Safotsid - instructions for use, analogs, reviews and release forms (tablets set of three types of 4 and 12 pieces per pack) of the drug for the treatment of gonorrhea, trichomoniasis, thrush in adults, children and pregnancy. Composition and alcohol

In this article, you can read the instructions for using the drug Safocid. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Safocid in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Safocides in the presence of existing structural analogues. Use for the treatment of gonorrhea, trichomoniasis, thrush in adults, children, as well as during pregnancy and lactation. Composition and interaction of the drug with alcohol.

Safocid - a combined kit containing an antifungal drug, an antibiotic and an antibacterial drug with antiprotozoal activity.

Fluconazole

Antifungal agent, has a highly specific effect, inhibiting the activity of enzymes of fungi, dependent on cytochrome P450. Blocking the conversion of lanosterol of fungal cells to ergosterol; increases the permeability of the cell membrane, disrupts its growth and replication. Fluconazole, being highly selective for cytochrome P450 fungi, practically does not inhibit these enzymes in the human body (in comparison with itraconazole, clotrimazole, econazole and Ketoconazole less inhibits oxidative processes dependent on cytochrome P450 in human liver microsomes). Does not have anti-androgenic activity.

Active with opportunistic fungal infections, incl. caused by Candida spp. (candida) (including generalized forms of candidiasis on the background of immunodepression), Cryptococcus neoformans and Coccidioides immitis (including intracranial infections), Microsporum spp. and Trichophyton spp .; with endemic mycoses caused by Blastomyces dermatidis, Histoplasma capsulation (including with immunodepression).

Azithromycin

Antibacterial agent of a wide spectrum of action, azalide, acts bacteriostatically.Linking to the 50S subunit of ribosomes, inhibits peptidranslokase at the stage of translation, suppresses protein synthesis, slows the growth and multiplication of bacteria, at high concentrations has a bactericidal effect. It is active against extracellular and intracellular pathogens.

Azithromycin susceptible microorganisms: aerobic Gram-positive microorganisms - Staphylococcus aureus (Staphylococcus) (methicillin-sensitive strains), Streptococcus pneumoniae (streptococcus) (penicillin susceptible strains), Streptococcus pyogenes; aerobic gram-negative microorganisms - Haemophilus influenzae, Haemophilus parainfluenzae, Legionella pneumophila (Legionella), Moraxella catarrhalis, Pasteurella multocida, Neisseria gonorrhoeae; anaerobic microorganisms - Clostridium perfringens, Fusobacterium spp., Prevotella spp., Porphyromonas spp .; other microorganisms - Chlamydia trachomatis (Chlamydia), Chlamydia pneumoniae, Chlamydia psittaci, Mycoplasma pneumoniae (mycoplasma), Mycoplasma hominis, Borrelia burgdorferi.

Microorganisms with acquired resistance to azithromycin: aerobic gram-positive microorganisms - Streptococcus pneumoniae (penicillin-resistant strains and strains with average sensitivity to penicillin).

Microorganisms with natural resistance: aerobic gram-positive microorganisms - Enterococcus faecalis (enterococcus), Staphylococcus aureus (methicillin-resistant strains), Staphylococcus epidermidis (methicillin-resistant strains); anaerobic microorganisms - Bacteroides fragilis.

Cases of cross-resistance between Streptococcus pneumoniae, Streptococcus pyogenes (group A beta-hemolytic streptococcus), Enterococcus faecalis and Staphylococcus aureus, including Staphylococcus aureus (methicillin-resistant strains) to erythromycin, azithromycin, other macrolides and lincosamides are described.

Secnidazole

Antimicrobial bactericide is a synthetic derivative of nitroimidazole. It is active against obligate anaerobic bacteria (sporo- and non-spore forming), pathogens of some protozoal infections: Trichomonas spp. (Trichomonas), Giardia lamblia, Entamoeba histolytica. Not active against aerobic bacteria.

Interacts with the DNA of a microbial cell, causes a violation of the spiral structure, rupture of threads, suppression of the synthesis of nucleic acids and cell death. Causes sensitization to alcohol (tetur-like action).

Composition

Fluconazole + Azithromycin dihydrate + Secnidazole + excipients.

Pharmacokinetics

Fluconazole

Absorption is high, bioavailability is 90%. Simultaneous food intake does not affect the absorption of the drug taken internally. It penetrates well into the cerebrospinal fluid, with fungal meningitis, the concentration in the cerebrospinal fluid is about 85% of that in the plasma.In the fluid, epidermis and stratum corneum (selective accumulation), concentrations exceeding serum levels are achieved. It is excreted mainly by the kidneys (80% - unchanged, 11% - in the form of metabolites).

