Donnatal Grape Elixir 5ml
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 (Antimuscarinic), 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 to relieve stomach and bowel cramps, pain, and spasms. It contains ingredients that relax the muscles in your digestive system and also a mild sedative to help calm you. It's often used for conditions like irritable bowel syndrome (IBS).
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, 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.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding bathrooms. Keep it in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist, who may be aware of local drug take-back programs.
Missing 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 one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, 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.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding bathrooms. Keep it in a secure location where children and pets cannot access it, and consider using a locked box or area to prevent unauthorized use. Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist, who may be aware of local drug take-back programs.
Missing 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 one.
Lifestyle & Tips
- Avoid alcohol and other sedatives, as they can increase drowsiness and dizziness.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause drowsiness, dizziness, and blurred vision.
- Avoid overheating in hot weather or during exercise, as this medication can decrease sweating and increase body temperature.
- Drink plenty of fluids and eat fiber-rich foods to help prevent constipation, a common side effect.
- Do not stop taking this medication suddenly, especially if you have been taking it regularly for a long time, as it contains phenobarbital which can cause withdrawal symptoms.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
5 mL (containing Hyoscyamine 0.1037 mg, Atropine 0.0194 mg, Scopolamine 0.0065 mg, Phenobarbital 16.2 mg) three or four times a day
Dose Range:
5 - 10 mg
Condition-Specific Dosing:
maximumDailyDose:
Not to exceed 8 doses (40 mL) in 24 hours for elixir
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Dosing must be individualized based on weight and response, typically 0.5 mL to 5 mL three or four times a day, not to exceed 0.5 mL/kg/day. Consult specific pediatric dosing guidelines.
Adolescent:
Typically adult dose, 5 mL three or four times a day.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for increased anticholinergic effects and phenobarbital accumulation.
Moderate:
Reduce dose; monitor closely for adverse effects. Phenobarbital excretion is reduced.
Severe:
Contraindicated or significantly reduced dose with extreme caution. Risk of accumulation and toxicity.
Dialysis:
Phenobarbital is dialyzable; however, the combination drug is generally not recommended in severe renal failure. Consult nephrologist.
Hepatic Impairment:
Mild:
Use with caution; monitor for increased phenobarbital levels and anticholinergic effects.
Moderate:
Reduce dose; monitor closely for CNS depression and other adverse effects due to impaired phenobarbital metabolism.
Severe:
Contraindicated or significantly reduced dose with extreme caution due to impaired phenobarbital metabolism and increased risk of hepatic encephalopathy.
Confidence:
Medium
Pharmacology
Mechanism of Action
Donnatal combines the anticholinergic actions of hyoscyamine, atropine, and scopolamine with the sedative action of phenobarbital. The anticholinergics competitively antagonize the effects of acetylcholine at muscarinic receptors, leading to decreased gastrointestinal motility and secretions, relaxation of smooth muscle, and other anticholinergic effects (e.g., mydriasis, cycloplegia, decreased salivation). Phenobarbital is a barbiturate that produces non-selective central nervous system depression, ranging from mild sedation to hypnosis and coma, by binding to GABA-A receptors and enhancing the inhibitory effects of GABA.
Pharmacokinetics
Absorption:
Bioavailability:
Good oral absorption for all components, though specific percentages for the combination are not readily available.
Tmax:
Hyoscyamine: 30-60 minutes; Atropine: 1 hour; Scopolamine: 20-60 minutes; Phenobarbital: 1-6 hours (variable)
FoodEffect:
Food may delay absorption but generally does not significantly affect the extent of absorption.
Distribution:
Vd:
Hyoscyamine: ~3 L/kg; Atropine: ~1.7 L/kg; Scopolamine: ~1.5 L/kg; Phenobarbital: ~0.5-1 L/kg
ProteinBinding:
Hyoscyamine: ~50%; Atropine: ~50%; Scopolamine: Low; Phenobarbital: 20-45%
CnssPenetration:
Yes (all components cross the blood-brain barrier, especially scopolamine and phenobarbital)
Elimination:
HalfLife:
Hyoscyamine: 3.5-13 hours; Atropine: 2-4 hours; Scopolamine: 4.5 hours; Phenobarbital: 53-118 hours (adults), 20-67 hours (children)
Clearance:
Not readily available for combination; individual component clearance varies.
