Belladonna and Opium

BELLADONNA AND OPIUM- atropa belladonna and opium suppository
Paddock Laboratories, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

WARNING: ADDICTION, ABOUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOD WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH ALCOHOL, BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

Belladonna and opium suppositories expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing belladonna and opium suppositories, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1) ].

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of belladonna and opium suppositories. Monitor for respiratory depression, especially during initiation of belladonna and opium suppositories or following a dose increase [see Warnings and Precautions (5.2) ].

Accidental Exposure

Accidental exposure of even one dose of belladonna and opium suppositories, especially by children, can result in a fatal overdose of opium [see Warnings and Precautions (5.2) ].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of belladonna and opium suppositories during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3) ].

Risks From Concomitant Use With Alcohol, Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.4), Drug Interactions (7) ].

Reserve concomitant prescribing of belladonna and opium suppositories and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation

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 doses [see Warnings and Precautions (5.1) ], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

Have not been tolerated, or are not expected to be tolerated,
Have not provided adequate analgesia, or are not expected to provide adequate analgesic

2 DOSAGE AND ADMINISTRATION

2.1 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) ].

Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1) ].

Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with belladonna and opium suppositories and adjust the dosage accordingly [see Warnings and Precautions (5.2) ].

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.

2.3 Maintenance of Therapy

Continually reevaluate patients receiving belladonna and opium suppositories to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1) ]. 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.

2.4 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. Do not stop belladonna and opium suppositories abruptly [see Warnings and Precautions (5.12), Drug Abuse and Dependence (9.3) ].

3 DOSAGE FORMS AND STRENGTHS

Belladonna and Opium Suppositories are available in two strengths.

Belladonna 16.2 mg and opium 30 mg
Belladonna 16.2 mg and opium 60 mg

4 CONTRAINDICATIONS

Belladonna and opium suppositories are contraindicated in patients with:
Significant respiratory depression [see Warnings and Precautions (5.2) ]
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.5) ]
Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions (5.7), Drug Interactions (7) ]
Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.9) ]
Hypersensitivity to opium or belladonna [see Adverse Events (6) ]
Glaucoma2
Severe hepatic or renal disease2
Narcotic idiosyncrasies2
Convulsive disorders2
Acute alcoholism2
Delirium tremens2
Premature labor2

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