Posac
Generic Name
Posaconazole
Manufacturer
Example Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| posac 100 mg tablet | ৳ 200.00 | ৳ 2,000.00 |
Description
Overview of the medicine
Posaconazole is a triazole antifungal agent used to treat and prevent severe fungal infections in immunocompromised patients.
Uses & Indications
Dosage
Adults
Prophylaxis of invasive fungal infections: 300 mg (three 100 mg tablets) once daily on the first day, then 300 mg once daily. Oropharyngeal candidiasis: 100 mg (one 100 mg tablet) once daily for 7 days. Refractory OPC: 400 mg twice daily (oral suspension) or 300 mg once daily (tablets) after loading dose.
Elderly
No specific dose adjustment required based on age alone, but monitor for adverse effects.
Renal_impairment
No dose adjustment needed for mild to severe renal impairment. For end-stage renal disease (CrCl < 15 mL/min), monitor closely for adverse reactions.
How to Take
Delayed-release tablets should be swallowed whole with food to enhance absorption. Do not crush, chew, or break the tablets. Take at the same time each day.
Mechanism of Action
Posaconazole inhibits the enzyme lanosterol 14α-demethylase, which is involved in the synthesis of ergosterol, a vital component of fungal cell membranes. This disruption leads to fungal cell damage and death.
Pharmacokinetics
Onset
Antifungal effects typically seen within days to weeks, depending on the infection.
Excretion
Mainly excreted unchanged in feces (77%), with a minor portion excreted in urine (<15%).
Half life
Approximately 20-31 hours.
Absorption
Oral absorption of posaconazole delayed-release tablets is improved with food, especially high-fat meals. Bioavailability is approximately 50-60%.
Metabolism
Primarily metabolized via UDP-glucuronidation (UGT1A4 is the major enzyme). It is a substrate and strong inhibitor of CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to posaconazole or any component of the formulation.
- Co-administration with substrates of CYP3A4 that prolong the QT interval (e.g., quinidine, pimozide, cisapride, terfenadine, astemizole, halofantrine) due to risk of serious ventricular arrhythmias.
- Co-administration with ergot alkaloids (e.g., ergotamine, dihydroergotamine) due to risk of ergotism.
- Co-administration with HMG-CoA reductase inhibitors metabolized by CYP3A4 (e.g., simvastatin, lovastatin, atorvastatin) due to risk of rhabdomyolysis.
Drug Interactions
Vinca Alkaloids (e.g., Vincristine, Vinblastine)
Increased plasma concentrations may lead to neurotoxicity; avoid co-administration if possible.
Proton Pump Inhibitors (PPIs) and H2-receptor antagonists
May reduce posaconazole absorption, especially with oral suspension. Less pronounced effect with delayed-release tablets, but still monitor.
CYP3A4 Inducers (e.g., Rifampin, Phenytoin, Carbamazepine)
May significantly decrease posaconazole plasma concentrations, leading to reduced efficacy. Avoid co-administration.
CYP3A4 Substrates (e.g., Midazolam, Tacrolimus, Cyclosporine, Sirolimus, Calcium Channel Blockers)
Posaconazole is a strong CYP3A4 inhibitor; co-administration may increase plasma concentrations of these drugs, requiring dose adjustment and monitoring.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. In cases of overdose, supportive care is recommended. Hemodialysis is unlikely to remove posaconazole effectively.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if posaconazole is excreted in human milk; caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to posaconazole or any component of the formulation.
- Co-administration with substrates of CYP3A4 that prolong the QT interval (e.g., quinidine, pimozide, cisapride, terfenadine, astemizole, halofantrine) due to risk of serious ventricular arrhythmias.
- Co-administration with ergot alkaloids (e.g., ergotamine, dihydroergotamine) due to risk of ergotism.
- Co-administration with HMG-CoA reductase inhibitors metabolized by CYP3A4 (e.g., simvastatin, lovastatin, atorvastatin) due to risk of rhabdomyolysis.
Drug Interactions
Vinca Alkaloids (e.g., Vincristine, Vinblastine)
Increased plasma concentrations may lead to neurotoxicity; avoid co-administration if possible.
Proton Pump Inhibitors (PPIs) and H2-receptor antagonists
May reduce posaconazole absorption, especially with oral suspension. Less pronounced effect with delayed-release tablets, but still monitor.
CYP3A4 Inducers (e.g., Rifampin, Phenytoin, Carbamazepine)
May significantly decrease posaconazole plasma concentrations, leading to reduced efficacy. Avoid co-administration.
CYP3A4 Substrates (e.g., Midazolam, Tacrolimus, Cyclosporine, Sirolimus, Calcium Channel Blockers)
Posaconazole is a strong CYP3A4 inhibitor; co-administration may increase plasma concentrations of these drugs, requiring dose adjustment and monitoring.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Limited experience with overdose. In cases of overdose, supportive care is recommended. Hemodialysis is unlikely to remove posaconazole effectively.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if posaconazole is excreted in human milk; caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months, as indicated on the packaging.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Patent expired; generic versions available
Clinical Trials
Posaconazole has undergone extensive clinical trials demonstrating its efficacy and safety in various fungal infections and prophylaxis settings, leading to its approval.
Lab Monitoring
- Liver function tests (ALT, AST, alkaline phosphatase, bilirubin) at baseline and during treatment.
- Serum electrolyte levels (especially potassium and magnesium) as hypokalemia can increase risk of QT prolongation.
- ECG monitoring, especially in patients at risk for QT prolongation.
- Therapeutic drug monitoring (TDM) of posaconazole levels may be considered in certain patients (e.g., transplant recipients, severe hepatic impairment) to ensure adequate exposure and minimize toxicity.
Doctor Notes
- Emphasize taking tablets with food for optimal absorption.
- Be vigilant for drug-drug interactions, especially with CYP3A4 substrates/inducers and QT prolonging agents.
- Monitor liver function and electrolytes regularly.
Patient Guidelines
- Take the tablets with food to improve absorption.
- Swallow tablets whole; do not crush, chew, or break.
- Complete the full course of treatment as prescribed, even if symptoms improve.
- Report any unusual side effects or signs of liver problems (e.g., severe nausea, vomiting, yellowing of skin/eyes) to your doctor immediately.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Posaconazole may cause dizziness or visual disturbances. Patients should be advised to exercise caution when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain good hydration.
- Avoid alcohol consumption during treatment, as it may worsen liver side effects.
- Follow a healthy diet as recommended by your healthcare provider.
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