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Belladonna Alkaloids and Barbiturates (Systemic)

This monograph includes information on the following:

1) Atropine, Hyoscyamine, Scopolamine, and Phenobarbital
2) Atropine and Phenobarbital 
3) Belladonna and Butabarbital 

VA CLASSIFICATION
Primary: GA802


Note: Atropine, Hyoscyamine, Scopolamine, and Phenobarbital combination and Hyoscyamine, Scopolamine, and Phenobarbital combination are controlled substances in Canada.

Commonly used brand name(s): Antrocol2; Barbidonna1; Barbidonna No. 21; Barophen1; Bellalphen1; Butibel3; Donnamor1; Donnapine1; Donnatal1; Donnatal Extentabs1; Donnatal No. 21; Donphen1; Hyosophen1; Kinesed1; Malatal1; Relaxadon1; Spaslin1; Spasmolin1; Spasmophen1; Spasquid1; Susano1.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

Not commercially available in Canada.



Category:


Anticholinergic-sedative—

Indications

Accepted

Ulcer, peptic (treatment adjunct) or
Bowel syndrome, irritable (treatment adjunct)—FDA has classified these medications as possibly effective for use as adjunctive therapy in the treatment of peptic ulcer and irritable bowel syndrome (irritable colon, spastic colon, mucous colitis). {01} {04}

Note: Less than effective classification requires the submission of adequate and well-controlled studies in order to provide substantial evidence of effectiveness. In the past, FDA has notified manufacturers of the possible withdrawal from the market of products containing a combination of an anticholinergic and a sedative because their efficacy as fixed combinations had not been proven in adequately designed clinical trials. To date, no final action has been taken.


Unaccepted
Anticholinergic and sedative combinations have been used as adjuncts in the treatment of acute enterocolitis; however, their use for this condition is controversial since they cause a reduction in gastrointestinal motility resulting in retention of the causative organism or toxin and the consequent prolongation of symptoms. {03}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Atropine: 289.37
    Butabarbital sodium: 234.13
    Hyoscyamine hydrobromide: 370.29
    Hyoscyamine sulfate: 712.85
    Phenobarbital: 232.24
    Scopolamine hydrobromide: 438.31

pKa—
    Atropine: 9.8
    Scopolamine: 7.55-7.81

Mechanism of action/Effect:

Anticholinergic—Atropine, hyoscyamine, and scopolamine, the principal belladonna alkaloids, produce an anticholinergic effect by the competitive inhibition of acetylcholine at the parasympathetic neuro-effector junction.

Sedative—Although the mechanism of action has not been completely established, the barbiturates produce a sedative effect probably as a result of their inhibition of synaptic neurotransmitters in the central nervous system (CNS).

Biotransformation:

Hepatic.

Elimination:
    Renal.
    Atropine—30 to 50% unchanged.
    Butabarbital—<1% unchanged.
    Hyoscyamine—Majority excreted unchanged. {08}
    Phenobarbital—25 to 50% unchanged.
    Scopolamine—1% unchanged.


        Drug
        Protein
        Binding
        (%)
        Half-life
        (hr)
        Duration of
        Effect
        (hr)
        Atropine
        50
        2.5
        4-6
        Butabarbital
        26
         34-42
        6-8
        Hyoscyamine
        50
        3.5
        4-6
        Phenobarbital
        20-45
         53-118 *
        10-12
        Scopolamine
        10
         8 (avg)
        4-6
*         Half - life is 40 to 70 in children.


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to any of the belladonna alkaloids or barbiturates may be sensitive to this medication also.

Pregnancy/Reproduction

Pregnancy—
Use of belladonna alkaloids and barbiturates combinations in pregnancy is not recommended.

For atropine: Atropine crosses the placenta. Although well-controlled studies in humans have not been done, studies in mice have not shown that atropine given in doses of 50 mg per kg of body weight (mg/kg) causes adverse effects in the fetus. {09}

FDA Pregnancy Category B. {09}

For atropine, hyoscyamine, scopolamine, and phenobarbital combination: Studies have not been done in either animals or humans.

FDA Pregnancy Category C.

For barbiturates: Barbiturates cross the placenta and have been shown to cause an increased incidence of fetal abnormalities. In addition, use of phenobarbital during pregnancy may contribute to neonatal hemorrhage due to reduction in vitamin K-dependent clotting factors in the neonate. {10}

FDA Pregnancy Category D. {10}

For belladonna: Belladonna crosses the placenta. Studies with belladonna have not been done in either animals or humans. {09}

FDA Pregnancy Category C. {09}

For hyoscyamine: Hyoscyamine crosses the placenta. Studies with hyoscyamine have not been done in either animals or humans. {09}

FDA Pregnancy Category C.

