Phenob/hyosc Atr/scop Elx 480ml
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, Anticholinergic
Pharmacologic Class
Anticholinergic (Muscarinic Antagonist), Barbiturate (GABA-A Receptor Modulator)
Pregnancy Category
Category D
FDA Approved
Jan 1970
DEA Schedule
Schedule IV
Overview
What is this medicine?
This medication is an elixir that combines several ingredients to help calm your stomach and intestines, reduce spasms, and provide a mild sedative effect. It's often used for conditions like irritable bowel syndrome. The anticholinergic ingredients (hyoscyamine, atropine, scopolamine) help relax the muscles in your gut and reduce secretions, while phenobarbital provides a calming effect.
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. You may also want to check if there are drug take-back programs in your area.
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. You may also want to check if there are drug take-back programs in your area.
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 CNS depressants (e.g., sleeping pills, anxiety medications) 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 and blurred vision.
- Stay hydrated to help manage dry mouth, a common side effect.
- Increase fiber intake and fluid intake to help prevent constipation.
- Avoid overheating and strenuous exercise in hot weather, as anticholinergics can impair sweating and increase body temperature.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 to 2 teaspoonfuls (5 to 10 mL) three or four times a day
Dose Range:
15 - 40 mg
Condition-Specific Dosing:
gastrointestinal_disorders:
For the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Dosage must be adjusted to individual response. Typically 0.5 to 1 teaspoonful (2.5 to 5 mL) three or four times a day, depending on age and weight.
Adolescent:
Similar to adult dosing, 1 to 2 teaspoonfuls (5 to 10 mL) three or four times a day.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for increased anticholinergic and sedative effects.
Moderate:
Reduce dose; monitor for increased anticholinergic and sedative effects. Phenobarbital elimination is reduced.
Severe:
Contraindicated or significantly reduced dose; monitor closely. Risk of accumulation of phenobarbital and anticholinergic agents.
Dialysis:
Phenobarbital is dialyzable; however, the anticholinergic components are not readily dialyzable. Use with extreme caution, if at all.
Hepatic Impairment:
Mild:
Use with caution; monitor for increased sedative effects.
Moderate:
Reduce dose; monitor for increased sedative effects and toxicity, especially from phenobarbital.
Severe:
Contraindicated or significantly reduced dose; monitor closely. Risk of severe CNS depression and toxicity due to impaired metabolism of phenobarbital.
Confidence:
Medium
Pharmacology
Mechanism of Action
Hyoscyamine, Atropine, and Scopolamine are anticholinergic/antimuscarinic agents that competitively antagonize the action of acetylcholine at postganglionic parasympathetic receptor sites, leading to decreased gastrointestinal motility, reduced gastric acid secretion, and relaxation of smooth muscle. Phenobarbital is a barbiturate that acts as a nonselective central nervous system depressant, primarily by binding to the GABA-A receptor complex, enhancing the inhibitory effects of GABA, leading to prolonged opening of chloride channels and neuronal hyperpolarization.
Pharmacokinetics
Absorption:
Bioavailability:
Generally well absorbed orally (variable for each component)
Tmax:
Hyoscyamine: 30-60 min; Atropine: 1-2 hrs; Scopolamine: 1 hr; Phenobarbital: 8-12 hrs
FoodEffect:
May delay absorption but not significantly alter total bioavailability.
