Medication info

Spongex 200 mg (Itraconazole)

Prescription medicationExpired
Ingredient · strength
Itraconazole›Strength being verified
Manufacturer / importer
Donggu Bio Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablet
Packaging
Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle
Approval status
Expired

MFDS item code 200711955 · Approved 2007.10.31

This product's status changed to Expired on 2023.04.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of fungal infections of the skin and nails, mucous membranes and cornea, and systemic fungal infections
Who uses it
Adults
Adult dosage
(Tablets)(Capsules) It is preferable to administer immediately after a meal. 1. Short-term treatment 1) Vulvovaginal candidiasis: Administer itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. 2) Pityriasis versicolor: Administer 200 mg once daily for 7 days. 3) Tinea corporis and tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital type) and tinea pedis (interdigital type): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palms) and tinea pedis (soles): Administer 100 mg once daily for 30 days or 200 mg twice daily for 7 days. 6) Oral candidiasis: Administer 100 mg once daily for 15 days. 7) Fungal keratitis: Administer 200 mg once daily for 21 days. 2. Onychomycosis 1) Pulse therapy Administer 200 mg twice daily for 1 week, followed by a 3-week drug-free interval; this constitutes 1 cycle. Administer up to 2 cycles for infection of the fingernails only and up to 3 cycles for infection of the toenails. 2) Continuous therapy Administer 200 mg once daily for 3 months. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients, the oral bioavailability of this drug may be reduced; if necessary, double the dose. Aspergillosis: 200mg once daily for 2~5 months. For invasive or disseminated disease, increase to 200mg twice daily. Candidiasis: 100~200mg once daily for 3 weeks~7 months. Cryptococcal meningitis: 200mg twice daily for 2 months~1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily for 6 months. (Oral solution) Do not administer with food. Hold this drug in the mouth for approximately 20 seconds so that it contacts the entire oral cavity, then swallow. After swallowing, do not rinse the mouth so that the drug remains in the mouth for a longer time. 1. Oral and esophageal candidiasis Take 200 mg (20 mL) daily in 1~2 divided doses for 1 week. If there is no effect after 1 week, continue for 1 additional week. 2. Fluconazole-resistant oral and esophageal candidiasis Take 200~400 mg (20~40 mL) daily in 1~2 divided doses for 2 weeks. If there is no effect after 2 weeks, continue for 2 additional weeks. Do not use 400 mg daily for more than 14 days, even if symptoms have not improved. 3. Prevention of fungal infections Administer 5 mg per kg of body weight per day in 2 divided doses. In clinical trials, prophylaxis was initiated immediately before cancer treatment and approximately 1 week before bone marrow transplantation. Deep fungal infections were confirmed in most patients with neutrophil counts below 100/μL. Continue treatment until the neutrophil count recovers (1,000/μL).

Ingredients

Manufacturer
Donggu Bio Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of fungal infections of the skin and nails, mucous membranes and cornea, and systemic fungal infections

  • Vaginal candidiasis
  • tinea versicolor
  • tinea corporis
  • tinea cruris
  • tinea manuum
  • tinea pedis
  • oral candidiasis
  • fungal keratitis
  • onychomycosis
  • aspergillosis
  • candidiasis
  • cryptococcosis
View approved original text

This medication is used to treat various fungal infections. It is effective for vaginal candidiasis, tinea versicolor, tinea corporis, tinea cruris, tinea manuum, tinea pedis, oral candidiasis, fungal keratitis, onychomycosis, and others. It is also used to treat systemic fungal infections such as aspergillosis, candidiasis, cryptococcosis (including meningitis), and paracoccidioidomycosis. The liquid formulation is particularly useful for the treatment of oral and esophageal candidiasis in immunocompromised patients and for preventing deep fungal infections in patients with hematological cancers or those undergoing bone marrow transplantation. This drug is effectively used in the treatment and prevention of various fungal diseases.

