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Paxlovid

Paxlovid

ritonavir

nirmatrelvir

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
4 pink tab each containing Nirmatrelvir 150 mg, 2 white tab each containing Ritonavir 100 mg
Indications/Uses
Covid-19 in adults who do not require supplemental O2 & are at increased risk for progression to severe Covid-19.
Dosage/Direction for Use
300 mg/100 mg bd for 5 days. Moderate renal impairment (eGFR ≥30 to <60 mL/min) 150 mg/100 mg bd for 5 days.
Administration
May be taken with or without food: Swallow whole, do not chew/break/crush.
Contraindications
History of clinically significant hypersensitivity. Concomitant use of medicinal products w/ highly dependent CYP3A clearance, potent CYP3A inducers. Severe hepatic or renal impairment.
Special Precautions
Discontinue use if signs & symptoms of clinically significant hypersensitivity reaction or anaphylaxis occur. Resistance to HIV PIs in individuals w/ uncontrolled or undiagnosed HIV-1 infection. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Closely & regularly monitor immunosuppressant serum conc. Concomitant use w/ CYP3A inhibitors or inducers, CYP3A-metabolised medicinal products. Pre-existing hepatic diseases, hepatic enzyme abnormalities or hepatitis. Women of childbearing potential should avoid becoming pregnant during & for 7 days after last dose. Pregnancy. Not to be used during lactation & 7 days after last dose. Paed patients <18 yr.
Adverse Reactions
Dysgeusia, headache; diarrhoea, nausea.
Drug Interactions
Increased plasma conc of alfuzosin, tamsulosin; methylphenidate, dexamefetamine; buprenorphine, norbuprenorphine, fentanyl, hydrocodone, oxycodone, meperidine; ranolazine; amiodarone, dronedarone, flecainide, propafenone, quinidine, digoxin, disopyramide; afatinib, abemaciclib, apalutamide, ceritinib, dasatinib, nilotinib, vincristine, vinblastine, encorafenib, fostamatinib, ibrutinib, neratinib, venetoclax; apixaban, dabigatran, rivaroxaban, vorapaxar; imipramine, amitriptyline, nortriptyline, fluoxetine, paroxetine, sertraline, desipramine, trazodone; colchicine; fexofenadine, loratadine; fusidic acid, rifabutin; ketoconazole, itraconazole, erythromycin, bedaquiline, clarithromycin; atazanavir, darunavir, efavirenz, maraviroc; lurasidone, pimozide, clozapine, quetiapine, haloperidol, risperidone, thioridazine; silodosin; amlodipine, diltiazem, nifedipine, verapamil; eplerenone, ivabradine, aliskiren, ticagrelor, cilostazol; betamethasone, budesonide, ciclesonide, fluticasone, methylprednisolone, mometasone, triamcinolone, dexamethasone, prednisolone; ivacaftor, elexacaftor/tezacaftor/ivacaftor, tezacaftor/ivacaftor; saxagliptin; bosentan; dihydroergotamine, ergonovine, ergotamine, methylergonovine; glecaprevir/pibrentasvir; voclosporin, cyclosporine, tacrolimus, everolimus; sirolimus; tofacitinib, upadacitinib; ovastatin, lovastatin, simvastatin, atorvastatin, rosuvastatin, fluvastatin, pravastatin, lomitapide; salmeterol; eletriptan, ubrogepant, rimegepant; finerenone; darifenacin; suvorexant, aripiprazole, brexpiprazole, cariprazine, iloperidone, lumateperone, pimavanserin; avanafil, sildenafil, tadalafil, vardenafil; riociguat; naloxegol; midazolam, triazolam, alprazolam, buspirone, clonazepam, clorazepate, diazepam, estazolam, flurazepam, zolpidem; flibanserin; tolvaptan. Decreased plasma conc of methadone, morphine; theophylline; R-warfarin; divalproex, lamotrigine; voriconazole, atovaquone; zidovudine; clopidogrel; ethinyl estradiol; bupropion. Decreased plasma conc w/ carbamazepine, phenobarb, phenytoin, primidone; rifampicin, rifapentine. Potential loss of virologic response & possible resistance w/ lumacaftor/ivacaftor; St. John's wort (Hypericum perforatum). Concomitant use w/ l-thyroxine, delamanid.
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
5 × 6's
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