Description
Opium tincture is used to treat diarrhea. This medicine belongs to the group of medicines called narcotics.
When a narcotic is used for a long time, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tincture
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of opium tincture in the pediatric population. Use in children is not recommended.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of opium tincture in the elderly. However, elderly patients are more likely to have age-related liver, lung, or breathing problems which may require caution for patients receiving opium tincture.
Breastfeeding
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.
Drug Interactions
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are 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.
- Naltrexone
- Safinamide
- Samidorphan
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Alfentanil
- Alprazolam
- Amphetamine
- Benzhydrocodone
- Benzphetamine
- Bromazepam
- Bromopride
- Buprenorphine
- Butalbital
- 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
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:
- 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.
Proper Use
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.
- For diarrhea:
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.
Precautions
It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine 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 with sleeping.
Side Effects
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 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.
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