Ayunova Pharmaceutical LLP

Product Name:

Fluconazole 150 mg Tablets BP

Description:

Fluconazole 150 mg Tablets BP is a broad-spectrum antifungal agent used for the treatment and prevention of fungal infections caused by susceptible Candida and other fungal species.

• Fluconazole – a triazole antifungal that inhibits fungal cytochrome P450 enzyme, preventing ergosterol synthesis and disrupting fungal cell membrane formation.

• Highly effective against vaginal candidiasis, oral thrush, systemic candidiasis, and cryptococcal infections.

• Offers high oral bioavailability, excellent tissue penetration, and convenient once-daily dosing, ensuring patient compliance.

Composition:

Each tablet contains:

• Fluconazole BP/USP – 150 mg

• Excipients: Suitable tablet base, binders, fillers, and disintegrants

Uses / Indications:

Fluconazole 150 mg Tablets are indicated for:

1. Vaginal candidiasis (yeast infection) – single-dose therapy

2. Oropharyngeal and esophageal candidiasis

3. Systemic Candida infections – bloodstream or disseminated candidiasis

4. Cryptococcal meningitis – in combination or maintenance therapy

5. Prophylaxis of fungal infections – in immunocompromised patients (HIV/AIDS, post-transplant)

6. Other fungal infections as determined by clinician

Dosage & Administration:

• Adults: One 150 mg tablet once daily or as prescribed

• Can be taken with or without food

• Duration depends on type and severity of infection

• Adjust dose in renal impairment

• Complete the full course to prevent relapse or resistance

Packaging:

• Blister packs: 1 / 2 / 4 / 7 tablets per strip

• Boxes with product information leaflet

Storage:

• Store below 25°C

• Protect from light and moisture

• Keep out of reach of children

Product Name:

Itraconazole 100 mg Tablets BP

Description:

Itraconazole 100 mg Tablets BP is a broad-spectrum triazole antifungal used for the treatment of various systemic and superficial fungal infections.

• Itraconazole – inhibits fungal cytochrome P450 enzyme, preventing ergosterol synthesis and compromising fungal cell membrane integrity.

• Effective against dermatophytes, Candida species, Aspergillus, and other pathogenic fungi.

• Provides excellent oral bioavailability, tissue penetration, and convenient dosing, making it ideal for hospital and outpatient antifungal therapy.

Composition:

Each tablet contains:

• Itraconazole BP/USP – 100 mg

• Excipients: Suitable tablet base, binders, fillers, and disintegrants

Uses / Indications:

Itraconazole 100 mg Tablets are indicated for:

1. Superficial Fungal Infections

   • Tinea corporis, tinea cruris, tinea pedis

2. Oral and Esophageal Candidiasis

3. Systemic Fungal Infections

   • Aspergillosis, histoplasmosis, blastomycosis

4. Onychomycosis (Nail Fungal Infection)

5. Other fungal infections as determined by clinician, particularly in immunocompromised patients

Dosage & Administration:

• Adults: 100 mg once or twice daily depending on type and severity of infection

• Take with food to enhance absorption

• Complete the full course to prevent relapse or resistance

• Dose adjustment may be required in hepatic impairment

Packaging:

• Blister packs: 10 / 14 / 20 / 28 tablets per strip

• Boxes with product information leaflet

Storage:

• Store below 25°C

• Protect from light and moisture

• Keep out of reach of childrens

Product Name:

Amphotericin B for Injection BP

Description:

Amphotericin B for Injection BP is a polyene antifungal antibiotic used for the treatment of serious systemic fungal infections.

It works by binding to ergosterol in fungal cell membranes, increasing membrane permeability, and causing fungal cell death. Amphotericin B is effective against a broad spectrum of fungi, including Candida species, Aspergillus species, Cryptococcus neoformans, and other systemic mycoses.

It is commonly used in immunocompromised patients, severe systemic fungal infections, and life-threatening mycoses.

Composition:

Each vial contains:

• Amphotericin B BP – 50 mg / 100 mg

• Excipients: q.s. for injection (lyophilized powder, usually with deoxycholate or lipid complex formulation)

After reconstitution with sterile water or suitable diluent, it is ready for intravenous (IV) infusion.

