Amoxicillin is a commonly prescribed antibiotic used to treat a variety of bacterial infections. It belongs to a class of antibiotics called penicillins and works by interfering with the bacteria’s cell wall formation, which weakens the cell wall and eventually leads to the death of the bacteria.
Amoxicillin is available in capsule, tablet, chewable tablet, oral suspension, and injectable formulations. The oral forms, like capsules or suspensions, often need to be stored under refrigeration to maintain potency and effectiveness. Many people wonder what happens if you don’t refrigerate amoxicillin as directed. Will it lose potency and not work as well? Does it become toxic or dangerous to take? Here is a detailed look at the effects of not refrigerating amoxicillin.
Does amoxicillin need to be refrigerated?
The manufacturer recommendations and FDA-approved product labeling for amoxicillin states that it should be stored at room temperature below 86°F (30°C) or in the refrigerator between 36-46°F (2-8°C). Refrigeration helps extend the product’s shelf life and potency.
Liquid amoxicillin suspension should especially be refrigerated to maintain its potency. The powder in the capsules and tablets are less prone to breakdown without refrigeration compared to the liquid form. Some pharmacists may advise keeping capsules and tablets refrigerated as well to be extra cautious.
So in summary, while not always mandatory, refrigeration of oral amoxicillin is recommended for ideal potency and shelf life. Not refrigerating it, especially the liquid forms, can lead to some degradation in drug effectiveness over time.
What happens when amoxicillin is not refrigerated?
When amoxicillin is not stored according to the manufacturer’s recommendations, there can be some subtle changes that occur over time:
1. Decreased potency
One of the main concerns with not refrigerating amoxicillin is a loss of potency. The antibiotic can start to slowly degrade when stored at higher temperatures. This means the medication gradually loses strength and may not work as well against infections.
Studies show liquid amoxicillin can lose around 5-10% of its potency when kept at room temperature for 7-14 days. Capsules and tablets fare slightly better, losing less than 5% potency over a couple weeks unrefrigerated.
So the antibiotic does start losing some ability to fight bacteria when not refrigerated properly. The impact is generally small over a week or two but can add up if stored at room temperature for many months.
2. Decreased shelf life
In addition to decreased potency, not refrigerating amoxicillin can shorten its shelf life. Properly stored in the refrigerator, amoxicillin generally has a shelf life around 2-3 years. At room temperature, this can decrease to 1-2 years.
The shelf life determines the length of time the medication stays fresh and retains its labeled potency. So while refrigeration may not be critical for short 10-14 day courses, it becomes important for keeping amoxicillin from expiring too quickly.
Checking the expiration date is important regardless of storage method. Amoxicillin should not be used past the manufacturer expiration to ensure you get the full effective dose.
3. Changed color or taste
You may notice some slight changes in the amoxicillin’s appearance and taste when stored at room temperature, especially with the oral suspensions.
It may darken slightly in color over time. The taste can also become somewhat bitter from the drug breaking down. These aesthetic changes do not necessarily affect potency though. As long as it is taken before the marked expiration date, the antibiotic should retain effectiveness against infections.
4. Upset stomach when taken
Some individuals report getting an upset stomach, nausea, or diarrhea when taking amoxicillin that has been kept unrefrigerated for an extended time.
This may be from slightly increased levels of the breakdown products as the amoxicillin loses potency. The stomach distress should resolve soon after finishing the medication course. Sticking to the proper storage recommendations can help minimize gastrointestinal side effects.
Is unrefrigerated amoxicillin dangerous or toxic?
While not ideal for maintaining full potency, there is no indication that taking amoxicillin that has not been refrigerated poses any serious health risks or toxic effects. No dangerous degradation products are formed.
Individuals with penicillin allergies should still avoid amoxicillin regardless of refrigeration status, due to risks of hypersensitivity reactions. But for most people without penicillin allergies, taking improperly stored amoxicillin should not cause safety issues.
The potency may drop slightly over time out of refrigeration, especially the liquid forms, but what remains of the active ingredient is still the same safe and effective amoxicillin molecule. No major toxicity concerns exist.
Of course, if the amoxicillin is used far past its expiration date, potency can degrade enough to significantly impact effectiveness. Extended use of expired antibiotics is never recommended. But otherwise, no toxic byproducts build up due to lack of refrigeration alone.
How long can amoxicillin safely be unrefrigerated?
Most forms of amoxicillin can safely be kept at room temperature for short periods of around 7-14 days without major potency loss or health risks. However, manufacturer refrigeration recommendations should be followed for long-term storage.
Here are some general guidelines on how long different forms of amoxicillin can be safely kept unrefrigerated:
Amoxicillin capsules and tablets:
– Retain nearly full potency for up to 2 weeks at room temperature.
– Can be stored this way for short-term uses.
– Should be refrigerated if keeping for more than 2 weeks.
Amoxicillin oral suspension (liquid):
– Starts degrading faster than capsules when unrefrigerated.
– Best to refrigerate and use within 7-10 days once mixed.
– Can still be used up to 14 days if kept under 77°F.
Amoxicillin injection (IV solution):
– Should always be refrigerated – check product labeling.
– IV bags and vials lose potency rapidly at room temperature.
– Never store injectable amoxicillin unrefrigerated.
Of note, amoxicillin combined with clavulanate (Augmentin) is more stable than amoxicillin alone. The clavulanate helps extend the refrigeration time for both tablets and suspensions.
Does effectiveness decrease with each day unrefrigerated?
The decrease in amoxicillin potency and effectiveness when stored improperly is not thought to be a linear decrease each day. Rather, there seems to be somewhat of a plateau initially.
