OPIUM COMBINATION PRODUCT

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Created Oct 2020

OPIUM COMBINATION PRODUCT

  • [PAREGORIC]
  • [TINCURA OPII CAMOHORATA]
  • [ANHYDROUS MORPHINE]
  • [OPIUM DEODORIZED]
  • [CAMPHORATED TINCTURE]

25 MG/DU

DEA CODE 9809: Schedule 3 Narcotic

Why is this medication prescribed?
Paregoric is used to relieve diarrhea. It decreases stomach and intestinal movement in the digestive system.

How should this medicine be used?
Paregoric comes as a liquid to take by mouth. It usually is taken one to four times a day or immediately after each loose bowel movement. Your prescription may be mixed with water before you take it; the water should turn cloudy white. Do not take more than six doses in 1 day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take paregoric exactly as directed. Paregoric can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.

Opium Tincture (Paregoric) is a prescription medication in the opioid class. This medication is used to decrease control diarrhea by the reducing the number and frequency of bowel movements. It works by increasing smooth muscle tone and decreasing fluid secretions in the intestines. This slows the movement of bowel matter through the intestines.

Paregoric (Opium Preparation)
Side Effects:
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
RxList
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
  • feelings of extreme happiness or sadness
Serious side effects may be more likely in older adults and those who are malnourished or debilitated.
Common side effects may include:
  • nausea, vomiting
  • constipation
  • dizziness, drowsiness
  • 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.

Hazard Alert: Recurring Confusion Between Tincture of Opium and Paregoric:
ISMP urges hospitals, community pharmacies, and other locations that use opium tincture and/or paregoric (camphorated tincture of opium) to take action immediately to minimize the risk of fatal confusion between these drugs. Last week, a Connecticut newspaper reported that a 51-year-old woman with chronic diarrhea died from morphine intoxication after receiving a teaspoonful of opium tincture (about 50 mg morphine) instead of paregoric. After a dose, the patient became weak, tired, and achy. Her son checked on her periodically, but when he tried to wake her later that day, she did not respond. Paramedics were summoned but they could not revive the woman.

Paragoric = Camphorated Tincture of Opium
Laudanum = Tincture of Opium

Prescribed for:
    What Conditions does it Treat?
  • Diarrhea

Uses:
This medication is used to treat diarrhea. It helps to decrease how often you have bowel movements. It works by slowing the movement of the intestines. Paregoric belongs to a class of drugs known as opioid pain relievers, but this medication acts mainly to slow the gut.

Since this medication slows the gut, it should not be used to treat diarrhea caused by poisoning until the toxin is removed from your gut.

Before using:
Tell your doctor or pharmacist your medical history, especially of:

  • Brain disorders (such as head injury, tumor, seizures)
  • Breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD)
  • Kidney disease
  • Liver disease
  • Mental/mood disorders (such as confusion, depression)
  • Personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
  • Stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus)
  • Difficulty urinating (such as due to enlarged prostate)
  • Disease of the pancreas (pancreatitis)
  • Gallbladder disease

Precautions:

  • This drug may make you dizzy or drowsy
  • Alcohol or marijuana (cannabis) can make you more dizzy or drowsy
  • Do not drive, use machinery, or do anything that needs alertness until you can do it safely.
  • Avoid alcoholic beverages.
  • Talk to your doctor if you are using marijuana (cannabis).

This product also contains alcohol. Caution is advised if you have diabetes, liver disease, or any other condition that requires you to limit/avoid alcohol in your diet. Ask your doctor or pharmacist about using this product safely.

User Reviews:

21 Total User Reviews
Paregoric Oral:
Read Reviews
Condition: Diarrhea (18 Reviews):
Effectiveness(4.72)

Ease of Use(4.78)

Satisfaction(4.78)

Interactions:

Drug Interactions (368) Alcohol/Food Interactions (1) Disease Interactions (17)


What other drugs will affect Paregoric?
Taking Paregoric with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, opioid pain medicine, prescription cough medicine, a 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 your doctor about all your current medicines and any medicine you start or stop using.

A total of 368 drugs are known to interact with Paregoric.

  • 22 major drug interactions
  • 345 moderate drug interactions
  • 1 minor drug interaction

Danger of confusion with Laudanum:
In the United States, opium tincture contains 10 mg per mL of anhydrous morphine. By contrast, opium tincture's weaker cousin, paregoric, also confusingly known as "camphorated tincture of opium", is 1/25th the strength of opium tincture, containing only 0.4 mg of morphine per mL. A 25-fold morphine overdose may occur if opium tincture is used where paregoric is indicated. Opium tincture is almost always dosed in drops, or fractions of a mL, or less commonly, in minims, while paregoric is dosed in teaspoons or tablespoons. Thus, an order for opium tincture containing directions in teaspoons is almost certainly in error. To avoid this potentially fatal outcome, the term "camphorated tincture of opium" is avoided in place of paregoric since the former can easily be mistaken for opium tincture.

In the very early 18th century, Jakob Le Mort (1650 - 1718), a professor of chemistry at Leiden University, prepared an elixir for asthma and called it "paregoric". The word "paregoric" comes from the Greek word "paregoricon" which was originally applied to oratory - to speak, but, more accurately, talk over, soothe, and finally came to have the same meaning as "anodyne". Le Mort's elixir, consisted of "honey, licorice, flowers of Benjamin, and opium, camphor, oil of aniseed, salt of tartar and spirit of wine," became official as "Elixir Asthmaticum" in the London Pharmacopoeia of 1721. Its ingredients were assembled out of the obsolete humoral philosophy and quasi-scientific reasoning of the Renaissance. Paregoric was used in various formulations for hundreds of years. Paregoric was a household remedy in the 18th and 19th centuries when it was widely used to control diarrhea in adults and children, as an expectorant and cough medicine, to calm fretful children, and to rub on the gums to counteract the pain from teething. During the twentieth century its use declined as governments regulated its ingredients (opium is a controlled substance in many countries). Beginning in late 2011, there was a period in which paregoric was not being manufactured in the United States. As of August 2012, however, the manufacture of paregoric has resumed.


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