Betaspan

Betaspan is a corticosteroid for systemic use. Contains the element betamethasone.

Indications Betaspana

It is used for therapy in a variety of pathologies that have a rheumatic or endocrine nature, allergic, respiratory, dermatological, hematological or gastrointestinal diseases, as well as collagenoses and other diseases that are sensitive to the effects of GCS. Hormonal treatment with corticosteroids is an auxiliary part of standard therapy, which is not a substitution therapy. Medication is prescribed if there is a need for rapid and intensive therapeutic effects of SCS.

Endocrine pathology:

• insufficiency of the adrenal cortex of the primary or secondary form (recommended in combination with mineralocorticosteroids);
• adrenal insufficiency in acute degree;
• supporting procedures before surgery (and in addition, with trauma or various concomitant diseases), if the patient is diagnosed with adrenal insufficiency or suspected of having it;
• shock state in the absence of reaction to standard medical procedures, when there is a suspicion of a lesion of the adrenal cortex;
• bilateral adrenalectomy;
• adrenal form of hyperplasia, which has a congenital character;
• thyroiditis in acute form, and in addition to the thyroid crisis and the non-swelling form of thyroiditis;
• hypercalcemia associated with oncology.

Brain puffiness (increased ICP values): Clinical efficacy from the concomitant use of corticosteroids in cerebral puffiness is likely to develop through suppression of cerebral inflammation. At the same time, corticosteroids should not be taken as a substitute for the procedure for neurosurgical intervention. They only contribute to reducing cerebral puffiness or preventing it (this swelling can be caused by a brain trauma of a surgical or other origin, cerebrovascular signs, and brain tumors of a metastatic or primary nature).

Situations with rejection of the renal allograft: the efficacy of the drug is noted during therapy with the primary character of rejection having an acute form, and also with the standard rejection of the delayed character, in combination with traditional treatment in preventing rejection of a kidney transplant.

Used before birth to prevent the development of RDSN - it is prescribed to prevent the occurrence of hyaline wall disease in premature infants. The drug is administered to the mother no later than the 32nd week of pregnancy.

Lesions affecting the skeleton and musculature: in the form of an adjuvant, prescribed for a short time (to eliminate the aggravation of pathological processes):

• rheumatoid arthritis;
• having a post-traumatic origin of osteoarthritis;
• psoriatic form of arthritis;
• Bechterew's disease;
• arthritis of a gouty character, having an acute form;
• bursitis of acute or subacute nature;
• myositis;
• acute rheumatic fever;
• fibromyalgia ;
• epikondilit;
• Tenosynovitis, having a non-specific form, at the stage of exacerbation;
• corns.

It is also used for the treatment of cystic neoplasms (ganglia) in the area of the aponeurosis or tendon.

With collagenoses: in case of exacerbation (or sometimes as a supporting agent) in SLE, scleroderma, rheumatic form of carditis (acute degree), as well as dermatomyositis.

Dermatological diseases:

• pemphigus;
• Bullous form of dermatitis having a herpetiform nature;
• severe severity of Stevens-Johnson syndrome ;
• dermatitis having exfoliative character;
• mushroom granuloma;
• a severe stage of psoriasis, and in addition eczema of allergic genesis (chronic form of dermatitis) and dermatitis of seborrheic nature in severe degree.

Use in affected areas of the epidermis is prescribed when:

• keloid scars;
• limited area of hypertrophy;
• the appearance of inflammation or infiltration;
• flat lichen, anular granuloma, and in addition to psoriatic plaques;
• common deprive in chronic stage (neurodermatitis);
• DKV;
• lipoid form of necrosis, having a diabetic character;
• alopecia of a focal character.

Pathologies of allergic origin:

• maintaining in severe allergic reactions, which is not possible to remove by standard therapeutic agents - including such diseases rhinitis of allergic origin having a year-round or seasonal form of nasal polyps, asthma (also with status asthmaticus), dermatitis, atopic or contact nature, allergy to medicamentous preparations and blood transfusion;
• Puffiness in the larynx, which is non-infectious in nature and acute in nature.

Diseases of ophthalmological nature: processes developing in the eye area with adjacent tissues that are inflammatory or allergic in nature (chronic or acute stage or severe degree). Among such keratitis, conjunctivitis of allergic origin, marginal ulcers in the cornea and the surrounding form of ocular herpes. In addition, the list also includes anterior uveitis or iritis, an inflammatory process in the anterior segment, chorioretinitis, a posterior form of uveitis of a diffuse nature, and also neuritis affecting the optic nerve region.

