Fact Sheet - Anthrax_Amoxicillin

Anthrax_Amoxicillin EUA Recipient FS_draft 05Oct18.pdf

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Fact Sheet - Anthrax_Amoxicillin

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Anthrax Emergency: How to Take Amoxicillin to Prevent Anthrax
Fact Sheet for Recipients

During an anthrax emergency, you may be given a medicine called amoxicillin (sounds like a-mox-i-SIL-in)
because you may have breathed in anthrax germs. These germs can be deadly. Taking certain medicines
called antibiotics (like amoxicillin) reduces your chance of getting sick and dying. People who may have
breathed in anthrax germs should take antibiotics for 60 days. If you started taking another medicine (like
ciprofloxacin or doxycycline) to prevent anthrax, and are now being switched to amoxicillin, it is important
that you take amoxicillin for as long as you are directed. To reduce your chance of getting sick, avoid
stopping early. Public health officials will provide information on who should get this medicine. If you have
questions, talk to a doctor or healthcare provider about taking amoxicillin.
What is anthrax?
Anthrax is a serious disease that can be deadly. You can get sick if you breathe in anthrax germs. You cannot
get anthrax from another person who has anthrax.
• Early on, you could have any of the following symptoms: fever, chills, tiredness, cough or headache.
• Later, you could develop shortness of breath, chest discomfort, confusion or nausea. Symptoms usually
start within 7 days of breathing in anthrax germs, but can start within 24 hours or take up to 7 weeks.
See a doctor right away if you have symptoms. If you take amoxicillin as directed and begin to feel sick
or show any of the symptoms mentioned above, get medical care right away.
What is amoxicillin?
Amoxicillin is a prescription antibiotic approved by the Food and Drug Administration (FDA) to treat various
infections, and has been used safely for many years, including in children. It is currently not FDA-approved
for anthrax. But scientific studies have shown that it may protect against anthrax disease. Therefore, FDA has
authorized emergency use of amoxicillin to help prevent anthrax during this anthrax emergency. Amoxicillin
gives another choice for children and certain adults who cannot tolerate or have side effects to other
medicines (like ciprofloxacin and doxycycline) to prevent anthrax. If you were given amoxicillin that has an
expired date on the container, please note that FDA is allowing the use of certain lots of amoxicillin beyond
the expiration date on the container based on FDA’s scientific review. For more information, go to the FDA
website at www.fda.gov (search for “amoxicillin expiration”).
Who should NOT take amoxicillin?
Do NOT take amoxicillin if you have had an allergic reaction to penicillin, amoxicillin or other penicillin-like
drug (such as ampicillin, oxacillin, dicloxacillin, piperacillin, ticarcillin, or nafcillin). A severe reaction may
include closing of the throat, trouble breathing, or swelling of the lips, tongue or face. Talk to your doctor or
public health official about other medicines available to prevent anthrax.
How do I take amoxicillin or give amoxicillin to my child?
Amoxicillin is taken by mouth, either as a pill or liquid. Liquid forms will be prioritized for infants and very
young children during an emergency.
For children who weigh 88 pounds (40 kg) or more and adults aged 18 years or older:
 Take 2 pills (500 mg each) in the morning with a full glass of water (with or without food)
 Take 2 pills (500 mg each) at noon with a full glass of water (with or without food)
 Take 2 pills (500 mg each) in the night with a full glass of water (with or without food)
Doses should be taken three times (8 hours apart) each day for as long as directed.
If you or your child cannot swallow pills, follow the instructions in How to Open Amoxicillin Capsules and
Mix with Food for Those Who Cannot Swallow Pills (which can also be found by searching “amoxicillin
mixing instructions” on www.cdc.gov).
Emergency Use Authorization of Amoxicillin for Anthrax Fact Sheet for Recipients

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For children weighing less than 88 pounds (40 kg), the dose is determined based on the child’s weight:
 Follow the instructions provided with liquid amoxicillin or amoxicillin pills. Give your child the right
dose in the morning, noon, and night (8 hours apart) each day for as long as directed.
 If your child is given pills and has trouble swallowing them, follow the instructions in How to
Open Amoxicillin Capsules and Mix with Food for Those Who Cannot Swallow Pills.
 If you received bottles of amoxicillin powder to mix at home, follow the instructions in the
Amoxicillin Liquid Preparation Instructions.
Do not skip doses. If you do miss a dose, do NOT take 2 doses at once. Take the next dose as scheduled.
People with severe kidney problems may need a different dose. Discuss this with your doctor.
If you get an upset stomach when you take the medicine, take it with food.
Keep the pills dry in a cool, dry place (at or below 68°F or 20°C). Amoxicillin powder for oral suspension
(400 mg/ 5 mL) should be stored at or below 25°C (77°F). Amoxicillin liquid should be stored in a tight
container in the refrigerator (preferred) or at room temperature for up to 14 days.
• Keep amoxicillin away from children and pets. Call the poison control center if children or pets consume
the medicine by accident (1-800-222-1222).