For scopolamine: Scopolamine crosses the placenta. Studies with scopolamine have not been done in either animals or humans. {09}

FDA Pregnancy Category C.

Breast-feeding

Problems in humans have not been documented; however, barbiturates and belladonna alkaloids are distributed into breast milk. {01}

Belladonna alkaloids may inhibit lactation.

Pediatrics

Infants and young children are especially susceptible to the toxic effects of the belladonna alkaloids. {08}

Close supervision is recommended for infants and children with spastic paralysis or brain damage since an increased response to belladonna alkaloids has been reported in these patients and dosage adjustments are often required.

When belladonna alkaloids are given to children where the environmental temperature is high, there is risk of a rapid increase in body temperature because of suppression of sweat gland activity. {32}

A paradoxical reaction characterized by hyperexcitability may occur in children taking barbiturates or large doses of belladonna alkaloids. Also, hyperkinetic states may be induced or increased in hypersensitive children taking barbiturates.


Geriatrics


Geriatric patients may respond to usual doses of belladonna alkaloids or barbiturates with excitement, agitation, drowsiness, or confusion. {06} {08}

Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of mouth, and urinary retention (especially in males), of the belladonna alkaloids. If these side effects occur and continue or are severe, medication should probably be discontinued.

Caution is also recommended when belladonna alkaloids are given to geriatric patients because of the danger of precipitating undiagnosed glaucoma.

Memory may become severely impaired in geriatric patients, especially those who already have memory problems, with the continued use of belladonna alkaloids since these drugs block the action of acetylcholine, which is responsible for many functions of the brain, including memory functions. {05} {06} {08}


Dental

Prolonged use of belladonna alkaloids may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidiasis, and discomfort. {31}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.
Only specific interactions between belladonna alkaloids and other oral medications have been identified in this monograph. However, because of decreased gastrointestinal motility and delayed gastric emptying, absorption of other oral medications may be decreased during concurrent use with belladonna alkaloids. {32}

Acetaminophen{30} or
» Anticoagulants, coumarin- or indandione-derivative{12}{14} or
Digitalis glycosides{11}{12} or
Doxycycline{11}{12}{14} or
Quinidine{11}{12}{14}    (effects may be decreased when these medications are used concurrently with barbiturates, especially phenobarbital, because of increased metabolism resulting from induction of hepatic microsomal enzymes; dosage adjustment of these medications, with the possible exception of digoxin, may be necessary {01})


» Adrenocorticoids, glucocorticoid{11}{12} or
» Corticotropin (ACTH){11}{12}    (concurrent long-term therapy with belladonna alkaloids may increase intraocular pressure)

    (effects may be decreased when these medications are used concurrently with barbiturates because of increased metabolism resulting from induction of hepatic microsomal enzymes)


» Alcohol or
» CNS depression-producing medications, other (See Appendix II )    (concurrent use may increase the CNS depressant effects of either these medications or barbiturates {14})


Alkalizers, urinary, such as:{11}
Antacids, calcium- and/or magnesium-containing
Carbonic anhydrase inhibitors
Citrates
Sodium bicarbonate    (urinary excretion of belladonna alkaloids may be delayed by alkalinization of urine, thus potentiating side effects)


» Anticholinergics or other medications with anticholinergic activity, other (See Appendix II )    (anticholinergic effects may be intensified when these medications are used concurrently with belladonna alkaloids {18})


» Antacids or
» Antidiarrheals, adsorbent    (administration within 1 hour of these medications will tend to reduce therapeutic effects of belladonna alkaloids and barbiturates because of particle adsorption {19} {20})


Antidepressants, tricyclic    (concurrent use with belladonna alkaloids may intensify anticholinergic effects; concurrent use with barbiturates may decrease the effect of the antidepressant as a result of hepatic microsomal enzyme induction; dosage adjustments may be necessary during and after concurrent therapy with belladonna alkaloids and barbiturates {14} {27})


Apomorphine    (prior administration of scopolamine-containing medications may decrease the emetic response to apomorphine in the treatment of poisoning; also, the CNS depressant effects of scopolamine and barbiturates are additive to those of apomorphine {15})


Griseofulvin    (absorption may be decreased when griseofulvin is used concurrently with barbiturates, especially phenobarbital, resulting in decreased blood concentrations; although the effect of decreased blood concentrations on therapeutic response has not been established, concurrent use should be avoided {11} {12} {13})


