Belladonna and opium for severe ureteral spasm

Belladonna and opium rectal suppositories contain atropine, scopolamine, and morphine.

It is used in the management of pain associated with ureteral spasm that does not settle with non-opioid analgesics.

It should only be used in patients in whom alternative therapies are ineffective, not tolerated, or contraindicated.

Belladonna and opium Dose in Adults

Dose in the treatment of pain associated with ureteral spasm:

  • One rectal suppository 1 - 2 times a day to a maximum of four doses/day

Belladonna and opium Dose in Children

Dose in the treatment of Pain:

  • Adolescents:
    • One rectal suppository 1 - 2 times a day to a maximum daily dose of four suppositories/day

Pregnancy Risk Factor: C

  • [US Boxed Warning]
  • A neonatal withdrawal syndrome can develop from prolonged use of opioids during pregnancy. If not treated, it could be fatal.
  • Avoid it before and during delivery

Belladonna, opium and breastfeeding

  • Breastmilk contains opium.
  • If the drug is to continue during breastfeeding, it should be considered carefully.
  • If opioids are being used postpartum for pain, infants must be monitored for signs of sedation or respiratory depression.
  • After the mother stops giving the drug, infants can experience withdrawal symptoms.

Belladonna and opium Dose in Renal Disease:

  • Its use is contraindicated in severe renal impairment.
  • The manufacturer has not provided any dose adjustment in patients with renal disease

Belladonna and opium Dose in Liver Disease:

  • Its use is contraindicated in severe hepatic impairment.
  • The manufacturer has not provided any dose adjustment in patients with liver disease.

Side Effects of Belladonna And Opium Frequency not defined.

  • Cardiovascular:
    • Palpitations
  • Central nervous system:
    • Dizziness
    • Drowsiness
  • Dermatologic:
    • Pruritus
    • Urticaria
  • Gastrointestinal:
    • Constipation
    • Nausea
    • Vomiting
    • Xerostomia
  • Genitourinary:
    • Urinary retention
  • Ophthalmic:
    • Blurred vision
    • Photophobia

Contraindication to Belladonna and opium include:

  • Allergy to belladonna, or opium or any other component of the formulation
  • Respiratory depression
  • Acute severe bronchial asthma
  • MAO inhibitors may be used in conjunction
  • Gastrointestinal obstruction including paralytic ileus
  • Glaucoma
  • Grave renal or liver disease
  • Opioid idiosyncrasies
  • Seizure disorders
  • Acute alcoholism
  • Delirium tremens
  • Premature labor.

Warnings and Precautions

  • CNS depression:
    • It can cause CNS depression.
    • The drug should be used with caution by patients who use heavy machinery or those who perform tasks that require mental alertness.
  • Hypotension
    • It can cause severe hypotension or syncope.
    • Hypovolemia, cardiovascular disease including myocardial Infarction and heart Failure, circulatory shock or drugs like diuretics, Phenothiazines and anesthetics should be avoided.
    • Hypotension should be closely monitored.
    • Patients with shock should avoid it.
  • Phenanthrene hypersensitivity:
    • People with allergies to codeine, oxycodone and oxymorphone should be cautious about taking the drug.
  • Respiratory depression [US Boxed Warning]
    • Respiratory depression can be a life-threatening side effect.
    • Patients at high risk for life-threatening depression include patients who are alcoholics or on sedative and/or hypnotic medications.
  • Insufficiency of the adrenal glands:
    • Long-term use of the drug may lead to hypogonadism and adrenal insufficiency.
    • Hypogonadism can lead to infertility and mood disorders, osteoporosis and sexual dysfunction.
  • Insufficiency of the biliary tract:
    • It could cause constriction to the sphincter Oddi. It should not be used in patients with severe pancreatitis, or any other biliary pathology.
  • Cardiovascular disease
    • Patients suffering from cardiovascular disease should be cautious about taking the drug.
  • Use of drugs:
    • People who have a history of substance abuse or excessive alcohol intake could be at risk for drug dependence.
    • These patients can develop physical and psychological dependence.
  • Head trauma
    • Patients with intracranial injuries, intracranial pressure elevations, and head injuries should be cautious about taking the drug.
  • Prostatic hyperplasia
    • It can cause urinary retention. It should be used with caution in patients at high risk, such as patients with prostatic hyperplasia.
  • Psychosis:
    • It can worsen toxic psychosis, so it should not be used in patients with this condition.
  • Respiratory disease
    • Patients suffering from chronic respiratory conditions such as emphysema, chronic bronchitis, interstitial lung disease, or uncontrolled asthma should be cautious about taking the drug.
    • These patients should not be prescribed non-opioid painkillers.
  • Seizure disorders:
    • Patients who have a history of seizure disorders should be cautious about using it as it can exacerbate an existing seizure disorder.
  • Thyroid dysfunction:
    • This medication can exacerbate myxedema, so it should not be used in patients with this condition.

