Release form, composition and packaging
Spray for external application in the form of a colorless, clear to slightly opalescent viscous solution with the odor of isopropanol.
1 g contains:
betamethasone dipropionate 0.640 mg
that corresponds to the content of betamethasone 0.5 mg
Excipients: isopropanol 400 ppm, carbomer 934Р 2.5 mg, water 596.86 mg, sodium hydroxide q.s.
20 ml – bottles plastic (1) – packs of cardboard.
50 ml – polyethylene bottles (1) – packs of cardboard.
Clinico-pharmacological group: corticosteroids for topical use
Pharmaco-therapeutic group: the Glucocorticosteroid for local use
Dermatitis, different types of eczema (including atopic, child, numulyarnaya), nodular pruritus Hyde, irritant dermatitis, exfoliative dermatitis, neurodermatitis, solar dermatitis, seborrheic dermatitis, radiation dermatitis, intertrigo, psoriasis (except extensive laskovogo psoriasis), skin or anogenital (excluding kandidomikozy) itching, diskoidna lupus erythematosus, an auxiliary agent in complex therapy of generalized erythroderma.
The dosage regimen
Dose set individually.
Apply a thin layer to the affected area of skin 2-6 times/day until clinical improvement, then apply 1-2 times/day. When use of betamethasone in children and in patients with lesions of the facial course of treatment should not exceed 5 days.
From the endocrine system: reduced tolerance to glucose, steroid diabetes mellitus or manifestation of latent diabetes, suppression of adrenal function, the syndrome Itsenko-Kushinga (including Crescent-shaped face, obesity, pituitary type, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis, striae), delayed sexual development in children.
From the metabolic: increased excretion of calcium, hypocalcemia, increase in body mass, negative nitrogen balance (increased protein breakdown), increased sweating, fluid retention, and sodium ions (peripheral edema), hypernatremia, hypokalemic syndrome (hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).
CNS: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, pseudotumor cerebellum, headache, convulsions.
From the side of cardiovascular system: arrhythmia, aetiology (until the heart failure), development (in predisposed patients) or increased severity of chronic heart failure, ECG changes typical of hypokalemia, the AD, hypercoagulability, thrombosis. In patients with acute and subacute myocardial infarction – distribution of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle, with intracranial introduction – nosebleeds.
From the digestive system: nausea, vomiting, pancreatitis, steroid ulcer of stomach and duodenum, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increased or decreased appetite, flatulence, hiccups. In rare cases – increase in liver transaminases and alkaline phosphatase.
From the senses: sudden loss of vision (in injecting a in the head, neck, nasal turbinates, the scalp may deposition of crystals medication in the vessels of eye), posterior subcapsular cataracts, increased intraocular pressure with possible damage to the optic nerve, the propensity to develop secondary bacterial, fungal or viral eye infections, trophic changes cornea, exophthalmos.
From the side of musculoskeletal system: slowing growth and ossification processes in children (premature closure of the epiphyseal growth zones), osteoporosis (very rarely – pathological fractures, aseptic necrosis of head of humerus and femur), rupture of tendons of muscles, steroid myopathy, reduction of muscle mass (atrophy), with intraarticular injection – increased pain in the joint.
Dermatological reactions: delayed wound healing, petechiae, ekhimozy, skin thinning, Hyper – or hypopigmentation, steroid acne, striae, susceptibility to the development of pyoderma and candidiasis.
Allergic reactions: generalized (skin rash, itching, anaphylactic shock), local allergic reactions.
Local reactions: in injecting a – burning, numbness, pain, paresthesia and infection at the injection site, rarely – necrosis of surrounding tissue, scarring at the injection site, in the/m introduction (especially in the deltoid muscle) atrophy of the skin and subcutaneous tissue.
Other: the development or worsening of infections (the emergence of this side effect contribute jointly used immunosuppressants and vaccination), pyuria, the syndrome.
At/in the introduction – arrhythmia, “tides” of blood to the face, convulsions.
