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Biltricide 600 mg 6 pcs. film-coated tablets

pharmachologic effect

Anthelmintic.

Composition and release form Biltricid 600 mg 6 pcs. film-coated tablets

Tablets - 1 tablet:

active substance: praziquantel 600 mg;
excipients: corn starch, microcrystalline cellulose, polyvinylpyrrolidone, sodium lauryl sulfate, magnesium stearate, hypromellose, polyethylene glycol MG 4000, titanium dioxide.

6 tablets in an amber glass bottle with a plastic stopper; 1 bottle along with instructions for use in a cardboard box.

Description of the dosage form

Oblong, biconvex tablets, film-coated, white or almost white with a slight orange tint. On the front side of the tablet there is an engraving “BAYER”, on the back - “LG”. There are 3 dividing marks on both sides of the tablet.

The appearance of the fracture is a homogeneous mass of white or almost white color.

Directions for use and doses

The tablet should be taken orally, without chewing, with a small amount of liquid during or after meals. If a single dose of the drug per day is recommended, the tablet should be taken in the evening. When using the drug multiple times during the day, it is recommended that the interval between doses is at least 4 and no more than 6 hours.

When dividing the tablet into 4 parts, each fragment contains 150 mg of the active ingredient, which makes it easy to select the dosage taking into account the patient’s body weight.

Adults and children over 4 years old

Doses of Biltricide® are selected strictly individually and depend on the type of pathogen.

Schistosoma haematobium: 40 mg/kg body weight once. Duration of treatment - 1 day.

Schistosoma mansoni and Schistosoma intercalatum: 40 mg/kg once daily or 20 mg/kg twice daily. Duration of treatment - 1 day.

Schistosoma iaponicum. Schistosoma mekongi: 60 mg/kg once daily or 30 mg/kg twice daily. Duration of treatment - 1 day.

Clonorchis sinensis. Opisthorchis viverrini: 25 mg/kg 3 times a day for 1-3 days.

Paragonimus westermani and other species of pulmonary flukes: 25 mg/kg 3 times a day for 2-3 days:

Children under 4 years old

The safety of the drug in children under 4 years of age has not been established.

Pharmacodynamics

Praziquantel increases the permeability of helminth cell membranes to calcium ions, which causes a generalized contraction of the muscles of the parasites. It also causes damage to the tegument (the outer covering of flatworms).

Inhibits the uptake of glucose by helminth cells, thereby reducing glycogen content and stimulating the release of lactic acid compounds. As a result, the parasites die.

Praziquantel is specifically active against trematodes and cestodes, but not active against nematodes (including filariae).

Safety data based on systemic toxicity, genotoxicity, carcinogenicity, and reproductive toxicity studies did not reveal any hazards of praziquantel in humans.

Pharmacokinetics

Absorption. After oral administration, praziquantel is rapidly and completely absorbed. Maximum plasma concentration is achieved within 1-2 hours. The half-life of praziquantel in unchanged form is 1-2.5 hours, together with metabolites - 4 hours.

To achieve a therapeutic effect, it is necessary to maintain a praziquantel plasma concentration of 0.19 mg/l for 4-6 (maximum up to 10) hours.

Distribution. Penetrates the blood-brain barrier; the concentration in the cerebrospinal fluid is 10-20% of its concentration in the blood plasma. Penetrates into breast milk in a concentration of 20-25% of the concentration in the blood serum.

Metabolism. It undergoes “first pass” metabolism through the liver. The main metabolites are hydroxylated products of praziquantel.

Excretion. It is carried out mainly through the kidneys. More than 80% of the dose is eliminated within 4 days, with 90% of this amount eliminated within 24 hours.

Kidney failure. Since praziquantel has a predominantly renal route of excretion (80% of praziquantel and its metabolites are excreted by the kidneys), its elimination may be delayed in case of renal failure.

Liver failure. In case of decompensated liver failure, the metabolism of the drug in the liver is reduced, which is accompanied by an extension of the half-life and an increase in the concentration of praziquantel in the blood.

Indications for use Biltricide 600 mg 6 pcs. film-coated tablets

Treatment of infections caused by various types of schistosomes (S. haematobium, S. mansoni, S. intercalatum, S. japonicum, S. mekongi).

Treatment of infections caused by liver flukes (Clonorchis sinensis, Opistorchis viverrini) and lung flukes (Paragonimus westermani, other species).

Contraindications

Hypersensitivity to any component of the drug; cysticercosis of the eye; combined use with strong cytochrome P450 inducers, such as rifampicin; children under 4 years of age (safety and effectiveness have not been established).

