Drugs Details

Drugs Info of Tessalon, Tessalon Perles, Zonatuss
Drugs Details
  • Drugs Type  : Multum
  • Date : 5th Jan 2015 12:44 am
  • Brand Name : Tessalon, Tessalon Perles, Zonatuss
  • Generic Name : benzonatate (Pronunciation: ben ZOE na tate)
Descriptions

TESSALON (benzonatate), a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan-28-yl p­(butylamino) benzoate; with a molecular weight of 603.7.

 

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Each TESSALON Perle contains:

Benzonatate, USP 100 mg

Each TESSALON Capsule contains:

Benzonatate, USP 200 mg

TESSALON (benzonatate) Capsules also contain: D&C Yellow 10, gelatin, glycerin, methylparaben and propylparaben.

What are the possible side effects of benzonatate (Tessalon, Tessalon Perles, Zonatuss)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking benzonatate and call your doctor at once if you have a serious side effect such as:

  • a choking feeling;
  • 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.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Tessalon »

What are the precautions when taking benzonatate capsules (Tessalon)?

Before taking benzonatate, tell your doctor or pharmacist if you are allergic to it; or to certain anesthetic agents (e.g., procaine, tetracaine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication...

Read All Potential Precautions of Tessalon »

This monograph has been modified to include the generic and brand name in many instances.

Indications

TESSALON (benzonatate) is indicated for the symptomatic relief of cough.

Dosage Administration

Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. TESSALON (benzonatate) should be swallowed whole. TESSALON (benzonatate) Capsules and Perles are not to be broken, chewed, dissolved, cut or crushed.

How Supplied

Perles, 100 mg (yellow); bottles of 100 NDC 0069-0122-01 Imprint: T.

Perles, 100 mg (yellow); bottles of 500 NDC 0069-0122-02 Imprint: T

Capsules, 200 mg (yellow); bottles of 100 NDC 0069-0124-01 Imprint: 0698.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Rev. 12/15. Mfd by: Catalent Pharma Solutions St. Petersburg, Florida 33716. Pfizer Inc. Madison, New Jersey 07940

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Potential Adverse Reactions to TESSALON (benzonatate) may include:

Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.

CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.

GI: constipation; nausea; GI upset.

Dermatologic: pruritus; skin eruptions.

Other: nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity.

Deliberate or accidental overdose has resulted in death, particularly in children.

Read the Tessalon (benzonatate capsules) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Hypersensitivity

Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.

Psychiatric Effects

Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking TESSALON (benzonatate) in combination with other prescribed drugs.

Accidental Ingestion and Death in Children

Keep TESSALON (benzonatate) out of reach of children. Accidental ingestion of TESSALON (benzonatate) resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE).

Precautions

Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g. procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.

Usage in Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with TESSALON (benzonatate). It is also not known whether TESSALON (benzonatate) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TESSALON (benzonatate) should be given to a pregnant woman only if clearly needed.

Nursing mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when TESSALON (benzonatate) is administered to a nursing woman.

Carcinogenesis, mutagenesis, impairment of fertility

Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with TESSALON (benzonatate).

Pediatric Use

Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.

This monograph has been modified to include the generic and brand name in many instances.
 

OverDose

Intentional and unintentional overdose may result in death, particularly in children.

The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.

Signs and Symptoms

The signs and symptoms of overdose of benzonatate have been reported within 15-20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise.

CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion.

Treatment

In case of overdose, seek medical attention immediately. Evacuate gastric contents and administer copious amounts of activated charcoal slurry. Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage.

Do not use CNS stimulants.

ContrainDications

Hypersensitivity to benzonatate or related compounds.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

TESSALON (benzonatate) acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. TESSALON (benzonatate) has no inhibitory effect on the respiratory center in recommended dosage.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Swallow TESSALON (benzonatate) Capsules and Perles whole. Do not break, chew, dissolve, cut, or crush TESSALON (benzonatate) Capsules and Perles. Release of TESSALON (benzonatate) from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.

Keep TESSALON (benzonatate) out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately.

Overdosage resulting in death may occur in adults.

Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of TESSALON (benzonatate), skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of TESSALON (benzonatate) at one time.

This monograph has been modified to include the generic and brand name in many instances.
 

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

BENZONATATE- ORAL

 

(ben-ZOE-na-tate)

 

COMMON BRAND NAME(S): Tessalon Perle, Zonatuss

 

USES: This medication is used to treat coughs caused by the common cold and other breathing problems (e.g., pneumonia, bronchitis, emphysema, asthma). It works by reducing the reflex in the lungs that causes the urge to cough.

