Donnatal Grape Elixir
It is used to treat irritable bowel syndrome.It is used to treat inflammation in the GI (gastrointestinal) tract and some intestinal ulcers.
Drug Class
Antispasmodic, Sedative
Pharmacologic Class
Anticholinergic, Barbiturate
Pregnancy Category
Category D
FDA Approved
Jan 1970
DEA Schedule
Schedule IV
Overview
What is this medicine?
Donnatal Grape Elixir is a liquid medicine that helps calm stomach and bowel spasms and can also help with nervousness. It contains ingredients that relax the muscles in your digestive system and a mild sedative to help you feel more relaxed. It's often used for conditions like irritable bowel syndrome.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. If you experience an upset stomach, taking it with food may help. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device to ensure accurate dosing.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms. Keep it in a safe location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or secure area to prevent unauthorized access. Keep all medications out of reach of pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, as there may be drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. If you experience an upset stomach, taking it with food may help. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device to ensure accurate dosing.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms. Keep it in a safe location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or secure area to prevent unauthorized access. Keep all medications out of reach of pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, as there may be drug take-back programs available in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Avoid alcohol while taking this medication, as it can increase drowsiness and other side effects.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
- Drink plenty of fluids and eat fiber-rich foods to help prevent constipation, a common side effect.
- Avoid overheating and strenuous exercise in hot weather, as this medication can reduce sweating and increase body temperature.
- Do not stop taking this medication suddenly, especially if you have been taking it regularly, as it contains phenobarbital which can cause withdrawal symptoms.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
5 mL (1 teaspoonful) three or four times a day
Dose Range:
5 - 20 mg
Condition-Specific Dosing:
irritableBowelSyndrome:
5 mL (1 teaspoonful) three or four times a day, adjusted to patient response and tolerance.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (use with extreme caution, increased sensitivity to anticholinergic effects and paradoxical excitement from phenobarbital)
Adolescent:
Not established (use with extreme caution, increased sensitivity to anticholinergic effects and paradoxical excitement from phenobarbital)
Dose Adjustments
Renal Impairment:
Mild:
Use with caution, monitor for increased side effects.
Moderate:
Reduce dose, monitor closely for accumulation and side effects.
Severe:
Contraindicated or significantly reduced dose with extreme caution due to phenobarbital accumulation and anticholinergic effects.
Dialysis:
Phenobarbital is dialyzable, but the combination product's use in dialysis patients requires careful consideration and monitoring.
Hepatic Impairment:
Mild:
Use with caution, monitor for increased side effects.
Moderate:
Reduce dose, monitor closely for accumulation and side effects due to impaired phenobarbital metabolism.
Severe:
Contraindicated or significantly reduced dose with extreme caution due to impaired phenobarbital metabolism and increased sensitivity to anticholinergic effects.
Pharmacology
Mechanism of Action
Donnatal combines the anticholinergic actions of hyoscyamine, atropine, and scopolamine with the sedative and antispasmodic effects of phenobarbital. The anticholinergics competitively block the action of acetylcholine at muscarinic receptors, primarily in the gastrointestinal tract, reducing smooth muscle spasm and secretions. Phenobarbital, a barbiturate, acts as a non-selective central nervous system depressant, binding to GABA-A receptor complexes, enhancing the inhibitory effects of GABA, leading to sedation and anxiolysis, which can contribute to the relief of functional gastrointestinal disorders.
Pharmacokinetics
Absorption:
Bioavailability:
High (for individual components)
Tmax:
Hyoscyamine: 30-60 minutes; Atropine: 30-60 minutes; Scopolamine: 20-60 minutes; Phenobarbital: 1-6 hours
FoodEffect:
May delay absorption but generally not significantly alter extent.
Distribution:
Vd:
Hyoscyamine: ~3 L/kg; Atropine: ~1.7 L/kg; Scopolamine: ~1.5 L/kg; Phenobarbital: ~0.5 L/kg
ProteinBinding:
Hyoscyamine: 50%; Atropine: 50%; Scopolamine: Low; Phenobarbital: 20-45%
CnssPenetration:
Yes (especially scopolamine and phenobarbital)
Elimination:
HalfLife:
Hyoscyamine: 3.5 hours; Atropine: 2-4 hours; Scopolamine: 4.5 hours; Phenobarbital: 53-118 hours
Clearance:
Not readily available for combination, varies by component.
