Universal reference book for medicines
Product name: BELODERM ® EXPRESS (BELODERM ® EXPRESS)

Active substance: betamethasone

Type: GCS for external use

Manufacturer: BELUPO, Pharmaceuticals & Cosmetics (Croatia)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
GCS.
Suppresses the function of white blood cells and tissue macrophages. Limits the migration of leukocytes to the area of ​​inflammation. Violates the ability of macrophages to phagocytosis, as well as to the formation of interleukin-1. Promotes the stabilization of lysosomal membranes, thereby reducing the concentration of proteolytic enzymes in the area of ​​inflammation. Reduces the permeability of capillaries due to the release of histamine. Suppresses the activity of fibroblasts and the formation of collagen.
Inhibits the activity of phospholipase A 2 , which leads to suppression of the synthesis of prostaglandins and leukotrienes.
Suppresses the release of COX (mainly COX-2), which also contributes to a decrease in the production of prostaglandins.
Reduces the number of circulating lymphocytes (T- and B-cells), monocytes, eosinophils and basophils due to their movement from the vascular bed into the lymphoid tissue;
suppresses the formation of antibodies.
Betamethasone suppresses pituitary release of ACTH and β-lipotropin, but does not reduce the level of circulating α-endorphin.
Oppresses the secretion of TSH and FSH.
With direct application on the vessels has a vasoconstrictor effect.

Betamethasone has a pronounced dose-dependent effect on the metabolism of carbohydrates, proteins and fats.
Stimulates gluconeogenesis, promotes the capture of amino acids by the liver and kidneys and increases the activity of gluconeogenesis enzymes. In the liver, betamethasone enhances the storage of glycogen, stimulating the activity of glycogen synthetase and the synthesis of glucose from protein metabolism products. Increasing the glucose level in the blood activates the release of insulin.
Betamethasone suppresses the capture of glucose by fat cells, which leads to activation of lipolysis.
However, due to an increase in the secretion of insulin, lipogenesis stimulates, which contributes to the accumulation of fat.
It detains sodium ions and water in the body, stimulates the excretion of potassium ions, reduces absorption of calcium from the digestive tract, cleans calcium ions from the bones, increases the excretion of calcium by the kidneys.

Has catabolic effect in lymphoid and connective tissue, muscles, fatty tissue, skin, bone tissue.
Osteoporosis and Itenko-Cushing's syndrome are the main factors limiting long-term therapy to SCS. As a result of catabolic action, growth can be suppressed in children.
In high doses, betamethasone can increase the excitability of brain tissue and helps lower the threshold of convulsive readiness.
Stimulates excess production of hydrochloric acid and pepsin in the stomach, which leads to the development of peptic ulcers.
In systemic application, the therapeutic activity of betamethasone is due to anti-inflammatory, antiallergic, immunosuppressive and antiproliferative action.

With external and local application, the therapeutic activity of betamethasone is due to anti-inflammatory, antiallergic and antiexcudative (due to vasoconstrictor effect) action.

For anti-inflammatory activity exceeds hydrocortisone 30 times, does not have mineralocorticoid activity.
The presence of fluorine in the molecule enhances the anti-inflammatory activity of betamethasone.
Betamethasone in the form of dipropionate is characterized by a prolonged action.

PHARMACOKINETICS
Binding to plasma proteins is about 64%, V d - 84 liters.
Metabolised in the liver. Metabolites are excreted mainly by the kidneys, a small part - with bile.
When absorbed through the skin, betamethasone is characterized by similar pharmacokinetic properties, both with external and with systemic application.
Systemic absorption after external application is 12-14%.
For local and external use with intact skin, absorption may be negligible.
The presence of an inflammatory process, as well as the use of an occlusive dressing, can increase the amount of absorption.
INDICATIONS
For oral administration: primary or secondary insufficiency of the adrenal gland function, congenital adrenal hyperplasia, acute (nasal) and subacute thyroiditis, hypercalcemia due to tumor disease, rheumatic diseases, collagen diseases, allergic diseases, symptomatic sarcoidosis, Leffler's syndrome, berylliosis, idiopathic or secondary thrombocytopenia adults, autoimmune hemolytic anemia, erythroblastopenia (erythrocyte anemia), erythroid hypoplastic anemia, transfusion
e response, palliative therapy of leukemia and lymphoma in adults and acute leukemia in children; ulcerative colitis, Bell's paralysis.
For parenteral administration: shock (including burn, traumatic, operational, toxic, cardiogenic, hemotransfusion, anaphylactic);
allergic reactions (acute, severe forms), anaphylactoid reactions; cerebral edema (including on the background of a brain tumor or associated with surgical intervention, radiation therapy or head trauma), increased intracranial pressure; bronchial asthma (severe form), asthmatic status; systemic connective tissue diseases (SLE, rheumatoid arthritis); acute adrenal insufficiency, prevention of insufficiency of the adrenal cortex in patients who received SCS for a long time; thyrotoxic crisis; acute hepatitis, hepatic coma;poisoning cauterizing fluids; cereals in diphtheria (in combination with appropriate antimicrobial therapy).
For intraarticular administration: rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteochondritis, acute gouty arthritis.
Diseases of soft tissues (including bursitis, fibrositis, tendonitis, tendosinovitis, myositis).
For external use: dermatoses, various types of eczema (including atopic, pediatric, numular), gnawing pruritus of Gaida, simple dermatitis, exfoliative dermatitis, neurodermatitis, sun dermatitis, seborrheic dermatitis, radiation dermatitis, diaper rash, psoriasis (except for extensive plaque psoriasis), cutaneous or anogenital (excluding candidomycosis) itching, discoid lupus erythematosus, as an aid in the complex therapy of generalized erythroderma.

