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Paxlovid

Paxlovid

ritonavir

nirmatrelvir

Manufacturer:

Pfizer Manufacturing Deutschland

Distributor:

Pfizer
Concise Prescribing Info
Contents
Each pink FC tab containing Nirmatrelvir 150 mg, each white to off-white FC tab containing ritonavir 100 mg
Indications/Uses
COVID-19 in adults not requiring supplemental O2 & at increased risk for progression to severe COVID-19.
Dosage/Direction for Use
Nirmatrelvir (two 150 mg or 300 mg) + ritonavir (one 100 mg or 100 mg) every 12 hr for 5 days. Moderate renal impairment (eGFR ≥30-<60 mL/min) 150 mg/100 mg every 12 hr for 5 days.
Administration
May be taken with or without food: Swallow whole, do not chew/break/crush.
Contraindications
Hypersensitivity. Serious &/or life-threatening reactions w/ alfuzosin; ranolazine; amiodarone, dronedarone, flecainide, propafenone, quinidine; fusidic acid; neratinib, venetoclax; colchicine; terfenadine; clozapine, lurasidone, pimozide, quetiapine; silodosin; eplerenone, ivabradine; dihydroergotamine, ergonovine, ergotamine, methylergonovine; cisapride; voclosporin; lovastatin, simvastatin; lomitapide; eletriptan; avanafil, sildenafil, tadalafil, vardenafil; clorazepate, diazepam, estazolam, flurazepam, oral midazolam & triazolam; tolvaptan. Potential for loss of virologic response & possible resistance w/ rifampicin; apalutamide; carbamazepine, phenobarb, phenytoin; St John's wort.
Special Precautions
Anaphylaxis & other hypersensitivity reactions. Risk for serious adverse reactions due to interactions w/ other medicinal products. Hepatotoxicity. Risk of HIV-1 resistance development. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not recommended in severe renal impairment or renal failure. Pre-existing liver diseases, enzyme abnormalities or hepatitis. Not recommended during pregnancy & in women of childbearing potential not using effective contraception. Not to be used during breast-feeding & 7 days after last dose. Ped patient <18 yr.
Adverse Reactions
Dysgeusia, headache; diarrhea, vomiting, nausea.
Drug Interactions
Concomitant administration w/ products that induce CYP3A may decrease plasma conc; inhibits CYP3A4 may increase plasma conc. May increase substrate conc w/ CYP2D6. Induced glucuronidation & oxidation by CYP1A2, CYP2C8, CYP2C9 & CYP2C19 may decreased systemic exposure & shorten therapeutic effect. Increase plasma conc of alfuzosin; amphetamine; buprenorphine, fentanyl, pethidine; ranolazine; amiodarone, dronedarone, flecainide, propafenone, quinidine, digoxin; abemaciclib, afatinib, apalutamide, ceritinib, dasatinib, nilotinib, vinblastine, vincristine, encorafenib, fostamatinib, ibrutinib, neratinib, venetoclax; dabigatran, rivaroxaban; ketoconazole; amitriptyline, fluoxetine, imipramine, nortriptyline, paroxetine, sertraline; colchicine; glecaprevir/pibrentasvir; fexofenadine, loratadine, terfenadine; efavirenz, maraviroc; bedaquiline, clarithromycin; erythromycin, itraconazole, fusidic acid, rifabutin; clozapine, pimozide, haloperidol, risperidone, thioridazine, lurasidone, quetiapine; silodosin; salmeterol; amlodipine, diltiazem, nifedipine, lercanidipine; eplerenone, ivabradine; bosentan, riociguat; dihydroergotamine, ergonovine, ergotamine, methylergonovine; cisapride; atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin; voclosporin; cyclosporine, tacrolimus, everolimus, sirolimus; eletriptan; lomitapide; avanafil, sildenafil, vardenafil, tadalafil; alprazolam, buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam, triazolam; zolpidem; dexamethasone, prednisolone; tolvaptan. Decreased plasma conc of methadone, morphine, piroxicam; theophylline; R-warfarin; divalproex, lamotrigine, phenytoin; raltegravir, zidovudine; atovaquone; voriconazole; ethinyl estradiol; bupropion. Decreased plasma conc w/ carbamazepine, phenobarb, phenytoin; rifampicin; St. John's wort. Frequent ECG monitoring is recommended throughout the full treatment period when used w/ delamanid. Decreased plasma cortisol levels w/ inhaled, injectable or intranasal fluticasone propionate; corticosteroids metabolised by CYP3A eg, budesonide & triamcinolone. Potential interaction w/ levothyroxine.
MIMS Class
Antivirals
ATC Classification
J05AE30 - nirmatrelvir and ritonavir ; Belongs to the class of protease inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
Paxlovid FC tab
Packing/Price
((20 nirmatrelvir tab + 10 ritonavir tab)) 30 × 6's
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