What is benzonatate used for. How does benzonatate work. What are the potential side effects of benzonatate. How should benzonatate be taken and stored. What precautions should be followed when using benzonatate.

Understanding Benzonatate: An Effective Cough Suppressant

Benzonatate is a medication primarily used to relieve cough symptoms. It belongs to a class of drugs known as antitussives, or cough suppressants. This medication works by reducing the cough reflex in the lungs and air passages, providing relief from persistent coughing.

Is benzonatate an antibiotic? No, benzonatate is not an antibiotic. It is specifically designed to suppress cough and does not have any antibacterial properties. This distinction is important for patients to understand, as it affects the medication’s intended use and effectiveness.

How Benzonatate Works

Benzonatate’s mechanism of action involves numbing the stretch receptors in the lungs and pleura. These receptors are responsible for triggering the cough reflex when irritated. By desensitizing these receptors, benzonatate helps to reduce the urge to cough, providing relief to patients suffering from persistent coughs.

Proper Usage and Administration of Benzonatate

Benzonatate is available in two forms: liquid-filled capsules and regular capsules. The typical dosage is three times a day, as needed, but it’s crucial to follow the specific instructions provided by your healthcare provider.

• Always swallow the capsules whole
• Do not break, dissolve, cut, crush, suck, or chew the capsules
• Take the medication exactly as prescribed by your doctor
• Do not exceed the recommended dosage or frequency

Why is it important to swallow benzonatate capsules whole? Swallowing the capsules whole prevents the medication from being released in the mouth, which could cause numbness and potentially lead to choking. If you experience numbness or tingling in your mouth, tongue, throat, or face after taking benzonatate, refrain from eating or drinking and seek medical attention if the symptoms persist or worsen.

Potential Side Effects and Risks of Benzonatate

Like all medications, benzonatate can cause side effects. While many people tolerate the medication well, it’s important to be aware of potential adverse reactions.

Common Side Effects

• Nausea
• Constipation
• Drowsiness
• Headache
• Dizziness
• Stuffy nose
• Feeling chilly
• Burning sensation in the eyes

Serious Side Effects

While rare, some side effects of benzonatate can be serious and require immediate medical attention:

1. Rash or hives
2. Severe itching
3. Tightening of the throat
4. Difficulty breathing or swallowing
5. Chest numbness
6. Confusion
7. Hallucinations

If you experience any of these serious side effects, it’s crucial to contact your healthcare provider immediately or seek emergency medical care.

Important Precautions When Taking Benzonatate

Before starting benzonatate, it’s essential to inform your healthcare provider about your medical history and any current medications you’re taking. This includes prescription drugs, over-the-counter medications, vitamins, and herbal supplements.

Allergies and Interactions

Inform your doctor if you have allergies to benzonatate, procaine (Novocain), tetracaine, or any other medications. It’s also important to disclose any allergies to the inactive ingredients in benzonatate capsules.

Pregnancy and Breastfeeding

If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential risks and benefits of benzonatate with your healthcare provider. Limited data is available on the effects of benzonatate during pregnancy and lactation, so caution is advised.

Surgical Procedures

If you’re scheduled for surgery, including dental procedures, inform your healthcare provider about your benzonatate use. The medication may interact with anesthetics or affect your recovery process.

Proper Storage and Disposal of Benzonatate

Proper storage and disposal of benzonatate are crucial for safety, especially in households with children.

Storage Guidelines

• Keep benzonatate in its original container, tightly closed
• Store at room temperature, away from excess heat and moisture
• Keep out of reach of children in a child-proof container
• Do not store in the bathroom

Why is proper storage of benzonatate particularly important? The liquid-filled capsules may be attractive to children due to their shape and appearance. Accidental ingestion can be fatal, making it crucial to store the medication securely.

