FLOSTERON 7 mg. 1 ml. 5 ampules
FLOSTERON. 2 mg. +5 Mg. / 1 ml. 5 ampules
Active substance: Betamethasone.
Excipients natiriev hydrogen phosphate dihydrate, sodium chloride, sodium edetate, polysorbate 80E, benzyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium carboxymethyl cellulose, macrogol, concentrated hydrochloric acid, water for injections.
1. FLOSTERON WHAT IS AND WHAT IT IS USED FOR?
Injecting 1 ml of a suspension (1 ampoule) contains 2 mg betamethasone disodium phosphate as 5 and as mg betamethasone dipropionate.
Box of 5 ampoules of 1 ml suspension for injection.
What is Flosteron?
Flosteron active substance contains betamethasone, which is a synthetic corticosteroid. It has anti-inflammatory and immunosuppressive effects and prevent hypersensitivity reactions. Betamethasone disodium phosphate is readily soluble compound is rapidly absorbed into the tissues and has a quick effect. Betamethasone dipropionate has a long duration of action due to slow absorption. The combination of the two compounds enables the implementation of a fast and prolonged effect. Depending on the mode of administration (intraarticular, periarticular, intralesional, intradermal, intramuscular, exceptionally) gave local or systemic therapeutic effects.
What is it used Flosteron?
Flosteron suspension for injection (injection) is prescribed for patients in whom primarily local and only in exceptional cases, systemic therapy with corticosteroids.
Flosteron prescribing intraarticular and periarticular inflammation in rheumatic diseases, intraarticular - degenerative rheumatic diseases, especially in the case of inflammation of the synovial lining (which is not prescribed in arthrosis
hip), non-arthritic rheumatism, certain skin diseases where the treatment was carried out otherwise no effect on the changes
Systemic action Flosteron used in some severe allergic diseases (seasonal or chronic inflammation of the nasal mucosa, hypersensitivity reactions).
2. BEFORE YOU USE FLOSTERON
Tell your doctor if you have any chronic disease, metabolic disease, if you are hypersensitive (allergic) or if you take other medicines.
Who should not take Flosteron?
You should not take this medicine if you are hypersensitive to betamethasone or any of its subsidiary substances.
Excluding emergencies, the product should not be used:
- If you are being treated or have been treated for tuberculosis
- If you are being treated or have been treated for mental illness (psychosis)
- If Lucullus of peptic ulcer of the stomach and duodenum,
- If you have had intestinal surgery or have bowel inflammation (diverticulitis)
- If you have had recent surgery or serious injury,
- If you are being treated for glaucoma
- If you are being treated for diabetes
- If you are being treated for thrombophlebitis (thromboembolism)
- If you have a bacterial or systemic fungal infection and did not receive adequate treatment
- If you have kidney failure,
- If you have a symptom caused by excessive use of corticosteroids (Cushing's syndrome).
You must inform your doctor that you are treated with betamethasone before being vaccinated with a live vaccine (at least 8 weeks should be an interval between the last dose Flosteron and date of vaccination), or if you have stopped treatment with betamethasone less than 14 days prior to vaccination.
Special precautions and warnings
Flosteron should not be prescribed for intravenous administration or in unstable or inflamed joints.
Flosteron should not be applied in the area of the Achilles tendon, because of the risk of tendon rupture.
Before starting treatment with Flosteron, tell your doctor:
- If you are being treated for osteoporosis
- If you are being treated for high blood pressure
- If you are being treated for muscle weakness (myasthenia gravis),
- If you are being treated for heart failure
- If you are being treated for epilepsy
- If you have decreased thyroid activity (hypothyroidism)
- If you have severe liver damage.
During treatment with Flosteron, should avoid contact with patients suffering from chickenpox or shingles. In case of accidental contact, you should consult with your doctor as soon as possible.
During treatment with Flosteron, there is an increased risk of low levels of potassium in the blood, so the doctor will often control the potassium level during prolonged therapy.
Treatment will need to be discontinued gradually after prolonged administration of large doses.
Before performing skin tests for allergies, tell your doctor that you are taking Flosteron.
You always need to have some basic information about your treatment.
Talk to your doctor or pharmacist before taking any medicine.
Corticosteroids, when used during pregnancy may have a harmful effect on the fetus. Pregnant women should not take this medicine only if the potential benefit to the mother outweighs the risk to the fetus
Talk to your doctor or pharmacist before taking any medicine.
