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Drug Interactions between Aldroxicon II and Nizoral

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

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Interactions between your drugs

Moderate

ketoconazole aluminum hydroxide

Applies to: Nizoral (ketoconazole) and Aldroxicon II (aluminum hydroxide / magnesium hydroxide / simethicone)

ADJUST DOSING INTERVAL: The dissolution of oral ketoconazole requires an acidic environment. Medications that decrease the acidity of the stomach, such as omeprazole or H2 antagonists can reduce the bioavailability of ketoconazole by 75% to 80%. Antacids are also expected to impair ketoconazole absorption. Levoketoconazole, which is an enantiomer of ketoconazole is expected to have similar interactions.

MANAGEMENT: It is recommended to administer antacids at least 1 hour before or 2 hours after ketoconazole. Patients should be monitored for altered antifungal effects and the ketoconazole dosage adjusted if necessary. Levoketoconazole manufacturer recommends administering antacids at least 2 hours after taking levoketoconazole. Patients should be monitored for diminished levoketoconazole effects.

References

  1. Brass C, Galgiani JN, Blaschke TF, et al. "Disposition of ketoconazole, an oral antifungal, in humans." Antimicrob Agents Chemother 21 (1982): 151-8
  2. Van der Meer JW, Keuning JJ "The influence of gastric acidity on the bio-availability of ketoconazole." J Antimicrob Chemother 6 (1980): 552-4
  3. Carlson JA, Mann HJ, Canafax DM "Effect of pH on disintegration and dissolution of ketoconazole tablets." Am J Hosp Pharm 40 (1983): 1334-6
  4. Chin TWF, Loeb M, Fong IW "Effects of an acidic beverage (coca-cola) on absorption of ketoconazole." Antimicrob Agents Chemother 39 (1995): 1671-5
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. Cerner Multum, Inc. "Canadian Product Information." O 0 (2015):
  7. Cerner Multum, Inc "ANVISA Bulário Eletrônico." O 0 (2015):
  8. "Product Information. Ketoconazole (ketoconazole)." Mylan Pharmaceuticals Inc (2019):
View all 8 references

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Moderate

ketoconazole magnesium hydroxide

Applies to: Nizoral (ketoconazole) and Aldroxicon II (aluminum hydroxide / magnesium hydroxide / simethicone)

ADJUST DOSING INTERVAL: The dissolution of oral ketoconazole requires an acidic environment. Medications that decrease the acidity of the stomach, such as omeprazole or H2 antagonists can reduce the bioavailability of ketoconazole by 75% to 80%. Antacids are also expected to impair ketoconazole absorption. Levoketoconazole, which is an enantiomer of ketoconazole is expected to have similar interactions.

MANAGEMENT: It is recommended to administer antacids at least 1 hour before or 2 hours after ketoconazole. Patients should be monitored for altered antifungal effects and the ketoconazole dosage adjusted if necessary. Levoketoconazole manufacturer recommends administering antacids at least 2 hours after taking levoketoconazole. Patients should be monitored for diminished levoketoconazole effects.

References

  1. Brass C, Galgiani JN, Blaschke TF, et al. "Disposition of ketoconazole, an oral antifungal, in humans." Antimicrob Agents Chemother 21 (1982): 151-8
  2. Van der Meer JW, Keuning JJ "The influence of gastric acidity on the bio-availability of ketoconazole." J Antimicrob Chemother 6 (1980): 552-4
  3. Carlson JA, Mann HJ, Canafax DM "Effect of pH on disintegration and dissolution of ketoconazole tablets." Am J Hosp Pharm 40 (1983): 1334-6
  4. Chin TWF, Loeb M, Fong IW "Effects of an acidic beverage (coca-cola) on absorption of ketoconazole." Antimicrob Agents Chemother 39 (1995): 1671-5
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. Cerner Multum, Inc. "Canadian Product Information." O 0 (2015):
  7. Cerner Multum, Inc "ANVISA Bulário Eletrônico." O 0 (2015):
  8. "Product Information. Ketoconazole (ketoconazole)." Mylan Pharmaceuticals Inc (2019):
View all 8 references

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Drug and food interactions

Major

aluminum hydroxide food

Applies to: Aldroxicon II (aluminum hydroxide / magnesium hydroxide / simethicone)

GENERALLY AVOID: The concomitant administration of aluminum-containing products (e.g., antacids and phosphate binders) and citrates may significantly increase serum aluminum concentrations, resulting in toxicity. Citrates or citric acid are contained in numerous soft drinks, citrus fruits, juices, and effervescent and dispersible drug formulations. Citrates enhance the gastrointestinal absorption of aluminum by an unknown mechanism, which may involve the formation of a soluble aluminum-citrate complex. Various studies have reported that citrate increases aluminum absorption by 4.6- to 50-fold in healthy subjects. Patients with renal insufficiency are particularly at risk of developing hyperaluminemia and encephalopathy. Fatalities have been reported. Patients with renal failure or on hemodialysis may also be at risk from soft drinks and effervescent and dispersible drug formulations that contain citrates or citric acid. It is unknown what effect citrus fruits or juices would have on aluminum absorption in healthy patients.

