Posac^®

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Posac^® delayed release tablet is indicated for-

• Treatment of invasive Aspergillosis in adults and pediatric patients 13 years of age and older.
• Prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy in adults and pediatric patients 2 years of age and older who weigh greater than 40 kg.

Route of administration: Posac^® delayed release tablet should be given orally with or without food. Swallow tablets whole. Do not divide, crush, or chew.

Adult

Children (ages 2 to less than 18 years of age)

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Posaconazole should be used in pregnancy only if the potential benefit outweighs the potential risk to the fetus.
Lactation: Discontinue drug or nursing, taking into consideration the importance of drug to the mother.
Use in children and adolescents
The safety and efficacy of posaconazole in pediatric patients younger than 2 years of age and weighting less then 40 kg have not been established.

Calcineurin-inhibitor toxicity: Posaconazole increases concentrations of cyclosporine or tacrolimus; reduce dose of cyclosporine and tacrolimus and monitor concentrations frequently.
Arrhythmias and QTc prolongation: Posaconazole has been shown to prolong the QTc interval and cause cases of Torsades de Pointes (TdP). Administer with caution to patients with potentially proarrhythmic conditions. Do not administer with drugs known to prolong QTc interval and metabolized through CYP3A4.
Electrolyte disturbances: Monitor and correct, especially those involving potassium (K+), magnesium (Mg++) and calcium (Ca++), before and during posaconazole therapy.
Hepatic toxicity: Elevations in liver tests may occur. Discontinuation should be considered in patients who develop abnormal liver tests or monitor liver tests during treatment.
Breakthrough fungal infections: Monitor patients with severe diarrhea or vomiting when receiving posaconazole delayed release tablets.

The most common side effects are diarrhea, nausea, fever, vomiting, headache, coughing and hypokalemia.

It is contraindicated in patients with known hypersensitivity to posaconazole or any of its components or other azole antifungal agents. It is also contraindicated in patients receiving the drugs [sirolimus, CYP3A4 substrates (pimozide, quinidine), HMG-CoA reductase inhibitors primarily metabolized through CYP3A4, ergot alkaloids] as because posaconazole increases the concentrations of that drugs.

Drug interaction with medication: Posaconazole is primarily metabolized via UDP glucuronidation (phase 2 enzymes) and is a substrate for p-glycoprotein (P-gp) efflux. Therefore, inhibitors or inducers of these clearance pathways may affect posaconazole plasma concentrations. Rifabutin, phenytoin, cimetidine, efavirenz, esomeprazole, metoclopramide will affect posaconazole concentrations. Co-administration of these drugs with posaconazole may result in lower plasma concentrations of posaconazole. Posaconazole is a potent inhibitor of CYP3A4. Co-administration of posaconazole with CYP3A4 substrates may result in large increases the plasma concentrations of these drugs. Therefore, plasma concentrations of sirolimus, cyclosporine, tacrolimus, rifabutin, midazolam, phenytoin, ritonavir, atazanavir predominantly metabolized by CYP3A4 may be increased by posaconazole. Posaconazole administration with glipizide does not require a dose adjustment in either drug; however, glucose concentrations decreased in some patient after co-administration with glipizide. Thereafter, it is prudent to monitor blood glucose carefully when posaconazole is administered with glipizide.

Drug interaction with food and others: Not applicable.

There is no experience with overdosage of posaconazole. Posaconazole is not removed by hemodialysis. There is no special treatment available in the case of overdose with posaconazole. Supportive care may be considered.

Posac^® is the prepration of Posaconazole which blocks the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of cytochrome P-450 dependent enzyme lanosterol 14-α-demethylase responsible for the conversion of lanosterol to ergosterol in the fungal cell membrane. This results in an accumulation of methylated sterol precursors and a depletion of ergosterol within the cell membrane thus weakening the structure and function of the fungal cell membrane.

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Posac^® tablet: Each box contains 10 tablets in blister pack.