Each belladonna and opium suppository contains (in a water-soluble base consisting of Polyethylene Glycol 400, 1450, 8000 and Polysorbate 60):

Belladonna (16.2 mg) and Opium (30 mg): Powdered opium 30 mg (Warning: May be habit forming.) and powdered belladonna extract 16.2 mg.

Belladonna (16.2 mg) and Opium (60 mg): Powdered opium 60 mg (Warning: May be habit forming.) and powdered belladonna extract 16.2 mg.

This drug falls into the pharmacological/ therapeutic class of narcotic analgesic/ antispasmotic agents.

The pharmacologically active principles present in the belladonna extract component of belladonna and opium suppositories are:

Established Name: Atropine

Chemical Name: dl Tropyl Tropate

Chemical Structure:

and

Established Name: Scopolamine

Chemical Name: dl Scopolamine

Chemical Structure:

Opium contains more than twenty alkaloids, the principle ones being morphine (10%), narcotine (6%), papaverine (1%) and codeine (0.5%). The major pharmacologically active principle of the powdered opium component of belladonna and opium suppositories, however, is:

Name: Morphine

Chemical Name: 7,8-Didehydro-4,5-epoxy-17- Methyl-morphinan-3,6-diol

Chemical Structure:

Last updated on RxList: 12/8/2004

Belladonna and opium suppositories are used for relief of moderate to severe pain associated with ureteral spasm not responsive to non-narcotic analgesics and to space intervals between injections of opiates.

Adults

One belladonna and opium suppository rectally once or twice daily, not to exceed four doses daily or as recommended by the physician. Moisten finger and suppository with water before inserting. Absorption is dependent on body hydration and not on body temperature.

Not recommended for use in children 12 years of age and under.

Belladonna (16.2 mg) and Opium (30 mg) suppositories are easy to open, color-coded and available in cartons of 12's.

12's - NDC 0574-7045-12

Belladonna (16.2 mg) and Opium (60 mg) suppositories are easy to open, color coded and available in cartons of 12's and 20's.

12's - NDC 0574-7040-12

20's - NDC 0574-7040-20

Store at room temperature. DO NOT REFRIGERATE.

Schedule II controlled substances - DEA order required.

Caution: Federal law prohibits dispensing without prescription. Federal law prohibits transfer of this drug to any person other than the patient for whom it was prescribed.

REFERENCE

1. Gilman, A.G. Goodman, L.S. & Gilman, A 6th Edition, The Pharmacological Basis of Therapeutics, MacMillan Pub. Co., NY 1980, pp. 121-127

2. Ibid, pp. 494-513

Last updated on RxList: 12/8/2004

Belladonna may cause drowsiness, dry mouth, urinary retention, photophobia, rapid pulse, dizziness and blurred vision. Opium usage may result in constipation, nausea or vomiting. Pruritis and urticaria may occasionally occur.

DRUG ABUSE AND DEPENDENCE

Because of their content of opium, belladonna and opium suppositories are considered as Schedule II drugs by the Drug Enforcement Administration. No data exists on chronic abuse effects or dependence characteristics of belladonna and opium suppositories.

Tell your doctor of all nonprescription or prescription medication you use, especially of: muscle relaxants, antidepressants (tricyclic), tranquilizers, sleep medicine, amantadine, antiparkinson drugs, narcotic pain relievers, cough medicines, quinidine, procainamide, disopyramide, MAO inhibitors (e.g., furazolidone, linezolid, phenelzine, selegiline, tranylcypromine), antihistamines, levodopa, digoxin, ketoconazole, potassium supplements, corticosteroids (e.g., prednisone), amphetamines, alcohol, cimetidine. Do not start or stop any medicine without doctor or pharmacist approval.

Last updated on RxList: 12/8/2004

True addiction may result from opium usage. These preparations are not recommended for use in children.

Administer with caution to persons with a known idiosyncrasy to atropine or to atropine-like compounds; to persons known to be sensitive to or addicted to morphine or morphine-like drugs; to persons with cardiac disease, incipient glaucoma or prostatic hypertrophy. Caution should be used in the administration of this drug to elderly and debilitated patients and patients with increased intracranial pressure, toxic psychosis and myxedema.

Pregnancy Category C

Animal studies have not been conducted with belladonna and opium suppositories. It is also not known whether belladonna and opium suppositories can affect reproductive capacity. The active principles of belladonna and opium suppositories, atropine and morphine, are known to enter the fetal circulation. Regular use of opium alkaloids during pregnancy has resulted in addiction of the fetus leading to withdrawal symptoms in the neonate. Belladonna and opium suppositories therefore should be used by a pregnant woman with caution and only when clearly indicated.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when belladonna and opium suppositories are administered to a nursing woman.

Last updated on RxList: 12/8/2004

As with morphine and related narcotics, overdosage is characterized by respiratory depression, pinpoint pupils and coma. Respiratory depression may be reversed by intravenous administration of naloxone hydrochloride. In addition, supportive measures such as oxygenation, intravenous fluids and vasopressors should be used as indicated. As with atropine derivatives, hot, dry, flushed skin; dry mouth and hyperpyrexia may occur.

Do not use belladonna and opium suppositories in patients suffering from glaucoma, severe hepatic or renal disease, bronchial asthma, narcotic idiosyncrasies, respiratory depression, convulsive disorders, acute alcoholism, delirium tremens and premature labor.