Uses / Indications:

Amphotericin B for Injection is indicated for:

1. Severe systemic fungal infections:

   • Candidemia and invasive Candida infections

   • Aspergillosis

   • Cryptococcal meningitis

   • Histoplasmosis, blastomycosis, and other systemic mycoses

2. Empirical therapy for febrile neutropenic patients

3. Leishmaniasis (visceral leishmaniasis)

4. Treatment of life-threatening fungal infections in immunocompromised patients

Dosage & Administration:

• Adults: 0.3–1 mg/kg/day IV infusion depending on infection severity and formulation

• Children: 0.3–0.7 mg/kg/day IV infusion

• Route: IV infusion over 2–6 hours (slow infusion to reduce toxicity)

• Monitoring: Renal function, electrolytes, and infusion reactions should be monitored during therapy

• Should be administered under medical supervision

Packaging:

• Vials: 50 mg / 100 mg per vial

• Lyophilized powder, single-use vials

• Bulk and institutional packaging available

Storage:

• Store below 25°C

• Protect from light and moisture

• Keep out of reach of children

Product Name:

Voriconazole for Injection BP

Description:

Voriconazole for Injection BP is a triazole antifungal agent used for the treatment of serious and invasive fungal infections.

It works by inhibiting fungal cytochrome P450-dependent 14α-lanosterol demethylation, which disrupts ergosterol synthesis, leading to fungal cell membrane dysfunction and death.

Voriconazole is effective against a broad spectrum of fungi, including Aspergillus species, Candida species, Fusarium, and Scedosporium. It is commonly used for immunocompromised patients, systemic mycoses, invasive aspergillosis, and severe Candida infections.

Composition:

Each vial contains:

• Voriconazole BP – 200 mg

• Excipients: q.s. for injection (lyophilized powder)

After reconstitution with sterile water or suitable diluent, it is ready for intravenous (IV) infusion.

Uses / Indications:

Voriconazole for Injection is indicated for:

1. Invasive fungal infections including:

   • Invasive aspergillosis

   • Serious Candida infections (including Candida krusei and Candida glabrata)

   • Fusariosis and Scedosporium infections

2. Systemic mycoses in immunocompromised patients

3. Empirical antifungal therapy for febrile neutropenic patients

4. Serious fungal infections not responding to amphotericin B

Dosage & Administration:

• Adults: 6 mg/kg IV every 12 hours for the first 24 hours (loading dose), followed by 4 mg/kg IV every 12 hours

• Children: 7 mg/kg IV every 12 hours (as per pediatric guidelines)

• Route: IV infusion over 1–2 hours

• Monitoring: Liver function tests and renal function should be monitored during therapy

• Should be administered under medical supervision

Packaging:

• Vials: 200 mg per vial

• Lyophilized powder, single-use vials

• Bulk and institutional packaging available

Storage:

• Store below 25°C

• Protect from light and moisture

• Keep out of reach of children

Product Name:

Caspofungin for Injection BP

Description:

Caspofungin for Injection BP is an echinocandin antifungal agent used for the treatment of serious systemic fungal infections, including invasive candidiasis and invasive aspergillosis.

It works by inhibiting β-(1,3)-D-glucan synthesis, an essential component of the fungal cell wall, leading to cell wall disruption and fungal cell death.

Caspofungin is effective against Candida species (including fluconazole-resistant strains) and Aspergillus species. It is particularly useful in immunocompromised patients, ICU settings, and severe fungal infections not responding to conventional therapy.

Composition:

Each vial contains:

• Caspofungin Acetate BP – 50 mg / 70 mg / 70 mg (depending on formulation)

• Excipients: q.s. for injection (lyophilized powder)

After reconstitution with sterile water or suitable diluent, it is ready for intravenous (IV) infusion.