Belladonna and opium: Drug Interaction

Note: Drug Interaction Categories:

  • Risk Factor C: Monitor When Using Combination
  • Risk Factor D: Consider Treatment Modification
  • Risk Factor X: Avoid Concomitant Use

Risk Factor C (Monitor therapy).

Acetylcholinesterase inhibitors Anticholinergic Agents may have a decreased therapeutic effect. Anticholinergic Agents can decrease the therapeutic effects of Acetylcholinesterase inhibitors.
Alizapride CNS Depressants may increase the CNS depressant effects.
Amantadine Anticholinergic Agents may have an enhanced anticholinergic effect.
Amphetamines May increase the analgesic effects of Opioid Agonists.
Anticholinergic Agents Other Anticholinergic Agents may have an adverse/toxic effect.
Anticholinergic Agents This combination may increase the toxic/adverse effects of Opioid Agonists. This combination may increase the risk of constipation or urinary retention.
Botulinum Toxin-Containing Products Anticholinergic Agents may have an enhanced anticholinergic effect.
Brimonidine (Topical) CNS Depressants may increase the CNS depressant effects.
Bromopride CNS Depressants may increase the CNS depressant effects.
Cannabidiol CNS Depressants may increase the CNS depressant effects.
Cannabis CNS Depressants may increase the CNS depressant effects.
Chlorphenesin Carbamate CNS Depressants may have an adverse/toxic effect that can be exacerbated by them.
Desmopressin Desmopressin's toxic/adverse effects may be exacerbated by Opioid Agonists.
Dimethindene (Topical). CNS Depressants may increase the CNS depressant effects.
Diuretics Opioid Agonists can increase the toxic/adverse effects of Diuretics. Opioid Agonists can decrease the therapeutic effects of Diuretics.
Dronabinol CNS Depressants may increase the CNS depressant effects.
Gastrointestinal Agents (Prokinetic) Anticholinergic Agents can reduce the therapeutic effects of Gastrointestinal Agents (Prokinetic).
Gastrointestinal Agents (Prokinetic) Opioid Agonists can decrease the therapeutic effects of Gastrointestinal Agents.
Glucagon Anticholinergic agents may increase the toxic/adverse effects of Glucagon. Particularly, there may be an increase in the likelihood of gastrointestinal adverse reactions.
Itopride Itopride's therapeutic effects may be diminished by anticholinergic agents.
Kava Kava CNS Depressants may have an adverse/toxic effect that can be exacerbated by them.
Lofexidine CNS Depressants may have a greater depressant effect on the brain. Management: Separate drug interaction monographs are available for drugs listed as an exception to this monograph.
Magnesium Sulfate CNS Depressants may increase the CNS depressant effects.
MetyroSINE MetyroSINE may have a sedative effect that can be enhanced by CNS depressants.
Minocycline CNS Depressants may increase the CNS depressant effects.
Mirabegron Anticholinergic agents may increase the toxic/adverse effects of Mirabegron.
Nabilone CNS Depressants may increase the CNS depressant effects.
Nitroglycerin The absorption of Nitroglycerin may be decreased by anticholinergic agents. Anticholinergic Agents may reduce the dissolution sublingual nitroglycerin tablet, which could impair or slow down nitroglycerin absorbtion.
Opioid Agonists Opioid Agonists can have an adverse/toxic effect that may be exacerbated by anticholinergic agents. This combination may increase the likelihood of constipation or urinary retention.
Pegvisomant Pegvisomant's therapeutic effects may be diminished by Opioid Agonists.
Piribedil CNS Depressants could increase the CNS depressant effects of Piribedil.
Pramipexole Pramipexole may have a greater sedative effect if it is combined with CNS depressants.
Ramosetron Ramosetron's constipating effects may be enhanced by anticholinergic agents.
Ramosetron Ramosetron's constipating effects may be enhanced by Opioid Agonists.
ROPINIRole CNS Depressants can increase the sedative effects of ROPINIRole.
Rotigotine CNS Depressants can increase the sedative effects of Rotigotine.
Rufinamide CNS Depressants may have an adverse/toxic effect that can be exacerbated by this. Particularly, dizziness and sleepiness may be increased.
Selective Serotonin Reuptake inhibitors CNS Depressants can increase the toxic/adverse effects of Selective Serotonin Resuptake Inhibitors. Particularly, psychomotor impairment could be increased.
Serotonin Modulators Serotonin modulators may be enhanced by Opioid Agonists. This could lead to serotonin syndrome. Nicergoline is an exception.
Succinylcholine May increase the bradycardic effects of Opioid Agonists.
Tetrahydrocannabinol CNS Depressants may increase the CNS depressant effects.
Tetrahydrocannabinol, and Cannabidiol CNS Depressants may increase the CNS depressant effects.
Thiazide and Thiazide - Like Diuretics Anticholinergic Agents can increase serum Thiazide or Thiazide-Like Diuretics.

