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Panimun Bioral
Last reviewed: 23.04.2024
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[Indications of the panimuna Biorala
Shows:
- as a means of suppressing the immune system after bone marrow transplantation or kidneys, and besides this solid organs;
- In addition, it is used for rheumatoid arthritis (with a high degree of activity of pathology), in case of resistance to basic drugs;
- apply it and in severe stages of atopic dermatitis, as well as psoriasis (if the standard treatment has not produced a result);
- the drug is prescribed to eliminate the nephrotic syndrome that develops due to the glomerular vascular disease (among them, nephropathy with minimal changes, membranous nephropathy, as well as focal or segmental form of glomerulosclerosis).
Release form
Produced in capsules with a volume of 25, 50 or 100 mg. In one blister contains 6 capsules, inside one package contains 5 blister plates. Also, the blister can contain 5 capsules - in this case, 10 such blister plates are placed in the pack.
Pharmacodynamics
Panimun biolal is a selective immunosuppressant with an active component of cyclosporin. It blocks the lymphocyte cell cycle inside the Go or G1 phases, and also inhibits the production and secretion of lymphokines (this includes IL-2, which is a growth factor of T cells), which is triggered by the antigen by activated T cells.
It also suppresses the development of cellular responses, including the rejection reaction of the homotransplant, and in addition to this, BTFT, a delayed form of hypersensitivity to the skin, an allergic form of encephalomyelitis, as well as Freund's arthritis-induced arthritis and the formation of antibodies under the influence of T cells.
Dosing and administration
The treatment regimen is established taking into account the indications and is individual. When selecting initial dosages and correcting the established regimen, already during the therapy, laboratory tests with clinical indices are taken into account, and besides this, the plasma level of cyclosporine, which are fixed every day. The daily dose of LS for oral use is 3.5-6 mg / kg.
Use of the panimuna Biorala during pregnancy
There is only limited information about the use of cyclosporine in pregnant women. Information obtained from persons with transplanted organs demonstrates that, in comparison with standard medical methods, this substance does not increase the likelihood of adverse effects on the course of pregnancy and its outcome.
The substance penetrates into the mother's milk, so during the treatment it is necessary to cancel breastfeeding.
Experimental tests have shown that cyclosporine does not have teratogenic properties.
Contraindications
Among the contraindications:
- uncontrolled increase in blood pressure;
- acute forms of infectious pathologies;
- Malignant neoplasms (except for skin neoplasms in people with atopic dermatitis, and in addition to psoriasis);
- disorders in the work of the kidneys (except for people suffering from nephrotic syndrome).
Side effects of the panimuna Biorala
Taking medication can trigger the development of such side effects:
- organs of the digestive system: there may be a feeling of heaviness in the epigastrium, nausea (especially at the initial stage of therapy), diarrhea, vomiting, swelling of the gums, and in addition, loss of appetite, pancreatitis and liver function disorder;
- organs of PNS and CNS: there may be paresthesias, headaches, and seizures;
- organs of the cardiovascular system: increased blood pressure;
- organs of the urinary system: a disorder in the kidneys;
- metabolic processes: an increase in uric acid and potassium in the body;
- organs of the endocrine system: reversible forms of amenorrhea and dysmenorrhea, as well as hirsutism;
- muscular and bone structure: occasionally there is myopathy and weakness or muscle spasms;
- organs of the hematopoietic system: an insignificant degree of anemia; Occasionally thrombocytopenia develops.
Interactions with other drugs
The combination of cyclosporine with potassium medicines or potassium-sparing diuretics increases the likelihood of the patient experiencing hyperkalemia.
As a result of simultaneous use with antibiotics from the aminoglycoside category, as well as melphalan with amphotericin B and colchicine, and in addition to ciprofloxacin and trimethoprim, the likelihood of nephrotoxicity increases.
Combination with NSAIDs increases the risk of side effects from the kidneys.
A combination with colchicine or lovastatin increases the risk of weakness or pain in the muscles.
A variety of drugs can increase or lower plasma cyclosporine levels by inducing or inhibiting hepatic enzymes involved in the metabolism and elimination of this substance.