Disposal Methods

Proper disposal of unused or expired benzonatate is essential to prevent accidental consumption:

• Do not flush benzonatate down the toilet
• Use a medicine take-back program if available in your community
• Contact your local garbage/recycling department for disposal guidelines
• If a take-back program is not available, follow the FDA’s Safe Disposal of Medicines guidelines

Managing Missed Doses and Potential Overdose

Benzonatate is typically taken as needed, but if you’re on a regular dosing schedule and miss a dose, it’s important to know how to proceed.

Missed Doses

If you miss a scheduled dose of benzonatate, skip the missed dose and continue with your regular dosing schedule. Do not double up on doses to make up for a missed one, as this can increase the risk of side effects.

Overdose Risk

An overdose of benzonatate can be dangerous and potentially life-threatening. Symptoms of overdose may include:

• Severe drowsiness
• Confusion
• Seizures
• Cardiac arrest

If you suspect an overdose, seek emergency medical attention immediately or contact your local poison control center.

Alternative Uses and Considerations for Benzonatate

While benzonatate is primarily prescribed for cough relief, healthcare providers may sometimes recommend it for other uses. These off-label uses should only be pursued under the guidance of a qualified medical professional.

Potential Off-Label Uses

Some healthcare providers may consider benzonatate for:

• Chronic cough associated with certain respiratory conditions
• Cough suppression in patients undergoing certain medical procedures
• Management of cough in palliative care settings

It’s important to note that these uses are not FDA-approved and should be discussed thoroughly with your healthcare provider.

Considerations for Special Populations

Certain groups may require special consideration when using benzonatate:

• Elderly patients: May be more sensitive to side effects
• Patients with liver or kidney disease: May require dose adjustments
• Children: Benzonatate is not recommended for children under 10 years old due to the risk of accidental ingestion and severe side effects

Interactions with Other Medications and Substances

Understanding potential drug interactions is crucial for safe and effective use of benzonatate.

Common Drug Interactions

Benzonatate may interact with various medications and substances, including:

• Other cough and cold medications
• Certain antidepressants
• Muscle relaxants
• Sedatives and sleep aids
• Alcohol

How can you minimize the risk of drug interactions with benzonatate? Always inform your healthcare provider and pharmacist about all medications, supplements, and herbal products you’re taking. They can assess potential interactions and adjust your treatment plan if necessary.

Alcohol Consumption

Combining benzonatate with alcohol can increase the risk of side effects such as drowsiness and dizziness. It’s generally advisable to avoid alcohol while taking this medication.

Long-Term Use and Monitoring

While benzonatate is often prescribed for short-term use, some patients may require longer-term treatment. Understanding the implications of extended use is important for both patients and healthcare providers.

Monitoring for Long-Term Use

If benzonatate is prescribed for an extended period, your healthcare provider may recommend:

• Regular check-ups to assess the medication’s effectiveness
• Monitoring for potential side effects
• Evaluating the underlying cause of persistent cough
• Considering alternative treatments if necessary

Tolerance and Dependence

Unlike some other cough suppressants, benzonatate is not known to cause physical dependence. However, the effectiveness of the medication may decrease over time if used continuously, a phenomenon known as tolerance.

Can long-term use of benzonatate lead to addiction? Benzonatate is not considered addictive, but as with any medication, it’s important to use it only as prescribed and to discuss any concerns about long-term use with your healthcare provider.

Benzonatate in the Context of Overall Cough Management

While benzonatate can be an effective tool for managing cough symptoms, it’s important to view it as part of a comprehensive approach to cough treatment.

Complementary Approaches

In addition to medication, other strategies for managing cough may include:

• Staying hydrated
• Using a humidifier
• Avoiding irritants like smoke or strong odors
• Elevating the head while sleeping
• Using honey or other natural remedies (under medical guidance)

When to Seek Further Medical Evaluation

While benzonatate can provide relief from cough symptoms, it’s important to address the underlying cause of persistent cough. Consult your healthcare provider if:

• Your cough persists for more than a few weeks
• You experience additional symptoms like fever, chest pain, or difficulty breathing
• Your cough is accompanied by unexplained weight loss or fatigue
• You’re coughing up blood or discolored mucus

By understanding the proper use, potential side effects, and important considerations associated with benzonatate, patients can make informed decisions about their cough management in consultation with their healthcare providers. Always follow medical advice and report any concerns or unusual symptoms promptly to ensure safe and effective treatment.

