контрактне виробництво
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Metronidazole
Release form
Vaginal suppositories.
For children
Not used
For pregnant women
Not recommended
For nursing mothers
Contraindicated
For drivers
Contraindicated
Storage temperature
to 25 °C
INSTRUCTION
storage
active substance: metronidazole; 1 suppository contains metronidazole 0.1 g (100 mg); excipient: solid fat.
Medicinal form
Vaginal suppositories. Main physicochemical properties: suppositories are white or white with a slightly yellowish tint.
Pharmacotherapeutic group
Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives. ATX code G01A F01.
Pharmacological properties
Pharmacodynamics. Metronidazole belongs to nitro-5-imidazoles and has a wide spectrum of action. Threshold concentrations that differentiate susceptible strains (S) from moderately susceptible strains and moderately susceptible strains from resistant strains (R) are as follows: S ≤ 4 mg/L and R > 4 mg/L. The following are sensitive to the drug: Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Fusobacterium spp., Porphyromonas, Bilophila, Helicobacter pylori, Prevotella spp., Veilonella. Metronidazole inhibits the development of protozoa - Trichomonas vaginalis, Giardia intestinalis (Lamblia intestinalis), Entamoeba histolytica. Inconstantly sensitive to the drug: Bifidobacterium spp., Eubacterium spp. Insensitive strains of microorganisms: Propionibacterium, Actinomyces, Mobiluncus. Pharmacokinetics. After vaginal administration, systemic penetration is minimal. The half-life from blood plasma is 8-10 hours. Binding to plasma proteins is insignificant (less than 20%). Rapid and pronounced diffusion in the lungs, kidneys, liver, bile, cerebrospinal fluid, skin, saliva and vaginal secretions. Penetrates through the placental barrier and penetrates into breast milk. Metabolism occurs mainly in the liver: two unconjugated oxidized active metabolites are formed (5-30% activity). Excretion is mainly by the kidneys: 35-65% of the received dose is excreted in the urine in the form of metronidazole and its oxidized metabolites.
Indication
Local treatment of trichomonad and nonspecific vaginitis.
Contraindication
Cockayne syndrome (see section "Adverse reactions"). Hypersensitivity to metronidazole or another component of the drug. Hypersensitivity to imidazole derivatives. This drug is not recommended to be prescribed in combination with disulfiram or alcohol (see the section "Interaction with other drugs and other types of interactions").
Interaction with other medicinal products and other forms of interaction
Disulfiram: Cases of acute transient disorders with delirium (acute attack of delirium, confusion) have been reported in patients taking metronidazole and disulfiram at the same time. Alcohol: you should not drink alcoholic beverages and take drugs that contain alcohol during treatment and for at least one more day after its completion due to the possible occurrence of a disulfiram-like (Antabuse) effect (flushes, erythema, vomiting, tachycardia). It is necessary to take into account the time of complete removal of the drug from the body, taking into account its half-life, before the start of drinking alcoholic beverages or taking medicines that contain alcohol. Oral therapy with anticoagulants (warfarin-like): strengthening the effects of oral anticoagulants and increasing the risk of hemorrhagic complications due to slowing down of their metabolism in the liver. It is necessary to monitor the levels of prothrombin more often and monitor the levels of the international normalized ratio, INR. It is recommended to adjust the dose of an oral anticoagulant while taking metronidazole and for 8 days after its withdrawal. Rifampicin. Reduction of metronidazole concentrations in blood plasma due to stimulation of its metabolism in the liver by rifampicin. Clinical monitoring should be performed during and after treatment with rifampicin. It may be necessary to adjust the dose of metronidazole. Lithium: the level of lithium in the blood plasma may increase when taking metronidazole. Plasma concentrations of lithium, creatinine, and electrolytes should be monitored in patients receiving lithium and metronidazole at the same time. Cyclosporine: There is a risk of increased cyclosporine serum levels. If the drugs must be taken simultaneously, cyclosporine and creatinine levels should be carefully monitored. Anticonvulsants that are enzyme inducers (carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone): causes a decrease in metronidazole plasma levels due to stimulation of its metabolism in the liver by the inducer. Fluorouracil (as well as tegafur and capecitacin). A decrease in the clearance of fluorouracil causes an increase in its toxicity. Busulfan: Metronidazole may increase plasma levels of busulfan, which may result in significant busulfan toxicity. Change of EOM. In patients who received antibacterial therapy, numerous cases of increased activity of oral anticoagulants were registered. At the same time, risk factors predisposing to such a complication are the presence of infection or severe inflammation, the patient's age and his general state of health. In these circumstances, it is difficult to determine to what extent the infection itself or its treatment affects the MNV imbalance. However, some classes of antibiotics play a greater role in this, in particular: fluoroquinolones, macrolides, cyclins, cotrimoxazole and some cephalosporins. Results of laboratory studies. Metronidazole is able to immobilize treponemes, which leads to a false-positive Nelson test.