» Ketoconazole    (belladonna alkaloids may increase gastrointestinal pH; concurrent administration with belladonna alkaloids may result in a marked reduction in absorption of ketoconazole; patients should be advised to take these medications at least 2 hours after ketoconazole {21})


Metoclopramide    (concurrent use with belladonna alkaloids may antagonize metoclopramide's effects on gastrointestinal motility)

    (concurrent use with barbiturates may increase the sedative effects of either these medications or metoclopramide {22} {23})


» Monoamine oxidase (MAO) inhibitors, including furazolidone, procarbazine, and selegiline    (concurrent use with barbiturates may potentiate the CNS depressant effects of either medication; dosage adjustments may be necessary {11} {12})


Opioid (narcotic) analgesics    (concurrent use with belladonna alkaloids may result in increased risk of severe constipation, which may lead to paralytic ileus, and/or urinary retention {28} {29})

    (concurrent use may potentiate the CNS effects of either these medications or the barbiturates, resulting in additive sedation {07} {14})


Phenytoin, and possibly other hydantoin anticonvulsants    (concurrent use with barbiturates may produce variable and unpredictable effects on phenytoin; serum phenytoin concentrations should be monitored {11} {14} {16} {24} {25} {26})


» Potassium chloride, especially wax-matrix preparations    (concurrent use with belladonna alkaloids may increase severity of potassium chloride-induced gastrointestinal lesions {24} {25} {26})


Valproic acid    (concurrent use with barbiturates may cause higher serum concentrations of barbiturates, leading to increased CNS depression and neurological toxicity because of protein binding displacement of the barbiturate and reduced barbiturate metabolism; half-life of valproic acid is decreased; dosage adjustment of barbiturates may be necessary {11} {14} {17})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
» Gastric acid secretion test    (belladonna alkaloids may antagonize the effects of pentagastrin and histamine in the evaluation of gastric acid secretory function; administration of belladonna alkaloids is not recommended during the 24 hours preceding the test)


» Phenolsulfonphthalein (PSP) excretion test    (atropine utilizes the same tubular mechanism of excretion as PSP resulting in decreased urinary excretion of PSP; concurrent use of atropine-containing medication is not recommended in patients receiving PSP excretion test)

With physiology/laboratory test values
Bilirubin concentrations, serum    (barbiturates may cause a decrease in serum bilirubin concentrations in neonates, in patients with congenital nonhemolytic unconjugated hyperbilirubinemia, and in epileptics; this effect is presumably due to induction of glucuronyl transferase, the enzyme responsible for the conjugation of bilirubin {01})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Brain damage, in children    (CNS effects of belladonna alkaloids may be exacerbated; dosage adjustment may be required {01})


Cardiac disease, including cardiac arrhythmias, congestive heart failure, coronary heart disease, and mitral stenosis{01}    (increase in heart rate that may be caused by belladonna alkaloids may be undesirable)


Down's syndrome    (use of belladonna alkaloids may produce abnormal increase in pupillary dilation and acceleration of heart rate; dosage adjustment may be required)


» Gastrointestinal tract obstructive disease as in achalasia and pyloroduodenal stenosis{01}    (decrease in motility and tone may occur with the use of belladonna alkaloids, resulting in obstruction and gastric retention)


» Glaucoma, angle-closure, or predisposition to    (mydriatic effect of belladonna alkaloids resulting in increased intraocular pressure may precipitate an acute attack of angle-closure glaucoma {01})


» Glaucoma, open angle    (mydriatic effect of belladonna alkaloids may cause a slight increase in intraocular pressure; glaucoma therapy may need to be adjusted {01})


» Hepatic function impairment    (decreased metabolism of belladonna alkaloids and barbiturates {01})


Hyperkinesis, in children    (may be exacerbated by the use of barbiturates {01})


Prostatic hypertrophy or
» Urinary retention    (anticholinergic effects may precipitate or aggravate urinary retention {01})


» Renal function impairment    (decreased excretion may increase the risk of side effects {01})


Respiratory disease involving dyspnea or obstruction, particularly status asthmaticus    (anticholinergic ``drying'' effects may cause thickening of secretions and impair expectoration; serious ventilatory depression may occur with the use of barbiturates {01})


Sensitivity to belladonna alkaloids and/or barbiturates
Spastic paralysis, in children    (response to belladonna alkaloids may be increased; dosage adjustment may be required)


Xerostomia    (prolonged use of belladonna alkaloids may further reduce limited salivary flow)


Caution in use is also recommended in patients over 40 years of age because of the danger of precipitating undiagnosed glaucoma.


