FLAGYSTATIN VAGINAL OVULE

Metronidazole
Nystatin

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

1-(2-hydroxy-1-ethyl)-2-methyl-5-nitroimidazole | 1-(2-hydroxyethyl)-2-methyl-5-nitroimidazole | 1-(beta-Ethylol)-2-methyl-5-nitro-3-azapyrrole | 1-(beta-Hydroxyethyl)-2-methyl-5-nitroimidazole | 1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole | 1-(β-ethylol)-2-methyl-5-nitro-3-azapyrrole | 1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole | 1-(β-oxyethyl)-2-methyl-5-nitroimidazole | 2-methyl-1-(2-hydroxyethyl)-5-nitroimidazole | 2-methyl-3-(2-hydroxyethyl)-4-nitroimidazole | 2-methyl-5-nitroimidazole-1-ethanol | Metronidazol | Metronidazolum | Metronidazole |

Description

A nitroimidazole used to treat amebiasis; vaginitis; trichomonas infections; giardiasis; anaerobic bacteria; and treponemal infections. It has also been proposed as a radiation sensitizer for hypoxic cells. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985, p133), this substance may reasonably be anticipated to be a carcinogen (Merck, 11th ed).

Indication

For the treatment of anaerobic infections and mixed infections, surgical prophylaxis requiring anaerobic coverage, Clostridium difficile-associated diarrhea and colitis, Helicobacter pylori infection and duodenal ulcer disease, bacterial vaginosis, Giardia lamblia gastro-enteritis, amebiasis caused by Entamoeba histolytica, acne rosacea (topical treatment), and Trichomonas infections.

Mechanism of Action

Metronidazole is a prodrug. Unionized metronidazole is selective for anaerobic bacteria due to their ability to intracellularly reduce metronidazole to its active form. This reduced metronidazole then covalently binds to DNA, disrupt its helical structure, inhibiting bacterial nucleic acid synthesis and resulting in bacterial cell death.

Pharmacodynamics

Metronidazole, a synthetic antibacterial and antiprotozoal agent of the nitroimidazole class, is used against protozoa such as Trichomonas vaginalis, amebiasis, and giardiasis. Metronidazole is extremely effective against anaerobic bacterial infections and is also used to treat Crohn's disease, antibiotic-associated diarrhea, and rosacea.

Pharmacokinetics

Absorption:

Well absorbed (at least 80%) with peak plasma concentrations achieved in 1-3 hours following oral administration of therapeutic doses of immediate release formulation.

Distribution:

Not Available

Metabolism:

Hepatic metabolism by hydroxylation, oxidation, and glucuronidation.

Elimination:

Not Available

Half-life

6-8 hours

Clearance

Not Available

Toxicity

LD50=500 mg/kg/day (orally in rat). Adverse effects include reversible peripheral neuropathy with prolonged therapy, CNS toxicity, disulfiram effect with alcohol, dark red-brown urine, metallic taste, nausea, epigastric distress, dizziness, vertigo and paresthesias associated with high doses, and neutropenia (reversible and mild).

Source of information: Drugbank (External Link). Last updated on: 3rd July 18
*Trade Name used in the content below may not be the same as the HSA-registered product.

Active Ingredient / Synonyms

Nistatina | NYS | Nystatin | Nystatine | Nystatinum | Nystatin |

Description

Nystatin is a polyene antifungal drug to which many molds and yeasts are sensitive, including Candida spp. Nystatin has some toxicity associated with it when given intravenously, but it is not absorbed across intact skin or mucous membranes. It is considered a relatively safe drug for treating oral or gastrointestinal fungal infections.

Indication

For treatment of cutaneous or mucocutaneous mycotic infections caused by Candida species

Mechanism of Action

Nystatin exerts its antifungal activity by binding to ergosterol found in fungal cell membranes. Binding to ergosterol causes the formation of pores in the membrane. Potassium and other cellular constituents leak from the pores causing cell death.

