Oravig Miconazole 50 mg Tablet, 14-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Azole Antifungal class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Buccal miconazole is used to treat yeast infections of the mouth and throat in adults and children 16 years of age and older. Miconazole buccal is in a class of medications called imidazoles. It works by stopping the growth of fungi that cause infection.
Read the full MedlinePlus article ↗- For a 7-night vaginal cream, you insert one full applicator into your vagina at bedtime for 7 nights in a row. If you have itching or irritation on the outside, squeeze a small amo...
- I bought a miconazole cream for a vaginal yeast infection — how do I use it correctly?
- Yes — topical miconazole creams and powders are specifically made for those conditions. For athlete's foot and ringworm, you'd apply it to clean, dry skin twice a day for 4 weeks....
- Can I use miconazole cream on my skin for athlete's foot or jock itch?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Miconazole — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 48268V50D5
Casein is a milk-derived protein used as a binder and filler in tablets and capsules. It helps hold the medication together and adds bulk to make the dose easier to handle and swallow.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
-
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
-
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
-
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $86.25 | $1,207.43 / 14 tablets |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Oravig 50 mgthis 61825-0303-14 | Galt | 14 tablets | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
🗺️ Medicaid utilization & spend
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 61825-0303-14 You're viewing this | 14 TABLET in 1 BOTTLE (61825-303-14) | 2021-12-31 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE ORAVIG is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults. ORAVIG is an azole antifungal indicated for the local treatment of oropharyngeal candidiasis in adults.
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION Application of one ORAVIG 50 mg buccal tablet to the gum region once daily for 14 consecutive days (2.1) . Instruct patients not to crush, chew, or swallow tablets (2.2) .
2.1Basic Dosing Information The recommended dosing schedule for ORAVIG is the application of one 50 mg buccal tablet to the upper gum region (canine fossa) once daily for 14 consecutive days.
2.2Administration Instructions ORAVIG should be applied in the morning, after brushing the teeth. The tablet should be applied with dry hands. The rounded side surface of the tablet should be placed against the upper gum just above the incisor tooth (canine fossa) and held in place with slight pressure over the upper lip for 30 seconds to ensure adhesion.
The tablet is round on one side for comfort, but either side of the tablet can be applied to the gum. Once applied, ORAVIG stays in position and gradually dissolves. [ See Clinical Pharmacology (12.3) ] Subsequent applications of ORAVIG should be made to alternate sides of the mouth. Before applying the next tablet, the patient should clear away any remaining tablet material.
In addition, ORAVIG should not be crushed, chewed or swallowed. Food and drink can be taken normally when ORAVIG is in place but chewing gum should be avoided. If ORAVIG does not adhere or falls off within the first 6 hours, the same tablet should be repositioned immediately.
If the tablet still 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. [ see Patient Counseling Information (17) ].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS ORAVIG is a buccal tablet containing 50 mg of miconazole. ORAVIG tablets are round, off-white tablets, with a rounded side and a flat side. The tablets are marked with an “L” on the flat side. 50 mg buccal tablets
⛔ Contraindications ▾
4 CONTRAINDICATIONS ORAVIG is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to miconazole, milk protein concentrate, or any other component of the product. Known hypersensitivity to miconazole, milk protein concentrate, or any other component of the product.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Anaphylactic reactions have been reported in patients receiving miconazole. Discontinue ORAVIG immediately at the first sign of hypersensitivity (5.1).
5.1Hypersensitivity Allergic reactions, including anaphylactic reactions and hypersensitivity, have been reported with the administration of miconazole products, including ORAVIG. Discontinue ORAVIG immediately at the first sign of hypersensitivity. There is no information regarding cross-hypersensitivity between miconazole and other azole antifungal agents. Monitor patients with a history of hypersensitivity to azoles.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse drug reactions are discussed in detail in other sections of labeling: Hypersensitivity reactions [see Warnings and Precautions (5.1)] Most common adverse reactions (≥2%) are: diarrhea, headache, nausea, dysgeusia, upper abdominal pain, and vomiting (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Galt Pharmaceuticals, LLC Marietta, GA 30067 at 1-833-757-0904 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The overall safety of ORAVIG was assessed in 480 adult subjects: 315 HIV-infected subjects, 147 subjects with head and neck cancer, and 18 healthy subjects. HIV Infected Patients Two trials were conducted in immunocompromised HIV-infected patients: one randomized, double-blind, double-dummy, active-controlled design (N = 290 ORAVIG, 287 control) and one non-comparative trial (N = 25).
