ITRANSTAD 100MG Stella Treatment of candidiasis in the mouth, throat, vagina, vulva (1 blister x 6 tablets)

Dosage form Box of 1 blister x 6 tablets
Specifications Itraconazole

Ingredient

Composition information	Content
Itraconazole	100mg

Uses

indications

ITRANSTAD 100mg drug is indicated in the following cases:

Candida fungus treatment:

Candida mushrooms in the mouth - throat. Body, interstitial skin. The multiplication does not respond or does not tolerate amphotericin b). Synthetic Triazole derivative. ITraconazole inhibits enzymes dependent on Cytochrom P450 in sensitive mushrooms, resulting in a decrease in ergosterol synthesis in the fungal cell membrane. ITraconazole has a wider antifungal spectrum than ketoconazole.

The anti -mushroom activity: Aspergillus spp., Blastomyces dermatitidis, Candida spp. Brasiliensis, Sportothrix Schenckii, and Trichophyton spp.

Dynamic pharmacokinetics

absorption

Itraconazole is absorbed through the gastrointestinal tract. The absorption increases by the acidic environment in the stomach and the highest when using the dose along with food. The peak concentration of plasma is reached from 1.5 to 5 hours, about 2 mcg/ml after daily use of 200 mg.

distribution

iTraconazole is linked to high protein; Only 0.2% circulate in the form of free drugs. Itraconazole is widely distributed but only a small amount diffuses into the cerebrospinal fluid.

The concentration achieved in the skin, pus, many organs and tissues are many times higher than the concentration in the same hemorrhage. Itraconazole's treatment concentration is still in the skin and mucosa from 1 to 4 weeks after stopping the drug. A small amount is distributed into breast milk.

transformation

iTraconazole is metabolized in the liver mainly by Cytochrome P450 ISoenzyme CYP3A4. Main metabolites, hydroxyitraconazole, with antifungal activity equivalent to iTraconazole.

Elimination

iTraconazole is also excreted in the form of metabolites that do not work in bile or urine; 3-18% are eliminated in feces in constant form. A small amount is removed in the horny and hair layer.

iTraconazole is not removed by fertilizer. The sale time after the single dose of 100 mg has been reported for 20 hours, increasing to 30-40 hours if continued to use.

Before taking ITRANSTAD 100MG Stella Treatment of candidiasis in the mouth, throat, vagina, vulva (1 blister x 6 tablets)

How to use

ITRANSTAD 100mg drugs have a hard -tablet capsule. Take the medicine right after the meal, swallow the whole tablet.

Dosage

Dosage in case of short -term treatment:

Candida mushrooms in the mouth - pharynx: 100 mg x 1 time/day, drink for 15 days. Patients with AIDS or neutropenia: 200 mg x 1 time/day, taking for 15 days.

Candida mushrooms in the vagina - vulva: 200 mg x 2 times/day, only drink 1 day or 200 mg x 1 time/day, drink for 3 days.

Visit: 200 mg x 1 time/day, drink for 7 days.

Fungal skin: 100 mg x 1 time/day, drink for 15 days. If in high horny areas, it is necessary to treat for 15 days at a dose of 100 mg/day.

Dosage in case of long -term treatment (body fungal infection) depends on clinical and mushroom response:

Fungal nail disease: 200 mg x 1 time/day, for 3 months.

Aspergillus fungal disease: 200 mg x 1 time/day for 2-5 months. Can increase the dose to 200 mg 2 times/day if the disease spreads.

Candida fungus: 100 - 200 mg x 1 time/day, drink for 3 weeks to 7 months. Can increase the dose: 200 mg x 2 times/day, if the disease spreads.

Cryptococcus fungus (no meningitis): 200 mg x 1 time/day, taken for 2 months to 1 year.

Cryptococcus meningitis: 200 mg x 2 times/day. Maintain treatment: 200 mg x 1 time/day.

Histoplasma and Blastomyces fungal disease: 200 mg x 1 or 2 times/day, drink for 8 months.

Maintain treatment in AIDS patients: 200 mg x 1 time/day.

Preventive in neutropenia: 200 mg x 1 time/day.

Children: The safety and effectiveness of iTraconazole in children under 18 have not been determined.

What to do when overdose? You can wash your stomach within an hour after drinking. An activated carbon can also be used if necessary. Itraconazole is not excluded by hemolysis. There is currently no specific antidote for iTraconazole.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

Common, ADR> 1/100

TKTW: Dizziness, headache.

digestive: Nausea, abdominal pain, constipation, indigestion.

Uncommon, 1/1000

Systemic: allergic reactions such as itching, external rash, urticaria and angioedema, Stevens-Johnson syndrome.

Endocrine: Menstrual disorders. liver: Increased liver recovery, hepatitis, especially after long -term treatment. There is also a risk of hepatitis, hepatitis, edema and hair loss, hair, especially after a long -term treatment of over 1 month with Itraconazole.

