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Voriconazole Eye Drops

Description

Voriconazole Eye Drops

For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only.

Vorishov™

वोरिशोव Eye Drops 💧

COMPOSITION:

Voriconazole IP …… 1% w/v
Sterile Aqueous Base …… q.s.

DESCRIPTION:

Vorishov Eye Drops is an antifungal drug to treat serious fungal infections.

CLINICAL PHARMACOLOGY

Vorishov Eye Drops is a triazole antifungal agent. The primary mode of action of Voriconazole is the inhibition of fungal cytochrome p-450 mediated 14 alpha lanosterol demethylation, an essential step in fungal ergosterol biosynthesis. The accumulation of 14 alpha-methyl sterols correlated with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the antifungal activity of voriconazole. It is more selective for fungal cytochrome P-450 enzymes than for various mammalian cytochrome P-450 systems.

INDICATIONS

In the treatment of fungal keratitis and infections like treatment of invasive aspergillosis in clinical trials. Treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in patient’s intolerant of or refractory to other medications.

In-vitro studies have shown Voriconazole exhibits broad spectrum of action against yeast and yeast-like species (Candida albicans, Candida parapsilosis, Candida tropicalis, Cryptococcus neoformans), moniliaceous molds (Aspergillus fumigatus, Aspergillus flavus, Fusarium species, Paecilomyces lilacinus, Acremonium alabamensis), dimorphic fungi (Blastomyces dermatitidis, Coccidioides immitis, Histoplasma capsulatum, Penicillium marneffei), dematiaceous fungi (Curvularia species, Scedosporium apiospermum). Clinical Efficacy 2.

CONTRAINDICATIONS

Known hypersensitivity to voriconazole or its excipients. It is also contraindicated with:

CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine can lead to QT prolongation.
Sirolimus – will significantly increase sirolimus concentrations (in healthy subjects).
Rifampin, carbamazepine and long-acting barbiturates.
Rifabutin – significantly increases rifabutin plasma concentrations and rifabutin also significantly decreases voriconazole plasma concentrations.
Ergot alkaloids – may increase the plasma concentration of ergot alkaloids, which may lead to ergotism.

WARNINGS

Not for injection. For topical use only. Do not touch the nozzle tip to any surface, since this may contaminate the solution.

PRECAUTIONS

Vorishov Eye Drops may cause allergic reactions to other azoles. Caution should be used in prescribing Voriconazole to patients with hypersensitivity to other azoles.

INTERACTIONS WITH OTHER MEDICATIONS

Concomitant use of certain drugs can alter the Voriconazole activity. Cyclosporine, Macrolide antibiotics, Terfenadine, Astemizole, Prednisolone, Benzodiazepines and Warfarin.

PREGNANCY & LACTATION USE PRECAUTIONS

Voriconazole can cause fetal harm; should not be used by pregnant woman unless the benefit clearly outweighs the risk. Vorishov Eye Drops should not be used by nursing mothers unless the benefit clearly outweighs the risk. Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

ADVERSE REACTIONS

No reported adverse reaction, sometimes it may cause visual disturbances like mild transient stinging, and burning sensation, headache and photophobia. The visual symptoms spontaneously resolve within 60 min.

DOSAGE & ADMINISTRATION

As directed by the Physician.

STORAGE

Store in a cool, dry & dark place below 30°C. Protect from light & moisture. Do not allow to freeze.

PACKAGING INFORMATION

Vorishov Eye Drops is available in 5 ml LDPE vial.

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