For topical application: eye and ear diseases with a pronounced allergic or inflammatory component.

DOSING MODE
The dose is set individually.

At intake the daily dose for adults makes 0.25-8 mg, for children - 17-250 mkg / kg.
After long-term use, the abolition of betamethasone should be carried out gradually, reducing the dose by 250 micrograms every 2-3 days.
For intravenous administration (jet slowly or drip) a single dose is 4-8 mg, if necessary, an increase of up to 20 mg is possible;
the maintenance dose is usually 2-4 mg. A single dose for the / m administration is 4-6 mg.
For intraarticular administration and administration directly to the lesion in soft tissue diseases, depending on the size of the joint and the size of the affected area, a single dose is 0.4-6 mg.

Subconjunctivalally single dose - 2 mg.

With external application, apply a thin layer on the affected area of ​​the skin 2-6 times / day until the clinical improvement, then apply 1-2 times / day.
When using betamethasone in children, as well as in patients with facial lesions, the course of treatment should not exceed 5 days.
SIDE EFFECT
On the part of the endocrine system: a decrease in glucose tolerance, steroid diabetes mellitus or manifestation of latent diabetes mellitus, oppression of the adrenal gland function, Itzenko-Cushing syndrome (including the lunar face, obesity of the pituitary type, hirsutism, increased blood pressure, dysmenorrhea, amenorrhea, myasthenia gravis , stria), delayed sexual development in children.

From the side of metabolism: increased excretion of calcium ions, hypocalcemia, weight gain, negative nitrogen balance (increased protein breakdown), increased sweating, fluid retention and sodium ions (peripheral edema), hypernatremia, hypokalemic syndrome (including hypokalemia, arrhythmia, myalgia or muscle spasm, unusual weakness and fatigue).

From the side of the central nervous system: delirium, disorientation, euphoria, hallucinations, manic-depressive psychosis, depression, paranoia, increased intracranial pressure, nervousness or anxiety, insomnia, dizziness, vertigo, pseudotumor, cerebral palsy, headache, convulsions.

From the cardiovascular system: arrhythmias, bradycardia (up to cardiac arrest);
development (in predisposed patients) or increased severity of chronic heart failure, changes in ECG, characteristic of hypokalemia, increased blood pressure, hypercoagulation, thrombosis. In patients with acute and subacute myocardial infarction - the spread of the focus of necrosis, slowing the formation of scar tissue, which can lead to rupture of the heart muscle; when intracranial introduction - nosebleeds.
On the part of the digestive system: nausea, vomiting, pancreatitis, steroid ulcer of the stomach and duodenum, erosive esophagitis, bleeding and perforation of the gastrointestinal tract, increase or decrease in appetite, flatulence, hiccough.
In rare cases - increased activity of hepatic transaminases and alkaline phosphatase.
From the senses: sudden loss of vision (with parenteral administration in the region of the head, neck, nasal concha, scalp may precipitate crystals of the drug in the vessels of the eye), posterior subcapsular cataracts, increased intraocular pressure with possible damage to the optic nerve, propensity to develop secondary bacterial , fungal or viral infections of the eyes, trophic changes in the cornea, exophthalmos.

From the musculoskeletal system: slowing growth and ossification processes in children (premature closure of the epiphyseal growth zones), osteoporosis (very rarely - pathological bone fractures, aseptic necrosis of the head of the humerus and thigh bone), rupture of muscle tendons, steroid myopathy, (atrophy);
with intra-articular injection - increased pain in the joint.
Dermatological reactions : delayed healing of wounds, petechiae, ecchymosis, thinning of the skin, hyper- or hypopigmentation, steroid acne, striae, propensity to develop pyoderma and candidiasis.

