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belladonna alkaloids/phenobarbital (Barbidonna, Donnatal, Donnatal Elixir, Donnatal Extentab, Haponal, Hyonatol, Hyosophen)

 

Classes: Anticholinergic, Antispasmodic Agents

Dosing and uses of Barbidonna, Donnatal (belladonna alkaloids/phenobarbital)

 

Adult dosage forms and strengths

belladonna alkaloids/phenobarbitaL

tablet

  • (atropine0.0194mg/hyoscyamine0.1037mg/scopolamine0.0065mg/phenobarbital16.2mg

extended release tablet

  • atropine0.0582mg/hyoscyamine0.3111mg/scopolamine0.0195mg/phenobarbital48.61 mg

oral elixir

  • (atropine0.0194mg/hyoscyamine0.10372mg/scopolamine0.0065mg/phenobarbital16.2mg)/5mL

 

Duodenal Ulcer, Irritable Bowel (Off-label)

FDA has classified as "possibly" effective

Tablet: 1-2 tablets PO TID-QId

Extended Release Tablet: 1 tablet PO q12hr; may increase to q8hr if needed

Liquid: 5-10 mL PO TID-QId

 

Pediatric dosage forms and strengths

belladonna alkaloids/phenobarbitaL

tablet

  • (atropine0.0194mg/hyoscyamine0.1037mg/scopolamine0.0065mg/phenobarbital16.2mg

extended release tablet

  • atropine0.0582mg/hyoscyamine0.3111mg/scopolamine0.0195mg/phenobarbital48.61 mg

oral elixir

  • (atropine0.0194mg/hyoscyamine0.10372mg/scopolamine0.0065mg/phenobarbital16.2mg)/5mL

 

Irritable Bowel (Off-label)

4.5-9 kg: 0.5 mL PO q4hr OR 0.75 mL PO q6hr; individualize

9-13.5 kg: 1 mL PO q4hr OR 1.5 mL PO q6hr; individualize

13.5-22.6 kg: 1.5 mL PO q4hr OR 2 mL PO q6hr; individualize

22.7-34 kg: 2.5 mL PO q4hr OR 3.75 mL PO q6hr; individualize

34-45.4 kg: 3.75 mL PO q4hr OR 5 mL PO q6hr; individualize

> 45.4 kg: 5 mL PO q4hr OR 7.5 mL PO q6hr; individualize

 

Geriatric dosage forms and strengths

High incidence of anticholinergic effects and uncertain effectiveness

Avoid except in short-term palliative care to decrease oral secretions

 

Barbidonna, Donnatal (belladonna alkaloids/phenobarbital) adverse (side) effects

Frequency not defined

Belladonna Alkaloids

  • Sedation
  • Constipation
  • Dizziness
  • Dry mouth
  • Urinary retention
  • Blurred vision

PhenobarbitaL

  • Respiratory depression with IV, ICP
  • Common (but decr w/continued Tx): Drowsiness, fatigue, ataxia, irritability, HA, restlessness, nystagmus, dizziness, vertigo, dysarthria, paresthesia
  • Common (in Peds): Paradoxical excitement/hyperactivity
  • Common (in geriatrics): Excitement, confusion, depression
  • Less common: Mental dullness, N/V, constipation, diarrhea, megaloblastic (folate-deficiency) anemia
  • Uncommon: Hepatotoxicity, hypocalcemia, rash
  • Rare: Stevens-Johnson syndrome, rickets, osteomalacia

 

Warnings

Contraindications

Belladonna alkaloids

  • Bladder obstruction, closed angle glaucoma, GI obstruction, hypersensitivity

PhenobarbitaL

  • Porphyria, intra-arterial administration, hypersensitivity, severe hepatic impairment, COPD, dyspnea, pregnancy/lactation

 

Cautions

Belladonna alkaloids

  • Known substance abuse, concomitant sedative or anticholinergic medications

PhenobarbitaL

  • May render OCPs ineffective

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Not recommended; inhibits lactation and appears in breast milk

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Barbidonna, Donnatal (belladonna alkaloids/phenobarbital)

Belladonna Alkaloids

Onset: 1-2 hr

Excretion: urine

 

Phenobarbital

Half-Life: 50-140 hr

Peak Plasma Time: 8-12 hr

Bioavailability: 70-90%

Protein Bound: 20-45%

Metabolism: hepatic oxidative hydroxylation

Metabolites: inactive

Excretion: urine

Enzymes induced: CYP1A2, CYP2B6, CYP2C19, CYP2C9/10, CYP3A4

 

Mechanism of action

Belladonna alkaloids: anticholinergic alkaloids; competitively inhibit Ach actions at muscarinic receptors

Phenobarbital: Depresses sensory and motor cortex, cerebellum