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Panimune Bioral
Last reviewed: 03.07.2025
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[ Indications Panimuna biorala
Shown:
- as a means of suppressing the immune system after bone marrow or kidney transplantation, as well as solid organs;
- in addition, it is used for rheumatoid arthritis (with a high degree of pathology activity), in case of resistance to basic drugs;
- It is also used in severe stages of atopic dermatitis, as well as psoriasis (if standard treatment has not produced results);
- The drug is prescribed to eliminate nephrotic syndrome, which develops due to glomerular disease (including minimal change nephropathy, membranous nephropathy, and focal or segmental glomerulosclerosis).
Release form
Available in capsules of 25, 50 or 100 mg. One blister contains 6 capsules, one package contains 5 blister plates. A blister can also contain 5 capsules - in this case, 10 such blister plates are placed in a pack.
Pharmacodynamics
Panimun bioral is a selective immunosuppressant with the active component cyclosporine. It blocks the lymphocyte cell cycle within the Go or G1 phases, and also inhibits the process of production and release of lymphokines (this includes IL-2, which is a T-cell growth factor), which is triggered by an antigen with the help of activated T-cells.
It also suppresses the development of cellular responses, including the reaction of homograft rejection, as well as GVHD, delayed form of hypersensitivity of the skin, allergic form of encephalomyelitis, as well as arthritis caused by Freund's adjuvant 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 adjusting the established regimen, laboratory tests with clinical indicators are taken into account already during therapy, and in addition, the plasma level of cyclosporine, which is recorded every day. The daily dose of the drug for oral use is 3.5-6 mg / kg.
Use Panimuna biorala during pregnancy
There is limited information on the use of cyclosporine in pregnant women. The data from organ transplant recipients indicate that, compared with standard treatments, it does not increase the likelihood of adverse effects on pregnancy progression or outcome.
The substance penetrates into breast milk, so breastfeeding should be discontinued during treatment.
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 skin neoplasms in people with atopic dermatitis, and also psoriasis);
- kidney disorders (except for people suffering from nephrotic syndrome).
Side effects Panimuna biorala
Taking the medication may cause the development of the following side effects:
- digestive system organs: 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 dysfunction may occur;
- PNS and CNS organs: paresthesia, headaches, and convulsions may occur;
- cardiovascular system: increased blood pressure;
- urinary system organs: kidney dysfunction;
- metabolic processes: increase in uric acid and potassium levels in the body;
- endocrine system organs: reversible forms of amenorrhea and dysmenorrhea, as well as hirsutism;
- Muscle and bone structures: myopathy and muscle weakness or spasms occasionally occur;
- Hematopoietic system organs: slight degree of anemia; thrombocytopenia occasionally develops.
Interactions with other drugs
The combination of cyclosporine with potassium-containing drugs or potassium-sparing diuretics increases the likelihood of the patient developing hyperkalemia.
As a result of the simultaneous use with antibiotics from the aminoglycoside category, as well as melphalan with amphotericin B and colchicine, and in addition with ciprofloxacin and trimethoprim, the likelihood of nephrotoxicity increases.
Combination with NSAIDs increases the risk of adverse effects on the kidneys.
Concomitant use with colchicine or the substance lovastatin increases the risk of muscle weakness or pain.
A variety of drugs can increase or decrease plasma levels of cyclosporine by inducing or inhibiting liver enzymes involved in the metabolism and elimination of this substance.
Among the drugs that increase the plasma level of cyclosporine are: josamycin with erythromycin, doxycycline with clarithromycin, and also midecamycin with roxithromycin and chloramphenicol, and ketoconazole with fluconazole (probably in high doses). Also included in this list are diltiazem, verapamil, itraconazole, and nicardipine with amiodarone and propafenone, and also metoclopramide with carvedilol. Increased concentrations are observed with a combination of danazol, oral contraceptives, methylprednisolone (in high doses), allopurinol, as well as cholic acid and its derivatives.
Medicines that reduce plasma levels 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 drugs containing St. John's wort.
There is evidence that cyclosporine reduces the clearance rate of the substance prednisolone, and with therapy with prednisolone in high doses, an increase in blood levels of the substance cyclosporine is possible.
Glibenclamide is able to increase the steady-state plasma levels of cyclosporine.
As a result of the combination of the drug with diuretics, the likelihood of developing renal dysfunction increases.
Combination with doxorubicin leads to an increase in its plasma indices, and along with this, its toxic properties.
Methotrexate increases plasma levels of cyclosporine, and in addition, increases the frequency of episodes of increased blood pressure, as well as the development of a nephrotoxic effect.
The substance melphalan (administered in large doses intravenously) can cause severe kidney failure.
As a result of simultaneous use with teniposide, a decrease in the clearance rates of this substance is observed, and along with this, an increase in its toxic properties and an extension of the half-life.
When combined with warfarin, there is a mutual reduction in the effect of both active substances.
The combination of cyclosporine and potassium-containing drugs, ACE inhibitors, and in addition potassium-sparing diuretics increases the likelihood of hyperkalemia.
Combination with enalapril may cause acute renal failure, and combination with nifedipine may increase gingival hyperplasia.
In individuals taking cyclosporine, there is a marked increase in the bioavailability of the substance diclofenac, which may result in reversible renal dysfunction. The 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 in the liver.
Concomitant use of cyclosporine with prednisolone reduces the clearance level of the latter. In case of using high doses of prednisolone, the cyclosporine index in the blood may increase. The level of cyclosporine is also increased by the substance methylprednisolone.
Use of cisapride in individuals taking cyclosporine may increase peak plasma levels and the rate of absorption of cyclosporine.
Combination with cyclosporine may cause a decrease in the clearance rates of substances such as colchicine and pravastatin with digoxin, as well as prednisolone and lovastatin with simvastatin. This, in turn, may provoke an increase in the toxic effect: glycoside poisoning (digoxin) and muscle toxicity (pravastatin with lovastatin and simvastatin with colchicine), which manifests itself in the form of muscle weakness or pain, as well as myositis. Rarely, rhabdomyolysis may develop.
Aminoglycoside antibiotics, antiviral drugs, ACE inhibitors, as well as trimethoprim, cephalosporins, ciprofloxacin and amphotericin B with melphalan and co-trimoxazole enhance the nephrotoxic properties of cyclosporine.
The combination of cyclosporine with quinidine and its derivatives, as well as theophylline and its derivatives, may enhance the effects of these substances on the body.
When combined with imipenem, cilastatin may increase cyclosporine levels, which may result in the development of neurotoxicity (such as increased excitability and tremors).
The 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 protected from sunlight and moisture, and inaccessible to small children. The temperature level should not exceed 25°C.
Shelf life
Panimun Bioral is permitted for use within 2 years from the date of release of the drug.
Attention!
To simplify the perception of information, this instruction for use of the drug "Panimune 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.