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Molecule

Posaconazole

Azole Antifungal
Available on requestOrphanCold chainAntifungals
Presentations
8
Brands
1
Manufacturers
1
Available from stock
0

Posaconazole is an azole antifungal indicated as follows, among other approved uses. It is available as delayed-release tablets, injection and tablets for oral and intravenous use. MedsAcross supplies Posaconazole for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Azole Antifungal
ATC classification
J02AC04 Posaconazole · Antifungals for systemic use, subgroup J02A, subgroup J02AC
US FDA first approval
15 September 2006
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral, Intravenous
Dosage forms
Delayed-release tablet, Injection, Tablet, Oral suspension, Powder for oral suspension
Identifiers
UNII 6TK1G07BHZRxCUI 282446CAS 171228-49-2DrugBank DB01263Q906453

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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 2 years of age and older who weigh greater than 40 kg.

Source: US FDA prescribing information

Dosing overview

Posaconazole formulations are supplied in different dose strengths of posaconazole, are approved for different indications, age groups, and weights, have different dosages and duration of therapy, and have different preparation and administration instructions. 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. Administer Posaconazole delayed-release tablets with or without food. Administer Posaconazole oral suspension with a full meal. See the full prescribing information for important administration and preparation instructions for Posaconazole (delayed-release tablets and Posaconazole oral suspension.

Source: US FDA prescribing information

Contraindications

Known hypersensitivity to posaconazole or other azole antifungal agents. Coadministration of posaconazole with the following drugs is contraindicated: posaconazole increases concentrations and toxicities of: Sirolimus. CYP3A4 substrates (pimozide, quinidine): can result in QTc interval prolongation and cases of torsades de pointes (TdP). HMG-CoA Reductase Inhibitors Primarily Metabolized through CYP3A4. Ergot alkaloids. Venetoclax: In patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) at initiation and during the ramp-up phase

Source: US FDA prescribing information

Warnings and precautions

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 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. Pseudoaldosteronism: Manifested by the onset or worsening of hypertension, and abnormal laboratory findings. Monitor blood pressure and potassium levels, and manage as necessary. Hepatic Toxicity: Elevations in liver tests may occur.

Source: US FDA prescribing information

Side effects

The following serious and otherwise important adverse reactions are discussed in detail in another section of the labeling: Arrhythmias and QT Prolongation Electrolyte Disturbances Pseudoaldosteronism Hepatic Toxicity Common adverse reactions in studies with posaconazole are diarrhea, nausea, fever, vomiting, headache, coughing, and hypokalemia.

Source: US FDA prescribing information

Interactions

Table 12 and Table 13 include drugs with clinically important drug interactions when administered concomitantly with posaconazole and instructions for preventing or managing them. Table 14 includes important drug interactions specific to the absorption of posaconazole administered as Posaconazole oral suspension. These recommendations are based on either drug interaction studies or predicted interactions due to the expected magnitude of interaction and potential for serious adverse reactions or loss of efficacy. The following information was derived from data with Noxafil oral suspension or another posaconazole tablet formulation unless otherwise noted.

Source: US FDA prescribing information

Storage

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). Posaconazole Oral Suspension Store at 25°C (77°F), excursions permitted to 15 to 30°C (59 to 86°F). DO NOT FREEZE.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

8 presentations of Posaconazole, sorted by availability.

MedicineManufacturerRegisterAvailability
Posaconazole 100 mg delayed-release tabletOralGeneric name—US FDAAvailable on request
Posaconazole 300.6 mg/16.7 mL injectionIntravenous Cold chainGeneric name—US FDAAvailable on request
Posaconazole 100 mg tabletOralGeneric name—US FDAAvailable on request
Posaconazole 40 mg/mL oral suspensionOralGeneric name—US FDAAvailable on request
Noxafil 100 mg tabletOral Cold chainMerck Sharp & DohmeUS FDAAvailable on request
Noxafil 300 mg powder for oral suspensionOral Cold chainMerck Sharp & DohmeUS FDAAvailable on request
Noxafil 300.6 mg/16.7 mL injectionIntravenous Cold chainMerck Sharp & DohmeUS FDAAvailable on request
Noxafil 40 mg/mL oral suspensionOral Cold chainMerck Sharp & DohmeUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 15 September 2006Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Posaconazole in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Posaconazole available for export from India?

Yes, on request. MedsAcross lists 8 presentations of Posaconazole and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Posaconazole have?

The catalogue lists 1 brand names for Posaconazole, including Noxafil.

Is Posaconazole approved by the US FDA?

Yes. The US FDA first approved Posaconazole on 15 September 2006, according to Drugs@FDA.

Is Posaconazole authorised in the European Union?

Yes. Posaconazole has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Posaconazole need cold chain shipping?

At least one listed presentation of Posaconazole must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Posaconazole in?

Posaconazole is classified under ATC code J02AC04 (Posaconazole).

References

  1. POSACONAZOLE prescribing information (Endo). U.S. National Library of Medicine, DailyMed. Retrieved 18 February 2026
  2. Noxafil: European public assessment report (EPAR). European Medicines Agency. Retrieved 1 July 2026
  3. Posaconazole Accord: European public assessment report (EPAR). European Medicines Agency. Retrieved 12 June 2026

Request Posaconazole for export supply

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