Video: Latest Treatment for Hep C.

Miconazole

Pronunciation

Pronunciation: me-KON-a-zole
Class: Anti-infective, Antifungal agent

Trade Names

Aloe Vesta
- Ointment 2%

Breezee Mist Antifungal
- Powder 2%

Cruex
- Spray Powder 2%

Fungoid Cream
- Cream 2%

Fungoid Tincture
- Solution 2%

Lotrimin AF
- Spray Liquid 2%
- Spray Powder 2%
- Powder 2%

M-Zole 3 Combination Pack
- Vaginal Suppositories 200 mg
- Topical Cream 2%

M-Zole 7 Dual Pack
- Vaginal Suppositories 100 mg
- Topical Cream 2%

Maximum Strength Desenex Antifungal
- Cream 2%

Micatin
- Cream 2%
- Spray Liquid 2%
- Spray Powder 2%
- Powder 2%

Miranel AF
- Solution 2%

Monistat 3
- Vaginal Suppositories 200 mg

Monistat 7
- Vaginal Suppositories 100 mg
- Vaginal Cream 2%

Monistat 7 Combination Pack
- Vaginal Suppositories 100 mg
- Topical Cream 2%

Monistat Dual-Pak
- Vaginal Suppositories 200 mg
- Topical Cream 2%

Neosporin AF
- Topical Cream 5 mg per 5 mL

Only-Clear
- Spray 2%

Oravig
- Tablet, buccal 50 mg

Prescription Strength Desenex
- Spray powder 2%
- Spray liquid 2%

Tetterine
- Ointment 2%

Triple Paste AF
- Cream 2%

Zeasorb-AF
- Powder 2%

Micozole (Canada)
Monistat 1 Combination Pack (Canada)
Monistat 1 Vaginal Ovule (Canada)
Monistat 3 Vaginal Ovules (Canada)
Monistat Derm Cream (Canada)

Pharmacology

Alters permeability of fungal cell membrane, leading to cell death.

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

Pharmacokinetics

Absorption

C max is approximately 15.1 mcg/mL and T max is 7 h (buccal tablet).

Metabolism

Metabolized by the liver.

Elimination

Less than 1% was found unchanged in the urine; terminal half-life is 24 h following systemic administration (buccal tablet).

Indications and Usage

Buccal tablets

For the local treatment of oropharyngeal candidiasis.

Parenteral form

Treatment of severe systemic fungal infections.

Topical form

Treatment of topical fungal infections, including tinea infections and candidiasis.

Vaginal form

Local treatment of vulvovaginal candidiasis (moniliasis).

Contraindications

Hypersensitivity to imidazoles; milk proteins (buccal tablet).

Dosage and Administration

Oropharyngeal Candidiasis
Adults and Children (16 y of age and older)

Buccal Place one 50 mg tablet to the upper gum region (canine fossa) once daily for 14 consecutive days.

Systemic Infections
Adults

IV 200 to 3,600 mg/day. May divide into 3 doses. Treatment of meningitis is supplemented by intrathecal injections of 20 mg/dose. Treatment of bladder infections is supplemented by bladder instillations of 200 mg/dose.

Children (1 to 12 y of age)

IV 20 to 40 mg/kg/day (max, 15 mg/kg/dose).

Children (younger than 1 y of age)

IV 15 to 30 mg/kg/day (max, 15 mg/kg/dose).

Topical Infections
Adults

Topical Apply twice daily to infected area.

Vaginal Infections
Adults

Intravaginal 1 suppository (200 mg) at bedtime for 3 days, 1 suppository (100 mg) for 7 days, or 1 applicatorful at bedtime for 7 days.

General Advice

  • Buccal tablets
  • Tablets should be applied in the morning with dry hands after brushing the teeth.
  • Tablets should not be crushed, chewed, or swallowed.
  • Place the rounded side of tablet against upper gum just above the incisor tooth and hold in place with slight pressure over the upper lip for 30 sec to ensure adhesion. Once applied, the tablet stays in position and gradually dissolves. Subsequent applications should be made to alternate sides of the mouth.
  • If the tablet does not adhere or falls off within 6 h, the same tablet should be repositioned immediately. If the tablet is swallowed within the first 6 h, drink a glass of water and a new tablet should be applied only once. If the tablet falls off or is swallowed after it was in place for 6 h or more, a new tablet should not be applied until the next regularly scheduled dose.

Storage/Stability

Store at 59° to 86°F. Protect tablets from moisture.