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: ~40%; Phenobarbital: 20-45%
CnssPenetration:
Yes (especially Scopolamine and Phenobarbital)
Elimination:
HalfLife:
Hyoscyamine: 3.5-13 hrs; Atropine: 2-4 hrs; Scopolamine: 4.5 hrs; Phenobarbital: 50-120 hrs
Clearance:
Variable for each 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); 8-12 hours (phenobarbital sedation)
DurationOfAction:
4-6 hours (anticholinergic); 10-16 hours (phenobarbital sedation)
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
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, seek medical attention right away:
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 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 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. 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 for advice:
Feeling dizzy, sleepy, tired, or weak
Blurred vision
Headache
Constipation
Bloating
Dry mouth
Upset stomach or vomiting
Feeling nervous and 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, seek medical attention right away:
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 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 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. 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 for advice:
Feeling dizzy, sleepy, tired, or weak
Blurred vision
Headache
Constipation
Bloating
Dry mouth
Upset stomach or vomiting
Feeling nervous and 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
- Confusion or hallucinations
- Difficulty breathing or shallow breathing
- Rapid or irregular heartbeat
- Severe dry mouth, difficulty swallowing or speaking
- Blurred vision or eye pain
- Inability to urinate
- Severe constipation or abdominal pain
- 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. 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 (trouble passing urine)
+ Ulcerative colitis
A history of porphyria, a rare genetic disorder
Previous experiences of restlessness or overexcitement after taking phenobarbital
* A history of 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 change the dose 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 involves the stomach)
+ Myasthenia gravis
+ Slow-moving gastrointestinal (GI) tract
+ Urinary retention (trouble passing urine)
+ Ulcerative colitis
A history of porphyria, a rare genetic disorder
Previous experiences of restlessness or overexcitement after taking phenobarbital
* A history of 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 change the dose 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 discontinuing. Your doctor may recommend a gradual tapering off the medication to minimize potential withdrawal effects.
When starting this medication, be cautious when engaging in activities that require alertness and clear vision, such as driving, until you understand how the drug affects you. Additionally, discuss the use of alcohol, marijuana, or other cannabis products, as well as prescription or over-the-counter medications that may cause drowsiness, with your doctor before consumption.
To avoid dehydration, drink plenty of fluids, especially in hot weather or during physical activity, to prevent excessive fluid loss. If you have a known allergy to tartrazine (FD&C Yellow No. 5), consult 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. Furthermore, women of childbearing age should be aware that this medication may reduce the effectiveness of birth control pills and other hormone-based contraceptives. 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 also consult their doctor to discuss potential risks to their infant.
When starting this medication, be cautious when engaging in activities that require alertness and clear vision, such as driving, until you understand how the drug affects you. Additionally, discuss the use of alcohol, marijuana, or other cannabis products, as well as prescription or over-the-counter medications that may cause drowsiness, with your doctor before consumption.
To avoid dehydration, drink plenty of fluids, especially in hot weather or during physical activity, to prevent excessive fluid loss. If you have a known allergy to tartrazine (FD&C Yellow No. 5), consult 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. Furthermore, women of childbearing age should be aware that this medication may reduce the effectiveness of birth control pills and other hormone-based contraceptives. 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 also consult their doctor to discuss potential risks to their infant.
Overdose Information
Overdose Symptoms:
- Severe CNS depression (coma, respiratory depression)
- Exaggerated anticholinergic effects (hot, dry, flushed skin; dilated pupils; rapid heart rate; urinary retention; paralytic ileus; hyperthermia)
- Hypotension
- Shock
- Seizures (especially with phenobarbital withdrawal after chronic use)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management includes supportive care, gastric lavage, activated charcoal, and potentially physostigmine for severe anticholinergic toxicity or flumazenil for benzodiazepine overdose (if co-ingested).
Drug Interactions
Contraindicated Interactions
- Potassium chloride (solid dosage forms) - increased risk of GI lesions
- Other CNS depressants (e.g., opioids, benzodiazepines, alcohol) - severe respiratory depression, profound sedation, coma, death
- MAO inhibitors - enhanced anticholinergic effects
- Anticholinergics (e.g., tricyclic antidepressants, antihistamines, phenothiazines) - additive anticholinergic effects
Major Interactions
- Warfarin - phenobarbital can decrease warfarin efficacy (CYP induction)
- Oral contraceptives - phenobarbital can decrease efficacy
- Corticosteroids - phenobarbital can decrease efficacy
- Doxycycline - phenobarbital can decrease efficacy
- Griseofulvin - phenobarbital can decrease efficacy
- Valproic acid - altered phenobarbital levels and increased toxicity
- Digoxin - decreased absorption of digoxin
- Antacids - decreased absorption of anticholinergics (separate administration)
Moderate Interactions
- Metoclopramide - antagonized effects
- Ketoconazole/Itraconazole - decreased absorption due to altered gastric pH
- Levodopa - decreased efficacy of levodopa
- Phenothiazines - additive anticholinergic effects, decreased phenothiazine levels
- Amantadine - additive anticholinergic effects
Minor Interactions
- None specifically noted for minor severity, but caution with any drug affecting GI motility or CNS.