Azithromycin

Azithromycin is rapidly absorbed from the digestive tract, which is due to its resistance to acidic environment and lipophilicity. It penetrates well into the respiratory tract, urino-genital organs and tissues, into the prostate gland, into the skin and soft tissues; accumulates in a medium with low pH, in lysosomes (which is especially important for the eradication of intracellular pathogens). It is also transported by phagocytes, polymorphonuclear leukocytes and macrophages (without significantly affecting their function). It penetrates the membranes of cells and creates high concentrations in them. The concentration in the foci of infection is significantly higher (by 24-34%) than in healthy tissues, and correlates with the severity of the inflammatory edema. In the focus of inflammation persists in effective concentrations within 5-7 days after taking the last dose. The connection with plasma proteins is 7-50% (inversely proportional to the concentration in the blood). It is excreted with bile in unchanged form (50%) and kidneys (6%).

Secnidazole

Absorption is high, bioavailability is 80%. Penetrates through the placental barrier, excreted in breast milk. Metabolised in the liver. It is excreted in the urine for 72 hours (16% of the dose).

Indications

Combined infections of the genitourinary tract, transmitted sexually:

• gonorrhea;
• trichomoniasis;
• chlamydia;
• bacterial vaginosis;
• fungal infections;
• concomitant specific and nonspecific cystitis, urethritis, vulvovaginitis, cervicitis.

Forms of release

A set of tablets of three types (4 or 12 pieces per pack).

Other medicinal forms, whether candles, ointment or cream, do not exist.

Instructions for use and reception scheme

The drug should be taken orally - at the same time, all 4 tablets (1 tablet of fluconazole, 1 tablet of azithromycin and 2 tablets of secydidazole) included in the blister, taking into account the intake of food (as absorption of azithromycin varies with simultaneous intake of food, it is better to take it for 1 h before meals or 2 hours after meals), once.

It is possible to use the drug, both men and women.

Side effect

• headache;
• dizziness;
• convulsions;
• insomnia;
• drowsiness;
• tremor;
• abdominal pain;
• diarrhea, constipation;
• flatulence;
• nausea, vomiting;
• change in taste;
• "metallic" taste in the mouth;
• glossitis;
• stomatitis;
• dyspepsia;
• dryness of the oral mucosa;
• impaired liver function (jaundice, hyperbilirubinemia, increased alkaline phosphatase concentration, cholestasis, increased activity of "hepatic" enzymes, hepatitis, hepatocellular necrosis);
• skin rash;
• multiforme exudative erythema (including Stevens-Johnson syndrome);
• toxic epidermal necrolysis (Lyell's syndrome);
• Anaphylactic reactions (including angioedema, facial edema, hives, itching of the skin);
• leukopenia, thrombocytopenia, neutropenia, agranulocytosis;
• pain in the chest;
• arrhythmia;
• arrhythmia ventricular tachysystolic type "pirouette" (torsade de pointes);
• a decrease in blood pressure;
• increase in the duration of the QT interval;
• fibrillation / flutter of the ventricles;
• impaired renal function;
• alopecia;
• increased sweating;
• myalgia;
• asthenia;
• weakness;
• fever;
• photosensitization;
• conjunctivitis;
• vaginal candidiasis;
• vaginitis.

Contraindications

• simultaneous administration of astemizole, erythromycin, pimozide, quinidine, cisapride, ergotamine, dihydroergotamine;
• simultaneous reception of other drugs that extend the QT interval;
• organic diseases of the central nervous system;
• severe hepatic impairment;
• renal failure with CC less than 40 ml / min;
• blood diseases (including in the anamnesis);
• pregnancy;
• lactation period;
• children's age till 18 years;
• increased sensitivity to fluconazole and other azole compounds;
• hypersensitivity to fluconazole (including other azole antifungal drugs in history), azithromycin (including macrolides), secnidazole (including other nitroimidazoles);
• Hypersensitivity to other components of the tablets included in the kit.

Application in pregnancy and lactation

Safocid is contraindicated for use in pregnancy and lactation (breastfeeding).

Use in children

Contraindicated in children and adolescents under the age of 18 years.

special instructions

With simultaneous use of antacids, a break of 2 hours should be observed before taking azithromycin.

Due to the fact that with joint use of secnidazole with alcohol, a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headache, blood rush to the face) may develop, during the treatment it is necessary to avoid the use of ethanol (alcohol).

Secnidazole can cause immobilization by treponem, which leads to false positive Nelson's test (reaction of immobilization of pale treponemes, RIBT).

Influence on ability to drive vehicles, mechanisms

The use of the Safocid tablet set does not generally affect the ability to drive and perform work that requires a high rate of mental and physical reactions, but it can lead to dizziness and other side effects that may affect the above abilities.

