ITROSPIN-SB 130 Capsules – Itraconazole IP 130 mg

ITROSPIN-SB 130 contains Itraconazole IP 130 mg in a Supra-Bioavailable (SB) formulation. The uploaded artwork identifies it as an HPMC capsule, with 10 × 10 capsules per pack.

Super-bioavailable itraconazole is a modified formulation designed to provide more predictable itraconazole exposure than conventional itraconazole. In India, 130 mg is one of the recognized strengths of the SB itraconazole formulation.

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1. Product Information

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2. Composition

Each HPMC capsule contains:

Itraconazole IP — 130 mg

Excipients — q.s.

Approved colours used in empty capsule shells.

This composition and dosage form are based on the uploaded product artwork.

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3. What is ITROSPIN-SB 130?

ITROSPIN-SB 130 is an oral super-bioavailable itraconazole formulation.

Itraconazole is a broad-spectrum triazole antifungal that acts by inhibiting fungal ergosterol synthesis.

The SB formulation was developed to address some of the absorption variability associated with conventional itraconazole. Published pharmacokinetic research and Indian dermatology literature describe lower intersubject variability and improved/predictable exposure with SB itraconazole compared with conventional formulations.

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4. What Does “Supra-Bioavailable” Mean?

Conventional itraconazole capsules can have variable absorption.

The SB formulation uses a modified drug-delivery system intended to improve dissolution and drug exposure and make absorption less dependent on the acidic gastric environment.

Importantly, 130 mg SB itraconazole should not simply be treated as equivalent to 130 mg of conventional itraconazole.

The Indian regulatory and clinical literature recognizes SB itraconazole as a distinct formulation with different dosing.

Important statement for your website

ITROSPIN-SB 130 should not be substituted mg-for-mg with conventional itraconazole capsules without medical advice.

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5. Mechanism of Action

Itraconazole inhibits the fungal enzyme lanosterol 14-alpha-demethylase (CYP51).

This enzyme is necessary for the synthesis of ergosterol, an important component of the fungal cell membrane.

Mechanism

Itraconazole
↓
Inhibits fungal 14-alpha-demethylase
↓
Reduced ergosterol synthesis
↓
Disruption of fungal cell membrane
↓
Inhibition of fungal growth

This mechanism provides antifungal activity against susceptible fungal organisms.

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6. Therapeutic Uses

For the 130 mg supra-bioavailable formulation, Indian regulatory documentation identifies adult indications including:

1. Blastomycosis

Including:

• Pulmonary blastomycosis
• Extrapulmonary blastomycosis

2. Histoplasmosis

Including:

• Histoplasmosis
• Chronic cavitary pulmonary histoplasmosis
• Disseminated, non-meningeal histoplasmosis

3. Aspergillosis

Including:

• Pulmonary aspergillosis
• Extrapulmonary aspergillosis

particularly in patients who are intolerant to amphotericin B therapy, according to the Indian approval documentation.

The CDSCO documentation also specifies specialist prescription for the supra-bioavailable formulation.

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7. Dermatophytosis and Skin Fungal Infections

Super-bioavailable itraconazole is also being used and studied in India for dermatophytosis.

Clinical literature has evaluated SB itraconazole in conditions such as:

• Tinea corporis
• Tinea cruris
• Tinea faciei
• Extensive dermatophytosis
• Recurrent/recalcitrant dermatophytosis
• Onychomycosis

A 2024 Indian dermatologist consensus statement reported 130 mg once daily as the preferred SB itraconazole dose for dermatophytosis, with 65 mg twice daily considered when 130 mg once daily is not tolerated. The same consensus suggested 4–6 weeks for naïve dermatophytosis and 6–8 weeks for recalcitrant disease.

However, these are clinical consensus recommendations, not automatically the approved indication/dosing for every marketed product. Your final product page should follow the current approved package insert for ITROSPIN-SB 130.

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8. Clinical Evidence in Dermatophytosis

A randomized Indian clinical study evaluated:

• SB itraconazole 130 mg once daily
• Conventional itraconazole 200 mg once daily
• Conventional itraconazole 100 mg twice daily

in patients with glabrous tinea.

The study included 261 patients, with 240 included in the final analysis. At week 6, complete cure was reported in 69% of the analyzed SB-130 group, compared with 61% for conventional 200 mg once daily and 46% for conventional 100 mg twice daily. The study reported no statistically significant difference in mycological cure between groups and reported that all treatments were well tolerated.

