Sebidine® (Sebidin®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceChlorhexidine + [Ascorbic acid]Chlorhexidine + [Ascorbic acid]
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  • Sebidine®
    pills inwards 
    Bittner Pharma, LLC    
    • Dosage form: & nbsplozenges
    Composition:

    Each tablet contains:

    Components

    Quantity, mg / tablet

    Active substances

    Chlorhexidine dihydrochloride

    5.00 mg

    Ascorbic acid

    50.00 mg

    Excipients

    Sucrose

    546.80 mg

    Methylcellulose

    70.00 mg

    Magnesium stearate

    7.00 mg

    Talc

    21.00 mg

    Quinoline yellow dye

    0.15 mg

    Crimson dye [Ponso 4R]

    0.05 mg

    Fruit essence1

    q.s.

    Total tablet weight

    700.00 mg

    Notes:

    1. Fruit essence contains a solvent that evaporates in the process of production, in this regard, the amount of added fruit essences is uncountable.

    Description:

    Tablets are pink-orange in color, round, in the form of a flat disc with oblique margins.

    Pharmacotherapeutic group:Antiseptic.
    ATX: & nbsp

    A.01.A.B.03   Chlorhexidine

    Pharmacodynamics:

    Mechanism of action

    The antibacterial effect of chlorhexidine is caused by its non-specific binding to phospholipids of bacterial cell membranes. It inhibits dehydrogenase and ATPase activity inside bacterial cell membranes and breaks the permeability of the membrane for potassium ions, nucleotides and amino acids. Chlorhexidine has bacteriostatic and bactericidal effects, especially on gram-positive bacteria and Candida albicans, to a lesser extent - on gram-negative bacteria. High sensitivity to the drug was noted in Streptococcus pyogenes, Streptococcus anginosus, Moraxella catarrhalis, Hemophilus influenzae and Staphylococcus aureus, Streptococcus mutans, Streptococcus salivarius, Escherichia coli, Selenomonas, anaerobic bacteria and Candida albicans. Streptococcus sanguis, Proteus, Pseudomonas, Klebsiella and. Veillonella species demonstrate less sensitivity.

    The antibacterial effect of chlorhexidine depends on the concentration. The drug has a bacteriostatic effect at a low concentration (less than 20 mg / l) and bactericidal effect at higher concentrations.

    Ascorbic acid (vitamin C) is a necessary cofactor of many metabolic reactions, an important antioxidant in the aqueous environment of the human body, promotes the removal of free radicals, supports the redox balance in the body.

    Ascorbic acid is involved in the synthesis of carnitine, bile acids and steroid hormones, inhibits the reactions of peroxidation with free radicals and singlet oxygen. It takes part in the formation of collagen and other connective tissue proteins, providing regeneration and integrity of the bone and promoting the healing of wounds and burns. Ascorbic acid is necessary for intracellular reactions associated with the conversion of folic acid into folinic, the transformation of aromatic amino acids (phenylalanine, tyrosine) involved in the metabolism of adrenaline, facilitates the removal of free radicals that are formed as a result of activation of neutrophils and neutralization of peroxide anions produced by macrophages. Ascorbic acid takes part in reducing the concentration of unbound iron, increasing its utilization and use for the synthesis of hemoglobin.

    Pharmacokinetics:

    Chlorhexidine is practically not absorbed from the surface of the skin and mucous membrane. When the tablet is resorbed chlorhexidine gradually released into saliva and, due to the positive charge of its particles, binds to the surface of the mucous membrane of the mouth and tongue, and then again slowly emerges into the saliva and manifests its antibacterial effect. Part of chlorhexidine can be swallowed with saliva, but it is absorbed from the gastrointestinal tract (GIT) slightly. Chlorhexidine is minimally metabolized in the liver and excreted with bile in the intestine.Usually about 90% of the swallowed dose is excreted unchanged with feces. Chlorhexidine in liquid body fluids is detected using high-performance liquid chromatography with a sensitivity of 1 mg / l.