ExcretionRoute:
Renal (primarily unchanged for anticholinergics, metabolites for phenobarbital)
Unchanged:
Hyoscyamine: 13-50%; Atropine: 30-50%; Scopolamine: ~10%; Phenobarbital: 25-50%
Pharmacodynamics
OnsetOfAction:
30-60 minutes
PeakEffect:
1-6 hours (influenced by phenobarbital's slower peak)
DurationOfAction:
6-8 hours (primarily due to phenobarbital's longer half-life and sustained anticholinergic effects)
Confidence:
Medium
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 indicate a severe bowel problem
Inability to sweat during physical activity or in warm temperatures
Muscle pain or cramping
Fast or abnormal heartbeat
Difficulty urinating
Changes in vision, eye pain, or severe eye irritation
Erectile dysfunction
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, which can cause severe health problems and potentially be life-threatening. Seek immediate medical help 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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Headache
Constipation
Bloating
Dry mouth
Nausea or vomiting
Feeling nervous or excitable
* Changes in taste
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 indicate a severe bowel problem
Inability to sweat during physical activity or in warm temperatures
Muscle pain or cramping
Fast or abnormal heartbeat
Difficulty urinating
Changes in vision, eye pain, or severe eye irritation
Erectile dysfunction
A severe skin reaction, known as Stevens-Johnson syndrome or toxic epidermal necrolysis, which can cause severe health problems and potentially be life-threatening. Seek immediate medical help 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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Headache
Constipation
Bloating
Dry mouth
Nausea or vomiting
Feeling nervous or excitable
* Changes in taste
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 drowsiness or dizziness
- Difficulty breathing or shallow breathing
- Severe dry mouth, difficulty swallowing or speaking
- Blurred vision or eye pain (especially if sudden)
- Difficulty urinating or inability to urinate
- Severe constipation or abdominal bloating
- Confusion, agitation, or hallucinations
- Fast or irregular heartbeat
- Skin rash or allergic reaction
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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Heart problems caused by bleeding
+ Bowel blockage
+ Enlarged colon
+ Glaucoma
+ Hiatal hernia (a hernia that involves the stomach)
+ Myasthenia gravis
+ Slow-moving gastrointestinal (GI) tract
+ 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 problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing health conditions and other medications. 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Heart problems caused by bleeding
+ Bowel blockage
+ Enlarged colon
+ Glaucoma
+ Hiatal hernia (a hernia that involves the stomach)
+ Myasthenia gravis
+ Slow-moving gastrointestinal (GI) tract
+ 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 problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing health conditions and other medications. 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, so if you have been taking it for an extended period, consult your doctor before stopping. To minimize potential withdrawal effects, your doctor may recommend gradually tapering off the medication.
Until you understand how this drug affects you, avoid operating a vehicle, performing tasks that require alertness, or engaging in activities that demand clear vision. Before 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), a component found in some products, consult your doctor before taking this medication.
Individuals aged 65 and older should exercise caution when using this drug, as they may be more susceptible to side effects. Additionally, women taking birth control pills or other hormone-based contraceptives should be aware that this medication may reduce their effectiveness. To prevent pregnancy, consider using an alternative form of birth control, such as a condom, in conjunction with your regular contraceptive method.
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. Furthermore, if you are breastfeeding, consult your doctor to discuss potential risks to your infant and determine the best course of action.
Until you understand how this drug affects you, avoid operating a vehicle, performing tasks that require alertness, or engaging in activities that demand clear vision. Before 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), a component found in some products, consult your doctor before taking this medication.
Individuals aged 65 and older should exercise caution when using this drug, as they may be more susceptible to side effects. Additionally, women taking birth control pills or other hormone-based contraceptives should be aware that this medication may reduce their effectiveness. To prevent pregnancy, consider using an alternative form of birth control, such as a condom, in conjunction with your regular contraceptive method.
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. Furthermore, if you are breastfeeding, consult your doctor to discuss potential risks to your infant and determine the best course of action.
