Belladonna 30 [hp_X]/30[hp_X]
ATROPA BELLADONNA · PELLET · Boiron
Belladonna is a pellet containing atropa belladonna at 30 [hp_X]/30[hp_X], taken oral. Manufactured by Boiron.
Key Facts
- Brand Name
- Belladonna
- Generic Name
- ATROPA BELLADONNA
- NDC Code (Product)
0220-0743- Manufacturer
- Boiron
- Strength
- 30 [hp_X]/30[hp_X]
- Dosage Form
- PELLET
- Route
- ORAL
- Marketing Status
- Marketing Start
- 03/03/1983
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
West-Ward Pharmaceutical Corp.
Presence of Foreign Substance: Belladonna Alkaloids with Phenobarbital Tablets with black specks comprised of degraded organic material on tablets.
Standard Homeopathic Company
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Physicians Total Care, Inc.
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.
Washington Homeopathic Products, Inc.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
West-Ward Pharmaceutical Corp.
Presence of Foreign Substance: black specks comprised of degraded organic material found on tablets
West-ward Pharmaceutical Corp.
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
West-Ward Pharmaceutical Corp.
Cross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
Standard Homeopathic Company
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 Belladonna and opium suppositories are an opioid agonist 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 product…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. (2.1) • Individualize dosing based on the severity of pain, patient response, and prior analgesic experience, and risk factor for addiction, abuse, and misuse. (2.1) • Initiate dosing with one suppository once or twice daily as needed for pain. (2.2) • Do not stop belladonna and opium suppositories abruptly in a physically dependent patient. (2.4) 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…
Contraindications
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) ] • 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. (…
Drug Interactions
7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with belladonna and opium suppositories. Table 1: Clinically Significant Drug Interactions with Belladonna and Opium Suppositories Alcohol, Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact : Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Intervention : Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [ see Warnings and Precautions (5.4) ]. Examples : Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol. Serotonergic Drugs Clinical Impact : The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Intervention : If concomitant use i…
Adverse Reactions
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. The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [ see Warnings and Precautions (5.1) ] • Life-Threatening Respiratory Depression [ see Warnings and Precautions (5.2) ] • Neonatal Opioid Withdrawal Syndrome [ see Warnings and Precautions (5.3) ] • Interactions with Benzodiazepines and Other CNS Depressants [ see Warnings and Precautions (5.4) ] • Adrenal Insufficiency [ see Warnings and Precautions (5.6) ] • Severe Hypotension [ see Warnings and Precautions (5.7) ] • Gastrointestinal Adverse Reactions [ see Warnings and Precautions (5.9) ] • Seizures [ see Warnings and Precautions (5.11) ] • Withdrawal [ see Warnings and Precautions (5.12) ] Most common adverse reactions are drowsiness, dry mouth, urinary retention, photophobia, rapid pulse, dizziness and blurred vision, constipation, nausea and vomit…
Frequently Asked Questions
What is Belladonna used for?
Belladonna contains ATROPA BELLADONNA. It is a pellet taken oral. Consult your doctor for specific uses.
Is Belladonna a controlled substance?
Belladonna is not classified as a controlled substance by the DEA.
What is the generic name for Belladonna?
The generic name for Belladonna is ATROPA BELLADONNA. There are 7 other brand versions of ATROPA BELLADONNA.
What is the NDC code for Belladonna 30 [hp_X]/30[hp_X]?
The NDC (National Drug Code) for Belladonna 30 [hp_X]/30[hp_X] is 0220-0743, listed by Boiron.