Allergic reactions : generalized (skin rash, skin itching, anaphylactic shock), local allergic reactions.

Local reactions: with parenteral administration - burning, numbness, pain, paresthesia and infection at the injection site, rarely - necrosis of surrounding tissues, scar formation at the injection site;
with the / m introduction (especially in the deltoid muscle) - atrophy of the skin and subcutaneous tissue.
Other: development or exacerbation of infections (the appearance of this side effect is promoted by jointly used immunosuppressants and vaccination), leukocyturia, withdrawal syndrome.

With iv administration - arrhythmias, "tides" of blood to the face, convulsions.

With external application: rarely - itching, hyperemia, burning, dryness, folliculitis, acne, hypopigmentation, perioral dermatitis, allergic dermatitis, skin maceration, secondary infection, skin atrophy, striae, sweating.
With prolonged use or application to large areas of the skin, it is possible to develop systemic side effects characteristic of GCS.
CONTRAINDICATIONS
For short-term use according to vital indications - hypersensitivity to betamethasone.

For intraarticular administration and introduction directly into the lesion: previous arthroplasty, pathological bleeding (endogenous or caused by the use of anticoagulants), intraarticular bone fracture, infectious (septic) inflammatory process in the joint and periarticular infections (including in the anamnesis), as well as general infectious disease, expressed near-joint osteoporosis, absence of signs of inflammation in the joint ("dry" joint, for example, with osteoarthritis without synovitis), pronounced bone destruction
and joint deformity (sharp narrowing of the joint gap, ankylosis), joint instability as the outcome of arthritis, aseptic necrosis of the joints forming the epiphyses of bones.
For external use: rosacea, acne and common (youthful) acne;
primary viral skin infections (including chicken pox).
PREGNANCY AND LACTATION
Application in pregnancy is possible in exceptional cases on strict indications.

If it is necessary to use lactation, breastfeeding should be discontinued.

APPLICATION FOR FUNCTIONS OF THE LIVER
Use with caution in severe chronic renal failure, nephrourolythiasis.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Use with caution in severe chronic liver failure.

SPECIAL INSTRUCTIONS
Use with caution in case of parasitic and infectious diseases of a viral, fungal or bacterial nature (currently or recently transferred, including recent contact with a patient) - herpes simplex, herpes zoster (viremic phase), chicken pox, measles, amebiasis, strongyloidiasis (established or suspected), systemic mycosis;
active and latent tuberculosis. The use in severe infectious diseases is permissible only against the background of specific therapy.
Use with caution for 8 weeks before and 2 weeks after vaccination), with lymphadenitis after BCG vaccination, in immunodeficient conditions (including AIDS or HIV infection).

Use with caution in diseases of the digestive tract: peptic ulcer of stomach and duodenum, esophagitis, gastritis, acute or latent peptic ulcer, newly created intestinal anastomosis, ulcerative colitis with perforation or abscessing, diverticulitis.

With caution apply for diseases of the cardiovascular system, incl.
after a recent myocardial infarction (in patients with acute and subacute myocardial infarction it is possible to spread the necrosis foci, slow the formation of scar tissue and, as a result, rupture of the heart muscle), with decompensated chronic heart failure, hypertension, hyperlipidemia), endocrine diseases - diabetes mellitus including violation of tolerance to carbohydrates), thyrotoxicosis, hypothyroidism, Itenko-Cushing's disease, with severe chronic renal and / or hepatic insufficiency, nephrourolythiasis, hypoalbuminemia and conditions predisposing to its occurrence, with systemic osteoporosis, myasthenia gravis, acute psychosis, obesity (grade III-IV), poliomyelitis (except for the form of bulbar encephalitis), open and closed angle glaucoma, pregnancy, lactation .
If necessary, intraarticular administration should be used with caution in patients with a general severe condition, ineffectiveness (or short-term) of the effect of the previous 2 injections (taking into account the individual properties of the SCS used).

When ingesting it is necessary to monitor blood glucose, blood pressure, electrolyte balance.
In case of irritation or the appearance of symptoms of hypersensitivity to betamethasone treatment should be stopped and appropriate therapy should be carried out. When secondary infection is attached, appropriate antimicrobial agents are treated.
Not indicated for the treatment of hyaline membranes of newborns.

Do not use topically to treat primary skin lesions in fungal (eg, candidiasis, trichophytosis) and bacterial (eg, impetigo) infection, perianal and anogenital itching.

DRUG INTERACTION
With simultaneous use with cardiac glycosides, their action is enhanced;
with diuretics - the excretion of potassium increases; with hypoglycemic drugs, oral anticoagulants - weakening of their action; with NSAIDs - the risk of erosive-ulcerative lesions and bleeding from the gastrointestinal tract increases.
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