Monitoring
Baseline Monitoring
Renal function (BUN, Creatinine)
Rationale: To assess baseline kidney function as components are renally excreted.
Timing: Prior to initiation
Hepatic function (ALT, AST, Bilirubin)
Rationale: To assess baseline liver function as phenobarbital is hepatically metabolized.
Timing: Prior to initiation
Mental status/CNS assessment
Rationale: To establish baseline for sedative effects.
Timing: Prior to initiation
Routine Monitoring
Signs of anticholinergic toxicity (dry mouth, blurred vision, urinary retention, constipation)
Frequency: Daily, especially during dose titration
Target: Absence of severe symptoms
Action Threshold: If severe or persistent symptoms occur, consider dose reduction or discontinuation.
Level of sedation/CNS depression
Frequency: Daily, especially during dose titration
Target: Alertness appropriate for activity, no excessive drowsiness
Action Threshold: Excessive drowsiness, confusion, or respiratory depression warrants immediate medical attention and dose adjustment.
Bowel function
Frequency: Daily
Target: Regular bowel movements
Action Threshold: Severe constipation or paralytic ileus requires intervention.
Urinary output
Frequency: Daily
Target: Normal urinary flow
Action Threshold: Urinary retention requires intervention.
Symptom Monitoring
- Dry mouth
- Blurred vision
- Drowsiness
- Dizziness
- Nausea
- Constipation
- Urinary hesitancy or retention
- Nervousness
- Excitement (paradoxical effect, especially in children/elderly)
- Rash
Special Patient Groups
Pregnancy
Category D. Should not be used during pregnancy unless the potential benefit outweighs 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., cardiac defects, cleft lip/palate) 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) and respiratory depression in the neonate due to phenobarbital. Anticholinergics may cause fetal tachycardia.
Lactation
Not recommended. 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 (sedation, poor feeding, withdrawal, reduced milk supply)
Pediatric Use
Use with caution. Children, especially infants and young children, may be more susceptible to the toxic effects of anticholinergics and phenobarbital, including paradoxical excitement, hyperthermia, and respiratory depression. Dosage must be carefully individualized and monitored.
Geriatric Use
Use with extreme caution. Elderly patients are more susceptible to the anticholinergic side effects (e.g., confusion, urinary retention, constipation, blurred vision) and the sedative effects of phenobarbital. Start with lower doses and titrate slowly. Increased risk of falls.
Clinical Information
Clinical Pearls
- This is an older combination product; newer, more targeted therapies are often preferred for GI conditions.
- Due to the phenobarbital component, assess for potential for abuse, dependence, and withdrawal, especially with long-term use.
- Educate patients thoroughly on anticholinergic side effects and CNS depression, emphasizing avoidance of driving and alcohol.
- Monitor for paradoxical excitement, especially in pediatric and geriatric populations.
- Consider alternative therapies if anticholinergic side effects or sedation are intolerable or if long-term use is anticipated.
Alternative Therapies
- Antispasmodics (e.g., Dicyclomine, Hyoscyamine)
- Antidepressants (e.g., TCAs, SSRIs for IBS with pain/diarrhea)
- Antidiarrheals (e.g., Loperamide)
- Laxatives (for constipation-predominant IBS)
- Probiotics
- Fiber supplements
- Specific IBS medications (e.g., Linaclotide, Lubiprostone, Rifaximin, Eluxadoline)
Cost & Coverage
Average Cost:
Varies widely per 480ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization due to older drug class and potential for abuse/misuse)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure safe and effective treatment, 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.