Risk Factor D (Regard therapy modification)

 
Alvimopan Alvimopan's toxic/adverse effects may be exacerbated by Opioid Agonists. Patients who have been taking opiates for more than seven days prior to Alvimopan initiation will be most affected. Patients who have been receiving opioids for more that 7 days consecutively prior to alvimopan initiation are not advised to take Alvimopan.
Blonanserin CNS Depressants can increase the CNS depressant effects of Blonanserin.
Chlormethiazole CNS Depressants may increase the CNS depressant effects. Monitoring: Look out for signs of CNS depression. If a combination of chlormethiazole and other drugs is required, a reduced dose should be used.
CNS Depressants This may increase the CNS depressant effects of Opioid Agonists. Management: When possible, avoid the simultaneous use of opioid agonists, benzodiazepines, or other CNS depressionants. Combining these agents is not recommended unless there are other options. Limit the amount and duration of each drug when combined.
Droperidol CNS Depressants may increase the CNS depressant effects. Management: Droperidol and other CNS agents, such as opioids, may be reduced or used in combination with droperidol. Separate drug interaction monographs provide more detail on exceptions to this monograph.
Flunitrazepam CNS Depressants can increase the CNS depressant effects of Flunitrazepam.
HYDROcodone CNS Depressants can increase the CNS depressant effects of HYDROcodone. When possible, avoid concomitant use with hydrocodone and other CNS depressants. Combining these agents is not recommended unless there are other options. Limit the amount and duration of each drug when combined.
Methotrimeprazine Methotrimeprazine may have a higher CNS depressant activity than CNS Depressants. Methotrimeprazine can increase the CNS depressant effects of CNS Depressants. Management: Lower the adult dose of CNS Depressants by 50% and start concomitant methotrimeprazine treatment. After clinically proven efficacy of methotrimeprazine, further CNS depressant dose adjustments should only be made.
Nalmefene This may reduce the therapeutic effects of Opioid Agonists. Management: Avoid concomitant opioid agonists and nalmefene use. Stop using nalmefene one week before any planned use of opioid agonistss. Combinations of opioid agonists may require higher doses.
Naltrexone This may reduce the therapeutic effects of Opioid Agonists. Management: Look for alternatives to opioids. For more information, see the full drug interaction monograph.
Opioid Agonists CNS Depressants can increase the CNS depressant effects of Opioid Aggonists. Management: When possible, avoid concomitant use opioid agonists and other CNS depressants. Combining these agents is not recommended unless there are other options. Limit the amount and duration of each drug when combined.
OxyCODONE CNS Depressants can increase OxyCODONE's CNS depressant effects. When possible, avoid the simultaneous use of oxycodone, benzodiazepines, or other CNS depression drugs. Combining these agents is not recommended unless there are other options. Limit the amount and duration of each drug when combined.
Perampanel CNS Depressants may have a greater CNS depressant effect. Perampanel and any other CNS depressant drug should be used in combination. Patients who take perampanel together with any other drug should not engage in complex or high-risk activities until they have had experience using the combination.
Pramlintide Anticholinergic Agents may have an enhanced anticholinergic effect. These effects are only for the GI tract.
Secretin Secretin's therapeutic effects may be diminished by anticholinergic agents. Concomitant use: Secretin and anticholinergic agents should be avoided. Stop using anticholinergic drugs for at least five half-lives before administering secretin.
Sincalide Sincalide may be less effective if drugs that affect gallbladder function are taken. Management: Before Sincalide is used to stimulate the gallbladder, discontinue any drugs that affect gallbladder motility.
Sodium Oxybate CNS Depressants may have a greater depressant effect if taken in combination. Management: Look for alternatives to the combination use. If you must combine use, reduce the dose of any one or more drugs. It is not recommended to combine sodium oxybate and alcohol, or any sedative hypnotics.
Suvorexant CNS Depressants can increase the CNS depressant effects of Suvorexant. Management: Suvorexant or any other CNS depressionant can be reduced in doses. Suvorexant should not be taken with alcohol. It is also not recommended to take suvorexant along with any other drugs for insomnia.
Tapentadol CNS Depressants may increase the CNS depressant effects. Tapentadol, benzodiazepines and other CNS depressants should be avoided when possible. Combining these agents is not recommended unless there are other options. Limit the amount and duration of each drug when combined.
Zolpidem CNS Depressants can increase the CNS depressant effects of Zolpidem. Management: For men who also take CNS depressants, reduce the adult Intermezzo brand sublingual Zolpidem dose to 1.75mg. For women, no dose adjustment is advised. Avoid using CNS depressants at night; do not use alcohol.

