POSACONAZOLE suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POSACONAZOLE (UNII: 6TK1G07BHZ) (POSACONAZOLE - UNII:6TK1G07BHZ)

Available from:

Hikma Pharmaceuticals USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Posaconazole is indicated for the 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 [see Clinical Studies ( 14.2 )] as follows: Posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole in adults and pediatric patients 13 years of age and older. Posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. Posaconazole is contraindicated with sirolimus. Concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity [see Drug Interactions (7.1) a

Product summary:

Posaconazole Oral Suspension Posaconazole oral suspension is available as a white to off-white, cherry brandy flavored suspension in 4-ounce (120 mL) amber glass bottles with child-resistant closures containing 105 mL of suspension (40 mg of posaconazole per mL). NDC 0054-0449-49: Bottle of 105 mL Supplied with each oral suspension bottle is a plastic dosing spoon calibrated for measuring 2.5-mL and 5-mL doses. Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature.] DO NOT FREEZE.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POSACONAZOLE- POSACONAZOLE SUSPENSION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POSACONAZOLE ORAL
SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR POSACONAZOLE
ORAL SUSPENSION.
POSACONAZOLE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Indications and Usage (1) 6/2021
Dosage and Administration (2) 6/2021
Contraindications (4) 1/2022
Warnings and Precautions (5) 1/2022
INDICATIONS AND USAGE
Posaconazole is an azole antifungal indicated as follows:
•
•
DOSAGE AND ADMINISTRATION
•
•
TABLE 1: RECOMMENDED DOSAGE IN ADULT PATIENTS
INDICATION
DOSAGE FORM, DOSE, AND DURATION OF THERAPY
Prophylaxis of invasive
_Aspergillus_ and _Candida_
infections
POSACONAZOLE ORAL SUSPENSION: 200 mg (5 mL) three times a day.
Duration
of therapy is based on recovery from neutropenia or immunosuppression.
(2.2,
2.3)
Oropharyngeal
Candidiasis (OPC)
POSACONAZOLE ORAL SUSPENSION:
Loading Dose: 100 mg (2.5 mL) twice a day on the first day.
Maintenance Dose: 100 mg (2.5 mL) once a day for 13 days. (2.2, 2.3)
OPC Refractory (rOPC)
to Itraconazole and/or
Fluconazole
POSACONAZOLE ORAL SUSPENSION: 400 mg (10 mL) twice a day. Duration of
therapy is based on the severity of the patient’s underlying disease
and clinical
response. (2.2, 2.3)
•
DOSAGE FORMS AND STRENGTHS
Posaconazole oral suspension: 40 mg per mL (3)
CONTRAINDICATIONS
POSACONAZOLE is indicated for the 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 as follows: (1.2)
o
POSACONAZOLE ORAL SUSPENSION: adults and pediatric patients 13 years
of age and older
POSACONAZOLE ORAL SUSPENSION is indicated for the treatment of
oropharyngeal cand