Instructions for Tevalor-Teva lozenges blister pack No. 20
Composition
active ingredients: 1 tablet contains dequalinium chloride 0.25 mg; ascorbic acid 30 mg;
excipients: glucose monohydrate, sodium saccharin, pectin, vanillin, sucrose, cocoa powder, lactose monohydrate, magnesium stearate.
Dosage form
Lozenges.
Main physicochemical properties: round flat tablets with a double-sided bevel and a notch on one side, 13 mm in diameter; brown, mosaic color.
Pharmacotherapeutic group
Drugs used in throat diseases. Various antiseptics. ATX code R02A A20.
Pharmacological properties
Pharmacodynamics
Tevalor-Teva is a combined drug with a well-pronounced local antiseptic, antibacterial and antifungal effect. It is used for sore throats. It has mainly bacteriostatic (according to some reports, bactericidal) action against a number of gram-positive and gram-negative microorganisms, including strains resistant to antibiotics. The drug is most effective at an alkaline pH value (as in the environment in the oral cavity). Dequalinium chloride is a local antiseptic of the quinoline group. It is a bis-quaternary quinoline with antiseptic and bacteriostatic action.
Dequalinium chloride has an antiseptic effect, mainly local; antibacterial effect - mainly against gram-negative and gram-positive microorganisms, mainly against pyogenic pathogens and strains resistant to antibiotics (pyogenic streptococci, Borrelia, etc.); antifungal effect - mainly against Candida albicans, some species of Trichophyton and epidermophytes. It does not show activity against Mycobacterium. The antibacterial effect is due to the denaturation of proteins and enzymes of pathogens by dissolution and depolymerization, as well as glycolysis and inactivation of dehydrogenases - initially the effect is reversible, but long-term contact with the pathogen inactivates them irreversibly; disruption of protein synthesis at the ribosome level; cytolysis of the cell membrane. The surface-active cationic effect is the basis of bacteriostatic activity, it is stronger against gram-positive than against gram-negative microorganisms.
Ascorbic acid, which is part of the drug, acts on intracellular oxidation and reduction processes; increases the synthesis of specific antibacterial antitoxins and improves the functions of the reticuloendothelium; reduces the permeability of cell membranes; improves the condition of the capillaries of the vascular wall and limits exudative, inflammatory and allergic reactions.
The resistance of microorganisms to the drug Tevalor-Teva develops slowly, with long-term use (more than 15–20 days). The development of resistance is minimal for gram-positive microorganisms and some fungi, the drug is effective against microorganisms resistant to penicillin, streptomycin and sulfonamide.
Pharmacokinetics
It has a local antiseptic effect in the oral cavity. It is absorbed rapidly from the gastrointestinal tract. It is distributed by diffusion through the liver, lungs, kidneys. It is excreted continuously with urine and feces.
Indication
Local antiseptic treatment of inflammatory processes of the oral cavity and throat caused by pathogens sensitive to the drug (catarrhal, ulcerative, fibrous gingivitis, aphthous stomatitis, candidiasis, pharyngitis, tonsillitis, laryngitis and glossitis).
In the complex treatment of more severe throat infections in combination with antibiotics and sulfonamides.
Prevention of infections before and after surgical interventions in the mouth and throat.
Contraindication
Hypersensitivity to the active substances or to any of the excipients. Thrombosis, tendency to thrombosis, thrombophlebitis, severe kidney disease, diabetes mellitus, fructose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome. Allergy to quaternary ammonium compounds (e.g. benzalkonium chloride).
Interaction with other medicinal products and other types of interactions
The antibacterial activity of dequalinium chloride is reduced by the simultaneous use of detergents, such as toothpaste. The use of the drug should not be combined with the administration of cholinesterase inhibitors.
Absorption of ascorbic acid is reduced with simultaneous use of oral contraceptives, consumption of fruit or vegetable juices, alkaline drinks. Ascorbic acid when taken orally increases the absorption of penicillin, tetracycline, iron, and also promotes the absorption of aluminum in the intestine, which should be taken into account during simultaneous treatment with antacids containing aluminum.
Long-term administration of large doses of ascorbic acid by individuals treated with disulfiram inhibits the disulfiram-alcohol reaction. Large doses of ascorbic acid reduce the effectiveness of tricyclic antidepressants, neuroleptics - phenothiazine derivatives, tubular reabsorption of amphetamine, and disrupt the renal excretion of mexiletine.
Ascorbic acid increases the total clearance of ethyl alcohol. Quinoline drugs, calcium chloride, salicylates, corticosteroids, with prolonged use, reduce the reserves of ascorbic acid in the body.
When taken simultaneously with polystyrene sulfonate (kayexalate), a drug used to treat hyperkalemia, there is a possibility of developing severe necrotic lesions of the skin and mucous membranes, especially the gastrointestinal tract.