Pharmacodynamics

Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes. Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Pharmacokinetics

Absorption:

Nystatin is not absorbed from intact skin or mucous membrane.

Distribution:

Not Available

Metabolism:

Not Available

Elimination:

Not Available

Half-life

Not Available

Clearance

Not Available

Toxicity

Not Available

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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Approval Information

FLAGYSTATIN VAGINAL OVULE was registered with Health Science Authority of Singapore by SANOFI-AVENTIS SINGAPORE PTE LTD. It is marketed with the registration number of SIN03798P with effective from 1990-01-02.

This product contains 500mg of Metronidazole, and 100000 iu of Nystatin in the form of SUPPOSITORY.

The medicine was manufactured by P.T. Aventis Pharma in INDONESIA

It is a Presciption Only Medicine which can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Anatomical Therapeutic Chemical (ATC) Classification

Products Containing as Single Ingredient

Drug ID Trade Name Active Ingredients Forensic Class Registrant Status
1 DEXTROMETHORPHAN LINCTUS 15mg/5ml Dextromethorphan P Only DRUG HOUSES OF AUSTRALIA PTE LTD Active
22 ZENMOLIN SYRUP 2mg/5ml Salbutamol P Only DRUG HOUSES OF AUSTRALIA PTE LTD Active
41 APO-PROPRANOLOL TABLET 40mg Propranolol POM PHARMAFORTE SINGAPORE PTE LTD Active
42 APO-DIAZEPAM TABLET 2mg Diazepam POM PHARMAFORTE SINGAPORE PTE LTD Active
44 APO-DIAZEPAM TABLET 5mg Diazepam POM PHARMAFORTE SINGAPORE PTE LTD Active
45 APO-DIAZEPAM TABLET 10mg Diazepam POM PHARMAFORTE SINGAPORE PTE LTD Active
46 APO-PROPRANOLOL TABLET 10mg Propranolol POM PHARMAFORTE SINGAPORE PTE LTD Active
55 APO-ISDN TABLET 10mg Isosorbide Dinitrate POM PHARMAFORTE SINGAPORE PTE LTD Active
63 DIAPO TABLET 10mg Diazepam POM BEACONS PHARMACEUTICALS PTE LTD Active
64 FURMIDE TABLET 40mg Furosemide POM BEACONS PHARMACEUTICALS PTE LTD Active

Products Containing as Mixture Ingredient

Drug ID Trade Name Active Ingredients Forensic Class Registrant Status
5 DIPHENHYDRAMINE EXPECTORANT PAED. Ammonium Chloride|Diphenhydramine|Sodium Citrate P Only DRUG HOUSES OF AUSTRALIA PTE LTD Active
400 FAKTU SUPPOSITORY Cinchocaine|Policresulen P Only TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE LTD Active
407 TRIMAXAZOLE TABLET Sulfamethoxazole|Trimethoprim POM BEACONS PHARMACEUTICALS PTE LTD Active
435 APO-SULFATRIM TABLET Sulfamethoxazole|Trimethoprim POM PHARMAFORTE SINGAPORE PTE LTD Active
508 APO-SULFATRIM PEDIATRIC TABLET Sulfamethoxazole|Trimethoprim POM PHARMAFORTE SINGAPORE PTE LTD Active
526 B.S. SUSPENSION Sulfamethoxazole|Trimethoprim POM APEX PHARMA MARKETING PTE LTD Active
583 CO-TRIMEXAZOLE SUSPENSION Sulfamethoxazole|Trimethoprim POM BEACONS PHARMACEUTICALS PTE LTD Active
676 BANEOCIN OINTMENT Bacitracin|Neomycin POM NOVARTIS (SINGAPORE) PTE LTD Active
678 BANEOCIN POWDER Bacitracin|Neomycin POM NOVARTIS (SINGAPORE) PTE LTD Active
706 TIENAM 500 FOR INJECTION Imipenem|Cilastatin POM MSD PHARMA (SINGAPORE) PTE LTD Active