Overdose Information
Overdose Symptoms:
- Severe drowsiness, stupor, or coma
- Respiratory depression (slow, shallow breathing)
- Hypotension (low blood pressure)
- Tachycardia (rapid heart rate)
- Hyperthermia (high body temperature)
- Flushed, dry skin
- Dilated pupils (mydriasis)
- Blurred vision
- Urinary retention
- Paralytic ileus
- Ataxia (loss of coordination)
- Nystagmus (involuntary eye movements)
- Agitation, delirium, or hallucinations (especially in children or elderly)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment may involve supportive care, activated charcoal, gastric lavage, and specific antidotes for anticholinergic toxicity (e.g., physostigmine) or measures to support respiration and circulation.
Drug Interactions
Contraindicated Interactions
- Potassium chloride (solid dosage forms) - increased risk of GI lesions
- Other CNS depressants (e.g., opioids, benzodiazepines, alcohol) - severe additive CNS depression
- Other anticholinergics (e.g., tricyclic antidepressants, antihistamines, phenothiazines) - severe additive anticholinergic effects
- MAO inhibitors - enhanced anticholinergic effects
- Patients with glaucoma, obstructive uropathy, obstructive GI disease, paralytic ileus, severe ulcerative colitis, myasthenia gravis, unstable cardiovascular status in acute hemorrhage, or acute intermittent porphyria.
Major Interactions
- Warfarin - phenobarbital can decrease anticoagulant effect
- Oral contraceptives - phenobarbital can decrease efficacy
- Corticosteroids - phenobarbital can decrease efficacy
- Doxycycline - phenobarbital can decrease efficacy
- Griseofulvin - phenobarbital can decrease efficacy
- Quinidine - anticholinergics can decrease absorption
- Digoxin - anticholinergics can increase absorption
- Antacids - may decrease absorption of anticholinergics (separate administration by 2-3 hours)
- Metoclopramide - antagonizes GI effects
- Amantadine - increased anticholinergic effects
Moderate Interactions
- Antidiabetics - phenobarbital may alter glucose levels
- Valproic acid - may increase phenobarbital levels
- Chloramphenicol - may increase phenobarbital levels
- Disulfiram - may increase phenobarbital levels
- Rifampin - may decrease phenobarbital levels
- Charcoal - may decrease absorption of Donnatal components
- Topiramate - may decrease phenobarbital levels
- Lamotrigine - phenobarbital may decrease lamotrigine levels
Minor Interactions
- Certain herbal supplements (e.g., St. John's Wort, Valerian) - additive CNS depression
Monitoring
Baseline Monitoring
Complete Medical History and Physical Exam
Rationale: To identify contraindications (e.g., glaucoma, prostatic hypertrophy, obstructive GI/GU disease, porphyria) and assess overall health.
Timing: Prior to initiation of therapy
Renal and Hepatic Function Tests (BUN, Creatinine, AST, ALT, Bilirubin)
Rationale: Phenobarbital is metabolized by the liver and excreted by the kidneys; impairment can lead to accumulation and toxicity.
Timing: Prior to initiation, especially in patients with suspected impairment
Intraocular Pressure (IOP) measurement
Rationale: Anticholinergics can precipitate acute angle-closure glaucoma in susceptible individuals.
Timing: Prior to initiation in patients at risk or with history of glaucoma
Routine Monitoring
Clinical response and symptom control (e.g., abdominal pain, cramping, diarrhea)
Frequency: Regularly during therapy, especially during dose titration
Target: Reduction or resolution of target symptoms
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.
Adverse effects (e.g., dry mouth, blurred vision, urinary retention, constipation, drowsiness, dizziness, confusion)
Frequency: At each visit, especially during initial therapy and dose changes
Target: Minimal to tolerable side effects
Action Threshold: Intolerable or severe side effects require dose reduction or discontinuation.
Phenobarbital serum levels (if chronic use or suspected toxicity)
Frequency: As clinically indicated (e.g., suspected toxicity, non-response, drug interactions)
Target: Therapeutic range for phenobarbital is typically 15-40 mcg/mL (for anticonvulsant use, lower for sedation)
Action Threshold: Levels above therapeutic range or signs of toxicity (e.g., excessive sedation, ataxia) require dose reduction or discontinuation.
