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Drug Interactions between dasabuvir / ombitasvir / paritaprevir / ritonavir and Pravigard Pac

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

pravastatin paritaprevir

Applies to: Pravigard Pac (aspirin / pravastatin) and dasabuvir / ombitasvir / paritaprevir / ritonavir

ADJUST DOSE: Coadministration with ombitasvir/paritaprevir/ritonavir plus dasabuvir may significantly increase the plasma concentrations of pravastatin. The mechanism may involve inhibition of OATP1B1-mediated hepatic uptake of pravastatin by both paritaprevir and ritonavir. In 12 study subjects, administration of pravastatin 10 mg once daily in combination with once daily morning doses of ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg) plus twice daily doses of dasabuvir resulted in increases of approximately 37% and 82% in mean pravastatin peak plasma concentration (Cmax) and systemic exposure (AUC), respectively. High levels of HMG-CoA reductase inhibitory activity in plasma is associated with an increased risk of musculoskeletal toxicity. Myopathy manifested as muscle pain and/or weakness associated with grossly elevated creatine kinase exceeding ten times the upper limit of normal has been reported occasionally. Rhabdomyolysis has also occurred rarely, which may be accompanied by acute renal failure secondary to myoglobinuria and may result in death. Pravastatin had no significant effect on the pharmacokinetics of ombitasvir, paritaprevir, ritonavir, and dasabuvir.

MANAGEMENT: The benefits of using pravastatin with ombitasvir/paritaprevir/ritonavir plus dasabuvir should be carefully weighed against the potentially increased risk of myopathy including rhabdomyolysis. If coadministration is required, the lowest effective dosage of pravastatin should be used and close monitoring for musculoskeletal toxicity is recommended. The dosage of pravastatin should be limited to 40 mg/day. Alternatively, an interruption of pravastatin may be considered during treatment with ombitasvir/paritaprevir/ritonavir plus dasabuvir, or a different HMG-CoA reductase inhibitor such as fluvastatin or pitavastatin may be substituted. All patients receiving statin therapy should be advised to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by fever, malaise and/or dark colored urine. Therapy should be discontinued if creatine kinase is markedly elevated in the absence of strenuous exercise or if myopathy is otherwise suspected or diagnosed.

References

  1. (2022) "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprev/ritonav)." AbbVie US LLC

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Moderate

pravastatin ritonavir

Applies to: Pravigard Pac (aspirin / pravastatin) and dasabuvir / ombitasvir / paritaprevir / ritonavir

MONITOR: Coadministration with ritonavir may decrease the plasma concentrations of pravastatin. The proposed mechanism is ritonavir induction of pravastatin metabolism via glucuronosyl transferase. In 13 healthy volunteers, the combination of ritonavir (300 mg twice a day for 3 days, then 400 mg twice a day) and saquinavir (soft gelatin capsule 400 mg twice a day) given for 14 days decreased the mean peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) of pravastatin (40 mg once a day for 4 days) by 42% and 50%, respectively. The clinical relevance of these changes is unknown. Pravastatin appeared to have no significant effect on the plasma levels of ritonavir and saquinavir based on comparison with historical controls. It is not known to what extent, if any, the interaction may occur when ritonavir is used in lower dosages as a pharmacokinetic booster. No interaction was observed when pravastatin was given with lopinavir-ritonavir in drug interaction studies.

MANAGEMENT: Pravastatin appears to be safe when coadministered with ritonavir, although the potential for diminished hypolipidemic efficacy should be considered when antiretroviral dosages of ritonavir is prescribed. Pharmacologic response to pravastatin should be monitored more closely whenever ritonavir is added to or withdrawn from therapy, and the pravastatin dosage adjusted as necessary.

References

  1. Everett DW, Chando TJ, Didonato GC, Singhvi SM, Pan HY, Weinstein SH (1991) "Biotransformation of pravastatin sodium in humans." Drug Metab Dispos, 19, p. 740-8
  2. (2001) "Product Information. Kaletra (lopinavir-ritonavir)." Abbott Pharmaceutical
  3. Fichtenbaum CJ, Gerber JG, Rosenkranz SL, et al. (2002) "Pharmacokinetic interactions between protease inhibitors and statins in HIV seronegative volunteers: ACTG Study A5047." AIDS, 16, p. 569-577

