Bystrumgel - instructions for use, doses, side effects, contraindications

Excipients: ethanol (rectified ethyl alcohol), carbomer 940 or 980, trometamol, methyl parahydroxybenzoate (nipagin), lavender oil, orange flower oil (neroli oil), purified water.

Description:

A colorless, almost transparent gel with a specific odor. Opalescence is allowed.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.02.A.A.10 Ketoprofen

Pharmacodynamics:

Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID). Has a local anti-inflammatory, antiexudative and analgesic effect. Provides local treatment for lesions of joints, tendons, ligaments, muscles. With articular syndrome, weakening of pain in joints at rest and during movement, reduction of morning stiffness and swelling of the joints. Ketoprofen does not have a catabolic effect on articular cartilage.

Pharmacokinetics:

With topical application in the form of a gel, it is absorbed extremely slowly and practically does not accumulate in the body. Bioavailability of the gel is about 5%.After application in a dose of 50-150 mg concentration in the plasma after 5-8 hours - 0,08-0,15 mcg / ml.

Indications:

Acute and chronic inflammatory diseases of the musculoskeletal system (articular syndrome with exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis, osteochondrosis with radicular syndrome, sciatica, inflammatory defeat of ligaments and tendons, bursitis, sciatica, lumbago).

Muscular pain of rheumatic and non-rheumatic origin.

Post-traumatic inflammation of soft tissues and musculoskeletal system (injuries and ruptures of ligaments, bruises).

Contraindications:

Hypersensitivity to ketoprofen or other non-steroidal anti-inflammatory drugs, skin damage (wet dermatoses, eczema, infected abrasions, wounds), pregnancy III trimester and lactation period, children's age (up to 6 years).

Carefully:

Erosive-ulcerative lesions of the gastrointestinal tract, pronounced impaired renal and hepatic function, chronic heart failure, bronchial asthma, pregnancy I-II trimester, hepatic porphyria.

Dosing and Administration:

Outwardly.

Adults and children from the age of 12 apply a small amount of gel (3-5 cm) 2-3 times a day with a thin layer, followed by a long and careful rubbing into the inflamed or painful parts of the body.

Children from 6 to 12 years old Do not apply more than 1 -2 cm of the drug no more often than 2 times a day. The duration of the course of treatment should not exceed 14 days without consulting a doctor. Can be used in phonophoresis.

Side effects:

Local reactions: allergic dermatitis, eczema, skin hyperemia, photodermatitis, boule dermatitis, exanthema, purpura.

Systemic reactions: urticaria, generalized skin rash, swelling, photosensitivity, stomatitis.

Overdose:

Extremely low systemic absorption of active components of the drug with external application makes an overdose almost impossible.

Interaction:

With external application of ketoprofen, interaction with other drugs has not been established.

Special instructions:

The drug should be applied only to undamaged skin areas, avoiding contact with open wounds, eyes and mucous membranes. After applying the drug, you should wash your hands. Do not use with occlusive dressings.

Before using the gel for patients with impaired liver and / or kidney function, gastrointestinal diseases in history, bronchial asthma, heart failure, it is necessary to consult a doctor.

The gel has a pH close to that of the skin.

Form release / dosage:

Gel for external use 2.5%.

Packaging:

For 30, 50 or 100 g in an aluminum tube.

Each tube together with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:P N002919 / 01

Date of registration:29.09.2008 / 30.07.2015

Expiration Date:Unlimited

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp14.03.2017

Illustrated instructions

Instructions

Bystrumgel® (Bystrumgel®)