Side/Adverse Effects

Note: When belladonna alkaloids are given to patients, especially children, where the environmental temperature is high, there is risk of a rapid increase in body temperature because of suppression of sweat gland activity. {32}
Infants, patients with Down's syndrome, and children with spastic paralysis or brain damage may show an increased response to belladonna alkaloids, thus increasing the potential for side effects; dosage adjustments may be required in these patients. {03}
Geriatric or debilitated patients may respond to usual doses of belladonna alkaloids and barbiturates with excitement, agitation, drowsiness, or confusion; lower doses may be required in these patients. {06}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare {01}
    
Agranulocytosis (sore throat and fever)
    
allergic reaction (skin rash or hives)
    
hepatitis
    
jaundice (yellow eyes or skin)
    
increased intraocular pressure (eye pain)
    
thrombocytopenia (unusual bleeding or bruising)



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent {01}
    
Constipation
    
decreased sweating
    
dizziness
    
drowsiness
    
dryness of mouth, nose, throat, or skin

Incidence less frequent or rare {01}
    
Bloated feeling
    
decreased flow of breast milk
    
decreased saliva secretion (difficulty in swallowing)
    
difficult urination
    
difficulty in eye accommodation (blurred vision)
    
headache
    
loss of memory, especially in elderly patients
    
mydriatic effect (increased sensitivity of eyes to sunlight)
    
nausea or vomiting
    
unusual tiredness or weakness
Note: Difficult urination is more likely to occur in older men and may require medical attention in patients with symptoms of prostatism.







Overdose
For specific information on the agents used in the management of overdose with belladonna alkaloids and barbiturates, see:
   • Charcoal, Activated (Oral-Local) monograph;
   • Neostigmine Methylsulfate in Antimyasthenics (Systemic) monograph; and/or
   • Physostigmine Salicyclate (Systemic) monograph.
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
    
Blurred vision, continuing, or changes in near vision
    
clumsiness or unsteadiness
    
confusion
    
dizziness, continuing
    
drowsiness, severe
    
dryness of mouth, nose, or throat, severe
    
fast heartbeat
    
fever
    
hallucinations
    
paradoxical reaction (unusual excitement, nervousness, restlessness, or irritability)
    
respiratory depression (shortness of breath or troubled breathing)
    
seizures
    
slurred speech
    
unusual warmth, dryness, and flushing of skin (particularly in blush area because of dilation of cutaneous blood vessels)


Treatment of overdose
Recommended treatment for overdose includes:


To decrease absorption:
Emesis or gastric lavage with 4% tannic acid solution. {01}

Administration of an aqueous slurry of activated charcoal. {01}



Specific treatment:
Slow intravenous administration of physostigmine in doses of 0.5 to 2 mg (0.5 to 1 mg in children, up to a total dose of 2 mg), at a rate not to exceed 1 mg per minute, to reverse severe anticholinergic symptoms; may be given in repeated doses of 1 to 4 mg as needed, up to a total dose of 5 mg in adults. {01}

Or, intramuscular administration of neostigmine methylsulfate in doses of 0.5 to 1 mg, repeated every 2 to 3 hours; or intravenously in doses of 0.5 to 2 mg, repeated as needed.



Supportive care:
Artificial respiration with oxygen if needed for respiratory depression.

Adequate hydration.

Symptomatic treatment as necessary.

Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Belladonna Alkaloids and Barbiturates (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to any of the belladonna alkaloids or barbiturates

Pregnancy—Use not recommended because belladonna alkaloids and barbiturates cross placenta; barbiturates may cause fetal abnormalities; phenobarbital may cause neonatal hemorrhage





Breast-feeding—Distributed into breast milk; possible inhibition of lactation




Use in children——Increased susceptibility to toxic effects of anticholinergics; increased response in infants and children with spastic paralysis or brain damage; risk of increased body temperature in hot weather; hyperexcitability (paradoxical reaction); hyperkinesis may be induced in hypersensitive children





Use in the elderly—— Increased susceptibility to mental and other toxic effects of anticholinergics and barbiturates; danger of precipitating undiagnosed glaucoma; possible impairment of memory




Dental——Possible development of dental problems because of decreased salivary flow
Other medications, especially adrenocorticoids or corticotropin, other anticholinergics, antacids, anticoagulants, antidiarrheals, ketoconazole, CNS depressants, MAO inhibitors, or potassium chloride
Other medical problems, especially gastrointestinal obstructive disease, glaucoma, hepatic function impairment, renal function impairment, or urinary retention