Features of use
It is better to start therapy at the beginning of the menstrual cycle. Postmenopausal women can start treatment at any time. It is advisable to avoid douching. During the treatment of trichomonad vaginitis, it is recommended to refrain from sexual life, it is advisable to simultaneously treat the sexual partner with oral metronidazole. Metronidazole does not have a direct effect on aerobic or facultative anaerobic bacteria. Metronidazole should not be prescribed for more than 10 days and no more than 2 or 3 times a year. During treatment with metronidazole, alcohol consumption should be avoided (the antabuse effect (see the section "Interaction with other drugs and other types of interactions"). There is a possibility of persistence of gonococcal infection after the elimination of trichomonad infection. In patients undergoing hemodialysis, metronidazole and its metabolites are removed within 8 hours of hemodialysis, so metronidazole should be taken immediately after hemodialysis. Dose adjustment is not necessary for patients with renal insufficiency undergoing peritoneal dialysis. The drug should be discontinued if the patient develops ataxia, dizziness, or confusion. In patients with severe , chronic or progressive diseases of the peripheral or central nervous system, the risk of exacerbation of the neurological status should be taken into account. In patients with a history of hematological disorders or who receive the drug in high doses and/or for a long time, regular blood tests should be performed, especially determination content of leukocytes. Metronidazole should be used with caution in patients with hepatic encephalopathy. In patients with hepatic encephalopathy, the daily dose must be reduced by a third and can be used once a day. In patients with leukopenia, the possibility of continuing treatment with the drug will depend on the severity of the course of the infectious disease. In the case of long-term treatment with the drug, it is necessary to monitor the patient for signs of adverse reactions, such as central or peripheral neuropathy (paresthesia, ataxia, dizziness, convulsions). Patients should be informed that metronidazole can stain urine in a dark color (due to an active metabolite). Using vaginal suppositories while using condoms or diaphragms may increase the risk of latex rupture. Hypersensitivity/disorders from the skin and its derivatives. Allergic reactions may occur, including anaphylactic shock, which may be life-threatening (see section "Adverse reactions"). In this case, it is necessary to cancel the treatment with metronidazole and start appropriate therapy. If, at the beginning of treatment, the patient develops generalized erythema and pustular eruptions, which are accompanied by an increase in body temperature, acute generalized exanthematous pustulosis should be suspected (see section "Side reactions"); in the event of the development of such a reaction, treatment with the drug should be stopped, and further use of metronidazole both as monotherapy and in combination with other drugs is contraindicated. Acute skin reactions, including Stevens-Johnson syndrome, Lyell's syndrome, acute generalized exanthematous pustulosis, are associated with metronidazole administration. Patients should be informed of symptoms of such reactions and careful skin monitoring should be performed. If the patient develops symptoms of Stevens-Johnson syndrome, Lyell's syndrome (for example, the gradual appearance of rashes and skin blisters or mucosal lesions) or generalized erythema with pustular rashes, which are accompanied by an increase in body temperature, treatment with the drug should be stopped, and in the future, the use of metronidazole as in in the form of monotherapy and in combination with other drugs is contraindicated. Disorders of the central nervous system. If symptoms suggestive of encephalopathy or cerebellar syndrome occur, the patient's treatment should be reviewed immediately and metronidazole should be discontinued. Cases of encephalopathy have been reported during post-marketing surveillance of the drug. In addition, there have been cases of MRI changes associated with encephalopathy (see section "Adverse reactions"). Areas of lesions are most often localized in the cerebellum (especially in the dentate nucleus) and in the corpus callosum. In most cases, encephalopathy and MRI changes disappeared after stopping treatment with the drug. Fatalities have been reported very rarely. Patients should be monitored for possible signs of encephalopathy or exacerbation of symptoms in the presence of CNS disorders. If aseptic meningitis develops during treatment with the drug, re-prescribing metronidazole is not recommended, and in patients with a serious infectious disease, a re-evaluation of the benefit/risk ratio should be carried