Benzonatate: MedlinePlus Drug Information

pronounced as (ben zoe’ na tate)

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Benzonatate is used to relieve cough. Benzonatate is in a class of medications called antitussives (cough suppressants). It works by reducing the cough reflex in the lungs and air passages.

Benzonatate comes as a liquid-filled capsule and a capsule to take by mouth. It is usually taken three times a day as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take benzonatate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules and liquid-filled capsules whole; do not break, dissolve, cut, crush, suck or chew them. If the medication is released in the mouth, it may make the mouth numb and cause choking. Do not eat or drink if you feel numbness or tingling of your mouth, tongue, throat, or face. If feelings of numbness or tingling continue or get worse, get medical help right away.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking benzonatate,

• tell your doctor and pharmacist if you are allergic to benzonatate, procaine (Novocain), tetracaine (in Synera),any other medications, or any of the ingredients in benzonatate capsules. Ask your doctor or pharmacist for a list of ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking benzonatate, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking benzonatate.

Unless your doctor tells you otherwise, continue your normal diet.

This medication is usually taken as needed. If you are taking benzonatate regularly and you miss a dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Benzonatate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• constipation
• drowsiness
• headache
• dizziness
• stuffy nose
• feeling chilly
• burning in the eyes

Some side effects can be serious.

If you experience any of these symptoms, call your doctor immediately:

• rash or hives
• itching
• tightening of the throat
• difficulty breathing or swallowing
• numbness of the chest
• confusion
• hallucinations (seeing or hearing things that do not exist)

Benzonatate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed. It is very important to store this medication in a closed child-proof container and to keep it out of reach of children. Children may be attracted to the shape and look of the liquid-filled capsules and may die if they swallow the medication. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

If benzonatate is taken accidentally, call for medical help immediately. Symptoms of overdose can occur rapidly (within 15–20 minutes of taking medication) and death in children has been reported within an hour. These symptoms may include the following:

• restlessness
• uncontrollable shaking of a part of the body
• confusion
• seizures
• unconsciousness

• Tessalon^®
• Zonatuss^®

Last Revised – 08/15/2017

Browse Drugs and Medicines

Benzonatate Monograph for Professionals – Drugs.com

Brand name: Tessalon
Drug class: Antitussives
ATC class: R05DB01
VA class: RE302
CAS number: 104-31-4

Medically reviewed by Drugs. com on Mar 6, 2023. Written by ASHP.

Introduction

Local anesthetic antitussive agent.

Uses for Benzonatate

Cough

Used for symptomatic relief of cough.

May be effective in suppressing cough in acute respiratory conditions such as pneumonia, bronchitis, pertussis, and the common cold; and in chronic diseases such as pulmonary emphysema, bronchial asthma, tuberculosis, and pulmonary tumor.

Has been shown to be more effective than codeine in reducing the frequency of experimentally induced cough, ^{and may be effective in providing symptomatic relief in patients with opiate-resistant cough.}

Conscious Intubation

Has been applied locally in the oral cavity in adults by releasing the drug from the liquid-filled capsules (e.g., by chewing or dissolving two 100-mg liquid-filled capsules in the mouth) to provide sufficient oropharyngeal anesthesia for conscious intubation^{† [off-label]}.

Do not employ this method of administration^{† [off-label]} when the drug is used as an antitussive because of the risk of potentially life-threatening complications resulting from local effects on the oropharyngeal tract. ^{(See Sensitivity Reactions under Cautions and also Oral Administration under Dosage and Administration.)}

Benzonatate Dosage and Administration

Administration

Oral Administration

Swallow the liquid-filled capsules whole.

