Tericin Injection

Amphotericin B (Liposomal)

50mg/vial

Beacon Pharmaceuticals Ltd.

Pack size	1's pack
Dispensing mode
Source
Agent
Retail Price	15045.10 AED

Indications

Tericin Injection is used for: Systemic fungal infections, Visceral leishmaniasis, Cryptococcal meningitis

Adult Dose

Adult: Intravenous Systemic fungal infections Indicated for treatment of Aspergillus species, Candida species, and/or Cryptococcus species infections As liposomal amphotericin B: Test dose 1 mg infused over 10 minutes, then 3 mg/kg once daily given via infusion over 30-60 minutes. Max: 5 mg/kg daily. Duration of treatment: At least 14 days. Cryptococcal Meningitis Indicated for treatment of Cryptococcal meningitis in HIV-infected patients 6 mg/kg IV qDay Visceral Leishmaniasis Indicated for treatment of visceral leishmaniasis Immunocompetent patients 3 mg/kg IV qDay on days 1-5, 14, and 21 May repeat course of therapy if parasitic clearance not achieved Immunocompromised patients 4 mg/kg IV qDay on days 1-5, 10, 17, 24, 31, and 38

Child Dose

Systemic Fungal Infections Test dose: 0.1 mg/kg IV, not to exceed 1 mg; administer over 20-60 min Initial dose: 0.25 mg/kg/dose IV qDay/qOD Maintenance: Increase by 0.25 mg/day increments as tolerated to 1-1.5 mg/kg/day

Renal Dose

Renal Impairment CrCl <10 mL/min: 0.5-0.7 mg/kg IV q24-48hr Consider other antifungal agents that may be less nephrotoxic Intermittent hemodialysis: 0.5-1 mg/kg IV q24hr after dialysis session Continuous renal replacement therapy: 0.5-1 mg/kg IV q24hr

Administration

IV Preparation Reconstitute by adding 12 mL sterile water for injection to 50 mg-vial (resulting concentration 4 mg/mL); do not use fluids containing NaCl or bacteriostatic agent Do not admix with other drugs or electrolytes Shake vial vigorously for 30 seconds Dilute further by withdrawing appropriate amount of reconstituted solution and adding to D5W to provide a final concentration of 1-2 mg/mL; lower concentrations (0.2-0.5 mg/mL) may be appropriate for infants and small children IV Administration May be infused through in-line filter provided pore diameter >1 micron May be administered through existing IV line; if doing so, flush line with D5W prior to infusion, otherwise use separate line Infuse over at least 2 hr using controlled infusion device; if well tolerated, infusion time may be reduced to 1 hr Infusion time may need to be increase if discomfort during infusion occurs Withdraw dosage amount into a syringe and inject through a 5-micron filter into appropriate amount of D5W Use a controlled infusion device and an inline filter (with a mean pore diameter >1 micron)

Contra Indications

Hypersensitivity; lactation; do not give to patients receiving antineoplastics.

Precautions

Indicated for patients with progressive and potentially fatal fungal infections Do not use for noninvasive fungal infections (eg, oral thrush, vaginal candidiasis, esophageal candidiasis) in patients with normal neutrophil counts Acute pulmonary toxicity reported with simultaneous leukocyte transfusions Therapy should be administered by medically trained personnel; during initial dosing period, patients should be under close clinical observation; this drug has been shown to be significantly less toxic than amphotericin B deoxycholate; however, adverse events may still occur

Pregnancy-Lactation

Pregnancy There have been no adequate and well-controlled studies in pregnant women; systemic fungal infections have been successfully treated in pregnant women with amphotericin B deoxycholate, but the number of cases reported has been small Animal data Studies in both rats and rabbits have concluded that this dosage form had no teratogenic potential in these species; in rats, maternal non-toxic dose of this drug was estimated to be 5 mg/kg (equivalent to 0.16 to 0.8 times the recommended human clinical dose range of 1 to 5 mg/kg) and in rabbits, 3 mg/kg (equivalent to 0.2 to 1 times the recommended human clinical dose range), based on body surface area correction Rabbits receiving the higher doses, (equivalent to 0.5 to2 times the recommended human dose) of this dosage form experienced a higher rate of spontaneous abortions than did the control groups Use during pregnancy if possible benefits to be derived outweigh potential risks involved Lactation Many drugs are excreted in human milk; however, it is not known whether this dosage form is excreted in human milk; due to potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or whether to discontinue the drug, taking into account importance of the drug to the mother

Interactions

Concurrent use of antineoplastic agents may enhance potential for renal toxicity, bronchospasm, and hypotension; antineoplastic agents should be given concomitantly with caution Concurrent use of corticosteroids and ACTH may potentiate hypokalemia, which could predispose patient to cardiac dysfunction; if used concomitantly, serum electrolytes and cardiac function should be closely monitored Concurrent use with digitalis glycosides may induce hypokalemia and may potentiate digitalis toxicity; when administered concomitantly, serum potassium levels should be closely monitored Concurrent use of flucytosine may increase toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion In vitro and in vivo animal studies of combination of amphotericin B and imidazoles suggest that imidazoles may induce fungal resistance to amphotericin B; combination therapy should be administered with caution, especially in immunocompromised patients Acute pulmonary toxicity has been reported in patients simultaneously receiving intravenous amphotericin B and leukocyte transfusions Concurrent use of amphotericin B and other nephrotoxic medications may enhance potential for drug-induced renal toxicity; intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications Amphotericin B-induced hypokalemia may enhance curariform effect of skeletal muscle relaxants (eg tubocurarine) due to hypokalemia; when administered concomitantly, serum potassium levels should be closely monitored Potentially Fatal: Potentiates K loss by corticosteroids. Avoid diuretics. Enhances digitalis toxicity and neuromuscular blocker effects.

Adverse Effects

Side effects of Amphotericin B (Liposomal) : >10% Anorexia,Chills,Diarrhea,Fever,Headache,Hypokalemia,Hypomagnesemia,Hypotension,Malaise,Nausea,Pain (generalized),Pain at injection site,Renal function abnormalities,Tachypnea,Vomiting 1-10% Arachnoiditis,Delerium,Flushing,Hypertension,Leukocytosis,Lumbar nerve pain,Paresthesia,Urinary retention <1% Agranulocytosis,Anuria,Bone marrow suppression,Cardiac arrest,Coagulation defects,Convulsions,Dyspnea,Hearing loss,Leukopenia,Maculopapular rash,Renal failure,Thrombocytopenia,Vision changes Potentially Fatal: Anaphylactic reaction; leucoencephalopathy. Overdosage can result in cardio-respiratory arrest.

Mechanism of Action

Amphotericin B is a polyene antifungal antibiotic which alters cell membrane permeability by binding to ergosterol, thus causing leakage of cell components and subsequent cell death. It is active against Absidia spp, Aspergillus spp, Basidiobolus spp, B. dermatitidis, Candida spp, C. immitis, Conidobolus spp, C. neoformans, H. capsulatum, Mucor spp, P. brasiliensis, Rhizopus spp, Rodotorula spp. and S. schenckii.

Note

Tericin 50mg/vial Injection manufactured by Beacon Pharmaceuticals Ltd.. Its generic name is Amphotericin B (Liposomal). Tericin is availble in Bangladesh. Farmaco BD drug index information on Tericin Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.