Protopam Chloride

What is Protopam Chloride?

Protopam Chloride is a prescription medicine that is used to treat some overdoses. It is used to treat poisoning from nerve gas or chemicals that kill insects.

Description

Chemical name: 2-formyl-1-methylpyridinium chloride oxime. Available in the United States as PROTOPAM Chloride for Injection (PROTOPAM Chloride), pralidoxime chloride is frequently referred to as 2-PAM Chloride.

Structural formula:

Pralidoxime chloride occurs as an odorless, white, nonhygroscopic, crystalline powder which is soluble in water. Stable in air, it melts between 215º and 225º C, with decomposition.

The specific activity of the drug resides in the 2-formyl-1-methylpyridinium ion and is independent of the particular salt employed. The chloride is preferred because of physiologic compatibility, excellent water solubility at all temperatures, and high potency per gram, due to its low molecular weight.

Pralidoxime chloride is a cholinesterase reactivator.

PROTOPAM Chloride for intravenous injection or infusion is prepared by cryo-desiccation. Each vial contains 1000 mg of sterile pralidoxime chloride, and sodium hydroxide to adjust pH, to be reconstituted with 20 mL of Sterile Water for Injection, USP. The pH of the reconstituted solution is 3.5 to 4.5. Intramuscular or subcutaneous injection may be used when intravenous injection is not feasible.

Before taking Protopam Chloride, tell your doctor:

• If you are allergic to Protopam Chloride; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Protopam Chloride with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Protopam Chloride?

• Tell all of your health care providers that you take Protopam Chloride. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Protopam Chloride while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Protopam Chloride best taken?

Use Protopam Chloride as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given into a vein for a period of time.
• It may be given as a shot into a muscle.
• It may be given as a shot into the fatty part of the skin.

What are the side effects of Protopam Chloride that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• A fast heartbeat.
• Fast breathing.
• Change in eyesight.
• Muscle weakness.
• Signs that are worse have happened when Protopam Chloride was given into a vein very fast. This includes chest pain or pressure, fast heartbeat, throat irritation, rigid muscles, or not being able to move. If any of these side effects happen, tell the doctor right away.

What are some other side effects of Protopam Chloride?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Injection:

• Headache.
• Dizziness.
• Feeling sleepy.
• Upset stomach.

Injection (if given in the muscle):

• Pain where the shot was given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Protopam Chloride?

• If you need to store Protopam Chloride at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL