M-Zole

M-Zole Cream:

Topical treatment of fungal infections, including tinea pedis (athlete's foot), jock itch (groin rash), tinea corporis (ringworm), pityriasis versicolor (white spots), candidiasis (thrush), thrush infected napkin rash, and fungal infections where bacterial infections may be present. Helps protect the skin from chafing, water, urine and other irritants.

M-Zole Powd: Treatment of fungal infections of the skin eg, athlete's foot, tinea, jock itch (groin rash) and napkin rash.

M-Zole topical is an antifungal medication. M-Zole topical prevents fungus from growing on your skin.

M-Zole topical (for the skin) is used to treat skin infections such as athlete's foot, jock itch, ringworm, tinea versicolor (a fungus that discolors the skin), and yeast infections of the skin.

M-Zole topical may also be used for purposes not listed in this medication guide.

Usual Adult Dose for

Oral Thrush

Oropharyngeal candidiasis: Apply 50 mg buccally to the upper gum region once a day for 14 consecutive days.

Usual Pediatric Dose for

Oral Thrush

Oropharyngeal candidiasis:

16 years or older: Apply 50 mg buccally to the upper gum region once a day for 14 consecutive days.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

The manufacturer recommends caution when administering this drug to patients with liver dysfunction.

Precautions

M-Zole buccal tablets are contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to milk protein concentrate.

Allergic reactions (including anaphylactic reactions and hypersensitivity) have been reported with the use of M-Zole products. M-Zole should be discontinued at once at the first sign of hypersensitivity.

There are no data regarding cross-hypersensitivity between M-Zole and other azole antifungal agents. Patients with a history of hypersensitivity to azoles should be monitored.

Safety and effectiveness have not been established in pediatric patients less than 16 years of age.

Dialysis

No adjustment recommended.

Other Comments

M-Zole buccal tablets should be applied with dry hands each morning after brushing teeth. The tablets should be placed against the upper gum, above the incisor tooth, and held in place with slight pressure over the upper lip for 30 seconds to ensure adhesion. Once in place, the buccal tablet stays in position and gradually dissolves. Subsequent applications should be made to alternate sides of the mouth. Any remaining tablet material should be cleared away before the next tablet is applied.

M-Zole buccal tablets should not be crushed, chewed, or swallowed. Food and drink can be taken normally when the buccal tablet is in place but chewing gum should be avoided.

If the M-Zole buccal tablet does not adhere or falls off within the first 6 hours, the same tablet should be repositioned at once; however, if the tablet still does not adhere, a new tablet should be used. If the buccal tablet 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 the buccal tablet falls off or is swallowed after it was in place for at least 6 hours, a new tablet should not be applied until the next scheduled dose.

See also:
What is the most important information I should know about M-Zole?

Patients with any kind of liver disease; hypersensitivity to any of the ingredients of Daktarin

Oral Gel.

The effects and/or side effects of many prescription medications, when taken with Daktarin

Oral Gel, can be increased. Hence, patients taking or about to take any other medications, must consult the doctor or pharmacist before starting Daktarin

Oral Gel therapy.

Use in infants: Daktarin

Oral Gel is contraindicated in infants <6 months because of the risk of choking.

Use M-Zole suppositories as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• M-Zole suppositories comes with an additional patient leaflet. Read it carefully and reread it each time you get M-Zole suppositories refilled.
• M-Zole suppositories is for vaginal use only. Do not use in the eyes or take by mouth.
• Using the applicator provided, insert 1 suppository high into the vagina at bedtime for 7 days.
• M-Zole suppositories comes with one applicator to be used for all 7 days of treatment. Do not throw away applicator after use. Separate the pieces of the applicator and wash with warm, soapy water immediately after use. Rinse thoroughly. Make sure the applicator is completely dry before the next use.
• Wash your hands immediately after using M-Zole suppositories.
• To clear up your infection completely, continue using M-Zole suppositories for the full course of treatment.
• If you miss a dose of M-Zole suppositories, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use M-Zole suppositories.

