
after a meal or with food or milk.
Missed Dose
If you take APO-PIROXICAM once a day and if you miss a dose of this medicine and remember within 8 hours of the missed dose, take it right away. If you take APO-PIROXICAM twice a day and if you miss a dose and remember within 2 hours of the missed dose take it right away. Then go back to your regular dosing schedule.
Overdose
APO-PIROXICAM may cause some side effects,
especially when used for a long time or in large
doses. When these side effects occur, you may
require medical attention. Report all symptoms or
side effects to your health care provider.
APO-PIROXICAM may cause you to become
drowsy or tired. Be careful about driving or
participating in activities that require you to be alert.
If you become drowsy, dizzy or light-headed after
taking APO-PIROXICAM, do NOT drive or operate
machinery.
APO-PIROXICAM may cause you to become more
sensitive to sunlight. Any exposure to sunlight or
sunlamps may cause sunburn, skin blisters, skin rash,
redness, itching or discolouration, or vision changes.
If you have a reaction from the sun, check with your
health care provider.
Check with your health care provider
IMMEDIATELY if you develop chills, fever, muscle
aches or pains, or other flu-like symptoms, especially
if they occur before or together with a skin rash.
These symptoms may be the first signs of a
SERIOUS ALLERGIC REACTION to this
medication.
Symptom | STOP taking APOPIROXICAM and get emergency medical attention IMMEDIATELY | STOP taking APOPIROXICAM and talk to your physician or pharmacist |
---|---|---|
Bloody or black tarry stools | ✔ | |
Shortness of breath, wheezing, any trouble breathing, chest tightness, | ✔ | |
Skin rash, hives, swelling or itching | ✔ | |
Blurred vision, or any visual disturbance | ✔ | |
Any change in the amount or colour of urine (red or brown) | ✔ | |
Any pain or difficulty experienced while urinating | ✔ | |
Swelling of the feet, lower legs; weight gain | ✔ | |
Vomiting or persistent indigestion, nausea stomach pain or diarrhea | ✔ | |
Yellow discoloration of the skin or eyes, with or without itchy skin | ✔ | |
Malaise, fatigue, loss of appetite | ✔ | |
Headaches, stiff neck | ✔ | |
Mental confusion, depression | ✔ | |
Dizziness, lightheadedness | ✔ | |
Hearing problems | ✔ |
This is NOT a complete list of side effects. For any unexpected effects while taking APO-PIROXICAM, contact your doctor or pharmacist.
Store between 15°C and 30°C.
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to : Canada Vigilance Program
Health Canada
Address Locator: 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
For more information, please contact your doctor,
pharmacist or other healthcare professional.
This leaflet plus the full product monograph,
prepared for health professionals, can be obtained by
contacting DISpedia, Apotex's Drug Information
Service at:
1-800-667-4708
This leaflet can also be found at:
http://www.apotex.ca/products.
This leaflet was prepared by Apotex Inc., Toronto,
Ontario,
M9L 1T9.
Last revised: June 23, 2010
Side effects and what to do about them
APO-PIROXICAM may cause some side effects,
especially when used for a long time or in large
doses. When these side effects occur, you may
require medical attention. Report all symptoms or
side effects to your health care provider.
APO-PIROXICAM may cause you to become
drowsy or tired. Be careful about driving or
participating in activities that require you to be alert.
If you become drowsy, dizzy or light-headed after
taking APO-PIROXICAM, do NOT drive or operate
machinery.
APO-PIROXICAM may cause you to become more
sensitive to sunlight. Any exposure to sunlight or
sunlamps may cause sunburn, skin blisters, skin rash,
redness, itching or discolouration, or vision changes.
If you have a reaction from the sun, check with your
health care provider.
Check with your health care provider
IMMEDIATELY if you develop chills, fever, muscle
aches or pains, or other flu-like symptoms, especially
if they occur before or together with a skin rash.
These symptoms may be the first signs of a
SERIOUS ALLERGIC REACTION to this
medication.
Symptom | STOP taking APOPIROXICAM and get emergency medical attention IMMEDIATELY | STOP taking APOPIROXICAM and talk to your physician or pharmacist |
---|---|---|
Bloody or black tarry stools | ✔ | |
Shortness of breath, wheezing, any trouble breathing, chest tightness, | ✔ | |
Skin rash, hives, swelling or itching | ✔ | |
Blurred vision, or any visual disturbance | ✔ | |
Any change in the amount or colour of urine (red or brown) | ✔ | |
Any pain or difficulty experienced while urinating | ✔ | |
Swelling of the feet, lower legs; weight gain | ✔ | |
Vomiting or persistent indigestion, nausea stomach pain or diarrhea | ✔ | |
Yellow discoloration of the skin or eyes, with or without itchy skin | ✔ | |
Malaise, fatigue, loss of appetite | ✔ | |
Headaches, stiff neck | ✔ | |
Mental confusion, depression | ✔ | |
Dizziness, lightheadedness | ✔ | |
Hearing problems | ✔ |
This is NOT a complete list of side effects. For any unexpected effects while taking APO-PIROXICAM, contact your doctor or pharmacist.
How to store
Store between 15°C and 30°C.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to : Canada Vigilance Program
Health Canada
Address Locator: 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
For more information, please contact your doctor,
pharmacist or other healthcare professional.
This leaflet plus the full product monograph,
prepared for health professionals, can be obtained by
contacting DISpedia, Apotex's Drug Information
Service at:
1-800-667-4708
This leaflet can also be found at:
http://www.apotex.ca/products.
This leaflet was prepared by Apotex Inc., Toronto,
Ontario,
M9L 1T9.
Last revised: June 23, 2010