Rare ADR

Neurological: peripheral neuropathy.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

ITRANSTAD 100mg contraindications in the following cases:

Hypersensitivity to iTraconazole and other Azols or any ingredients of the drug.

Patients who are being treated with terfenadin, astemizol, oral triazolam, oral midazolam and cisaprid.

Use iTraconazole to treat nail mushrooms for pregnant women or intended to get pregnant.

Be cautious when using

should not use iTraconazole to treat nail fungus for patients with signs of ventricular dysfunction such as congestion heart failure or a history of congestive heart failure; Treatment should be stopped if the patient progresses to congestive heart failure while taking the drug.

Do not use iTraconazole for patients with liver enzymes in serum, progressive liver disease or a history of liver toxicity due to other drugs, unless the benefits are higher than those. Moreover, the serum liver enzyme should be closely monitored for all patients who are taking Itraconazole, especially those who have used Itraconazole for more than 1 month.

If neuropathy occurs due to iTraconazole, medication must be stopped.

In the body's body, the whole body of Candida is suspected of being resistant to Fluconazole, it may also be not sensitive to Itraconazole. Therefore, it is necessary to check the sensitivity to iTraconazole before treatment.

The ability to drive and operate machinery

There has been no research on the influence of Itraconazole on driving and operating machinery. When driving and operating machinery, dizziness, visual disorders and hearing loss may occur in some cases, which should be noted.

Pregnancy

Itraconazole causes abnormal development in the mouse fetus. There is no study in pregnant women, so ITRAConazole is used for pregnant women when the benefits are higher than the risk.

breastfeeding period

Non -breastfeeding women use iTraconazole.

Interactive drug

Anti -arrhythmia drugs: ITRACONazole simultaneous use with quinidine or dofetilide increases the concentration of anti -arrhyths in plasma, which can cause many unwanted effects on cardiovascular disease such as life -threatening arrhythmia and/or sudden death. Contraindicated Itraconazole with these drugs.

Hemodialysis hypoglycemia: Use a combination of HMG-CoA Reductase inhibitors (such as Atorvastatin, Cerivastatin, Lovastatin, Simvastatin) and otraconazole increase the concentration of these drugs in plasma, leading to increased effects and increased risk of toxicity. Contraindicated Itraconazole with these drugs.

HIV Protease inhibitors: ITRACONazole and HIV Protease inhibitors (PIS) (such as Amprenavir, Atazanavir, Darunavir, Fosamprenavir, Indinavir, Lopinavir, Nelfinavir, Ritonavir, SaQuavir, Tipranavir) change PIS and anti -fungus in blood concentration Thanh.

Terfenadin: Unwanted effects on serious cardiovascular disease include death, ventricular tachycardia and existing ventricular tachycardia occurred when the patient used simultaneously iTraconazole and Terfenadin.

Benzodiazepin drugs: Use combinations of otraconazole and benzodiazepin drugs (such as Alprazolam, Diazepam, Midazolam oral, Triazolam) increase the concentration of these drugs in plasma leading to increased potential and prolong sedative effects, causing sleep.

Cisaprid: ITraconazole inhibits the metabolism of Cisaprid and increases the cisaprid level in plasma and increases the unwanted effect on the heart.

Pimozid: Romantic arrhythmia and/or sudden death occur when patients use simultaneously pimozid with iTraconazole and/or other CYP3A4 enzyme inhibitors.

Phosphodiesterase inhibitors: Itraconazole inhibit cytochrom P-450 isoenzyme 3A4, and a combination with phosphodiesterase inhibitors (PDE) (such as Sildenafil, Tadalafil, Vardenafil) can significantly increase the concentration of PDE inhibitors in plasma and may increase risks that occur, such as desirable blood pressure visual disorder, penis).

Diazepam, Midazolam, Triazolam orally are contraindicated with ITraconazole.

iTraconazole is used with warfarin to increase the anticoagulant effect of this substance. Need to monitor prothrombin time in patients to reduce the dose of warfarin if needed.

Digoxin, used with Itraconazole, plasma concentrations will increase. Must monitor to adjust the dose.

Hypoglycemia occurs when taking anti -diabetic drugs with Azol antifungal drugs. Therefore, it is necessary to closely monitor blood sugar levels to adjust the dose of anti -diabetic drugs.

iTraconazole needs gastric acid environment to be absorbed well. So if taken with acid resistance, or H2 resistant (such as cimetidin, ranitidin) or omeprazol, sucralfate, biological use of iTraconazole will be significantly reduced, loss of anti -fungal treatment effect. So should not be used simultaneously or you must replace iTraconazole with fluconazole or amphotericin b.

Enzyme induction drugs such as rifampicin, isoniazid, phenobarbital, phenytoin reduces the concentration of otraconazole in plasma. Therefore, other antifungal drugs should be replaced if it found that treatment with isoniazid or rifampicin is necessary.

Storage

In closed boxes, at temperatures below 300C.

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