Dosage and Administration

Adult dosage

(Tablets)(Capsules) It is preferable to administer immediately after a meal. 1. Short-term treatment 1) Vulvovaginal candidiasis: Administer itraconazole 200 mg twice daily (morning and evening) for 1 day, or 200 mg once daily for 3 days. 2) Pityriasis versicolor: Administer 200 mg once daily for 7 days. 3) Tinea corporis and tinea cruris: Administer 100 mg once daily for 15 days. 4) Tinea manuum (interdigital type) and tinea pedis (interdigital type): Administer 100 mg once daily for 15 days. 5) Tinea manuum (palms) and tinea pedis (soles): Administer 100 mg once daily for 30 days or 200 mg twice daily for 7 days. 6) Oral candidiasis: Administer 100 mg once daily for 15 days. 7) Fungal keratitis: Administer 200 mg once daily for 21 days. 2. Onychomycosis 1) Pulse therapy Administer 200 mg twice daily for 1 week, followed by a 3-week drug-free interval; this constitutes 1 cycle. Administer up to 2 cycles for infection of the fingernails only and up to 3 cycles for infection of the toenails. 2) Continuous therapy Administer 200 mg once daily for 3 months. 3. Systemic fungal infections In patients with impaired immune function, such as those with neutropenia, AIDS, or organ transplant recipients, the oral bioavailability of this drug may be reduced; if necessary, double the dose. Aspergillosis: 200mg once daily for 2~5 months. For invasive or disseminated disease, increase to 200mg twice daily. Candidiasis: 100~200mg once daily for 3 weeks~7 months. Cryptococcal meningitis: 200mg twice daily for 2 months~1 year. Maintenance therapy: 200mg once daily. Paracoccidioidomycosis: 100mg once daily for 6 months. (Oral solution) Do not administer with food. Hold this drug in the mouth for approximately 20 seconds so that it contacts the entire oral cavity, then swallow. After swallowing, do not rinse the mouth so that the drug remains in the mouth for a longer time. 1. Oral and esophageal candidiasis Take 200 mg (20 mL) daily in 1~2 divided doses for 1 week. If there is no effect after 1 week, continue for 1 additional week. 2. Fluconazole-resistant oral and esophageal candidiasis Take 200~400 mg (20~40 mL) daily in 1~2 divided doses for 2 weeks. If there is no effect after 2 weeks, continue for 2 additional weeks. Do not use 400 mg daily for more than 14 days, even if symptoms have not improved. 3. Prevention of fungal infections Administer 5 mg per kg of body weight per day in 2 divided doses. In clinical trials, prophylaxis was initiated immediately before cancer treatment and approximately 1 week before bone marrow transplantation. Deep fungal infections were confirmed in most patients with neutrophil counts below 100/μL. Continue treatment until the neutrophil count recovers (1,000/μL).

Precautions

It is very important not to use this medication in patients with compromised heart function. Particularly those with heart issues such as congestive heart failure should be cautious as this medication can worsen heart function. Additionally, individuals who have had allergic reactions to this medication should avoid it, and pregnant or potentially pregnant women, as well as nursing mothers, should refrain from taking it. Patients with poor liver or renal function should take special precautions while using this medication and regular liver function tests are necessary. This medication is primarily metabolized in the liver, which can impose a burden on the liver. This medication can interact with various other drugs, so if you are currently taking any other medications, be sure to consult with your doctor or pharmacist. Particularly when used in combination with heart medications, pain relievers, antibiotics, anticancer drugs, or antipsychotics, side effects may be exacerbated. During the use of this medication, gastrointestinal symptoms such as headaches, nausea, abdominal pain, diarrhea, as well as adverse allergic reactions such as skin rashes and itching may occur, so if any unusual symptoms arise, medical personnel should be notified immediately. Caution is required while driving or operating machinery as dizziness or visual disturbances may occur. In case of overdose, there is no specific antidote, so it is vital to adhere to the recommended dosage and seek immediate medical attention if overdose occurs. This medication should be kept out of the reach of children and stored in its original container to prevent misuse or degradation in quality.

Side effects

Headache, nausea, abdominal pain, rhinitis, sinusitis, upper respiratory infection, leukopenia, hypersensitivity, taste disorder, sensory impairment, sensory abnormalities, tinnitus, constipation, diarrhea, dyspepsia, bloating, vomiting, liver dysfunction, hyperbilirubinemia, itching, rash, hives, polyuria, erectile dysfunction, menstrual disorders, edema, granulocytopenia, thrombocytopenia, anaphylactoid reaction, hyperglycemia, hyperkalemia, hypokalemia, hypomagnesemia, confusional states, peripheral neuropathy, dizziness, drowsiness, tremor, heart failure, left ventricular failure, tachycardia, hypertension, hypotension, pulmonary edema, voice disturbance, cough, gastrointestinal disorders, liver failure, hepatitis, jaundice, erythematous rash, hyperhidrosis, myalgia, arthralgia, renal impairment, urinary incontinence, general edema, facial swelling, chest pain, fever, pain, fatigue, chills, leukocytosis, eosinophilia, anemia, vascular edema, serum sickness, angioedema, anaphylaxis, anaphylactic shock, allergic reaction, diplopia, hearing loss, ventricular extrasystoles, atrioventricular block, palpitations, increased intestinal motility, belching, glossitis, stomatitis, abdominal lower back pain, pancreatitis, elevated serum total protein, increased total bilirubin, elevated LAP, loss of appetite, malaise, brown urine, erythema multiforme, hair loss, photosensitivity reaction, exfoliative dermatitis, leukocytoclastic vasculitis, acute generalized exanthematous pustulosis, elevated BUN, positive urine protein reaction, positive urine sugar reaction, decreased libido, drowsiness, shoulder stiffness, insomnia, chest pain, elevated serum triglycerides, flushing, elevated serum uric acid, elevated serum potassium, serum sickness, angioedema, anaphylaxis reaction, hypertriglyceridemia, tremor, visual impairment, transient hearing loss, permanent hearing loss, congestive heart failure, dyspnea, significant hepatotoxicity, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, increased serum creatine phosphokinase

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent air from entering and kept at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the efficacy of the medication and prevents degradation.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.