Proper use of this medication
Taking dose 30 to 60 minutes before meals unless otherwise directed by physician

» Importance of not taking more medication than the amount prescribed

» Proper dosing
Missed dose: Taking as soon as possible; not taking if almost time for next dose; not doubling doses

» Proper storage

Precautions while using this medication
» Avoiding use of alcohol or other CNS depressants

Not taking antacids and antidiarrheal medications within 1 hour of taking this medication

» Caution during exercise and hot weather; overheating may result in heat stroke

Possible increased sensitivity of eyes to light

» Caution if drowsiness or blurred vision occurs

Possible dryness of mouth, nose, and throat; using sugarless candy or gum, ice, or saliva substitute for relief; checking with physician or dentist if dry mouth continues for more than 2 weeks


Side/adverse effects
Signs of potential side effects, especially agranulocytosis, allergic reaction, hepatitis, increased intraocular pressure, and thrombocytopenia


General Dosing Information
Administration of belladonna alkaloids and barbiturates combination 30 to 60 minutes before meals is recommended to maximize absorption, and, when used for reducing stomach acid formation, to allow its effect to coincide better with antacid administration following the meal.

Prolonged uninterrupted use of barbiturates has the potential of producing psychic or physical dependence, especially in the higher dose range.

ATROPINE, HYOSCYAMINE, SCOPOLAMINE, AND PHENOBARBITAL


Oral Dosage Forms

ATROPINE SULFATE, HYOSCYAMINE SULFATE (or HYOSCYAMINE HYDROBROMIDE), SCOPOLAMINE HYDROBROMIDE, AND PHENOBARBITAL CAPSULES

Usual adult and adolescent dose
Anticholinergic-sedative
Oral, 1 or 2 capsules two to four times a day, the dosage being adjusted as needed and tolerated. {32}


Usual pediatric dose
Dosage must be individualized by physician.

Usual geriatric dose
See Usual adult and adolescent dose.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.


Strength(s) usually available
U.S.—


19.4 mcg (0.0194 mg) of atropine sulfate, 104 mcg (0.104 mg) of hyoscyamine sulfate (or hydrobromide), 6.5 mcg (0.0065 mg) of scopolamine hydrobromide, and 16 mg of phenobarbital (Rx) [Donnatal (lactose)] [Hyosophen]

Note: Strengths of individual components may vary slightly among products of different manufacturers.


Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from light.

Auxiliary labeling:
   • May cause drowsiness.
   • Avoid alcoholic beverages.


ATROPINE SULFATE, HYOSCYAMINE SULFATE (or HYOSCYAMINE HYDROBROMIDE), SCOPOLAMINE HYDROBROMIDE, AND PHENOBARBITAL ELIXIR

Usual adult and adolescent dose
Anticholinergic-sedative
Oral, 5 to 10 mL three or four times a day, the dosage being adjusted as needed and tolerated. {33}


Usual pediatric dose
Anticholinergic-sedative
Children 4.5 to 9 kg of body weight: Oral, 0.5 to 0.75 mL every four to six hours. {33}

Children 9 to 13.5 kg of body weight: Oral, 1.0 to 1.5 mL every four to six hours. {33}

Children 13.5 to 22.5 kg of body weight: Oral, 1.5 to 2 mL every four to six hours. {33}

Children 22.5 to 36.5 kg of body weight: Oral, 2.5 to 3.75 mL every four to six hours. {33}

Children 36.5 to 45.4 kg of body weight: Oral, 3.75 to 5 mL every four to six hours. {33}

Children 45.4 kg of body weight and over: Oral, 5 to 7.5 mL every four to six hours. {33}


Note: Dosage must be adjusted for each patient as needed and tolerated.


Usual geriatric dose
See Usual adult and adolescent dose.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.


Strength(s) usually available
U.S.—


19.4 mcg (0.0194 mg) of atropine sulfate, 103.7 mcg (0.1037 mg) of hyoscyamine sulfate (or hydrobromide), 6.5 mcg (0.0065 mg) of scopolamine hydrobromide, and 16 mg of phenobarbital, per 5 ml (Rx) [Barophen] [Donnamor] [Donnapine] [Donnatal] [Hyosophen] [Spasmophen] [Spasquid] [Susano]

Note: Contain 23% alcohol.



