Itraconazole 130 mg (Supra Bioavailable Formulation) Capsules.

REALZOLE-130 SB is the next-generation oral antifungal capsule containing Itraconazole 130 mg in the Supra Bioavailable (SB) formulation offered by Bioglint Derma Care. This designation of SB (Supra Bioavailable) has an important meaning in medicine since the usual Itraconazole capsules have highly inconsistent and low oral bioavailability (about 55% in the optimal fed state and only 30% in the fasted state) due to its lipophilicity and pH-dependent solubility. The novel drug formulation, Itraconazole 130 mg Capsules, uses modern methods of pharmaceutical production, including solid dispersion, SMEDDS (Self-Microemulsifying Drug Delivery System), and nanoparticle formulation, to increase the dissolution and absorption of Itraconazole in the GI tract and ensure the plasma drug concentration is not less than that in the case of using usual Itraconazole capsules (200 mg).

In other words, Itraconazole 130 mg Capsules provides a similar clinical efficacy to the usual 200 mg Itraconazole capsules but in a smaller dosage and with better consistency of drug absorption in different conditions of its use and, possibly, better tolerability and safety for the liver. REALZOLE-130 SB is distributed via Bioglint Derma Care’s Derma PCD Franchise — the exclusive antifungal drug for dermatologists dealing with onychomycosis, dermatophytosis, and systemic fungal infections.

Uses and Indications

Indications of REALZOLE-130 SB capsules include the following conditions as per the prescription of dermatologists and doctors for their systemic management:

• Onychomycosis (Nail Fungus) – the major and most commonly used dermatological indication; nail fungus of fingers as well as toes due to dermatophytes, Candida, and non-dermatophytic moulds
• Tinea corporis, tinea cruris, and tinea pedis – moderate to severe or extensive dermatophyte infections that require systemic antifungal treatment
• Tinea capitis – Scalp ringworm that requires systemic antifungal treatment
• Pityriasis versicolor (tinea versicolor) – generalised or recurrent Malassezia skin infection
• Oral and oesophageal candidiasis – Candida infection of mouth and food pipe
• Systemic candidiasis – Candida infections of internal organs in appropriate clinical settings
• Aspergillosis – pulmonary and invasive aspergillosis as per directions of specialists
• Cryptococcosis – in course of treatment or secondary prophylaxis under the direction of specialists
• Blastomycosis, Histoplasmosis and other endemic mycoses

How Itraconazole 130 mg Capsules Works

Itraconazole is a chemical triazole antifungal that inhibits the activity of lanosterol 14α-demethylase (CYP51A1), an enzyme involved in the biosynthesis of ergosterol, a major sterol found in the fungal cell membrane. Since Itraconazole blocks the activity of CYP51A1, ergosterol levels become depleted while the toxic methylated sterols accumulate within fungal cells. Therefore, Itraconazole leads to damage to cell membrane integrity, increased membrane permeability, fungal cell growth inhibition, and ultimately cell death.

Supra Bioavailable (SB) form of REALZOLE-130 SB utilises the latest drug delivery system in order to address the major pharmacokinetic issues related to conventional Itraconazole. In particular, Itraconazole demonstrates limited solubility in aqueous environments, which is dependent on the acidity of pH, and its lipophilic nature leads to low and inconsistent absorption in the gastrointestinal tract, especially when taken in conjunction with meals. For this reason, the SB form ensures that Itraconazole is delivered in a soluble form, leading to rapid and complete dissolution regardless of pH and the presence of food and increased plasma concentrations of Itraconazole and hydroxy-itraconazole (metabolite). As a result, dose equivalency between the current form and traditional 200 mg can be achieved due to the reduced dosage.