ExcretionRoute:
Renal (primarily unchanged for anticholinergics, metabolites for phenobarbital)
Unchanged:
Hyoscyamine: 13-50%; Atropine: 30-50%; Scopolamine: <5%; Phenobarbital: 25-50%
Pharmacodynamics
OnsetOfAction:
30-60 minutes
PeakEffect:
1-2 hours (anticholinergic); 2-6 hours (phenobarbital)
DurationOfAction:
4-6 hours (anticholinergic); 10-16 hours (phenobarbital, due to long half-life, but sedative effect may wane)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Trouble sleeping
Diarrhea
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Inability to sweat during activities or in warm temperatures
Muscle pain or cramping
Fast or abnormal heartbeat
Difficulty passing urine
Changes in eyesight, eye pain, or severe eye irritation
Erectile dysfunction
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause severe health problems and may be life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Feeling dizzy, sleepy, tired, or weak
Blurred eyesight
Headache
Constipation
Bloating
Dry mouth
Upset stomach or vomiting
Feeling nervous and excitable
Changes in taste
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Trouble sleeping
Diarrhea
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Inability to sweat during activities or in warm temperatures
Muscle pain or cramping
Fast or abnormal heartbeat
Difficulty passing urine
Changes in eyesight, eye pain, or severe eye irritation
Erectile dysfunction
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause severe health problems and may be life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Feeling dizzy, sleepy, tired, or weak
Blurred eyesight
Headache
Constipation
Bloating
Dry mouth
Upset stomach or vomiting
Feeling nervous and excitable
Changes in taste
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe constipation or inability to have a bowel movement
- Inability to urinate or difficulty passing urine
- Severe drowsiness, dizziness, or confusion
- Blurred vision or eye pain
- Fast or irregular heartbeat
- Skin rash or allergic reaction
- Unusual excitement or restlessness (especially in children or elderly)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Heart problems caused by bleeding
+ Bowel blockage
+ Enlarged colon
+ Glaucoma
+ Hiatal hernia (a hernia that affects the stomach)
+ Myasthenia gravis
+ Slow-moving gastrointestinal (GI) tract
+ Urinary retention or difficulty passing urine
+ Ulcerative colitis
A history of porphyria, a rare genetic disorder
Previous experiences of restlessness or overexcitement after taking phenobarbital
* Past or current struggles with alcohol or drug use disorder
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Heart problems caused by bleeding
+ Bowel blockage
+ Enlarged colon
+ Glaucoma
+ Hiatal hernia (a hernia that affects the stomach)
+ Myasthenia gravis
+ Slow-moving gastrointestinal (GI) tract
+ Urinary retention or difficulty passing urine
+ Ulcerative colitis
A history of porphyria, a rare genetic disorder
Previous experiences of restlessness or overexcitement after taking phenobarbital
* Past or current struggles with alcohol or drug use disorder
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Long-term use of this drug may lead to dependence. If you have been taking this medication for an extended period, consult your doctor before discontinuing its use. Your doctor may recommend a gradual tapering of the dosage to minimize potential withdrawal effects.
Until you are familiar with how this medication affects you, avoid operating a vehicle, performing tasks that require alertness, or engaging in activities that demand clear vision. Prior to consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, discuss the potential risks with your doctor.
In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration. If you are allergic to tartrazine (FD&C Yellow No. 5), consult your doctor, as some formulations of this medication may contain this ingredient.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
Note that this drug may reduce the effectiveness of birth control pills and other hormone-based contraceptives. To prevent pregnancy, consider using an additional form of birth control, such as a condom, while taking this medication.
If you are pregnant or become pregnant while taking this medication, immediately contact your doctor, as it may pose a risk to the unborn baby.
