Betaspan

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

Indications Betaspan

It is used for therapy of various pathologies of rheumatic or endocrine nature, diseases of allergic, respiratory, dermatological, hematological or gastrointestinal nature, as well as collagenoses and other diseases sensitive to the influence of GCS. Hormonal treatment using corticosteroids is an auxiliary part of standard therapy, which is not a replacement. The drug is prescribed when there is a need for rapid and intensive therapeutic effect of GCS.

Endocrine pathologies:

• adrenal cortex insufficiency of primary or secondary form (recommended to be used in combination with mineralocorticosteroids);
• acute adrenal insufficiency;
• supportive procedures before surgery (and also in case of injuries or various concomitant diseases), if the patient has been diagnosed with adrenal insufficiency or is suspected of having it;
• shock state in the absence of a response to standard treatment procedures, when there is a suspicion of damage to the adrenal cortex;
• bilateral adrenalectomy;
• adrenal form of hyperplasia, which is congenital in nature;
• acute thyroiditis, as well as thyroid crisis and non-purulent thyroiditis;
• cancer-related hypercalcemia.

Cerebral edema (increased ICP values): the clinical benefit of concomitant corticosteroids in cerebral edema is likely to develop through suppression of cerebral inflammation. However, corticosteroids should not be considered as a substitute for neurosurgical intervention. They only help to reduce or prevent cerebral edema (this edema may be caused by brain trauma of surgical or other origin, cerebrovascular signs, as well as metastatic or primary brain tumors).

Situations with kidney allograft rejection: the drug is effective during therapy for primary rejection, which has an acute form, as well as for standard delayed rejection - in combination with traditional treatment to prevent kidney transplant rejection.

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

Lesions affecting the skeleton and muscles: as an adjunct, prescribed for a short time (to eliminate the exacerbation of pathological processes):

• rheumatoid arthritis;
• osteoarthritis of post-traumatic origin;
• psoriatic arthritis;
• Bechterew's disease;
• arthritis of a gouty nature, which has an acute form;
• acute or subacute bursitis;
• myositis;
• acute rheumatic fever;
• fibromyalgia;
• epicondylitis;
• tenosynovitis, which has a non-specific form, in the acute stage;
• calluses.

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

For collagenoses: in case of exacerbation (or sometimes as a supportive agent) in SLE, scleroderma, rheumatic carditis (acute stage), and also dermatomyositis.

Diseases of dermatological nature:

• pemphigus;
• bullous form of dermatitis of herpetiform nature;
• severe degree of Stevens-Johnson syndrome;
• dermatitis of an exfoliative nature;
• fungoid granuloma;
• severe stage of psoriasis, and in addition to this, eczema of allergic origin (chronic form of dermatitis) and severe seborrheic dermatitis.

Use in affected areas of the epidermis is prescribed for:

• keloid scars;
• limited area of hypertrophy;
• the appearance of inflammation or infiltration;
• lichen planus, anular granuloma, and also psoriatic plaques;
• common lichen in the chronic stage (neurodermatitis);
• DKV;
• lipoid form of necrosis, which is diabetic in nature;
• focal alopecia.

Pathologies of allergic origin:

• support for severe allergic manifestations that cannot be eliminated with standard treatments - such diseases include allergic rhinitis, which can be year-round or seasonal, nasal polyps, bronchial asthma (also with asthmatic status), atopic or contact dermatitis, allergies to medications and blood transfusions;
• swelling in the larynx area that is non-infectious in nature and acute in nature.

Ophthalmologic diseases: processes developing in the eye area with adjacent tissues that have an inflammatory or allergic nature (chronic or acute stage or severe degree). Among them are keratitis, allergic conjunctivitis, marginal ulcers in the cornea and herpes zoster ocularis. In addition, the list also includes anterior uveitis or iritis, an inflammatory process in the anterior segment, chorioretinitis, posterior uveitis of a diffuse nature, and neuritis affecting the optic nerve.

Diseases affecting the respiratory function: manifestations of Beck's sarcoidosis and Loeffler's syndrome, which could not be stopped 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 pneumonia.

Diseases of a hematological nature: secondary or idiopathic form of thrombocytopenia (in adults), hemolytic form of anemia of an acquired nature, red cell aplasia, as well as hypoplastic form of anemia of a congenital nature and transfusion signs.

Pathologies developing in the gastrointestinal tract: ulcerative colitis (non-specific) and Crohn's disease.

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

For edema caused by SLE, or to increase diuresis or achieve remission in case of proteinuria in the background of nephrotic syndrome, which is idiopathic in nature and not accompanied by uremia.

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

Release form

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

Pharmacodynamics

Betamethasone is a synthetic GCS preparation for systemic use. It has a strong anti-inflammatory, anti-allergic, and at the same time antirheumatic effect during therapy for diseases that respond to GCS activity.