For external use: rarely – itching, hyperemia, burning, dryness, folliculitis, acneiform eruption, hypopigmentation, perioral dermatitis, allergic dermatitis, maceration of skin, secondary infection, skin atrophy, striae, miliaria. With prolonged use or application on extensive areas of skin may develop systemic side effects characteristic of SCS.
For short-term use for health reasons – hypersensitivity to betamethasone.
For intraarticular administration and injection directly into the lesion: previous arthroplasty, abnormal bleeding (endogenic or caused by anticoagulants), intra-articular fracture of bone, infectious (septic) inflammatory process in joints and periarticular infections (including in history), as well as the overall infectious disease, expressed juxta-articular osteoporosis, lack of signs of inflammation in the joints (“dry” joint, such as osteoarthrosis without synovitis), marked bone destruction and deformity of the joint (sharp narrowing of the joint space, ankylosis), joint instability as a result of arthritis, aseptic necrosis forming joint epiphyses of bones.
For external use: acne rosacea, acne ordinary (youth) acne, primary viral skin infections (including chickenpox).
Application of pregnancy and breastfeeding
Application of pregnancy is possible in exceptional cases under strict indications.
If necessary, use during lactation breastfeeding should be discontinued.
Application for violations of liver function
To apply caution in severe chronic liver failure.
Application for violations of renal function
To apply caution in severe chronic renal failure, nefrourolitiaz.
C caution if the parasitic and infectious diseases virus, fungal or bacterial origin (currently or recently migrated, including the recent contact with sick) – herpes simplex, herpes zoster (vermicella phase), chickenpox, measles, amoebiasis, strongyloidiasis (established or suspected), systemic mycosis, active and latent tuberculosis. Application for serious infectious diseases is admissible only against specific therapies.
Be wary for 8 weeks before and 2 weeks after vaccination), lymphadenitis when after BCG, with immunodeficiency (including AIDS or HIV infection).
To apply caution in diseases of the gastrointestinal tract: gastric ulcer and duodenal ulcer, esophagitis, gastritis, acute or latent peptic ulcer, the recently established bowel anastomosis, ulcerative colitis with the threat of perforation or abecedarian, diverticulitis.
To apply caution in diseases of cardiovascular system, including after recent myocardial infarction (in patients with acute and subacute myocardial infarction may spread of necrosis, slowing the formation of scar tissue and consequently, rupture of the heart muscle), in decompensated chronic heart failure, arterial hypertension, hyperlipidemia), when endocrine diseases – diabetes mellitus (including violation of tolerance to carbohydrates), thyrotoxicosis, hypothyroidism, disease Itsenko-Kushinga, with severe chronic renal and/or liver failure, nefrourolitiaz, when gipoalbuminemii and conditions, predisposing to its occurrence, with systemic osteoporosis, myasthenia gravis, acute psychosis, obesity (III-IV degree), when polio (except bulbar form of encephalitis), open – and angle-closure glaucoma, pregnancy, lactation.
If necessary, intra-articular injection with caution in patients with a common grave condition, the ineffectiveness of (or short duration) action 2 previous introductions (taking into account the individual properties of the used GCS).
The ingestion necessary to control the level of blood glucose, blood pressure, indicators of water-electrolyte balance. In case of irritation or symptoms of hypersensitivity to betamethasone treatment should be stopped and appropriate therapy. When you join secondary infection is the treatment of the corresponding antimicrobial agents.
Not indicated for the treatment of hyaline membrane disease of the newborn.
It should not be used topically for treating primary skin lesions when a fungal (e.g., candidiasis, dermatophytosis) and bacterial (e.g. impetigo) infections, perianal and anogenital pruritus.
With simultaneous use with cardiac glycosides their effect is enhanced with a diuretic – increases the excretion of potassium, hypoglycemic drugs, oral anticoagulants – the weakening of their actions, with an NSAID increases the risk of erosivno-yazvennah losses and bleeding from the gastrointestinal tract.