Uses / Indications:

Caspofungin for Injection is indicated for:

1. Invasive candidiasis including:

   • Candidemia

   • Intra-abdominal candidiasis

   • Esophageal candidiasis

2. Invasive aspergillosis in patients who are refractory to or intolerant of other therapies

3. Empirical antifungal therapy in febrile neutropenic patients

4. Treatment of multidrug-resistant fungal infections in immunocompromised patients

Dosage & Administration:

• Adults:

  • Loading dose: 70 mg IV on day 1

  • Maintenance dose: 50 mg IV once daily

• Children: 50 mg/m² IV once daily (pediatric dosing as per guidelines)

• Route: IV infusion over 1 hour

• Monitoring: Liver function tests recommended during therapy

• Should be administered under medical supervision

Packaging:

• Vials: 50 mg / 70 mg per vial

• Lyophilized powder, single-use vials

• Bulk and institutional packaging available

Storage:

• Store below 25°C

• Protect from light and moisture

• Keep out of reach of children

Product Name

Vorinostat (SAHA) Tablets BP – 100 mg

Product Description

Vorinostat Tablets BP, also known as Suberoylanilide Hydroxamic Acid (SAHA), is an oral histone deacetylase (HDAC) inhibitor used for the treatment of cutaneous T-cell lymphoma (CTCL) and other malignancies.

Vorinostat inhibits HDAC enzymes, resulting in accumulation of acetylated histones and proteins, which promotes cell cycle arrest, apoptosis, and tumor suppression. It is especially effective in patients with progressive, persistent, or recurrent CTCL after prior systemic therapy.

Composition

Each film-coated tablet contains:

• Vorinostat BP – 100 mg

• Excipients: q.s.

Major Indications / Uses Primary Indications

• Cutaneous T-cell lymphoma (CTCL) in adults

• Treatment of progressive, persistent, or recurrent CTCL after prior systemic therapy

• Relapsed or refractory CTCL

Additional / Investigational Uses

• Other hematologic malignancies (as part of clinical trials or specialist supervision)

• Solid tumors expressing HDAC targets (off-label, under oncologist supervision)

Dosage & Administration

• Route: Oral

• Usual Dose: 400 mg daily (administered as 4 × 100 mg tablets or as prescribed by oncologist)

• Administration: Take with food to improve absorption and reduce gastrointestinal irritation

⚠ Monitor liver function, blood counts, and electrolytes regularly
⚠ Dose modification may be required for toxicity or hepatic impairment

Packaging Details

• Blister strips / HDPE bottles

• Hospital, institutional & export packaging available

Storage Conditions

• Store below 30°C

• Protect from light and moisture

• Keep out of reach of children

Product Description

Fluconazole IV Injection IP is a triazole antifungal medication used for the treatment and prevention of a wide range of fungal infections. It is administered intravenously and is especially useful in hospitalized patients or in cases where oral administration is not feasible. The injection works by inhibiting fungal cell membrane synthesis, thereby stopping the growth of fungi.

Composition

Each 100 ml contains:

• Fluconazole IP – 200 mg

• Water for Injection IP q.s.

Uses / Indications

Fluconazole IV Injection is indicated for:

• Candidemia and systemic candidiasis

• Oropharyngeal and esophageal candidiasis

• Cryptococcal meningitis

• Fungal urinary tract infections

• Prophylaxis of fungal infections in immunocompromised patients

• Severe fungal infections requiring IV therapy

Dosage & Administration

• Dosage: As prescribed by the physician

• Route: Intravenous infusion only

• Administer slowly by IV infusion under medical supervision

Storage Instructions

• Store below 25°C

• Protect from light

• Do not freeze

• Keep out of reach of children

Warnings & Precautions

• To be used only under medical supervision

• Use with caution in patients with liver or renal impairment

• Monitor liver function during prolonged therapy

• Not recommended in patients with known hypersensitivity to azole antifungals

Packaging Details

• Pack Size: 100 ml

• Packaging Type: Glass / Plastic IV bottle

• Form: Ready-to-use IV infusion

Regulatory Information

• Pharmacopoeia: IP

• Prescription Required: Yes

• Sterile: Yes

MYKES 50 mg – Micafungin Sodium for Injection Product Description

MYKES Injection contains Micafungin Sodium, an echinocandin class antifungal agent used for the treatment and prevention of serious fungal infections. It is effective against Candida and Aspergillus species and is commonly used in immunocompromised patients. The injection is supplied as a sterile lyophilized powder for intravenous administration after reconstitution.

Composition

Each vial contains:

• Micafungin Sodium
  (Equivalent to Micafungin IP/USP) – 50 mg

• Sterile excipients – q.s.