Application features
Due to the absence of an analgesic component in the drug, it is inappropriate to use it for inflammatory processes accompanied by severe sore throat. If there are major clinical symptoms of generalization of infection, you should consult a doctor who will prescribe systemic antibacterial treatment. If any side effects appear, Tevalor-Teva should be discontinued. Simultaneous administration with other drugs for local treatment should be carried out with caution, under the supervision of a doctor.
Absorption of ascorbic acid may be impaired in intestinal dyskinesias, enteritis, and achilia. Use with caution in patients with glucose-6-phosphate dehydrogenase deficiency.
Ascorbic acid as a reducing agent can affect the results of laboratory tests, for example, when determining the blood content of glucose, bilirubin, transaminase activity, and lactate dehydrogenase.
When taking ascorbic acid in excess of 1 g per day and prolonged use exceeding more than three times the recommended daily dose and duration of treatment with Tevalor-Teva, it is necessary to monitor kidney function and blood pressure, as well as pancreatic function. The drug should be used with caution in patients with a history of kidney disease and patients with progressive cancer, as the course of the disease may be complicated.
In case of urolithiasis, the daily dose of ascorbic acid should not exceed 1 g, because there is a risk of calcium oxalate stones when using high doses of ascorbic acid in patients prone to kidney stones. The drug should be used with caution in patients with galactosemia. Since ascorbic acid increases iron absorption, its use in high doses, over 1 g, can be dangerous for patients with hemochromatosis, thalassemia, polycythemia, leukemia and sideroblastic anemia. Patients with high iron content in the body should use the drug in recommended doses.
Large doses of the drug should not be prescribed to patients with increased blood clotting.
This medicinal product contains glucose, lactose, sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product (see section "Contraindications").
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug Tevalor-Teva does not affect the patient's ability to perform work requiring increased attention (driving vehicles and working with moving mechanisms).
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, use with caution, under the supervision of a doctor, strictly following the recommended doses.
Method of administration and doses
Adults and children over 4 years of age should take 1 lozenge every 2–3 hours (no more than 8–10 lozenges per day).
Do not chew the tablets. After taking the medicine, the patient is advised not to eat or drink for 30 minutes.
It is recommended to continue treatment for 1–2 days after the symptoms of the disease disappear. The total duration of treatment should not exceed 5–7 days (there is a risk of disruption of the normal bacterial flora in the mouth and throat).
Children
The drug should not be used in children under 4 years of age in this dosage form due to the risk of aspiration.
Overdose
Increased manifestations of adverse reactions.
Ascorbic acid is well tolerated. It is a water-soluble vitamin, its excess is excreted in the urine. However, with prolonged use of vitamin C in large doses, inhibition of the function of the insular apparatus of the pancreas is possible, which requires monitoring of the condition of the latter. Overdose can lead to changes in the renal excretion of ascorbic and uric acids during urine acetylation with the risk of precipitation of oxalate stones.
The use of large doses of the drug may cause vomiting, nausea or diarrhea, which disappear after its withdrawal, in rare cases ulcers and necrosis of the esophagus may occur. Treatment is symptomatic.
Adverse reactions
from the digestive tract: nausea, vomiting, burning sensation and irritation in the throat, dry mouth, oral dysbacteriosis (with prolonged use in high doses); other: very rarely - allergic reactions; local reactions: in rare cases, namely with abuse - the appearance of ulcers and necrosis.
The following adverse reactions associated with ascorbic acid are possible:
from the immune system: allergic reactions, including rash, itching, angioedema, urticaria; sometimes - anaphylactic shock in the presence of sensitization; from the skin and subcutaneous tissue: eczema; from the cardiovascular system: arterial hypertension; from the nervous system: increased excitability, sleep disturbances, headache, feeling of heat, fatigue; with prolonged use in high doses (more than 1 g of ascorbic acid per day): damage to the insular apparatus of the pancreas (hyperglycemia, glucosuria) and impaired glycogen synthesis up to the appearance of diabetes mellitus; myocardial dystrophy; thrombocytosis, hyperprothrombinemia, erythrocytopenia, neutrophilic leukocytosis; in patients with glucose-6-phosphate dehydrogenase deficiency in erythrocytes, hemolysis is possible; oral dysbacteriosis; irritation of the gastrointestinal mucosa, heartburn, vomiting, diarrhea; damage to the glomerular apparatus of the kidneys, crystalluria, formation of urate, cystine and/or oxalate stones in the kidneys and urinary tract, renal failure; impaired metabolism of zinc and copper.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children!
Packaging
20 tablets in a blister, 1 blister in a cardboard pack.
Vacation category
Without a prescription.
Producer
Balkanfarma-Razgrad JSC. Balkanfarma-Dupnytsia JSC.
Location of the manufacturer and its business address
Blvd. April Uprising 68, Razgrad 7200, Bulgaria. St. Samokovskoe Shosse 3, Dupnitsa, 2600, Bulgaria.
