KETOPROFEN GEL 2.5% 30G

International non-proprietary name:

Ketoprofen

Dosage Form:

gel for external use

Composition:

100 g of gel contains the active substance - Ketoprofen 2.5 g and excipients - propylene glycol, 95% ethyl alcohol (ethanol), carbomer 940 (carboxy vinyl polymer), triethanolamine (trolamine), benzalkonium chloride, purified water.

Description:

Colorless, transparent gel with the smell of ethyl alcohol. The presence of opalescence is allowed.

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory drug (NSAIDs).

Pharmachologic effect:

It has a local anti-inflammatory, antiexudative and analgesic effects. In the form of a gel, it provides a local healing effect on the affected joints, tendons, ligaments, and muscles. In case of articular syndrome, it causes a reduction in pain in the joints at rest and during movement, a decrease in morning stiffness and swelling of the joints. It has no catabolic effect on articular cartilage.
Pharmacokinetics. When skin application is absorbed slowly. Practically does not accumulate in the body. The bioavailability of the gel is about 5%.

Indications:

• Diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of the peripheral joints and spine, rheumatic lesions of soft tissues
• Muscle aches of rheumatic and non-rheumatic origin
• Traumatic soft tissue damage without damaging the skin

Contraindications:

Hypersensitivity to ketoprofen or other components of the drug, Acetylsalicylic acid or other NSAIDs, "aspirin" asthma, pregnancy (III trimester), period of latency, children's age (up to 6 years), violation of the integrity of the skin, weeping dermatosis, eczema.

Carefully:

hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe impaired liver and kidney function, chronic heart failure, bronchial asthma, old age, children under 12 years old, pregnancy I and II trimester.

Use during pregnancy and during breastfeeding:

The drug can not be used in the III trimester of pregnancy. Experience with the use of drugs ketoprofen during lactation is not available. Use in the I and II trimesters is possible only after consulting a doctor.

Doses, method and duration of use:

The drug is applied externally. Once use 3-5 cm of the drug (volume of large cherries). Depending on the size of the damaged area, apply the gel 2-3 times a day or as prescribed by a doctor, rubbing gently until completely absorbed. The duration of treatment without consulting a doctor should not exceed 10 days.

Side effects:

Allergic reactions, photosensitivity. In the case of the development of any adverse events, you should consult a doctor.

Overdose:

Extremely low systemic absorption of the active components of the drug for external use makes overdosing almost impossible.

Special instructions:

The drug should be applied only to intact skin. Avoid contact with eyes and mucous membranes. In order to avoid manifestations of hypersensitivity and photosensitivity, it is recommended to avoid exposure of the skin to sunlight during the course of treatment.

Release form:

Gel for external use of 2.5%. On 30 g or on 50 g in tubas aluminum or in banks on 30 g. Tuba or bank together with the application instruction is placed in a pack from a cardboard.

Storage conditions:

In a dry, dark place inaccessible to children, at a temperature not higher than 20 ° C.

Shelf life:

2 years.
Do not apply after the expiration date.