•
•
•
•

How long do I take amoxicillin for?
If you started with a different antibiotic to prevent anthrax (such as doxycycline or ciprofloxacin) and now
switching to amoxicillin, you will need to take amoxicillin until you complete a total of 60 days of antibiotics.
If you are also receiving anthrax vaccine (BioThrax®), it is important to take amoxicillin for as long your
healthcare provider tells you. Healthy adults 18 to 65 years of age can stop taking antibiotics 42 days after
the first dose of the anthrax vaccine or 2 weeks after the last dose, whichever happens later. Older adults,
pregnant women, and people with certain conditions should take antibiotics for 60 days.
What are common side effects of amoxicillin?
During the first few days of taking amoxicillin you might have an upset stomach, diarrhea, nausea, or vomiting.
Vaginal yeast infections may also occur while taking amoxicillin. KEEP taking the medicine if you have if these
symptoms, but let your doctor know if they continue or become very bad.
What are possible serious side effects of amoxicillin?
Serious side effects from amoxicillin are rare. STOP taking the medicine and get medical care right away (go
to the emergency room or call 911) if you have:
• Closing of the throat or trouble breathing
• Seizures, dizziness, tremors, or serious mood changes
• Swelling of the face, lips, tongue, or throat
• Yellowing of eyes or skin or dark brown or tea-colored urine
• Severe itching or rash, especially hives or wheals • Unusual bleeding or bruising
(red, swollen bumps on the skin)
• Excessive tiredness or lack of energy
• Severe stomach cramps with fever or bloody or
watery diarrhea
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact
your healthcare provider.
What are the risks if I am pregnant or breastfeeding?
Taking amoxicillin for a short time is not likely to cause problems for an unborn baby. It is unknown what the
effects are on pregnant women taking amoxicillin for a long time, but it is expected to have similar effects as
taking amoxicillin for a short time. Taking amoxicillin should reduce your risk of getting anthrax, which can be
deadly. Amoxicillin passes into breast milk, but you can continue to breastfeed while taking the medicine.
What if I am taking other medicines?
• Be sure to tell your doctor about any prescription and over-the-counter medications you use, especially if
you are taking any of the following medications:
 Probenecid (also called Probalan)
Emergency Use Authorization of Amoxicillin for Anthrax Fact Sheet for Recipients

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 Blood thinners such as heparin, Coumadin (warfarin), Xarelto (rivaroxaban), Pradaxa (dabigatran),
Eliquis (apixaban)
 Methotrexate (also called Rasuvo, Trexall, or Otrexup)
 Any type of antibiotic
What else do I need to know about amoxicillin?
• Brown, yellow, or gray tooth discoloration has previously occurred in some patients, especially children,
taking amoxicillin, but is rare and can be prevented by brushing or dental cleaning.
• Birth control pills may not work as well while you take amoxicillin. Use another form of birth control until
you finish taking all of your amoxicillin.
• Tell your doctor if you are or become pregnant or are breastfeeding.
• If you receive anthrax vaccine (BioThrax®), your healthcare provider will tell you how long you need to take
amoxicillin.
What other antibiotics can I take instead of amoxicillin?
Public health officials will tell you if other antibiotics (such as doxycycline, ciprofloxacin, or levofloxacin) are
available. The risks and benefits of other available antibiotics will be explained in separate instructions.
Risk-Benefit Statement
Although amoxicillin has some potential and serious side effects, the expected benefit of amoxicillin in
helping to prevent disease and death associated with anthrax exposure outweighs these risks.
How do I report side effects or medication errors?
Tell your doctor right away and report side effects or medication errors to FDA MedWatch at
www.fda.gov/medwatch or 1-800-FDA-1088.
A federal program called the Countermeasures Injury Compensation Program (CICP) may help pay for costs of
medical care and other specific expenses of certain people who have been seriously injured by some
medicines or vaccines. To learn more about this program, visit www.hrsa.gov/cicp or call 1-855-266-2427
(toll-free).
Space Reserved for State/Local Public Health Information