This supports clinical evaluation of SB-130 in dermatophytosis, but it should not be converted into a blanket claim of superiority for every patient or infection.

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9. Dosage and Administration

Important

The 130 mg strength is specific to the supra-bioavailable formulation.

A 130 mg SB capsule should not be treated as equivalent to a 130 mg conventional itraconazole capsule.

For dermatophytosis, an Indian expert consensus recommends:

SB itraconazole 130 mg once daily

and, where 130 mg once daily is not tolerated:

65 mg twice daily.

For other systemic fungal infections, the appropriate dose and duration may differ.

Recommended website wording

Take ITROSPIN-SB 130 exactly as prescribed by the physician. The dose and duration depend on the type and severity of fungal infection and the patient’s clinical condition. Do not substitute ITROSPIN-SB 130 with conventional itraconazole capsules without medical advice.

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10. How to Take ITROSPIN-SB 130

The prescribing information for SB itraconazole recommends administration with food. Indian dermatology guidance also recommends following fed-condition administration because safety and pharmacokinetic data are established under those conditions.

General instructions

• Take the capsule with food as directed.
• Swallow the capsule whole.
• Do not crush or chew the capsule.
• Take it at approximately the same time each day when prescribed once daily.
• Complete the prescribed course.
• Do not independently change between SB and conventional itraconazole.

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11. Why the SB Formulation Matters

Itraconazole has historically demonstrated considerable interindividual variability in absorption.

The SB formulation uses a specialized drug-delivery system designed to improve exposure consistency.

The IADVL position statement reports substantially lower intersubject variability with SB itraconazole compared with conventional itraconazole and describes its absorption as less dependent on gastric acidity.

The Indian Pharmacopoeia Commission also recognizes 50 mg, 65 mg, 100 mg and 130 mg as usual strengths for supra-bioavailable itraconazole capsules.

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12. Drug Interactions

Itraconazole has a major drug-interaction profile, largely because of its strong inhibition of CYP3A4.

Potential interactions may occur with medicines used for:

• Heart disease
• Arrhythmias
• Hypertension
• Hyperlipidaemia
• Anticoagulation
• Immunosuppression
• Diabetes
• Anxiety/sedation
• Gastrointestinal conditions
• Other infections

Some combinations can result in substantially increased concentrations of the interacting medicine and potentially serious toxicity.

Patients should inform their physician about:

• Prescription medicines
• OTC medicines
• Vitamins
• Herbal supplements
• Other antifungals

A complete medication review is particularly important before starting treatment.

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13. Heart Failure Warning

Itraconazole has negative inotropic effects and can cause or worsen congestive heart failure.

Patients should inform their doctor if they have:

• Heart failure
• Cardiomyopathy
• Significant cardiac disease
• Previous unexplained swelling
• Significant shortness of breath

Seek medical attention if you develop:

• Shortness of breath
• Swelling of ankles or legs
• Sudden weight gain
• Difficulty breathing while lying down
• Unusual fatigue

The risk-benefit assessment is particularly important when prolonged itraconazole therapy is being considered.

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14. Liver Safety

Serious hepatic toxicity has been reported with itraconazole.

Patients should seek medical advice if they develop:

• Yellowing of skin or eyes
• Dark urine
• Persistent nausea
• Loss of appetite
• Severe fatigue
• Abdominal discomfort
• Unusual itching

Patients with pre-existing liver disease require particular medical consideration.

For prolonged treatment, clinicians may consider liver-function monitoring based on the clinical situation.

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15. Pseudoaldosteronism

Itraconazole has been associated with pseudoaldosteronism, which can involve:

• Increased blood pressure
• Low potassium
• Fluid retention
• Swelling
• Fatigue

Patients receiving prolonged therapy or those with relevant cardiovascular/metabolic conditions may require appropriate clinical monitoring.

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16. Peripheral Neuropathy

Peripheral neuropathy has been reported with itraconazole.

Patients should report:

• Tingling
• Numbness
• Burning sensations
• Unusual weakness
• Changes in sensation

Treatment may need to be reassessed if clinically significant neuropathy develops.

