Adult Dosing

Bacterial vaginosis

• 1 applicatorful (5 g) intravaginally qhs x 5 days; alternatively, 1 applicatorful (5 g) intravaginally bid x 5 days

Pediatric Dosing

• Safety and efficacy in pre-menarchal females have not been established

Bacterial vaginosis

• Post-menarchal females: 1 applicatorful (5 g) intravaginally qhs x 5 days; alternatively, 1 applicatorful (5 g) intravaginally bid x 5 days

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of bacterial vaginosis in non-pregnant women

• Hypersensitivity to any of the ingredients of the product
• History of hypersensitivity to metronidazole and other nitroimidazole derivatives
• Hypersensitivity to parabens
• Patients with disulfiram use within 2 weeks

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Severe impairment: Dose adjustments not defined, use with caution

See Supplemental Patient Information

• Metronidazole (vaginal) could be absorbed in sufficient amounts to produce systemic effects
• Use vaginal metronidazole cautiously in patients with CNS diseases, because convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, numbness, and paresthesias have occurred with the use of oral or IV metronidazole
• Avoid unnecessary use of metronidazole
• Metronidazole may interfere with laboratory parameters; values of zero may be observed
• Do not administer to patients who have taken disulfiram within the last 2 weeks
• Caution patients about the use of alcohol during therapy with vaginal gel

Cautions: Use cautiously in

• CNS disease
• Seizure disorder
• Peripheral neuropathy

Supplemental Patient Information

• Discontinue use if vaginal irritation occurs during the therapy
• Instruct patients not to consume alcohol during and for at least 3 days after treatment
• Advise patients not to use vaginal gel if they have taken disulfiram within the last 14 days
• Abstain from vaginal intercourse and use of other vaginal products during therapy
• Advise nursing mothers to discontinue breastfeeding during therapy and for 24 hours after the last dose of vaginal metronidazole
• Avoid accidental exposure to the eye as it may cause burning and irritation of the eye

Flagyl, MetroGel-Vaginal, Vandazole interacts with :

	Acenocoumarol
	Amaryl
	Avandia
	Cerebyx
	Chlorpropamide
	Coumadin
	DiaBeta
	Diabinese
	Dilantin
	Dilantin Infatabs
	Dilantin-125
	Fosphenytoin
	Glimepiride
	Glipizide
	Glucotrol
	Glucotrol XL
	Glucovance
	Glyburide
	Glynase
	Jantoven
	Nateglinide
	Orinase
	Phenytek
	Phenytoin
	Rosiglitazone
	Starlix
	Tolbutamide
	Warfarin

Pregnancy Category:B

Breastfeeding: Vaginal use of metronidazole during breastfeeding is unlikely to be of concern. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 19 February 2011). Manufacturer advises caution.

• CNS: Headache
• DERM: Pruritus, rash
• RESP: Pharyngitis
• GI: Abdominal pain, nausea, diarrhea
• GU: Dysmenorrhea, metrorrhagia, Candida vaginitis, vaginal candidiasis
• MISC: Infection, breast pain

• Antibacterial agent; enters bacterial or protozoal cell and impairs synthesis of DNA resulting in cell death
• Partially metabolized by liver; CYP450: 2C9 inhibitor
• Renally excreted (60-80 %); feces: 6-15%
• Half-life: 6-8 hrs

US Trade Name(s)

• MetroGel-Vaginal
• Vandazole

US Availability

metronidazole (generic)

• GEL: 0.75%, 1.3%

MetroGel-Vaginal

• GEL: 0.75%

Vandazole

• GEL: 0.75%

Canadian Trade Name(s)

• Nidagel
• Flagyl

Canadian Availability

Nidagel

• GEL: 0.75%

Flagyl

• CRE: 10%

UK Trade Name(s)

• Zidoval

UK Availability

Zidoval

• GEL: 0.75 %

Australian Trade Name(s)

• Zidoval

Australian Availability

Zidoval

• GEL: 0.75%

[Outline]

Antimicrobials

Vaginal Agents; Anti-infectives

Infectious Disease

Vaginal Agents; Anti-infectives

Obstetrics/Gynecology

Vaginal Agents; Anti-infectives

Pricing data from www.DrugStore.com in U.S.A.

• MetroGel-Vaginal 0.75 % GEL [Tube] (GRACEWAY PHARMACEUTICALS)
  70 % = $45.99
  140 % = $79.97
• Vandazole 0.75 % GEL [Tube] (UPSHER-SMITH)
  70 % = $46.99
  140 % = $81.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.