Emergency Use Authorization of Amoxicillin for Anthrax Fact Sheet for Recipients

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At-Home Mixing Instructions for Amoxicillin Oral Suspension
100 mL Bottle with 400 mg/5 mL dose concentration

These instructions show you how to prepare any 100 mL bottle of 400 mg/ 5 mL amoxicillin powder regardless
of the manufacturer’s name on the bottle. The label on your amoxicillin powder bottle may tell you to
measure a different amount of water than what is recommended in these instructions. This small difference
will not affect how well the medicine works.

Step 1. Gather the supplies you need.

• Bottle of Amoxicillin Powder for Oral Suspension:
 Make sure the bottle you have says ‘400 mg / 5 mL’ on the label. If it has a different number
listed, do not use these instructions and talk to your healthcare provider about how much to take.
• Drinkable water (70 mL of distilled or bottled water)
• Measuring tools to accurately measure and pour 70 mL of water:
o Common household kitchen tools like one-quarter (¼) cup and a 1 teaspoon, OR a measuring
container with a marking for 70 milliliters (mL). Clean before use.
o A bowl or cup with a spout to hold and help pour the measured water into the amoxicillin
powder bottle OR a funnel to pour the measured water into the powder bottle

Example Measuring Tools to Use to Measure 70 mL of Water

¼ cup measuring tool

AND

+

Baby bottle or other measuring
container with a 70 mL marking*

1 teaspoon

OR

*Note: The baby bottle is shown only as a suggestion for measuring water, not for giving the medication to a child.

Step 2. Measure out 70 mL of drinkable water and pour the water into a container.

• Option A: If using a measuring cup and teaspoon to measure the water, measure one-quarter (¼)
cup and 2 teaspoons (tsp) of water. You now have 70 mL of water.

=
¼ cup
¼ cup water = 60 mL

2 TEAspoons water = 10 mL

¼ cup + 2 TEAspoons water = 70 mL water

OR
• Option B: If using a baby bottle or measuring container with a 70 mL marking, fill the baby bottle or
container with 70 mL of water.

Amoxicillin Emergency Use Authorization: Power Mixing Instructions

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Step 3. Add water in two parts into the amoxicillin powder bottle and mix.
1. To help loosen the power, turn the amoxicillin powder bottle upside down and back to upright.
Lightly tap the sides and bottom of the bottle to help prevent the powder from sticking to the sides
when water is added. Open the cap and remove the inner seal, if present.
2. Add about half (about 35 mL) of the measured water (from Step 2) to the amoxicillin powder bottle.
3. Screw the cap back completely on the amoxicillin bottle and shake vigorously for about 15 seconds.
4. Remove the cap of the amoxicillin bottle and add the rest of the water. Screw the cap back
completely on the amoxicillin bottle and shake vigorously again (about 15 seconds). Make sure all
the powder gets mixed with the water. There should be no visible dry powder.
•

If the powder sticks to the sides or is not completely mixed, tap the bottle firmly using the palm of
your hand until no clumps are visible. Do not put a utensil into the bottle to stir since this will not
help to mix it and may accidentally cause some of the medicine to be removed. Shake the bottle
before giving each dose.

You now have liquid amoxicillin (reconstituted) in the bottle ready for use.

Step 4. Write the expiration date and store the reconstituted amoxicillin bottle.
1. Figure out the expiration date by counting 14 days from the day you mixed the powder with water
(reconstituted) and write that date on the bottle. For example, if you mixed the amoxicillin powder
with water on January 1, write January 15 on the bottle.
Do not use any medicine remaining in the bottle after the expiration date. Start a new bottle and
follow the mixing instructions above. Throw away the expired bottle.
2. Store the mixed bottle in a refrigerator and out of the reach of children. Keep the bottle tightly
closed.

Step 5. Give the correct dose.

