APO-PIROXICAM piroxicam 20 mg capsule blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

piroxicam, Quantity: 20 mg

可用日期:

Arrotex Pharmaceuticals Pty Ltd

药物剂型:

Capsule

组成:

Excipient Ingredients: stearic acid; microcrystalline cellulose; maize starch; allura red AC; iron oxide red; lactose monohydrate; Gelatin; purified talc; brilliant blue FCF; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; Shellac; sulfuric acid

给药途径:

Oral

每包单位数:

25 capsules

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

Symptomatic treatment of rheumatoid arthritis, oesteoarthritis and ankylosing spondylitis.

產品總結:

Visual Identification: Hard gelatin capsules with maroon body and cap filled with off-white powder and printed "APO 20".; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

授权状态:

Registered

授权日期:

2000-08-30

资料单张

APO-PIROXICAM
APO-PIROXICAM Capsules
1
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
APO-PIROXICAM contains the active ingredient piroxicam. APO-PIROXICAM
is used to treat the symptoms of rheumatoid arthritis,
osteoarthritis and ankylosing spondylitis, a chronic inflammatory
rheumatic disorder that primarily affects, but is not limited to, the
spine.
For more information, see Section 1. Why am I using APO-PIROXICAM? in
the full CMI.
Do not use if you have ever had an allergic reaction to APO-PIROXICAM,
any other medicine containing piroxicam, any COX-2
inhibitor, aspirin or NSAID medicines or any of the ingredients listed
at the end of the CMI.
Do not take APO-PIROXICAM if you are pregnant, or intend on becoming
pregnant, unless your doctor says otherwise
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant
or are breastfeeding. For more information, see Section 2. What should
I know before I use APO-PIROXICAM? in the full CMI.
Some medicines may interfere with APO-PIROXICAM and affect how it
works. Examples of such medicines include aspirin or other
NSAIDs, warfarin, digoxin, medicine for diabetes or epilepsy or
depression, certain antibiotics, diuretics, medicine for blood
pressure
or cholesterol and alcohol. A list of these medicines is in Section 3.
What if I am taking other medicines? in the full CMI.
The usual dose of APO-PIROXICAM is between 10 mg and 20 mg, taken as a
single dose each day. However, depending on your
condition and how you react to the medicine, your doctor may ask you
to take some other dose.
More instructions can be found in Section 4. How do I use
APO-PIROXICAM? in the full CMI.
THINGS YOU
SHOULD DO
•
If you become pregnant while taking APO-PIROXICAM, tell your doctor
immediately.
•
If you get an infection while taking APO-PIROXICAM, tell your doctor.
•
Tell all doctors, dentists and pharmacists who are treating you that
y

产品特点

AUSTRALIAN PRODUCT INFORMATION
APO-PIROXICAM (PIROXICAM) CAPSULES
1
NAME OF THE MEDICINE
Piroxicam.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains piroxicam 10mg or 20mg.
EXCIPIENTS WITH KNOWN EFFECT
Contains sugars (as lactose), and sulfites from gelatin.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-PIROXICAM 10 MG CAPSULES: Deep powder blue opaque body, maroon
opaque cap, hard
gelatin capsule. Imprinted APO 10. Off-white powder fill.
APO-PIROXICAM 20 MG CAPSULES: Maroon body and cap, marked “APO
20”.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Piroxicam is indicated for symptomatic treatment of rheumatoid
arthritis, osteoarthritis and
ankylosing spondylitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Piroxicam 10mg and 20 mg Capsules are intended for oral
administration.
Pregnancy: see section 4.6 FERTILITY, PREGNANCY AND LACTATION.
RHEUMATOID ARTHRITIS, OSTEOARTHRITIS AND ANKYLOSING SPONDYLITIS
After assessing the risk versus benefit for each patient, use the
minimum effective dose for the
shortest duration possible. The duration of treatment should
preferably be limited to 14 days.
If continued treatment is considered necessary, this should be
accompanied by evaluation at
14 days and subsequent frequent review with regards to efficacy, risk
factors and ongoing
need for treatment.
The dose should be adjusted to each individual patient's response and
toleration. In studies to
date, the optimal response generally has been achieved at a daily dose
of 20 mg, given as a
single dose.
The recommended starting dose is 10 mg. Administration of doses higher
than 20 mg daily
carries an increased risk of adverse effects and is not recommended.
4.3
CONTRAINDICATIONS
Piroxicam should not be administered to patients with active peptic
ulcerations, active
gastrointestinal ulceration ulcers, gastrointestinal bleeding or
perforations, active inflammatory
disease of the gastrointestinal tract, or a recent history of these
conditions.
Piroxicam should not