Do not chew or dissolve in the mouth when used as an antitussive, since temporary, potentially life-threatening local anesthesia of the oral mucosa, choking, or severe hypersensitivity reactions could occur; oropharyngeal anesthesia develops rapidly with such improper administration.

Local administration^{† [off-label]} (chewing the capsules or allowing to dissolve in mouth) can be employed to facilitate conscious intubation^{† [off-label]}. ^{(See Conscious Intubation under Uses.)}

Dosage

Pediatric Patients

Cough

Oral

Children ≤10 years of age: 8 mg/kg daily in 3–6 divided doses^{† [off-label]}, ^{although safety and efficacy have not been established in this age group. (See Pediatric Use under Cautions.)}

Children >10 years of age: 100 or 200 mg 3 times daily.

Adults

Cough

Oral

100 or 200 mg 3 times daily; ^{doses up to 600 mg daily may be given in divided doses if necessary.}

Prescribing Limits

Pediatric Patients

Cough

Oral

Children >10 years of age: Maximum 600 mg daily in divided doses.

Adults

Cough

Oral

Maximum 600 mg daily in divided doses.

Special Populations

Hepatic Impairment

No specific dosage recommendations for hepatic impairment.

Renal Impairment

No specific dosage recommendations for renal impairment.

Geriatric Patients

No specific geriatric dosage recommendations.

Cautions for Benzonatate

Contraindications

Warnings/Precautions

Sensitivity Reactions

Severe hypersensitivity reactions, including bronchospasm, laryngospasm, and cardiovascular collapse, have been reported with benzonatate.

Such reactions may have resulted from local anesthesia secondary to sucking or chewing the liquid-filled capsules rather than swallowing them whole.

Severe reactions have required medical intervention with vasopressor therapy and supportive measures.

Major Toxicities

Overdosage

Deliberate or accidental overdosage of benzonatate can result in CNS stimulation which may lead to restlessness, tremors, and seizures; profound CNS depression and death can follow. ^{(See Pediatric Use under Cautions.)}

Dizziness, ^{disorientation, drunken feeling, unresponsiveness, pulmonary congestion, ventricular tachycardia, cardiac arrest, and nausea also have been reported with overdosage.}

General Precautions

CNS Effects

Rarely, bizarre behavior, including mental confusion and visual hallucinations, when used concomitantly with certain other drugs.

Possibility that adverse CNS effects associated with other p-aminobenzoic acid-derivative local anesthetics (e.g., procaine, tetracaine) could occur with benzonatate should be considered.

Specific Populations

Pregnancy

Category C.

Lactation

Not known whether benzonatate is distributed into milk. ^{Caution if used in nursing women.}

Pediatric Use

Safety and effectiveness of benzonatate in children <10 years of age have not been established.

FDA has warned that accidental ingestion by children <10 years of age can result in death from overdose. ^{Overdose in children <2 years of age has been reported following accidental ingestion of as few as 1 or 2 capsules. Benzonatate may be attractive to children because of drug’s appearance; it is a round-shaped liquid-filled gelatin capsule.}

Individuals who experience overdose of benzonatate may exhibit restlessness, tremors, convulsions, coma, and cardiac arrest. ^{Signs and symptoms of overdose can occur rapidly after ingestion (within 15–20 minutes). (See Overdosage under Cautions.)}

Deaths in children have been reported within hours of the accidental ingestion.

Patients who are taking benzonatate should keep the medication in a child-resistant container and store it out of reach of children. ^{If a child accidentally ingests benzonatate, caregivers should seek medical attention immediately.}

Common Adverse Effects

Generally well tolerated when the liquid-filled capsules are swallowed intact.