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

Pharmacokinetics

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

In people with liver diseases, drug clearance rates are lower. It has been found that therapeutic efficacy is more closely related to the values of the non-synthesized fraction of GCS than to its total plasma values. The duration of the drug effect does not depend on the plasma values of GCS. The substance passes through the BBB, placenta and other histohematic barriers without complications, and is excreted with breast milk.

Dosing and administration

Betaspan can be administered intravenously, intramuscularly, or intramuscularly into soft tissues and affected areas.

Portion sizes and treatment regimens are selected individually for each patient, taking into account the characteristics of the pathology, its degree of intensity and the therapeutic effectiveness of the drug.

The initial dose is a maximum of 8 mg of the drug per day. In milder forms of the disease, a lower dosage may be used. Also, if necessary, single initial doses can be increased. The initial dosage portion should be adjusted until the optimal clinical result is achieved. If it is not achieved after a certain period of time, it is necessary to stop using the drug and select another treatment.

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

In cases where the patient requires emergency care, it is recommended to administer Betaspan intravenously.

The drug is administered by drips together with 0.9% NaCl or glucose solution. The drug is added to infusion fluids during administration. Unused drug can be kept in the refrigerator (with subsequent use) for a maximum of 1 day.

Once the desired effect has been achieved, the initial dosage should be gradually (at regular intervals) reduced to the minimum values that will maintain the required medicinal effect.

If the patient experiences stress (not related to the underlying disease), it may be necessary to increase the dose of Betaspan.

If the medicine is discontinued after prolonged use, the dose should be reduced gradually.

Cerebral edema.

When injecting 2-4 mg of the drug, the condition improves after several hours. Patients in a coma are given an average single dose of 2-4 mg of the drug 4 times a day.

Symptoms of kidney allograft rejection.

After the first symptoms appear and rejection is diagnosed (in the acute or delayed stage), the medicinal substance is administered intravenously through a drip. The initial dose requires 60 mg of the drug, which is used during the first 24 hours. Minor adjustments to the medicinal doses are also allowed on an individual basis.

Prenatal prevention of the development of RDSN in premature infants.

In cases of labor stimulation before the 32nd week, or if premature labor (due to obstetric complications) cannot be prevented, it is necessary to administer intramuscular injections of 4-6 mg of Betaspan at intervals of 12 hours (2-4 doses are administered) 24-48 hours before the expected birth.

Therapy should be started at least 24 hours (but 48-72 hours would be more appropriate) before delivery. This is necessary to ensure that the effect of GCS reaches its maximum effectiveness with the required therapeutic result.

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

Application schemes for diseases in the area of soft tissues and lesions of the skeleton and muscles:

• area of large joints (for example, hip joints) – administration of 2-4 mg of the drug;
• area of small joints – use of 0.8-2 mg of the drug;
• synovial bursa area – injection of 2-3 mg of substance;
• tendon sheath or callus area – use of 0.4-1 mg of LS;
• soft tissue area – administration of 2-6 mg of medication;
• ganglion zone – use of 1-2 mg betamethasone.

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

If repeated blood transfusions are performed, the total dose of the drug may be up to 4 times the dose administered, if necessary, over 24 hours.

Subconjunctival injections are usually given in doses equal to 0.5 ml of medication (containing 2 mg of the medicinal substance).

Use Betaspan during pregnancy

There is no information on the safety of Betaspan use in pregnant women, which is why it is used in this period only in situations where the probability of benefit from the drug is higher than the risk of complications in the fetus. Doctors should be guided by the same instructions when deciding on the advisability of using the drug for prenatal prevention of the development of RDS after the 32nd week of pregnancy.

It is necessary to examine the newborns of those women who were given large doses of GCS during pregnancy for the purpose of determining the symptoms of adrenocortical insufficiency. In the infants of those women who were given injections of the drug during pregnancy, temporary suppression of embryonic somatotropin was observed, and in addition, apparently, of the pituitary hormones responsible for the production of corticosteroids in the fetal and definitive parts of the adrenal glands. However, the suppression of the activity of embryonic hydrocortisone had no effect on the pituitary-adrenocortical response processes during postnatal stress.

Since corticosteroids can cross the placenta, infants born to women who used corticosteroids during pregnancy should be carefully monitored for the possibility of developing congenital cataracts (which occurs rarely).

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

Since GCS are excreted in breast milk, it is necessary to stop using the drug during lactation, or breastfeeding during therapy - to avoid the appearance of negative symptoms in the baby.

Contraindications

Contraindicated for systemic mycoses, as well as for intolerance to betamethasone, other components of the drug and other GCS drugs.

