Benzonatate 150mg Capsules
It is used to relieve coughing.
Drug Class
Antitussive
Pharmacologic Class
Non-narcotic antitussive; Local anesthetic
Pregnancy Category
Category C
FDA Approved
May 1958
DEA Schedule
Not Controlled
Overview
What is this medicine?
Benzonatate is a non-narcotic medicine used to relieve cough. It works by numbing the cough reflex in your lungs and airways, helping to reduce the urge to cough.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Swallow the medication whole, without chewing, breaking, opening, or dissolving it.
Do not suck on the medication.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, protected from light.
Keep it in a dry place, away from the bathroom.
Store all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you take your medication on a regular schedule:
Take the missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
* If you take your medication as needed, do not take it more frequently than directed by your doctor.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Swallow the medication whole, without chewing, breaking, opening, or dissolving it.
Do not suck on the medication.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, protected from light.
Keep it in a dry place, away from the bathroom.
Store all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you take your medication on a regular schedule:
Take the missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
* If you take your medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Do NOT chew, crush, or dissolve the capsule. Swallow it whole. Chewing or dissolving the capsule can cause numbness and choking in your mouth and throat.
- Do not take more than the prescribed dose.
- Keep this medication out of reach of children. Accidental ingestion by children can be fatal.
- If you experience numbness or tingling in your mouth or throat after taking the capsule, do not eat or drink until the numbness wears off to avoid choking.
- Avoid driving or operating machinery if you experience dizziness or drowsiness.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
100 mg or 200 mg three times daily as needed
Dose Range:
100 - 600 mg
Condition-Specific Dosing:
maximumDailyDose:
600 mg/day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Contraindicated in children under 10 years of age due to risk of fatal overdose.
Adolescent:
Not established (generally not recommended for children under 10 years; for adolescents 10 years and older, adult dosing may be considered with extreme caution and careful risk-benefit assessment, but generally not recommended due to safety concerns)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended; use with caution due to potential for accumulation of metabolites
Dialysis:
Not available; likely not dialyzable due to high protein binding
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended; use with caution due to potential for altered metabolism
Pharmacology
Mechanism of Action
Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by desensitizing them, thereby reducing the cough reflex at its source. It also has a central antitussive effect, though less prominent, by inhibiting the transmission of the cough reflex in the central nervous system.
Pharmacokinetics
Absorption:
Bioavailability:
Not available
Tmax:
Approximately 5-20 minutes (onset of action)
FoodEffect:
Not well-studied; generally taken without regard to food
Distribution:
Vd:
Not available
ProteinBinding:
Not available (assumed to be high based on lipophilicity)
CnssPenetration:
Limited (primarily peripheral action, but some central effect suggested)
Elimination:
HalfLife:
Not precisely established, estimated to be short (e.g., 2.5 hours based on some sources)
Clearance:
Not available
ExcretionRoute:
Renal (primarily metabolites)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
15-20 minutes
PeakEffect:
Not precisely established, generally within 1 hour
DurationOfAction:
3-8 hours
Safety & Warnings
BLACK BOX WARNING
Fatal Overdose in Children: Accidental ingestion of benzonatate by children under 10 years of age has resulted in death. Keep benzonatate out of reach of children. In case of accidental ingestion, seek medical attention immediately.
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
Changes in behavior
Confusion
Hallucinations (seeing or hearing things that are not there)
Numbness and tingling of the mouth, tongue, throat, and face (especially if the medication is broken, crushed, chewed, dissolved, or sucked before taking)
Choking or severe allergic reactions
If you experience numbness or tingling, do not eat or drink until the sensation resolves. If the numbness or tingling persists or worsens, or if you have an allergic reaction, contact your doctor immediately.
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not resolve:
Constipation
Dizziness or headache
Drowsiness
Stuffy nose
* Upset stomach
This list is not exhaustive, and you may experience other 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
Changes in behavior
Confusion
Hallucinations (seeing or hearing things that are not there)
Numbness and tingling of the mouth, tongue, throat, and face (especially if the medication is broken, crushed, chewed, dissolved, or sucked before taking)
Choking or severe allergic reactions
If you experience numbness or tingling, do not eat or drink until the sensation resolves. If the numbness or tingling persists or worsens, or if you have an allergic reaction, contact your doctor immediately.
