FLAGYSTATIN Metronidazole / Nystatin 500mg / 100,000IU Vaginal Suppository 1's
RXDRUG-DRP-088-1pc
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Features
Brand
Flagystatin
Full Details
Dosage Strength
500 mg / 100.000 IU
Drug Ingredients
- Metronidazole
- Nystatin
Drug Packaging
Vaginal Suppository 1's
Generic Name
Metronidazole / Nystatin
Dosage Form
Vaginal Suppository
Registration Number
DRP-088
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Vaginitis due to Trichomonas vaginalis, Gardnerella vaginalis, bacterial vaginosis, Candida (Monilia) albicans and other fungal infections.
Dosage/Direction for Use
One vaginal suppository per day to be inserted deep into the vagina before retiring for 7 to 10 days or as recommended by the physician.
Overdosage
Signs and Symptoms: No case of accidental massive ingestion of Metronidazole + Nystatin (Flagystatin) has been reported yet.
However, single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation.
The administration of massive peroral nystatin doses can as well induce gastro-intestinal disorders (nausea, vomiting, and diarrhoea).
Management: Treatment should be symptomatic.
However, single oral doses of metronidazole, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation.
The administration of massive peroral nystatin doses can as well induce gastro-intestinal disorders (nausea, vomiting, and diarrhoea).
Management: Treatment should be symptomatic.
Contraindications
Hypersensitivity to Metronidazole + Nystatin (Flagystatin) or any of its constituents, or to imidazoles.
Warnings
Metronidazole, like any other imidazole derivative, has been shown to be carcinogenic in rodents. Unnecessary use of the drug should therefore be avoided.
Combined treatment with oral metronidazole should be avoided in cases of history of blood dyscrasia, hypothyroidism or hypoadrenalism unless, in the opinion of the physician, the benefits outweigh the possible hazard to the patient.
Once candidiasis has been confirmed, care must be taken to investigate the possible ecological factors which are permitting and promoting fungal growth. To avoid recurrences, it is essential to eradicate or offset these promoting factors. It is best to treat all sites associated with Candida concomitantly (intestinal and vaginal or other infections).
Severe cutaneous adverse reactions (SCARs): Serious skin reactions including Stevens-Johnson syndrome (SJS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with metronidazole and nystatin treatment (see Adverse Reactions).
Cases of severe bullous skin reactions such as toxic epidermal necrolysis (TEN) have been reported with metronidazole (see Adverse Reactions).
Patients should be informed about the signs and symptoms of serious skin manifestations and monitored closely. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of skin hypersensitivity.
For Nystatin: Primary resistance to nystatin is rare; cross-resistance with other polyene antibiotics has been reported.
Local irritation or sensitizations have occasionally been reported after local application. If this occurs, it is recommended to stop the treatment (see Adverse Reactions).
For Metronidazole: Metronidazole should be used with caution in patients with active or chronic severe peripheral and central nervous system diseases due to the risk of neurological aggravation.
Patients should be advised not to take alcohol during metronidazole therapy and for at least one day afterwards because of the possibility of a disulfiram-like (Antabuse effect) reaction.
Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation, in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use. In this population, Metronidazole should therefore be used after careful benefit-risk assessment and only if no alternative treatment is available. Liver functions tests must be performed just prior to the start of therapy, throughout and after end of treatment until liver function is within normal ranges, or until the baseline values are reached. If the liver function tests become markedly elevated during treatment, the drug should be discontinued.
Patients with Cockayne syndrome should be advised to immediately report any symptoms of potential liver injury to their physician and stop taking metronidazole.
Combined treatment with oral metronidazole should be avoided in cases of history of blood dyscrasia, hypothyroidism or hypoadrenalism unless, in the opinion of the physician, the benefits outweigh the possible hazard to the patient.
Once candidiasis has been confirmed, care must be taken to investigate the possible ecological factors which are permitting and promoting fungal growth. To avoid recurrences, it is essential to eradicate or offset these promoting factors. It is best to treat all sites associated with Candida concomitantly (intestinal and vaginal or other infections).
Severe cutaneous adverse reactions (SCARs): Serious skin reactions including Stevens-Johnson syndrome (SJS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with metronidazole and nystatin treatment (see Adverse Reactions).
Cases of severe bullous skin reactions such as toxic epidermal necrolysis (TEN) have been reported with metronidazole (see Adverse Reactions).
Patients should be informed about the signs and symptoms of serious skin manifestations and monitored closely. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of skin hypersensitivity.
For Nystatin: Primary resistance to nystatin is rare; cross-resistance with other polyene antibiotics has been reported.
Local irritation or sensitizations have occasionally been reported after local application. If this occurs, it is recommended to stop the treatment (see Adverse Reactions).
