Phenob/hyosc Atr/scop Elx 120ml
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
Mar 1948
DEA Schedule
Schedule IV
Overview
What is this medicine?
This medicine is a combination of drugs that help calm your stomach and intestines, reduce spasms, and also have a mild calming effect on your nervous system. It's used to treat conditions like irritable bowel syndrome (IBS) or other stomach and bowel problems.
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 medication and follow the instructions closely. You can take this medication with or without food. If it causes stomach upset, taking it with food may help. When taking the liquid form, measure the dose accurately using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring tool.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. 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 store your medication. 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. Instead, consult your pharmacist for guidance on the best disposal method. You may also want to check if there are 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 the missed one.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food. If it causes stomach upset, taking it with food may help. When taking the liquid form, measure the dose accurately using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring tool.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. 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 store your medication. 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. Instead, consult your pharmacist for guidance on the best disposal method. You may also want to check if there are 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 the 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 and blurred vision.
- Stay hydrated to help with dry mouth and prevent constipation.
- Avoid overheating during exercise or in hot weather, as this medication can reduce sweating and increase body temperature.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements, to avoid harmful interactions.
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:
gastrointestinalDisorders:
5 mL (1 teaspoonful) three or four times a day, adjusted to patient response and tolerance.
Pediatric Dosing
Neonatal:
Not established
Infant:
0.5 mL to 1 mL three or four times a day (adjust based on weight and response, consult specific guidelines)
Child:
0.5 mL to 5 mL three or four times a day (adjust based on weight and response, consult specific guidelines)
Adolescent:
5 mL three or four times a day
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for increased effects.
Moderate:
Reduce dose; monitor closely for increased effects and toxicity.
Severe:
Contraindicated or significantly reduced dose with extreme caution; monitor for accumulation and toxicity.
Dialysis:
Phenobarbital is dialyzable; anticholinergics are not significantly dialyzable. Use with extreme caution, monitor for effects.
Hepatic Impairment:
Mild:
Use with caution; monitor for increased effects.
Moderate:
Reduce dose; monitor closely for increased effects and toxicity, especially phenobarbital.
Severe:
Contraindicated or significantly reduced dose with extreme caution; monitor for accumulation and toxicity.
Pharmacology
Mechanism of Action
Phenobarbital acts as a non-selective central nervous system (CNS) depressant, primarily by binding to the GABA-A receptor complex, enhancing the inhibitory effects of GABA. This leads to increased chloride ion influx, hyperpolarization, and decreased neuronal excitability. Hyoscyamine, Atropine, and Scopolamine are anticholinergic agents that competitively block the action of acetylcholine at muscarinic receptors in the autonomic nervous system. This blockade leads to decreased gastrointestinal motility and spasm, reduced glandular secretions (salivary, bronchial, sweat), and other anticholinergic effects.
Pharmacokinetics
Absorption:
Bioavailability:
Phenobarbital: ~90%; Anticholinergics: Variable, generally well-absorbed orally.
Tmax:
Phenobarbital: 8-12 hours; Anticholinergics: 0.5-2 hours.
FoodEffect:
Food may delay absorption but generally does not significantly affect total absorption.
Distribution:
Vd:
Phenobarbital: 0.5-1 L/kg; Anticholinergics: Variable, generally high.
ProteinBinding:
Phenobarbital: 20-45%; Anticholinergics: Variable (e.g., Atropine ~18%).
CnssPenetration:
Yes (all components)
Elimination:
HalfLife:
Phenobarbital: 50-120 hours (adults); Hyoscyamine: 2-3.5 hours; Atropine: 2-4 hours; Scopolamine: 4.5 hours.
Clearance:
Phenobarbital: Renal and hepatic; Anticholinergics: Renal and hepatic.
ExcretionRoute:
Renal (primary for unchanged drug and metabolites)
Unchanged:
Phenobarbital: 25-50%; Anticholinergics: Variable (e.g., Atropine ~50% unchanged).
Pharmacodynamics
OnsetOfAction:
Anticholinergics: 30-60 minutes; Phenobarbital: 30-60 minutes (oral).