With caution: decompensated liver failure, hepatolienal schistosomiasis, heart rhythm disturbances.

Application Biltricide 600 mg 6 pcs. film-coated tablets during pregnancy and breastfeeding

Use during pregnancy

Safety studies provided no evidence of potential adverse effects on the mother or fetus. In accordance with WHO publications, a benefit-risk analysis showed that in regions with endemic schistosomiasis or soil-borne helminth infections, the benefits of treatment for pregnant women and women of reproductive age significantly outweigh the risks to the health of women and their children. Benefits of treating pregnant women include reducing the incidence of maternal anemia, increasing infant weight gain, and increasing infant survival.

According to available data, women living in endemic regions (schistosomiasis and soil-transmitted helminthiasis) can receive treatment with praziquantel in the first, second and third trimesters of pregnancy.

In non-endemic regions, it is not recommended to prescribe praziquantel in the first trimester of pregnancy.

Use during lactation

The concentration of praziquantel in human milk is 20-25% of the concentration in plasma. It is unknown how likely this substance is to cause pharmacological effects in infants. When using the drug during lactation, the diagnosis must be established accurately.

For short-term therapy with praziquantel during lactation, breastfeeding should be avoided during the course of therapy (1 to 3 days) and the subsequent 24 hours (i.e., for a maximum of 4 days). When deciding whether to discontinue breastfeeding, the clinician must assess the benefit/risk balance, taking into account the availability of nutrition equivalent to breast milk and the possible loss of maternal milk production. The benefit of continuing breastfeeding while treated with praziquantel certainly outweighs the risk of child starvation and loss of maternal milk production.

special instructions

In case of decompensated liver failure and hepatolienal schistosomiasis, the drug Biltricid® should be used with caution due to a decrease in metabolism in the liver and the risk of a longer presence in an increased concentration of the drug in the vascular bed, including collateral vessels. Such patients may be hospitalized for treatment.

Published in vitro data have shown the possible lack of efficacy of praziquantel against schistosome migration. Data from two observational cohort studies in patients showed that treatment with praziquantel in the acute phase of infection cannot prevent the disease from becoming chronic.

In addition, the use of praziquantel in patients with schistosomiasis may cause clinical disorders (paradoxical reactions, serum sickness-like reactions, Jarisch-Herxheimer reactions: an acute inflammatory immune reaction that is associated with the release of schistosome antigens). Basically, these reactions occur in patients treated during the acute phase of schistosomiasis. They can lead to possible life-threatening events such as respiratory failure, encephalopathy and/or cerebral vasculitis.

Since 80% of praziquantel and its metabolites are eliminated by the kidneys, elimination may be delayed in patients with impaired renal function. The nephrotoxic effects of praziquantel are unknown.

In cases of heart rhythm disturbances and when taken simultaneously with digitalis preparations, treatment with Biltricid® should be carried out under the supervision of a physician. Patients who live or have lived in areas endemic for cysticercosis and trematodosis are recommended to undergo treatment in an inpatient setting.

Since Biltricid® can cause exacerbations of diseases of the central nervous system caused by schistosomiasis, paragonimiasis or cysticercosis caused by Taenia solium, as a rule, this drug should not be prescribed to persons with a history of epilepsy and/or other symptoms of possible damage to the central nervous system, for example, subcutaneous nodules suggestive of cysticercosis.

Impact on the ability to drive vehicles and operate machinery

When using the drug Biltricid®, you should refrain from driving a car or moving machinery on the day(s) of taking the drug and for the next 24 hours.

Overdose

There are no toxicity data for humans.

In case of overdose, osmotic laxatives should be prescribed.

Side effects Biltricid 600 mg 6 pcs. film-coated tablets

Side effects vary depending on the dose and duration of treatment with praziquantel. In addition, they depend on the types of helminths, the degree of infection, the duration of the infection and the location of the helminths in the body.

The following adverse events noted when using the drug Biltricid® are distributed according to the frequency of occurrence in accordance with the following gradation: very often (≥10% of patients), often (from ≥1% to

Nervous system disorders - Very common: headache, dizziness. Common: vertigo, somnolence. Very rare: convulsions.

Cardiovascular disorders - Very rare: unspecified arrhythmia.

Digestive system disorders - Very common: gastrointestinal and abdominal pain, nausea, vomiting. Common: anorexia, diarrhea (very rarely with blood).

Skin and subcutaneous tissue disorders - Very common: urticaria. Common: rash. Very rare: itching.

