Alcofan

Topical gel
Ketoprofen 2.5%
1.Name of the medicinal product:
Alcofan gel

2.Qualitative and Quantitative Composition:

agents, including ketoprofen, when administered by the

systemic route.

4.6. Pregnancy and lactation:

- No embryopathic effects have been demonstrated in

animals, but there is no epidemiological evidence of the
safety of ketoprofen in human pregnancy. During the last
3.Pharmaceutical Form: Gel
trimester of pregnancy the use of NSAIDs may result in
pulmonary and cardiac toxicity in the foetus. Therefore, it
4.Clinical particulars:
is recommended that ketoprofen should be avoided during
4.1. Therapeutic indications:
pregnancy. Non-steroidal anti-inflammatory drugs may also
-Ketoprofen is a non-steroidal anti-inflammatory drug. It has delay labour.
anti-inflammatory and analgesic actions.
- Trace amounts of ketoprofen are excreted in breast milk
- Relief of acute painful musculoskeletal conditions caused after systemic administration , shouldnt be used during
by trauma, such as sports injuries, sprains, strains and breast feeding .
contusions.
4.7. Effects on ability to drive and use
- Pain of non serious arthritis.
Ketoprofen 2.5% w/w.

4.2. Posology and method of administration:

Adults:

To be applied two to four times daily to the skin

in the painful or inflamed region for up to 7 days.
Apply gently but massage well to ensure gel
penetration. The usual recommended dose is 15g
per day (7.5 grams correspond to approximately
14cm of gel).
Elderly: There are no specific dosage recommendations
for the elderly.
Children: Not recommended as safety in children has not
been established.

machines:
None known.

4.8. Undesirable effects:

Adverse reactions: Skin reactions, including photosensitivity

reactions, pruritus, localised erythema. These are usually
mild and resolve after cessation of the gel. Cases of more
severe reactions such as bullous or phylcytenar eczema
which may spread or become generalised have occurred
rarely.

4.9. Overdose:

- Overdose is unlikely by topical administration.

- If accidentally ingested, the gel may cause systemic
adverse effects depending on the amount ingested.
4.3. Contraindications:
Patients with a known hypersensitivity to ketoprofen or any However, if they occur, treatment should be supportive and
of the excipients, aspirin or other non-steroidal anti-inflam- symptomatic.
matory agents; patients suffering from or with a history of
bronchial asthma or allergic disease. Alcofan gel should be 5. Pharmacological properties:
avoided in patients with exudative dermatoses, eczema, 5.1. Pharmacodynamic properties:
sores and infected skin lesions or broken skin. Alcofan gel Ketoprofen is a non-steroidal anti-inflammatory drug. It has
should not be applied to mucous membranes, anal or geni- anti-inflammatory and analgesic actions.
tal areas, eyes or used with occlusive dressings.
5.2. Pharmacokinetic properties:
4.4. Special warnings and precautions for use: - Plasma and tissue levels of ketoprofen have been
Cardiovascular risk:
measured in 24 patients undergoing knee surgery. After
NSAIDs may cause an increased risk of serious cardiovas- repeated percutaneous administration of Alcofan gel the
cular thrombotic events, myocardial infarction, and stroke, plasma levels were about 60 fold less (9 - 39 ng/g) than
which can be fatal. This risk may increase with duration of those obtained after a single oral dose of ketoprofen (490
use. Patients with cardiovascular disease or risk factors for - 3300 ng/g). Tissue levels at the area of application were
cardiovascular disease may be at greater risk. NSAIDs are within the same concentration range for the gel as for the
contraindicated for the treatment of peri-operative pain in oral treatment, although the gel was associated with a
the setting of coronary artery bypass graft (CABG) surgery. considerably higher inter-individual variability.
Gastrointestinal risk:
- The bioavailability of ketoprofen after topical administraNSAIDs cause an increased risk of serious gastrointestinal tion has been estimated to be approximately 5% of the level
adverse events including inflammation, bleeding, ulceration, obtained after an orally administered dose, based on urinary
and perforation of the stomach or intestines, which can be excretion data.
fatal. These events can occur at any time during use and - The protein binding in plasma is approximately 99%.
without warning symptoms. Elderly patients are at greater Ketoprofen is excreted through the kidneys mainly as
glucuronide conjugate.
risk for serious gastrointestinal events.
DO NOT USE THE PRODUCT FOR MORE THAN 12 DAYS.
AVOID EXPOSURE TO SUNLIGHT DURING USING THE
PRODUCT AND FOR 2 WEEKS.

Although systemic effects are minimal, the gel should be

used with caution in patients with severe renal impairment.
Should a skin rash occur after gel application, treatment
must be stopped. Do not apply Alcofan gel beneath
occlusive dressings. Areas of skin treated with Alcofan gel
should not be exposed directly sunlight, or solarium
ultraviolet light, either during treatment or for two weeks
following treatment discontinuation. Keep the gel away from
naked flames. Do not incinerate.

5.3. Preclinical safety data:

No additional pre-clinical data of relevance to the prescriber.

6.Pharmaceutical particulars:
6.1. List of excipients

Carboxypolymethylene (Carbopol 940 ), Triethanolamine,

Lavender oil , Ethyl alcohol 95%, Purified water

6.2. Incompatibilities:

The gel should not be diluted.

6.3. Shelf life:

3 years

4.5. Interaction with other medicinal products 6.4. Special precautions for storage
Store at a temperature not exceeding 30C.
and other forms of interaction:
-Interactions are unlikely as serum concentrations following 6.5. Package:
topical administration are low.
- Serious interactions have been recorded after the use of
high dose methotrexate with non-steroidal anti-inflammatory

A Carton box contains collapsible tube of 30 gm and

(20, 15 gm gel for export & tenders) , inner pamphlet.
Finance code: 524 / 20


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Finance code: 524 / 20