Fladystin

Fladystin

metronidazole + nystatin

Manufacturer:

Dexa Medica
Full Prescribing Info
Contents
Metronidazole, nystatin.
Description
Each ovule contains metronidazole 500 mg and nystatin 22.7 mg (equivalent to 100,000 IU).
Action
Pharmacology: Metronidazole is not ionized in physiologic pH and can readily be taken by organisms or anaerobic cells. In certain sensitive organisms or cells, metronidazole undergoes reduction process by electron transport protein, low-potential redox (like nitroreductase eg, ferredoxin). Therefore, polar products which have lost their nitro groups become unknown. This reduction process seems to be responsible for the cytotoxic and antimicrobial effects of metronidazole, which includes disruption of DNA and inhibition of nucleic acid synthesis. Metronidazole has similar efficacy against both dividing and nondividing cells.
Nystatin exerts its antifungal activity by binding to sterol (especially ergosterol) in the fungal cell membrane. Nystatin is not active against organisms (eg, bacteria) that do not have sterol in their cell membranes. As a result of this binding, the cell membrane is no longer able to function as a selective barrier; therefore, potassium and other compounds will be lost.
Microbiology: Metronidazole is effective against: Anaerobic Gram-Positive Bacteria: Clostridium spp, Eubacterium spp, Peptococcus spp and Peptostreptococcus spp.
Anaerobic Gram-Negative Bacteria: Bacteroides fragilis group (B. fragilis, B. ovatus, B. distasonis, B. thetaiotaomicron, B. vulgatus), Fusobacterium spp.
Protozoal Parasites: Entamoeba sp, Trichomonas vaginalis.
The main activity of nystatin is against Candida (Monilia) spp.
Indications/Uses
Treatment of vaginitis infection especially caused by Trichomonas vaginalis and Candida (Monilia) albicans.
Dosage/Direction for Use
1-2 ovules daily for 5-10 days to be inserted into the vagina before bedtime.
Contraindications
Hypersensitivity to metronidazole and nystatin, or to any components of Fladystin; 1st trimester of pregnancy.
Special Precautions
Avoid concomitant use with alcoholic beverages or in alcoholic patients.
Use with caution in patients with blood dyscrasias. Total and differential leukocyte count should be assessed before and after treatment.
Treatment should be infrequent or totally discontinued if irritation occurs.
Patients should be advised to avoid sexual intercourse and to discontinue use of vaginal douche during treatment.
Use with caution in patients with severe liver dysfunction. Doses should be reduced and the concentration of metronidazole should be monitored.
Peripheral neuropathy and epilepsy are serious side effects which may affect the nervous system resulting from treatment with high doses of metronidazole or during long-term use (see Adverse Reactions). In patients receiving metronidazole for >10 days, laboratory and clinical monitoring is recommended.
Impairment of Fertility: A reproductive study in mice using metronidazole >6-fold the adult (human) dose showed no fertility problems.
Use in pregnancy & lactation: Avoid Fladystin administration during pregnancy (especially during the 1st trimester) and lactation, especially when using high doses (see Contraindications).
Use in children: Safety and efficacy of intravaginal metronidazole in children have not been established.
Use in the elderly: Reduction in liver function occurs more often in elderly patients. Therefore, attention should be given on dose adjustments.
Adverse Reactions
Although very rarely, the possible adverse reactions (in gel administration) are: Hypersensitivity: Hypersensitivity reactions with chills, fever, erythema and maculopapular rash may develop after administration of a single dose of metronidazole in patients who have had a history of itching or rash during metronidazole intravaginal therapy. Dryness and burning sensation in the vagina. Skin itching, urticaria and pruritus is frequent, while erythema multiforme, angioedema and anaphylaxis are rarely reported.
Gastrointestinal: Common side effects are gastrointestinal disturbances eg, nausea, metallic taste and occasionally, vomiting and anorexia. Diarrhea, dry mouth, furred tongue, glossitis and stomatitis may occur. Pseudomembranous colitis is reported rarely.
Nervous System: Peripheral neuropathy, characterized by numbness or tingling during extreme attacks, and seizures are serious side effects which may occur on high-dose or prolonged use of metronidazole.
Hematologic Effect: Mild and transient leucopenia and thrombocytopenia may occur in some patients.
Others: Increased liver enzymes, hepatitis and cholestatic jaundice.
Drug Interactions
Coumarin Anticoagulants: Use of metronidazole may prolong the effects of oral anticoagulants, causing a prolonged prothrombin or blood clotting time. Therefore, the concomitant use of metronidazole with anticoagulants should be avoided as much as possible.
Alcohol: Metronidazole may interact with alcohol and cause a disulfiram-like reaction in some patients. Caution is required on the use of alcohol during Fladystin therapy.
Disulfiram: Concomitant use of disulfiram with metronidazole may cause acute psychosis and confusion in some patients. Therefore, metronidazole should not be used concurrently until 2 weeks after the end of disulfiram treatment.
Lithium: Short-term treatment of metronidazole in patients stabilized with relatively high doses of lithium has been reported to increase serum lithium concentration, causing signs of toxicity in some patients.
Storage
Store in the refrigerator or at cold temperature (between 2°-8°C). Protect from light.
ATC Classification
G01AA51 - nystatin, combinations ; Belongs to the class of antibiotics. Used in the treatment of gynecological infections.
Presentation/Packing
Ovule 2 x 5's.
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