Imunorix [Pidotimod]
Doppel Pharmaceutici
1786 Items
2019-09-19
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Clinical Pharmacology
Immunostimulating drug.
Pidotimod stimulates and regulates cellular immunity. Induces maturation and formation of immunocompetent T-lymphocytes in case of their insufficiency, which are assigned the role of coordinators of specific immunity under physiological conditions due to partial replacement or enhancement of the functions of the thymus gland. In addition, pidotimod stimulates macrophages, the main function of which is to capture the antigen and present it on the cell membrane in combination with histocompatibility antigens. The body's ability to counteract infectious agents is expressed in effective specific immune, cellular, and antigen-antibody protective responses.
Pidotimod provides therapeutic effects through an immune stimulating effect on innate immunity and antibody production, on cellular immunity, and on cytokine production.
Pidotimod increases the production of superoxide anions, tumor necrosis factor alpha, NO (bactericidal action), as well as chemotaxis and, accordingly, phagocytosis. The drug also increases the cytotoxic activity of natural killer cells.
Pidotimod enhances the functional activity of T-and B-lymphocytes, increases the stimulation of the antigen-antibody reaction and prevents the development of apoptosis induced by dexamethasone, 12-O-tetradecanoylforbol-13-acetate and calcium ionophore A-23I87.
Pidotimod increases the content of interleukin-2 (IL-2) in old rats and the expression of the IL-2 gene in the spleen of rats. In particular, it was shown that pidotimod has an immunostimulating effect in cases of insufficiency of the immune system, as well as its functioning at the physiological level.
PharmacokineticsIndications
Immunostimulating therapy of disorders in the cellular component of the immune system:
- with infections of the upper and lower respiratory tract;
- with urinary tract infections.
It is used both to prevent exacerbations and reduce the duration and severity of individual episodes, and as an adjuvant during antibiotic treatment of acute infections.
Composition
Excipients: sodium chloride - 5.6 mg, sodium saccharinate - 5 mg, disodium edetate - 3.5 mg, trometamol - q.s. to pH 6.5, sodium methyl parahydroxybenzoate - 10.3 mg, propyl parahydroxybenzoate sodium - 1.6 mg, sorbitol 70% - 2500 mg, fruit flavoring (with the smell of wild berries) - 21 mg, anthocyanin dye - 5.6 mg, dye crimson (Ponso 4R) - 0.5 mg , purified water - up to 7 ml.
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Dosage and Administration
The drug is taken orally. Since food affects the absorption of Imunorix drug, it should be taken outside the meal.
Adults in the acute phase of the disease are prescribed 800 mg (2 bottles) 2 times / day 2 hours before or 2 hours after a meal within 2 weeks; as maintenance therapy, 800 mg (2 bottles) 1 time per day for 60 days.
For prophylaxis, you should take 800 mg (2 bottles) 1 time / day 2 hours before or 2 hours after meals for 60 days.
Children older than 3 years in the acute phase of the disease should be prescribed 400 mg (1 bottle) 2 times / day 2 hours before or 2 hours after meals for 2 weeks; as maintenance therapy - 400 mg (1 bottle) 1 time / day for 60 days.
For prophylaxis, 400 mg (1 bottle) is prescribed 1 time / day 2 hours before or 2 hours after a meal within 60 days.
Adverse reactions
The few adverse events reported in clinical trial reports (stomach pain, burning sensation in the stomach) were comparable to adverse events in the placebo group in double-blind clinical trials; apparently, these phenomena were associated with concomitant antibiotic therapy.
In the process of post-registration use, the following adverse effects were reported, the frequency of which was determined as follows: very often (≥1 / 10), often (≥1 / 100, but
In 1 million patients receiving pidotimod, one case of uveitis and one case of Shenlein-Genoch syndrome was reported.
On the part of the digestive system: very rarely - nausea, diarrhea, abdominal pain.
Allergic reactions: very rarely - allergic dermatitis, including urticaria, skin rash, swelling of the lips, itching.
The drug should be used with caution in patients with hyperimmunoglobulinemia E syndrome, allergic reactions or atopic dermatitis in history.
Drug interactions
Pidotimod does not bind to plasma proteins and is not metabolized; therefore, pharmacokinetic interaction is not expected.
The drug can affect the effectiveness of drugs that suppress or stimulate the functional activity of lymphocytes or affect the activity of the immune system.
ATexperimental studies in animals with a combination of pidotimod with other widely used drugs (for example, hypoglycemic agents (tolbutamide), antiepileptic drugs (phenobarbital), antihypertensive drugs (nifedipine, captopril, atenolol), diuretics (chlorothiazide), anticoagulants (warfarid). , painkillers (acetylsalicylic acid) or antipyretic (paracetamol)) did not reveal undesirable interactions.
Pregnancy and Lactation
Experience with pidotimod during pregnancy is absent or limited (less than 300 outcomes of pregnancy). In experimental studies in animals did not reveal direct or indirect adverse effects on reproductive function.
It is necessary to avoid the use of the drug Imunorix in the first trimester of pregnancy.
There is no data on the allocation of pidotimod or its metabolites in breast milk. Breastfeeding should be discontinued during the period of drug treatment to avoid exposure of the active substance to the child.
Special instructions
The drug does not affect the ability to drive vehicles and control mechanisms.
Overdosage
Cases of overdose and use of the drug for other purposes were not reported.
Treatment: There is no specific data on the treatment of an Imunorix drug overdose; in case of an overdose, the patient should immediately consult a doctor. Recommended symptomatic and supportive therapy. Careful observation should be continued until the patient recovers.
Special instructions
The drug does not affect the ability to drive vehicles and control mechanisms.
- Brand name: Imunorix
- Active ingredient: Pidotimod
- Dosage form: Solution for oral administration of red-purple color, transparent, with the smell of wild berries.
- Manufacturer: Doppel Pharmaceutici
- Country of Origin: Italy
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