Pyridostigmine Extended-Release: Uses, Side Effects and Dosage

Important Information

Rx Only

PYRIDOSTIGMINE BROMIDE extended-release tablets 105 mg

Protection Against Soman Nerve Agent Poisoning

Pyridostigmine bromide (PB) is approved for pretreatment against the chemical nerve agent Soman (GD). PB has not been approved for use against other chemical nerve agents including Sarin (GB), Tabun (GA) and VX. Nerve agents work by making your muscles weak. They can make you lose control of your muscles. You can die if your breathing muscles are paralyzed.

Your main protection against chemical weapons is your chemical protective mask and battle dress overgarment. You also have other items to help you ifyou are exposed to chemical warfare agents. These items are:

1. 1. Two antidotes (atropine and 2-PAM)
2. 2. PB is approved as a pretreatment against a soman nerve agent attack. The approval is based on safety studies in humans and effectiveness (how well it works) studies conducted in animals. The FDA has approved PB based only on animal studies of effectiveness because it is not ethical to do these studies in humans. Human studies would require exposing people to the deadly effects of nerve agents, risking poisoning them or even killing them. Studies in monkeys and guinea pigs show that pretreatment with PB makes the antidotes (atropine and 2-PAM) work better against soman (GD). PB pretreatment in animals has not been shown to make the antidotes (atropine and 2-PAM) work better against other nerve agents. Based on the animal studies of whether PB works against soman, it is thought that any potential benefits from use of PB occur only if:

1. 1. PB is taken with enough time before, but not right before, exposure to the nerve agent soman. (If PB is taken right before (when the nerve gas attack alarm is given) or during nerve agent exposure, it may not work and may make the effects of soman worse.)
2. 2. Atropine and 2-PAM are used when symptoms of nerve agent poisoning occur.

How To Take Your PB

1. 1. Your chain of command will tell you when it is time to take PB. This decision will be based on the threat of exposure to soman nerve agent.
2. 2.

   You must take 1 tablet of PB by mouth every 24 hours with a meal that is medium-fat medium calorie (e.g., 650 calories and 40% fat) or high-fat high calorie (e.g., 1000 calories and 50% fat). Do not take PB on an empty stomach. Take daily until your chain of command tells you to stop taking PB. PB should not be taken with alcohol.

3. 3. Do not take PB more often than you are told. If you miss a dose of PB, take the missed dose as soon as possible, then take the next dose 24 hours after taking the missed dose. This will put you back on schedule. Do not double up on your dose or take extra doses of PB.
4. 4. There is no known advantage to taking extra PB right before soman exposure.
5. 5. Do not continue to take PB after nerve agent exposure has occurred, instead:
6. 6. If you experience most or all of the Mild symptoms of nerve agent poisoning, you should Immediately hold your breath (Do Not Inhale) and Put On Your Protective Mask. Then administer atropine and 2-PAM.
7. 7. Contact your unit medical officer if side effects from PB continue and limit duty performance.

Who should not take PB?

Do not Take PB if you:

• have a history of bowel or bladder blockage (obstruction)
• are allergic to anticholinesterase medicines (certain drugs used during surgery like physostigmine, edrophonium, neostigmine, and ambenonium)

Tell your doctor or medic before taking PB if you:

• are pregnant
• have asthma
• are allergic to bromide
• take blood pressure medicine
• have high eye pressure (glaucoma)
• have problems with your kidneys (renal impairment)

Also, tell your doctor about all your other medical conditions you may have including heart problems, or reflux esophagitis (GERD).

Side Effects

If your side effects do not go away, see your unit doctor or medic.

This is not a complete list of symptoms that may occur. See your unit doctor right away if your side effects are very bad or for any symptoms that concern you.

About your rights and welfare: DOD may collect information on the use of PB to help decide how best to protect deployed forces in the future. Information that identifies you will remain private (confidential). However, the FDA may review any data collected by DOD for the purpose of evaluating PB. Direct questions about your rights and welfare to your unit medical officer, or e-mail questions to hsrrb@det.amedd.army.mil.

For more information about PB: Talk to your unit medical officer or medic. You can also e-mail questions about PB directly to the U.S. Army Medical Research and Materiel Command at address hsrrb@det.amedd.army.mil.

Manufactured and Distributed by:

Amneal Specialty, a division of Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807 Issued 10/2024