PeakEffect:
Anticholinergics: 1-2 hours; Phenobarbital: 8-12 hours.
DurationOfAction:
Anticholinergics: 4-6 hours; Phenobarbital: 10-16 hours (sedative effects can last longer).
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 passing urine
Changes in eyesight, eye pain, or severe eye irritation
Erectile dysfunction
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the 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 attention if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Headache
Constipation
Bloating
Dry mouth
Upset stomach or vomiting
Nervousness or excitability
* Changes in taste
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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 passing urine
Changes in eyesight, eye pain, or severe eye irritation
Erectile dysfunction
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the 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 attention if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Headache
Constipation
Bloating
Dry mouth
Upset stomach or vomiting
Nervousness or excitability
* Changes in taste
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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
- Fast 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 itching
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 your 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 whether 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 your 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 whether 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 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 drug.
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.
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 drug.
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.
Overdose Information
Overdose Symptoms:
- Severe drowsiness or coma
- Respiratory depression (slow, shallow breathing)
- Extreme dry mouth, nose, throat
- Dilated pupils, blurred vision
- Hot, dry, flushed skin
- Rapid heart rate (tachycardia)
- High fever
- Agitation, delirium, hallucinations
- Muscle weakness or paralysis
- Seizures
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- MAO inhibitors (due to anticholinergic effects)
- Potassium chloride (solid dosage forms, increased risk of GI lesions due to delayed transit)
- Myasthenia gravis (unless used to reduce muscarinic side effects of cholinesterase inhibitors)
- Glaucoma (narrow-angle)
- Obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy)
- Obstructive gastrointestinal disease (e.g., pyloroduodenal stenosis, paralytic ileus, toxic megacolon)
- Severe ulcerative colitis or toxic megacolon
Major Interactions
- Other CNS depressants (alcohol, opioids, benzodiazepines, tricyclic antidepressants, antihistamines, antipsychotics) - additive CNS depression.
- Other anticholinergic drugs (e.g., tricyclic antidepressants, phenothiazines, antihistamines, amantadine) - additive anticholinergic effects.
- CYP3A4 inducers/inhibitors (affect phenobarbital levels).
- Oral anticoagulants (phenobarbital may decrease effect).
- Corticosteroids (phenobarbital may decrease effect).
- Doxycycline (phenobarbital may decrease effect).
- Griseofulvin (phenobarbital may decrease effect).
- Oral contraceptives (phenobarbital may decrease effect, leading to contraceptive failure).
- Quinidine (anticholinergics may increase quinidine levels).
- Digoxin (anticholinergics may increase digoxin absorption).
Moderate Interactions
- Antacids (may decrease absorption of anticholinergics; separate administration by 1-2 hours).
- Ketoconazole, Itraconazole (anticholinergics may decrease absorption).
- Metoclopramide (anticholinergics antagonize prokinetic effect).
- Phenothiazines (additive anticholinergic effects, increased risk of hyperpyrexia).
- Thiazide diuretics (may enhance anticholinergic effects).
Minor Interactions
- Not specifically categorized as minor due to potential for significant effects with most interactions.
Monitoring
Baseline Monitoring
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function, as all components are metabolized by the liver, and phenobarbital can cause hepatotoxicity.
Timing: Prior to initiation
Renal function (BUN, creatinine)
Rationale: To assess baseline renal function, as components and metabolites are renally excreted.
Timing: Prior to initiation
Baseline mental status and cognitive function
Rationale: To assess for potential CNS depression or anticholinergic delirium.
Timing: Prior to initiation
Intraocular pressure (in patients at risk for narrow-angle glaucoma)
Rationale: Anticholinergics can precipitate acute glaucoma.
Timing: Prior to initiation
Routine Monitoring
Sedation level/CNS depression
Frequency: Daily, especially during dose titration or with concomitant CNS depressants.
Target: Minimal to no excessive sedation.
Action Threshold: Excessive drowsiness, confusion, ataxia; consider dose reduction or discontinuation.