Among the drugs that increase the plasma level of cyclosporine: josamycin with erythromycin, doxycycline with clarithromycin, and in addition midekamycin with roxithromycin and chloramphenicol and ketoconazole with fluconazole (probably in a large dose). Also included in this list are diltiazem, verapamil, itraconazole and nicardipine with amiodarone and propafenone, and in addition metoclopramide with carvedilol. Increases in concentrations are observed when combined with danazol, oral contraceptives, methylprednisolone (in high dosages), allopurinol, and cholic acid and its derivatives.
Drugs that lower the plasma level of cyclosporine: carbamazepine, nafcillin, phenytoin with barbiturates, as well as metamizole, rifampicin and sulfadimidine (intravenous administration). In addition, terbinafine with probucol and griseofulvin, orlistat with octreotide, troglitazone and LS, which contain St. John's wort.
There is evidence that cyclosporine reduces the clearance of prednisolone, and in the treatment with prednisolone in high doses, an increase in the blood values of cyclosporin is possible.
Glibenclamide is capable of raising equilibrium plasma values of cyclosporine.
As a result of a combination of drugs with diuretics, the probability of renal function disorders increases.
The combination with doxorubicin leads to an increase in its plasma parameters, and with it its toxic properties.
Methotrexate enhances the plasma values of cyclosporine, and besides it increases episodes of increasing blood pressure and the development of nephrotoxic effect.
The substance melphalan (injected in large doses intravenously) can cause the development of kidney failure in severe form.
As a result of simultaneous use with teniposide, a decrease in the clearance of this substance is observed, along with an increase in its toxic properties and an elongation of the half-life.
In the case of combination with warfarin, the mutual effect of both active substances is reduced.
The combination of cyclosporine and potassium drugs, ACE inhibitors, and besides this potassium-sparing diuretic increases the likelihood of hyperkalemia.
Combination with enalapril may cause an acute form of kidney failure, and a combination with nifedipine may increase gingival hyperplasia.
In people taking cyclosporine, there is a marked increase in the level of bioavailability of diclofenac, which can lead to a reversible disorder in the kidneys. An increase in the bioavailability of this component is most likely due to a slowdown in its metabolic processes as a result of the "first pass" process within the liver.
Simultaneous reception of cyclosporine together with prednisolone lowers the level of clearance of the latter. In the case of using large dosages of prednisolone, the cyclosporin level in the blood can increase. The level of cyclosporin increases and the substance methylprednisolone.
The use of cisapride by people taking cyclosporine can increase the peak plasma level and the absorption rate of the latter.
Combination with cyclosporine may cause a decrease in clearance rates of substances such as colchicine and pravastatin with digoxin, as well as prednisolone and lovastatin with simvastatin. This, in turn, can provoke an increase in the toxic effect: glycoside poisoning (digoxin) and toxic effect on muscles (pravastatin with lovastatin and simvastatin with colchicine), which manifests itself in the form of muscle weakness or pain as well as myositis. Occasionally, the development of rhabdomyolysis.
Aminoglycoside antibiotics, antiviral drugs, ACE inhibitors, as well as trimethoprim, cephalosporins, ciprofloxacin and amphotericin B with melphalan and co-trimoxazole enhance nephrotoxic properties of cyclosporine.
The combination of cyclosporin with quinidine and its derivatives, as well as theophylline and its derivatives, can enhance the effect of these substances on the body.
Combined with imipenem cilastatin can increase the rate of cyclosporine, resulting in the development of manifestations of neurotoxicity (such as increased excitability and trembling).
Combined use of the drug with other immunosuppressants increases the likelihood of infectious processes and lymphoproliferative pathologies.
Storage conditions
The medicine must be kept in a place that is closed from penetration of sunlight and moisture, and also inaccessible to small children. The temperature level is not more than 25 ° C.
Shelf life
Panimun biolal is allowed to be used in the period of 2 years from the date of release of the medicinal product.
Attention!
To simplify the perception of information, this instruction for use of the drug "Panimun Bioral" translated and presented in a special form on the basis of the official instructions for medical use of the drug. Before use read the annotation that came directly to medicines.
Description provided for informational purposes and is not a guide to self-healing. The need for this drug, the purpose of the treatment regimen, methods and dose of the drug is determined solely by the attending physician. Self-medication is dangerous for your health.