Adverse effects may include sedation, headache, mild dizziness, bizarre behavior (e.g., mental confusion, visual hallucinations), nasal congestion, nausea, GI upset, constipation, sensation of burning in the eyes, a vague “chilly” sensation, pruritus and skin eruptions, numbness in the chest, and hypersensitivity (e. g., bronchospasm, laryngospasm, cardiovascular collapse, possibly related to local anesthesia from chewing or sucking the liquid-filled capsules). ^{(See Sensitivity Reactions under Cautions.)}

Benzonatate Pharmacokinetics

Absorption

Onset

Usually within 15–20 minutes after swallowing capsules intact.

Oropharyngeal anesthesia: Develops rapidly when applied locally (e.g., by chewing or dissolving the liquid-filled capsules in the mouth), ^{with complete anesthesia occurring within about 1 minute.}

Duration

Approximately 3–8 hours following a single oral dose.

Stability

Storage

Oral

Liquid-filled Capsules

Tight, light-resistant containers at 15–30°C.

Actions

• Inhibits cough production by anesthetizing stretch receptors of vagal afferent fibers in the bronchi, alveoli, and pleura that mediate the cough reflex; also suppresses transmission of the cough reflex at the level of the medulla where the afferent impulse is transmitted to the motor nerves.

• Does not depress respiration at recommended dosages ^{; in patients with bronchial asthma, the drug has been reported to increase the rate and depth of respiration, minute volume, and vital capacity.}

Advice to Patients

• Importance of warning patients using benzonatate as an antitussive to swallow the liquid-filled capsules whole without chewing or dissolving in the mouth because of risk of potentially life-threatening local anesthesia. ^{(See Oral Administration under Dosage and Administration and also Sensitivity Reactions under Cautions.)}

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. ^{(See Cautions.)}

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

AHFS ^{DI Essentials™. © Copyright 2023, Selected Revisions March 15, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.}

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

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Frequently asked questions

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instructions for use, dosage, composition, analogues, side effects / Pillintrip

Page reviewed by pharmacist Fedorchenko Olga Valerievna Last update 2022-04-17

Attention!
The information on this page is for healthcare professionals only!
The information is collected from open sources and may contain significant errors!
Be careful and double-check all the information on this page!

Top 20 drugs with the same ingredients:

Ambroxol/Benzonatate Celltius

Name of the drug

Description The name of the drug Ambroxol/Benzonatate is an automatic translation from the original language.
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Ambroxol/Benzonatate

Therapeutic indications

Description Therapeutic indications Ambroxol/Benzonatate is an automatic translation from the original language.
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more. ..

A prescription is a term used to refer to a list of conditions, symptoms, or diseases for which a drug is prescribed or used by a patient. For example, acetaminophen or paracetamol is used by a patient for a fever, or a doctor prescribes it for a headache or body aches. Now fever, headache and body aches are signs of paracetamol. The patient should be aware of the indications for drugs used in common conditions because they can be taken without a prescription from a pharmacy.

For use by Max Pidek Pharmaceuticals alone and in combination with clavulanic acid: infectious and inflammatory diseases caused by susceptible microorganisms, including bronchitis, pneumonia, tonsillitis, pyelonephritis, urethritis, gastrointestinal tract infections, gynecological infections, skin infections and soft tissues, listeria, leptospirosis, gonorrhea.

For the use of Max Pidek Pharmaceuticals in combination with metronidazole: chronic gastritis in the acute period, peptic ulcer of the stomach and duodenum in the acute period associated with Helicobacter Pylori.

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Benzonatate is a medicine taken by mouth to suppress coughs. It has an analgesic (numbing) effect similar to that of benzocaine and “numbs” the stretch sensors in the lungs. It is the stretching of these sensors during breathing that causes coughing. Benzonatate begins to act within 15-20 minutes, and its effect lasts approximately 3 hours. Benzonatate is not related to drugs such as codeine, which are often used to suppress coughs. (Another commonly used cough suppressant, dextromethorphan, found in many over-the-counter cough and cold medicines, is a drug derivative. ) Benzonatate was approved by the FDA in 1958

Relief of cough, throat and respiratory irritation due to colds, flu or hay fever. It may also be used for other conditions as determined by your doctor.