    Ascorbic acid is easily absorbed into the digestive tract, mainly in the jejunum (a dose below 200 mg is absorbed almost 100%). The maximum concentration in the serum is achieved 2-3 hours after application. Only 25 % comes into contact with plasma proteins, a significant part is in leukocytes and platelets. The average equilibrium concentration of ascorbic acid in the body is low and is about 20 mg / kg, and in the greatest quantities is in the adrenal glands, mucous glands, liver, brain and leukocytes. The main metabolites are L-dehydroascorbic acid with an intermediate form in the form of L-monodehydroascorbic acid, and oxalic acid. Only a small amount of ascorbic acid metabolizes to carbon dioxide. Ascorbic acid penetrates into breast milk in a concentration of about 1-10 mg%. The loss of vitamin C during excretion with sweat is high, and with severe physical exertion it can reach 2 mg / hour. Displayed ascorbic acid mainly through kidneys in a conjugated form with sulfates or in the form of metabolites, preferably oxalic acid. At a significant excess of the threshold of renal excretion (concentration in the blood plasma is 1.4 mg%) ascorbic acid is displayed unchanged.

    Indications:

    Symptomatic therapy of infectious-inflammatory diseases of the pharyngeal mucosa.

    Contraindications:

    Hypersensitivity to chlorhexidine, ascorbic acid or any of the excipients;

    children's age till 12 years;

    deficiency of sugar and / or isomaltase; intolerance to fructose; glucose-galactose malabsorption.

    Carefully:

    In connection with the presence of ascorbic acid, the drug should be taken with caution to the patient with deficit glucose-6-phosphate dehydrogenase, hemochromatosis, sideroblastic anemia, thalassemia, hyperoxaluria, kidney stone disease.

    Since sucrose is one of the excipients, caution should be taken in patients with diabetes mellitus and / or caries.

    Pregnancy and lactation:

    Pregnancy

    Studies on the effects of chlorhexidine on the fetus in pregnant women have not been conducted. Ascorbic acid well penetrates the placental barrier. Daily intake of vitamin C in a dosage not exceeding 100 mg is safe for the fetus, however higher doses may cause symptoms of its insufficiency in newborns (children's scurvy).

    You should consult your doctor before taking the drug during pregnancy. The drug should be used only if the intended benefit to the mother exceeds the potential risk to the fetus.

    Breastfeeding period

    It is not known whether the blood is excreted chlorhexidine with breast milk. Ascorbic acid penetrates into breast milk.

    You should consult a doctor before taking the medication while breastfeeding. The drug should be used only if the intended benefit to the mother exceeds the potential risk to the child.

    Dosing and Administration:

    Locally.

    Adults and children over 12 years old: rassasyvat slowly 1 tablet 4 times a day (every 6 hours).

    The drug is taken after eating and brushing your teeth.

    It is not recommended to rinse your mouth and drink plenty of fluids within 2 hours after taking the medication.

    The recommended course of taking the drug is not more than 2 weeks.

    Side effects:

    From the immune system:

    allergic reactions (skin rash and superficial scaling of the oral mucosa, and swelling of the salivary glands, which can occur rarely).

    From the gastrointestinal tract:

    irritation or inflammation of the oral mucosa, soreness of the tongue and mucous membranes, taste disturbance, deposition of calculus, irritation of the gastrointestinal mucosa, nausea, vomiting, belching, epigastric pain and diarrhea. If the drug is taken for more than 7 days, temporary staining of the tongue, teeth and acrylic fillings may be found.

    Laboratory indicators:

    thrombocytosis, hyperprothrombinemia, erythropenia, neutrophilic leukocytosis, hypokalemia, glucosuria.

    Other:

    oppression of the insular pancreas function (hyperglycemia, glucosuria).

    In case of unusual reactions, you should see a doctor.