In the randomized, double blind trial (Study 1), 290 HIV infected subjects used ORAVIG once daily for 14 days, and 287 subjects used 10 mg clotrimazole troches five times daily for 14 days. Adverse reactions occurring in ≥ 2% of patients in either treatment are presented in Table 1. Table 1 Adverse Reactions (Treatment-Emergent) Occurring in ≥ 2% of HIV-Infected Patients in the Controlled Clinical Trial Adverse Reaction (MedDRA v
9.1System Organ Class and Preferred Term) ORAVIG N = 290 (%) Clotrimazole troches N = 287 (%) Patients with any adverse reaction during the study 158 (54.5) 146 (50.9) Gastrointestinal disorders Diarrhea Nausea Vomiting Dry mouth Abdominal pain upper 25.9 9.0 6.6 3.8 2.8 1.7 23.7 8.0 7.7 3.1 1.7
2.8Infections and infestations Upper respiratory infection Gastroenteritis 15.9 2.1 1.4 17.1 2.4
2.8Nervous system disorders Headache Ageusia 13.1 7.6 2.4 8.4 6.6
0.3Blood and lymphatic disorders Anemia Lymphopenia Neutropenia 6.9 2.8 1.7 0.7 8.4 1.7 2.1
2.1General disorders and administration site conditions Fatigue Pain 6.6 2.8 1.0 8.0 2.1
2.8Respiratory/thoracic Cough Pharyngeal pain 5.2 2.8 0.7 7.7 1.7
2.4Investigations Increased GGT 5.5 1.0 6.3
2.8Overall local adverse reactions, including oral discomfort, oral burning, oral pain, gingival pain, gingival swelling, gingival pruritis, tongue ulceration, mouth ulceration, glossodynia, dry mouth, application site pain or discomfort, toothache, loss of taste, and altered taste, were reported by 35 (12.1%) patients who received miconazole buccal tablet compared to 27 (9.4%) patients who received clotrimazole troches. Head and Neck Cancer Patients In the randomized, open-label comparative trial of oropharyngeal candidiasis in patients with head and neck cancer who had received radiation therapy (Study 2), 147 patients used ORAVIG once daily for 14 days and 147 patients used 125 mg of miconazole oral gel four times daily for 14 days.
Adverse reactions occurring in ≥2% of patients in either arm are listed in Table 2. Table 2: Adverse Reactions (Treatment-Emergent) Occurring in ≥ 2% of Patients with Head and Neck Cancer who had Received Radiation Therapy (Controlled Clinical Trial) Adverse Reaction (MedDRA v
9.1System Organ Class and Preferred Term) ORAVIG N = 147 (%) Miconazole gel N = 147 (%) Patients with at least one adverse reaction 30 (20.4) 32 (21.8) Gastrointestinal disorders Abdominal pain, upper Oral discomfort Nausea Vomiting Glossodynia 8.8 1.4 2.7 0.7 0.7 0 13.6 2.0 2.7 2.7 2.0
2.0Nervous system disorders Dysgeusia 5.4 4.1 1.4 0 Skin and subcutaneous Pruritus 3.4 2.0 0.7
0.7Overall local adverse reactions, including oral discomfort, oral pain, dry mouth, glossodynia, loss of taste, altered taste, tongue ulceration, mouth ulceration, tooth disorder, and application site discomfort or pain, were experienced b…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Warfarin: Miconazole may enhance anticoagulant effect. Monitor prothrombin time, INR, and watch for bleeding (7.1).
7.1Warfarin Concomitant administration of miconazole and warfarin has resulted in enhancement of anticoagulant effect. Cases of bleeding and bruising following the concomitant use of warfarin and topical, intravaginal, or oral miconazole were reported. Closely monitor prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests if ORAVIG is administered concomitantly with warfarin. Also monitor for evidence of bleeding.
