Miconazole (Oravig) Oral - Uses, Dose, MOA, Brands, Side effects

Miconazole is an antifungal medication commonly used to treat fungal infections. While it's more commonly known for topical applications (like treating athlete's foot or vaginal yeast infections), there are also oral forms available.

Oral miconazole is typically used to treat fungal infections in the mouth, throat, and esophagus, such as oral thrush (a fungal infection caused by Candida albicans). It works by inhibiting the growth of fungi, thereby helping to eliminate the infection.

Miconazole (Oravig) Oral tablet is used to treat mild candidal infections of the oral cavity and pharynx.

Oral Miconazole Uses:

  • for the therapeutic treatment of oropharyngeal candidiasis, this drug can be used

Oral Miconazole Dose in Adults:

Treatment of mild oropharyngeal candidiasis with an oral dose of miconazole (Oravig)

  • The recommended dose of miconazole is a 50 mg buccal tablet.
  • This tablet is placed in the upper gum area (specifically the canine fossa) once a day.
  • You'd keep it in place until it dissolves, which usually takes about 30 minutes.
  • This treatment should be done every day for 7 to 14 days.

Miconazole Dose in Children:

Refer to adults' dosing.


Pregnancy Risk Factor C

  • Miconazole, when used as a buccal tablet for oral thrush during pregnancy, falls under Pregnancy Risk Factor C, meaning adverse effects were seen in animal studies, but there's minimal absorption into the bloodstream after applying it to the upper gum area.

Use during breastfeeding:

  • For breastfeeding women, it's uncertain if miconazole passes into breast milk.
  • The manufacturer advises caution when using it while breastfeeding.
  • However, since there's minimal absorption into the bloodstream after applying the buccal tablet, the risk to the nursing baby is likely low.

Miconazole Dose in Kidney Disease:

  • No adjustment in dosage is needed for individuals with renal impairment when using miconazole.

Miconazole Dose in Liver disease:

  • The manufacturer's labeling does not specify any dosage adjustments for individuals with hepatic (liver) impairment when using miconazole.

Common Side Effects of Miconazole (Oravig):

  • Local:
    • Includes application site reaction
      • Local discomfort
      • Local pain
      • Oral mucosa ulcer
      • Localized edema
      • Toothache
      • Local pruritus
      • Localized burning
      • Glossalgia

Less Common Side Effects of Miconazole (Oravig):

  • Gastrointestinal:
    • Dysgeusia
    • Vomiting
    • Gastroenteritis
    • Sore throat
    • Oral discomfort
    • Xerostomia
    • Diarrhea
    • Nausea
    • Abdominal pain
    • Ageusia
  •  
  • Central nervous system:
    • Headache
    • Fatigue
    • Pain
  • Respiratory:
    • Cough
    • Upper respiratory tract infection
  • Endocrine & metabolic:
    • Increased gamma-glutamyl transferase
  • Dermatologic:
    • Pruritus
  • Hematologic & oncologic:
    • Anemia
    • Lymphocytopenia
    • Neutropenia

Contraindications to Miconazole (Oravig):

  • If someone has a hypersensitivity (an allergic reaction) to miconazole, milk protein concentrate, or any other component in the formulation of the medication, they should avoid using it.

Warnings and precautions

Hypersensitivity reactions

  • Hypersensitivity reactions, including severe ones like anaphylaxis, have been reported with miconazole use.
  • However, there's no clear data on whether there's cross-reactivity between miconazole and other azole antifungals.
  • It's important to keep an eye on patients who have a history of hypersensitivity reactions to azole antifungals when using miconazole and be vigilant for any signs of allergic reactions.

Hepatic impairment

  • While systemic absorption of miconazole is usually minimal, it's advisable to exercise caution when administering it to patients with hepatic impairment (liver problems).

Miconazole (oral): Drug Interaction

Risk Factor C (Monitor therapy)

Fosphenytoin

The blood levels of fosphenytoin may rise after using miconazole (Orally).

Phenytoin

The blood levels of phenytoin may rise after using miconazole (Orally).

Sulfonylureas

Sulfonylureas' hypoglycemic impact may be enhanced by miconazole (Oral). The blood content of sulfonylureas may rise after using miconazole (Oral).

Warfarin

Warfarin serum levels may rise after using miconazole (oral).

Risk Factor X (Avoid combination)

Saccharomyces boulardii

Antifungal (Systemic, Oral) Agents may lessen Saccharomyces boulardii's therapeutic impact.

Monitoring Parameters:

None mentioned. Monitor the response to treatment.


How to administer Miconazole (Oravig)?

Timing: Apply in the morning after brushing teeth.

Application Method:

  • With dry hands, place either side of the tablet against the upper gum above the incisor tooth.
  • Hold with slight pressure over the upper lip for 30 seconds.
  • Placing the rounded side of the tablet against the gum may be more comfortable.

Dos and Don'ts:

  • Do Not: Crush, chew, or swallow the tablet.
  • Avoid: Chewing gum while the tablet is in place.

Changing or Reapplying:

  • If the tablet does not adhere to the gum or falls off within 6 hours of application, reposition the same tablet immediately.
  • If the tablet does not adhere, use a new tablet.
  • If the tablet is swallowed within 6 hours of application, drink a glass of water and apply a new tablet (only once).
  • If the tablet falls off or is swallowed more than 6 hours after application, wait until the next regularly scheduled dose to apply a new tablet.

Mechanism of action of Oral Miconazole (Oravig):

  • Miconazole works by inhibiting the production of ergosterol, a crucial component of fungal cell walls.
  • Without enough ergosterol, the cell wall becomes weak, leading to damage.
  • This damage increases the permeability of the fungal cell wall, causing it to leak essential nutrients.
  • Ultimately, this disruption weakens and kills the fungal cells, helping to eliminate the infection.

Duration of Buccal Adhesion:

  • The buccal adhesion, or how long the tablet stays in place in the upper gum, typically lasts for around 15 hours.

Absorption:

  • Miconazole absorption through the buccal route is minimal, meaning very little of the medication is absorbed into the bloodstream.

International Brand Names of Oral Miconazole:

  • Oravig
  • A-Migel
  • Brentan
  • Daktar
  • Daktarin
  • Daktarin Oral Gel
  • Decozole Oral Gel
  • Fungisidin
  • Loramyc
  • Micoral
  • Micotar Mundgel
  • Mikozal
  • Mycoheal
  • Oramic
  • Oravi Mucoadhesive tablets
  • Rojazol
  • Tibozole

Miconazole Brand Names in Pakistan:

Miconazole Nitrate Oral Solution 2 % W/W in Pakistan

Miconit

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