Donnatal Mint Elixir

Donnatal Mint Elixir combines the anticholinergic effects of hyoscyamine, atropine, and scopolamine with the sedative effects of phenobarbital. The anticholinergics competitively block the action of acetylcholine at muscarinic receptors, leading to decreased gastrointestinal motility and spasm, reduced gastric acid secretion, and other anticholinergic effects (e.g., mydriasis, cycloplegia, decreased salivation). Phenobarbital, a barbiturate, produces non-selective central nervous system depression, primarily by binding to a distinct site on the GABA-A receptor complex, enhancing the inhibitory effects of GABA, leading to sedation, hypnosis, and anticonvulsant activity.

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 passing urine
Changes in eyesight, 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. 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 or seek medical help:

Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Headache
Constipation
Bloating
Dry mouth
Upset stomach or vomiting
Nervousness or excitability
* 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.

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 involves 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 problems with your doctor and pharmacist. They will help determine if it is safe to take this medication 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 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 discontinuing. Your doctor may recommend gradually tapering off the medication to minimize potential withdrawal effects.

To ensure your safety, avoid operating a vehicle or performing tasks that require alertness and clear vision until you understand how this medication affects you. Additionally, consult your doctor before consuming alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter medications that may impair your reactions.

Be cautious in hot weather or during physical activity, as this medication can increase the risk of dehydration. Drink plenty of fluids to prevent fluid loss and related complications.

If you are allergic to tartrazine (FD&C Yellow No. 5), discuss this with your doctor, as some formulations of this medication may contain this ingredient.

Older adults (65 years and older) should exercise caution when taking this medication, as they may be more susceptible to adverse effects.

Women taking birth control pills or other hormone-based contraceptives should be aware that this medication may reduce their effectiveness. To prevent unintended 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.

Breastfeeding mothers should consult their doctor to discuss potential risks to their infant and determine the best course of action.

• Potassium chloride (solid dosage forms) - increased risk of GI lesions due to delayed transit
• Other CNS depressants (e.g., opioids, benzodiazepines, alcohol) - severe respiratory depression, profound sedation, coma, death
• MAO inhibitors - enhanced anticholinergic effects
• Drugs that prolong QT interval (e.g., quinidine, disopyramide, some antipsychotics) - theoretical risk with anticholinergics

• Anticholinergics (e.g., tricyclic antidepressants, antihistamines, phenothiazines, amantadine) - additive anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation)
• CYP3A4 substrates (e.g., oral contraceptives, corticosteroids, warfarin, cyclosporine, tacrolimus) - phenobarbital is a strong inducer, leading to decreased efficacy of these drugs
• Valproic acid - decreased phenobarbital metabolism, increased phenobarbital levels
• Chloramphenicol - increased phenobarbital levels
• Doxycycline - decreased doxycycline levels
• Griseofulvin - decreased griseofulvin levels
• Rifampin - decreased phenobarbital levels
• St. John's Wort - decreased phenobarbital levels

• Antacids - may decrease absorption of anticholinergics; separate administration by 1-2 hours
• Digoxin - anticholinergics may increase digoxin absorption
• Metoclopramide - antagonistic effects on GI motility
• Levodopa - decreased absorption of levodopa
• Ketoconazole, Itraconazole - decreased absorption due to anticholinergic effects on gastric pH
• Other sedatives (e.g., muscle relaxants, hypnotics) - additive CNS depression

• Food - may delay absorption

• Dry mouth
• Blurred vision
• Drowsiness
• Dizziness
• Constipation
• Urinary hesitancy or retention
• Nausea
• Vomiting
• Nervousness
• Confusion (especially in elderly)
• Palpitations
• Headache

Category D. Donnatal Mint Elixir is generally not recommended during pregnancy due to the phenobarbital component, which is associated with an increased risk of congenital malformations (e.g., cleft lip/palate, cardiac defects) and neonatal withdrawal syndrome (e.g., irritability, tremors, hypertonia, feeding difficulties) if used during the third trimester. The anticholinergic components may also have effects on fetal heart rate and gastrointestinal motility.

L4 (Potentially Hazardous). All active ingredients are excreted into breast milk. Phenobarbital can cause significant sedation, poor feeding, and withdrawal symptoms in breastfed infants, especially with chronic use. Anticholinergics can reduce milk supply and cause anticholinergic effects in the infant. Use is generally not recommended.

Use is generally not recommended, especially in infants and young children, due to the risk of respiratory depression, paradoxical excitement, and increased sensitivity to anticholinergic side effects. Safety and efficacy have not been established in pediatric patients. If used, extreme caution and close monitoring are required.

Elderly patients are more susceptible to the anticholinergic and sedative effects of Donnatal Mint Elixir. They may experience increased confusion, disorientation, urinary retention, constipation, and falls. Lower doses and careful monitoring are recommended. Avoid use in elderly patients with cognitive impairment or prostatic hypertrophy.

• Donnatal is a 'grandfathered' drug, meaning it was marketed before modern FDA approval processes. Its continued use should be carefully weighed against newer, more targeted therapies.
• The long half-life of phenobarbital (53-118 hours) means that steady-state levels take a long time to achieve, and effects can persist for an extended period after discontinuation. Accumulation can occur with repeated dosing.
• Be highly vigilant for additive CNS depression when co-prescribing with other sedatives, alcohol, or opioids.
• Educate patients thoroughly on anticholinergic side effects (dry mouth, blurred vision, constipation, urinary retention) and CNS effects (drowsiness, dizziness) and advise against driving or operating machinery.
• Contraindicated in patients with glaucoma, obstructive uropathy, obstructive disease of the GI tract, paralytic ileus, intestinal atony, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon, myasthenia gravis, or hypersensitivity to any component.
• Consider alternative therapies for IBS or GI spasms that do not carry the risks associated with barbiturates and multiple anticholinergics, especially in vulnerable populations (elderly, pediatric, pregnant/lactating).

• Antispasmodics: Dicyclomine, Hyoscyamine (single agent)
• Antidepressants (for IBS with pain/diarrhea): TCAs (e.g., amitriptyline), SSRIs
• GABA modulators (for anxiety/sedation): Benzodiazepines (e.g., lorazepam, alprazolam - short-term), Buspirone
• Other IBS-specific agents: Linaclotide, Lubiprostone, Rifaximin, Eluxadoline, Alosetron (for specific IBS subtypes)
• Lifestyle and dietary modifications for IBS

If your symptoms or health issues persist or worsen, it's 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 be sure 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.