MANAGEMENT: The concomitant use of aluminum- and citrate-containing products and foods should be avoided by renally impaired patients. Hemodialysis patients should especially be cautioned about effervescent and dispersible over-the-counter remedies and soft drinks. Some experts also recommend that healthy patients should separate doses of aluminum-containing antacids and citrates by 2 to 3 hours.

ADJUST DOSING INTERVAL: The administration of aluminum-containing antacids with enteral nutrition may result in precipitation, formation of bezoars, and obstruction of feeding tubes. The proposed mechanism is the formation of an insoluble complex between the aluminum and the protein in the enteral feeding. Several cases of esophageal plugs and nasogastric tube obstructions have been reported in patients receiving high-protein liquids and an aluminum hydroxide-magnesium hydroxide antacid or an aluminum hydroxide antacid.

MANAGEMENT: Some experts recommend that antacids should not be mixed with or given after high protein formulations, that the antacid dose should be separated from the feeding by as much as possible, and that the tube should be thoroughly flushed before administration.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Wohlt PD, Zheng L, Gunderson S, Balzar SA, Johnson BD, Fish JT "Recommendations for the use of medications with continuous enteral nutrition." Am J Health Syst Pharm 66 (2009): 1438-67

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Moderate

ketoconazole food

Applies to: Nizoral (ketoconazole)

GENERALLY AVOID: Excessive use of alcohol or products containing alcohol together with ketoconazole or levoketoconazole may potentiate the risk of liver injury. Serious hepatotoxicity has been reported with levoketoconazole. Hepatotoxicity requiring liver transplantation has been reported with the use of oral ketoconazole, of which levoketoconazole is an enantiomer. Some patients had no obvious risk factors for liver disease. In addition, use of alcohol or products containing alcohol during ketoconazole or levoketoconazole therapy may result in a disulfiram-like reaction in some patients. Symptoms of disulfiram-like reaction include flushing, rash, peripheral edema, nausea, and headache.

GENERALLY AVOID: Coadministration with grapefruit juice may increase the plasma concentrations of ketoconazole or levoketoconazole. The mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruits. Inhibition of hepatic CYP450 3A4 may also contribute. In general, the effect of grapefruit juice is concentration-, dose- and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition. Pharmacokinetic interactions involving grapefruit juice are also subject to a high degree of interpatient variability, thus the extent to which a given patient may be affected is difficult to predict.

When administered to healthy volunteers with a high-fat meal (875 calories; 62% fat), levoketoconazole systemic exposure (AUC) increased by 30% while peak plasma concentration (Cmax) did not change and the time to reach Cmax (Tmax) was delayed from 2 to 4 hours, compared to fasted conditions.

MANAGEMENT: Levoketoconazole may be administered with or without food. Excessive consumption of alcohol should generally be avoided during ketoconazole or levoketoconazole therapy. Patients should preferably avoid or limit consumption of grapefruit, grapefruit juice, or any supplement containing grapefruit extract during ketoconazole or levoketoconazole therapy. Patients receiving ketoconazole or levoketoconazole should be instructed to contact their doctor immediately if they experience swelling, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, abdominal pain, dark colored urine, light colored stools, and/or yellowing of the skin or eyes, as these may be signs and symptoms of liver damage.

References

  1. "Product Information. Ketoconazole (ketoconazole)." Mylan Pharmaceuticals Inc (2019):
  2. "Product Information. Recorlev (levoketoconazole)." Xeris Pharmaceuticals Inc (2022):
  3. Auchus R, Pivonello R, Fleseriu M, et al. "Levoketoconazole: a novel treatment for endogenous Cushing's syndrome. https://www.tandfonline.com/doi/pdf/10.1080/17446651.2021.1945440" (2022):
  4. "Product Information. Ketoconazole (ketoconazole)." Burel Pharmaceuticals Inc (2021):
View all 4 references

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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.


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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.