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Logo RHEUGESIC GEL (Gel)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

RHEUGESIC GEL (Gel)

COMPOSITION:
The active ingredient piroxicam is an oxicam derivative.
It is a non-steroidal anti-inflammatory drug, 4-hydroxy-2-methyl-N-2-pyridinyl-2H-1,2-benzothiazine-3-carboxyamide 1,1-dioxide, with a long half-life ( ± 50 hours). It occurs as an off-white to light yellow, odourless crystalline powder and is practically insoluble in water, sparingly soluble in alcohol and soluble in methylene chloride.
Contains
Piroxicam        5 mg/g
Preservatives:
Benzyl alcohol        1,0% m/m
Chlorocresol        0,12% m/m

PHARMACOLOGICAL CLASSIFICATION:
A 3.1 Antirheumatics (anti-inflammatory agents).

PHARMACOLOGICAL ACTION:
Piroxicam has anti-inflammatory, analgesic and antipyretic properties.
As a topical gel, piroxicam is absorbed to some degree. It is metabolised in the liver and excreted predominantly in the urine and in smaller amounts in the faeces. The elimination half-life is approximately 50 hours.

INDICATIONS:
For the symptomatic treatment of musculo-skeletal and joint disorders such as osteoarthritis of superficial joints, peri-arthritis, tendinitis, soft tissue disorders and acute musculo-skeletal injuries.

CONTRA-INDICATIONS:
Hypersensitivity to anti-inflammatory agents or aspirin. Porphyria. Not recommended for use in children.

DOSAGE AND DIRECTIONS FOR USE:
Apply 3 cm of gel to the affected area three to four times daily.
Treatment should be reviewed after 2 weeks,

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
A skin rash may occur in patients using RHEUGESIC GEL.
Also erythema and pruritus.
Phototoxic reactions have been reported.
Serious skin reactions such as toxic epidermal necrolysis and pemphigus vulgaris have been attributed to the use of piroxicam.
Nephrotic syndrome and interstitial nephritis have been reported very rarely with the use of piroxicam gel.
Special precautions:
Piroxicam is distributed in breast milk and may also inhibit lactation.
Pregnancy: Studies in humans have not been done.
Geriatrics: There is a tendency toward an increased half-life and steady state concentrations especially in females.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions".
Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear yellow gel with a slight odour of menthol.

PRESENTATION:
A 30g, 40g or 100g collapsible aluminium tube.

STORAGE INSTRUCTIONS:
Store at or below 25°C. Keep tube well-closed.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
34/3.1/0141

NAME AND BUSINESS ADDRESS OF APPLICANT:
CIPLA MEDPRO (PTY) LTD
Building 9, Parc du Cap.
Mispel Street, Bellville, 7530 RSA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
September 2001

Namibia [NS1] 04/3.1/1188
101 BE

New addition to this site: January 2017
Source: Pharmaceutical Industry
http://www.cipla.co.za/wp-content/uploads/2014/05/rheugesic_PI.pdf

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