Drug Interactions

Fluconazole

With the simultaneous use of astemizole with fluconazole, a decrease in the clearance of astemizole and an increase in its plasma concentration may occur, which may cause prolongation of the QT interval and the development of ventricular arrhythmia such as pirouette.

With the simultaneous use of pimozide with fluconazole, inhibition of the metabolism of pimozide is possible. An increase in the concentration of pimozide in the blood plasma can cause prolongation of the QT interval and the development of ventricular arrhythmia such as pirouette.

With the simultaneous use of quinidine with fluconazole, inhibition of quinidine metabolism is possible.The use of quinidine is associated with prolongation of the QT interval and rare cases of development of ventricular arrhythmia such as pirouette.

With the simultaneous use of Fluconazole and erythromycin, an increased risk of cardiotoxicity (prolongation of the QT interval, development of ventricular arrhythmia of the "pirouette" type), up to sudden cardiac arrest is possible.

With the simultaneous use of cisapride and fluconazole, there have been cases of serious cardiac abnormalities, including paroxysms of ventricular tachycardia (torsade de pointes). With the simultaneous administration of fluconazole (200 mg per day) and cisapride (20 mg 4 times a day), a significant increase in the concentration of cisapride in plasma and an increase in the duration of the QT interval were observed.

Benzodiazepines (short-acting): fluconazole increases the concentration of midazolam after ingestion of the latter, which can lead to an increased risk of psychomotor effects. Fluconazole increases AUC and T1 / 2 triazolam after ingestion of the latter, so that an increase in the effect and an increase in the duration of the action of triazolam are possible. With the simultaneous use of short-acting benzodiazepines and fluconazole, a dose reduction of benzodiazepines and careful monitoring of the patients' condition may be required.

Rifampicin increases the metabolism of fluconazole, as a result of which T1 / 2 and plasma concentrations of fluconazole are reduced by 20% and 25%, respectively. An increase in the dose of fluconazole may be required.

Fluconazole may increase the concentration of tacrolimus in the serum after ingestion of the latter, due to the inhibition of tacrolimus metabolism in the intestine by the CYP3A4 isoenzyme. After intravenous administration of tacrolimus, no significant changes in pharmacokinetic parameters were observed. When the concentration of tacrolimus increases, the risk of nephrotoxic action increases. It is necessary to monitor the concentration of tacrolimus and, if necessary, adjust the dose.

Fluconazole increases Cmax and AUC of zidovudine by 84% and 74%, respectively, due to a decrease in its clearance by approximately 45%. Therefore, there may be an increased risk of side effects of zidovudine. Patients should be carefully monitored for the development of zidovudine-associated adverse reactions.

Some azoles in combination with terfenadine were associated with the occurrence of serious rhythm disturbances, including paroxysms of ventricular tachycardia (torsade de pointes), due to the prolongation of the QT interval on the ECG.Studies conducted with fluconazole showed that with a daily dose of fluconazole 200 mg, no prolongation of the QT interval was observed. With the use of fluconazole at a dose of 400 or 800 mg, a significant increase in the concentration of terfenadine in plasma was observed. The administration of fluconazole 400 mg or more in combination with terfenadine is contraindicated. Patients should be carefully observed while taking terfenadine and fluconazole at a dose of less than 400 mg per day.

Hydrochlorothiazide increases the concentration of fluconazole in the plasma by 40% (clinical significance is unlikely).

Fluconazole increases plasma concentrations and T1 / 2 hypoglycemic medicines for oral use, derivatives of sulfonylurea: chlorpropamide, glibenclamide, glipizide and tolbutamide. Periodically monitor the concentration of glucose in the blood (risk of hypoglycemia) and, if necessary, adjust the dose of oral hypoglycemic drugs.

With the simultaneous administration of fluconazole during treatment with coumarin derivatives (warfarin), prothrombin time increased. Patients who simultaneously receive indirect anticoagulants, coumarin derivatives, require careful monitoring of prothrombin time.

The simultaneous use of fluconazole and rifabutin can lead to an increase in plasma concentrations of plasma; with simultaneous application described cases of uveitis.

Fluconazole reduces the clearance of theophylline and increases its plasma concentration. Patients who receive high doses of theophylline or who are likely to develop theophylline intoxication should be monitored for the early detection of symptoms of theophylline overdose.

Fluconazole clinically significantly increases the concentration in the plasma of phenytoin. With simultaneous application it is necessary to monitor the concentration of phenytoin in the plasma and, if necessary, carry out dose adjustment.