Use of this medication is not recommended in children younger than 10 years. Discuss the risks and benefits with your doctor.

 

HOW TO USE: Take this medication by mouth with or without food, usually 3 times daily as needed or as directed by your doctor.

Swallow this medication whole. Do not chew, suck, or dissolve this medication in your mouth. Doing so will cause a loss of feeling in your mouth/throat and may cause choking or a severe allergic reaction. (See also Side Effects section.) Do not eat or drink until the numbness goes away. Get medical help right away if the numbness persists or worsens.

Dosage is based on your medical condition and response to therapy. Do not take more than 200 milligrams at one time. Taking more benzonatate than prescribed will not make your cough go away faster but may result in serious side effects.

Tell your doctor if your condition persists or worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Drowsiness, dizziness, headache, stomach upset, constipation, and stuffy nose may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, loss of feeling in the chest, burning in the eyes.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. The possibility of an allergic reaction may increase if you chew, suck, or dissolve this medication in your mouth. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fainting.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Tessalon (benzonatate capsules) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking benzonatate, tell your doctor or pharmacist if you are allergic to it; or to certain anesthetic agents (e.g., procaine, tetracaine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Tell your doctor or pharmacist if you take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected or if a child accidentally swallows this medication, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: restlessness, shaking (tremors), seizures, inability to wake up (coma).

 

NOTES: Do not share this medication with others.

 

MISSED DOSE: If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Always store benzonatate in a child-resistant container. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Tessalon, Tessalon Perles, Zonatuss

Generic Name: benzonatate (Pronunciation: ben ZOE na tate)

  • What is benzonatate (Tessalon)?
  • What are the possible side effects of benzonatate (Tessalon)?
  • What is the most important information I should know about benzonatate (Tessalon)?
  • What should I discuss with my healthcare provider before taking benzonatate (Tessalon)?
  • How should I take benzonatate (Tessalon)?
  • What happens if I miss a dose (Tessalon)?
  • What happens if I overdose (Tessalon)?
  • What should I avoid while taking benzonatate (Tessalon)?
  • What other drugs will affect benzonatate (Tessalon)?
  • Where can I get more information?

What is benzonatate (Tessalon)?

Benzonatate is a non-narcotic cough medicine. It works by numbing the throat and lungs, making the cough reflex less active.

Benzonatate is used to relieve coughing.

Benzonatate may also be used for purposes not listed in this medication guide.

Benzonatate 100 mg-MUT

capsule, yellow, imprinted with IL

What are the possible side effects of benzonatate (Tessalon)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking benzonatate and call your doctor at once if you have a serious side effect such as:

  • a choking feeling;
  • 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.

Less serious side effects may include:

  • headache;
  • dizziness;
  • drowsiness;
  • nausea, vomiting, constipation; or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Tessalon (benzonatate capsules) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about benzonatate (Tessalon)?

You should not use this medication if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams).

Never suck or chew on a benzonatate capsule. Swallow the pill whole. Sucking or chewing the capsule may cause your mouth and throat to feel numb or cause other serious side effects.

Serious side effects of benzonatate include choking feeling, 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 medication to a child younger than 10 years old without medical advice. An overdose of benzonatate can be fatal to a child.

Side Effects Centers
  • Tessalon

Patient Detailed How Take

What should I discuss with my healthcare provider before taking benzonatate (Tessalon)?

You should not use this medication if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams).

FDA pregnancy category C. It is not known whether benzonatate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether benzonatate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 10 years old without medical advice. An overdose of benzonatate can be fatal, especially to a child.

How should I take benzonatate (Tessalon)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Always ask a doctor before giving a cough medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Take each dose with a full glass of water.

Never suck or chew on a benzonatate capsule. Swallow the pill whole. Sucking or chewing the capsule may cause your mouth and throat to feel numb or cause other serious side effects.

Store at room temperature away from moisture, heat, and light.

Side Effects Centers
  • Tessalon

Patient Detailed Avoid Taking

What happens if I miss a dose (Tessalon)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Tessalon)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzonatate can be fatal, especially to a child. Accidental death has occurred in children under 2 years old who took only 1 or 2 capsules.

Overdose symptoms may include numbness in the mouth or throat, feeling restless or very sleepy, tremors or shaking, seizure (convulsions), slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop).

What should I avoid while taking benzonatate (Tessalon)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using benzonatate

What other drugs will affect benzonatate (Tessalon)?

Before taking benzonatate, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to drowsiness and other side effects of benzonatate.

There may be other drugs that can interact with benzonatate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about benzonatate.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 8.01. Revision date: 3/9/2011.

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