Description
Latin name
Klion-D 100
packaging 10 pcs – aluminum strips (1) – packs of cardboard.
Pharmacological action
Klion-D 100 – a combined preparation with antibacterial, antiprotozoal and antifungal effects for intravaginal use.
Metronidazole, a derivative of nitro-5-imidazole. The mechanism of its action is the biochemical reduction of the 5-nitro group by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group of metronidazole interacts with the DNA of the cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms. Metronidazole is an effective antimicrobial and antiprotozoal agent with a wide spectrum of action.
Active against: Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, Obligate anaerobes (spore-forming and non-spore-forming): Bacteroides spp, Bacteroides fragilis, Bacteroides ovatus, Bacteroides distasonis, Bacteroides thetaiotaomicron, Bacteroides vulgatus, Fusobacterium spp, Clostridium spp, Peptostreppococ.
Optional anaerobes and obligate aerobes are resistant to metronidazole.
Miconazole has an antifungal effect against dermatophytes, yeast fungi, as well as an antibacterial effect against certain gram-positive bacteria. Miconazole inhibits ergosterol biosynthesis and changes the composition of other lipid components in the membrane, which leads to fungal cell necrosis. Miconazole eliminates the itching that often accompanies infections caused by yeast and dermatophytes. Does not change the composition of microflora and pH of the vagina.
Indications
Topical treatment of mixed etiology vaginitis caused by Trichomonas spp. and Candida spp.
Contraindications
leukopenia (including history)
organic lesions of the central nervous system (including epilepsy)
liver failure
pregnancy (I trimester)
lactation (breastfeeding 12 months of pregnancy) sensitivity to the components of the drug
hypersensitivity to other azoles.
Precautions should be prescribed for diabetes mellitus, microcirculation disorders.
Use during pregnancy and lactation
The drug is contraindicated for use in the first trimester of pregnancy and during breastfeeding.
Composition
1 tab.
metronidazole 100 mg
miconazole nitrate 100 mg
Excipients:
sodium lauryl sulfate – 0.5 mg,
silicon dioxide colloidal – 7 mg,
magnesium stearate – 13 mg,
povidone – 26 mg,
hydrochloride 90 mg srdl sbrlkp
acid – 100 mg,
sodium carboxymethyl starch (type A) – 100 mg, crodpovidone
– 100 mg, hypromellose
– 190 mg, lactose
monohydrate – 473.5 mg.
Dosage and administration
Intravaginally.
1 vaginal tablet (pre-moistened with water) is injected deep into the vagina in the evening before bedtime for 10 days in combination with the administration of metronidazole inside.
Side effects
Local reactions: burning, itching, pain and irritation of the vaginal mucosa thick, white, mucous discharge from the vagina odorless or with a faint smell burning sensation or irritation of the penis of the partner.
From the digestive system: nausea, vomiting, change in taste, metallic taste in the mouth, decreased appetite, abdominal pain of a spastic nature, constipation or diarrhea.
From the side of the central nervous system: headache, dizziness.
From the hemopoietic system: leukopenia or leukocytosis.
Allergic reactions: urticaria, itching of the skin, rash.
From the urinary system: staining of urine in red-brown color due to the presence of a water-soluble pigment (metronidazole metabolite – 2 oxymetronidazole), resulting from the metabolism of metronidazole.
Overdose
No data on overdose on intravaginal administration of metronidazole vaginal tablets are available. However, when used with metronidazole, systemic effects may develop internally.
Symptoms of metronidazole overdose: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, movement disorders (ataxia), dizziness, paraesthesia, convulsions, peripheral neuropathy, leukopenia, darkening.
Symptoms of miconazole overdose were not detected.
Storage conditions
The drug should be stored in a place protected from light and moisture at a temperature of 15 ° to 30 ° C.
Expiration
5 years.
Pharmacy terms of sale
Prescription
dosage form
dosage form
vaginal tablets
Gedeon Richter Vengriya
