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

Interaction Checker

and belladonna alkaloids/phenobarbital

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              Serious - Use Alternative (3)

              • methylene blue

                methylene blue and belladonna alkaloids both increase serotonin levels. Avoid or Use Alternate Drug. If drug combination must be administered, monitor for evidence of serotonergic or opioid-related toxicities

              • pramlintide

                pramlintide, belladonna alkaloids. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Synergistic inhibition of GI motility.

              • umeclidinium bromide/vilanterol inhaled

                belladonna alkaloids, umeclidinium bromide/vilanterol inhaled. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Concomitant use with other anticholinergic-containing drugs may lead to additive anticholinergic adverse effects.

              Monitor Closely (93)

              • aclidinium

                belladonna alkaloids and aclidinium both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • amantadine

                belladonna alkaloids, amantadine. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Potential for increased anticholinergic adverse effects.

              • amitriptyline

                belladonna alkaloids and amitriptyline both decrease cholinergic effects/transmission. Modify Therapy/Monitor Closely.

              • amoxapine

                belladonna alkaloids and amoxapine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • anticholinergic/sedative combos

                anticholinergic/sedative combos and belladonna alkaloids both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • aripiprazole

                belladonna alkaloids decreases levels of aripiprazole by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of aripiprazole by pharmacodynamic antagonism. Use Caution/Monitor.

                aripiprazole increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • atracurium

                atracurium and belladonna alkaloids both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • atropine

                atropine and belladonna alkaloids both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • atropine IV/IM

                atropine IV/IM and belladonna alkaloids both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • belladonna and opium

                belladonna alkaloids and belladonna and opium both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • benperidol

                belladonna alkaloids decreases levels of benperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of benperidol by pharmacodynamic antagonism. Use Caution/Monitor.

                benperidol increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • benztropine

                belladonna alkaloids and benztropine both decrease cholinergic effects/transmission. Use Caution/Monitor. Additive anticholinergic adverse effects may be seen with concurrent use.

              • bethanechol

                bethanechol increases and belladonna alkaloids decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • carbachol

                carbachol increases and belladonna alkaloids decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • cevimeline

                cevimeline increases and belladonna alkaloids decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • chlorpromazine

                belladonna alkaloids decreases levels of chlorpromazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of chlorpromazine by pharmacodynamic antagonism. Use Caution/Monitor.

                chlorpromazine increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • cisatracurium

                belladonna alkaloids and cisatracurium both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • clomipramine

                belladonna alkaloids and clomipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • clozapine

                belladonna alkaloids decreases levels of clozapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of clozapine by pharmacodynamic antagonism. Use Caution/Monitor.

                clozapine increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • cyclizine

                belladonna alkaloids and cyclizine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • cyclobenzaprine

                belladonna alkaloids and cyclobenzaprine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • darifenacin

                belladonna alkaloids and darifenacin both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • dicyclomine

                belladonna alkaloids and dicyclomine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • diphenhydramine

                belladonna alkaloids and diphenhydramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • donepezil

                donepezil increases and belladonna alkaloids decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • dosulepin

                belladonna alkaloids and dosulepin both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • doxepin

                belladonna alkaloids and doxepin both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • droperidol

                belladonna alkaloids decreases levels of droperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of droperidol by pharmacodynamic antagonism. Use Caution/Monitor.

                droperidol increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • echothiophate iodide

                echothiophate iodide increases and belladonna alkaloids decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • fesoterodine

                belladonna alkaloids and fesoterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • flavoxate

                belladonna alkaloids and flavoxate both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • fluphenazine

                belladonna alkaloids decreases levels of fluphenazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of fluphenazine by pharmacodynamic antagonism. Use Caution/Monitor.

                fluphenazine increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • galantamine

                galantamine increases and belladonna alkaloids decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • glycopyrrolate

                belladonna alkaloids and glycopyrrolate both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • glycopyrrolate inhaled

                belladonna alkaloids and glycopyrrolate inhaled both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • haloperidol

                belladonna alkaloids decreases levels of haloperidol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of haloperidol by pharmacodynamic antagonism. Use Caution/Monitor.

