belladonna alkaloids/phenobarbital (Rx)

Brand and Other Names:Barbidonna, Donnatal, more...Donnatal Elixir, Donnatal Extentab, Haponal, Hyonatol, Hyosophen
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Dosing & Uses

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Dosage Forms & 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

Dosage Forms & 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

High incidence of anticholinergic effects and uncertain effectiveness

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

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Interactions

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            Adverse Effects

            Frequency Not Defined

            Belladonna alkaloids

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

            Phenobarbital

            • Respiratory depression with IV, ICP
            • Common (but decrreased with 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
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            Warnings

            Contraindications

            Hypersensitivity to drug or components

            Glaucoma

            Obstructive uropathy, including bladder neck obstruction due to prostatic hypertrophy

            Obstructive disease of gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc)

            Paralytic ileus, intestinal atony of the elderly or debilitated patient

            Unstable cardiovascular status in acute hemorrhage

            Severe ulcerative colitis especially if complicated by toxic megacolon

            Myasthenia gravis

            Hiatal hernia associated with reflux esophagitis

            Intermittent porphyria and in patients in whom phenobarbital produces restlessness and/or excitement

            Cautions

            If drug is used during pregnancy, or if patient becomes pregnant while taking drug, the patient should be apprised of potential hazard to the fetus

            In presence of a high environmental temperature, heat prostration can occur with belladonna alkaloids (fever and heatstroke due to decreased sweating)

            Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, treatment with this drug would be inappropriate and possibly harmful

            Elixir may produce drowsiness or blurred vision.

            The patient should be warned, should these occur, not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery

            Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect; when phenobarbital is discontinued, the dose of anticoagulant may have to be decreased

            Phenobarbital may be habit forming and should not be administered to individuals known to be addiction prone or to those with a history of physical and/or psychological dependence upon drugs

            Since barbiturates are metabolized in liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction

            Use with caution in patients with autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia, hypertension

            Belladonna alkaloids may produce a delay in gastric emptying (antral stasis) which would complicate the management of gastric ulcer

            Do not rely on the use of the drug in the presence of complication of biliary tract disease

            Theoretically, with overdosage, a curare-like action may occur

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            Pregnancy & 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.

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            Pharmacology

            Mechanism of Action

            Drug combination provides natural belladonna alkaloids in a specific, fixed ratio combined with phenobarbital to provide peripheral anticholinergic/antispasmodic action and mild sedation

            Belladonna alkaloids

            • Anticholinergic alkaloids; competitively inhibit acetylcholine actions at muscarinic receptors

            Phenobarbital

            • Depresses sensory and motor cortex, cerebellum

            Absorption

            Belladonna alkaloids

            • Onset: 1-2 hr

            Phenobarbital

            • Peak plasma time: 8-12 hr
            • Bioavailability: 70-90%

            Distribution

            Phenobarbital

            • Protein bound: 20-45%

            Metabolism

            Phenobarbital

            • Hepatic oxidative hydroxylation
            • Metabolites: Inactive
            • Enzymes induced: CYP1A2, CYP2B6, CYP2C19, CYP2C9/10, CYP3A4

            Elimination

            Belladonna alkaloids

            • Excretion: Urine

            Phenobarbital

            • Half-life: 50-140 hr
            • Excretion: Urine
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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.