ORAVIG- miconazole tablet

Oravig by

Drug Labeling and Warnings

Oravig by is a Prescription medication manufactured, distributed, or labeled by Galt Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS & USAGE

    ORAVIG is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults.

  • 2 DOSAGE & ADMINISTRATION

    2.1 Basic 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.

    2.2 Administration 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)].


  • 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. 

  • 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.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Hypersensitivity

    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.

  • 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)]

    6.1 Clinical 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 9.1 System 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
    2.8
    Infections and infestations
        Upper respiratory infection
        Gastroenteritis
    		15.9
    2.1
    1.4
    		17.1
    2.4
    2.8
    Nervous system disorders
        Headache
        Ageusia
    		13.1
    7.6
    2.4
    		8.4
    6.6
    0.3
    Blood and lymphatic disorders
        Anemia
        Lymphopenia
        Neutropenia
    		6.9
    2.8
    1.7
    0.7
    		8.4
    1.7
    2.1
    2.1
    General disorders and administration site conditions
        Fatigue
        Pain
    		6.6
     
    2.8
    1.0
    		8.0
     
    2.1
    2.8
    Respiratory/thoracic
        Cough
        Pharyngeal pain
    		5.2
    2.8
    0.7
    		7.7
    1.7
    2.4
    Investigations
        Increased GGT
    		5.5
    1.0
    		6.3
    2.8

    Overall 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 9.1 System 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
    2.0
    Nervous system disorders
          Dysgeusia
    		5.4
    4.1
    		1.4
    0
    Skin and subcutaneous
          Pruritus
    		3.4
    2.0
    		0.7
    0.7

    Overall 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 by 14 (9.5%) patients who used ORAVIG compared to 16 (10.9%) patients who used miconazole gel. 


    Overall ORAVIG Safety Experience In Patients and Healthy Subjects
    Adverse reactions reported in the overall safety database of 480 subjects who received miconazole buccal tablet is listed in Table 3.

    Table 3 Adverse Reactions Reported in ≥ 2% of Patients and Healthy Subjects who Received ORAVIG in Clinical Trials

    Adverse reaction
    (MedDRA v 9.1 System Organ Class and Preferred Term)
    		ORAVIG
    N = 480 (%)
    Patients with at least one AE
    		209 (43.5)
    Gastrointestinal disorders
         Diarrhea
         Nausea
         Abdominal pain upper
         Vomiting
    		20.6
    6.0
    4.6
    2.5
    2.5
    Infections and infestations
    		11.9
    Nervous system disorders
         Headache
         Dysgeusia
    		10.6
    5.0
    2.9

    Discontinuation of ORAVIG due to adverse drug reactions occurred in 0.6% overall.

  • 7 DRUG INTERACTIONS

    7.1 Warfarin

    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.

    7.2 Drugs 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.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    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.  

    8.2 Lactation

    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.

    8.4 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 application instructions has not been evaluated. Use in younger children is not recommended due to potential risk of choking.

    8.5 Geriatric 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. 

    8.6 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 in patients with hepatic impairment.

    8.7 Renal 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.

  • 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.

  • 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 18H 14Cl 4N 2O and a molecular weight of 416.13. The structural formula is shown in Figure 1.

    Figure 1:        Structural Formula of Miconazole
    oravig 01
    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.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Miconazole is an antifungal drug [see Microbiology (12.4)].

    12.3 Pharmacokinetics

    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.

    12.4 Microbiology

    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 Candidaalbicans,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.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility


    Carcinogenicity studies with miconazole have not been conducted.
    Miconazole nitrate was not genotoxic when tested in vitro in 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 and bone marrow cells, and morphologic abnormalities in sperm at doses similar to or below clinical doses.  However, no impairment of fertility was observed in intravenous studies with 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 ORAVIG buccal tablet, based on body surface area comparisons.

    13.2 Animal Pharmacology & OR Toxicology

    Local tolerance studies (LLNA sensitization test and tolerance study on the jugal mucosa of hamster) did not reveal any toxicity.

  • 14 CLINICAL STUDIES

    Study in HIV Infected Patients

    The efficacy and safety of ORAVIG in the treatment of OPC was evaluated in a randomized, double-blind, double-dummy, multicenter trial comparing ORAVIG 50 mg once daily for 14 consecutive days (n = 290) with clotrimazole troches 10 mg 5 times per day for 14 days (n = 287) in HIV-positive patients with OPC. Seventy-five percent of patients were not receiving highly active antiretroviral treatment, 5% had CD4+ cell count < 50 cells/mm 3, and 17% had a history of previous OPC. The mean viral load was 117,000 copies/mL.  Patients were required to have symptoms and microbiological documentation of OPC for study entry.  Most of the infections were caused by C. albicans (85%), followed by C. tropicalis (9%), and C. parapsilosis (3%).  About 2% of the subjects were infected with more than one Candida species.

    Clinical cure [defined as a complete resolution of both signs and symptoms of OPC at the test of cure (TOC) visit (days 17-22)], and clinical relapse by days 35-38 (21-24 days after end of therapy) are presented in Table 5.  Mycological cure [defined as eradication (i.e., no yeast isolates) of Candida species] at the TOC visit (days 17-22) is also reported in the table.