Ambroxol is a combination cough suppressant and expectorant. A cough suppressant works in the brain to help reduce the cough reflex to reduce dry coughs. An expectorant works by loosening the mucus and lung secretions in the chest and making the cough more productive.

Benzonatate is used to relieve cough due to a cold or influenza (flu). It should not be used for chronic cough associated with smoking, asthma, emphysema, or unusually large amounts of mucus or sputum.

Benzonatate relieves coughs by acting directly on the lungs and airways. It can also affect the cough center in the brain.

benzonatate is only available with your doctor’s prescription.

Dosage and administration

Description Dosage and Administration Ambroxol/Benzonatate is an automatic translation from the original language.
Do not use this information for any medical prescription or manipulation under any circumstances.
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Sustained release capsule: Adults and children over 12 years old: 1 capsule once a day after meals with plenty of liquid (sufficient liquid supports the expectorant effect of Ambroxol).

Ambroxol SR Capsule is not suitable for children under 12 years of age.

Tablet: Adults and children over 12 years old: 1 tab thrice a day for the first 2-3 days, then 1 tab twice a day or ½ tab thrice a day. Children 6-12 years old: ½ tab 2-3 times a day.

Syrup: Adults and children over 12 years old: 10 ml thrice a day for the first 2-3 days, 10 ml twice a day or 5 ml thrice a day. Children 6-12 years: 5 ml 2-3 times a day, 2-5 years: 2.5 ml 3 times a day, <2 years: 2.5 ml 2 times a day.

DS syrup: Adults and children over 12: 5 ml thrice daily for 2-3 days, then 5 ml twice daily 2.5 ml thrice daily. Children 6-12 years old: 2.5 ml 2-3 times a day.

Baby Drops: Children 13-24 months: 1.25 ml twice daily, 7-12 months: 1 ml twice daily, 900 61 ≤6 months: 0.5 ml twice a day.

Adults and children over 10 years of age: The usual dose is one 100 mg or 200 mg capsule three times daily as needed for coughing. If cough control is needed, up to 600 mg per day in three divided doses may be given. Benzonatate capsules should be swallowed whole. Benzonatate capsules should not be broken, chewed, dissolved, cut or crushed.

As supplied

Benzonatate Capsules USP, 100 mg are light yellow, round shaped soft gelatin capsules imprinted with the letter “Z” containing a clear, pale yellow viscous liquid and supplied as follows:

NDC 9 0016 65841 -614-01 100 capsule vial

NDC 65841-614-05 500 capsule vial

Benzonatate capsules USP, 200 mg are light yellow, round shaped soft gelatin capsules s printed with the letter “β ”, containing a clear, viscous, pale yellow liquid, and are supplied as follows:

NDC 65841-615-01 in vial of 100 capsules

Store between 20° – 25°C (68° – 77°F).

Dispense into a sealed, light-resistant container.

Seek medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Manufacturer: Cadila Healthcare Ltd., Ahmedabad, India. Edition: 11/03/2011

Contraindications

Description Contraindications Ambroxol/Benzonatate is an automatic translation from the original language.
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See also:
What is the most important information I should know about Ambroxol?

Hypersensitivity to Ambroxol hydrochloride or any other excipients of Ambroxol.

In rare hereditary conditions that may be incompatible with Ambroxol excipient, the use of Ambroxol is contraindicated.

See also:
What is the most important information I should know about benzonatate?

You should not use this drug if you are allergic to benzonatate or local pain relievers such as tetracaine or procaine (found in some insect bite and sunburn creams).

Do not suck or chew benzonatate capsules. Swallow the tablet whole. Sucking or chewing a capsule may cause numbness in your mouth and throat or cause other serious side effects.

Serious side effects of benzonatate include a feeling of choking, chest pain or numbness, feeling like you might pass out, confusion or hallucinations. Some of these side effects may result from chewing or sucking on a benzonatate capsule.

