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