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Drug and food interactions

Moderate

ritonavir food

Applies to: dasabuvir / ombitasvir / paritaprevir / ritonavir

ADJUST DOSING INTERVAL: Administration with food may modestly affect the bioavailability of ritonavir from the various available formulations. When the oral solution was given under nonfasting conditions, peak ritonavir concentrations decreased 23% and the extent of absorption decreased 7% relative to fasting conditions. Dilution of the oral solution (within one hour of dosing) with 240 mL of chocolate milk or a nutritional supplement (Advera or Ensure) did not significantly affect the extent and rate of ritonavir absorption. When a single 100 mg dose of the tablet was administered with a high-fat meal (907 kcal; 52% fat, 15% protein, 33% carbohydrates), approximately 20% decreases in mean peak concentration (Cmax) and systemic exposure (AUC) were observed relative to administration after fasting. Similar decreases in Cmax and AUC were reported when the tablet was administered with a moderate-fat meal. In contrast, the extent of absorption of ritonavir from the soft gelatin capsule formulation was 13% higher when administered with a meal (615 KCal; 14.5% fat, 9% protein, and 76% carbohydrate) relative to fasting.

MANAGEMENT: Ritonavir should be taken with meals to enhance gastrointestinal tolerability.

References

  1. (2001) "Product Information. Norvir (ritonavir)." Abbott Pharmaceutical

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Moderate

paritaprevir food

Applies to: dasabuvir / ombitasvir / paritaprevir / ritonavir

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of ombitasvir, paritaprevir, ritonavir, and dasabuvir. Relative to fasting conditions, administration of ombitasvir, paritaprevir, ritonavir, and dasabuvir with a moderate-fat meal (approximately 600 Kcal; 20% to 30% calories from fat) increased the mean systemic exposure (AUC) by 82%, 211%, 49%, and 30%, respectively. Relative to fasting conditions, administration of ombitasvir, paritaprevir, ritonavir, and dasabuvir with a high-fat meal (approximately 900 Kcal; with 60% calories from fat) increased the mean AUC by 76%, 180%, 44%, and 22%, respectively.

MANAGEMENT: Ombitasvir/paritaprevir/ritonavir plus dasabuvir should always be administered with a meal. The fat or calorie content does not matter.

References

  1. (2022) "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprev/ritonav)." AbbVie US LLC

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Moderate

aspirin food

Applies to: Pravigard Pac (aspirin / pravastatin)

GENERALLY AVOID: The concurrent use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) and ethanol may lead to gastrointestinal (GI) blood loss. The mechanism may be due to a combined local effect as well as inhibition of prostaglandins leading to decreased integrity of the GI lining.

MANAGEMENT: Patients should be counseled on this potential interaction and advised to refrain from alcohol consumption while taking aspirin or NSAIDs.

References

  1. (2002) "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn

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Moderate

pravastatin food

Applies to: Pravigard Pac (aspirin / pravastatin)

MONITOR: Concomitant use of statin medication with substantial quantities of alcohol may increase the risk of hepatic injury. Transient increases in serum transaminases have been reported with statin use and while these increases generally resolve or improve with continued therapy or a brief interruption in therapy, there have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury. Active liver disease or unexplained transaminase elevations are contraindications to statin use.

MANAGEMENT: Patients should be counseled to avoid substantial quantities of alcohol in combination with statin medications and clinicians should be aware of the increased risk for hepatotoxicity in these patients.

References

  1. (2001) "Product Information. Pravachol (pravastatin)." Bristol-Myers Squibb
  2. (2001) "Product Information. Zocor (simvastatin)." Merck & Co., Inc
  3. (2001) "Product Information. Lescol (fluvastatin)." Novartis Pharmaceuticals
  4. (2001) "Product Information. Lipitor (atorvastatin)." Parke-Davis
  5. (2002) "Product Information. Altocor (lovastatin)." Andrx Pharmaceuticals
  6. (2003) "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc
  7. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  8. Cerner Multum, Inc. "Australian Product Information."
  9. (2010) "Product Information. Livalo (pitavastatin)." Kowa Pharmaceuticals America (formerly ProEthic)
View all 9 references

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Minor

aspirin food

Applies to: Pravigard Pac (aspirin / pravastatin)

One study has reported that coadministration of caffeine and aspirin lead to a 25% increase in the rate of appearance and 17% increase in maximum concentration of salicylate in the plasma. A significantly higher area under the plasma concentration time curve of salicylate was also reported when both drugs were administered together. The exact mechanism of this interaction has not been specified. Physicians and patients should be aware that coadministration of aspirin and caffeine may lead to higher salicylate levels faster.

References

  1. Yoovathaworn KC, Sriwatanakul K, Thithapandha A (1986) "Influence of caffeine on aspirin pharmacokinetics." Eur J Drug Metab Pharmacokinet, 11, p. 71-6

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

See also

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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