Donnatal
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Questions & Answers
Side Effects & Adverse Reactions
Donnatal® Elixir can cause fetal harm when administered to a pregnant woman. Animal reproduction studies have not been conducted with Donnatal® Elixir. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
In the 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.
Donnatal® 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, and not to perform hazardous work.
Phenobarbital may decrease the effect of anticoagulants, and necessitate larger doses of the anticoagulant for optimal effect. When the phenobarbital is discontinued, the dose of the 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 the liver, they should be used with caution and initial doses should be small in patients with hepatic dysfunction.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Based on a review of this drug by the National Academy of Sciences–National Research Council and/or other information, FDA has classified the indications as follows: “Possibly” effective: For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
May also be useful as adjunctive therapy in the treatment of duodenal ulcer.
Final classification of the less-than-effective indications requires further investigation.
IT HAS NOT BEEN SHOWN CONCLUSIVELY WHETHER ANTICHOLINERGIC/ANTISPASMODIC DRUGS AID IN THE HEALING OF A DUODENAL ULCER, DECREASE THE RATE OF RECURRENCES OR PREVENT COMPLICATIONS.
History
There is currently no drug history available for this drug.
Other Information
Donnatal® Elixir - Grape
Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:
Phenobarbital, USP.............................. 16.2 mg
Hyoscyamine Sulfate, USP............... 0.1037 mg
Atropine Sulfate, USP...................... 0.0194 mg
Scopolamine Hydrobromide, USP.... 0.0065 mg
Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Artificial and Natural Grape Flavor, FD&C Red #3, and FD&C Blue #1.
Donnatal® Elixir - Mint
Each 5 mL (teaspoonful) of elixir (alcohol not more than 23.8%) contains:
Phenobarbital, USP.............................. 16.2 mg
Hyoscyamine Sulfate, USP............... 0.1037 mg
Atropine Sulfate, USP...................... 0.0194 mg
Scopolamine Hydrobromide, USP.... 0.0065 mg
Purified Water, Glycerin, Sorbitol, Ethyl Alcohol, Sucrose, Saccharin Sodium, Natural Mint Flavor, FD&C Yellow #5, and FD&C Blue #1.
Sources
Donnatal Manufacturers
-
Concordia Pharmaceuticals Inc.
![Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir [Concordia Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Donnatal | Concordia Pharmaceuticals Inc.
The dosage of Donnatal® Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
Donnatal® Elixir. Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.
Pediatric patients: may be dosed every 4 to 6 hours. Use a pediatric dosing device or oral syringe to measure the dose.
Starting Dosage Body weight
Every 4 hours Every 6 hours 10 lb. (4.5 kg)
0.5 mL
0.75 mL
20 lb. (9.1 kg)
1 mL
1.5 mL
30 lb. (13.6 kg)
1.5 mL
2 mL
50 lb. (22.7 kg)
2.5 mL
3.75 mL
75 lb. (34 kg)
3.75 mL
5 mL
100 lb. (45.4 kg)
5 mL
7.5 mL
-
Kaiser Foundation Hospitals
Donnatal | Kaiser Foundation Hospitals
The dosage of Donnatal® Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
Donnatal® Elixir
Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.Pediatric patients: may be dosed every 4 to 6 hours.
Starting Dosage
Body Weight
q4h q6h 10 lb. (4.5 kg)
0.5 mL
0.75 mL
20 lb. (9.1 kg)
1.0 mL
1.5 mL
30 lb. (13.6 kg)
1.5 mL
2.0 mL
50 lb. (22.7 kg)
1/2 tsp
3/4 tsp
75 lb. (34 kg)
3/4 tsp
1 tsp
100 lb. (45.4kg)
1 tsp
1 1/2 tsp
-
Rebel Distributors Corp
Donnatal | Rebel Distributors Corp
The dosage of Donnatal® should be adjusted to the needs of the dividual patient to assure symptomatic control with a minimum of adverse effects.
Donnatal® Tablets. Adults: One or two Donnatal® tablets three or four times a day according to condition and severity of symptoms. -
Kaiser Foundation Hospitals
Donnatal | Kaiser Foundation Hospitals
The dosage of Donnatal® should be adjusted to the needs of the dividual patient to assure symptomatic control with a minimum of adverse effects.
Donnatal® Tablets. Adults: One or two Donnatal® tablets three or four times a day according to condition and severity of symptoms. -
Pbm Pharmaceuticals Inc.
Donnatal | Pbm Pharmaceuticals Inc.
The dosage of Donnatal® Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
Donnatal® Elixir. Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.
Pediatric patients: may be dosed every 4 to 6 hours.