34 mcg (0.034 mg) of atropine sulfate, 174 mcg (0.174 mg) of hyoscyamine sulfate (or hydrobromide), 10 mcg (0.01 mg) of scopolamine hydrobromide, and 21.6 mg of phenobarbital, per 5 mL (Rx) [Barbidonna (alcohol 15%)]

Canada—


19 mcg (0.019 mg) of atropine sulfate, 104 mcg (0.104 mg) of hyoscyamine sulfate, 7 mcg (0.007 mg) of scopolamine hydrobromide, and 16.2 mg of phenobarbital, per 5 ml (Rx) [Donnatal (alcohol 23%)]

Note: Strengths of individual components may vary slightly among products of different manufacturers.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing.

Auxiliary labeling:
   • May cause drowsiness.
   • Avoid alcoholic beverages.
   • Keep container tightly closed.

Note: When dispensing for pediatric administration, include a calibrated liquid-measuring device and explain its proper use.
Controlled substance in Canada.



ATROPINE SULFATE, HYOSCYAMINE SULFATE (or HYOSCYAMINE HYDROBROMIDE), SCOPOLAMINE HYDROBROMIDE, AND PHENOBARBITAL TABLETS

Usual adult and adolescent dose
Anticholinergic-sedative
Oral, 1 or 2 tablets two to four times a day, the dosage being adjusted as needed and tolerated. {33}


Usual pediatric dose
Dosage must be individualized by physician.

Usual geriatric dose
See Usual adult and adolescent dose.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.


Strength(s) usually available
U.S.—


19.4 mcg (0.0194 mg) of atropine sulfate, 104 mcg (0.104 mg) of hyoscyamine sulfate (or hydrobromide), 6.5 mcg (0.0065 mg) of scopolamine hydrobromide, and 16 mg of phenobarbital (Rx) [Bellalphen] [Donnapine] [Donnatal] [Malatal] [Relaxadon] [Spaslin] [Spasmolin] [Susano][Generic]


19.4 mcg (0.0194) of atropine sulfate, 104 mcg (0.104 mg) of hyoscyamine sulfate, 6.5 mcg (0.0065 mg) of scopolamine hydrobromide, and 32 mg of phenobarbital (Rx) [Donnatal No. 2]


20 mcg (0.02 mg) of atropine sulfate, 100 mcg (0.1 mg) of hyoscyamine sulfate (or hydrobromide), 6.0 mcg (0.006 mg) of scopolamine hydrobromide, and 15 mg of phenobarbital (Rx) [Donphen] [Spasmophen]


25 mcg (0.025 mg) of atropine sulfate, 128.6 mcg (0.1286 mg) of hyoscyamine sulfate (or hydrobromide), 7.4 mcg (0.0074 mg) of scopolamine hydrobromide, and 16 mg of phenobarbital (Rx) [Barbidonna]


25 mcg (0.025 mg) of atropine sulfate, 128.6 mcg (0.1286 mg) of hyoscyamine sulfate (or hydrobromide), 7.4 mcg (0.0074 mg) of scopolamine hydrobromide, and 32 mg of phenobarbital (Rx) [Barbidonna No. 2]

Canada—


19 mcg (0.019 mg) of atropine sulfate, 104 mcg (0.104 mg) of hyoscyamine sulfate, 7 mcg (0.007 mg) of scopolamine hydrobromide, and 16.2 mg of phenobarbital (Rx) [Donnatal]

Note: Strengths of individual components may vary slightly among products of different manufacturers.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from light.

Auxiliary labeling:
   • May cause drowsiness.
   • Avoid alcoholic beverages.

Note: Controlled substance in Canada.



ATROPINE SULFATE, HYOSCYAMINE SULFATE, SCOPOLAMINE HYDROBROMIDE, AND PHENOBARBITAL CHEWABLE TABLETS

Usual adult and adolescent dose
Anticholinergic-sedative
Oral, 1 or 2 tablets three or four times a day, the dosage being adjusted as needed and tolerated. {34}


Usual pediatric dose
Anticholinergic-sedative
Children up to 2 years of age: Use is not recommended.

Children 2 to 12 years of age: Oral, 1/2 to 1 tablet three or four times a day, the dosage being adjusted as needed and tolerated. {34}


Usual geriatric dose
See Usual adult and adolescent dose.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.


Strength(s) usually available
U.S.—


120 mcg (0.12 mg) of atropine sulfate, 120 mcg (0.12 mg) of hyoscyamine sulfate, 7 mcg (0.007 mg) of scopolamine hydrobromide, and 16 mg of phenobarbital (Rx) [Kinesed]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from light.