Diseases affecting the respiratory function: manifestations of Beck's sarcoidosis and Leffler's syndrome, which could not be copied by other methods. In addition, pulmonary tuberculosis, which has a disseminated or fulminant form (Betaspan is used as an auxiliary part of anti-tuberculosis treatment of a specific nature), berylliosis and aspiration form of pneumonia.

Hematological diseases: secondary or idiopathic form of thrombocytopenia (in an adult), hemolytic form of anemia, which has acquired character, red cell aplasia, and in addition hypoplastic form of anemia of an innate character and transfusion signs.

Pathologies developing in the gastrointestinal tract: ulcerative form of colitis (nonspecific character) and Crohn's disease.

Oncological diseases: acute forms of childhood leukemia, as well as palliative therapy for lymphomas and leukemia developing in an adult.

With swabs caused by SLE, or to enhance diuresis or remission with proteinuria on the background of a nephrotic syndrome that is idiopathic, and not accompanied by uremia.

Others: a tuberculous form of meningitis, accompanied by a blockade of the subarachnoid type (or at its threat), and caused by specific chemotherapy aimed at treating tuberculosis. In addition, it is used for trichinosis, accompanied by lesions of the myocardial and neurological nature.

Release form

The release of the substance is realized in a solution inside the ampoule with a capacity of 1 ml. The box contains 1 or 5 ampoules. Also ampoules (5 pieces) can be packed in blisters, according to the first blister inside the pack.

Pharmacodynamics

Betamethasone is an artificial preparation of GCS for systemic use. Has a strong anti-inflammatory, antiallergic, and at the same time anti-rheumatic effect during therapy in diseases that react to SCS activity.

The medication modifies the activity of the body's immune system. Betaspan has a pronounced SCS activity and a weak mineralocorticoid effect.

Pharmacokinetics

Absorption of the active element from the injection site occurs rapidly. The substance reaches the level of Cmax within the blood plasma after 1 hour. Almost the entire portion of the drug is excreted from the body within 24 hours through the kidneys. Synthesized with blood protein in large quantities. Exchange processes occur inside the liver. The half-life of betamethasone is 300+ minutes.

In people with hepatic disease, the drug clearance is lower. It was found that the therapeutic efficiency is more related to the values of the non-synthesized fraction of GCS than to its total plasma indices. The duration of the drug effect does not depend on the plasma values of the GCS. The substance without complications passes through GEB, the placenta and other histohematological barriers, and is excreted with the mother's milk.

Dosing and administration

Betaspan can be administered intravenously, iv, and also in / m ways - into the soft tissue and affected areas.

The sizes of portions and the scheme of therapy are selected individually for each patient, taking into account the features of the pathology, the degree of its intensity and the therapeutic effectiveness of the drug.

The size of the initial portion is a maximum of 8 mg of LS per day. In more mild forms of the disease, a lower dosage can be used. Also, if required, it is possible to increase single initial doses. Correct the initial dose is necessary until the optimal clinical result. If it is absent after the expiration of a certain time interval, it is necessary to cancel the use of drugs and to choose another treatment.

Children are often prescribed an injection of 20-125 μg / kg per day for the beginning. Doses for children of different age groups are selected according to the schemes used in adults.

In cases where a patient needs emergency care, it is recommended to administer Betaspan IV way.

Droppers of the drug are administered together with 0.9% NaCl or glucose solution. In infusion liquids, the drug is added during the administration. Unused medication can be kept in the refrigerator (with subsequent use) for a maximum of 1 day.

When the desired effect is achieved, it is necessary to begin gradually (at equal time intervals) to lower the initial dosage to the minimum values that will support the required drug effect.

When a patient develops stresses (not related to the underlying disease), an increase in the portion of Betaspan may be necessary.

If the medicine is canceled after prolonged use, you need to reduce portions gradually.

Headache swelling.

With the injection of 2-4 mg of the drug, the condition improves after a few hours. Patients in a coma, 4 times a day, administered an average single dose of drugs, equal to 2-4 mg.

Symptoms of rejection of the transplanted renal allograft.

After the appearance of the first manifestations and the diagnosis of rejection (in acute or delayed stage), the drug substance is administered via a dropper intravenously. For the initial portion requires 60 mg of the drug, which is used during the first 24 hours. Small adjustments of medicinal portions are also allowed on an individual basis.

Pre-natal prevention of RDSN development in premature infants.

In cases of stimulation of labor before the 32-week period is reached, or if premature birth (due to obstetric complications) is prevented, it is necessary 24-48 hours before the planned delivery to perform IV injections of 4-6 mg Betaspane with intervals of 12 hours (2-4 servings are administered).

Therapy is required to begin at least 24 hours in advance (but a period of 48-72 hours will be more suitable) before delivery. This is necessary to ensure that the effect of GCS has reached the most effective indicators with the required therapeutic result.