Starting dosage
Body weight q4h q6h
10 lb. (4.5 kg) 0.5 mL 0.75 mL
20 lb. (9.1 kg) 1.0 mL 1.5 mL
30 lb. (13.6 kg) 1.5 mL 2.0 mL
50 lb. (22.7 kg) ½ tsp ¾ tsp
75 lb. (34 kg) ¾ tsp 1 tsp
100 lb. (45.4 kg) 1 tsp 1½ tsp
-
Pbm Pharmaceuticals Inc.
Donnatal | Pbm Pharmaceuticals Inc.
The dosage of Donnatal® Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
Donnatal® Elixir. Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.
Pediatric patients: may be dosed every 4 to 6 hours.
Starting dosage
Body weight q4h q6h
10 lb. (4.5 kg) 0.5 mL 0.75 mL
20 lb. (9.1 kg) 1.0 mL 1.5 mL
30 lb. (13.6 kg) 1.5 mL 2.0 mL
50 lb. (22.7 kg) ½ tsp ¾ tsp
75 lb. (34 kg) ¾ tsp 1 tsp
100 lb. (45.4 kg) 1 tsp 1½ tsp
-
Pbm Pharmaceuticals Inc.
Donnatal | Pbm Pharmaceuticals Inc.
The dosage of Donnatal® Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
Donnatal® Elixir. Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.
Pediatric patients: may be dosed every 4 to 6 hours.
Starting dosage
Body weight q4h q6h
10 lb. (4.5 kg) 0.5 mL 0.75 mL
20 lb. (9.1 kg) 1.0 mL 1.5 mL
30 lb. (13.6 kg) 1.5 mL 2.0 mL
50 lb. (22.7 kg) ½ tsp ¾ tsp
75 lb. (34 kg) ¾ tsp 1 tsp
100 lb. (45.4 kg) 1 tsp 1½ tsp
-
Pbm Pharmaceuticals Inc.
Donnatal | Pbm Pharmaceuticals Inc.
The dosage of Donnatal® Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
Donnatal® Elixir. Adults: One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms.
Pediatric patients: may be dosed every 4 to 6 hours.
Starting dosage
Body weight q4h q6h
10 lb. (4.5 kg) 0.5 mL 0.75 mL
20 lb. (9.1 kg) 1.0 mL 1.5 mL
30 lb. (13.6 kg) 1.5 mL 2.0 mL
50 lb. (22.7 kg) ½ tsp ¾ tsp
75 lb. (34 kg) ¾ tsp 1 tsp
100 lb. (45.4 kg) 1 tsp 1½ tsp
-
Pbm Pharmaceuticals Inc.
Donnatal | Pbm Pharmaceuticals Inc.
The dosage of Donnatal® should be adjusted to the needs of the dividual patient to assure symptomatic control with a
minimum of adverse effects.
Donnatal® Tablets. Adults: One or two Donnatal® tablets three or four times a day according to condition and severity
of symptoms.
-
Avkare, Inc.
Donnatal | Teva Parenteral Medicines, Inc.
The patient’s pretreatment body weight should be obtained for calculation of correct dosage. Amikacin sulfate injection may be given intramuscularly or intravenously.
The status of renal function should be estimated by measurement of the serum creatinine concentration or calculation of the endogenous creatinine clearance rate. The blood urea nitrogen (BUN) is much less reliable for this purpose. Reassessment of renal function should be made periodically during therapy.
Whenever possible, amikacin concentrations in serum should be measured to assure adequate but not excessive levels. It is desirable to measure both peak and trough serum concentrations intermittently during therapy. Peak concentrations (30 to 90 minutes after injection) above 35 mcg/mL and trough concentrations (just prior to the next dose) above 10 mcg/mL should be avoided. Dosage should be adjusted as indicated.
Intramuscular Administration for Patients with Normal Renal FunctionThe recommended dosage for adults, children and older infants (see WARNINGS box) with normal renal function is 15 mg/kg/day divided into 2 or 3 equal doses administered at equally divided intervals, i.e., 7.5 mg/kg q12h or 5 mg/kg q8h. Treatment of patients in the heavier weight classes should not exceed 1.5 grams/day.
When amikacin is indicated in newborns (see WARNINGS box), it is recommended that a loading dose of 10 mg/kg be administered initially to be followed with 7.5 mg/kg every 12 hours.
The usual duration of treatment is 7 to 10 days. It is desirable to limit the duration of treatment to short-term whenever feasible. The total daily dose by all routes of administration should not exceed 15 mg/kg/day. In difficult and complicated infections where treatment beyond 10 days is considered, the use of amikacin should be reevaluated. If continued, amikacin serum levels and renal, auditory and vestibular functions should be monitored. At the recommended dosage level, uncomplicated infections due to amikacin-sensitive organisms should respond in 24 to 48 hours. If definite clinical response does not occur within 3 to 5 days, therapy should be stopped and the antibiotic susceptibility pattern of the invading organism should be rechecked. Failure of the infection to respond may be due to resistance of the organism or to the presence of septic foci requiring surgical drainage.