Auxiliary labeling:
   • May be chewed or swallowed with liquids.
   • May cause drowsiness.
   • Avoid alcoholic beverages.


ATROPINE SULFATE, HYOSCYAMINE SULFATE, SCOPOLAMINE HYDROBROMIDE, AND PHENOBARBITAL EXTENDED-RELEASE TABLETS

Usual adult and adolescent dose
Anticholinergic-sedative
Oral, 1 tablet every eight to twelve hours, the dosage being adjusted as needed and tolerated. {35}


Usual pediatric dose
Use is not recommended.

Usual geriatric dose
See Usual adult and adolescent dose.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.


Strength(s) usually available
U.S.—


58.2 mcg (0.0582 mg) of atropine sulfate, 311.1 mcg (0.3111 mg) of hyoscyamine sulfate, 19.5 mcg (0.0195 mg) of scopolamine hydrobromide, and 48.6 mg of phenobarbital (Rx) [Donnatal Extentabs]

Canada—


58.2 mcg (0.0582 mg) of atropine sulfate, 311.1 mcg (0.3111 mg) of hyoscyamine sulfate, 19.5 mcg (0.0195 mg) of scopolamine hydrobromide, and 48.6 mg of phenobarbital (Rx) [Donnatal Extentabs]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from light.

Auxiliary labeling:
   • Swallow tablets whole.
   • May cause drowsiness.
   • Avoid alcoholic beverages.

Note: Controlled substance in Canada.



ATROPINE AND PHENOBARBITAL


Oral Dosage Forms

ATROPINE SULFATE AND PHENOBARBITAL CAPSULES

Usual adult and adolescent dose
Anticholinergic-sedative
Oral, 1 or 2 capsules two to four times a day, the dosage being adjusted as needed and tolerated.


Usual pediatric dose
Dosage must be individualized by physician.

Usual geriatric dose
See Usual adult and adolescent dose.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.


Strength(s) usually available
U.S.—


195 mcg (0.195 mg) of atropine sulfate and 16 mg of phenobarbital (Rx) [Antrocol]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from light.

Auxiliary labeling:
   • May cause drowsiness.
   • Avoid alcoholic beverages.


ATROPINE SULFATE AND PHENOBARBITAL ELIXIR

Usual adult and adolescent dose
Anticholinergic-sedative
Oral, 5 to 10 mL three or four times a day, the dosage being adjusted as needed and tolerated.


Usual pediatric dose
Anticholinergic-sedative
Children 7 to 14 kg of body weight: Oral, 0.5 to 1 mL every four to six hours.

Children 14 to 21 kg of body weight: Oral, 1 to 1.5 mL every four to six hours.

Children 21 to 28 kg of body weight: Oral, 1.5 to 2 mL every four to six hours.

Children 28 to 35 kg of body weight: Oral, 2 to 2.5 mL every four to six hours.

Children 41 kg of body weight and over: Oral, 3 mL every four to six hours.


Note: Dosage must be adjusted for each patient as needed and tolerated.


Usual geriatric dose
See Usual adult and adolescent dose.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.


Strength(s) usually available
U.S.—


195 mcg (0.195 mg) of atropine sulfate and 16 mg of phenobarbital, per 5 mL (Rx) [Antrocol (alcohol 20%)]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing.

Auxiliary labeling:
   • May cause drowsiness.
   • Avoid alcoholic beverages.
   • Keep container tightly closed.

Note: When dispensing for pediatric administration, include the manufacturer-provided calibrated dropper and explain its proper use.



ATROPINE SULFATE AND PHENOBARBITAL TABLETS

Usual adult and adolescent dose
Anticholinergic-sedative
Oral, 1 or 2 tablets three or four times a day, the dosage being adjusted as needed and tolerated.


Usual pediatric dose
Dosage must be individualized by physician.

Usual geriatric dose
See Usual adult and adolescent dose.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.


Strength(s) usually available
U.S.—


195 mcg (0.195 mg) of atropine sulfate and 16 mg of phenobarbital (Rx) [Antrocol]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from light.

Auxiliary labeling:
   • May cause drowsiness.
   • Avoid alcoholic beverages.


BELLADONNA AND BUTABARBITAL


Oral Dosage Forms

BELLADONNA EXTRACT AND BUTABARBITAL SODIUM ELIXIR

Usual adult and adolescent dose
Anticholinergic-sedative
Oral, 5 to 10 mL three or four times a day, the dosage being adjusted as needed and tolerated.


