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

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: