Itralase Sb(65mg)

ITRALASE SB(65MG) by CIPLA LTD.

Name

Brand Name: Itralase SB 65mg Capsule, Itralase SB 65 Capsule 10's

Composition

Active Ingredient: Itraconazole (65 mg) Itraconazole is an azole antifungal that works by inhibiting the production of ergosterol, a vital component of fungal cell membranes. This action weakens and damages the fungal cell membranes, preventing unwanted substances from entering and stopping the leakage of cell contents, thereby halting fungal growth and leading to fungal cell death.

Uses

Itralase SB 65mg Capsule is an antifungal medication primarily used to treat a wide range of fungal and yeast infections in individuals with both weakened and strong immune systems. These include:

• Pulmonary and extrapulmonary blastomycosis
• Various forms of histoplasmosis, including chronic cavitary pulmonary disease and disseminated non-meningeal histoplasmosis
• Pulmonary and extrapulmonary aspergillosis, particularly in patients who cannot tolerate amphotericin B therapy
• Systemic fungal infections like cryptococcosis
• Onychomycosis (fungal infections of fingernails and toenails)
• Skin infections, including ringworm infection, athlete's foot, and infections in the groin and buttocks
• Fungal infections of the mouth, throat, and vagina (thrush)

Dosage and Administration

Itralase SB 65mg Capsule should be taken in the dose and duration prescribed by your doctor. It should be swallowed whole with a glass of water, without crushing, breaking, or chewing. It is recommended to take the medication with food, preferably at the same time each day, to enhance absorption and reduce potential side effects. It is crucial to complete the full prescribed course of treatment, even if symptoms improve, to prevent the infection from returning or developing resistance. Avoid taking antacids or similar medicines that reduce stomach acid within 2 hours of taking Itralase SB 65mg Capsule; if antacids are necessary, take the capsule with a cola drink.

Side Effects

Common Side Effects:

• Nausea, vomiting, stomach pain, abdominal pain, diarrhea, constipation, dyspepsia
• Headache, dizziness
• Tiredness, cough, cold, throat pain, back pain

Serious Side Effects (Seek immediate medical advice if experienced):

• Signs of liver damage: yellowing of eyes or skin, dark urine, stomach pain, pale stools, loss of appetite, unusual tiredness, vomiting
• Severe allergic reactions: severe skin rash, tingling, difficulty breathing, swelling of face, lips, tongue, or throat
• Irregular heartbeat, fits
• Nerve pain, hearing loss

Precautions

• Pregnancy: Itralase SB 65mg Capsule is generally not recommended during pregnancy as it may cause harm to the unborn baby and increases the risk of birth defects, especially at high doses. Consult your doctor if you are pregnant or planning a pregnancy.
• Breastfeeding: It is generally not recommended for breastfeeding women, as a small amount may pass into breast milk and potentially harm the baby.
• Alcohol: Caution is advised when consuming alcohol, as it may increase potential side effects.
• Liver Problems: Inform your doctor if you have a history of liver problems, as this medicine may exacerbate liver issues and is not recommended for such conditions. Your doctor may monitor liver function with blood tests before and during prolonged treatment.
• Kidney Problems: Use with caution in patients with kidney disease as it can worsen pre-existing kidney conditions.
• Heart Failure: Itralase SB 65mg Capsule can increase the risk of heart failure and is contraindicated in individuals with a history of heart failure.
• Hearing Loss: Use with caution in individuals with a history of hearing loss.
• Neuropathy: This capsule may aggravate neuropathy.
• Drug Interactions: Inform your doctor about all medications, including herbal supplements, you are taking, as Itralase SB 65mg Capsule can interact with various drugs. For instance, certain antiarrhythmics, anticonvulsants, anti-HIV agents, and antineoplastics may have elevated levels when taken with Itralase SB 65mg Capsule. Some antibiotics (e.g., rifampicin, isoniazid) and antivirals (e.g., efavirenz) may reduce its effect, while others (e.g., ciprofloxacin, clarithromycin, ritonavir) may increase its effectiveness.

Storage

Store Itralase SB 65mg Capsule below 30°C. Protect it from light and moisture, and keep it out of reach and sight of children.

What is ITRALASE SB(65MG) used for?