    Overdose:

    Symptoms

    Chlorhexidine is not practically absorbed from the digestive tract.The probability of overdose by this component is small.

    Symptoms of overdose can be associated with the presence of ascorbic acid: diarrhea, nausea, irritation of the mucous membrane of the gastrointestinal tract, flatulence, abdominal pain of a spastic nature, frequent urination, nephrolithiasis, insomnia, irritability, hypoglycemia.

    In case of overdose, it is recommended to observe the doctor, symptomatic treatment, forced diuresis.

    Interaction:

    If necessary, the drug can be used concomitantly with other local antimicrobial agents.

    Chlorhexidine is pharmaceutically incompatible with soap, alkalis and other anionic compounds (colloids, gum arabic, carboxymethyl cellulose). Compatible with drugs containing a cationic group (benzalkonium chloride, cetrimonium bromide). Ethanol strengthens the effectiveness of the drug.

    Ascorbic acid increases the concentration in the blood of benzylpenicillin and tetracyclines. Reduces the effectiveness of heparin and indirect anticoagulants. Acetylsalicylic acid, oral contraceptives, fresh juices and alkaline drink reduce absorption and absorption.With simultaneous use with acetylsalicylic acid, urinary excretion of ascorbic acid increases and the excretion of acetylsalicylic acid decreases. Acetylsalicylic acid, the acid reduces the absorption of ascorbic acid by about 30%. Increases the risk of developing crystalluria in the treatment of salicylates and sulfonamides short-acting, slows the excretion of kidney acids, increases the excretion of drugs that have an alkaline reaction (including alkaloids), reduces the concentration of oral contraceptives in the blood. Increases the total clearance of ethanol, which in turn reduces the concentration of ascorbic acid in the body. With simultaneous use reduces the chronotropic effect of isoprenaline. Barbiturates and primidon increase the excretion of ascorbic acid in the urine. Reduces the therapeutic effect of antipsychotic drugs (neuroleptics) - phenothiazine derivatives, tubular reabsorption of amphetamine and tricyclic antidepressants.

    Special instructions:

    Taking medication can distort the taste sensations, which are usually restored 4 hours after ingestion. Tablets should be taken after meals.

    The drug should not be taken more than 14 days.

    Prolonged use of the drug can cause pigmentation of teeth and language, which disappears after discontinuation of treatment or should be removed by a doctor.

    In some cases (in patients with diseases of the stomach or liver) gastrointestinal disturbances such as nausea, vomiting and belching may occur. In this situation, the drug should be discontinued.

    In connection with the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor the function of the adrenals and arterial pressure. In patients with elevated iron levels in the body, ascorbic acid should be used in minimal doses. Ascorbic acid as the reductant can distort the results of various laboratory tests (blood and urine content of glucose, bilirubin, activity of "hepatic" transaminases and lactate dehydrogenase). The minimum daily requirement for ascorbic acid in II-III trimesters of pregnancy - about 60 mg. It should be borne in mind that the fetus can adapt to high doses of ascorbic acid, which is taken by a pregnant woman, which can cause symptoms of its insufficiency in newborns (children's scurvy).Theoretically, there is a danger for the child when using high-dose high-dosage ascorbic acid (mothers are recommended not to exceed the daily requirement for ascorbic acid in the feeding period).

    Effect on the ability to drive transp. cf. and fur:

    The drug does not interfere with physical and mental activity, does not affect the ability to drive or drive machinery.

    Form release / dosage:

    Tablets for resorption, 5 mg + 50 mg.

    Packaging:For 20 tablets in a blister of PVC / PVDC / aluminum foil, 1 blister together instructions for use in a cardboard bundle.
    Storage conditions:

    Keep in dry the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date stated on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N011931 / 01
    Date of registration:25.06.2010
    The owner of the registration certificate:Bittner Pharma, LLCBittner Pharma, LLC
    Manufacturer: & nbsp
    Information update date: & nbsp17.06.2013
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