Taking Geodon with food?

[pharaday]

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I had a lady call the store yesterday in a complete panic about how much food to eat with Geodon. Apparently she used to be extremely overweight, and is concerned about having to eat with her bedtime dose. She said she has to take it at bedtime due to sleepiness from it. Everything I looked up just said to "take with food", but some websites I found said it had to be at least 500 calories, or had to be a high fat meal etc., but none of these sites seemed necessarily reputable. Does anyone have any experience treating patients with this and know if the amount or type of food makes a significant difference in absorption? This lady wanted to take it with only a plum. Seems like that may not be enough?

 

[Trent Steele]

I used to have the patient eat it with a piece of fruit and spoonful of natural peanut butter (fat) if they werent ok with eating a meal... seemed to work well but this is bro science as Ive never actually drew a level heh... id def recc. a tbsp of PB tho if anything

 

[Ackj]

I've never found a source to verify (nor have I looked very hard) but I've heard from more than one person that FDA's definition of a "meal" is quite a generous portion. None of that "My Plate" nonsense, we're talking some fatty goodness.

 

[npage148]

I've never found a source to verify (nor have I looked very hard) but I've heard from more than one person that FDA's definition of a "meal" is quite a generous portion. None of that "My Plate" nonsense, we're talking some fatty goodness.

D. Test Meal
We recommend that food-effect BA and fed BE studies be conducted using meal conditions that are expected to provide the greatest effects on GI physiology so that systemic drug availability is maximally affected. A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal is recommended as a test meal for food-effect BA and fed BE studies. This test meal should derive approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively.(4) The caloric breakdown of the test meal should be provided in the study report. If the caloric breakdown of the meal is significantly different from the one described above, the sponsor should provide a scientific rationale for this difference. In NDAs, it is recognized that a sponsor can choose to conduct food-effect BA studies using meals with different combinations of fats, carbohydrates, and proteins for exploratory or label purposes. However, one of the meals for the food-effect BA studies should be the high-fat, high-calorie test meal described above.

(4) An example test meal would be two eggs fried in butter, two strips of bacon, two slices of toast with butter, four ounces of hash brown potatoes and eight ounces of whole milk. Substitutions in this test meal can be made as long as the meal provides a similar amount of calories from protein, carbohydrate, and fat and has comparable meal volume and viscosity.

At Food-Effect Bioavailability and Fed Bioequivalence Studies

 

[xiphoid2010]

I had a lady call the store yesterday in a complete panic about how much food to eat with Geodon. Apparently she used to be extremely overweight, and is concerned about having to eat with her bedtime dose. She said she has to take it at bedtime due to sleepiness from it. Everything I looked up just said to "take with food", but some websites I found said it had to be at least 500 calories, or had to be a high fat meal etc., but none of these sites seemed necessarily reputable. Does anyone have any experience treating patients with this and know if the amount or type of food makes a significant difference in absorption? This lady wanted to take it with only a plum. Seems like that may not be enough?

Actually there are specific study for this med. Yes, size matters I remember reading about the study, whether it was on package insert or I pulled from pubmed during my residency, I dont remember. But the jist of it was that small and medium sized meal had significant differences in bioavailability but medium and large did not differ much. I'm too tired to look it up for you. Sorry.

 

[schamj01]

holy cow! That is one pretty huge meal. Sounds like they're trying to make us fat so we'll have to take more meds with meals....

 

[PumpkinSmasher]

There are small PK studies done independently and by the manufacturer that show reductions in bio availability of around 50%. I remember reading one small PK study that looked at doubling the dose in the fasting state to compensate for decreased bio availbility, they found AUC and serum drug concentration under fasting state were less than proportional. Study concluded that ziprasidone administration with a 500kcal meal is imperative for optimal and reproducible bioavailability. I do not think the fat content of the meal mattered.

I believe Lurasidone requires a similar calorie intake, 350-500kcal.

I found a copy of the study if you want me to email it to you.

 

[xiphoid2010]

Actually there are specific study for this med. Yes, size matters I remember reading about the study, whether it was on package insert or I pulled from pubmed during my residency, I dont remember. But the jist of it was that small and medium sized meal had significant differences in bioavailability but medium and large did not differ much. I'm too tired to look it up for you. Sorry.

Here is the study I was referring to earlier.

J Clin Psychiatry. 2009 Jan;70(1):58-62. Epub 2008 Oct 21.
The impact of calories and fat content of meals on oral ziprasidone absorption: a randomized, open-label, crossover trial.
Gandelman K, Alderman JA, Glue P, Lombardo I, LaBadie RR, Versavel M, Preskorn SH.
Source
Clinical Pharmacology, Pfizer Inc, New York, NY 10017, USA. [email protected]
Abstract
BACKGROUND:
Food is known to increase the bioavailability of ziprasidone. Therefore, we evaluated the effects of meals of differing caloric and fat content on steady-state ziprasidone exposure in a stable, treated group of subjects with DSM-IV diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder, or psychotic disorder (not otherwise specified) who were already receiving oral ziprasidone as their standard therapy.