    Table 5: Clinical Cure and Mycological Cure at the TOC Visit and Relapse at Days 35-38 in HIV Infected Patients

     
    		ORAVIG 
       50 mg
    N=290 a (%) 
    		Clotrimazole
        troches
    N=287 a (%) 
    Clinical cure†
    		176 (60.7%)
    		187 (65.2%)
       Clinical relapse‡
    		 
    		 
              Yes b  
    		48 (27.3%)
    		52 (27.8%)
               No 
    		124 (70.5%)
    		133 (71.1%)
               Missing
    		4 (2.3%)
    		2 (1.1%)
    Mycological cure
    		79 (27.2%)
    		71 (24.7%)

    a Analysis population includes all randomized patients who took at least 1 dose of study medication. One  randomized subject excluded from the ORAVIG arm.

    b In those subjects who relapsed, the mean time to relapse was 15.3 days (SD 4.6) and 15.7 days (SD 6.6), in the ORAVIG and Clotrimazole treatment arms, respectively.

    † Difference in clinical cure rates (ORAVIG-clotrimazole troche) was -4.5%, with a 95% CI: (-12.4%, 3.4%).

    ‡ Percentage based on those who had clinical cure.

    Study in Head and Neck Cancer Patients

    The efficacy and safety of ORAVIG 50 mg was evaluated in an open-label, randomized, multicenter trial comparing ORAVIG 50 mg once daily for 14 days to miconazole oral gel 125 mg four times daily for 14 days in head and neck cancer patients who had received radiation therapy.  Most of the infections were caused by C. albicans (71%), and  C. tropicalis (8%).  About 7% of the subjects were infected with more than one Candida species.  Success rates of treatment at day 14 [defined as a complete (complete disappearance of candidiasis lesions) or partial response (improvement by at least 2 points of the score for extent of oral lesion compared with the score at day 1) based on a blind assessment] are shown in Table 6.  Also reported in Table 6 are relapse rate at day 30, and mycologic cure assessed at day 14.  

    Table 6:  Clinical Success and Mycological Cure at Day 14, in Patients with Head and Neck Cancer who had Received Radiation Therapy

     
    		ORAVIG 
      50 mg                                              
    N=148 a (%)
    		Miconazole oral    gel 
    N=146 a (%)
    Success rate (CR+PR) b
    		79 (53.4%)
    		69 (46.6%)
    CR †
    		74 (50.0%)
    		64 (43.8%)
       Clinical relapse‡
    		 
    		 
              Yes c  
    		14 (18.9%)
    		8 (12.5%)
               No 
    		59 (79.7%)
    		56 (87.5%)
               Missing
    		1 (1.4%)
    		0
      Mycological cure
    		66 (44.6%)
    		78 (53.4%)

    a Analysis population includes all subjects who received at least one dose of study medication.  Reasons for not receiving treatment included negative mycological culture, informed consent withdrawn, or lost during screening. Six patients excluded per arm.

    bCR: complete response;  PR: partial response

    cIn those subjects who relapsed, the mean time to relapse was 18.8 days (SD 16.3) and 20.6 days (SD 13.5), in the ORAVIG and Miconazole oral gel group, respectively.

    †Difference in clinical complete response rates (ORAVIG-Miconazole oral gel) was 6.2%, with a 95% CI: (-5.2%, 17.6%).


    ‡Percentage based on those who had complete response.

  • 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 oC (68 to 77 oF) [see USP controlled room temperature]; excursions between 15 and 30 oC permitted at room temperature. Protect from moisture, and keep out of reach of children.

  • 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


    oravig-07

    oravig-08


    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).


    oravig 02


    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.


    oravig 03


    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.


    oravig 04


    Step 4. Hold the ORAVIG tablet in place by applying a slight pressure with your finger on the outside of your upper lip for 30 seconds (See Figure D). This will make the tablet stick to your gum.



    oravig 05


    Step 5. Leave the ORAVIG tablet in place until it dissolves. Do not remove the tablet.
    Step 6. Before applying your next dose, be sure to clear away any remaining ORAVIG tablet material on
                your gum.

    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

    This Instructions for Use has been approved by the U.S. Food and Drug Administration
    Approved: 06/2021   

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


    NDC: 61825-303-14

    once-daily
    ORAVIG®
    (miconazole) buccal tablets 50 mg

    50 mg

    14 Tablets

    Rx only


    oraviag06

       

  • INGREDIENTS AND APPEARANCE
    ORAVIG 
    miconazole tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 61825-303
    Route of AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE (UNII: 7NNO0D7S5M) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    CASEIN (UNII: 48268V50D5)  
    Product Characteristics
    Colorwhite (Off-White) Scoreno score
    ShapeROUND (rounded side / flat side marked with "L") Size8mm
    FlavorImprint Code L
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 61825-303-1414 in 1 BOTTLE; Type 0: Not a Combination Product12/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02240412/31/2021
    Labeler - Galt Pharmaceuticals, LLC (079214973)

    • Trademark Results [Oravig]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ORAVIG
    ORAVIG
    88094144 not registered Live/Pending
    Midatech Pharma US Inc.
    2018-08-27
    ORAVIG
    ORAVIG
    85188886 3966483 Dead/Cancelled
    DARA BIOSCIENCES, INC.
    2010-12-02
    ORAVIG
    ORAVIG
    77627417 not registered Dead/Abandoned
    Par Pharmaceutical Companies, Inc
    2008-12-05
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