Antifungal Drugs

Critical Care Products

The infectious disease burden in India is among the highest in the world, and hospital-acquired infections are of particular concern. These infections pose a great risk to the timely recovery of patients and are associated with high mortality rates. As a result, critical care medicines play a vital role in reducing morbidity and mortality. In addition, critical care patients have life-threatening conditions requiring healthcare professionals to often use a multi-pronged treatment approach that can affect the cost of daily therapy.

To satisfy the unmet medical needs of seriously ill patients in intensive care units, Mylan India launched its Critical Care division in 2014, with several high quality, affordable antifungal and antibacterial therapies. 

  • AmBisome®

    Brand Name: AmBisome®
    Generic name: Liposomal Amphotericin B
    SKU: 50mg
    How supplied: Pack of 10 single-dose vials in 1 carton
    Storage Conditions (As per PI): Do not store above 25 degrees
    Pack shots:
    Abbreviated prescribed information: (Liposomal Amphotericin-B for Injection 50 mg) Powder for concentrate for dispersion for infusion. Each vial contains as active ingredient 50 mg of amphotericin B (50,000 units) encapsulated in liposomes. After reconstitution, the concentrate contains 4 mg/mL amphotericin B.
    Indications: AmBisome® is indicated in the treatment of
    1. Systemic fungal infections due to organisms susceptible to this anti-infective, such as cryptococcosis, North American blastomycosis, disseminated candidiasis, coccidioidomycosis, aspergillosis, histoplasmosis, mucormycosis and in the treatment of some cases of American mucocutaneous leishmaniasis.
    2. For the treatment of fever of unknown origin (FUO) in neutropenic patients. In this context, FUO is defined as persisting fever, unresponsive to at least 96 hours of antibiotic treatment; it is highly indicative for systemic fungal infection in this patient population. Before initiating AmBisome® treatment, common viral, parasitic or mycobacterial infections should also be excluded as far as possible as causes for the observed FUO.
    3. As the primary therapy of visceral leishmaniasis in immunocompetent patients including both adults and children. In immunocompromised patients (e.g. HIV positive) AmBisome® is also indicated as the primary therapy of visceral leishmaniasis.
    Dosage and administration: A test dose (1 mg) should be infused slowly for up to 10 minutes and the patient carefully observed for 30 minutes afterward. AmBisome® should be administered by intravenous infusion over a 30 - 60-minute period. For doses greater than 5mg/kg/day, intravenous infusion over a 2-hour period is recommended. The recommended concentration for intravenous infusion is 0.20 mg/mL to 2.00 mg/mL amphotericin B as AmBisome®. AmBisome® must be reconstituted using Sterile Water for Injection (without a bacteriostatic agent) and diluted in Dextrose solution (5%, 10% or 20%) for infusion only.
    • Adult Patients - Treatment of mycoses: Therapy is usually instituted at a daily dose of 1.0 mg/kg of body weight, and increased stepwise to 3.0 mg/kg, as required. A cumulative dose of 1.0 - 3.0 g of amphotericin B as AmBisome® over 3 - 4 weeks has been typical. Empirical treatment of febrile neutropenia: Therapy should be initiated at 1.0 mg/kg/ day; the dose may be raised to 3 mg/ kg/day if indicated. Treatment of visceral leishmaniasis: 1.0 to 1.5 mg/kg/day for 21 days or alternatively a dose of 3.0 mg/kg/day for 10 days.
    • Paediatric Patients: Both systemic fungal infections in children and presumed fungal infections in children with febrile neutropenia have been successfully treated with AmBisome®, without reports of unusual adverse events. AmBisome® has been studied in paediatric patients aged one month to 18 years old. Doses used in these clinical studies were the same as those used in adults on an mg/kg body weight basis.

    Disclaimer: For more details refer to full prescribing information leaflet.
    Liposomal Amphotericin B

  • Merowin®

    Brand Name: Merowin®
    Generic name: Meropenem inj.
    SKU: 1gm and 500mg
    How supplied: Single-dose vials available as mono cartons
    Storage Conditions (As per PI): Do not store above 25 degrees
    Abbreviated prescribed information: Merowin®(meropenem for injection) is a sterile white powder containing meropenem; 500 mg or 1g as the trihydrate blended with anhydrous sodium carbonate for constitution.
    Indications: Merowin® IV is indicated for treatment, in adults and children, of the following infections caused by single or multiple bacteria sensitive to Meropenem: Nosocomial pneumonias, Urinary Tract Infections, Intra-abdominal Infections, Gynaecological Infections, such as endometritis and pelvic inflammatory disease, Skin and Skin Structure Infections, Meningitis, Septicaemia, Empiric treatment, for presumed infections in adult patients with febrile neutropenia, used as monotherapy or in combination with anti-viral or anti-fungal agents. Merowin® has proved efficacious alone or in combination with other antimicrobial agents in the treatment of polymicrobial infections. There is no experience in paediatric patients with neutropenia or primary or secondary immunodeficiency.
    Dosage and Administration:
    1. Adults: The dosage and duration of therapy shall be established depending on the type and severity of the infection and the condition of the patient. The recommended daily dosage is as follows: 500 mg IV every 8 hours in the treatment of pneumonia, UTI, gynaecological infections such as endometritis, skin and skin structure infections.1 g IV every 8 hours in the treatment of nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients, septicaemia. In meningitis, the recommended dosage is 2 g every 8 hours. Dosage should be reduced in patients with a creatinine clearance of less than 51 ml/min.
    2. Paediatric patients: For children over 3 months and up to 12 years of age, the recommended dose is 10 - 20 mg/kg every 8 hours depending on the type and severity of infection, susceptibility of the pathogen and the condition of the patient. In children over 50 kg weight, the adult dosage should be used. In meningitis, the recommended dose is 40 mg/kg every 8 hours. There is no experience in children with renal impairment

