Opium (Oral)

Opium tincture is used to treat diarrhea. This medicine is part of a group called narcotics.

Using a narcotic for a long time may lead to habit formation, resulting in mental or physical dependence. If treatment is stopped suddenly, physical dependence may cause withdrawal side effects. However, severe withdrawal side effects can usually be avoided by slowly reducing the dose over time before stopping treatment entirely.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress while you are taking this medicine. This will help your doctor see if the medicine is working properly and decide if you should keep taking it.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that can make you sleepy or less alert). Some examples of CNS depressants are antihistamines or medicines for allergies or colds; sedatives, tranquilizers, or sleeping medicines; other prescription pain medicines or narcotics; medicines for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits of taking it. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been enough studies on the effects of opium tincture in children. It is not recommended for use in children.

Geriatric

Studies to date have not shown any specific problems in older adults that would limit the usefulness of opium tincture. However, older patients are more likely to have liver, lung, or breathing issues due to age, which may require caution when using opium tincture.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction might happen. In cases where two medicines are used together, your doctor may adjust the dose or take other precautions. It is important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant and not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Nalmefene
• Naltrexone
• Safinamide
• Samidorphan

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Alfentanil
• Alprazolam
• Amphetamine
• Benzhydrocodone
• Benzphetamine
• Bromazepam
• Bromopride
• Buprenorphine
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbinoxamine
• Cetirizine
• Citalopram
• Clobazam
• Clonazepam
• Clopidogrel
• Codeine
• Daridorexant
• Desmopressin
• Desvenlafaxine
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Diazepam
• Dihydrocodeine
• Doxylamine
• Duloxetine
• Escitalopram
• Esketamine
• Fenfluramine
• Fentanyl
• Flibanserin
• Fluoxetine
• Fluvoxamine
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Granisetron
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Ketamine
• Lacosamide
• Lasmiditan
• Lemborexant
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lithium
• Lofexidine
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Meclizine
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine
• Metoclopramide
• Midazolam
• Milnacipran
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Olanzapine
• Ondansetron
• Oxycodone
• Oxymorphone
• Ozanimod
• Paroxetine
• Pentazocine
• Periciazine
• Phenobarbital
• Potassium Oxybate
• Pregabalin
• Primidone
• Remifentanil
• Remimazolam
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Sertraline
• Sodium Oxybate
• Sufentanil
• Topiramate
• Tramadol
• Trazodone
• Vilazodone
• Vortioxetine
• Zolpidem
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Alcohol abuse, history of or
• Brain disease (e.g., cerebral arteriosclerosis) or
• Breathing problems (e.g., asthma, emphysema) or
• Drug dependence, especially narcotic abuse or dependence, or history of or
• Head injuries or
• Increased pressure in your head or
• Liver disease (e.g., cirrhosis) or
• Stomach or bowel bleeding or
• Underactive thyroid—Use with caution. May increase risk for more serious side effects.

• Diarrhea caused by poisoning—Should not be used in patients with this condition.

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

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Difficulty having a bowel movement (stool)
• hives or welts
• nausea
• vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Anxiety
• blurred vision
• blue lips and fingernails
• chest pain or discomfort
• chills
• cold sweats
• coma
• confusion
• constricted, pinpoint, or small pupils (black part of eye)
• cool, clammy skin
• coughing that sometimes produces a pink frothy sputum
• depression
• difficult, fast, or noisy breathing, sometimes with wheezing
• difficult or troubled breathing
• difficulty sleeping
• disorientation
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• drowsiness to profound coma
• fast heartbeat
• hallucination
• headache
• increased hunger
• increased sweating
• irregular, fast or slow, or shallow breathing
• lethargy
• lightheadedness
• mood or other mental changes
• nervousness
• nightmares
• no blood pressure or pulse
• no muscle tone or movement
• not breathing
• pale or blue lips, fingernails, or skin
• seizures
• shakiness
• shortness of breath
• slow or irregular heartbeat
• slurred speech
• stopping of heart
• swelling in legs and ankles
• unconsciousness
• unusual tiredness or weakness

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:

Incidence not known

• Itching skin
• redness of skin
• skin rash

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.

In Canada

• Pantopon

Available Dosage Forms:

• Tincture

Therapeutic Class: Antidiarrheal

Chemical Class: Opium (class)

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for young children and for elderly patients, who are especially sensitive to the effects of opium preparations. If too much is taken, this medicine may become habit-forming (causing mental or physical dependence) or lead to problems because of an overdose.

This medicine is to be taken by mouth even if it comes in a dropper bottle. The amount you should take is to be measured with the special dropper provided with your prescription and diluted with water just before you take each dose.

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 oral dosage form (tincture):For diarrhea: Adults—0.6 milliliters (mL) four times a day. Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Keep the bottle tightly closed after use.