POSACONAZOLE tablet, coated POSACONAZOLE suspension

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

posaconazole (UNII: 6TK1G07BHZ) (posaconazole - UNII:6TK1G07BHZ)

Διαθέσιμο από:

Par Pharmaceutical Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Posaconazole delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. 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 (14.1)] as follows: - Posaconazole delayed-release tablets : adults and pediatric patients 2 years of age and older who weigh greater than 40 kg - Posaconazole oral suspension: adults and pediatric patients 13 years of age and older 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 o

Περίληψη προϊόντος:

Posaconazole Delayed-Release Tablets Posaconazole delayed-release tablets are available as yellow, coated, oblong, debossed with "100" on one side containing 100 mg of posaconazole. Bottles with child-resistant closures of 60 delayed-release tablets (NDC 0254-2045-02). Posaconazole Oral Suspension Posaconazole oral suspension is available as a white, cherry-flavored suspension in 4-ounce (123 mL) amber glass bottles with child-resistant closures (NDC 0254-1016-36) containing 105 mL of suspension (40 mg of posaconazole per mL). Supplied with each oral suspension bottle is a plastic dosing spoon calibrated for measuring 2.5-mL and 5-mL doses. Posaconazole Delayed-Release Tablets Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Posaconazole Oral Suspension Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.

Καθεστώς αδειοδότησης:

New Drug Application Authorized Generic

Φύλλο οδηγιών χρήσης

Par Pharmaceutical Inc.
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This Patient Information has been approved by the U.S.
Food and Drug Administration.
Revised: 05/2019
Patient Information
Posaconazole delayed-release tablets
What is posaconazole?
Posaconazole delayed-release tablets are a prescription medicines used
to help prevent fungal infections that
can spread throughout your body (invasive fungal infections). These
infections are caused by fungi called
Aspergillus or Candida. Posaconazole is used in people who have an
increased chance of getting these
infections due to a weak immune system. These include people who have:
•
had a hematopoietic stem cell transplantation (bone marrow transplant)
with graft versus host disease
•
a low white blood cell count due to chemotherapy for blood cancers
(hematologic malignancy)
posaconazole delayed-release tablets are for adults and children over
13 years of age.
It is not known if Posaconazole delayed-release tablets are safe and
effective in children under 13 years of
age.
Who should not take posaconazole?
Do not take posaconazole if you:
•
are allergic to posaconazole, any of the ingredients in posaconazole,
or other azole antifungal
medicines. See the end of this leaflet for a complete list of
ingredients in posaconazole.
•
are taking any of the following medicines:
•
sirolimus
•
pimozide
•
quinidine
•
certain statin medicines that lower cholesterol (atorvastatin,
lovastatin, simvastatin)
•
ergot alkaloids (ergotamine, dihydroergotamine)
Ask your healthcare provider or pharmacist if you are not sure if you
are taking any of these medicines.
Do not start taking a new medicine without talking to your healthcare
provider or pharmacist.
What should I tell my healthcare provider before taking posaconazole?
Before you take posaconazole, tell your healthcare provider if you:
•
are taking certain medicines that lower your immune system like
cyclosporine or tacrolimus.
•
are taking certain drugs for HIV infection, such as ritonavir,
atazanavir, efavirenz, or fosamprenavir.
Efavirenz

Αρχείο Π.Χ.Π.

POSACONAZOLE- POSACONAZOLE TABLET, COATED
POSACONAZOLE- POSACONAZOLE SUSPENSION
PAR PHARMACEUTICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POSACONAZOLE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR POSACONAZOLE.
POSACONAZOLE DELAYED-RELEASE TABLETS, FOR ORAL USE
POSACONAZOLE ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Contraindications (4)
1/2022
Warnings and Precautions (5)
1/2022
INDICATIONS AND USAGE
Posaconazole is an azole antifungal indicated as follows:
POSACONAZOLE DELAYED-RELEASE TABLETS are indicated for the treatment
of invasive aspergillosis in
adults and pediatric patients 13 years of age and older. (1.1)
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 2
years of age and older
who weigh greater than 40 kg
POSACONAZOLE ORAL SUSPENSION: adults and pediatric patients 13 years
of age and older
POSACONAZOLE ORAL SUSPENSION is indicated for the treatment of
oropharyngeal candidiasis (OPC),
including OPC refractory (rOPC) to itraconazole and/or fluconazole in
adult and pediatric patients aged
13 years and older. (1.3)
DOSAGE AND ADMINISTRATION
POSACONAZOLE 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. Therefore, follow the specific dosage
recommendations for each of the
formulations. (2.1, 2.2, 2.3)
Administer POSACONAZOLE DELAYED-RELEASE TABLETS with or without food.
(2.1)
Administer POSACONAZOLE ORAL SUSPENSION with a full meal. (