1. Shake the bottle very well before each dose.
2. Find your child’s weight in the table below. Select the correct dose for the measuring device you are
using (teaspoon or milliliter).
Amoxicillin Dose using Oral Suspension Strength 400 mg/5 mL
Weight (lbs)*
Dose for teaspoon (tsp)
Dose for milliliter (mL)
measuring device
measuring device
< 8 lbs
1/4 tsp
1.25 mL
8 – 11 lbs
1/3 tsp
1.7 mL
12 – 17 lbs
1/2 tsp
2.5 mL
18 – 26 lbs
3/4 tsp
3.75 mL
27 – 35 lbs
1 tsp
5 mL
> 35 lbs
See Method 2: How to Prepare Amoxicillin with Food

*Weight-range dosing is provided since exact dose calculations (based on 25 mg/kg) may not be feasible during an emergency.

3. Give the dose using a teaspoon (tsp) measuring device or an oral dosing syringe or medicine cup with
milliliters (mL) marked.

Be sure to give the dose three times (8 hours apart) each day as long as instructed.

Amoxicillin Emergency Use Authorization: Power Mixing Instructions

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In an Emergency: How to Open Amoxicillin Capsules and Mix with Food for Those 
 
 
Who Cannot Swallow Pills 
 

During a public health emergency, you might need to prepare emergency doses of amoxicillin for children and adults 
who cannot swallow pills.  These instructions show you how to remove the powder inside the amoxicillin 500 mg 
capsules and mix the powder with food.  
 

Give the right amount of medicine every 8 hours (morning, noon, and night) each day for as long as directed.  Children 
younger than 1 year of age should be given amoxicillin oral suspension (see At‐Home Mixing Instructions for 
Amoxicillin Oral Suspension) instead of using the instructions below because measuring the right amount of medicine 
needed from a capsule is not feasible for this age group. Follow the directions depending on your child’s weight. 
 

Step A: Get the following supplies: 






The amoxicillin capsules (500 mg each) required for your child’s dose. For children weighing 44 lbs or less, you will 
need 1 amoxicillin capsule. For children weighing 45 lbs or more, you will need 2 amoxicillin capsules. 
1 metal spoon 
1 tablespoon 
2 small glass or metal bowls 
Food for mixing with the amoxicillin. Sweet foods with a thick, pudding‐like consistency  
such as chocolate pudding, sweet yogurt, or baby food will cover the taste of the medicine best. 

 

Step B: Determine the amount of amoxicillin powder needed  
1. Find your child’s weight on the chart below. Weight is better, but if you don’t know how much your child weighs, 
find your child’s age on the chart and follow instructions for the weight that is listed to the left of your child’s age.  
2. Follow the row of your child’s weight across to the column titled “Amount of Powder from Capsule Needed for 
Dose”. This column will tell you how much amoxicillin powder to use for your child’s dose.  
 

Child’s Weight 

Child’s 
Age 

Number of 
Dose of 
Capsules  Amoxicillin 
Needed 

Amount of Powder from Capsule Needed for Dose 

15 – 22 lbs 

‐‐‐* 

1 capsule 

250 mg 

Give half (1/2) the powder  
from 1 capsule  

 

23 – 44 lbs 

1 – 5 ½ 
years 

1 capsule 

500 mg 

Give all the powder  
from 1 capsule  

 

45 – 66 lbs 

6 – 9 ½ 
years 

2 capsules 

750 mg 

 
 
 

67 lbs or more 

10 years 
or older 

2 capsules 

1,000 mg 

Give all the powder from  
1 capsule and half (1/2) the  
powder from another capsule 
 
Give all the powder  
from 2 capsules 

 

*Children less than 1 year of age should receive amoxicillin suspension 
 

Step C: Open the first capsule required for your child’s dose 
1. Take one amoxicillin capsule and hold it over one of the bowls (Bowl A). Hold each end of the capsule between the 
thumb and index finger. 
2. Carefully pull the capsule open by twisting the ends of the capsule in opposite directions while pulling apart firmly. 
a. Be careful not to apply too much pressure to the capsule (this may cause the capsule to break into several 
pieces). If the capsule breaks into pieces, throw the capsule and contents of the bowl away and start over 
(clean the bowl and dry it thoroughly before using it again). 
3. After twisting the capsule open, pour the powder from the capsule into the bowl, tapping each end of the capsule 
until all the powder has been removed.  
4. Using the back of a metal spoon, crush the powder until it is smooth and there are no big pieces remaining (this may 
take about 1−2 minutes). You now have 1 crushed amoxicillin capsule in Bowl A.  
 