Medication can also be used for prevention - in cases where the proportions of lecithin and sphingomyelin are reduced inside the amniotic fluid. When adjusting the dosage in such cases, it is necessary to follow the above instructions, including those relating to the terms of drug administration before the birth process.

Schemes of application for diseases in the field of soft tissues and lesions of the skeleton and musculature:

• area of large joints (for example, hip) - the introduction of 2-4 mg of LS;
• area of small joints - use of 0.8-2 mg of the drug;
• a site of synovial bag - an injection of 2-3 mg of substance;
• zone of tendon vagina or calluses - application of 0.4-1 mg mg;
• soft tissue area - the introduction of 2-6 mg of the drug;
• ganglion zone - use of 1-2 mg Betamethasone.

To prevent the emergence of transfusion complications, it is required to intravenously apply the drug in a dose of 1-2 ml (contains 4-8 mg of betamethasone substance) immediately before the beginning of the procedure of blood transfusion. It is strictly forbidden to add the drug to the transfused blood.

If repeated blood transfusion is carried out, the size of the total portion of the drug can reach up to 4 times the dosages administered, if necessary, for 24 hours.

Subconjunctival injections are usually performed in portions equal to 0.5 ml of the drug (contains 2 mg of drug substance).

Use Betaspana during pregnancy

There is no information on the safety of use of Betaspan in pregnant women, which is why it is used only in situations when the probability of drug use is higher than the risk of complications in the fetus. By the same instruction, doctors should be guided when deciding whether to use the drug for prenatal prophylaxis of RDSN development after the 32nd week of pregnancy.

It is necessary to examine the newborns of those women who were given large portions of GCS during pregnancy to determine the symptoms of adrenocortical insufficiency. In infants of those women who received injections of drugs during pregnancy, there was a temporary suppression of embryonic somatotropin, and in addition, it appears that the pituitary hormones responsible for the production of a corticosteroid in the fetal, as well as definitive areas of the adrenal glands. But the inhibition of embryonic hydrocortisone activity had no effect on the response pituitary-adrenocortical processes in postnatal stress.

Since corticosteroids are able to penetrate the placenta, infants who were born to women who have used GCS during pregnancy should be carefully checked regarding the possible development of their cataracts of an innate nature (it happens sporadically).

Mothers who used SCS during pregnancy should be closely monitored for childbirth and for some time afterwards to prevent the development of adrenocortical insufficiency (due to birth stress).

Since GCS is excreted in the mother's milk, it is necessary to refuse the use of drugs during lactation, or from breastfeeding during therapy - to avoid the appearance of negative symptoms in the baby.

Contraindications

It is contraindicated to appoint in systemic fungal infections, as well as with intolerance with respect to betamethasone, other elements of drugs and other preparations of GCS.

Side effects Betaspana

The intensity and frequency of the appearance of negative symptoms (as in any SCS) is determined by the duration of the treatment cycle and the size of the portion used. Often, such signs are curable or can be minimized by lowering the dosage (which will allow to abandon the use of drugs). Among the side effects:

• disorders of the CCC: heart failure in a stagnant form in people with a predisposition, and in addition increase in blood pressure;
• disturbances in the function of the NA: headaches, an increase in ICP, in which the discs of the optic nerves swell (often observed after the end of therapy), dizziness, convulsions and migraines;
• psychic complications: psycho-emotional lability, a sense of euphoria, insomnia, personality changes, a severe stage of depression, reaching the development of strong psychotic symptoms (often in people with psychiatric problems in history), as well as increased irritability;
• manifestations on the part of the visual organs: an increase in IOP, exophthalmos, subcapsular cataracts of the rear type and glaucoma;
• disorders in the endocrine system: pituitary and adrenocortical insufficiency of secondary nature (often occurs against the background of stresses - surgical procedures, injuries, illnesses), a decrease in tolerance for carbohydrates. In addition, there is also a manifestation of prediabetes, an increase in the body's need for orally administered hypoglycemic drugs and insulin in diabetics, hypercorticism with hirsutism, a disorder of the menstrual cycle, acne and stretch marks on the skin, and suppression of fetal or child growth;
• metabolic disturbances: negative nitrogen balance values (due to protein catabolism), lipomatosis (this includes its epidural and mediastinal forms), which can cause neurological complications, and weight gain. In addition, there may be a VEB disorder developing in the form of potassium loss, sodium retention, increased calcium excretion, alkalosis of hypokalemic type, CHF (in people with intolerance), fluid retention and increased blood pressure;
• lesions of the musculoskeletal structure: myopathy of the corticosteroid nature, weakness in the muscles, potentiation of the signs of myasthenia gravis (against the background of the pseudo-paralytic form of the disease in the severe stage), a decrease in muscle mass and osteoporosis, which is sometimes accompanied by severe pain in the bone region and spontaneous fractures (having a compression fracture character vertebrae). In addition, necrosis can occur in the head region of the bones of the shoulders or hips (aseptic form of pathology), tendon hernia, major bone fracture related diseases, joint instability (due to constant injections into the joint region), and tendon ruptures;
• digestive disorders: gastric ulcers or erosions (later can develop into bleeding and perforation), pancreatitis, hiccups, ulcers in the esophagus, vomiting, intestinal perforation, ulcerative form of esophagitis, nausea and bloating;
• lesions of subcutaneous tissues and epidermis: delay in the processes of wound regeneration, brittle and thin epidermal layer, bruises, ecchymosis, atrophy, and in addition petechia, facial erythema, urticaria, dermatitis of allergic origin, hyperhidrosis and Quincke edema;
• immune disorders: corticosteroids are able to influence the data of skin tests, hide the signs of infections or activate latent lesions, and in addition to reduce resistance against infections (for example, viruses and mycobacteria with candida albicans). In addition, anaphylactoid manifestations or symptoms of hypersensitivity may occur, as well as conditions with reduced BP and shock.