Do not give this drug to a child under 10 years of age without the advice of a doctor. An overdose of benzonatate can be fatal to a child.

Special Warnings and Precautions

Description Special Warnings and Precautions Ambroxol/Benzonatate is an automatic translation from the original language.
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Use Ambroxol as directed by your doctor. Check the medication label for exact dosing instructions.

• Take Ambroxol by mouth with or without food.
• Drink plenty of water while taking Ambroxol.
• If you miss a dose of Ambroxol, take it as soon as possible. If it’s almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at the same time.

Ask your doctor any questions about how to use Ambroxol.

Use Benzonatate as directed by your doctor. Check the medication label for exact dosing instructions.

• Take benzonatate by mouth with or without food.
• Swallow the benzonatate whole. Do not break, crush, chew, dissolve, suck on or take on Benzonatate before swallowing.
• If you miss a dose of benzonatate, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at the same time.

Ask your doctor any questions about how to use benzonatate.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after a few days, some drugs need to be continued for an extended period to get the benefit from it.

Ambroxol is used to treat certain respiratory diseases and to relieve cough associated with mucosal thickening.

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after a few days, some drugs need to be continued for an extended period to get the benefit from it.

Use: Labeled indications

Cough: Symptomatic treatment of cough

Interaction with other drugs

Description Interaction with other drugs Ambroxol/Benzonatate is an automatic translation from the original language a.
Do not use this information for any medical prescription or manipulation under any circumstances.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

more…

See also:
What other drugs will affect Ambroxol?

Amoxicillin may reduce the effectiveness of oral contraceptives.

With the simultaneous use of Max Pidek with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin), synergism occurs, with bacteriostatic antibiotics (including macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) – antagonism.

Amoxicillin enhances the effect of indirect anticoagulants that inhibit the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index.

Amoxicillin reduces the effect of drugs that are metabolized to produce PABA.

Probenecid, diuretics, allopurinol, phenylbutazone, NSAIDs reduce the tubular secretion of amoxicillin, which may be accompanied by an increase in its concentration in blood plasma.

Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce absorption, and ascorbic acid enhances the absorption of amoxicillin.

With the combined use of amoxicillin and clavulanic acid, the pharmacokinetics of both components does not change.

See also:
What other drugs will affect benzonatate?

Drug interactions with benzonatate are unknown.

Side effects

Description Side effects Ambroxol/Benzonatate is an automatic translation from the original language.
Do not use this information for any medical prescription or manipulation under any circumstances.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

more. ..

See also:
What are the possible side effects of Ambroxol?

Used for albuterol: oral syrup, tablets, extended release tablets

Other dosage forms:

• inhalation aerosol, powder, inhalation capsule, powder for inhalation, inhalation with solutions

90 215

In addition to the desired effects, albuterol (active ingredient contained in Ambroxol) may cause unwanted side effects requiring medical attention.

Major Side Effects

If you experience any of the following side effects while taking albuterol, call your doctor immediately: or feet

• trembling or shaking hands or feet

Less common:

• Fast, irregular, rapid, or rapid heartbeat or pulse

Rare

• Cough
• difficulty breathing
• difficulty swallowing
• urticaria or blisters
• hoarseness
• Large beehive-like swelling on face, eyelids, lips, tongue, throat, arms, legs, feet or genitals
• noisy breathing
• redness of the skin
• shortness of breath
• skin rash
• slow or irregular breathing
• swelling of the mouth or throat
• chest tightness
• wheezing

Frequency not known:

• Agitation
• anxiety or jaw
• blurred vision
• chest pain or discomfort
• confusion
• convulsions
• additional heartbeats
• syncope
• hallucinations
• headache
• irritability
• dizziness
• mood or mental changes
• muscle pain or cramps
• muscle spasm or twitching of all limbs
• nervousness
• nightmares
• ringing in the ears
• restlessness
• sudden loss of consciousness
• sweating
• general body twitching
• unusual feeling excited
• vomiting

