Description

SUBA vet-IT 50 Capsules

Super Bioavailable Itraconazole 50mg Capsules

Advanced anti-fungal delivery at a lower dose

Manufactured/ Marketed by: Vivaldis Animal Health

Dosage form: Capsules

Presentation: 

10x 1 x10 Capsules

Ingredients & Composition:

Itraconazole Capsules BP 50 mg
(Supra-bioavailable Formulation)

Description / Action: 

SUBA vet-IT 50 Capsules contain itraconazole. It is a triazole antifungal agent with broad spectrum activity. It interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert lanosterol to ergosterol.

Comparison with other azoles:
Itraconazole has in-vitro activity against a greater range of Candida species than fluconazole & safer than both amphotericin B and ketoconazole.
Preferred to ketoconazole due to increased activity? Better tolerated than ketoconazole in dogs & cats.

Itraconazole + SERBA technology
A novel formulation containing a solid dispersion of Itraconazole to enhance its dissolution & absorption.
Rapid and reliable attainment of therapeutic levels. SERBA technology delivers approximately double the bioavailability of conventional 100 mg Itraconazole capsules in a smaller 50 mg dose. High dissolution rate.

The science of SERBA technology
• A novel technology for enhancing the bioavailability of poorly soluble drugs
• Improved absorption in the gastrointestinal tract to achieve “super bioavailability” compared to conventional formulations
• SERBA produces microencapsulated nanoparticles of Itraconazole dispersed in a polymer matrix, instead of the conventional crystalline

Conventional Itraconazole (Capsule & Liquid)
• No advanced delivery technology
• Poor bioavailability of 50-55%
• Affected by food
• Affected by co-administration with Proton Pump Inhibotors
• Requires low pH (e.g., acidic stomach) to release and absorb drug
• Precipitates in higher pH of intestine
• High absorption variability
• High patient variability

SUBA vet-IT 50
• Unique Super Bioavailable delivery technology
• ~2x greater relative bioavailability 90-95%
• Maintained similar therapeutic concentration levels in fed and fasted states
• Absorption not reduced by co-administration with PPI
• Does not rely on an acidic stomach for dissolution due to SERBA technology
• Improved solubility in higher pH of intestine
• Improved absorption due to improved solubility
• Maintains therapeutic levels

Enhanced Absorption & Solubility
• Less soluble in the acidic environment of the stomach & soluble in the higher pH of the small intestine, resulting in improved absorption

Improved Bioavailability
• Delivers double bioavailability at half the dose of 50mg unlike conventional formulations of 100mg

Consistent Therapeutic Levels (Low patient variability)
• High variability in the absorption of conventional Itraconazole formulations can result in varying levels of safety & efficacy. SUBA vet-IT 50 maintains therapeutic levels in both fed & fasted conditions

Class: Anti-fungal/ Triazole

Indication / Uses:

Itraconazole is used in both dogs and cats to treat infections caused by fungi and yeast. These infections may affect the skin, paws, brain, respiratory tract, bone and other tissues.

Infections treated by Itraconazole include:
• Dermatophytosis (ringworm)
• Malassezia (yeast dermatitis)
• Blastomycosis
• Cryptococcosis (window washer’s disease)
• Histoplasmosis
• Aspergillosis
• Candidiasis

Features:

• Broad spectrum of activity than Fluconazole
• Excellent tissue distribution
• Useful and safe agent in empirical antifungal therapy
• Potent fungistatic
• No requirements of an acidic environment for dissolution
• Targeted drug release at the site of absorption (duodenum)
• No interaction with food
• Less intra and inter-subject variability
• Improved clinical efficiency
• Easier to swallow
• Smaller capsule

Dosage and administration:

Recommended dose for SUBAvet-IT 50 can be 2.5mg-5mg/kg body weight due to Super Bioavailability of Itraconazole.

Conventional Itraconazole is at the dose of 5mg-10mg/kg body weight

Route: Oral administration only.

Species: In Dogs and Cats.

Over-dosage / Side effects / Contraindications /Warnings:

Do not use in combination with immunosuppressive like ciclosporin and corticosteroids. As a side effect, mild GI signs and hepatic toxicosis can be observed. Do not use in case of known hepatic pathology. Never use without veterinarian’s advice.

Pharmaceutical precautions / Instructions: 

Store in a cool and dry place at room temperature.

Safety: Age / Pregnancy/ Withdrawal:

Do not use it in pregnant female dogs and cats.

 Substitute: Izof Oral Solution, Felintra Oral Solution, Itrapet Capsules, Tablets and Oral Suspension, Vetconazole Itraconazole Capsule 100 200 mg oral Solution 20 mg, Itron Tablet and Oral Suspension, Itron Tablet and Oral Suspension,