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Posology: The recommended dosage is 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) all taken together orally every 12 hours for 5 days. Nirmatrelvir+Ritonavir (Paxlovid) should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset. Completion of the full 5-day treatment course is recommended even if the patient requires hospitalization due to severe or critical COVID-19 after starting treatment with Nirmatrelvir+Ritonavir (Paxlovid).
If the patient misses a dose of Nirmatrelvir+Ritonavir (Paxlovid) within 8 hours of the time it is usually taken, the patient should take it as soon as possible and resume the normal dosing schedule. If the patient misses a dose by more than 8 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not double the dose to make up for a missed dose.
Special populations: Renal impairment: No dose adjustment is needed in patients with mild renal impairment (eGFR ≥60 to <90 mL/min). In patients with moderate renal impairment (eGFR ≥30 to <60 mL/min), the dose of Nirmatrelvir+Ritonavir (Paxlovid) should be reduced to nirmatrelvir/ritonavir 150 mg/100 mg every 12 hours for 5 days to avoid over-exposure (this dose adjustment has not been clinically tested). Nirmatrelvir+Ritonavir (Paxlovid) should not be used in patients with severe renal impairment [eGFR <30 mL/min, including patients with End Stage Renal Disease (ESRD) under hemodialysis] (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment of Nirmatrelvir+Ritonavir (Paxlovid) is needed for patients with either mild (Child Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Nirmatrelvir+Ritonavir (Paxlovid) should not be used in patients with severe (Child-Pugh Class C) hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Concomitant therapy with ritonavir- or cobicistat-containing regimen: No dose adjustment of Nirmatrelvir+Ritonavir (Paxlovid) is needed. Patients diagnosed with human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection who are receiving ritonavir- or cobicistat-containing regimen should continue their treatment as indicated.
Pediatric population: The safety and efficacy of Nirmatrelvir+Ritonavir (Paxlovid) in patients below 18 years of age have not been established. No data are available.
Method of administration: For oral use.
Nirmatrelvir must be coadministered with ritonavir. Failure to correctly coadminister nirmatrelvir with ritonavir will result in plasma levels of this active substance that will be insufficient to achieve the desired therapeutic effect.
Nirmatrelvir+Ritonavir (Paxlovid) can be taken with or without food (see Pharmacology: Pharmacokinetics under Actions). The tablets should be swallowed whole and not chewed, broken or crushed, as no data is currently available.