Minor Side Effects

Some side effects of albuterol may not require medical attention. As your body gets used to the medication, these side effects may go away. Your health care provider can help you prevent or reduce these side effects, but be sure to check with them if any of the following side effects continue or bother you:

Less common:

• Dizziness
• feeling warm
• irritability
• nausea
• redness of the face, neck, arms, and sometimes upper chest
• insomnia
• problems holding or passing urine
• problems sleepy
• unable to sleep

Rare

• Drowsiness
• unusual sleepiness

Frequency not known:

• Bad, unusual or unpleasant (after) taste
• change in taste
• sensation of constant movement of self or surroundings
• gagging

9020 9 rough, raspy sound of voice

• sensation of rotation
• tightness in throat

See also:
What are the possible side effects of benzonatate?

Used for benzonatate: oral capsules, oral liquid-filled capsules

In addition to the desired effects, benzonatate (the active ingredient in benzonatate) may cause unwanted side effects requiring medical attention.

Major Side Effects

If you experience any of the following side effects while taking benzonatate, call your doctor immediately:

Rare

• Confusion 9 difficulty breathing
• difficulty speaking
• seeing things that don’t exist
• shortness of breath
• chest tightness
• wheezing

03

Overdose symptoms:

• Change of consciousness
• convulsions (fits)
• loss of consciousness
• no blood pressure or pulse
• restlessness
• tremors in legs, arms, hands or feet
• cardiac arrest
• trembling or shaking of arms or legs
• unconsciousness

Minor Side Effects

9000 2 Some side effects of benzonatate may not need medical attention. As your body gets used to the medication, these side effects may go away. Your health care provider can help you prevent or reduce these side effects, but be sure to check with them if any of the following side effects continue or bother you:

Less common or rare:

• Burning eyes
• constipation
• dizziness (mild)
• drowsiness (mild)
• headache pain
• itching
• nausea or vomiting
• skin rash
• nasal congestion

Overdose

Description Overdose Ambroxol/Benzonatate is an automatic translation from the original language.
Do not use this information for any medical prescription or manipulation under any circumstances.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

more…

Composition

Description Composition Ambroxol/Benzonatate is an automatic translation from the original language.
Do not use this information for any medical prescription or manipulation under any circumstances.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

more. ..

Each retard capsule contains 75 mg ambroxol hydrochloride.

Each tablet contains ambroxol hydrochloride 30 mg.

Each 5 ml syrup contains 15 or 30 mg ambroxol hydrochloride.

Each ml of syrup (children’s drops) contains ambroxol hydrochloride 6 mg.

Ambroxol hydrochloride is trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride.

It also contains the following excipients: Capsules Retard: Crospovidone collidone CL, carnauba wax, stearyl alcohol, magnesium stearate.

Tablets: Lactose, corn starch, colloidal silica, magnesium stearate.

Syrup: Purified water, sorbitol liquid, glycerin 85%, woodberry flavor (15 mg only), strawberry flavor (30 mg only), hydroxyethyl cellulose, benzoic acid, acesulfame potassium, vanilla flavor.

Baby Drops: Hydroxyethylcellulose, sorbitol solution, glycerin 85%, sodium saccharin, pharmaceutical flavors, menthol, benzoic acid, propylene glycol.

Benzonatate is a non-narcotic oral antitussive that works by anesthetizing lung and pleural tissues responsible for the cough reflex. It is chemically related to other ether anesthetics such as procaine. It has an analgesic (numbing) effect similar to that of benzocaine and “numbs” the stretch sensors in the lungs. It is the stretching of these sensors during breathing that causes the cough. It was approved by the FDA in 1958

Sources:

• https://www.drugs.com/search.php?searchterm=ambroxolbenzonatate
• https://pubmed.ncbi.nlm.nih.gov/ 215
  

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