Dosage and Administration

Itraconazole 130 mg Capsules are for oral use only. The dose, frequency, and duration of therapy are strictly as prescribed by a dermatologist or physician based on the indication, severity of infection, and patient clinical status. For onychomycosis, the pulse dosing regimen (one course of 130 mg SB daily for one week per month, repeated for 2–3 courses) or continuous dosing may be prescribed. For other indications, continuous daily dosing for the recommended duration is standard. Due to the Supra Bioavailable formulation, food restrictions that apply to conventional Itraconazole capsules may be relaxed — follow the prescribing doctor’s specific instructions on food intake. Do not exceed the prescribed dose.

Side Effects

Itraconazole 130 mg Capsules SB is normally well tolerated at prescribed dosages and duration. The possible side effects include:

• Nausea or mild stomach upset – the commonest of all side effects and temporary
• Headache or dizziness
• Pain in abdomen or diarrhoea
• Increased liver enzymes (AST/ALT) – check for liver function tests during long-term treatment
• Skin rash or hives
• Peripheral oedema – fluid accumulation in a few patients
• Hypertension due to negative inotropic effect of Itraconazole – caution in patients with heart problems
• Rarely, severe hepatic toxicity – should be stopped if symptoms of jaundice or dark colored urine appear
• Rarely, congestive heart failure – Itraconazole causes a negative inotropic effect; not used in patients with ventricular dysfunction

Stop the medication and consult your dermatologist or physician immediately if you develop any severe side effects.

Precautions and Warnings for Itraconazole 130 mg Capsules

• To be used strictly under the guidance of a qualified dermatologist or physician
• Inform the prescribing physician of any other medications that are being taken simultaneously, as Itraconazole has several drug interactions through the CYP3A4 enzyme system
• Liver function should be assessed before starting treatment in patients with risks of liver problems, and monitored at regular intervals during long-term treatment
• The treatment should be discontinued if any evidence of liver damage appears (jaundice, dark urine, abdominal pain, nausea)
• Itraconazole is absolutely contraindicated in pregnancy as it is teratogenic; contraceptive methods are to be used during treatment and 2 months after discontinuation in women of reproductive age
• Do not use in patients with ventricular dysfunction or heart failure as Itraconazole causes inotropic depression
• Itraconazole can be used cautiously in patients with kidney problems as hydroxy-Itraconazole tends to accumulate in cases of severe renal dysfunction
• Do not take while drinking grapefruit juice as it acts as an inhibitor of CYP3A4 and raises the level of Itraconazole in blood
• Keep out of reach of children

Storage Instructions

Store below 25°C in a cool and dry place, protected from light and moisture. Keep in original blister packaging and out of reach of children. Do not use after the printed expiry date.

Derma PCD Franchise for Itraconazole 130 mg Capsules – Bioglint Derma Care

Join hands with us and be a partner of Bioglint Derma Care for Derma PCD Franchise of REALZOLE-130 SB and the full range of Bioglint Itraconazole. Supra Bioavailability: Itraconazole is the high-end formulation in terms of prescription of oral antifungal medications in dermatology. The clinical superiority of REALZOLE-130 SB to 200 mg standard Itraconazole at 130 mg is an excellent differentiating factor that works well for dermatologists, thereby making it easier for franchisees to create a premium antifungal brand position.

Why choose Bioglint Derma Care for Derma PCD Franchise?

• Monopoly-based Derma PCD Franchise rights for REALZOLE-130 SB and the entire Bioglint range in your district or state
• High-end antifungal product with differentiated SB clinical superiority over standard Itraconazole capsules
• Portfolio of full derma products in the form of capsules, tablets, creams, gels, shampoos, lotions, soaps, etc.
• Quality manufacturing ensuring efficacy and safety of product
• Profitable pricing and competitive pricing across all derma formulations
• Promotional aids free of cost – VAs, MR Bags, sample kits, reminder cards, literature, etc.
• Pan India distribution network with assured logistics support and order fulfilment
• Professional support from franchise team for growth and development

Disclaimer: REALZOLE-130 SB is a Schedule H prescription-only medicine. Use strictly under the supervision of a registered dermatologist or qualified physician. This document is for informational and Derma PCD Franchise marketing purposes only and does not constitute medical advice.