Drug Interactions

Anticoagulants, oral (eg, warfarin)

May cause increased anticoagulant effect. Cases of bleeding have been reported following concomitant use of warfarin and miconazole. Closely monitor PT and INR of patients requiring miconazole while using warfarin, and instruct them to report any bleeding. Adjust the warfarin dose as needed.

CYP2C9 and CYP3A4 substrates (eg, ergot derivative [eg, ergotamine], hydantoins [eg, phenytoin], oral hypoglycemic agents [eg, glyburide])

Because miconazole is a known inhibitor of CYP2C9 and CYP3A4, the potential for interaction with these substrates cannot be ruled out.

Adverse Reactions

Cardiovascular

Arrhythmia, cardiorespiratory arrest, tachycardia.

CNS

Buccal tablets

Headache (8%); fatigue (3%).

Dermatologic

Phlebitis at infusion site; pruritus; rash; skin irritation, sensitization, and burning from topical preparations.

Buccal tablets

Pruritus (2%).

GI

Anorexia, diarrhea, nausea, vomiting.

Buccal tablets

Diarrhea (9%); nausea (7%); dysgeusia, vomiting (4%); dry mouth, oral discomfort, upper abdominal pain (3%); ageusia (2%); gastroenteritis (1%).

Hematologic

Thrombocytopenia, transient decreases in hematocrit.

Buccal tablets

Anemia (3%); lymphopenia (2%); neutropenia (1%).

Local

Buccal tablets

Altered taste, application-site discomfort or pain, dry mouth, gingival pain, gingival pruritis, gingival swelling, glossodynia, loss of taste, mouth ulceration, oral burning, oral discomfort, oral pain, tongue ulceration, toothache (12%).

Metabolic

Hyperlipemia possibly caused by vehicle.

Respiratory

Buccal tablets

Cough (3%); upper respiratory infection (2%); pharyngeal pain (1%).

Miscellaneous

Anaphylaxis, chills, fever. Topical or vaginal forms may cause similar reactions.

Buccal tablets

Infections and infestations (12%); increased GGT, pain (1%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy in children younger than 1 y of age not studied sufficiently; safety and efficacy of the buccal tablets in children younger than 16 y of age have not been established.

Hypersensitivity

Allergic reactions, including anaphylactic reactions, have been reported.

Hepatic Function

Use with caution.

Cardiac effects

Have occurred, possibly because of too-rapid administration.

Cremophor-type vehicle

Present in IV formulation; may cause electrophoretic abnormalities of lipoprotein; usually reversible.

Patient Information

  • With topical therapy, instruct patient to use for full treatment time, even if symptoms improve. Advise patient to notify health care provider if there is no improvement in 2 wk.
  • With topical therapy, if condition worsens or if burning, itching, or redness occurs, instruct patient to discontinue use and notify health care provider.
  • With vaginal therapy, instruct patient to refrain from sexual intercourse or to have her partner use a condom for protection and to prevent reinfection. Advise patient to apply medication at bedtime.
  • Suggest patient use sanitary pad to prevent staining of clothing.
  • With vaginal therapy, instruct patient not to discontinue use during menstruation.
  • Buccal
  • Advise patient to use the tablet immediately after removal from the bottle.
  • Instruct patient not to crush, chew, or swallow the tablet.
  • Advise patient to place the rounded side of the tablet to the upper gum above the incisor tooth in the morning, after brushing his or her teeth. Hold the tablet in place for 30 sec to make the tablet stick to the gum. Tell patient that as the tablet absorbs moisture from the mouth, it will slowly dissolve over time and to leave it in place. Patient should make subsequent applications to alternate sides of the gum.
  • If the buccal tablet does not stick or falls off within the first 6 h, instruct patient to reposition the same tablet immediately. If the tablet does not adhere, advise patient to place a new tablet. If the patient swallows the tablet within the first 6 h, instruct him or her to drink a glass of water and apply a new tablet only once. If the tablet falls off or is swallowed after it was in place for 6 h or more, the patient should not apply a new tablet until the next regularly scheduled dose.
  • Instruct patient that food and drink can be taken normally when the tablet is in place; however, he or she should avoid chewing gum.
  • Advise patient to avoid situations that could interfere with the sticking of the tablet, such as chewing gum, wearing an upper denture, or hitting the tablet when brushing his or her teeth.
  • Inform patient that he or she may experience adverse reactions such as diarrhea, headache, nausea, and change in taste. Tell patient who develops hives, skin rash, or other symptoms of an allergic reaction to contact health care provider.

Copyright © 2009 Wolters Kluwer Health.

Hide
(web1)