Along with this, among the negative reactions, there were isolated situations of the appearance of blindness (they are associated with the areas where therapeutic procedures were performed - for example, the head and face), and in addition, atrophy in the epidermis and subcutaneous layers, pigmentation disorders, postinjection inflammation (with pricks inside the joints), a sterile form of abscess and arthropathy of the form "Charcot".

With repeated injections in the joint area, their lesion may develop, creating the risk of infection.

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Overdose

In acute poisoning with corticosteroids, which list includes betamethasone, life-threatening conditions do not develop. Excluding the use of too high dosages, excessive administration of GCS does not cause (if the patient has no contraindications, he does not have glaucoma, diabetes or ulcer in the active phase and does not take indirect anticoagulants, digitalis medicines and potassium-withdrawing diuretics) of the appearance of negative symptoms.

In case of an overdose, symptomatic procedures are performed that help to eliminate complications that appeared under the influence of metabolic properties of SCS, major or accompanying pathologies or drug interactions.

It is required to ensure the presence of the necessary volume of fluid in the body, and in addition to monitor electrolyte indices inside urine and blood serum, especially closely monitoring the balance of potassium and sodium. If necessary, restoration of the salt balance is carried out.

Interactions with other drugs

Combination with rifampicin, ephedrine, phenytoin, or phenobarbital may increase the metabolic rate of GCS, due to which its medicinal effect is reduced.

The increased impact from the use of corticosteroids can develop in patients who use SCS with estrogens.

Combined use of a medicament with diuretic drugs of potassium-releasing type can provoke the appearance of hypokalemia.

Simultaneous use of the drug with SG substances may increase the risk of arrhythmia or increase the toxic effects of glycosides associated with hypokalemia.

Substances of SCS are capable of potentiating the excretion of potassium ions caused by amphotericin B. All patients using any of the indicated drug combinations need to closely monitor the serum electrolyte values, in particular, the potassium indices.

Combination of corticosteroids with indirect anticoagulants can cause potentiation or a decrease in the medicinal effects of the latter, which may necessitate a correction of the dose.

The combination of GCS with alcoholic beverages or NSAIDs may increase the incidence of ulcerative symptoms in the gastrointestinal tract or increase their severity.

The use of corticosteroids helps to reduce the blood salicylates. It is necessary to carefully combine aspirin with GCS, if the patient is diagnosed with hypoprothrombinemia.

The use of GCS in diabetics may require a change in the dosages used against the background of hypoglycemic drugs.

Possible weakening of the response to the effect of somatotropin in the application of GCS. Therefore, during the use of somatotropin, Betaspan dosages exceeding 300-450 μg / m ² (or 0.3-0.45 mg) per day should be discarded.

GKS preparations can influence the test data with nitrous tetrazolium against bacterial infections, and cause false negative information.

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Storage conditions

Betaspan is required to be kept out of the reach of children. Do not freeze medicinal product. The storage temperature is a maximum of 25 ° C.

Shelf life

Betaspan is allowed to be used within 24 months of the manufacture of the therapeutic drug.

Application for children

With prolonged use in an infant or child, it is required to monitor its development and growth (since the drug can inhibit the internal production of corticosteroids and growth processes).

Children who use corticosteroids in immunosuppressive portions should avoid contact with people who suffer from measles or chickenpox.

Analogues

The analogues of the drug are the means Depos and Flosteron with Diprospan.