Dermizol 2% Uses

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What is Dermizol 2%?

Dermizol 2% topical is an antifungal medication. Dermizol 2% topical prevents fungus from growing on your skin.

Dermizol 2% 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.

Dermizol 2% topical may also be used for purposes not listed in this medication guide.

Dermizol 2% 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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Dermizol 2% 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.

Dermizol 2% Powd: Treatment of fungal infections of the skin eg, athlete's foot, tinea, jock itch (groin rash) and napkin rash.

How should I use Dermizol 2%?

Use Dermizol 2% suppositories as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Dermizol 2% suppositories comes with an additional patient leaflet. Read it carefully and reread it each time you get Dermizol 2% suppositories refilled.
  • Dermizol 2% 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.
  • Dermizol 2% 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 Dermizol 2% suppositories.
  • To clear up your infection completely, continue using Dermizol 2% suppositories for the full course of treatment.
  • If you miss a dose of Dermizol 2% 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 Dermizol 2% suppositories.

Uses of Dermizol 2% 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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Dermizol 2% 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. Dermizol 2% is an azole antifungal that works by preventing the growth of fungus.

How to use Dermizol 2% 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 Dermizol 2%. 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.

Dermizol 2% description

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Dermizol 2% is an antifungal medication of the Imidazole class used to treat infections caused by a fungus or yeast. Dermizol 2% topical (skin) preparations are also available for ringworm, jock itch, athlete's foot, and tinea versicolor or "sun fungus". Dermizol 2% 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.

Dermizol 2% dosage

Basic Dosing Information

The recommended dosing schedule for Dermizol 2% is the application of one 50 mg buccalablet to the upper gum region (canine fossa) once daily for 14 consecutive days.

Administration Instructions

Dermizol 2% 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, Dermizol 2% stays in position and gradually dissolves. Subsequent applications of Dermizol 2% should be made to alternate sides of the mouth. Before applying the next tablet, the patient should clear away anyremaining tablet material. In addition,

  • Dermizol 2% should not be crushed, chewed or swallowed.
  • Food and drink can be taken normally when Dermizol 2% is in place but chewing gumshould be avoided.
  • If Dermizol 2% 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 Dermizol 2% is swallowed within the first 6 hours, the patient should drink a glass ofwater and a new tablet should be applied only once.
  • If Dermizol 2% 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

Dermizol 2% is a buccal tablet containing 50 mg of Dermizol 2%. Dermizol 2% 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

Dermizol 2% 50 mg buccal tablets are supplied as off-white tablets containing 50 mg ofmiconazole. Dermizol 2% tablets have a rounded side and a flat side. Dermizol 2% tablets are packaged in bottles of 14 tablets (NDC 43288-250-14).

Dermizol 2% 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

Dermizol 2% interactions

See also:
What other drugs will affect Dermizol 2%?

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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. Dermizol 2% 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 Dermizol 2%:

Oral Dermizol 2% 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 Dermizol 2%, 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.

Dermizol 2% side effects

See also:
What are the possible side effects of Dermizol 2%?

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 Dermizol 2% 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 Dermizol 2%, 287 control) and one non-comparative trial (N = 25).

In the randomized, double blind trial (Study 1), 290 HIV infected subjects used Dermizol 2% 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)

Dermizol 2%

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 Dermizol 2% 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 Dermizol 2% once daily for 14 days and 147 patients used 125 mg of Dermizol 2% 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)

Dermizol 2%

N = 147 (%)

Dermizol 2% 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 Dermizol 2% compared to 16 (10.9%) patients who used Dermizol 2% gel.

Overall Dermizol 2% Safety Experience In Patients and Healthy Subjects

Adverse reactions reported in the overall safety database of 480 subjects who received Dermizol 2% buccal tablet is listed in Table 3.

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

(MedDRA v 9.1 System Organ Class and Preferred Term)

Dermizol 2%

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 Dermizol 2% due to adverse drug reactions occurred in 0.6% overall.

Dermizol 2% contraindications

See also:
What is the most important information I should know about Dermizol 2%?

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 Dermizol 2%:

Miconazole in Egypt.


List of Dermizol 2% substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Dermon 2 % x 15 g (Unison)
Dermon 2 % x 450 g (Unison)
Dermotyl- M Clobetasol Propionate 0.05%w/w, Miconazole Nitrate 2% w/w CRM / 10g$ 0.35
Tablet; Oral; Benzocaine 3 mg; Iron / Ferrous Fumarate 3.33 mg; Nicotinamide 3.33 mg; Thiamine Hydrochloride 0.33 mg; Vitamin A / Vitamin A Acetate 1333 units; Vitamin B2 0.4 mg; Vitamin C / Sodium Ascorbate 10 mg; Vitamin D3 133 units (Chattem)
Dk Gel 2% w/w Topical Gel / 30g (H & H)$ 1.70
DK GEL topical gel 2 % w/w x 30g (H & H)$ 1.70
Ecziclo- M Clobetasol Propionate 0.05%w/w, Miconazole Nitrate 2% w/w CRM / 10g$ 0.40
EMICONAZOLE Cream/ Gel/ Ointment / 2/ % / 15gm units (Emcure)$ 0.30
2 % x 15g (Emcure)$ 0.30
Emiconazole 2% GEL / 15g (Emcure)$ 0.30
EMICONAZOLE topical gel 2 % x 15g (Emcure)$ 0.30
Emiconazole 2% GEL / 15g (Emcure)$ 0.30
Emizole / Tube 20 mg/1 g x 10 g
Fmina 20 mg/1 g x 5 g

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. PubChem. "miconazole". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "miconazole". http://www.drugbank.ca/drugs/DB01110 (accessed September 17, 2018).

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