For Metronidazole: Metronidazole should be used with caution in patients with active or chronic severe peripheral and central nervous system diseases due to the risk of neurological aggravation.
Patients should be advised not to take alcohol during metronidazole therapy and for at least one day afterwards because of the possibility of a disulfiram-like (Antabuse effect) reaction.
Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation, in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use. In this population, Metronidazole should therefore be used after careful benefit-risk assessment and only if no alternative treatment is available. Liver functions tests must be performed just prior to the start of therapy, throughout and after end of treatment until liver function is within normal ranges, or until the baseline values are reached. If the liver function tests become markedly elevated during treatment, the drug should be discontinued.
Patients with Cockayne syndrome should be advised to immediately report any symptoms of potential liver injury to their physician and stop taking metronidazole.
Special Precautions
The use of Metronidazole + Nystatin (Flagystatin) for prolonged treatment duration should be carefully weighed.
Treatment should not be stopped during the menstruation.
The simultaneous use of Metronidazole + Nystatin (Flagystatin) ovules with condoms or diaphragms may increase the risk of rupture of the latex.
Driving a Vehicle or Performing other Hazardous Tasks: Patients should be warned about the potential for confusion, dizziness, hallucinations, convulsions or eye disorders (see Adverse Reactions), and advised not to drive or operate machinery if these symptoms occur.
Treatment should not be stopped during the menstruation.
The simultaneous use of Metronidazole + Nystatin (Flagystatin) ovules with condoms or diaphragms may increase the risk of rupture of the latex.
Driving a Vehicle or Performing other Hazardous Tasks: Patients should be warned about the potential for confusion, dizziness, hallucinations, convulsions or eye disorders (see Adverse Reactions), and advised not to drive or operate machinery if these symptoms occur.
Use In Pregnancy & Lactation
Pregnancy: As metronidazole crosses the placental barrier and as its effects on human fetal organogenesis are not known, its use in pregnancy should be carefully evaluated.
Metronidazole + Nystatin (Flagystatin) should not be used during the first trimester of pregnancy.
Lactation: As metronidazole is excreted in human milk, unnecessary exposure to the drug should be avoided.
Metronidazole + Nystatin (Flagystatin) should not be used during the first trimester of pregnancy.
Lactation: As metronidazole is excreted in human milk, unnecessary exposure to the drug should be avoided.
Adverse Reactions
The following CIOMS frequency rating is used, when applicable: Very common ≥ 10%; Common ≥ 1 and ≥ 10%; Uncommon ≥ 0.1 and <1%; Rare ≥ 0.01 and <0.1%; Very rare <0.01%; Not known (cannot be estimated from available data).
Applies to Metronidazole + Nystatin (Flagystatin): Reproductive system disorders: Vaginal burning sensation.
Gastrointestinal disorders: Nausea, vomiting. diarrhea.
Applies only to metronidazole (usually observed after oral or I.V. administration, cannot be excluded for other formulations): Blood and lymphatic system disorders: Cases of agranulocytosis, neutropenia and thrombocytopenia have been reported.
Immune system disorders: Anaphylactic shock, angioedema.
Psychiatric disorders: Psychotic disorders including confusion, hallucinations. Depressed mood.
Nervous system disorders: Reports of encephalopathy (e.g., confusion) and subacute cerebellar syndrome (e.g., ataxia, dysarthria, gait impairment, nystagmus, and tremor), which may resolve with discontinuation of the drug.
Peripheral sensory neuropathy. Headache. Convulsions. Dizziness. Aseptic meningitis.
Eye disorders: Transient vision disorders such as diplopia, myopia, blurred vision, visual acuity reduced, changes in color vision. Optic neuropathy/neuritis.
Ear and labyrinth disorders: Hearing impaired/hearing loss (including sensorineural). Tinnitus.
Gastrointestinal disorders: Reversible cases of pancreatitis. Epigastric pain. Oral mucositis. Taste disorders. Anorexia. Tongue discoloration/furry tongue (e.g., due to fungal overgrowth).
Hepatobiliary disorders: Increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and hepatocellular liver injury, sometimes with jaundice, have been reported. Cases of liver failure requiring liver transplant have been reported in patients treated with metronidazole in combination with other antibiotic drugs.
Skin and subcutaneous tissue disorders: Pustular eruptions, acute generalized exanthematous pustulosis. Rash, pruritus, flushing, urticaria. Fixed drug eruption, Stevens-Johnson syndrome, toxic epidermal necrolysis.
General disorders and administration site conditions: Fever.
Applies only to nystatin: Immune system disorders: Local irritation or sensitizations have occasionally been reported after local application (see Warnings).
Hypersensitivity may occur.
Skin and subcutaneous tissue disorders: Very rarely skin reactions may occur, particularly Steven-Johnson syndrome, have been reported.