If you are breastfeeding, inform your doctor to discuss the potential risks to your infant and determine the best course of action.
Long-term use of this drug may lead to dependence. If you have been taking this medication for an extended period, consult your doctor before discontinuing its use. Your doctor may recommend a gradual tapering of the dosage to minimize potential withdrawal effects.
Until you are familiar with how this medication affects you, avoid operating a vehicle, performing tasks that require alertness, or engaging in activities that demand clear vision. Prior to consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, discuss the potential risks with your doctor.
In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration. If you are allergic to tartrazine (FD&C Yellow No. 5), consult your doctor, as some formulations of this medication may contain this ingredient.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
Note that this drug may reduce the effectiveness of birth control pills and other hormone-based contraceptives. To prevent pregnancy, consider using an additional form of birth control, such as a condom, while taking this medication.
If you are pregnant or become pregnant while taking this medication, immediately contact your doctor, as it may pose a risk to the unborn baby.
If you are breastfeeding, inform your doctor to discuss the potential risks to your infant and determine the best course of action.
Overdose Information
Overdose Symptoms:
- Severe dry mouth, nose, and throat
- Dilated pupils, blurred vision
- Hot, dry, flushed skin
- Fever
- Rapid heart rate
- Difficulty breathing
- Confusion, delirium, hallucinations
- Muscle weakness or paralysis
- Severe drowsiness, stupor, coma
- Respiratory depression
- Circulatory collapse
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment may involve activated charcoal, gastric lavage, supportive care, and specific antidotes for anticholinergic toxicity (e.g., physostigmine) or respiratory support for phenobarbital overdose.
Drug Interactions
Contraindicated Interactions
- Potassium chloride (solid dosage forms, increased risk of GI lesions)
- Other anticholinergics (additive effects)
- CNS depressants (additive effects, e.g., alcohol, opioids, benzodiazepines, tricyclic antidepressants)
- MAO inhibitors (can prolong and intensify effects of phenobarbital and anticholinergics)
Major Interactions
- Oral anticoagulants (phenobarbital can decrease effect)
- Corticosteroids (phenobarbital can decrease effect)
- Doxycycline (phenobarbital can decrease effect)
- Griseofulvin (phenobarbital can decrease effect)
- Oral contraceptives (phenobarbital can decrease efficacy)
- Quinidine (anticholinergics can increase effect)
- Digoxin (anticholinergics can increase absorption)
- Valproic acid (phenobarbital can increase valproic acid levels, valproic acid can increase phenobarbital levels)
- Chloramphenicol (can inhibit phenobarbital metabolism)
- Disulfiram (can inhibit phenobarbital metabolism)
Moderate Interactions
- Antacids (may decrease absorption of anticholinergics)
- Ketoconazole (anticholinergics may decrease absorption)
- Metoclopramide (anticholinergics antagonize effects)
- Phenothiazines (additive anticholinergic effects)
- Amantadine (additive anticholinergic effects)
- Class IA antiarrhythmics (e.g., disopyramide, additive anticholinergic effects)
Minor Interactions
- None specifically listed as minor, most interactions are significant due to the drug classes.
Monitoring
Baseline Monitoring
Gastrointestinal symptoms (frequency, severity of spasms, pain)
Rationale: To establish baseline for efficacy assessment.
Timing: Prior to initiation of therapy.
Mental status and cognitive function
Rationale: To assess baseline for potential CNS depression or paradoxical excitement, especially in elderly.
Timing: Prior to initiation of therapy.
Renal and hepatic function tests (BUN, creatinine, LFTs)
Rationale: To assess organ function for appropriate dosing and to monitor for potential toxicity.
Timing: Prior to initiation of therapy, especially in patients with pre-existing impairment.
Intraocular pressure (in patients with glaucoma or risk factors)
Rationale: Anticholinergics can precipitate acute angle-closure glaucoma.
Timing: Prior to initiation of therapy.
Routine Monitoring
Anticholinergic side effects (dry mouth, blurred vision, urinary retention, constipation)
Frequency: Daily, especially during dose titration or initiation.
