1. Name Of The Medicinal Product
POWERGEL 2.5% gel
2. Qualitative And Quantitative Composition
Powergel contains ketoprofen BP 2.5g/100g.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
A colourless, non-greasy, non-staining gel with an aromatic fragrance for topical application.
4. Clinical Particulars
4.1 Therapeutic Indications
For local relief of pain and inflammation associated with soft tissue injuries and acute strains and sprains.
4.2 Posology And Method Of Administration
Powergel should be applied topically to the affected area two or three times daily. Maximum duration of use should not exceed 7 days if supplied by a pharmacist or 10 days if supplied on prescription. Powergel should be applied with gentle massage only.
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4.3 Contraindications
Hypersensitivity to the active ingredient, to any of the excipients or to other substances which are closely related to these chemically, such as acetyl salicylic acid or other non-steroid anti-inflammatory drugs and fenofibrate. Ketoprofen gel should not be administered to patients in whom acetyl salicylic acid or other NSAIDs have caused asthma, rhinitis or urticaria.
Ketoprofen gel should not be applied to open wounds or lesions of the skin, or near the eyes.
4.4 Special Warnings And Precautions For Use
Discontinue use if skin rash develops.
Hands should be washed immediately after use.
Do not use with occlusive dressing.
Topical application of large amounts may result in systemic effects, including hypersensitivity and asthma.
Ketoprofen gel should be used with caution in patients with serious kidney failure.
The use of topical products, especially if it is prolonged, may give rise to phenomena of sensitisation or local irritation.
To prevent any phenomena of hypersensitivity or photosensitivity, avoid exposure to direct sunlight, including solarium (sunbeds), during the treatment and for 2 weeks afterwards.
Keep out of the reach and sight of children.
“P” warning: If symptoms persist after 7 days, consult your doctor.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No interactions of Powergel with other drugs have been reported. It is, however, advisable to monitor patients under treatment with coumarinic substances.
4.6 Pregnancy And Lactation
Powergel should not be used during pregnancy and lactation.
No embryopathic effects have been demonstrated in animals but epidemiological data give no clear evidence of the safety of ketoprofen in human pregnancy.
Clinical data show that the use of NSAIDs during the final three months of pregnancy may cause pulmonary and cardiac toxicity in the foetus. NSAIDs can also delay birth when administered during pregnancy.
Lactation:
After systemic administration, traces of ketoprofen have been detected in mothers' milk.
4.7 Effects On Ability To Drive And Use Machines
No effects on the ability to drive and use machinery have been reported.
4.8 Undesirable Effects
There have been reports of localised skin reactions which might subsequently spread beyond the area of application and in isolated cases be severe and generalised.
Other systemic effects of anti-inflammatory drugs: hypersensitivity, gastrointestinal and renal disorders (these depend on the transdermic spreading of the active ingredient, hence on the amount of gel applied, on the surface involved, on the degree of intactness of the skin, on the duration of the treatment and on the use of occlusive bandages).
Since marketing, the following adverse reactions have been reported. They have been listed according to classes of organ and system and classified according to their frequency as follows: very common (equal to or above 10%); common (ranging between 1% and 10 %), uncommon (ranging between 0.1% and 1%), rare (ranging between 0.01% and 0.1%); very rare (below 0.01%), including isolated reports.
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Elderly patients are particularly susceptible to the adverse effects of non-steroidal anti-inflammatory drugs.
4.9 Overdose
Considering the low blood levels of ketoprofen by the percutaneous route, no overdosage phenomena have been described yet.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic category: non-steroid anti-inflammatory drug for topical use.
ATC code: MO2AA10
Ketoprofen is an inhibitor of both the cyclo-oxygenase and lipoxygenase pathways. Inhibition of prostaglandin synthesis provides for potent anti-inflammatory, analgesic and antipyretic effects. Lipoxygenase inhibitors appear to attenuate cell-mediated inflammation and thus retard the progression of tissue destruction in inflamed joints. In addition, Ketoprofen is a powerful inhibitor of bradykinin (a chemical mediator of pain and inflammation), it stabilises lysosomal membranes against osmotic damage and prevents the release of lysosomal enzymes that mediate tissue destruction in inflammatory reactions.
5.2 Pharmacokinetic Properties
After oral administration of a single dose, maximum blood concentrations are achieved within 2 hours.
Ketoprofen plasma half-life ranges from 1 to 3 hours. Plasma protein binding is 60%-90%. Elimination is mainly by urinary route and in glucuronated form; approximately 90% of the amount administered is excreted within 24 hours.
By cutaneous route, absorption is instead very low. In fact the percutaneous application of 50-150 mg of ketoprofen produces plasma levels of the active ingredient of 0.08-0.15 μg/mL approx. 5-8 hours after application.
Powergel allows the site specific topical delivery of ketoprofen with very low plasma concentrations of drug. Therapeutic levels in the affected tissues provide relief from pain and inflammation, yet will satisfactorily overcome the problem of significant systemic unwanted effects.
5.3 Preclinical Safety Data
In animal trials no embryopathic effects have been found, while there is no epidemiological evidence of the safety of ketoprofen in human pregnancy. In preclinical and clinical trials on Ketoprofen no serious adverse effects have been observed, although anecdotal cases of systemic adverse reactions have been described. There are no preclinical data of relevance to the prescriber which are additional to that already included in other parts of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Powergel contains the following excipients: carbomer 940, ethanol, neroli essence, lavender essence, trolamine, purified water.
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
Tube and dispenser: 60 months.
6.4 Special Precautions For Storage
Store below 25oC.
6.5 Nature And Contents Of Container
Soft aluminium tube, treated inside with non-toxic epoxy resin. The tubes are packed in cardboard together with a package insert. The following pack sizes are approved:
P: 30g pack
POM: 30g sample pack, 50g pack, 2x50g twin pack, 100g pack
Dispenser: rigid polypropylene dispenser containing 50g or 100g gel.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
A Menarini Industrie Farmaceutiche Ruinite S.r.l.
Via Sette Santi, 3
50131 Florence
Italy
8. Marketing Authorisation Number(S)
PL 10649/0001.
9. Date Of First Authorisation/Renewal Of The Authorisation
28 January 1993/1 May 2008
10. Date Of Revision Of The Text
20 April 2010
Legal Category
P (30g pack, maximum duration of use 7 days).
POM (30g sample pack, 50g pack, 2x50g twinpack, 100g pack, 50 g and 100g dispenser pack).
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