Pronunciation:

bel-a-DON-a, OH-pee-um

Classifications:

Chemical—

Opium (class)

Uses of This Medicine:

Belladonna and opium suppositories are used to relieve moderate to severe pain caused by ureteral spasm. This medicine belongs to the group of medicines called narcotic analgesics (pain medicines).

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.

Before Using This Medicine:

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.

Children—

Use of belladonna and opium suppositories are not recommended in children 12 years of age and younger.

Older adults—

No information is available on the relationship of age to the effects of belladonna and opium suppositories in geriatric patients. However, elderly patients may be more sensitive to the effects of this medicine, which may require caution.

Breast-feeding—

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.

Other medicines—

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
• Potassium Chloride
• Potassium Citrate
• 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
• Amantadine
• Amphetamine
• Benzhydrocodone
• Benzphetamine
• Bromazepam
• Bromopride
• Buprenorphine
• Butalbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbidopa
• Carbinoxamine
• Cetirizine
• Citalopram
• Clobazam
• Clonazepam
• Clopidogrel
• Clozapine
• Codeine
• Cyclobenzaprine
• Cyproheptadine
• Daridorexant
• Desmopressin
• Desvenlafaxine
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Diazepam
• Dihydrocodeine
• Doxylamine
• Duloxetine
• Escitalopram
• Esketamine
• Fenfluramine
• Fentanyl
• Flibanserin
• Fluoxetine
• Fluvoxamine
• Foscarbidopa
• Foslevodopa
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Granisetron
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Ketamine
• Lacosamide
• Lasmiditan
• Lemborexant
• LetibotulinumtoxinA-wlbg
• Levocetirizine
• Levodopa
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofexidine
• Lorazepam
• Loxapine
• Magnesium Oxybate
• Meclizine
• Meperidine
• Metaxalone
• Methacholine
• Methadone
• Methamphetamine
• Methylene Blue
• Metoclopramide
• Midazolam
• Milnacipran
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Olanzapine
• Oliceridine
• Ondansetron
• Oxycodone
• Oxymorphone
• Ozanimod
• Paliperidone
• Palonosetron
• Paroxetine
• Pentazocine
• Periciazine
• Phenobarbital
• Potassium Oxybate
• Pregabalin
• Primidone
• Quetiapine
• Remifentanil
• Remimazolam
• Revefenacin
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secretin Human
• Sertraline
• Sodium Oxybate
• Sofpironium
• Sufentanil
• Tapentadol
• Ticagrelor
• Tiotropium
• Topiramate
• Tramadol
• Trazodone
• Venlafaxine
• Vilazodone
• Vortioxetine
• Ziprasidone
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetophenazine
• Chlorpromazine
• Desflurane
• Dixyrazine
• Ethopropazine
• Fluphenazine
• Mesoridazine
• Methdilazine
• Methotrimeprazine
• Perazine
• Periciazine
• Perphenazine
• Pipotiazine
• Prochlorperazine
• Promazine
• Promethazine
• Propiomazine
• Thiethylperazine
• Thioridazine
• Tizanidine
• Trifluoperazine
• Triflupromazine

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:

• Acute alcohol withdrawal or
• Allergy or reaction to narcotic medicines (e.g., morphine), history of or
• Asthma or
• Glaucoma or
• Kidney disease, severe or
• Liver disease, severe or
• Respiratory depression (very slow breathing) or
• Seizures or epilepsy—Should not be used in patients with these conditions.

• Drug dependence, especially narcotic abuse or dependence, or history of or
• Enlarged prostate or
• Glaucoma, incipient (starting to appear) or
• Head injuries, history of or
• Heart disease or
• Hypothyroidism (underactive thyroid) or
• Increased pressure in your head or
• Psychosis (mental illness) or
• Underactive thyroid—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is used for a long time, it may become habit-forming (causing mental or physical dependence).

To use the suppository:

• Never take rectal suppositories by mouth.
• Wash your hands with soap and water before using this medicine.
• Remove the foil or wrapper from the suppository before inserting it.
• Moisten your finger and the suppository with water. Lie down on your side and use your finger to push the suppository well up into the rectum.
• Keep lying down for about 15 minutes to keep the suppository from coming out before it melts. Then, wash your hands again.

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 rectal dosage form (suppository):
  • For relief of moderate to severe pain:
    • Adults and teenagers—One suppository inserted into the rectum once or two times a day. The dose is usually not more than 4 suppositories per day, unless your doctor tells you otherwise.
    • Children up to 12 years of age—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—

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.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not refrigerate the suppositories.

Precautions While Using This Medicine:

It is very important that your doctor check the progress of you or your child while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

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.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Side Effects of This Medicine:

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

Decrease in the frequency of urination

decrease in urine volume

difficulty in passing urine (dribbling)

painful urination

rapid pulse

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

Symptoms of overdose

Change in consciousness

difficult or troubled breathing

dry mouth

fever

hot, dry, or flushed skin

irregular, fast or slow, or shallow breathing

loss of consciousness

pale or blue lips, fingernails, or skin

pinpoint pupils (black part of the eye)

shortness of breath

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

Blurred vision

change in color vision

constipation

difficulty seeing at night

dizziness

drowsiness

hives or welts

increased sensitivity of the eyes to sunlight

itching skin

nausea or vomiting

redness of the 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.