Risk Factor X (Avoid Combination)

 
Aclidinium Anticholinergic Agents may have an enhanced anticholinergic effect.
Azelastine (Nasal) CNS Depressants could increase the CNS depressant effects of Azelastine.
Bromperidol CNS Depressants may increase the CNS depressant effects.
Cimetropium Cimetropium may have an anticholinergic effect that can be enhanced by the use of anticholinergic agents.
Eluxadoline Eluxadoline may cause constipation to be increased by Opioid Agonists.
Eluxadoline Eluxadoline may cause constipation by using anticholinergic agents.
Glycopyrrolate (Oral Inhalation) Anticholinergic agents may increase the anticholinergic effects of Glycopyrrolate (Oral inhalation).
Glycopyrronium (Topical) Anticholinergic Agents may have an enhanced anticholinergic effect.
Oral Inhalation with Ipratropium Anticholinergic Agents may have an enhanced anticholinergic effect.
Levosulpiride Anticholinergic Agents can reduce the therapeutic effects of Levosulpiride.
Monoamine Oxidase Inhibitors May increase the toxic/adverse effects of Opium.
Opioids (Mixed Antagonist / Agonist) This may reduce the analgesic effects of Opioid Agonists. Management: If patients are receiving pure opioid agonists, seek alternatives to mixed agonist/antagonist painkillers. Monitor for signs of withdrawal or therapeutic failure in patients who have received these combinations.
Orphenadrine Orphenadrine may be more effective against CNS depression than other drugs.
Oxatomide Anticholinergic Agents may have an enhanced anticholinergic effect.
Oxomemazine CNS Depressants may increase the CNS depressant effects.
Paraldehyde Paraldehyde may be enhanced by CNS Depressants.
Potassium Chloride Potassium Chloride may have an ulcerogenic effect that can be exacerbated by anticholinergic agents. Treatment: Patients taking drugs that have significant anticholinergic effects should not consume any oral dose form of potassium chloride.
Potassium Citrate Potassium Citrate may be more ulcerogenic if it is given to anticholinergic agents.
Revefenacin Revefenacin may be enhanced by anticholinergic agents.
Thalidomide CNS Depressants can increase Thalidomide's CNS depressant effects.
Tiotropium Anticholinergic agents may increase the anticholinergic effects of Tiotropium.
Umeclidinium Anticholinergic Agents may have an enhanced anticholinergic effect.

Monitoring Parameters:

  • Monitor for the relief of pain, blood pressure, respiratory and mental status.
  • Monitor for signs of abuse, misuse, and addiction. Monitor for clinical features of hypogonadism, and adrenal insufficiency.
  • Elderly patients should also be monitored for dry mouth, blurred vision, and urinary incontinence.

How to administer Belladonna and opium?

Before rectal insertion, the belladonna suppository should be moistened with water.

Mechanism of action of Belladonna and opium:

  • Atropine and Scopolamine are the active agents in belladonna components.
  • Atropine is a stimulant that relaxes smooth muscles and causes drying of secretions.
  • It does this by blocking the acetylcholine receptors in the parasympathetic areas of smooth muscle, secretory and central nervous systems.
  • The other agent and the principal agent in the tablets is morphine which binds to opiate receptors in the central nervous system, inhibiting the ascending pain pathways. It modifies and interrupts pain perception.

It is growing rapidlyabsorbedAfter rectal administration, it is primarilyMetabolizedBy the liver.

International Brands:

  • Belladonna Alkaloids-Opium Rectal

Belladona Brands in Pakistan:

Belladona [Tabs 30 mg]

Bellabitone Lisko Pakistan (Pvt) Ltd

Belladona [Tabs 12.5 mg]

Bellabarbitone Karachi Pharmaceutical Laboratory
Belladonna Phenobarbitone Karachi Chemical Industries