During treatment should be discontinued breastfeeding.
Effects on ability to drive and use machines
Betamethasone no data to influence the ability to drive and use machines.
What other drugs interact with Flosteron?
Tell your doctor or pharmacist if you are taking or have taken any medicines, even those not prescribed.
Tell your doctor or pharmacist if you are taking:
- Medicines to treat high blood pressure
- Medicinal products increase the secretion of urine (diuretics)
- Medicinal products for the treatment of diabetes
- Drugs to prevent the coagulation of blood
- Medicinal products for the treatment of insomnia (barbiturates)
- Medicines to treat epilepsy (carbamazepine, phenytoin, phenobarbitone, primidone),
- Medicinal products for the treatment of tuberculosis (rifampicin),
- Medicinal products decongestants (ephedrine),
- Drugs that relieve pain or reduce fever (also aspirin),
- Medicinal products for the treatment of heart failure (digitalis).
Special warnings about excipients
Benzyl alcohol should not be prescribed to children under 3 years of age. Para-hydroxybenzoates cause urticaria. Usually they cause delayed reactions such as contact dermatitis and rarely quick reactions like hives and bronchospasm.
3. HOW TO USE FLOSTERON
Dosage and method of administration
The dose should be adjusted individually depending on the condition of the patient and the severity of the disease.
A dose of 0.25 ml to 2 ml with an interval between the applications of at least 4 weeks. 1 to 2 ml prescribed for use in very large joints (hip) intra-articular or periarticular, 1 ml in large joints (knee, shoulder or ankle), 0.5 ml to 1 ml in medium joints (elbow, wrist) and 0.25 ml to 0.5 ml in small joints. Single doses should not exceed 0.2 ml/cm2 when prescribed for applications in skin lesions / (leather, not the skin); total weekly dose for the entire area affected shall not exceed 1 ml.
0.25 ml to 1 ml (2 ml in the acute stage) is prescribed for bursitis, 0.5 ml in tenosynovitis and tendinitis and 0.5 ml to 1 ml with fibrositis.
If necessary Flosteron may be mixed with a local anesthetic with the same syringe.
Systemic application for allergic diseases:
It can be used only a single dose of 1 to 2 ml (to be administered intramuscularly, intravenously never!).
The drug is administered by deep intramuscular injection in the gluteal region.
If you have the impression that the effect of the product is too strong or too weak, talk to your doctor or pharmacist.
If more than Flosteron should
Overdose can occur usually after several weeks of use with most of the side effects listed in this leaflet (see Possible side effects), particularly Cushing's syndrome. Treatment of overdose is symptomatic. The effects can last for several weeks.
If a dose is missed Flosteron
The doctor will determine the frequency of administration. If you do not receive the specified scheme injection, tell your doctor as quickly as possible.
Effect of discontinuation of Flosteron
Discontinuations your discretion can be dangerous. If you stop the treatment in advance, the disease may return.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Flosteron can also have side effects. With continued use of Flosteron, can be expected occurrence of these side effects: increased susceptibility to infections, development of latent infections (tuberculosis), Cushing syndrome (obesity, moon-shaped face and back "buffalo hump"), unilateral pain in the hip (presenting with avascular necrosis of bone), increased risk of peptic ulcer, increased blood clotting, poor wound healing.
In the literature one can find the following common side effects (seen in systemic use, very rarely with topical application): bone loss (osteoporosis), fracture of the spine or hip fractures, psychosis, depression, blood clots in the blood vessels (phlebothrombosis) suppression of growth in children, menstrual disorders, hair growth, weight gain, worsening of diabetes, ruptured tendons, muscle weakness, swelling, headaches, cataracts, glaucoma, thinning and loss of elasticity of the skin, stretch marks, increased vytreochno pressure, cataracts, skin atrophy, telangiectasia, striae, the occurrence of small blood vessels in the skin povarzhnast, acne, increased number of levkopintite (leukocytosis).
If you encounter any side effects of the medicinal product, tell your doctor or pharmacist.
Can only be used in a healthcare facility by qualified personnel.
6. INSTRUCTIONS FOR MEDICAL PERSONNEL
Flosteron suspension for injection may be mixed with a local anesthetic in the same syringe but compatibility must always be checked.
5. STORAGE FLOSTERON
Do not use after the expiry date stated on the packaging.
Do not store above 25 ° C.
Keep out of reach of children.