When amikacin is indicated in uncomplicated urinary tract infections, a dose of 250 mg twice daily may be used.
DOSAGE GUIDELINES
ADULTS AND CHILDREN WITH NORMAL RENAL FUNCTION Patient Weight Dosage lbs kg 7.5 mg/kg OR 5 mg/kg q12h q8h99
45
337.5 mg
225 mg
110
50
375 mg
250 mg
121
55
412.5 mg
275 mg
132
60
450 mg
300 mg
143
65
487.5 mg
325 mg
154
70
525 mg
350 mg
165
75
562.5 mg
375 mg
176
80
600 mg
400 mg
187
85
637.5 mg
425 mg
198
90
675 mg
450 mg
209
95
712.5 mg
475 mg
220
100
750 mg
500 mg
Intramuscular Administration for Patients with Impaired Renal FunctionWhenever possible, serum amikacin concentrations should be monitored by appropriate assay procedures. Doses may be adjusted in patients with impaired renal function either by administering normal doses at prolonged intervals or by administering reduced doses at a fixed interval.
Both methods are based on the patient’s creatinine clearance or serum creatinine values since these have been found to correlate with aminoglycoside half-lives in patients with diminished renal function. These dosage schedules must be used in conjunction with careful clinical and laboratory observations of the patient and should be modified as necessary. Neither method should be used when dialysis is being performed.
Normal Dosage at Prolonged IntervalsIf the creatinine clearance rate is not available and the patient’s condition is stable, a dosage interval in hours for the normal dose can be calculated by multiplying the patient’s serum creatinine by 9, e.g., if the serum creatinine concentration is 2 mg/100 mL, the recommended single dose (7.5 mg/kg) should be administered every 18 hours.
Reduced Dosage at Fixed Time IntervalsWhen renal function is impaired and it is desirable to administer amikacin at a fixed time interval, dosage must be reduced. In these patients, serum amikacin concentrations should be measured to assure accurate administration of amikacin and to avoid concentrations above 35 mcg/mL. If serum assay determinations are not available and the patient’s condition is stable, serum creatinine and creatinine clearance values are the most readily available indicators of the degree of renal impairment to use as a guide for dosage.
First, initiate therapy by administering a normal dose, 7.5 mg/kg, as a loading dose. This loading dose is the same as the normally recommended dose which would be calculated for a patient with a normal renal function as described above.
To determine the size of maintenance doses administered every 12 hours, the loading dose should be reduced in proportion to the reduction in the patient’s creatinine clearance rate:
An alternate rough guide for determining reduced dosage at 12 hour intervals (for patients whose steady state serum creatinine values are known) is to divide the normally recommended dose by the patient’s serum creatinine.
The above dosage schedules are not intended to be rigid recommendations but are provided as guides to dosage when the measurement of amikacin serum levels is not feasible.
Intravenous AdministrationThe individual dose, the total daily dose, and the total cumulative dose of amikacin sulfate are identical to the dose recommended for intramuscular administration. The solution for intravenous use is prepared by adding the contents of a 500 mg vial to 100 or 200 mL of sterile diluent such as 0.9% sodium chloride injection or 5% dextrose injection or any other compatible solutions listed below.
The solution is administered to adults over a 30 to 60 minute period. The total daily dose should not exceed 15 mg/kg/day and may be divided into either 2 or 3 equally-divided doses at equally-divided intervals.
In pediatric patients, the amount of fluid used will depend on the amount of amikacin sulfate ordered for the patient. It should be a sufficient amount to infuse the amikacin over a 30 to 60 minute period. Infants should receive a 1 to 2 hour infusion.
Amikacin should not be physically premixed with other drugs but should be administered separately according to the recommended dose and route.
Stability in IV Fluids
Amikacin sulfate is stable for 24 hours at room temperature at concentrations of 0.25 and 5 mg/mL in the following solutions:
5% Dextrose Injection USP
5% Dextrose USP and 0.2% Sodium Chloride Injection USP
5% Dextrose USP and 0.45% Sodium Chloride Injection USP
0.9% Sodium Chloride Injection USP
Lactated Ringer’s Injection USP
Normosol® M in 5% Dextrose Injection USP
(or Plasma-Lyte 56 injection in 5% Dextrose USP in water).Normosol® R in 5% Dextrose Injection USP
(or Plasma-Lyte 148 injection in 5% Dextrose USP in water).In the above solutions with amikacin sulfate concentrations of 0.25 and 5 mg/mL, solutions aged for 60 days at 4°C and then stored at 25°C had utility times of 24 hours.