Liver function tests (AST, ALT, Bilirubin)
Frequency: Periodically, especially with long-term use or in patients with hepatic impairment
Target: Within normal limits
Action Threshold: Significant elevations may indicate hepatotoxicity and require discontinuation.
Symptom Monitoring
- Dry mouth
- Blurred vision
- Photophobia
- Urinary hesitancy or retention
- Constipation
- Drowsiness
- Dizziness
- Confusion
- Nervousness
- Excitement (paradoxical effect)
- Rash
- Palpitations
- Tachycardia
Special Patient Groups
Pregnancy
Category D. Donnatal is contraindicated in pregnancy due to the phenobarbital component, which is a known teratogen associated with an increased risk of congenital malformations (e.g., cleft lip/palate, cardiac defects) and neonatal withdrawal syndrome (e.g., seizures, hyperirritability) if used during the third trimester.
Trimester-Specific Risks:
First Trimester:
Increased risk of major congenital malformations (e.g., oral clefts, cardiac defects, neural tube defects) due to phenobarbital.
Second Trimester:
Potential for fetal growth restriction and continued risk of malformations.
Third Trimester:
Risk of neonatal withdrawal syndrome (e.g., seizures, hyperirritability, feeding difficulties) and hemorrhagic disease of the newborn due to phenobarbital's enzyme-inducing effects.
Lactation
Contraindicated or not recommended. All active ingredients, especially phenobarbital, are excreted into breast milk and can cause significant adverse effects in the nursing infant, including sedation, poor feeding, and respiratory depression. Anticholinergics may also decrease milk supply.
Infant Risk:
High risk (sedation, poor feeding, respiratory depression, withdrawal symptoms upon discontinuation, potential for decreased milk supply).
Pediatric Use
Use with extreme caution, especially in infants and young children, due to increased susceptibility to the central nervous system effects of phenobarbital (e.g., paradoxical excitement, respiratory depression) and anticholinergic effects (e.g., hyperthermia, CNS toxicity). Dosing must be carefully individualized by weight. Not recommended for infants.
Geriatric Use
Use with extreme caution and generally at lower doses. Elderly patients are more susceptible to the anticholinergic side effects (e.g., dry mouth, constipation, urinary retention, blurred vision, confusion, cognitive impairment) and the sedative effects of phenobarbital (e.g., dizziness, falls, excessive sedation). May exacerbate underlying conditions like prostatic hypertrophy or glaucoma. The Beers Criteria recommend avoiding anticholinergics and barbiturates in older adults.
Clinical Information
Clinical Pearls
- Donnatal is an older combination drug; consider newer, more targeted therapies for IBS symptoms before initiating.
- Due to its phenobarbital content, Donnatal has abuse potential and can cause physical dependence and withdrawal symptoms.
- Educate patients thoroughly on anticholinergic side effects (dry mouth, blurred vision, constipation, urinary retention) and CNS depression (drowsiness, dizziness).
- Advise patients to avoid activities requiring mental alertness until they know how the drug affects them.
- Caution patients about the risk of heat prostration in hot environments due to decreased sweating from anticholinergic effects.
- Monitor for paradoxical excitement, especially in children and the elderly.
- Regularly assess the need for continued therapy, as long-term use of phenobarbital is generally discouraged.
Alternative Therapies
- Antispasmodics (e.g., dicyclomine, hyoscyamine alone)
- Antidepressants (e.g., tricyclic antidepressants, SSRIs for IBS with pain/diarrhea)
- Laxatives or antidiarrheals (e.g., loperamide, fiber supplements, rifaximin, eluxadoline, lubiprostone, linaclotide for IBS-C/D)
- Probiotics
- Dietary modifications (e.g., FODMAP diet)
- Behavioral therapies (e.g., cognitive behavioral therapy, hypnotherapy for IBS)
Cost & Coverage
Average Cost:
Not readily available for specific elixir formulation; varies widely by pharmacy and insurance. per 120 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (may require prior authorization due to phenobarbital content and older drug status)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. 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 for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.