Advanced Consumer Information

pralidoxime (Injection route)

pral-i-DOX-eem

Commonly used brand name(s):

In the U.S.

Protopam Chloride

Available Dosage Forms:

Powder for Solution
Injectable

Therapeutic Class: Nerve Gas Antidote

Uses For pralidoxime

Pralidoxime is used together with another medicine called atropine to treat poisoning caused by organic phosphorus pesticides (e.g., diazinon, malathion, mevinphos, parathion, and sarin) and by organophosphate chemicals (“nerve gases”) used in chemical warfare. Pralidoxime is also used to treat overdose of medicines, such as ambenonium, neostigmine, and pyridostigmine, that are used to treat myasthenia gravis. Poisoning with these chemicals or medicines causes your muscles, including the muscles that help you breathe, to become weak. Pralidoxime is used to help you get back strength in your muscles.

Pralidoxime is to be given only by or under the direct supervision of a doctor or trained military personnel.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, pralidoxime has been used in some patients to treat poisoning caused by certain carbamate pesticides.

Before Using pralidoxime

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pralidoxime, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pralidoxime or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of pralidoxime in children with use in other age groups, pralidoxime is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no information comparing use of pralidoxime in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of pralidoxime

For patients using the pralidoxime auto-injector (automatic injection device):

You will be trained to use the pralidoxime auto-injector by a medic or other trained military personnel. You will also be told the conditions under which it should be used. The auto-injector also comes with patient directions. Read them carefully before you actually need to use pralidoxime. Then, when an emergency arises, you will know how to inject the pralidoxime.
It is important that you do not remove the safety cap on the auto-injector until you are ready to use it. This prevents spillage of the medicine from the device during storage and handling.
To use the pralidoxime auto-injector:
- Remove the gray safety cap.
- Place the black tip of the device on the thigh, with the injector pointed straight at the thigh.
- Press hard into the thigh until the auto-injector functions. Hold in place for several seconds. Remove the auto-injector and dispose of it as directed.
- Massage the injected area for 10 seconds.

Use pralidoxime only as directed. Do not use more of it and do not use it more often than your doctor or medic ordered. Do not use more than recommended on the label unless otherwise directed by your doctor or medic.

Dosing

The dose of pralidoxime will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pralidoxime. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form:
- For treatment of organic phosphorus pesticide poisoning:
  - Adults and teenagers—The usual dose is 1 to 2 grams injected into a vein. The dose may be repeated after one hour, and then every eight to twelve hours if muscle weakness continues.
  - Children—The dose is based on body weight and must be determined by your doctor. It is usually 25 to 50 milligrams (mg) per kilogram (kg) (11.35 to 22.7 mg per pound) of body weight injected into a vein. The dose may be repeated after one hour, and then every eight to twelve hours if muscle weakness continues.
- For treatment of organic phosphorus chemical (“nerve gas”) poisoning:
  - Adults—The usual dose is 600 mg injected into a muscle. The dose may be repeated fifteen minutes after the first dose and again fifteen minutes after the second dose, if needed.
  - Children—Dose must be determined by your doctor.
- For treatment of overdose of medicines used to treat myasthenia gravis:
  - Adults and teenagers—At first, the dose is 1 to 2 grams injected into a vein. Then, the dose is 250 mg injected into a vein every five minutes.
  - Children—Dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using pralidoxime

pralidoxime will add to the effects of CNS depressants (medicines that may make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using pralidoxime.

pralidoxime Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Blurred or double vision
difficulty in focusing your eyes
difficulty in speaking
difficult or rapid breathing
dizziness
fast heartbeat
muscle stiffness or weakness
pain at the place of injection (after injection into a muscle)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Drowsiness
headache
nausea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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