out. Disorders of the peripheral nervous system. Patients should be monitored for possible signs of peripheral neuropathy, especially during long-term treatment with the drug or in the presence of severe, chronic or progressive peripheral neuropathy. Mental disorders. After the first dose of the drug, patients may experience psychotic reactions, including self-injurious behavior, especially if there is a history of psychiatric disorders (see section "Adverse reactions"). In this case, it is necessary to stop treatment with metronidazole, inform the doctor and take appropriate medical measures immediately. Hematological effects. In patients with a history of disorders of the blood system and in patients who receive the drug in high doses and/or for a long period of time, regular blood tests, especially control of the number of leukocytes, should be performed. Continuation of drug treatment of patients with leukopenia depends on whether how serious the infectious disease is. Interaction with other medicinal products. The simultaneous use of metronidazole and alcoholic beverages or drugs that contain alcohol is contraindicated (see the section "Interaction with other drugs and other types of interactions"). The simultaneous use of metronidazole and busulfan is not recommended (see the section "Interaction with other medicinal products and other types of interactions"). The simultaneous use of metronidazole and disulfiram is contraindicated (see the section "Interaction with other drugs and other types of interactions"). Other types of interactions. The maximum duration of treatment with metronidazole should not exceed 10 days, and the number of treatment courses should be 2-3 per year. The use of suppositories when using condoms or diaphragms increases the risk of latex rupture. Use during pregnancy or breastfeeding. Pregnancy. Animal studies have not shown a teratogenic effect. Since the teratogenic effect is not observed in animals, no developmental defects are expected in humans. According to the data, substances that lead to the formation of developmental defects in humans have a teratogenic effect in animals during adequately conducted studies on two species. Clinical data have not demonstrated any specific teratogenic or fetotoxic effects associated with metronidazole. However, the absence of such a risk can only be confirmed by epidemiological studies. In this regard, metronidazole can be prescribed during pregnancy only if necessary. Breast feeding. Metronidazole is excreted in breast milk. In this regard, it is necessary to avoid the use of this medicinal product during breastfeeding. The ability to influence the speed of reaction when driving vehicles or other mechanisms. If dizziness, confusion, hallucinations, convulsions or temporary visual impairment are observed during treatment with the drug, you should refrain from driving vehicles and working with other mechanisms. no developmental defects are expected in humans. According to the data, substances that lead to the formation of developmental defects in humans have a teratogenic effect in animals during adequately conducted studies on two species. Clinical data have not demonstrated any specific teratogenic or fetotoxic effects associated with metronidazole. However, the absence of such a risk can only be confirmed by epidemiological studies. In this regard, metronidazole can be prescribed during pregnancy only if necessary. Breast feeding. Metronidazole is excreted in breast milk. In this regard, it is necessary to avoid the use of this medicinal product during breastfeeding. The ability to influence the speed of reaction when driving vehicles or other mechanisms. If dizziness, confusion, hallucinations, convulsions or temporary visual impairment are observed during treatment with the drug, you should refrain from driving vehicles and working with other mechanisms. no developmental defects are expected in humans. According to the data, substances that lead to the formation of developmental defects in humans have a teratogenic effect in animals during adequately conducted studies on two species. Clinical data have not demonstrated any specific teratogenic or fetotoxic effects associated with metronidazole. However, the absence of such a risk can only be confirmed by epidemiological studies. In this regard, metronidazole can be prescribed during pregnancy only if necessary. Breast feeding. Metronidazole is excreted in breast milk. In this regard, it is necessary to avoid the use of this medicinal product during breastfeeding. The ability to influence the speed of reaction when driving vehicles or other mechanisms. If dizziness, confusion, hallucinations, convulsions or temporary visual impairment are observed during treatment with the drug, you should refrain from driving vehicles and working with other mechanisms.