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17. Common Side Effects

Possible adverse effects include:

• Nausea
• Vomiting
• Abdominal discomfort
• Diarrhoea
• Headache
• Dizziness
• Dyspepsia
• Fatigue
• Rash

The incidence can vary according to dose, duration, formulation and individual patient characteristics.

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18. Serious Adverse Effects

Seek medical attention for:

Severe allergic reaction

• Difficulty breathing
• Facial swelling
• Swelling of lips/tongue/throat
• Severe rash

Liver injury

• Jaundice
• Dark urine
• Severe fatigue
• Persistent vomiting

Heart failure

• Breathlessness
• Leg swelling
• Sudden weight gain
• Difficulty lying flat

Cardiac rhythm problems

• Fainting
• Severe palpitations
• Irregular heartbeat

Severe skin reaction

• Blistering
• Skin peeling
• Extensive rash
• Mouth or eye involvement

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19. Contraindications and Precautions

ITROSPIN-SB 130 should not be used in patients with:

• Known hypersensitivity to itraconazole
• Certain serious drug interactions
• Certain cardiovascular conditions where itraconazole is contraindicated
• Other contraindications specified in the current product prescribing information

Particular caution may be required in:

• Liver disease
• Heart failure
• Cardiovascular disease
• Renal impairment
• Patients taking multiple medicines
• Long-term antifungal treatment

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20. Pregnancy

ITROSPIN-SB 130 should only be used during pregnancy when specifically considered appropriate by the treating physician.

Women who are:

• Pregnant
• Planning pregnancy
• Trying to conceive

should inform their healthcare professional before treatment.

The decision depends on the severity of the fungal infection and available treatment alternatives.

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21. Breastfeeding

Itraconazole can pass into breast milk.

The decision to use ITROSPIN-SB 130 during breastfeeding should be made by the treating physician after considering:

• Maternal indication
• Dose
• Duration
• Infant age
• Alternative treatment options

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22. Pediatric Use

The uploaded artwork does not provide a pediatric dosage.

For your product page:

ITROSPIN-SB 130 should not be administered to children unless specifically prescribed by a qualified healthcare professional.

The 2024 Indian dermatologist consensus reported negative consensus for routine SB itraconazole use in children aged 6–12 years, while it did not establish consensus for all adolescent dosing situations.

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23. Elderly Patients

Elderly patients may have:

• Reduced liver function
• Reduced kidney function
• Cardiovascular disease
• Multiple medicines

Therefore, the physician should review the patient’s medical history and concomitant medications before prescribing itraconazole.

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24. Driving and Machinery

Itraconazole may cause dizziness and, in some patients, visual disturbances.

Patients who experience dizziness, blurred vision or double vision should avoid driving or operating machinery until symptoms resolve.

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25. Storage

Store ITROSPIN-SB 130:

• In a cool and dry place
• Away from excessive heat
• Protected from moisture
• Away from direct sunlight
• Out of reach of children

Keep capsules in their original packaging.

Follow the storage conditions printed on the final marketed pack.

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26. Key Product Features

Itraconazole IP 130 mg

Contains 130 mg itraconazole in a specialized SB formulation.

Supra-Bioavailable Formulation

Designed to provide more consistent itraconazole exposure than conventional formulations.

HPMC Capsule

The product artwork specifies an HPMC capsule.

Once-Daily SB Strength

An Indian dermatologist consensus identifies 130 mg once daily as the preferred SB itraconazole dose for dermatophytosis, with 65 mg twice daily as an alternative when 130 mg once daily is not tolerated.

Specialist-Directed Prescription Product

Indian regulatory documentation specifies specialist prescription for the supra-bioavailable formulation.

Non-Interchangeable Formulation

The SB formulation should not be substituted mg-for-mg with conventional itraconazole.

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27. Why ITROSPIN-SB 130?

ITROSPIN-SB 130 combines itraconazole with a supra-bioavailable formulation designed to provide more predictable drug exposure.

Product highlights

• Itraconazole IP 130 mg
• Supra-Bioavailable formulation
• HPMC capsule
• Oral triazole antifungal
• Designed for improved consistency of exposure
• 130 mg strength recognized for SB itraconazole in India
• Suitable for physician-directed treatment of selected susceptible fungal infections

Avoid unsupported promotional claims such as “100% absorption,” “guaranteed cure,” “zero side effects,” or “best itraconazole.”