Usual pediatric dose
Anticholinergic-sedative
Children up to 6 years of age: Oral, 1.25 to 2.5 mL three or four times a day, the dosage being adjusted as needed and tolerated.

Children 6 to 12 years of age: Oral, 2.5 to 5 mL three or four times a day, the dosage being adjusted as needed and tolerated.


Usual geriatric dose
See Usual adult and adolescent dose.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.


Strength(s) usually available
U.S.—


15 mg of belladonna extract and 15 mg of butabarbital sodium, per 5 mL (Rx) [Butibel (alcohol 7%)]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from light. Protect from freezing.

Auxiliary labeling:
   • May cause drowsiness.
   • Avoid alcoholic beverages.
   • Keep container tightly closed.

Note: When dispensing for pediatric administration, include a calibrated liquid-measuring device and explain its proper use.



BELLADONNA EXTRACT AND BUTABARBITAL SODIUM TABLETS

Usual adult and adolescent dose
Anticholinergic-sedative
Oral, 1 or 2 tablets three or four times a day, the dosage being adjusted as needed and tolerated.


Usual pediatric dose
Dosage must be individualized by physician.

Usual geriatric dose
See Usual adult and adolescent dose.

Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.


Strength(s) usually available
U.S.—


15 mg of belladonna extract and 15 mg of butabarbital sodium (Rx) [Butibel]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from light.

Auxiliary labeling:
   • May cause drowsiness.
   • Avoid alcoholic beverages.



Revised: 08/09/2000



References
  1. PDR-40: 1578, 1455; PDR-42.
  1. CPS-86: 92; CPS-87.
  1. AHFS '86: 513.
  1. Panel Comments.
  1. USP-DI, Belladonna Alkaloids (Systemic).
  1. Seifert R, Jamieson J, Gardner R. Use of anticholinergics in the nursing home: an empirical study and review. DICP 1983; 17: 470-2.
  1. AMA-DE 5th ed.: 421.
  1. The Medical Letter 1984; 26(668): 75-6.
  1. Anticholinergic/antispasmotic monograph, USP DI 1990.
  1. Barbiturate monograph, USP DI 1990.
  1. Drug Interactions Facts, 1990.
  1. Hanstens Drug Interactions, 6th Edition.
  1. Nizoral product information, Janssen—U.S., rev 3/89.
  1. Belladenal product information, rec 10/88, rev 5/87, U.S.
  1. Apomorphine product information, Lilly—U.S., rec 1/89, rev 4/88.
  1. Phenytoin product information, LyphoMed—U.S., rev 12/86.
  1. Valproic acid product information, Reid-Rowell, rec 4/89, rev 1/89.
  1. McInnes G, M Brodie. Drug interactions that matter. Drugs 1988; 36: 83-110.
  1. APhA, Handbook of nonprescription drugs, 5th Edition: 9.
  1. AMA-DE, 6th Edition: 963.
  1. Nizoral product information, Janssen—U.S., rev 3/89.
  1. Metoclopramide product information, Hoffman-LaRoche—Canada, rev 11/84, rec 2/90.
  1. Evaluations of drug interactions, 3rd Edition, 1985.
  1. K+ 10 product information, rev 9/87, U.S.
  1. Patterson D. Endoscopic comparison of solid and liquid potassium chloride supplements. The Lancet, 11/5/83: 1072.
  1. Barkin J et al. Potassium chloride and gastrointestinal injury. Ann Int Med, 2/83.
  1. Atropine sulfate injection (BW—U.S.) rev 5/85, rec 10/88.
  1. Analgesics panel consensus.
  1. Portenoy R. Causes and treatment of constipation. Syllabus of Postgraduate course, Sloan-Kettering Cancer Center, 1985.
  1. Manufacturer comment, 1991 revision cycle.
  1. Accepted Dental Therapeutics, 40th Edition, 1984.
  1. Hyosophen product information, Rugby—U.S., rec 3/89, rev 5/87.
  1. Donnatal product information, Robins, 1991 PDR.
  1. Kinesed product information, Stuart—U.S., rec 10/88, rev 10/85.
  1. Donnatal Extentabs product information, Robins, 1991 PDR.
  1. Chardonna-2 product information, rec 1/89, rev 11/87, U.S.
  1. Levsin PB Drops product information, Kremers Urban—U.S., rev 12/87, rec 1/89.
  1. Levsin with Phenobarbitol Tablets product information, Kremers Urban—U.S., rec 12/87, rec 1/89.
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