• Dosage Form: Lyophilized powder for injection

Uses / Indications

MYKES Injection is indicated for:

• Candidemia and other invasive Candida infections

• Esophageal candidiasis

• Prophylaxis of Candida infections in patients undergoing stem cell transplantation

• Invasive fungal infections caused by susceptible organisms

Dosage & Administration

• For intravenous (IV) infusion only

• To be reconstituted and diluted before administration

• Dosage and duration to be determined by a registered medical practitioner based on patient condition

Key Features

• Echinocandin class antifungal

• Effective against resistant Candida species

• Suitable for critical care and hospital use

• Lyophilized formulation for stability

Storage Instructions

• Store below 25°C

• Protect from light and moisture

• Do not freeze

• Keep out of reach of children

MYKES 100 mg – Micafungin Sodium for Injection Product Description

MYKES Injection contains Micafungin Sodium, an echinocandin class antifungal agent used in the treatment and prevention of serious fungal infections. It is particularly effective against Candida species and is used in patients with compromised immunity. The injection is supplied as a sterile lyophilized powder for intravenous infusion after reconstitution and dilution.

Composition

Each vial contains:

• Micafungin Sodium
  (Equivalent to Micafungin) – 100 mg

• Sterile excipients – q.s.

• Dosage Form: Lyophilized powder for injection

Uses / Indications

MYKES Injection is indicated for:

• Candidemia and other invasive Candida infections

• Esophageal candidiasis

• Prophylaxis of Candida infections in hematopoietic stem cell transplant patients

• Invasive fungal infections caused by susceptible organisms

Dosage & Administration

• For intravenous (IV) infusion only

• Must be reconstituted and diluted prior to administration

• Dosage and duration to be determined by a registered medical practitioner

Key Features

• Echinocandin class antifungal agent

• Effective against resistant Candida species

• Suitable for critical care and hospital use

• Stable lyophilized formulation

Storage Instructions

• Store below 25°C

• Protect from light and moisture

• Do not freeze

• Keep out of reach of children

Packaging Details

• Strength: 100 mg

• Pack Type: Glass vial

• Pack Size: 1 vial

Voriconazole Tablets 200 mg Product Description

Voriconazole Tablets contain Voriconazole, a broad-spectrum triazole antifungal agent used in the treatment of serious and life-threatening fungal infections. It is particularly effective against invasive aspergillosis, candidemia, and other severe fungal infections in immunocompromised patients. Voriconazole works by inhibiting fungal cell membrane synthesis, leading to fungal cell death. The tablets are intended for oral administration under strict medical supervision.

Composition

Each film-coated tablet contains:

• Voriconazole IP – 200 mg

• Excipients – q.s.

• Dosage Form: Film-coated tablet

Uses / Indications

Voriconazole Tablets are indicated for the treatment of:

• Invasive aspergillosis

• Serious Candida infections, including candidemia

• Scedosporiosis and fusariosis

• Other severe systemic fungal infections as prescribed by a specialist

Dosage & Administration

• For oral use only

• Dosage and duration as prescribed by a registered medical practitioner

• Tablets should be taken at least 1 hour before or after meals

• Swallow tablets whole with water; do not crush or chew

Key Features

• Broad-spectrum triazole antifungal

• Effective in invasive and resistant fungal infections

• IP-grade formulation

• Suitable for hospital and specialty care use

Storage Instructions

• Store below 25°C

• Protect from light and moisture

• Keep out of reach of children

Product Description

Voriconazole Tablets IP 200 mg are a broad-spectrum triazole antifungal medication used for the treatment of serious and invasive fungal infections. Voriconazole works by inhibiting fungal cell membrane synthesis, leading to fungal cell death. It is especially effective against Aspergillus and Candida species and is widely used in immunocompromised patients. The tablets are intended for oral administration under medical supervision.

Composition

Each film-coated tablet contains:

• Voriconazole IP – 200 mg

• Excipients – q.s.

Uses / Indications

Voriconazole Tablets IP 200 mg are indicated for the treatment of:

• Invasive aspergillosis

• Serious Candida infections, including fluconazole-resistant strains

• Scedosporiosis and fusariosis

• Other severe systemic fungal infections as prescribed

Dosage & Administration

• Dosage as prescribed by the physician

• Usually taken twice daily

• To be taken at least 1 hour before or after meals

• Swallow the tablet whole with water

Storage Instructions

• Store below 25°C

• Protect from light and moisture

• Keep out of reach of children