Fluconazole increases the AUC of cyclosporine. With simultaneous application of fluconazole (200 mg per day) and cyclosporine (2.7 mg / kg / day) in patients with kidney transplantation, the amount of AUC cyclosporine was increased 1.8-fold.

With the simultaneous use of fluconazole at a dose of 50 mg and oral contraceptives, there were no significant changes in plasma concentrations of ethinylestradiol and levonorgestrel, but with 200 mg of fluconazole, there was an increase in ethinyl estradiol AUC by 40% and levonorgestrel by24%. Therefore, the effect of fluconazole on the efficacy of combined oral contraceptives is not expected.

Azithromycin

Antacids (aluminum and magnesium-containing), ethanol (alcohol) and food slow down and reduce the absorption of azithromycin.

When co-administration of Warfarin and azithromycin (in normal doses) changes in prothrombin time were found, however, given that the interaction of macrolides and warfarin may be increased anticoagulant effect, patients requires careful monitoring of the prothrombin time.

Azithromycin has no clinically significant impact on the blood concentration of carbamazepine, cimetidine, didanosine, efavirenz, fluconazole, indinavir, midazolam, theophylline, triazolam, trimethoprim / sulfamethoxazole, cetirizine, sildenafil, atorvastatin, rifabutin and methylprednisolone, while the application.

Care must be taken with co-administration of terfenadine and azithromycin, since it has been found that simultaneous reception of terfenadine and various types of arrhythmia and antibiotics causes lengthening of the interval QT.Proceeding from this, it is impossible to exclude the aforementioned complications in the joint administration of terfenadine and azithromycin.

Ergotamine and dihydroergotamine: increased toxic effect (vasospasm, dysesthesia).

Macrolides slow down excretion, increase plasma concentrations and toxicity of cycloserine, indirect anticoagulants, methylprednisolone, felodipine, and drugs that undergo microsomal oxidation (carbamazepine, terfenadine, cyclosporine, hexobarbital, ergot alkaloids, valproic acid, disopyramide, bromocriptine, phenytoin, oral hypoglycemic medicines), however, with the use of azalides (including azithromycin), this type of interaction was not noted.

Lincosamides weaken, and Tetracycline and chloramphenicol increase the effectiveness of azithromycin.

With the joint administration of Digoxin and azithromycin, it is necessary to monitor the concentration of digoxin in the blood, many macrolides increase absorption of digoxin in the intestine, thereby increasing its concentration in the blood plasma.

If it is necessary to jointly use azithromycin with cyclosporine, it is recommended to monitor the content of cyclosporin in the blood because of a significant increase in AUC.

When used simultaneously with zidovudine, azithromycin does not affect the pharmacokinetic parameters of zidovudine in the blood plasma or on excretion of zidovudine and its glucuronated metabolite. Nevertheless, the concentration of the active metabolite - phosphorylated zidovudine in monocytes - increases. The clinical significance of this fact is not known.

With simultaneous application with nelfinavir, an increase in the concentration of azithromycin in the blood plasma is possible, not accompanied by a significant increase in adverse reactions and not requiring correction of the dose of drugs.

Secnidazole

Strengthens the effect of indirect anticoagulants. It is not recommended to combine with nondepolarizing muscle relaxants (vecuronium bromide). At simultaneous reception with preparations of lithium raises its concentration in plasma.

Strengthens the hypoglycemic effect of insulin and oral hypoglycemic agents.

Similarly, Disulfiram causes intolerance to ethanol (alcohol).

Analogues of the drug Safotsid

Structural analogues of the active substance of the drug Safotsid does not. The drug is unique in the combination of active ingredients that make up the composition.

Analogues on the curative effect (remedies for gonorrhea):

• Abaktal;
• Amoxiclav;
• Amoxisar;
• Amoxicillin;
• Ampioks;
• Augmentin;
• Atzilact;
• Benzylpenicillin;
• Vibramycin;
• Witsef;
• Garamycin;
• Hexicon;
• Gentamicin;
• Grosseptol;
• Doxilan;
• Doxycycline;
• Zanotsin;
• Zitrolide;
• Zitrolid forte;
• Quipro;
• Lactobacterin;
• Lidaprim;
• Longacef;
• Miramistin;
• Nolycin;
• Ospamox;
• Ofloxacin;
• Oflotsid;
• Panklav;
• Pipracil;
• Picillin;
• Recipro;
• Rifakomb;
• Selemycin;
• Siflox;
• Supraks;
• Tarevid;
• Tertsef;
• Trimezol;
• Felixin ;;
• Cephalexin;
• Cefosin;
• Cefotaxime;
• Ceftazidime;
• Ceftriabal;
• Ciprobay;
• Ciprofloxacin;
• Tsifran;
• Erythromycin;
• Hermitage;
• Yunidox Solutab.

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