The solution for oral administration is red-violet, transparent, with the smell of forest berries.
1 f.
Pidotimod 400 mg
Auxiliary substances: sodium chloride - 5.6 mg, sodium saccharinate - 5 mg, disodium edetate - 3.5 mg, trometamol - qs to pH 6.5, sodium methylparahydroxybenzoate 10.3 mg, sodium propylparahydroxybenzoate 1.6 mg, sorbitol 70% 2500 mg, fruit flavor with the smell of forest berries) - 21 mg, anthocyanin colorant - 5.6 mg, dye crimson [Ponso 4R] - 0.5 mg, purified water - up to 7 ml.
7 ml - single-dose vials of transparent glass type III (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Immunostimulating drug.
Pidotimod stimulates and regulates cellular immunity. It induces the maturation and formation of immunocompetent T-lymphocytes in their insufficiency, which are assigned the role of coordinators of specific immunity under physiological conditions due to partial replacement or strengthening of thymus gland functions. In addition, pidotimod stimulates macrophages, the main function of which is to capture the antigen and its presentation on the cell membrane in combination with histocompatibility antigens. The ability of the organism to counteract infectious agents is expressed in effective specific immune, cellular and antigen-antibody protective responses.
Pidotimod has therapeutic effects through immunostimulating effect on innate immunity and production of antibodies, on cellular immunity and on the production of cytokines.
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 killers.
Pidotimod enhances the functional activity of T and B lymphocytes, enhances the stimulation of the antigen-antibody reaction, and interferes with the development of dexamethasone-induced apoptosis, 12-O-tetradecanoylpherbol-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 has been shown that pidotimod has an immunostimulating effect in cases of deficiency of the immune system, as well as in its functioning at the physiological level.
PHARMACOKINETICS
Suction
When ingested absorption is high. Bioavailability is 45%.
The speed and degree of absorption of the pidotimod significantly decreases with simultaneous intake with food. Bioavailability when taken orally together with food is reduced to 50%, C max in the serum is reached 2 hours later, compared with taking the drug on an empty stomach.
Distribution and Metabolism
Pidotimod does not bind to plasma proteins and is not metabolized.
Excretion
T 1/2 is 4 hours. The drug is excreted unchanged in the urine (95% of the administered IV dose).
Pharmacokinetics in specific patient groups
Pharmacokinetic studies with elderly patients showed no difference from pharmacokinetics in young patients.
T 1/2 increases with renal insufficiency. Nevertheless, with renal failure of severe degree (creatinine content in blood plasma of 5 mg / dl), T 1/2 pidotimoda does not exceed 8-9 hours. patients take the drug every 12 hours or 24 hours, the risk of cumulation with renal failure is absent.
Studies with hepatic insufficiency have not been carried out, because the drug is almost completely excreted from the body with urine unchanged.
INDICATIONS
Immunostimulating therapy of disorders in the cell link of immunity:
- with infections of the upper and lower respiratory tract;
- with infections of the urinary tract.
It is used both to prevent exacerbations and to reduce the duration and severity of individual episodes, and as an adjuvant for antibiotic therapy for acute infections.
DOSING MODE
The drug is taken orally. Since the food affects the absorption of Imunoriks, it should be taken outside the meal.
Adults in the acute phase of the disease appoint 800 mg (2 bottles) 2 times / day for 2 hours before or 2 hours after eating for 2 weeks; as maintenance therapy - 800 mg (2 bottles) 1 time / day for 60 days.
For prevention, you should take 800 mg (2 bottles) 1 time / day for 2 hours before or 2 hours after a meal for 60 days.
Children over 3 years of age in the acute phase of the disease appoint 400 mg (1 bottle) 2 times / day for 2 hours before or 2 hours after eating for 2 weeks; as maintenance therapy - 400 mg (1 bottle) 1 time / day for 60 days.
For prevention, prescribe 400 mg (1 bottle) 1 time / day for 2 hours before or 2 hours after a meal for 60 days.
SIDE EFFECT
The few undesirable events reported in the clinical trials reports (stomach pain, burning sensation in the stomach) were comparable with undesirable phenomena in placebo groups in double-blind clinical trials; apparently, these phenomena were associated with concomitant antibiotic therapy.
In the process of post-registration use, the following undesirable effects were reported, the frequency of which was determined as follows: very often (? 1/10), often (? 1/100, but <1/10), infrequently (? 1/1000, but <1 / 100), rarely (? 1/10 000, but <1/1000), very rarely (<1 / 10,000), the frequency is unknown (it is impossible to ascertain from the available data).
For one million patients treated with pidotimod, one case of uveitis and one case of the Shenllein-Henoch syndrome were recorded.
From the digestive system: very rarely - nausea, diarrhea, abdominal pain.
Allergic reactions: very rarely - allergic dermatitis, including hives, rashes on the skin, swelling of the lips, itching.
CONTRAINDICATIONS
- children's age till 3 years;
- intolerance to fructose;
- hypersensitivity to pidotimod or to any other component of the drug.
With caution should be used in patients with hyperimmunoglobulinemia syndrome E, allergic reactions or atopic dermatitis in history.
PREGNANCY AND LACTATION
Experience with the use of pidotimoda in pregnancy is absent or limited (less than 300 pregnancy outcomes). In experimental studies , animals showed no direct or indirect adverse effects on reproductive function.
It should be avoided using Imunorix in the first trimester of pregnancy.
There is no data on the isolation of pidotimod or its metabolites with breast milk. It is necessary to stop breastfeeding during the treatment with the drug in order to avoid the effect of the active substance on the baby.
APPLICATION FOR FUNCTIONS OF THE LIVER
T 1/2 increases with renal insufficiency. Nevertheless, with renal failure of severe degree (creatinine content in blood plasma of 5 mg / dl), T 1/2 pidotimoda does not exceed 8-9 hours. patients take the drug every 12 hours or 24 hours, the risk of cumulation with renal failure is absent.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Studies with hepatic insufficiency have not been carried out, because the drug is almost completely excreted from the body with urine unchanged.
APPLICATION FOR CHILDREN
Contraindicated use of the drug in childhood to 3 years.
APPLICATION IN ELDERLY PATIENTS
Pharmacokinetic studies with elderly patients showed no difference from pharmacokinetics in young patients.
SPECIAL INSTRUCTIONS
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the ability to drive vehicles and control mechanisms.
OVERDOSE
On cases of overdose and the use of the drug for other purposes was not reported.
Treatment: there are no specific data on the treatment of an overdose of Imunoriks, in case of an overdose, the patient should immediately consult a doctor. It is recommended to carry out symptomatic and maintenance therapy. Careful observation should continue until the patient recovers.
DRUG INTERACTION
Pidotimod does not bind to blood plasma proteins and is not metabolized, so 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.
In experimental studies in animals with a combination of pidotimod with other widely used drugs (eg, hypoglycemic agents (tolbutamide), antiepileptic drugs (phenobarbital), antihypertensives (nifedipine, captopril, atenolol), diuretics (chlorothiazide), anticoagulants (warfarin), NSAIDs (indomethacin), analgesic (acetylsalicylic acid) or antipyretic (paracetamol)), undesirable interaction was not detected.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 30 В° C. Shelf life - 3 years.
The information is provided for your information, do not self-medicate, it is dangerous for your health.