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not resolve:
Constipation
Dizziness or headache
Drowsiness
Stuffy nose
* Upset stomach
This list is not exhaustive, and you may experience other 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:
- Numbness or tingling in mouth, tongue, or throat (if capsule is chewed/dissolved)
- Choking sensation
- Difficulty swallowing
- Chest tightness
- Allergic reactions (rash, hives, itching, swelling of face/lips/tongue/throat, severe dizziness, trouble breathing)
- Confusion
- Hallucinations
- Seizures
- Severe drowsiness or dizziness
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
When discussing your allergies, be sure to describe the symptoms you experienced.
This medication can interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about any health problems you have
You must verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
When discussing your allergies, be sure to describe the symptoms you experienced.
This medication can interact with other medications or health conditions. To ensure safe use, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about any health problems you have
You must verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you.
To prevent accidental ingestion, keep this medication out of the reach of children. There have been reported cases of accidental overdose and death in children under 10 years old who mistakenly took this medication. Signs of an overdose may include restlessness, tremors, seizures, loss of consciousness, or heart attack. If a child accidentally ingests this medication, seek immediate medical attention.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Before engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you.
To prevent accidental ingestion, keep this medication out of the reach of children. There have been reported cases of accidental overdose and death in children under 10 years old who mistakenly took this medication. Signs of an overdose may include restlessness, tremors, seizures, loss of consciousness, or heart attack. If a child accidentally ingests this medication, seek immediate medical attention.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Restlessness
- Tremors
- Convulsions
- Coma
- Cardiac arrest
- Respiratory arrest
What to Do:
Call 911 or Poison Control (1-800-222-1222) immediately. Do NOT induce vomiting. Provide supportive care, including maintaining airway and cardiovascular function.
Drug Interactions
Monitoring
Routine Monitoring
Cough frequency and severity
Frequency: Daily
Target: Reduction in cough
Action Threshold: Lack of efficacy after several days, or worsening cough
Adverse effects (e.g., drowsiness, dizziness, GI upset, skin rash)
Frequency: Daily
Target: Absence or mild, tolerable effects
Action Threshold: Severe or intolerable adverse effects
Symptom Monitoring
- Cough relief
- Drowsiness
- Dizziness
- Headache
- Nausea
- Constipation
- Skin rash
- Itching
- Numbness of mouth/throat (if capsule chewed/dissolved)
- Choking sensation
- Confusion
- Hallucinations
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential risk, avoid if possible.
Second Trimester:
Potential risk, avoid if possible.
Third Trimester:
Potential risk, avoid if possible.
Lactation
It is not known whether benzonatate is excreted in human milk. Caution should be exercised when benzonatate is administered to a nursing woman. Consider the benefits of breastfeeding, the risk of potential infant drug exposure, and the risk of untreated maternal condition.
Infant Risk:
Unknown; potential for sedation or other adverse effects in the infant.
Pediatric Use
Contraindicated in children under 10 years of age due to the risk of fatal overdose. Accidental ingestion has led to death in children. Symptoms of overdose can occur rapidly (within 15-20 minutes).
Geriatric Use
Use with caution in elderly patients, as they may be more sensitive to the effects of the drug, particularly CNS effects like drowsiness and dizziness. Start with the lowest effective dose.
Clinical Information
Clinical Pearls
- Emphasize to patients, especially parents, the critical importance of swallowing capsules whole and keeping them out of reach of children due to the high risk of fatal overdose from accidental ingestion.
- Advise patients that if the capsule is chewed or dissolved, oral numbness and choking can occur. Do not eat or drink until the numbness subsides.
- Benzonatate is not effective for all types of cough (e.g., productive cough where expectoration is desired).
- Patients should be advised to seek medical attention if cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.
Alternative Therapies
- Dextromethorphan (non-opioid antitussive)
- Codeine (opioid antitussive, controlled substance)
- Guaifenesin (expectorant, often combined with antitussives)
- Honey (for symptomatic relief of cough)
- Humidifiers
Cost & Coverage
Average Cost:
$10 - $50 per 30 capsules (100mg or 200mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.