    3. Disclaimer: For more details refer to full prescribing information leaflet.

    Brand Name: MICALAN™
    Generic name: Micafungin Sodium
    SKU: 50 mg (Lyophilized)
    How supplied: Single-dose vials available as mono cartons (Combipack)
    Storage Conditions (As per PI): Do not store above 25 degrees
    Pack shots:

    Micalan™  is an antifungal agent.

    Composition:  Micafungin Sodium for Injection 50 mg (Lyophilized) [COMBIPACK]. Each Combipack contains: (A) Micafungin Sodium for Injection 50 mg (Lyophilized). Each vial contains: Micafungin Sodium Equivalent to Micafungin 50 mg, Excipients q.s. (B) Sodium Chloride Injection IP 0.9% w/v (5 ml). Each ml contains: Sodium chloride IP 9 mg. Water for injections IP q.s.

    Dosage Form: Powder for solution for Infusion.
    Indication: Micafungin for Injection is indicated for the treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis, abscess, and esophageal candidiasis. For the prophylaxis of Candida infection in patients undergoing hematopoietic stem cell transplantation (HSCT). Prophylaxis of Aspergillus Infections in Patients Undergoing Hematopoietic Stem Cell Transplantation. Treatment of Patients with Fungemia, Respiratory mycosis, Gastrointestinal mycosis caused by Aspergillus Spp.
    Dosage:  Do not mix or co-infuse Micafungin sodium for injection with other medications. The dose is once daily. For Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses- 100 mg. For Treatment of Esophageal Candidiasis - 150 mg. For Prophylaxis of Candida and Aspergillus Infections in Hematopoietic Stem Cell Transplant (HSCT) Recipients - 50 mg.
    Administration: Reconstitute Micafungin Sodium for Injection vials by aseptically adding 5 mL of 0.9% Sodium Chloride solution for infusion (without a bacteriostatic agent). To minimize excessive foaming, gently dissolve the Micafungin Sodium powder by swirling the vial. Do Not Vigorously Shake the Vial. Visually inspect the vial for particulate matter and discoloration prior to administration. Micafungin Sodium for Injection 50 mg vial: after reconstitution, each mL contains 10 mg of micafungin. Do not use material if there is any evidence of precipitation or foreign matter. Aseptic technique must be strictly observed.

    Disclaimer:  For more details refer to full prescribing information leaflet.

  • Telanin®

    Brand Name: Telanin®
    Generic name: Teicoplanin
    SKU: 400mg
    How supplied: Single-dose vials

    Telanin® is a glycoside antibiotic. 

    Composition:  Each vial contains: Teicoplanin IP 400 mg, Excipients.q.s. One ampoule containing sterile water for injections IP.
    Indication: Teicoplanin Injection 400mg is indicated for use in serious gram +ve infection, staphylococcal infection in patients sensitive or unresponsive to penicillin and Cephalosporins CAPD related peritonitis, prophylaxis in orthopedic surgery at risk of gram +ve infections.
    Dosage: Prophylaxis: 400mg intravenously as a single dose at the induction of anaesthesia. Moderate infections: Skin and soft tissue infection, urinary tract infection, lower respiratory tract infection Loading dose: One single I.V. or I.M. injection of 400mg on the first day. Maintenance dose: A single i.v. or i.m. injection of 200mg daily. Severe infections: Joint and bone infection, septicaemia, endocarditis. Loading dose: Three 400mg i.v. injections, administered 12 hours apart. Maintenance dose: A single i.v. or i.m. injection of 400mg daily.
    Administration: The intravenous injection may be administered either as a bolus or as a 30-minute infusion. Only the infusion method must be used in neonates. The reconstituted solution may be injected directly, or alternatively diluted with 50 ml of 0.9% Sodium Chloride Injection or 5% Dextrose Injection for intravenous infusion.

    Disclaimer:  For more details refer to full prescribing information leaflet.

The product database is intended as a general reference source only and is not a substitute for qualified medical care from a licensed physician.

Caring for Seriously Ill Patients

Mylan India’s Critical Care division offers several high quality, affordable antifungal, antibacterial and anticoagulant therapies.

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