M-Zole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and other fungal skin infections (candidiasis). This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. M-Zole is an azole antifungal that works by preventing the growth of fungus.

How to use M-Zole topical

Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply this medication to the affected skin, usually twice a day or as directed by your doctor. If you are using the spray form, shake the bottle well before applying. Dosage and length of treatment depends on the type of infection being treated. Do not apply this more often than prescribed. Your condition will not clear faster, but side effects may be increased.

Apply enough medication to cover the affected area and some of the surrounding skin. After applying this medication, wash your hands. Do not wrap, cover or bandage the area unless directed to do so by your doctor.

Do not apply this medication in the eyes, nose, mouth, or vagina.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after starting M-Zole. Stopping the medication too early may allow the fungus to continue to grow, which may result in a relapse of the infection.

Inform your doctor if your condition persists or worsens.

See also:
What other drugs will affect M-Zole?

Interaction with other medicinal products and other forms of interaction: When using any concomitant medication, the corresponding label should be consulted for information on the route of metabolism. M-Zole can inhibit the metabolism of drugs metabolized by the CYP3A4 and CYP2C9 enzyme systems. This can result in an increase and/or prolongation of their effects, including adverse effects.

Drugs which should not be used during treatment with M-Zole:

Oral M-Zole is contraindicated with the co-administration of the following drugs that are subject to metabolism by CYP3A4 : Substrates known to prolong QT-interval eg, astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine; ergot alkaloids; HMG-CoA reductase inhibitors eg, simvastatin and lovastatin; triazolam and oral midazolam.

When co-administered with oral M-Zole, the following drugs should be used with caution because of a possible increase or prolongation of the therapeutic outcome and/or adverse effects. If necessary, their dosage should be reduced and when appropriate, plasma levels monitored: Others:

Oral hypoglycemics (CYP2C9), phenytoin (CYP2C9), carbamazepine, buspirone, alfentanil, sildenafil, alprazolam, brotizolam, midazolam IV, rifabutin, methylprednisolone, trimetrexate, ebastine and reboxetine.

Drugs subject to metabolism by CYP2C9 :

Oral anticoagulants eg, warfarin; oral hypoglycemics eg, sulfonylureas; phenytoin.

Other drugs subject to metabolism by CYP3A4: HIV protease inhibitors eg, saquinavir; certain antineoplastic agents eg, vinca alkaloids, busulfan and docetaxel; certain calcium channel blockers eg, dihydropyridines and verapamil; certain immunosuppressive agents: cyclosporine, tacrolimus, sirolimus (rapamycin); others: alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostasol, disopyramide, ebastin, methylprednisolone, midazolam IV, reboxetine, rifabutin, sildenafil and trimetrexate.

See also:
What are the possible side effects of M-Zole?

Applies to M-Zole: buccal mucosa tablet

In addition to its needed effects, some unwanted effects may be caused by M-Zole. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking M-Zole:

Less common:

• Body aches or pain
• cough
• difficulty with breathing
• ear congestion
• fever or chills
• headache
• loss of voice
• lower back or side pain
• nasal congestion
• painful or difficult urination
• pale skin
• runny nose
• sneezing
• sore throat
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

• Black, tarry stools
• pale skin
• shortness of breath
• ulcers, sores, or white spots in the mouth

Minor Side Effects

Some of the side effects that can occur with M-Zole may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Change in taste
• diarrhea
• dry mouth
• headache
• itching skin
• loss of taste
• nausea
• pain, redness, and swelling of the gums
• sores on the tongue
• toothache

• Abdominal or stomach pain
• loss of appetite
• pain
• upper abdominal or stomach pain
• weakness

M-Zole is an antifungal medication of the Imidazole class used to treat infections caused by a fungus or yeast. M-Zole topical (skin) preparations are also available for ringworm, jock itch, athlete's foot, and tinea versicolor or "sun fungus". M-Zole interacts with 14-± demethylase, a cytochrome P-450 enzyme that converts lanosterol to ergosterol, an essential component of the yeast membrane. In this way, tioconazole inhibits ergosterol synthesis, resulting in increased cellular permeability.