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OSAPIDERM DR
Incepta Pharmaceuticals Ltd.
Generic: Posaconazole
Safety Advices
বাংলা
English
CONSULT YOUR DOCTOR
It is not known whether it is safe to consume alcohol with OSAPIDERM DR. Please consult your doctor.
CONSULT YOUR DOCTOR
OSAPIDERM DR may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
CONSULT YOUR DOCTOR
OSAPIDERM DR is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
UNSAFE
OSAPIDERM DR may cause side effects which could affect your ability to drive.
As you may feel dizzy, sleepy, or have blurred vision while taking OSAPIDERM DR, which may affect your ability to drive.
CAUTION
OSAPIDERM DR should be used with caution in patients with kidney disease. Dose adjustment of OSAPIDERM DR may be needed. Please consult your doctor.
Regular monitoring of kidney function tests is advised while taking this medicine. Use of OSAPIDERM DR is not recommended in patients with moderate to severe kidney disease.
SAFE IF PRESCRIBED
OSAPIDERM DR is probably safe to use in patients with liver disease. Limited data available suggests that dose adjustment of OSAPIDERM DR may not be needed in these patients. Please consult your doctor.
Medicine Overview of OSAPIDERM DR 100mg Tablet
Introduction
OSAPIDERM DR belongs to a group of medicines called antifungals. It works by stopping the growth of fungus and is used to treat fungal infection. It kills fungi by destroying the fungal cell membrane. OSAPIDERM DR is an injectable drug and given as an injection by a healthcare professional. Do not self administered the injection. Your doctor or nurse will teach you the correct way of injecting it. To get the most benefit, take this medicine at evenly spaced times and continue using it until your prescription is finished, even if your symptoms disappear after a few days. If you...
... Show moreUses of OSAPIDERM DR
- Severe fungal infections
Side effects of OSAPIDERM DR
Common
- Headache
- Vomiting
- Cough
- Nausea
How to use OSAPIDERM DR
Your doctor or nurse will give you this medicine. Kindly do not self administer.
How OSAPIDERM DR works
OSAPIDERM DR is an antifungal medication. It kills fungi by destroying the fungal cell membrane. This treats your infection.
Quick Tips
- Your doctor has prescribed OSAPIDERM DR to cure your infection and improve symptoms.
- Do not skip any doses and finish the full course of treatment even if you feel better.
- It is given as an injection under the supervision of a healthcare professional.
- Your doctor may check your liver function before starting treatment and regularly thereafter. Inform your doctor if you notice yellowing of eyes or skin, dark urine, or stomach pain.
- Inform your doctor if you are pregnant, planning pregnancy or breastfeeding.
Brief Description
Indication
Prophylaxis of invasive Aspergillus, Candida Infections, Oropharyngeal candidiasis
Administration
IV Preparation Equilibrate the refrigerated vial to room temperature Aseptically transfer 16.7 mL (300 mg) of solution to an IV bag/bottle containing approximately 150 mL of 5% dextrose in water or sodium chloride 0.9% Should only be administered with these diluents; use of other infusion solutions may result in particulate formation Posaconazole injection is a single dose sterile solution without preservatives; once admixed, the product should be used immediately The diluted solution ranges from colorless to yellow IV Administration Must be administered through a 0.22 micron polyethersulfone (PES) or polyvinylidene difluoride (PVDF) filter Should be administered via a central venous...
... Show moreAdult Dose
Oral Prophylaxis of invasive fungal infections Adult: As delayed-release tab: 300 mg bid on the 1st day, then 300 mg once daily thereafter. As oral susp: 200 mg tid. Treatment duration is based on recovery from neutropenia or immunosuppression. Oral Oropharyngeal candidiasis Adult: As oral susp: 100 mg bid on the 1st day, then 100 mg once daily, for 13 days. Oropharyngeal candidiasis refractory to itraconazole and/or fluconazole Adult: As oral susp: 400 mg bid. Treatment duration is based on patient's underlying disease and clinical response. Intravenous Prophylaxis of invasive fungal infections Adult: 300 mg bid on the 1st day,...
