Mycoheal Uses

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What is Mycoheal?

Mycoheal topical is an antifungal medication. Mycoheal topical prevents fungus from growing on your skin.

Mycoheal 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.

Mycoheal topical may also be used for purposes not listed in this medication guide.

Mycoheal indications

infoAn indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Mycoheal 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.

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

How should I use Mycoheal?

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

  • Mycoheal suppositories comes with an additional patient leaflet. Read it carefully and reread it each time you get Mycoheal suppositories refilled.
  • Mycoheal 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.
  • Mycoheal 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 Mycoheal suppositories.
  • To clear up your infection completely, continue using Mycoheal suppositories for the full course of treatment.
  • If you miss a dose of Mycoheal 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 Mycoheal suppositories.

Uses of Mycoheal in details

infoThere are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Mycoheal 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. Mycoheal is an azole antifungal that works by preventing the growth of fungus.

How to use Mycoheal 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 Mycoheal. 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.

Mycoheal description

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Mycoheal is an antifungal medication of the Imidazole class used to treat infections caused by a fungus or yeast. Mycoheal topical (skin) preparations are also available for ringworm, jock itch, athlete's foot, and tinea versicolor or "sun fungus". Mycoheal 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.

Mycoheal dosage

Basic Dosing Information

The recommended dosing schedule for Mycoheal is the application of one 50 mg buccalablet to the upper gum region (canine fossa) once daily for 14 consecutive days.

Administration Instructions

Mycoheal should be applied in the morning, after brushing the teeth. The tablet should beapplied with dry hands. The rounded side surface of the tablet should be placed againsthe upper gum just above the incisor tooth (canine fossa) and held in place with slightpressure over the upper lip for 30 seconds to ensure adhesion. The tablet is round onone side for comfort, but either side of the tablet can be applied to the gum.

Once applied, Mycoheal stays in position and gradually dissolves. Subsequent applications of Mycoheal should be made to alternate sides of the mouth. Before applying the next tablet, the patient should clear away anyremaining tablet material. In addition,

  • Mycoheal should not be crushed, chewed or swallowed.
  • Food and drink can be taken normally when Mycoheal is in place but chewing gumshould be avoided.
  • If Mycoheal 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 Mycoheal is swallowed within the first 6 hours, the patient should drink a glass ofwater and a new tablet should be applied only once.
  • If Mycoheal 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..

How supplied

Dosage Forms And Strengths

Mycoheal is a buccal tablet containing 50 mg of Mycoheal. Mycoheal 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.

Storage And Handling

Mycoheal 50 mg buccal tablets are supplied as off-white tablets containing 50 mg ofmiconazole. Mycoheal tablets have a rounded side and a flat side. Mycoheal tablets are packaged in bottles of 14 tablets (NDC 43288-250-14).

Mycoheal should be stored at 20 to 25°C (68 to 77°F); excursions between 15 and 30°C permitted at room temperature. Protect frommoisture, and keep out of reach of children.

Manufactured By: Catalent Germany Schorndorf GmbH Steinbeisstra

Mycoheal interactions

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What other drugs will affect Mycoheal?

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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. Mycoheal 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 Mycoheal:

Oral Mycoheal 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 Mycoheal, 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.

Mycoheal side effects

See also:
What are the possible side effects of Mycoheal?

The following serious adverse drug reactions are discussed in detail in other sections of labeling:

  • Hypersensitivity reactions

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 Mycoheal 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 Mycoheal, 287 control) and one non-comparative trial (N = 25).

In the randomized, double blind trial (Study 1), 290 HIV infected subjects used Mycoheal 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)

Mycoheal

N = 290 (%)

Clotrimazole

troches

N = 287 (%)

Patients with any adverse reaction during the study

158 (54.5)

146 (50.9)

