Gynalgin® [Metronidazole, chlorquinaldol]
AiCn Polfa Rzeszow
1663 Items
2019-09-19
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Clinical Pharmacology
Trichomonacid, antiprotozoal, antifungal, bactericidal, antibacterial.
Combined preparation for intravaginal use.
Metronidazole refers to nitro-5-imidazoles. The mechanism of action of metronidazole is the biochemical reduction of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The recovered 5-nitro group of metronidazole interacts with the microbial cell DNA, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms.
Metronidazole is an effective antimicrobial and antiprotozoal agent of a wide spectrum of action. The drug exhibits high activity against Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, as well as against obligate anaerobes (spore-and non-sporiferous) - Bacteroides spp. (B. fragilis, B. ovatus, B. distasonis, B. thetaiotaomicron, B. vulgatus), Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., Sensitive Eubacterium strains.
Aerobic microorganisms and facultative anaerobes are not sensitive to metronidazole.
Chlorquinaldol acts on the following strains of pathogenic bacteria: Corynebacterium diphtheriae, Streptococcus pyogenes, Staphylococcus aureus, Pseudomonas aeruginosa, Proteus vulgaris, Salmonella, Shigella, Escherichia coli.
It also exhibits activity with respect to the simplest: Entamoeba histolytica, Lamblia intestinalis, Trichomonas vaginalis and some fungi.
Citric acid lowers the pH of the vagina, promotes the growth and reproduction of Doderlein sticks.
Pharmacokinetics
With intravaginal use, metronidazole undergoes systemic absorption. Cmax in blood after intravaginal administration is approximately 50% of Cmaxwhich is achieved after a single dose of an equivalent dose of metronidazole inside.
Metronidazole is almost completely metabolized in the liver to form inactive derivatives.
T1/2 - 8 h. Metronidazole is excreted mainly with urine.
With intravaginal application, chlorquinaldol is slightly absorbed. Trihomonacid, antiprotozoal, antifungal, bactericidal, antibacterial.
Combined preparation for intravaginal use.
Metronidazole refers to nitro-5-imidazoles. The mechanism of action of metronidazole is the biochemical reduction of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The recovered 5-nitro group of metronidazole interacts with the microbial cell DNA, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms.
Metronidazole is an effective antimicrobial and antiprotozoal agent of a wide spectrum of action. The drug exhibits high activity against Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, as well as against obligate anaerobes (spore-and non-sporiferous) - Bacteroides spp. (B. fragilis, B. ovatus, B. distasonis, B. thetaiotaomicron, B. vulgatus), Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., Sensitive Eubacterium strains.
Aerobic microorganisms and facultative anaerobes are not sensitive to metronidazole.
Chlorquinaldol acts on the following strains of pathogenic bacteria: Corynebacterium diphtheriae, Streptococcus pyogenes, Staphylococcus aureus, Pseudomonas aeruginosa, Proteus vulgaris, Salmonella, Shigella, Escherichia coli.
It also exhibits activity with respect to the simplest: Entamoeba histolytica, Lamblia intestinalis, Trichomonas vaginalis and some fungi.
Citric acid lowers the pH of the vagina, promotes the growth and reproduction of Doderlein sticks.
Pharmacokinetics
With intravaginal use, metronidazole undergoes systemic absorption. Cmax in blood after intravaginal administration is approximately 50% of Cmaxwhich is achieved after a single dose of an equivalent dose of metronidazole inside.
Metronidazole is almost completely metabolized in the liver to form inactive derivatives.
T1/2 - 8 h. Metronidazole is excreted mainly with urine.
With intravaginal use, chlorquinaldol is slightly absorbed.
Indications
Infectious and inflammatory diseases of the vagina caused by pathogens that are sensitive to the drug.
Composition
| Vaginal pills | 1 tab. |
| metronidazole | 250 mg |
| chlorochinaldol | 100 mg |
| excipients: anhydrous citric acid, lactose monohydrate; rice starch; sodium starch glycolate (ultraamylopectin); polyethylene glycol 6000 (carbowax 6000); magnesium stearate | |
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Dosage and Administration
Intravaginally. The tablet is introduced deep into the vagina, preferably in the evening before bedtime, 1 tab. Once a day for 7–10 days. Treatment begins at 2–4 days after menstruation.
If necessary, may conduct a second course of treatment.
Adverse reactions
Itching, burning, pain and irritation in the vagina; thick, white, mucous discharge from the vagina without odor or with a faint odor, frequent urination; after discontinuation of the drug - the development of vaginal candidiasis; burning sensation or irritation of the penis of the sexual partner; headache, dizziness, leukopenia, or leukocytosis; nausea, change in taste, metallic taste in the mouth, dry mouth, decreased appetite, cramping abdominal pain, vomiting, constipation or diarrhea; allergic reactions: urticaria, itchy skin, rash.
In rare cases, it is possible to stain urine in a red-brown color due to the presence of a water-soluble pigment, resulting from the metabolism of metronidazole.
Contraindications
Hypersensitivity to metronidazole or other nitroimidazole derivatives; individual intolerance to chlorquinaldol and other ingredients that make up the vaginal pills, blood disorders, leukopenia (including a history); impaired coordination of movements, organic lesions of the central nervous system (including epilepsy); liver failure (in the case of the appointment of large doses), pregnancy, breastfeeding.
Drug interactions
During treatment, alcohol should be avoided (similar to disulfiram causes alcohol intolerance).
Caution should be exercised while prescribing with certain medications.
Warfarin and other indirect anticoagulants. Metronidazole enhances the effect of indirect anticoagulants, which leads to an increase in the time of formation of prothrombin.
Disulfiram Development of neurological symptoms (depression of consciousness, development of mental disorders), therefore, Gynalgin should not be prescribed to patients who have taken disulfiram in the last two weeks.
Cimetidine inhibits the metabolism of metronidazole, which can lead to an increase in its concentration in serum and an increase in the risk of side effects.
Preparations of lithium increases the concentration of the latter in the plasma.
The effects of Gynalgin are reduced under the influence of barbiturates, since inactivation of metronidazole in the liver is accelerated.
When taken simultaneously with lithium preparations, the concentration of the latter in plasma may increase.
It is possible to reduce the effect of Gynalgin under the influence of barbiturates, since inactivation of metronidazole in the liver is accelerated.
Pregnancy and Lactation
Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.
Special instructions
During the period of drug treatment is recommended to refrain from sex.
With indications of a history of changes in the composition of peripheral blood, as well as with the use of the drug in high doses and / or with its long-term use, control of the complete blood count is necessary.
Metronidazole can immobilize treponemas, which leads to a false-positive TPI test (Nelson's test).
During treatment, you should refrain from performing potentially hazardous activities that require special attention and quick reactions (driving, etc.).
Overdosage
No data
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