... Show moreChild Dose
Invasive Aspergillus & Candida Infections Indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised (eg, hematopoietic stem cell transplant recipients with GVHD, hematologic malignancies with prolonged neutropenia from chemotherapy) 13 years Oral suspension: 200 mg (5 mL) TID Tablet: 300 mg PO BID on Day 1, then 300 mg PO qDay Duration of therapy is based on recovery from neutropenia or immunosuppression Oropharyngeal Candidiasis Oral suspension is indicated for oropharyngeal candidiasis 13 years Oral suspension: 100 mg (2.5 mL) PO BID on Day 1,...
... Show moreRenal Dose
Moderate-to-severe renal impairment (IV)
eGFR <50 mL/min: Avoid IV administration unless benefit/risk assessment justifies use
Accumulation of the IV vehicle, SBECD, is expected to occur
Serum creatinine levels should be closely monitored; if increases occur, consideration should be given to changing to oral posaconazole therapy
Severe renal impairment (tablets or oral suspension)
Variability of systemic exposure with tablets or oral suspension observed
Monitored closely for breakthrough fungal infections
Contraindication
Hypersensitivity. Co-admin w/ sirolimus, ergot alkaloids (e.g. ergotamine, dihydroergotamine), CYP3A4 substrates (terfenadine, astemizole, cisapride, pimozide, halofantrine, or quinidine), and HMG-CoA reductase inhibitors (e.g. simvastatin, lovastatin, atorvastatin).
Mode of Action
Blocks the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of the enzyme lanosterol 14-α-demethylase and accumulation of methylated sterol precursors. Posaconazole has activity against Candida spp., Aspergillus spp., Coccidioides immitis, Fonsecaea pedrosoi, and some species of Fusarium and zygomycetes.
Precaution
Patient w/ potentially proarrhythmic conditions. Hepatic impairment. Pregnancy and lactation. Patient Counselling May impair ability to drive or operate machinery.
Monitoring Parameters Monitor hepatic and renal function, electrolyte disturbances (e.g. Ca, Mg, K), CBC, breakthrough fungal infections and adequate oral intake.
Side Effect
>10%
Fever (45%)
Diarrhea (42%)
Nausea (38%)
Hypokalemia (30%)
Headache (28%)
Abd pain (27%)
Anemia (25%)
Cough (24%)
Nausea (38%)
Thrombocytopenia (29%)
Constipation (21%)
Dyspnea (20%)
Febrile neutropenia (20%)
Rigors (20%)
Rash (19%)
Bacteremia (18%)
HTN (18%)
Hypomagnesemia (18%)
Fatigue (17%)
Insomnia (17%)
Mucositis (17%)
Musculoskeletal pain (16%)
Anorexia (15%)
Herpes simplex (15%)
Leg edema (15%)
CMV infection (14%)
Epistaxis (14%)
Hypotension (14%)
Pharyngitis (12%)
Arthralgia (11%)
Dizziness (11%)
Hypoglycemia (11%)
Petechiae (11%)
Pruritus (11%)
Back pain (10%)
Dyspepsia (10%)
Vaginal hemorrhage (10%)
1-10%
Anxiety (9%)
Edema (9%)
Hypocalcemia (9%)
Weakness (8%)
URI (7%)
Pregnancy Category Note
Pregnancy Available data in pregnant women are insufficient to establish a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; based on findings from animal data, therapy may cause fetal harm when administered to pregnant women Animal data Skeletal malformations (cranial malformations and missing ribs) and maternal toxicity (reduced food consumption and reduced body weight gain) observed when dosed orally to pregnant rats; during organogenesis at doses greater than or equal to 1.4 times the 400 mg twice daily oral suspension regimen recommended in humans; in pregnant rabbits dosed orally during organogenesis, increased resorptions, reduced...
... Show moreInteraction
Decreased plasma concentrations w/ efavirenz, fosamprenavir, cimetidine, esomeprazole, metoclopramide, phenytoin and rifabutin. May increase plasma concentration of ritonavir and atazanavir. May increase risk of neurotoxicity w/ vinca alkaloids (e.g. vincristine, vinblastine). May increase plasma concentrations of tacrolimus, ciclosporin, midazolam, Ca channel blockers (e.g. verapamil, diltiazem, nifedipine, nicardipine, felodipine) and digoxin.
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