Benzonatate 200mg Capsules

Manufacturer STRIDES PHARMA Active Ingredient Benzonatate(ben ZOE na tate) Pronunciation ben ZOE na tate
It is used to relieve coughing.
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Drug Class
Antitussive
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Pharmacologic Class
Non-narcotic antitussive; Local anesthetic
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Pregnancy Category
Category C
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FDA Approved
Jan 1958
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Benzonatate is a non-narcotic cough medicine that works by numbing the cough reflex in your lungs and airways. It helps to reduce the urge to cough.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. When taking your medication, swallow the tablet whole without chewing, breaking, opening, or dissolving it. Avoid sucking on the tablet. Unless your doctor advises you to limit your fluid intake, drink plenty of non-caffeinated liquids to help your body absorb the medication effectively.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. Ensure that all medications are kept out of the reach of children and 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 by your doctor or pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or explore drug take-back programs in your area.

Missing a Dose

If you take your medication on a regular schedule and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take your medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Swallow capsules whole. Do NOT chew, crush, or dissolve the capsules, as this can cause numbness in the mouth and throat, and potentially lead to choking or severe allergic reactions.
  • If you experience numbness or tingling in your mouth or throat after taking the medicine, do not eat or drink until the numbness wears off to avoid choking.
  • Avoid activities requiring mental alertness (e.g., driving, operating machinery) if you experience dizziness or drowsiness.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 100 mg to 200 mg three times daily (TID)
Dose Range: 100 - 200 mg

Condition-Specific Dosing:

maximumDailyDose: Do not exceed 600 mg per day
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Pediatric Dosing

Neonatal: Not established (Contraindicated for children under 10 years)
Infant: Not established (Contraindicated for children under 10 years)
Child: Contraindicated for children under 10 years due to risk of fatal overdose
Adolescent: 100 mg to 200 mg three times daily (TID) for adolescents 10 years of age and older, not to exceed 600 mg per day
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment provided; use with caution
Moderate: No specific dose adjustment provided; use with caution
Severe: No specific dose adjustment provided; use with caution
Dialysis: Not specifically studied; use with caution

Hepatic Impairment:

Mild: No specific dose adjustment provided; use with caution
Moderate: No specific dose adjustment provided; use with caution
Severe: No specific dose adjustment provided; use with caution

Pharmacology

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Mechanism of Action

Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura, thereby reducing the cough reflex at its source. It may also have a central antitussive effect, although this is less prominent than its peripheral action.
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Pharmacokinetics

Absorption:

Bioavailability: Not available
Tmax: Approximately 1-2 hours
FoodEffect: Not well-documented; generally taken without regard to food, but some sources suggest taking with food to minimize GI upset.

Distribution:

Vd: Not available
ProteinBinding: Not available
CnssPenetration: Limited (primarily peripheral action, but some central effect suggests limited penetration)

Elimination:

HalfLife: Not precisely defined; effects last 3-8 hours
Clearance: Not available
ExcretionRoute: Presumed renal excretion of metabolites
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: 15-20 minutes
PeakEffect: Not precisely defined, but effects are sustained
DurationOfAction: 3-8 hours

Safety & Warnings

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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 help immediately.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

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 was broken, crushed, chewed, dissolved, or sucked before taking)
+ If numbness or tingling occurs, do not eat or drink until it resolves
+ If an allergic reaction occurs or if numbness or tingling persists or worsens, 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 go away:

Constipation
Dizziness or headache
Drowsiness
Stuffy nose
Upset stomach

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.
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Seek Immediate Medical Attention If You Experience:

  • Choking sensation
  • Numbness or tingling in the mouth, throat, or face
  • Difficulty swallowing
  • Chest tightness
  • Allergic reactions (e.g., rash, hives, itching, swelling of face/lips/tongue/throat, severe dizziness, trouble breathing)
  • Confusion
  • Hallucinations
  • Unusual behavior
  • Seizures
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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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.

To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in combination with your other medications and health conditions. Your doctor and pharmacist will work together to ensure that all your medications, including this one, are safe and appropriate for you to take.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To ensure your safety, avoid operating a vehicle or engaging in any activities that require alertness until you understand how this medication affects you.

Store this medication in a secure location, out of reach of children, as accidental ingestion can be fatal. Children under 10 years old are at risk of accidental overdose, which can be life-threatening. Signs of overdose may include restlessness, tremors, seizures, loss of consciousness, or cardiac arrest. If a child accidentally ingests this medication, seek immediate medical attention.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremors
  • Convulsions (seizures)
  • Coma
  • Cardiac arrest
  • Circulatory collapse

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Overdose can be fatal, especially in children.

Drug Interactions

Monitoring

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Symptom Monitoring

  • Cough frequency and severity
  • Signs of hypersensitivity reactions (e.g., bronchospasm, laryngospasm, cardiovascular collapse)
  • Signs of central nervous system effects (e.g., sedation, confusion, hallucinations)
  • Gastrointestinal upset (e.g., nausea, constipation)
  • Choking sensation or numbness in mouth/throat (if capsule is chewed or dissolved)

Special Patient Groups

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Pregnancy

Category C. Benzonatate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have not been conducted.

Trimester-Specific Risks:

First Trimester: Potential risk not ruled out; use only if clearly needed.
Second Trimester: Potential risk not ruled out; use only if clearly needed.
Third Trimester: Potential risk not ruled out; use only if clearly needed.
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Lactation

L3 (Moderately Safe). It is not known whether benzonatate is excreted in human milk. Caution should be exercised when benzonatate is administered to a nursing woman. Monitor infant for sedation or feeding difficulties.

Infant Risk: Low to moderate; potential for sedation or gastrointestinal upset in infant. Use with caution.
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Pediatric Use

Contraindicated in children under 10 years of age due to the risk of fatal overdose from accidental ingestion. For adolescents 10 years and older, dosing is similar to adults, but careful monitoring is advised.

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Geriatric Use

Use with caution in elderly patients, as they may be more sensitive to the adverse effects, particularly CNS effects like confusion or sedation. Start with the lowest effective dose and titrate slowly if necessary.

Clinical Information

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Clinical Pearls

  • Emphasize to patients the critical importance of swallowing the capsule whole without chewing, crushing, or dissolving, due to the risk of local anesthesia and potential for choking or severe hypersensitivity reactions.
  • Stress the black box warning regarding accidental ingestion by children and the need to keep the medication out of reach.
  • Benzonatate is a non-narcotic option for cough suppression, which can be beneficial for patients who need to avoid opioids.
  • Onset of action is relatively quick (15-20 minutes), providing rapid relief for acute cough.
  • Advise patients to seek immediate medical attention if they experience any signs of an allergic reaction or overdose symptoms.
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Alternative Therapies

  • Dextromethorphan (non-opioid antitussive)
  • Codeine (opioid antitussive)
  • Hydrocodone (opioid antitussive)
  • Guaifenesin (expectorant, often combined with antitussives)
  • Honey (natural antitussive)
  • Humidifiers/vaporizers
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Cost & Coverage

Average Cost: $10 - $50 per 30 capsules (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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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 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.