ITRALASE SB(65MG) contains Itraconazole, an antifungal medication used to treat a variety of fungal infections. These include fungal infections of the skin (like ringworm, athlete's foot, jock itch), nails (onychomycosis), mouth (oral candidiasis/thrush), throat, vagina (vulvovaginal candidiasis), and systemic (internal) fungal infections affecting organs such as the lungs (e.g., histoplasmosis, blastomycosis, aspergillosis), and other parts of the body.

How does ITRALASE SB(65MG) work?

Itraconazole, the active ingredient in ITRALASE SB(65MG), works by inhibiting the production of ergosterol, a crucial component of the fungal cell membrane. By disrupting ergosterol synthesis, the fungal cell membrane becomes weak and damaged, preventing the entry of unwanted substances and causing essential cell contents to leak out. This action ultimately halts fungal growth and kills the fungi, clearing the infection. The "SB" in ITRALASE SB indicates "Super Bioavailable" technology, which enhances the absorption of itraconazole.

What is the usual dosage for ITRALASE SB(65MG)?

The dosage of ITRALASE SB(65MG) varies significantly depending on the type and severity of the fungal infection, and it must be prescribed by a doctor. Itraconazole capsules are typically taken with food to enhance absorption. For some systemic infections, a loading dose might be prescribed for the first few days, followed by a regular maintenance dose which could be 65 mg or 130 mg once or twice daily. For nail infections, it's often administered as pulse therapy (e.g., taking the medicine for one week every month for a few months). Always follow your doctor's specific instructions.

What are the possible side effects of ITRALASE SB(65MG)?

Common side effects can include nausea, vomiting, diarrhea, abdominal pain, headache, and dizziness. More serious but rare side effects that require immediate medical attention include signs of liver problems (e.g., yellowing of the skin or eyes, dark urine, unusual fatigue, persistent nausea, vomiting, loss of appetite, upper right abdominal pain), symptoms of heart failure (e.g., shortness of breath, swelling of ankles/feet, sudden weight gain, unusual fatigue), severe allergic reactions (e.g., rash, itching, swelling of the face/tongue/throat), or nerve problems (e.g., tingling, numbness, weakness in hands or feet, hearing loss).

Is ITRALASE SB(65MG) safe during pregnancy or breastfeeding?

ITRALASE SB(65MG) is generally not recommended during pregnancy and is contraindicated unless it's a life-threatening infection where the potential benefit to the mother outweighs the potential harm to the fetus. Women of childbearing potential should use a reliable method of contraception during treatment and for at least two months after the last dose. For breastfeeding, it is generally not recommended as limited data suggest the drug may pass into breast milk. Your doctor will advise if the benefits justify the potential risks, and monitoring of the infant's liver enzymes might be considered.

Can ITRALASE SB(65MG) be taken with other medications?

Itraconazole can interact with many other medications, significantly affecting their efficacy or increasing the risk of side effects. It is crucial to inform your doctor about all medications you are taking, including over-the-counter drugs, herbal remedies, and supplements. Some specific interactions include:

• Antacids: These can reduce itraconazole absorption. Take antacids or acid reducers at least 2 hours before or 2 hours after ITRALASE SB(65MG).
• Contraindicated drugs: Several medications are contraindicated due to the risk of serious side effects, including certain cholesterol-lowering drugs (statins like lovastatin, simvastatin), blood thinners (warfarin), certain heart medications (e.g., felodipine, ranolazine, dronedarone, quinidine), and some anti-anxiety medications (e.g., alprazolam, oral midazolam, triazolam). Your doctor will need to review all your current medications.

What precautions should be taken while using ITRALASE SB(65MG)?

Before taking ITRALASE SB(65MG), inform your doctor if you have a history of liver disease, kidney disease, or heart conditions, especially congestive heart failure, as the medication can worsen these conditions. Avoid consuming alcohol during treatment, as it can increase the risk of liver strain and make dizziness worse. It is important to take this medicine with food to optimize absorption. Your doctor may perform blood tests to monitor liver function, especially during prolonged treatment. Do not stop taking the medication abruptly, even if your symptoms improve, to ensure the infection is fully cleared and prevent recurrence.

What happens if a dose of ITRALASE SB(65MG) is missed?

If you miss a dose of ITRALASE SB(65MG), take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.

How should ITRALASE SB(65MG) be stored?

Store ITRALASE SB(65MG) capsules at room temperature, away from moisture, heat, and direct light. Do not freeze the medicine. Keep it out of the reach of children and pets.