 
In an Emergency: How to Open Amoxicillin Capsules and Mix with Food for Those Who Cannot Swallow Pills 
 

Page 1 of 2 

 

Step D: Prepare the powder required for your child’s dose 
1. Look at the titles on the four boxes below. Find the box that matches the amount of amoxicillin powder needed for 
your child’s dose determined in Step B.  Using the powder you just crushed in Bowl A, follow the directions in the 
appropriate box below that corresponds to the dose needed.  
 
 
 
 
 
IF YOUR CHILD WEIGHS 15–22 LBS, EACH DOSE IS  
IF YOUR CHILD WEIGHS 23–44 LBS, EACH DOSE IS  
ONE‐HALF (½) CAPSULE (250 MG): 
1 CAPSULE (500 MG): 
 



You will need only half the powder from this capsule in  
Bowl A. Using the spoon, gather all of the crushed 
powder into the middle of Bowl A.  

Separate out half of the powder to one side of the bowl 
and the other half of the powder to the other side of 
the bowl.  
Use the spoon to scoop up half of the amoxicillin 
powder and put it into another bowl (Bowl B). You now 
have a 250 mg dose in each bowl.  
You now have the amount of amoxicillin required for 
your child’s dose (250 mg) in Bowl A. Using the powder 
in Bowl A, proceed to Step E. Save the powder in 
Bowl B for Step F. 






 

Bowl A contains 1 capsule, which is the amount 
required for your child’s dose.  
You now have the amount of amoxicillin required for 
your child’s dose (500 mg) in Bowl A. Using the powder 
in Bowl A, proceed to Step E. 

 
 

IF YOUR CHILD WEIGHS 45–66 LBS, EACH DOSE IS  
ONE AND ONE‐HALF (1 AND ½) CAPSULES (750 MG): 
 

You will need only half the powder from this capsule in  
Bowl A. Using the spoon, gather all of the crushed 

powder into the middle of Bowl A.  
Separate out half of the powder to one side of the bowl 
and the other half of the powder to the other side of 
the bowl.  
Use the spoon to scoop up half of the amoxicillin 

powder and put it into another bowl (Bowl B). You now 
have a 250 mg dose in each bowl. Set Bowl B aside.  
Take Bowl A. You need to add one more capsule to 
Bowl A to get your child’s dose. Using another 
amoxicillin capsule, repeat Step C to open another 
capsule and add it to Bowl A. Make sure to repeat all 
parts of Step C, including crushing the capsule with a 
spoon. Once you have completed this, you now have 
1 and ½ crushed capsules in Bowl A. 
You now have the amount of amoxicillin required for 
your child’s dose (750 mg) in Bowl A. Using the powder 
in Bowl A, proceed to Step E. Save the powder in 
Bowl B for Step F. 








 

IF YOUR CHILD WEIGHS 67 LBS OR MORE, EACH DOSE IS  
2 CAPSULES (1,000 MG): 
 

Bowl A contains 1 capsule, so you need to add one more 
capsule to this bowl to get your child’s required dose. 
Using another amoxicillin capsule, repeat Step C to open 
another capsule and add it to Bowl A. Make sure to 
repeat all parts of Step C, including crushing the capsule 
with a spoon. Once you have completed this, you now 
have 2 crushed capsules in Bowl A. 
You now have the amount of amoxicillin required for 
your child’s dose (1,000 mg) in Bowl A. Using the 
powder in Bowl A, proceed to Step E.  
 

 
 

Step E: Mix the amoxicillin powder with food and give to your child 
1. Add 2−3 tablespoons of a thick, sweet food to the amoxicillin powder in Bowl A and mix well before feeding the 
mixture to your child. Be sure your child eats all the mixture to receive the correct dose. 
 

Step F: Store the powder remaining in Bowl B**  
**This step is only applicable if your child’s dose was ½ capsule or 1 and ½ capsule 
1. Cover the powder remaining in Bowl B with plastic wrap or aluminum foil and label it with your child’s name, 
“250 mg”, and the date and time of the next dose. If your child’s dose is one‐half (½) capsule, then this amount will 
be enough for your child’s entire next dose. If your child’s dose is one and one‐half (1 and ½) capsules, then you will 
need to add one more capsule (500 mg) to the saved powder to make your child’s next dose (750 mg).  
2. Store the bowl at room temperature, out of the reach of children and pets. You can keep the powder stored this way 
to use for the next dose. If it is not used for the next dose, throw it away. 
In an Emergency: How to Open Amoxicillin Capsules and Mix with Food for Those Who Cannot Swallow Pills 
 

Page 2 of 2 


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