Side effects Betaspan

The intensity and frequency of negative symptoms (as with any GCS) are determined by the duration of the treatment cycle and the size of the dose used. Often, such symptoms are curable or can be minimized by reducing the dosage (which will allow you to avoid discontinuing the drug). Among the side effects:

• disorders of the cardiovascular system: congestive heart failure in people with a predisposition, and in addition, increased blood pressure;
• dysfunction of the nervous system: headaches, increased intracranial pressure, in which the optic nerve discs swell (often observed after the end of therapy), dizziness, convulsions and migraines;
• mental complications: psycho-emotional lability, a feeling of euphoria, insomnia, personality changes, a severe stage of depression, leading to the development of strong psychotic symptoms (often in people with a history of psychiatric problems), as well as increased irritability;
• manifestations from the visual organs: increased IOP, exophthalmos, posterior subcapsular cataract and glaucoma;
• disorders of the endocrine system: secondary pituitary and adrenocortical insufficiency (often occurs due to stress - surgical procedures, injuries, diseases), weakening of tolerance to carbohydrates. In addition, there is also the manifestation of prediabetes, an increased need for oral hypoglycemic drugs and insulin in diabetics, hypercorticism with hirsutism, menstrual cycle disorders, acne and stretch marks on the skin, as well as suppression of fetal or child growth;
• metabolic disorders: negative nitrogen balance values (due to protein catabolism), lipomatosis (including its epidural and mediastinal forms), which can cause neurological complications, and weight gain. In addition, EBV disorder may be observed, developing in the form of potassium loss, sodium retention, increased calcium excretion, hypokalemic alkalosis, CHF (in people with intolerance), fluid retention, and elevated blood pressure;
• lesions of the musculoskeletal structure: myopathy of corticosteroid origin, muscle weakness, potentiation of myasthenia signs (against the background of the pseudoparalytic form of the disease in a severe stage), decreased muscle mass and osteoporosis, which is sometimes accompanied by severe pain in the bone area and spontaneous fractures (vertebral fractures of a compression nature). In addition, necrosis in the area of the heads of the bones of the shoulders or hips (aseptic form of pathology), tendon hernia, disease-related fractures of large bones, joint instability (due to constant injections into the joint area) and tendon ruptures may develop;
• digestive disorders: gastric ulcers or erosions (which may later develop into bleeding and perforation), pancreatitis, hiccups, ulcers in the esophagus, vomiting, intestinal perforation, ulcerative esophagitis, nausea and bloating;
• lesions of subcutaneous tissues and epidermis: slowing down of wound regeneration processes, fragile and thin epidermal layer, bruises, ecchymosis, atrophy, as well as petechiae, facial erythema, urticaria, dermatitis of allergic origin, hyperhidrosis and Quincke's edema;
• Immune disorders: Corticosteroids may affect skin test results, mask signs of infection or activate latent lesions, and may also reduce resistance to infections (eg, viruses and mycobacteria with Candida albicans). In addition, anaphylactoid or hypersensitivity reactions may occur, as well as conditions with decreased blood pressure and shock.

Along with this, among the negative reactions, isolated cases of blindness were noted (they are associated with the areas where the treatment procedures were carried out - for example, the head and face), as well as atrophy in the epidermis and subcutaneous layers, pigmentation disorders, post-injection inflammation (with injections into the joints), sterile abscess and Charcot arthropathy.

With repeated injections into the joint area, damage to the joints may develop, creating a risk of infection.

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Overdose

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

In case of overdose, symptomatic procedures are carried out to help eliminate complications that have arisen under the influence of the metabolic properties of GCS, primary or concomitant pathologies or drug interactions.

It is necessary to ensure the presence of the required volume of fluid in the body, and in addition to this, to monitor the electrolyte indicators in the urine and blood serum, especially carefully monitoring the balance of potassium with sodium. If necessary, the salt balance is restored.

Interactions with other drugs

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

Increased effects from corticosteroid use may occur in patients taking corticosteroids with estrogens.

The combined use of the drug with potassium-wasting diuretics may provoke the development of hypokalemia.

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

GCS substances are capable of potentiating the excretion of potassium ions caused by amphotericin B. All patients using any of the indicated drug combinations require careful monitoring of serum electrolyte values, especially potassium levels.

The combination of corticosteroids with indirect anticoagulants can cause potentiation or reduction of the medicinal effect of the latter, which may require adjustment of the dosage portion.

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 blood levels of salicylates. Aspirin should be combined with GCS with caution if the patient is diagnosed with hypoprothrombinemia.

The use of GCS in diabetics may require changes in the dosages of hypoglycemic drugs used in combination.

The response to the effects of somatotropin may be weakened when using GCS. Therefore, during the use of somatotropin, it is necessary to avoid Betaspan dosages exceeding 300-450 mcg/m2 ⁽ or 0.3-0.45 mg) per day.

GCS drugs can affect the results of tests using nitroblue tetrazolium for infections of bacterial origin and cause false negative results.

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Storage conditions

Betaspan must be kept in a place closed to children. It is prohibited to freeze the medicine. Storage temperature – maximum 25°C.

Shelf life

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

Application for children

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

Children taking corticosteroids in immunosuppressive doses should avoid contact with people who have measles or chickenpox.

Analogues

Analogues of the medication are Depos and Flosteron with Diprospan.