Universal reference book for medicines
Product name: FASTUM ® (FASTUM ® )

Active substance: ketoprofen

Type: NSAID for external use

Manufacturer: A.MENARINI INDUSTRIE FARMACEUTICHE RIUNITE (Italy) manufactured by A.Menarini Manufacturing Logistics and Services (Italy)
Composition, form of production and packaging
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Gel for external use 2.5% colorless, almost transparent, viscous, with a pleasant smell.
100 g

ketoprofen 2.5 g

Auxiliary substances: Carbomer 940 - 1.5 g, ethanol 96% - 40 ml, non-saline oil - 0.05 g, lavender oil (lavender hydrous Lavender oil) - 0.05 g, trolamine (triethanolamine) - 2.8 mg, purified water - up to 100 g .

30 g - aluminum tubes (1) - cardboard packs.

50 g - aluminum tubes (1) - packs of cardboard.

100 g - aluminum tubes (1) - packs of cardboard.

100 g - polypropylene containers with dispensing equipment (dispensers) (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2008.

PHARMACHOLOGIC EFFECT

NSAIDs for external use.
The mechanism of action is related to the inhibition of the synthesis of prostaglandins. Has a local analgesic, anti-inflammatory, antiexudative action. With symptomatic treatment of diseases of joints, tendons, ligaments, muscles, skin; with articular syndrome reduces joint pain at rest and during movement, morning stiffness and swelling of the joints.
PHARMACOKINETICS

When topical application is absorbed extremely slowly.
Bioavailability - 5%. When used in a dose of 50-150 mg, the concentration in the blood plasma is 0.08-0.15 μg / ml. Do not cum in the body.
INDICATIONS

- Diseases of the musculoskeletal system (articular syndrome with exacerbation of gout, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthrosis, osteochondrosis with radicular syndrome, inflammatory lesions of ligaments, tendons, bursitis, sciatica, lumbago);

- myalgia of rheumatic and non-rheumatic origin;

- Post-traumatic inflammation of soft tissues and musculoskeletal system.

DOSING MODE

The drug is intended for external use.
A small amount of gel (a column 3-5 cm long) 1-2 times / day is applied a thin layer on the skin above the inflammation focus and lightly rubbed. The duration of treatment should not exceed 14 days.
SIDE EFFECT

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

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

CONTRAINDICATIONS

- wet dermatoses, eczema, infected abrasions, wounds;

- An indication in the history of bronchospasm, urticaria, or rhinitis caused by the use of acetylsalicylic acid;

- children's age till 12 years;

- III trimester of pregnancy;

- lactation (breastfeeding);

- Hypersensitivity to the drug, acetylsalicylic acid and other NSAIDs.

They are used with caution for erosive and ulcerative gastrointestinal lesions, marked violations of kidney and liver function, chronic heart failure, bronchial asthma, hepatic porphyria.

PREGNANCY AND LACTATION

The drug is contraindicated for use in the III trimester of pregnancy and lactation (breastfeeding).
In the I and II trimesters, the drug is used with caution.
APPLICATION FOR FUNCTIONS OF THE LIVER

With caution should prescribe the drug for severe impairment of kidney function.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution should prescribe the drug for severe violations of liver function.

APPLICATION FOR CHILDREN

Contraindication: children under 12 years.

SPECIAL INSTRUCTIONS

Avoid getting the gel on open wounds, inflamed skin, mucous membranes and in the eyes.

After applying the gel, you should immediately wash your hands.

The drug should not be used with occlusive (airtight) dressings.

Impact on the ability to drive vehicles and manage mechanisms

There is no data on the effect of the drug on the ability to drive vehicles and control mechanisms.

OVERDOSE

Due to extremely low systemic absorption, an overdose of the drug is unlikely.

DRUG INTERACTION

The interaction of the drug Fastum with other drugs is not described.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a place protected from light and inaccessible to children at a temperature of 15 ° to 25 ° C.
Shelf life - 5 years.
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