Last updated on RxList: 12/8/2004

Through its parasympatholytic action, atropine relaxes smooth muscle resulting from parasympathetic stimulation. It is the dl isomer of 1-hyoscyamine and therefore exhibits the same clinical effects. It is, however, approximately one-half as active peripherally as 1-hyoscyamine, the latter being the major active plant alkaloid. The dl isomer, atropine, is formed during the process of isolation of the belladonna extract.¹

Morphine, the major active principle of powdered opium, is responsible for the action of powdered opium although the other alkaloids present also contribute to it. The sedative and analgesic action of morphine, the effect desired by inclusion in belladonna and opium suppositories of powdered opium, are thought to be due to the depressant effect on the cerebral cortex, hypothalamus and medullary centers. In large doses, the opiates and their analogs also exhibit synaptic conduction in the spinothalamic tracts, depress the function of the reticular formation, the lemniscus and the thalamic relays, and inhibit spinal synaptic reflexes: but these inhibitor actions should not be elicited with therapeutic doses of the drug. Moderate doses of powdered opium should not alter the electroencephalogram.

The action of morphine consists mainly of a descending depression of the central nervous system. It exerts its analgesic action by increasing the pain threshold or the magnitude of stimulus required to evoke pain and by dulling the sensibility or reaction to pain. In addition to its action in abolishing pain, morphine induces a sense of well-being (euphoria) facilitating certain mental processes while retarding others. Upon absorption of morphine, oxidative dealkylation to produce nor-compounds appears to be the first step in the reaction sequence which imparts analgesia. Morphine is conjugated in the liver to form the 3-glucuronide which passes into the bile and is reabsorbed and excreted in the urine. The atropine effect of the belladonna extract serves to eliminate morphine induced smooth muscle spasm without affecting the sedative analgesic action of powdered opium².

Onset of Action: Within 30 minutes
Metabolism: Hepatic, with formation of glucoronide metabolites

Last updated on RxList: 12/8/2004

NOTES: This is a potent drug. Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

STORAGE: Store at room temperature away from sunlight and moisture. Do not refrigerate

See WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

BELLADONNA/OPIUM SUPPOSITORY - RECTAL

(bell-uh-DON-uh/OH-pee-um)

USES: This product is used to treat moderate to severe pain from spasms of the urinary tract. It contains 2 medications, belladonna and opium. Belladonna helps to decrease the spasms. Opium is a narcotic medication that helps to relieve pain.

This product is not recommended for use in children 12 years or younger.

HOW TO USE: Wash your hands before and after using the suppository. Unwrap the suppository and moisten it with water. Insert 1 suppository into the rectum as directed by your doctor. Lie down on your left side with right knee bent. Gently push the suppository into the rectum with your finger. Remain lying down for a few minutes, and avoid having a bowel movement for an hour or longer so the drug will be absorbed. The suppository is for use in the rectum only.

If you have nausea, consult your doctor or pharmacist about ways to decrease nausea (such as taking antihistamines, lying down for 1 to 2 hours with as little head movement as possible).

The dosage is based on your medical condition and response to treatment. Do not increase your dose, use the medication more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.

Pain medications work best if they are used when the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

This medication may cause dependence, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal reactions (such as restlessness, watery eyes, widened pupils, sweating, runny nose) may occur if you suddenly stop this drug. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Use this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your pain persists or worsens.

SIDE EFFECTS: Nausea, vomiting, constipation, blurred vision, increased eye discomfort in bright light, lightheadedness, dizziness, drowsiness, increased/decreased sweating, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, hallucinations, confusion), difficulty urinating, fainting, slow/fast heartbeat, eye pain, vision changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures, slow/shallow breathing.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to belladonna or opium; or to narcotic pain medications (such as morphine, codeine); or to atropine or scopolamine; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain muscle/nerve disease (myasthenia gravis), certain stomach/bowel diseases (paralytic ileus, blockage, infectious diarrhea), glaucoma (narrow-angle).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung diseases (such as asthma, chronic obstructive pulmonary disease-COPD), breathing problems (such as slow/shallow breathing, sleep apnea), a certain spinal problem (kyphoscoliosis), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), personal or family history of regular use/abuse of drugs/alcohol, heart problems (such as irregular heartbeat, heart failure, coronary artery disease), high blood pressure, brain disorders/injuries (such as seizures, head injury, tumor, increased intracranial pressure), thyroid disease, gallbladder disease, disease of the pancreas (such as pancreatitis), adrenal gland problems (such as Addison's disease), mental/mood disorders (such as toxic psychosis), stomach/intestinal disorders (such as colitis, ulcer), glaucoma (open-angle), heartburn.

This drug may make you dizzy or drowsy or cause blurred vision. Use caution while driving, using machinery, or doing any activity that requires alertness or clear vision. Avoid alcoholic beverages because they may increase the risk of this drug's side effects.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Before having surgery, tell your doctor or dentist that you are using this medication.

This medication can make you more likely to get heat stroke, a very serious condition. Avoid activities that might cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs).

Older adults may be more sensitive to the effects of this drug, especially slow/shallow breathing and drowsiness.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for a long time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

It is unknown if belladonna passes into breast milk. Opium passes into breast milk, and the effect on a nursing infant is not known. Discuss the risks and benefits with your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medication because very serious interactions may occur: naltrexone.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting belladonna/opium suppositories.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: cimetidine, certain medications for pain (opiate partial agonists such as butorphanol, nalbuphine, pentazocine), potassium tablets/capsules, pramlintide, rifampin.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, other narcotic pain relievers (such as morphine), and psychiatric medicines (such as risperidone, amitriptyline, trazodone). Your medications or doses of your medications may need to be changed.

Check the labels on all your medicines (such as cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (including amylase and lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, slow/shallow breathing, severe dizziness, fast heartbeat.

NOTES: Do not share this medication with others. It is against the law.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you are using this medication regularly and miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not refrigerate. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2008 Copyright(c) 2008 First DataBank, Inc.