METHOD:
Patients took ziprasidone under 6 meal conditions in randomized sequences (fasted, low calorie/low fat, low calorie/high fat, medium calorie/high fat, high calorie/low fat, and high calorie/high fat); each crossover period was separated by at least 3 days for washout of the previous meal condition. Serial blood samples were obtained over the 12 hours postdose. The study was conducted from July 27 to September 28 of 2006.

RESULTS:
Maximum ziprasidone exposures in this study were observed with high-calorie meals (1000 kcal), which were nearly twice those observed under fasting conditions. The medium-calorie meal (500 kcal) was associated with exposures similar to the high-calorie meals. Low-calorie meals (250 kcal) were associated with exposures that were approximately 60% to 90% lower than those of medium- and high-calorie meals, and approached exposures seen under fasting conditions. Fat content of the meal had no significant effect on ziprasidone absorption. The ziprasidone exposures observed with medium- and high-calorie meals had less variability than those with low-calorie meals and under fasting conditions.

CONCLUSIONS:
These results confirm that ziprasidone should be taken with food and that a meal equal to or greater than 500 kcal, irrespective of fat content, is required for optimal and reproducible bioavailability of the administered dose.

Copyright 2009 Physicians Postgraduate Press, Inc.

PMID: 19026256 [PubMed - indexed for MEDLINE]
Publication Types, MeSH Terms, Substances

LinkOut - more resources

 

[xiphoid2010]

Food intake on geodon absoroption is nothing compared to posaconazole. Taking it alone, the drug level is 25% of that with a high fat meal, so might as well not bother waste your time treating. Unfortunately, those needing posa are usually leukemia patients under intensive chemo and ANC of 0, nauseated 24/7. At the same time, oncologists and ID docs usually don't remember these treatment issues that's kind of outside of their knowledge base, and that's where a well educated pharmacist is key.

 

[PumpkinSmasher]

Here is the study I was referring to earlier.

J Clin Psychiatry. 2009 Jan;70(1):58-62. Epub 2008 Oct 21.
The impact of calories and fat content of meals on oral ziprasidone absorption: a randomized, open-label, crossover trial.
Gandelman K, Alderman JA, Glue P, Lombardo I, LaBadie RR, Versavel M, Preskorn SH.
Source
Clinical Pharmacology, Pfizer Inc, New York, NY 10017, USA. [email protected]
Abstract
BACKGROUND:
Food is known to increase the bioavailability of ziprasidone. Therefore, we evaluated the effects of meals of differing caloric and fat content on steady-state ziprasidone exposure in a stable, treated group of subjects with DSM-IV diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder, or psychotic disorder (not otherwise specified) who were already receiving oral ziprasidone as their standard therapy.

METHOD:
Patients took ziprasidone under 6 meal conditions in randomized sequences (fasted, low calorie/low fat, low calorie/high fat, medium calorie/high fat, high calorie/low fat, and high calorie/high fat); each crossover period was separated by at least 3 days for washout of the previous meal condition. Serial blood samples were obtained over the 12 hours postdose. The study was conducted from July 27 to September 28 of 2006.

RESULTS:
Maximum ziprasidone exposures in this study were observed with high-calorie meals (1000 kcal), which were nearly twice those observed under fasting conditions. The medium-calorie meal (500 kcal) was associated with exposures similar to the high-calorie meals. Low-calorie meals (250 kcal) were associated with exposures that were approximately 60% to 90% lower than those of medium- and high-calorie meals, and approached exposures seen under fasting conditions. Fat content of the meal had no significant effect on ziprasidone absorption. The ziprasidone exposures observed with medium- and high-calorie meals had less variability than those with low-calorie meals and under fasting conditions.

CONCLUSIONS:
These results confirm that ziprasidone should be taken with food and that a meal equal to or greater than 500 kcal, irrespective of fat content, is required for optimal and reproducible bioavailability of the administered dose.

Copyright 2009 Physicians Postgraduate Press, Inc.

PMID: 19026256 [PubMed - indexed for MEDLINE]
Publication Types, MeSH Terms, Substances

LinkOut - more resources

That was the study I was referring to also.👍

 

[pharaday]

Thanks so much for the information. That was very helpful! I feel like I didn't give this patient the best answer. I didn't realize that so many calories were necessary for optimal absorption. At least I'll know from now on though. Trying to learn as much as I can! 🙂