At the same concentrations, solutions frozen and aged for 30 days at -15°C, thawed, and stored at 25°C had utility times of 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Aminoglycosides administered by any of the above routes should not be physically premixed with other drugs but should be administered separately.
Because of the potential toxicity of aminoglycosides, “fixed dosage” recommendations which are not based upon body weight are not advised. Rather, it is essential to calculate the dosage to fit the needs of each patient.
-
Avkare, Inc.
Donnatal | Walgreen Co.
do not take more than directed
do not take more than 8 caplets in 24 hours adults and children 12 years and over: take 2 caplets every 4 hours children 4 to under 12 years: ask a doctor -
Rxpak Division Of Mckesson Corporation
Donnatal | Rxpak Division Of Mckesson Corporation
The dosage of Donnatal® should be adjusted to the needs of the dividual patient to assure symptomatic control with a
minimum of adverse effects.
Donnatal® Tablets. Adults: One or two Donnatal® tablets three or four times a day according to condition and severity
of symptoms.
-
Carilion Materials Management
Donnatal | Carilion Materials Management
The dosage of Donnatal® should be adjusted to the needs of the dividual patient to assure symptomatic control with a
minimum of adverse effects.
Donnatal® Tablets. Adults: One or two Donnatal® tablets three or four times a day according to condition and severity
of symptoms.
-
Atlantic Biologicals Corps
Donnatal | Atlantic Biologicals Corps
The dosage of Donnatal® Elixir should be adjusted to the needs of the individual patient to assure symptomatic control with a minimum of adverse effects.
One or two teaspoonfuls of elixir three or four times a day according to conditions and severity of symptoms. Donnatal®Elixir. Adults:
may be dosed every 4 to 6 hours. Pediatric patients:
Starting dosage
Body weight q4h q6h
10 lb. (4.5 kg) 0.5 mL 0.75 mL
20 lb. (9.1 kg) 1.0 mL 1.5 mL
30 lb. (13.6 kg) 1.5 mL 2.0 mL
50 lb. (22.7 kg) ½ tsp ¾ tsp
75 lb. (34 kg) ¾ tsp 1 tsp
100 lb. (45.4 kg) 1 tsp 1½ tsp
-
Concordia Pharmaceuticals Inc.
Donnatal | Deseret Biologicals, Inc.
1-10 drops under the tongue, 2 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.
![Donnatal (Belladonna Alkaloids W/ Phenobarbital) Elixir [Kaiser Foundation Hospitals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a23f0d69-44c7-422c-ba1e-dad068984fdf&name=Donnatal-01.jpg)
![Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablet [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1cc18146-d9be-4975-89ba-e99a85f71c76&name=1cc18146-d9be-4975-89ba-e99a85f71c76-01.jpg)
![Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablet [Kaiser Foundation Hospitals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=859dee23-89bd-4929-817f-9fe75d742157&name=Donnatal-01.jpg)
![Donnatal (Phenobarbital Elixir) Elixir [Pbm Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=faa67498-fdff-4fe7-9057-2045e9463c32&name=donnatal16ozlblrev0311.jpg)
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![Donnatal (Phenobarbital Elixir) Elixir [Pbm Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8d395651-e406-4448-98a7-fc6afc61282d&name=Donnatal_16ozmintlbl0411.jpg)
![Donnatal (Phenobarbital Elixir) Elixir [Pbm Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ae03915e-8eca-4dab-94ac-00a4571b699b&name=Donnatal4ozmintlbl0411.jpg)
![Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablet [Pbm Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=54f28743-bb66-4234-8d20-8502a5ffdc26&name=Donnatal_label_1000tablets.jpg)
![Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablet [Avkare, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a47f8cf6-dbdc-46f7-b0a0-e56adcb8b087&name=image-03.jpg)
![Donnatal (Phenobarbital Elixir) Elixir [Avkare, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=93d5b1db-e9ad-4a6a-b869-fd0d1a11df02&name=walgreens-44-640-1.jpg)
![Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablet [Rxpak Division Of Mckesson Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=df43332e-6696-4452-8dc6-4eefbe6231e1&name=Donnatal_label_100tablets.jpg)
![Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablet [Carilion Materials Management]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7343cfab-9bd9-4dcb-bbef-9592ffd5d7e6&name=68151-0607.jpg)
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![Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Tablet [Concordia Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e66d3794-3395-45e6-901f-21e26ad42a2e&name=DSRT0124BioUbichinonCompositum.jpg)
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