Belladonna and opium

Belladonna and opium are combination medications used to relieve pain associated with ureteral spasms. 

• Belladonna and opium are available under the following different brand names: B and O Suppositories

Common side effects of Belladonna and opium include:

• Drowsiness,
• Dizziness,
• Blurred vision,
• Constipation,
• Itching,
• Rash,
• Dry mouth, and
• Increasing sensitivity to light

Serious side effects of Belladonna and opium include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Weak or shallow breathing,
• Lightheadedness,
• Fast heartbeats,
• Painful or difficult urination,
• Little or no urination,
• Severe constipation, and
• Stomach pain

Rare side effects of Belladonna and opium include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Suppository: Schedule II

• 16.2 mg/30 mg
• 16.2 mg/60 mg

Ureteral Spasm Pain

Adult and geriatric dosage

• 1 suppository per rectum once a day or every 12 hours
• Not to exceed 4 doses/day

Pediatric dosage

• Aged below 12 years:
  • Not recommended

Aged above 12 years

• 1 suppository per rectum once a day or every 12 hours
• Not to exceed 4 doses/day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, 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, health care provider, or pharmacist first

• Belladonna and opium have severe interactions with the following drug:
  • alvimopan
  • Belladonna and opium have serious interactions with the following drugs:
  • buprenorphine
  • buprenorphine buccal
  • butorphanol
  • calcium/magnesium/potassium/sodium oxybates
  • cimetidine
  • diazepam intranasal
  • isocarboxazid
  • linezolid
  • methylene blue
  • metoclopramide intranasal
  • nalbuphine
  • oliceridine
  • pentazocine
  • phenelzine
  • pramlintide
  • selegiline transdermal
  • selinexor
  • sodium oxybate
  • tramadol
  • tranylcypromine
• Belladonna and opium have moderate interactions with at least 229 other drugs.
• Belladonna and opium have minor interactions with the following drugs:
  • brimonidine
  • dextroamphetamine
  • dimenhydrinate
  • donepezil
  • eucalyptus
  • galantamine
  • levodopa
  • lidocaine
  • sage
  • ziconotide

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Respiratory disease/depression, acute or severe bronchial asthma in an unmonitored setting or absence of resuscitative equipment, convulsive disorders, GI obstruction including paralytic ileus, glaucoma, severe renal or hepatic disease, within 14 days of taking a monoamine oxidase inhibitor, acute alcoholism, delirium tremens, premature labor

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Belladonna and opium?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Belladonna and opium?”

Cautions

• Use caution in patients with head trauma, including injury, intracranial lesions, or elevated intracranial pressure (ICP); significant ICP may occur
• Use caution in patients with toxic psychosis; may exacerbate symptoms
• Use caution in prostatic hyperplasia; may cause urinary retention
• Use caution in cardiovascular disease or with thyroid dysfunction resulting in myxedema; may exacerbate symptoms
• Use caution in patients with seizure disorders; may cause or exacerbate preexisting seizures
• Use caution in patients with biliary tract impairment, including acute pancreatitis, which may cause cons the traction of the sphincter of Oddi
• Serious life-threatening or fatal respiratory depression may occur monitor closely for respiratory depression, especially during initiation or dose escalation; carbon dioxide retention resulting from respiratory depression can exacerbate sedating effects of opioids; educate patients and caregivers about how to recognize respiratory depression and get emergency assistance immediately in the event of an overdose
• May cause severe hypotension, including syncope and orthostatic hypotension; use caution in patients with cardiovascular disease, hypovolemia, circulatory shock, or therapeutic agents that may significantly decrease blood pressure, including anesthetics or phenothiazines; monitor for hypotension upon initiating or titrating dose; avoid use in patients with circulatory shock
• In patients with significant COPD or pulmonary or patients with a significant reduction in respiratory reserve, hypercapnia, hypoxia, or preexisting respiratory depression, especially when initiating and titrating therapy; significant respiratory depression may occur, including at therapeutic dosages; consider using nonopioid analgesics in these patients
• Use caution in patients with adrenal insufficiency, including Addison disease; long-term opioid use of one or more months may cause secondary hypogonadism, with may lead to osteoporosis and mood disorders
• Patients with a history of opioid abuse or alcoholism are at greater risk for drug dependency; psychological, physical dependence, and tolerance may occur with prolonged use
• May cause CNS depression, impairing physical or mental abilities; caution patients about performing tasks requiring mental alertness or operating heavy machinery

Pregnancy and Lactation

• Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome; there are no available data on belladonna and opium suppositories in pregnant women to inform a drug-associated risk for major birth defects and miscarriage
• Chronic use of opioids may cause reduced fertility in females and males of reproductive potential; not known whether the effects on fertility are reversible

Fetal/Neonatal Adverse Reactions

• Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth
• Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity, abnormal sleep pattern, high pitched chromosome, vomiting, diarrhea, and failure to gain weight
• The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn; observe new-borns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly

Labor or delivery

• Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates; an opioid antagonist, such as naloxone, must be available for the reversal of opioid-induced respiratory depression in the neonate
• Belladonna and opium suppositories are not recommended for use in pregnant women during or immediately before labor when other analgesic techniques are more appropriate; opioid analgesics, including belladonna and opium suppositories, can prolong labor through actions that temporarily reduce strength, duration, and frequency of uterine contractions
• However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor; monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression

Lactation

• Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for belladonna and opium suppositories and any potential adverse effects on the breastfed infant from belladonna and opium suppositories or underlying maternal condition
• Infants exposed to belladonna and opium suppositories through breast milk should be monitored for excess sedation and respiratory depression; withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped