belladonna alkaloids/phenobarbital (Rx)

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

AdultPediatricGeriatric

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
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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
more...

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

Interaction Checker

and belladonna alkaloids/phenobarbital

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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 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
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            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
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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

            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

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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
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
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