One study found liquid amoxicillin retained almost 100% potency for the first 5 days unrefrigerated. After this, potency began to decline, with about a 5-10% total loss after 14 days at room temperature.
So the first several days may show minimal drops in potency, with the decline accelerating after around a week without refrigeration. Check product expiration dates for guidance on long-term storage needs.
Can you freeze amoxicillin?
Some people wonder if freezing amoxicillin could extend its shelf life even longer than refrigeration alone. However, available evidence does not really support freezing as an optimal storage method.
The extremely cold temperatures of freezing can actually hasten the degradation of amoxicillin. Rapid potency declines have been reported in frozen antibiotic suspensions. Freezing may also damage the inactive ingredients in capsules or affect absorption.
Overall, refrigerator temperatures between 36-46°F are ideal for amoxicillin storage. Freezing is not recommended and may do more harm than good in terms of preserving drug potency. Simply keeping it refrigerated is best.
Tips for proper storage
Here are some tips for storing your amoxicillin properly:
– Always keep amoxicillin in its original prescription bottle or packaging.
– Do not transfer to any other containers, as this could cause confusion and medication errors.
– Check that capsules and tablets are kept in a cool, dry place below 86°F if refrigeration is not possible.
– Refrigerate liquid amoxicillin suspension promptly after reconstituting and store between 36-46°F.
– Use refrigerated amoxicillin within 14 days to ensure full potency.
– Do not freeze amoxicillin capsules, tablets, or liquid suspension.
– Always discard amoxicillin after its marked expiration date.
Proper storage both preserves the medication and decreases risks of accidentally taking expired antibiotics. Be sure to ask your pharmacist if you have any questions about refrigerating your specific prescription.
What if some doses are left unrefrigerated?
If you need to take some doses of amoxicillin away from refrigeration temporarily, the short time out of the fridge likely will not cause significant potency loss.
For example, carrying a few capsules or tablets with you for doses while at work or school should be fine. Just keep them in a cool, dry place and avoid excessive heat above 86°F when possible.
Similarly, one or two days of missed refrigeration for an oral suspension is unlikely to degrade potency much at all. However, make sure to return it to the refrigerator for any leftover doses rather than leaving it out.
Try to limit unrefrigerated time to less than a week. And do not remove injectable amoxicillin from refrigeration at any time. With sensible precautions, brief periods out of the fridge should not pose an issue.
Can you still take amoxicillin if not refrigerated?
If your amoxicillin was not stored according to the manufacturer recommendations, you may still be able to take it safely in most cases. However, a few factors should be considered:
– Check the expiration date – never take expired amoxicillin.
– Look for changes in smell, taste, or color – significant degradation may have occurred.
– Consider the duration unrefrigerated – 1-2 weeks is less concerning vs. many months.
– Think about the remaining course length – longer courses may need more potency.
– Factor in the infection severity – less potency may be insufficient for serious infections.
For milder infections and short remaining courses, taking improperly stored amoxicillin will likely still provide adequate effectiveness. But for severe infections or longer treatment durations, speak to your pharmacist or doctor first before taking amoxicillin that was not properly refrigerated. They can help assess if potency loss is a significant issue.
Does amoxicillin need to be refrigerated after reconstituting?
Oral amoxicillin powder for suspension requires mixing with water prior to use according to instructions. This reconstituted liquid amoxicillin definitely requires prompt refrigeration after mixing up the dose.
Leaving reconstituted oral suspension at room temperature can lead to faster potency degradation than with the powder alone. Refrigerate immediately after reconstituting and for any leftover doses.
Also, make sure to discard any reconstituted oral suspension within 14 days. Never use reconstituted amoxicillin beyond the specified 2 week refrigerated shelf life indicated on the product labeling.
Can you refrigerate again after leaving unrefrigerated?
If your amoxicillin was left unrefrigerated for a while, putting it back in the refrigerator will help slow further potency loss. However, it does not reverse any degradation that already occurred during room temperature storage.
Refrigerating again can still extend the shelf life and duration the medication remains usable. Just be aware the potency may be slightly lower than originally.
Also double check for any color changes, odors, or expiration date issues before using amoxicillin that was left unrefrigerated for a significant time. Contact a pharmacist if you have any concerns about placing your amoxicillin back into the refrigerator after storage at room temperature.
Does the pharmacy label always indicate refrigeration needed?
Pharmacy prescription labels do not always clearly indicate whether refrigeration is required for dispensed antibiotics like amoxicillin. This can lead to confusion for some patients.
The FDA does require refrigeration instructions on the manufacturer’s packaging and product information. But individual pharmacy prescription vial labels may neglect to include proper storage details.
Always first check the original packaging or patient information leaflet to see refrigeration guidelines for your specific amoxicillin product. The pharmacy label alone may not provide complete storage instructions. Contact the pharmacist with any questions.
Conclusion
While refrigeration is recommended for ideal stability, short periods of amoxicillin storage at room temperature below 86°F are generally not problematic, especially for tablets and capsules. The liquid suspension does degrade faster than solid forms when unrefrigerated though.
Leaving amoxicillin out too long can lead to some subtle changes like decreased potency, altered taste/smell, and shortened shelf life. But significant toxicity does not occur due to lack of refrigeration alone. Of more concern is use of expired antibiotics with weakened potency.
Be sure to follow the manufacturer’s refrigerator storage guidelines for liquid suspensions and long-term storage. Check expiration dates frequently if keeping amoxicillin unrefrigerated. And inspect for any changes in the product over time.
With proper refrigerated storage, amoxicillin remains a very safe and effective antibiotic. While not ideal, short periods at room temperature will likely not cause major issues or dangers either. Use common sense storage practices, refrigerate liquid forms promptly, and speak to your pharmacist with any concerns.
