NIDAL^® GEL

COMPOSITION:

Each tube contains:

Ketoprofen.................................................................. 2.5%

Excipients: Triethanolamine, Carbomer 940, Diethylene glycol monoethyl ether, Ethanol 96%, Butylated hydroxytoluene, Methylparaben, Propylparaben, Menthol, Purified water q.s. one tube.

ATC Code: M02AA10

PROPERTIES

Pharmacodynamics

NIDAL^® gel contains ketoprofen, a phenyl propionic acid derivative of a non-steroid nature with analgesic and anti-inflammatory properties.

Ketoprofen inhibits the prostaglandin synthesis and the thrombocyte aggregation.

Pharmacokinetics

 Gel formula for cutaneous use.

Plasma and tissue levels of ketoprofen have been measured in 24 patients undergoing knee surgery. After repeated percutaneous administration of ketoprofen gel the plasma levels were about 60 fold less (9 - 39 ng/g) than those obtained after a single oral dose of ketoprofen (490 - 3300 ng/g).  Tissue levels in the actual area were within the same concentration range, for the gel as for the oral treatment, though the gel had a considerably higher interindividual variability.

Bioavailability of ketoprofen after cutaneous administration has been estimated to approximately 5% of the level obtained after an orally administered dose based on urinary excretion data.

The protein binding in plasma is approximately 99%.

Ketoprofen is excreted through the kidneys mainly as glucuronide conjugate.

INDICATIONS

Topical NSAID in the treatment of acute and chronic pain, of both rheumatic and traumatic origin as well as postoperative pain, including osteoarthritis, tendonitis, muscle strains, sprains, and swelling.

DOSAGE AND ADMINISTRATION

Adults: The gel should be applied on to the painful or inflammed area two to three times daily. The amount of gel should be adjusted so that it covers the painful area. The total daily dose shall not exceed 15 grams per day. The length of treatment should not exceed one week.

Method of administration: for cutaneous use, the gel should be massaged onto the painful or inflammed skin for a few minutes to enure the drug well diffused through the skin. Wash your hands after applying medication. The tube should be closed after use.

CONTRAINDICATIONS

• History of any photosensitivity reaction.
• History of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate, other NSAID or UV blocker or parfumes.
• Hypersensitivity to any of the excipients listed in the composition.
• Skin diseases such as eczema or acne; or in infectious skin or open wounds.
• Third trimester of pregnancy.

ADVERSE DRUG REACTIONS (ADR)

Localised skin reactions have been reported which may secondarily spread outside the application site and may in isolated cases be severe and generalized.  Isolated cases of systemic adverse reactions, such as renal affection, have been reported.

• Uncommon: Local skin reactions such as erythema, eczema, pruritis and burning sensations.
• Rare: photosensitisation and urticaria. Cases of more severe reactions such as bullous or phlyctenular eczema which may spread or become generalized have occurred rarely.
• Very rare: Cases of aggravation of previous renal insufficiency.

Inform your doctor in case of any adverse reactions related to drug use.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

None known.

WARNING AND PRECAUTIONS

The gel should be used with caution in patients with reduced heart, liver or renal function.

The gel must not be used with occlusive dressings.

The gel must not come into contact with mucous membranes or the eyes.

Treatment should be discontinued immediately upon development of any skin reaction including cutaneous reactions after co-application of octocrylene containing products.

It is recommended to protect treated areas by wearing clothing during all the application of the product and two weeks following its discontinuation to avoid the risk of photosensitisation. Hands should be washed thoroughly after each application of the product.

The recommended length of treatment should not be exceeded due to the risk of developing contact dermatitis and photosensitivity reactions increases over time.

The safety and efficacy of ketoprofen gel in children have not been established.

Safety in pregnancy and lactation

In absence of clinical experience with the cutaneous form and by reference with the systemic forms:

Pregnancy

During the first and second trimester, as the safety of ketoprofen in pregnant women has not been evaluated, the use of ketoprofen during the first and second trimester of pregnancy should be avoided.

During the third trimester of pregnancy, all prostaglandin synthetase inhibitors including ketoprofen may induce cardiopulmonary and renal toxicity in the fetus.  At the end of the pregnancy, prolonged bleeding time in both mother and child, may occur. Therefore, ketoprofen is contra-indicated during the last trimester of pregnancy.

Breastfeeding

No data is available on excretion of ketoprofen in human milk.  Ketoprofen is not recommended in nursing mothers.

DRUG INTERACTIONS

Interactions are unlikely as serum concentrations following cutaneous administration are low.

OVERDOSE AND TREATMENT OR INTOXICATION

Overdose is unlikely to be caused by cutaneous administration.  If accidentally ingested, the gel may cause systemic adverse effects depending on the amount ingested. However, if they occur, treatment should be symptomatic and supportive in accordance with overdosage of oral NSAIDs.

STORAGE: Store at temperature below 30°C. Avoid direct sunlight and moisture.

PRESENTATION

Aluminium tube:  30g. Box of 1 tube.

EXPIRY DATE: 36 months from the manufacturing date.

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Manufactured and Distributed by: AMPHARCO U.S.A - PJSC

Nhon Trach 3 Industrial Park, Hiep Phuoc Ward, Nhon Trach District, Dong Nai Province

Tel: 02513 566 202    -     Fax: 02513 566 203