Sporal

Uses

What is Sporal® (itraconazole) used for?

Sporal® is an azole antifungal. It kills sensitive fungi by interfering with the formation of the fungal cell membrane.

Sporal® is commonly used for treating fungal infections. It may also be used for other conditions as determined by your doctor.

How should I take Sporal® (itraconazole)?

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

Sporal® capsules should be taken with a full meal because food improves absorption. The capsule and liquid are not interchangeable, and only the liquid form is used for treating oral candidiasis.

To clear up your infection completely, use Sporal® for the full course of treatment. Keep using it even if you feel better in a few days. Do not miss any doses.

Sporal® works best if it is taken at the same time each day.

Ask your health care provider any questions you may have about how to use Sporal®.

How do I store Sporal® (itraconazole)?

Sporal® is usually handled and stored by a health care provider.

If you are using Sporal® at home, store Sporal® as directed by your pharmacist or health care provider.

Precautions & warnings

What should I know before using Sporal® (itraconazole)?

Do not use Sporal® if:

• You are allergic to any ingredient in Sporal®.
• You have severe kidney problems or kidney failure.
• You are taking an aldosterone blocker (e.g., eplerenone), alprazolam, astemizole, cisapride, conivaptan, dofetilide, an ergot alkaloid (e.g., ergotamine), certain HMG-CoA reductase inhibitors (e.g., lovastatin, simvastatin), levacetylmethadol (levomethadyl), oral midazolam, nevirapine, nisoldipine, pimozide, a quinazoline (e.g., alfuzosin), quinidine, rifabutin, rifampin, terfenadine, triazolam, or certain 5-HT receptor agonists (e.g., eletriptan).

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Sporal® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Sporal®. Sporal® is pregnancy risk category C, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk
• B=No risk in some studies
• C=There may be some risk
• D=Positive evidence of risk
• X=Contraindicated
• N=Unknown

Side effects

What side effects can occur from Sporal® (itraconazole)?

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most common side effects persist or become bothersome:

• Diarrhea
• Dizziness
• Gas
• Headache
• Nausea
• Runny nose
• Stomach pain
• Upset
• Vomiting

Seek medical attention right away if any of these severe side effects occur:

• Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue)
• Bloating
• Chest pain
• Confusion
• Coughing up white or pink mucus
• Dark urine
• Decreased sexual ability
• Depression
• Fast or irregular heartbeat
• Fever, chills, or sore throat
• Hair loss
• Increased or uncontrolled urination
• Joint pain
• Loss of appetite
• Loss of hearing
• Muscle pain, weakness, or cramping
• Numbness, burning, or tingling of the hands, arms, legs, or feet
• Pain, redness, or swelling at the injection site
• Pale stools
• Red, swollen, blistered, or peeling skin
• Ringing in the ears
• Sensitivity to sunlight
• Severe or persistent nausea or vomiting
• Severe stomach or back pain
• Shortness of breath
• Sudden weight gain
• Swelling of the hands, ankles, or feet
• Swollen or tender stomach
• Trouble sleeping
• Unusual bruising or bleeding
• Unusual tiredness or fatigue
• Vision changes (e.g., blurred vision, double vision)
• Yellowing of the skin or eyes

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

Interactions

What drugs may interact with Sporal® (itraconazole)?

Sporal® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products may interact with Sporal® including:

• Many prescription and nonprescription medicines (e.g., used for infections, HIV, seizures, anxiety, sleep, heartburn, diabetes, high cholesterol, heart problems, high blood pressure, allergies, irregular heartbeat, pain, blood thinning, asthma, migraines, mood or mental problems, cancer, prostate problems, immune system suppression, erectile dysfunction, urinary problems, or birth control), multivitamin products, and herbal or dietary supplements may interact with Sporal®, increasing the risk of serious side effects.
• Nevirapine, rifabutin, or rifampin because they may decrease Sporal®’s effectiveness.
• Astemizole, cisapride, dofetilide, levacetylmethadol (levomethadyl), nisoldipine, pimozide, quinidine, or terfenadine because the risk of severe heart effects may be increased.
• Alprazolam, midazolam, or triazolam because their actions and the risk of their side effects may be increased by Sporal®, resulting in increased risk of sedation and breathing difficulties.
• Aldosterone blockers (e.g., eplerenone), calcium channel blockers (e.g., verapamil), conivaptan, ergot alkaloids (e.g., ergotamine), certain HMG-CoA reductase inhibitors (e.g., lovastatin, simvastatin), 5-HT receptor agonists (e.g., eletriptan), or quinazolines (e.g., alfuzosin) because the risk of their side effects may be increased by Sporal®.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sporal® may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Does food or alcohol interact with Sporal® (itraconazole)?

Sporal® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Sporal® (itraconazole)?

Sporal® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Sporal® (itraconazole).

What is the dose of Sporal® (itraconazole) for an adult?

The usual recommended dose is 200-400 mg daily as a single dose or two divided doses.

This medication works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. If you are taking this medication on a schedule other than every day (e.g., 1 week every month), it may help to mark your calendar with a reminder.

You may need to take this medication for several months to treat the infection. Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear. Stopping the medication too early may result in a return of the infection.

What is the dose of Sporal® (itraconazole) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Sporal® (itraconazole) available?

Sporal® is available in the following dosage forms and strengths:

• Capsules: 100 mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Sporal®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.