POSACONAZOLE tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Posaconazole (UNII: 6TK1G07BHZ) (Posaconazole - UNII:6TK1G07BHZ)

Available from:

Dr.Reddys Laboratories Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Posaconazole  delayed-release tablets are 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 chemotherap y [see Clinical Studies ( 14.2)] as follows: • Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older. Additional Pediatric Use information is approved for Merck Sharp & Dohme Corp.’s NOXAFIL (posaconazole delayed-release tablets). However, due to Merck Sharp & Dohme Corp.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Posaconazole delayed-release tablets are contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. Posaconazole delayed-release tablets are contraindicated wit

Product summary:

Posaconazole delayed-release tablets, 100 mg are available as brown, capsule shaped, bevelled edge, film-coated tablet, debossed with 470 on one side and plain on other side and free from physical defects. Bottles of 60 NDC 43598-470-60 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

POSACONAZOLE- POSACONAZOLE TABLET, DELAYED RELEASE
DR.REDDYS LABORATORIES INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POSACONAZOLE DELAYED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR POSACONAZOLE DELAYED-RELEASE TABLETS.
POSACONAZOLE DELAYED-RELEASE TABLETS, FOR ORAL USE
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:
• 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)
POSACONAZOLE DELAYED-RELEASE TABLETS: adults and pediatric patients 13
years of age and older .
DOSAGE AND ADMINISTRATION
• NOXAFIL ORAL SUSPENSION is not substitutable with POSACONAZOLE
DELAYED-RELEASE TABLETS or
NOXAFIL POWDERMIX FOR DELAYED-RELEASE ORAL SUSPENSION due to the differences
in the dosing of
each formulation.
• Administer POSACONAZOLE DELAYED-RELEASE TABLETS with or without
food. (2.1)
TABLE 1. RECOMMENDED DOSAGE IN ADULT PATIENTSAND PEDIATRIC PATIENTS
AGED 13 YEARS AND
OLDER
INDICATION
DOSAGE FORM, DOSE, AND DURATION OF THERAPY
Prophylaxis of invasive
_Aspergillus_ and
_Candida_ infections
POSACONAZOLE DELAYED-RELEASE TABLETS:
Loading dose: 300 mg (three 100 mg delayed-release tablets) twice a
day on the
first day.
Maintenance dose: 300 mg (three 100 mg delayed-release tablets) once a
day,
starting on the second day. Duration of therapy is based on recovery
from
neutropenia or immunosuppression. (2.2, 2.3)
DOSAGE FORMS AND STRENGTHS
• Posaconazole delayed-rele