Target: Minimal to tolerable
Action Threshold: If severe or persistent, consider dose reduction or discontinuation.
CNS depression (drowsiness, dizziness, confusion)
Frequency: Daily, especially during dose titration or initiation.
Target: Minimal to tolerable
Action Threshold: If excessive, consider dose reduction or discontinuation; assess for paradoxical excitement in children/elderly.
Bowel habits and urinary output
Frequency: Daily
Target: Normal
Action Threshold: Significant constipation or urinary hesitancy/retention requires intervention.
Therapeutic response (reduction in GI spasms/pain)
Frequency: Regularly, based on patient symptoms.
Target: Symptom improvement
Action Threshold: Lack of efficacy may warrant dose adjustment or alternative therapy.
Symptom Monitoring
- Dry mouth
- Blurred vision
- Constipation
- Urinary hesitancy or retention
- Drowsiness
- Dizziness
- Confusion
- Nausea
- Vomiting
- Nervousness
- Rash
- Palpitations
- Tachycardia
- Headache
- Paradoxical excitement (especially in children and elderly)
Special Patient Groups
Pregnancy
Category D. Donnatal should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Phenobarbital can cause fetal harm, including congenital malformations and neonatal withdrawal syndrome.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital malformations (e.g., cleft lip/palate, cardiac defects) associated with phenobarbital exposure.
Second Trimester:
Risk of fetal growth restriction and potential for neonatal withdrawal syndrome if continued.
Third Trimester:
High risk of neonatal withdrawal syndrome (irritability, tremors, hypertonia, feeding difficulties) if used near term. Anticholinergics may also affect fetal heart rate.
Lactation
L4 (Possibly Hazardous). Not recommended during breastfeeding. Phenobarbital is excreted into breast milk and can cause sedation, poor feeding, and withdrawal symptoms in the infant. Anticholinergics can also be excreted and may reduce milk supply.
Infant Risk:
High risk of sedation, poor feeding, irritability, and withdrawal symptoms in the infant due to phenobarbital. Potential for anticholinergic effects in the infant and reduction of milk supply in the mother.
Pediatric Use
Use with extreme caution. Children are more susceptible to the toxic effects of anticholinergics (e.g., hyperthermia, CNS effects) and may experience paradoxical excitement from phenobarbital. Safety and efficacy have not been established in pediatric patients.
Geriatric Use
Use with extreme caution and generally avoid due to increased sensitivity to anticholinergic side effects (e.g., confusion, delirium, urinary retention, constipation) and CNS depression from phenobarbital. Included in the Beers Criteria for potentially inappropriate medication use in older adults.
Clinical Information
Clinical Pearls
- Donnatal is a combination product, meaning it carries the risks and benefits of all its active ingredients (anticholinergics and a barbiturate).
- Due to the phenobarbital component, there is a risk of physical and psychological dependence, especially with prolonged use. Tapering is necessary upon discontinuation.
- Patients should be advised about the potential for additive CNS depression when combining with alcohol or other sedatives.
- Anticholinergic side effects (dry mouth, blurred vision, constipation, urinary retention) are common and can be particularly problematic in elderly patients.
- Not recommended for long-term use due to the risks associated with phenobarbital and the potential for tolerance to anticholinergic effects.
- Consider alternative therapies first for IBS or GI spasms that do not carry the risks of a controlled substance or significant anticholinergic burden.
Alternative Therapies
- Dicyclomine (Bentyl)
- Hyoscyamine (Levsin, Anaspaz)
- Peppermint oil (enteric-coated)
- Tricyclic antidepressants (e.g., amitriptyline, imipramine for IBS with pain)
- SSRIs (for IBS with anxiety/depression)
- Fiber supplements (for IBS with constipation)
- Loperamide (for IBS with diarrhea)
- Rifaximin (Xifaxan for IBS-D)
- Linaclotide (Linzess for IBS-C)
- Lubiprostone (Amitiza for IBS-C)
- Alosetron (Lotronex for severe IBS-D in women, restricted use)
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200 per 120 mL elixir
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may require prior authorization due to phenobarbital component)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.