Gastrointestinal disorders

25.9

23.7

Diarrhea

9.0

8.0

Nausea

6.6

7.7

Vomiting

3.8

3.1

Dry mouth

2.8

1.7

Abdominal pain upper

1.7

2.8

Infections and infestations

15.9

17.1

Upper respiratory infection

2.1

2.4

Gastroenteritis

1.4

2.8

Nervous system disorders

13.1

8.4

Headache

7.6

6.6

Ageusia

2.4

0.3

Blood and lymphatic disorders

6.9

8.4

Anemia

2.8

1.7

Lymphopenia

1.7

2.1

Neutropenia

0.7

2.1

General disorders and administration site conditions

6.6

8.0

Fatigue

2.8

2.1

Pain

1.0

2.8

Respiratory/thoracic

5.2

7.7

Cough

2.8

1.7

Pharyngeal pain

0.7

2.4

Investigations

5.5

6.3

Increased GGT

1.0

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 Mycoheal 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 Mycoheal once daily for 14 days and 147 patients used 125 mg of Mycoheal 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)

Mycoheal

N = 147 (%)

Mycoheal gel

N = 147 (%)

Patients with at least one adverse reaction 30 (20.4) 32 (21.8)
Gastrointestinal disorders 8.8 13.6
Abdominal pain, upper 2.7 2.0

Oral discomfort

1.4 2.7
Nausea 0.7 2.7
Vomiting 0.7 2.0
Glossodynia 0 2.0
Nervous system disorders 5.4 1.4
Dysgeusia 4.1 0
Skin and subcutaneous 3.4 0.7
Pruritus 2.0 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 Mycoheal compared to 16 (10.9%) patients who used Mycoheal gel.

Overall Mycoheal Safety Experience In Patients and Healthy Subjects

Adverse reactions reported in the overall safety database of 480 subjects who received Mycoheal buccal tablet is listed in Table 3.

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

(MedDRA v 9.1 System Organ Class and Preferred Term)

Mycoheal

N = 480 (%)

Patients with at least one AE 209 (43.5)
Gastrointestinal disorders 20.6
Diarrhea 6.0
Nausea 4.6
Abdominal pain upper 2.5
Vomiting 2.5
Infections and infestations 11.9
Nervous system disorders 10.6
Headache 5.0
Dysgeusia 2.9

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

Mycoheal contraindications

See also:
What is the most important information I should know about Mycoheal?

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.

Active ingredient matches for Mycoheal:

Miconazole in Bahrain, Iraq, Jordan, Kuwait, Lebanon, Libya, Nigeria, Oman, Qatar, Romania, Saudi Arabia, Somalia, Sudan, Tunisia, United Arab Emirates, Yemen.

Hydrocortisone in Romania.


List of Mycoheal substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Mycoban 2 % x 450 g x 1's (Adcock ingram)
Mycon 20mg LOTION / 50ml$ 1.51
Mycorine 2 % x 5 g x 1's (Galenium)$ 1.98
Mycorine 2 % x 15 g x 1's (Galenium)$ 3.88
Mycorine / Sachet 2 % x 10 g x 1's (Galenium)$ 1.57
Mycorine / Tin 2 % x 25 g x 1's (Galenium)$ 4.45
Mycort 100mg VIAL / 1 (Novogen Captab)$ 0.95
Mysocort 2 % x 5 g (Greater pharma)
Mysocort 2 % x 15 g (Greater pharma)
Mysocort 2 % x 450 g (Greater pharma)
Cream; Topical; Hydrocortisone Acetate 2%
Cream; Topical; Miconazole Nitrate 2% (Medix)
Ovules; Vaginal; Miconazole Nitrate 250 mg (Medix)
Neopolygramin H Skin 3 gm Ointment (Sunways India Pvt. Ltd.)$ 0.08
Nikarin 0.2 % x 10 g (T. O. Chemicals)
Nikarin 450 g x 1's (T. O. Chemicals)
Nikarin cream 450 g 1's (T. O. Chemicals)
Nikarin oral gel 0.2 % 10 g x 1's (T. O. Chemicals)

References

  1. DailyMed. "MICONAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. PubChem. "hydrocortisone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Mycoheal are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Mycoheal. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

Consumer reported useful

No survey data has been collected yet


1 consumer reported price estimates

Was the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by ndrugs.com website users about whether the Mycoheal drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Users%
Not expensive1
100.0%


Consumer reported time for results

No survey data has been collected yet


6 consumers reported age

Users%
< 13
50.0%
1-52
33.3%
30-451
16.7%


Consumer reviews

Abraham Juma Biliu08 Oct 2015 14:42
What i want to know is that. Can it be swallow n after how may can be use 4 times/day by >6yr.


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