Methods of application
The drug is allowed to be used for the treatment of adult patients only. Trichomonas vaginitis. Prescribe 2 vaginal suppositories 2 times a day for 10 days. Insert the suppository deep into the vagina. Treatment should be carried out with simultaneous oral administration of Metronidazole tablets. Nonspecific vaginitis. Insert 2 vaginal suppositories deep into the vagina, 2 times a day, for 7 days. If necessary, Metronidazole tablets can be prescribed orally. Simultaneous treatment of the patient's sexual partner is absolutely necessary, even if he has no symptoms of infection. The maximum duration of treatment with Metronidazole should not exceed 10 days, and the number of treatment courses should be 2-3 per year. Children. Do not use the drug for children.
Overdose
Leukopenia, neuropathy, ataxia, vomiting, mild disorientation may be observed. Since the specific antidote of metronidazole is unknown, symptomatic therapy is recommended.
Side effects
From the blood and lymphatic system: very rarely - agranulocytosis, neutropenia, thrombocytopenia, pancytopenia and leukopenia. Hypersensitivity reactions: skin rash with hyperemia, itching, redness, urticaria, erythema multiforme; hot flashes, laryngitis, angioedema, exceptional cases of anaphylactic shock, isolated cases of pustular rash, toxic epidermal necrolysis, fixed toxicoderma, Lyell's syndrome, Stevens-Johnson syndrome. From the central and peripheral nervous system: peripheral sensory neuropathy, headache, convulsions, dizziness, ataxia, drowsiness, aseptic meningitis; encephalopathy (eg, confusion, fever, increased sensitivity to light, torticollis, hallucinations, paralysis, visual and movement disorders), and subacute cerebellar syndrome (ataxia, dysarthria, gait disturbance, tremor, nystagmus), which may resolve after discontinuation taking the drug. Psychiatric disorders: mental disorders, including confusion, hallucinations, psychotic reactions with paranoia and/or delirium, which in rare cases may be accompanied by suicidal thoughts or suicide attempts (see section "Particulars of use"); depressed depressed mood. On the part of the organs of vision: temporary disturbances of visual functions, such as diplopia, myopia, blurred image, decrease in visual acuity, changes in color perception; optic neuropathy/neuritis. From the side of the hepatobiliary system: increased levels of liver enzymes (ACT, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and damage to liver cells (hepatocytes), sometimes with jaundice; reported cases of liver failure requiring liver transplantation in patients treated with metronidazole and other antibiotics. On the part of the genitourinary system: a brownish-red coloration of the urine is possible due to the presence of pigments associated with the metabolism of metronidazole; with long-term treatment, excessive development of the fungal flora of the vagina (candidiasis) is sometimes observed, which requires the appointment of antifungal drugs. From the side of the digestive system: minor disorders of the gastrointestinal tract (pain in the epigastrium, nausea, vomiting, diarrhea); inflammation of the mucous membrane of the oral cavity, taste disorders, (metallic taste in the mouth), glossitis with dry mouth, stomatitis, coated tongue, change in color or appearance of the tongue (mycosis), anorexia, pancreatitis, which is reversible. From the musculoskeletal system and connective tissue: myalgia, arthralgia. From the organs of hearing and balance: hearing impairment/loss of hearing (including neurosensory); tingle. Other side effects: increase in body temperature. Adverse reactions reported with metronidazole Cases of severe irreversible hepatotoxicity / acute liver failure, including cases with fatal consequences with a very rapid course after the start of systemic metronidazole, reported in patients with Cockayne's syndrome (see section "Contraindications"). Reporting of suspected adverse reactions. The reporting of suspected adverse reactions after the registration of a medicinal product is an important procedure. This makes it possible to monitor the benefit/risk ratio of the use of this medicinal product. Healthcare professionals are asked to report all suspected adverse reactions through the national pharmacovigilance system.
Expiration date
2 years.
Storage conditions
. Store in the original packaging at a temperature not higher than 25 ºС. Keep out of the reach of children.
Packaging
5 suppositories in a strip. 2 strips in a pack.
Leave category
By prescription.
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.