Pronunciation:

pral-i-DOX-eem

Brand Names:

• Protopam Chloride

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Nerve Gas Antidote

Uses of This Medicine:

Pralidoxime injection 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 injection is also used to treat overdose of medicines (e.g., ambenonium, neostigmine, 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.

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

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pralidoxime injection in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pralidoxime injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving pralidoxime injection.

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.

Other 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.

Other interactions—

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Myasthenia gravis (severe muscle weakness)—Use with caution. May make this condition worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or clinic. You may also be taught how to give your medicine at home. This medicine is preferably given through a needle placed in one of your veins. It may also be given as a shot under your skin or into a muscle.

This medicine is available in two forms: a vial and an autoinjector.

For patients using the pralidoxime autoinjector (automatic injection device):

• You will be trained to use the pralidoxime autoinjector by a medic or other trained military personnel. You will also be told the conditions under which it should be used.
• The autoinjector also comes with patient directions. Read them carefully before you actually need to use this medicine. 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 autoinjector until you are ready to use it. This prevents spillage of the medicine from the device during storage and handling.
• To use the pralidoxime autoinjector:
  • 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 autoinjector functions. Hold in place for several seconds. Remove the autoinjector and dispose of it as directed.
  • Massage the injected area for 10 seconds.

Dosing—

The dose of this medicine 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 this medicine. 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—At first, 1000 to 2000 milligrams (mg) injected into a vein usually as an infusion in 100 milliliters (mL) of normal saline, over a 15- to 30-minute period. The dose may be repeated after one hour, and then every eight to twelve hours if muscle weakness persists.
    • Children and teenagers 16 years of age and younger—Dose is based on body weight and must be determined by your doctor. The dose is usually 20 to 50 milligrams (mg) per kilogram (kg) (9.07 to 22.7 mg per pound) of body weight injected into a vein. The dose may be repeated after one hour, and then every ten to twelve hours if muscle weakness persists.
  • For treatment of organic phosphorus chemical (“nerve gas”) poisoning:
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—600 milligrams (mg) or 2 milliliters (mL) injected into a muscle. The dose may be repeated fifteen minutes after the first dose and fifteen minutes after the second dose, if needed.
    • Children and teenagers 16 years of age and younger weighing less than 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is 15 milligrams (mg) per kilogram (kg) of body weight injected into the muscles of the thighs. The dose may be repeated fifteen minutes after the first dose and fifteen minutes after the second dose, if needed.
  • For treatment of overdose of medicines used to treat myasthenia gravis:
    • Adults and teenagers—At first, 1000 to 2000 milligrams (mg) injected into a vein. Then, 250 mg is injected into a vein every five minutes.
    • Children—Use and 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

Call your doctor right away if you or your child have fast heartbeat, difficulty or trouble with breathing, increased muscle weakness, or severe tiredness after receiving this medicine.

This medicine 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 this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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 or nurse immediately if any of the following side effects occur:

More common

Blurred or double vision

change in near or distance vision

difficult or rapid breathing

difficulty in focusing the eyes

difficulty with speaking

dizziness

fast, pounding, or irregular heartbeat or pulse

muscle stiffness or weakness

pain at the injection site (after injection into a muscle)

Incidence not known

Deep or fast breathing with dizziness

numbness of the feet, hands, and around the mouth

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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.