                haloperidol increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • henbane

                belladonna alkaloids and henbane both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • homatropine

                belladonna alkaloids and homatropine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • huperzine A

                huperzine A increases and belladonna alkaloids decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • hyoscyamine

                belladonna alkaloids and hyoscyamine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • hyoscyamine spray

                belladonna alkaloids and hyoscyamine spray both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • iloperidone

                belladonna alkaloids decreases levels of iloperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of iloperidone by pharmacodynamic antagonism. Use Caution/Monitor.

                iloperidone increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • imipramine

                belladonna alkaloids and imipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • incobotulinumtoxinA

                belladonna alkaloids, incobotulinumtoxinA. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Use of anticholinergic drugs after administration of botulinum toxin-containing products may potentiate systemic anticholinergic effects.

              • ipratropium

                belladonna alkaloids and ipratropium both decrease cholinergic effects/transmission. Use Caution/Monitor. Due to the poor systemic absorption of ipratropium, interaction unlikely at regularly recommended dosages.

              • lofepramine

                belladonna alkaloids and lofepramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • loxapine

                belladonna alkaloids decreases levels of loxapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of loxapine by pharmacodynamic antagonism. Use Caution/Monitor.

                loxapine increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • loxapine inhaled

                loxapine inhaled increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

                belladonna alkaloids decreases levels of loxapine inhaled by pharmacodynamic antagonism. Use Caution/Monitor.

              • maprotiline

                belladonna alkaloids and maprotiline both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • meclizine

                belladonna alkaloids and meclizine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • methscopolamine

                belladonna alkaloids and methscopolamine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • neostigmine

                neostigmine increases and belladonna alkaloids decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • nortriptyline

                belladonna alkaloids and nortriptyline both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • olanzapine

                belladonna alkaloids decreases levels of olanzapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of olanzapine by pharmacodynamic antagonism. Use Caution/Monitor.

                olanzapine increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • oliceridine

                belladonna alkaloids increases toxicity of oliceridine by Other (see comment). Use Caution/Monitor. Comment: Anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor for signs of urinary retention or reduced gastric motility if oliceridine is coadministered with anticholinergics.

              • onabotulinumtoxinA

                belladonna alkaloids and onabotulinumtoxinA both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • orphenadrine

                belladonna alkaloids and orphenadrine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • oxybutynin

                belladonna alkaloids and oxybutynin both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • oxybutynin topical

                belladonna alkaloids and oxybutynin topical both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • oxybutynin transdermal

                belladonna alkaloids and oxybutynin transdermal both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • paliperidone

                belladonna alkaloids decreases levels of paliperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of paliperidone by pharmacodynamic antagonism. Use Caution/Monitor.

                paliperidone increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • pancuronium

                belladonna alkaloids and pancuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • perphenazine

                belladonna alkaloids decreases levels of perphenazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of perphenazine by pharmacodynamic antagonism. Use Caution/Monitor.

                perphenazine increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • physostigmine

                physostigmine increases and belladonna alkaloids decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • pilocarpine

                pilocarpine increases and belladonna alkaloids decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • pilocarpine ophthalmic

                pilocarpine ophthalmic increases and belladonna alkaloids decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • pimozide

                belladonna alkaloids decreases levels of pimozide by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of pimozide by pharmacodynamic antagonism. Use Caution/Monitor.

                pimozide increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • pralidoxime

                belladonna alkaloids and pralidoxime both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • prochlorperazine

                belladonna alkaloids decreases levels of prochlorperazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of prochlorperazine by pharmacodynamic antagonism. Use Caution/Monitor.

                prochlorperazine increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • promethazine

                belladonna alkaloids decreases levels of promethazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of promethazine by pharmacodynamic antagonism. Use Caution/Monitor.

                promethazine increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • propantheline

                belladonna alkaloids and propantheline both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • protriptyline

                belladonna alkaloids and protriptyline both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • pyridostigmine

                pyridostigmine increases and belladonna alkaloids decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • quetiapine

                belladonna alkaloids decreases levels of quetiapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of quetiapine by pharmacodynamic antagonism. Use Caution/Monitor.

                quetiapine increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • rapacuronium

                belladonna alkaloids and rapacuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • rimabotulinumtoxinB

                belladonna alkaloids, rimabotulinumtoxinB. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Anticholinergics may enhance botulinum toxin effects. Closely monitor for increased neuromuscular blockade.