7.2Drugs Metabolized Through CYP 2C9 and 3A4 No formal drug interaction studies have been performed with ORAVIG. Miconazole is a known inhibitor of CYP2C9 and CYP3A4. Although the systemic absorption of miconazole following ORAVIG administration is minimal and plasma concentrations of miconazole are substantially lower than when given intravenously, the potential for interaction with drugs metabolized through CYP2C9 and CYP3A4 such as oral hypoglycemics, phenytoin, or ergot alkaloids cannot be ruled out.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm (8.1). Pediatric Use: Safety and efficacy not established in patients less than 16 years of age (8.4). See 12 for PATIENT COUNSELING INFORMATION and FDA-Approved Patient Labeling
8.1Pregnancy Risk Summary Based on findings from animal data, ORAVIG may cause fetal harm when administered to pregnant women. There are no available data on ORAVIG use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, prolonged gestation, dystocia and/or increased number of resorptions were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits.
(See Data). Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data: Miconazole nitrate administered orally at doses of 80 mg/kg/day or higher to pregnant rats 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. Teratogenicity was not reported in any animal study with miconazole.
8.2Lactation Risk Summary There is no available information on the presence of miconazole in human milk, or the effects on the breastfed child, or the effects on milk production following use of ORAVIG. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ORAVIG and any potential adverse effects on the breastfed infant from ORAVIG or from the underlying maternal condition.
8.4Pediatric 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 application instructions has not been evaluated. Use in younger children is not recommended due to potential risk of choking.
8.5Geriatric Use Clinical studies of ORAVIG did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
8.6Hepatic Impairment Miconazole is metabolized by the liver. While miconazole systemic exposure is minimal following the application of ORAVIG, ORAVIG should be administered with caution in patients with hepatic impairment.
8.7Renal Impairment Less than 1% of miconazole is excreted as unchanged drug in the urine; therefore, no adjustment to therapy is necessary in patients with renal impairment.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on findings from animal data, ORAVIG may cause fetal harm when administered to pregnant women. There are no available data on ORAVIG use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, prolonged gestation, dystocia and/or increased number of resorptions were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits.
(See Data). Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data: Miconazole nitrate administered orally at doses of 80 mg/kg/day or higher to pregnant rats 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. Teratogenicity was not reported in any animal study with miconazole.
🧒 Pediatric Use ▾
8.4Pediatric 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 application instructions has not been evaluated. Use in younger children is not recommended due to potential risk of choking.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of ORAVIG did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
🆘 Overdosage ▾
10 OVERDOSAGE Overdose with miconazole in humans has not been reported in the literature. Miconazole absorption and systemic exposure following application of ORAVIG are minimal [see Clinical Pharmacology (12.3)]. Symptomatic and supportive care is the basis for management.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Miconazole is an antifungal drug [see Microbiology (12.4)].
12.3Pharmacokinetics Absorption and Distribution Salivary Single dose application of ORAVIG containing 50 mg of miconazole to the buccal mucosa of 18 healthy volunteers provided mean maximum salivary concentrations of 15 mcg/mL at 7 hours after application of the tablet. This provided an average saliva exposure to miconazole estimated from the AUC (0-24h) of 55.23 mcg·h/mL. The pharmacokinetic parameters of miconazole in the saliva of healthy volunteers are provided in Table 4.
Table 4: Pharmacokinetic (PK) Parameters of Miconazole in Saliva Following Application of a Single ORAVIG 50 mg Tablet in Healthy Volunteers (N = 18) Salivary PK Parameters (N = 18) Mean ± SD (Min - Max) AUC 0-24h (mcg-h/mL) 55.2 ±35.1 (0.5 – 128.3) C max (mcg/mL) 15.1 ±16.2 (0.5 – 64.8) T max (hour) 7* (2.0 – 24.1) *Median In healthy volunteers, the duration of buccal adhesion was on average 15 hours following a single dose application of ORAVIG 50 mg. Plasma Plasma concentrations of miconazole were below the lower limit of quantification (0.4 mcg/mL) in 157/162 (97%) samples from healthy volunteers following single-dose application of ORAVIG 50 mg.
Measurable plasma concentrations ranged from 0.5 to 0.83 mcg/mL. Plasma concentrations of miconazole evaluated after 7 days of treatment in 40 HIV-positive patients were all below the limit of quantification (0.1 mcg/mL). Metabolism and Excretion Most of the absorbed miconazole is metabolized by the liver with less than 1% of the administered dose found unchanged in urine.
In healthy volunteers, the terminal half-life is 24 hours following systemic administration. There are no active metabolites of miconazole. Food Effect There was no formal food effect study conducted with ORAVIG; however, in clinical studies patients were allowed to eat and drink while taking ORAVIG.