Not known: Acute generalized exanthematous pustulosis (see Warnings).
Applies to Metronidazole + Nystatin (Flagystatin): Reproductive system disorders: Vaginal burning sensation.
Gastrointestinal disorders: Nausea, vomiting. diarrhea.
Applies only to metronidazole (usually observed after oral or I.V. administration, cannot be excluded for other formulations): Blood and lymphatic system disorders: Cases of agranulocytosis, neutropenia and thrombocytopenia have been reported.
Immune system disorders: Anaphylactic shock, angioedema.
Psychiatric disorders: Psychotic disorders including confusion, hallucinations. Depressed mood.
Nervous system disorders: Reports of encephalopathy (e.g., confusion) and subacute cerebellar syndrome (e.g., ataxia, dysarthria, gait impairment, nystagmus, and tremor), which may resolve with discontinuation of the drug.
Peripheral sensory neuropathy. Headache. Convulsions. Dizziness. Aseptic meningitis.
Eye disorders: Transient vision disorders such as diplopia, myopia, blurred vision, visual acuity reduced, changes in color vision. Optic neuropathy/neuritis.
Ear and labyrinth disorders: Hearing impaired/hearing loss (including sensorineural). Tinnitus.
Gastrointestinal disorders: Reversible cases of pancreatitis. Epigastric pain. Oral mucositis. Taste disorders. Anorexia. Tongue discoloration/furry tongue (e.g., due to fungal overgrowth).
Hepatobiliary disorders: Increase in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and hepatocellular liver injury, sometimes with jaundice, have been reported. Cases of liver failure requiring liver transplant have been reported in patients treated with metronidazole in combination with other antibiotic drugs.
Skin and subcutaneous tissue disorders: Pustular eruptions, acute generalized exanthematous pustulosis. Rash, pruritus, flushing, urticaria. Fixed drug eruption, Stevens-Johnson syndrome, toxic epidermal necrolysis.
General disorders and administration site conditions: Fever.
Applies only to nystatin: Immune system disorders: Local irritation or sensitizations have occasionally been reported after local application (see Warnings).
Hypersensitivity may occur.
Skin and subcutaneous tissue disorders: Very rarely skin reactions may occur, particularly Steven-Johnson syndrome, have been reported.
Not known: Acute generalized exanthematous pustulosis (see Warnings).
Storage
Store at temperatures not exceeding 25°C.
Action
A combination of two effective drugs which provide a valuable and comprehensive means of treating many types of vaginitis, whether of single or multiple etiology.
Metronidazole (Flagyl) is a potent trichomonacide. It is also active against other protozoa and anaerobic bacteria (G. vaginalis).
Nystatin is a fungistatic and fungicidal antibiotic which is active topically against Candida albicans.
Pharmacology: Toxicology: Genotoxicity: Applies only to metronidazole: Metronidazole has been shown to be mutagenic in bacteria in vitro. In studies conducted in mammalian cells in vitro as well as in rodent or humans in vivo, there was inadequate evidence of a mutagenic effect of metronidazole, with some studies reporting mutagenic effects, while other studies were negative.
Therefore, the use of Metronidazole + Nystatin (Flagystatin) for prolonged treatment duration should be carefully weighed (see Precautions).
Carcinogenicity: Applies only to metronidazole: Metronidazole has been shown to be carcinogenic in the mouse and in the rat. However similar studies in the hamster have given negative results and epidemiological studies in humans have provided no evidence of an increased carcinogenic risk in humans.
Therefore, the use of Metronidazole + Nystatin (Flagystatin) for prolonged treatment duration should be carefully weighed (see Precautions).
Metronidazole (Flagyl) is a potent trichomonacide. It is also active against other protozoa and anaerobic bacteria (G. vaginalis).
Nystatin is a fungistatic and fungicidal antibiotic which is active topically against Candida albicans.
Pharmacology: Toxicology: Genotoxicity: Applies only to metronidazole: Metronidazole has been shown to be mutagenic in bacteria in vitro. In studies conducted in mammalian cells in vitro as well as in rodent or humans in vivo, there was inadequate evidence of a mutagenic effect of metronidazole, with some studies reporting mutagenic effects, while other studies were negative.
Therefore, the use of Metronidazole + Nystatin (Flagystatin) for prolonged treatment duration should be carefully weighed (see Precautions).
Carcinogenicity: Applies only to metronidazole: Metronidazole has been shown to be carcinogenic in the mouse and in the rat. However similar studies in the hamster have given negative results and epidemiological studies in humans have provided no evidence of an increased carcinogenic risk in humans.
Therefore, the use of Metronidazole + Nystatin (Flagystatin) for prolonged treatment duration should be carefully weighed (see Precautions).
MedsGo Class
Preparations for Vaginal Conditions
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