Paregoric

Name: Paregoric

What is Paregoric (opium preparation)?

Opium preparation is an opioid. An opioid is sometimes called a narcotic.

Opium is derived from the seed pod of a poppy plant. It works by increasing smooth muscle tone and decreasing fluid secretions in the intestines. This slows the movement of bowel matter through the intestines.

Opium preparation (sometimes called "opium tincture") is used to treat diarrhea.

Opium preparation may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Paregoric (opium preparation)?

Do not use this medicine if the safety seal on the cap is broken or missing.

You should not use opium preparation if you are allergic to morphine, or if you have a seizure disorder. Opium preparation should not be given to treat diarrhea that is caused by poisoning (until the toxin is no longer in the digestive tract).

What should I discuss with my health care provider before taking Paregoric (opium preparation)?

Do not use this medicine if the safety seal on the cap is broken or missing.

You should not use opium preparation if you are allergic to morphine, or if you have:

  • a seizure disorder; or

  • diarrhea that is caused by poisoning (until the toxin is no longer in the digestive tract).

To make sure opium preparation is safe for you, tell your doctor if you have:

  • any type of breathing problem or lung disease;

  • a history of stomach problems;

  • a history of head injury, brain tumor, or seizures;

  • liver or kidney disease;

  • a heart rhythm disorder;

  • enlarged prostate, urination problems; or

  • problems with your gallbladder, adrenal gland, or thyroid.

Opium preparation is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Opium preparation may be habit-forming when used over a long period of time. Never share opium preparation with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away opium preparation is against the law.

FDA pregnancy category C. It is not known whether opium preparation will harm an unborn baby. Tell your doctor if you are pregnant.

Opium preparation can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Paregoric (opium preparation) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using opium preparation and call your doctor at once if you have:

  • weak or shallow breathing;

  • a light-headed feeling, like you might pass out;

  • confusion; or

  • feelings of extreme happiness or sadness.

Common side effects may include:

  • nausea, vomiting;

  • constipation;

  • dizziness, drowsiness; or

  • itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Paregoric (opium preparation)?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking opium preparation with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with opium preparation, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What do I need to tell my doctor BEFORE I take Paregoric?

  • If you have an allergy to paregoric or any other part of paregoric.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have loose stools (diarrhea) caused by poisoning.
  • If you have seizures.

This is not a list of all drugs or health problems that interact with this medicine.

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 paregoric with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about paregoric, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about paregoric. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using paregoric.

Review Date: October 4, 2017

Clinical pharmacology

Morphine produces its major effects on the central nervous system (CNS) and on the bowel.

Dosage and administration

Usual Pediatric Dosage

0.25 to 0.5 mL/kg of body weight 1 to 4 times a day or as directed by a physician.

Usual Adult Dosage

5 to 10 mL 1 to 4 times a day or as directed by a physician.

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