              • risperidone

                belladonna alkaloids decreases levels of risperidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of risperidone by pharmacodynamic antagonism. Use Caution/Monitor.

                risperidone increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • rocuronium

                belladonna alkaloids and rocuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • scopolamine

                belladonna alkaloids and scopolamine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • solifenacin

                belladonna alkaloids and solifenacin both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • succinylcholine

                succinylcholine increases and belladonna alkaloids decreases cholinergic effects/transmission. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • thioridazine

                belladonna alkaloids decreases levels of thioridazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of thioridazine by pharmacodynamic antagonism. Use Caution/Monitor.

                thioridazine increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • thiothixene

                belladonna alkaloids decreases levels of thiothixene by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of thiothixene by pharmacodynamic antagonism. Use Caution/Monitor.

                thiothixene increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • tiotropium

                belladonna alkaloids and tiotropium both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • tolterodine

                belladonna alkaloids and tolterodine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • trifluoperazine

                belladonna alkaloids decreases levels of trifluoperazine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of trifluoperazine by pharmacodynamic antagonism. Use Caution/Monitor.

                trifluoperazine increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • trihexyphenidyl

                belladonna alkaloids and trihexyphenidyl both decrease cholinergic effects/transmission. Use Caution/Monitor. Potential for additive anticholinergic effects.

              • trimipramine

                belladonna alkaloids and trimipramine both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • trospium chloride

                belladonna alkaloids and trospium chloride both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • umeclidinium bromide

                umeclidinium bromide and belladonna alkaloids both decrease cholinergic effects/transmission. Use Caution/Monitor. If possible, avoid coadministration of additional anticholinergic agents

              • vecuronium

                belladonna alkaloids and vecuronium both decrease cholinergic effects/transmission. Use Caution/Monitor.

              • ziprasidone

                belladonna alkaloids decreases levels of ziprasidone by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of ziprasidone by pharmacodynamic antagonism. Use Caution/Monitor.

                ziprasidone increases effects of belladonna alkaloids by pharmacodynamic synergism. Use Caution/Monitor. Additive anticholinergic effects, possible hypoglycemia.

              • zotepine

                belladonna alkaloids decreases levels of zotepine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                belladonna alkaloids decreases levels of zotepine by pharmacodynamic antagonism. Use Caution/Monitor.

              Minor (6)

              • desipramine

                belladonna alkaloids and desipramine both decrease cholinergic effects/transmission. Minor/Significance Unknown.

              • dimenhydrinate

                dimenhydrinate increases toxicity of belladonna alkaloids by pharmacodynamic synergism. Minor/Significance Unknown. Additive anticholinergic effects.

              • donepezil

                donepezil decreases effects of belladonna alkaloids by pharmacodynamic antagonism. Minor/Significance Unknown.

              • galantamine

                galantamine decreases effects of belladonna alkaloids by pharmacodynamic antagonism. Minor/Significance Unknown.

              • levodopa

                belladonna alkaloids, levodopa. Other (see comment). Minor/Significance Unknown. Comment: Anticholinergic agents may enhance the therapeutic effects of levodopa; however, anticholinergic agents can exacerbate tardive dyskinesia. In high dosage, anticholinergics may decrease the effects of levodopa by delaying its GI absorption. .

              • trazodone

                belladonna alkaloids and trazodone both decrease cholinergic effects/transmission. Minor/Significance Unknown.

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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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              Images

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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

              FormularyPatient Discounts

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              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
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.