Musculoskeletal disorders - Common: myalgia.

Systemic disorders and conditions - Very common: fatigue.

Immune system disorders - Very rare: allergic reactions (including generalized allergic reactions), eosinophilia. Common: malaise, fever.

Adverse reactions can be caused by praziquantel itself (I, direct relationship with taking the drug), or arise as a result of an endogenous reaction to the death of parasites (II, indirect relationship with taking the drug), and also be symptoms of infection (III, no relationship with taking the drug) drug). It is very difficult to make a differential diagnosis between options I, II and III and to establish the exact cause of the development of adverse reactions.

Drug interactions

When used simultaneously with drugs that induce liver enzymes of the cytochrome P450 system, for example, with anticonvulsants, dexamethasone, the concentration of praziquantel in the blood plasma may decrease, and when combined with drugs that inhibit these enzymes, for example, with cimetidine, it may increase.

Concomitant use of the drug with potent cytochrome P450 inhibitors, such as rifampicin, should be avoided, as it may interfere with the achievement of therapeutic plasma concentrations of praziquantel.

Detrimax tablets 30 pcs ➤ instructions for use

A vital fat-soluble vitamin necessary to ensure the functioning of almost all organs and systems of the human body. It is well absorbed in the gastrointestinal tract due to the formation of micellar compounds in the small intestine.

Skeletal system. Participates in the regulation of phosphorus-calcium metabolism: helps calcium absorption in the intestines, maintains the necessary levels of calcium and phosphorus in the blood, activates bone metabolism. Helps ensure the strength of bones and teeth, reducing the risk of developing rickets and osteomalacia.

Muscular system. Helps maintain muscle strength and neuromuscular conduction, thereby reducing the risk of falls and fractures.

The immune system. Promotes the activation of healthy immune function, positively influencing both innate and acquired immunity. Triggers the synthesis of the body's own antimicrobial peptides: catalicidin and defensin. Helps reduce the risk of developing colds. It has a regulatory effect on cell growth, development and renewal. A lack of vitamin D in the body leads to a weakening of the body's immune defense.

Regulation of cell energy potential. Helps relieve fatigue and increase body tone by regulating the cells' own energy potential. As a result of the influence of vitamin D in the mitochondria of cells, the production of ATP increases, which is its own universal source of energy for all biochemical processes occurring in the body.

Nervous system. It has a positive effect on the activity of the nervous system, including the psycho-emotional sphere and cognitive functions (mood, memory, attention, performance, general tone of the body), since it is involved in the production of neurotransmitters, biologically active substances through which nerve impulses are transmitted between nerve cells. It is necessary for the conversion of tryptophan (an amino acid that enters the body with food) into serotonin, a neurotransmitter that is of great importance for normal cognitive function and the psycho-emotional state of a person. Helps improve mood.

Vitamin D can have a positive effect on pain sensitivity due to its positive effect on the synthesis of neurotransmitters: serotonin, dopamine.

Bronchopulmonary system. Helps prevent changes in airway smooth muscle, regulates airway muscle contraction and the inflammatory response, which promotes normal lung function.

Reproductive function. Stimulates the synthesis of female and male sex hormones: estrogens, progesterone, testosterone. It has a positive effect on reproductive function in both women and men. In women with sufficient levels of vitamin D3, fertilization of eggs occurs more often. The absence of vitamin D3 deficiency can improve IVF results. Most likely, this effect is due to the effect of vitamin D3 on the endometrium. Taking vitamin D3 can increase endometrial thickness in women with polycystic ovary syndrome. In addition, D3 plays a significant role in the correction of obesity and the course of metabolic syndrome. Studies have found that maternal intake of vitamin D3 is associated with a lower risk of developing obstructive pulmonary diseases in children.

Endocrine system. Vitamin D affects the metabolism of glucose and insulin, and vitamin D deficiency is a risk factor for the development of insulin resistance, impaired glucose tolerance. Vitamin D can stimulate pancreatic beta cells to secrete insulin and also indirectly activates beta cell calcium-dependent endopeptidase, which converts proinsulin into active insulin. Vitamin D can influence tissue sensitivity to insulin directly by stimulating the expression of insulin receptors in cells. Vitamin D has a positive effect on lipid metabolism, helping to reduce the level of total cholesterol, triglycerides and low-density lipids in the blood.

SSS. Vitamin D plays a protective role in maintaining cardiovascular function. It has a positive effect on the inner layer and muscle wall of blood vessels, as well as on blood clotting processes.