12.4Microbiology Mechanism of Action Miconazole inhibits the enzyme cytochrome P450 14α-demethylase which leads to inhibition of ergosterol synthesis, an essential component of the fungal cell membrane. Miconazole also affects the synthesis of triglycerides and fatty acids and inhibits oxidative and peroxidative enzymes, increasing the amount of reactive oxygen species within the cell. Antimicrobial Activity Miconazole is active against Candida albicans, C. parapsilosis and C. tropicalis.
Correlation between minimum inhibitory concentration (MIC) results in vitro and clinical outcome has yet to be established. Resistance In vitro studies have shown that some Candida strains that demonstrate reduced susceptibility to one antifungal azole may also exhibit reduced susceptibility to other azoles suggesting cross-resistance. Clinically relevant resistance to systemically utilized triazoles may occur in Candida species.
Resistance may occur by multiple mechanisms such as changes in amino acids and/or in the regulation of the target enzyme and of a variety of efflux pump proteins. Multiple mechanisms may co‑exist in the same isolate. Resistance breakpoints, correlating in vitro activity with clinical efficacy, have not been established for miconazole.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Miconazole is an antifungal drug [see Microbiology (12.4)].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING ORAVIG 50 mg buccal tablets are supplied as off-white tablets containing 50 mg of miconazole. ORAVIG tablets have a rounded side and a flat side. ORAVIG tablets are packaged in bottles of 14 tablets (NDC 61825-303-14).
ORAVIG should be stored at 20 to 25 o C (68 to 77 o F) [see USP controlled room temperature]; excursions between 15 and 30 o C permitted at room temperature. Protect from moisture, and keep out of reach of children.
📋 Description ▾
11 DESCRIPTION ORAVIG (miconazole) buccal tablets are applied topically to the gum once daily and release miconazole as the buccal tablet gradually dissolves [see Clinical Pharmacology (12.3)] . Miconazole is an imidazole antifungal agent and is described chemically as 1-[(2RS)-2-[(2,4-dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole with an empirical formula of C 18 H 14 Cl 4 N 2 O and a molecular weight of 416.13. The structural formula is shown in Figure 1.
Figure 1: Structural Formula of Miconazole Miconazole drug substance is a white to almost white powder. ORAVIG contains 50 mg of miconazole base, USP and the following inactive ingredients: hypromellose, USP; milk protein concentrate; corn starch, NF; lactose monohydrate, NF; sodium lauryl sulfate, NF; magnesium stearate, NF; and talc, USP. oravig 01
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Important Administration Instructions 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 tablet including: • 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 ORAVIG and contact a healthcare provider.
Patients may experience other adverse reactions including diarrhea, headache, nausea, and change in taste. Potential Embryo-fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].
Manufactured By: Catalent Germany Schorndorf GmbH Steinbeisstraße 1-2 73614 Schorndorf Germany Distributed by: Galt Pharmaceuticals, LLC 1090 Northchase Pkwy., Suite 140 Marietta, GA 30067 Address medical inquires to: Galt Pharmaceuticals, LLC 1-833-757-0904 US patent numbers: 6,916,485; 7,651,698; 8,518,442. ©2021 Galt Pharmaceuticals, LLC INSTRUCTIONS FOR USE Oravig (OR-a-vig) (miconazole) buccal tablets Read this Instructions for Use before you start using ORAVIG and each time you get a refill. There may be new information.
This information does not take the place of talking to your doctor about your medical condition or treatment. Talk to your doctor or pharmacist if you have any questions about how to use ORAVIG. How should I store ORAVIG? • Store ORAVIG at room temperature between 68°F to 77oF (20°C to 25oC). • Keep ORAVIG dry.
Keep ORAVIG and all medicines out of the reach of children. How to use ORAVIG? Before applying the ORAVIG tablet Step 1.
Locate the area on the upper gum, just above the left or the right incisor tooth. The incisor tooth is the tooth just to the right or left of your two front teeth (See Figure A). Step 2.
With dry hands, take 1 ORAVIG tablet out of the bottle. ORAVIG is round on one side and flat on the other side (See Figure B). The tablet is marked with an “L” on the flat side.
Applying the ORAVIG tablet Step 3. Place the flat side of the ORAVIG tablet on your dry fingertip. Gently push the round side of the tablet against your upper gum in the area shown in Figure C.
Push the ORAVIG tablet up as high as it will go on your gum. The flat side will be facing the inside of your lip. Step 4.
Hold the ORAVIG tablet in place…