Anticholinergic side effects (dry mouth, blurred vision, urinary retention, constipation)
Frequency: Daily, especially during dose titration.
Target: Tolerable level of side effects.
Action Threshold: Severe dry mouth, significant vision changes, difficulty urinating, severe constipation; consider dose reduction or alternative.
Mental status/Cognitive function
Frequency: Periodically, especially in elderly patients.
Target: Stable cognitive function.
Action Threshold: New onset confusion, disorientation, memory impairment; consider dose reduction or discontinuation.
Liver function tests (ALT, AST)
Frequency: Periodically, especially with long-term use of phenobarbital.
Target: Within normal limits.
Action Threshold: Significant elevation (e.g., >3x ULN); investigate and consider discontinuation.
Symptom Monitoring
- Excessive drowsiness
- Dizziness
- Blurred vision
- Dry mouth
- Difficulty urinating
- Constipation
- Confusion
- Agitation
- Palpitations
- Nausea/vomiting (paradoxical effect or toxicity)
Special Patient Groups
Pregnancy
Category D. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Phenobarbital is associated with an increased risk of congenital malformations (e.g., cleft lip/palate, cardiac defects) and neonatal withdrawal syndrome. Anticholinergics may cause fetal tachycardia and decreased fetal heart rate variability.
Trimester-Specific Risks:
First Trimester:
Increased risk of congenital malformations due to 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 phenobarbital is used near term. Anticholinergics may cause fetal tachycardia.
Lactation
L4 (Potentially hazardous). All components are excreted into breast milk. Phenobarbital can cause sedation, poor feeding, and withdrawal symptoms in the infant. Anticholinergics can reduce milk supply and cause anticholinergic effects in the infant (e.g., drowsiness, constipation, dry mouth). Use is generally not recommended or requires careful monitoring of the infant.
Infant Risk:
High risk of sedation, poor feeding, irritability, and potential for withdrawal symptoms (phenobarbital). Risk of anticholinergic effects (dry mouth, constipation, urinary retention) and reduced milk supply (anticholinergics).
Pediatric Use
Use with caution. Infants and young children may be more susceptible to the CNS depressant effects of phenobarbital and the anticholinergic effects (e.g., hyperthermia, paradoxical excitement). Dosage must be carefully calculated based on weight. Not recommended for routine use in infants due to safety concerns.
Geriatric Use
Use with extreme caution. Elderly patients are highly susceptible to the CNS depressant effects (sedation, confusion, falls) and anticholinergic side effects (dry mouth, blurred vision, constipation, urinary retention, cognitive impairment, delirium). Included on the Beers List as a medication to avoid in older adults due to high anticholinergic burden and risk of adverse effects. Start with lower doses and titrate slowly.
Clinical Information
Clinical Pearls
- This combination product is an older medication; newer, more targeted therapies for GI disorders are often preferred due to the significant side effect profile and drug interactions of phenobarbital and anticholinergics.
- Due to the phenobarbital component, there is a risk of physical and psychological dependence with prolonged use. Tapering is necessary upon discontinuation.
- Patients should be warned about the additive CNS depressant effects with alcohol and other sedatives.
- Anticholinergic effects can be particularly problematic in the elderly, leading to falls, cognitive impairment, and urinary retention.
- Monitor for signs of anticholinergic toxicity ('hot as a hare, blind as a bat, dry as a bone, red as a beet, mad as a hatter').
- The long half-life of phenobarbital means that steady-state levels are reached slowly, and effects can accumulate.
Alternative Therapies
- Dicyclomine (anticholinergic/antispasmodic)
- Hyoscyamine (single agent anticholinergic)
- SSRIs/TCAs (for IBS with pain/anxiety)
- Peppermint oil (for IBS symptoms)
- Rifaximin (for IBS-D)
- Eluxadoline (for IBS-D)
- Linaclotide/Plecanatide (for IBS-C)
- Low-dose tricyclic antidepressants (for visceral pain modulation)
Cost & Coverage
Average Cost:
Varies widely, typically $30-$100+ per 120 mL 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 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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.