Loading…
Belladonna And Opium is a brand name for Opium. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. 1) • Individualize dosing based on the severity of pain, patient response, and prior analgesic experience, and risk factor for addiction, abuse, and misuse.
1) • Initiate dosing with one suppository once or twice daily as needed for pain. 2) • Do not stop belladonna and opium suppositories abruptly in a physically dependent patient. 1 Important Dosage and Administration Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ].
1) ]. 2) ]. 2 Dosing 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. Conversion from Other Opioids to Belladonna and Opium Suppositories There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of belladonna and opium suppositories.
It is safer to underestimate a patient’s 24-hour belladonna and opium suppositories dosage than to overestimate the 24-hour belladonna and opium suppositories dosage and manage an adverse reaction due to overdose. Conversion from Belladonna and Opium suppositories to Extended-Release Opioid The relative bioavailability of belladonna and opium suppositories compared to extended-release opioid is unknown, so conversion to extended-release drug product must be accompanied by close observation for signs of excessive sedation and respiratory depression.
1) ]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the belladonna and opium suppositories dosage.
If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions. 4 Discontinuation of Belladonna and Opium Suppositories When a patient who has been taking belladonna and opium suppositories regularly and may be physically dependent no longer requires therapy with belladonna and opium suppositories, use a gradual downward titration of the dosage to prevent signs and symptoms of withdrawal.
6 ADVERSE REACTIONS Belladonna may cause drowsiness, dry mouth, urinary retention, photophobia, rapid pulse, dizziness and blurred vision 7 . Opium usage may result in constipation, nausea or vomiting. Pruritis and urticaria may occasionally occur.
Hypersensitivity to opium or belladonna may occur. 12) ] Most common adverse reactions are drowsiness, dry mouth, urinary retention, photophobia, rapid pulse, dizziness and blurred vision, constipation, nausea and vomiting. gov/medwatch.
2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of opioids. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Serotonin syndrome:
Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency:
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis:
Anaphylaxis has been reported with products containing opioids.
Androgen deficiency:
Cases of androgen deficiency have occurred with chronic use of opioids
5 WARNINGS AND PRECAUTIONS These preparations are not recommended for use in children. • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.
5) • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. 6) • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Oral Solution in patients with circulatory shock.
7) • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of belladonna and opium suppositories in patients with impaired consciousness or coma.
1 Addiction, Abuse, and Misuse Belladonna and opium suppositories contains opium, a Schedule II controlled substance. As an opioid, belladonna and opium suppositories exposes users to the risks of addiction, abuse, and misuse [ see Drug Abuse and Dependence (9) ].
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed belladonna and opium suppositories. Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing belladonna and opium suppositories, and monitor all patients receiving belladonna and opium suppositories for the development of these behaviors or conditions.
, major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as belladonna and opium suppositories, but use in such patients necessitates intensive counseling about the risks and proper use of belladonna and opium suppositories along with intensive monitoring for signs of addiction, abuse, and misuse.
9) ] • Hypersensitivity to opium or belladonna [ see Adverse Events (6) ] • Glaucoma 2 • Severe hepatic or renal disease 2 • Narcotic idiosyncrasies 2 • Convulsive disorders 2 • Acute alcoholism 2 • Delirium tremens 2 • Premature labor 2 • Significant respiratory depression.
(4) • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4) • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days (4) • Known or suspected gastrointestinal obstruction, including paralytic ileus.
(4) • Hypersensitivity to opium or belladonna. (4)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in United States of America? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
3) ].
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing belladonna and opium suppositories. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [ see Patient Counseling Information (17) ].
Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. 2 Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended.
Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [ see Overdosage (10) ].
Carbon dioxide (CO 2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of belladonna and opium suppositories, the risk is greatest during the initiation of therapy or following a dosage increase.
Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases of belladonna and opium suppositories. 2) ]. Overestimating the belladonna and opium suppositories dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.
Accidental exposure of even one dose of belladonna and opium suppositories, especially by children, can result in respiratory depression and death due to an overdose of opium. 3 Neonatal Opioid Withdrawal Syndrome Prolonged use of belladonna and opium suppositories during pregnancy can result in withdrawal in the neonate.
Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. 1), Patient Counseling Information ].
, non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [ see Drug Interactions (7) ].
If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response.
If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation.
Advise both patients and caregivers about the risks of respiratory depression and sedation when belladonna and opium suppositories are used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined.
Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [ see Drug Interactions (7) and Patient Counseling Information (17) ].
5 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients The use of belladonna and opium suppositories in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
2) ]. 2) ]. 2) ]. Alternatively, consider the use of non-opioid analgesics in these patients. 6 Interactions with Monoamine Oxidase Inhibitors Monoamine oxidase inhibitors (MAOIs) may potentiate the effects of opioids, including respiratory depression, coma, and confusion.
Belladonna and Opium Suppositories should not be used in patients taking MAOIs or within 14 days of stopping such treatment. 7 Adrenal Insufficiency Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible.
If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers.
Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
8 Severe Hypotension Belladonna and opium suppositories may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. , phenothiazines or general anesthetics) [ see Drug Interactions (7) ]. Monitor these patients for signs of hypotension after initiating or titrating the dosage of belladonna and opium suppositories.
In patients with circulatory shock, belladonna and opium suppositories may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of belladonna and opium suppositories in patients with circulatory shock.
, those with evidence of increased intracranial pressure or brain tumors), belladonna and opium suppositories may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with belladonna and opium suppositories.
Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of belladonna and opium suppositories in patients with impaired consciousness or coma. 10 Risks of Use in Patients with Gastrointestinal Conditions Belladonna and opium suppositories are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.
The opium in belladonna and opium suppositories may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
11 Increased Risk of Seizures in Patients with Seizure Disorders The opium in belladonna and opium suppositories may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures.
Monitor patients with a history of seizure disorders for worsened seizure control during belladonna and opium suppositories therapy. , buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including belladonna and opium suppositories.
In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms [ see Drug Interactions (7) ]. 4) ]. 3) ]. 13 Risks of Driving and Operating Machinery Belladonna and opium suppositories may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of belladonna and opium suppositories and know how they will react to the medication [see Patient Counseling Information (17)].