Oravig

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity

Allergic reactions, including anaphylactic reactions and hypersensitivity, have been reported with the administration of miconazole products, including ORAVIG. DiscontinueORAVIG immediately at the first sign of hypersensitivity.

There is no information regarding cross-hypersensitivity between miconazole and otherazole antifungal agents. Monitor patients with a history of hypersensitivity to azoles.

Patient Counseling Information

See FDA-approved patient labeling.

Instructions for Use

The tablet should be used immediately after removal from the bottle.

  • Instruct patients not to crush, chew, or swallow the tablet.
  • The rounded side of the tablet should be applied to the upper gum above the incisor tooth in the morning, after brushing the teeth.
  • The tablet should be held in place for 30 seconds with a slight pressure of the finger over the upper lip to make the tablet stick to the gum.
  • The tablet may be used if it sticks to the cheek, inside of the lip or the gum.
  • If the tablet does not adhere, it should be repositioned.
  • As the ORAVIG tablet absorbs moisture from the mouth, it will slowly dissolve over time and should be left in place – there is no need to remove the tablet.
  • Subsequent applications of ORAVIG should be made to alternate sides of the gum.
  • If ORAVIG does not stick or falls off within the first 6 hours, the same tablet should be repositioned immediately. If the tablet does not adhere, a new tablet should be placed.
  • If ORAVIG is swallowed within the first 6 hours, the patient should drink a glass of water and a new tablet should be applied only once.
  • If ORAVIG falls off or is swallowed after it was in place for 6 hours or more, a new tablet should not be applied until the next regularly scheduled dose.

Patients should avoid situations that could interfere with the sticking of the tabletincluding:

  • touching or pressing the tablet after placement
  • wearing upper denture
  • chewing gum
  • hitting tablet when brushing teeth
  • rinsing mouth too vigorously

Hypersensitivity and Other Adverse Reactions

Patients who develop hives, skin rash, or other symptoms of an allergic reaction, and patients who develop swelling or pain, at the tablet application site should stop ORAVIGand contact a healthcare provider. Patients may experience other adverse reactionsincluding diarrhea, headache, nausea, and change in taste.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies with miconazole have not been conducted.

Miconazole nitrate was not genotoxic when tested in vitroin a bacterial reverse mutation (Ames) assay or in an in vivo mouse bone marrow micronucleus test. Intraperitoneal injections of miconazole to mice induced chromosomal aberrations in spermatocytes andbone marrow cells, and morphologic abnormalities in sperm at doses similar to or belowclinical doses. However, no impairment of fertility was observed in intravenous studieswith miconazole at 40 mg/kg/day in rats or 20 mg/kg/day in rabbits, which are approximately 8 times higher than the dose a patient would receive if she swallowed an ORAVIGbuccal tablet, based on body surface area comparisons.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled clinical trials of ORAVIG in pregnant women.ORAVIG should not be used during pregnancy unless the potential benefit to the motheroutweighs the potential risk to the fetus.

Miconazole nitrate administered orally at doses of 80 mg/kg/day or higher to pregnantrats or rabbits crossed the placenta and resulted in embryo- and fetotoxicity, including increased fetal resorptions. These doses also resulted in prolonged gestation and dystocia in rats, but not in rabbits. Embryofetotoxicity was not observed in intravenous studies with miconazole at lower doses of 40 mg/kg/day in rats and 20 mg/kg/day in rabbits,which are approximately 8 times higher than the dose a patient would receive if she swallowed an ORAVIG buccal tablet, based on body surface area comparisons. Teratogenicitywas not reported in any animal study with miconazole.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs areexcreted in human milk, caution should be exercised when ORAVIG is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of ORAVIG in pediatric patients below the age of 16 years have not been established. The ability of pediatric patients to comply with the applicationinstructions has not been evaluated. Use in younger children is not recommended due topotential risk of choking

Geriatric Use

Clinical studies of ORAVIG did not include sufficient numbers of subjects aged 65 andover to determine whether they respond differently from younger subjects.

Hepatic Impairment

Miconazole is metabolized by the liver. While miconazole systemic exposure is minimal following the application of ORAVIG, ORAVIG should be administered with caution inpatients with hepatic impairment.

Renal Impairment

Less than 1% of miconazole is excreted as unchanged drug in the urine; therefore, noadjustment to therapy is necessary in patients with renal impairment.

Last reviewed on RxList: 3/25/2013
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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