Tussilon100 mg

Tussilon is FDA-approved for the symptomatic relief of cough in adults and children older than 10 years of age.

• Established/FDA-approved use: Short-term relief of non-productive cough due to minor upper respiratory tract infections (e.g., the common cold), and cough associated with bronchitis, pneumonia, or other conditions where cough suppression is clinically appropriate.
• Off-label use (not FDA-approved): Tussilon is sometimes used off-label to suppress the gag reflex before upper endoscopy, transesophageal echocardiography, or dental procedures; evidence supporting this use is limited and it should be used this way only at a physician's discretion.

Tussilon relieves only the symptom of cough; it does not treat the underlying cause. A cough that is persistent, severe, worsening, or accompanied by fever, rash, or difficulty breathing should be evaluated by a physician.

Each soft capsule contains Benzonatate 100 mg or 200 mg for oral administration.

Tussilon is a non-narcotic, non-opioid oral antitussive (cough suppressant) that is chemically related to the local anesthetic tetracaine. Unlike opioid antitussives such as codeine, Tussilon does not act on the central cough center in the brain; instead it acts peripherally on stretch receptors in the airways. It is supplied as an oral soft capsule and is used for short-term, symptomatic relief of cough.

Tussilon belongs to the non-opioid, peripherally-acting antitussive class of drugs, distinct from opioid antitussives (e.g., codeine), centrally-acting non-opioid antitussives (e.g., dextromethorphan), and expectorants/mucolytics.

Benzonatate is structurally similar to local anesthetics such as tetracaine. It exerts a local anesthetic-like effect on the stretch (vagal afferent) receptors located in the respiratory passages, lungs, and pleura, thereby dampening the afferent limb of the cough reflex at its peripheral origin rather than suppressing the central cough center in the medulla. Onset of action with Benzonatate typically begins within 15 to 20 minutes of oral administration and lasts approximately 3 to 8 hours.

Swallow Tussilon capsules whole with water. Do not chew, crush, break, dissolve, or suck on the capsule. Puncturing or chewing releases a local anesthetic effect in the mouth and throat that can cause choking, numbness, or aspiration. Tussilon may be taken with or without food.

Well-documented, clinically significant drug interactions with Tussilon are limited. Because Tussilon can cause central nervous system depression (e.g., sedation, dizziness), concurrent use with alcohol, opioids, sedative-hypnotics, or other CNS depressants may result in additive sedation, and this combination should be used with caution.

Common side effects of Tussilon:

• Dizziness and sedation/drowsiness
• Headache
• Nausea, mild gastrointestinal upset, constipation
• Nasal congestion
• Pruritus or skin rash

Less common or serious side effects of Tussilon:

• Sensation of chest numbness or tightness
• Hypersensitivity reactions, including bronchospasm or laryngospasm (more likely if the capsule is chewed or punctured)
• Mental confusion or visual hallucinations, particularly in elderly patients
• Cardiovascular collapse and cardiac arrhythmia (reported in overdose — see Overdose)

Tussilon has not been well studied in pregnant women. It should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; consult a physician before use. It is not known whether Tussilon is excreted in human breast milk; caution is advised and a physician should be consulted before using Tussilon while breastfeeding.

Warning — Accidental Ingestion: Serious and sometimes fatal overdose has occurred following accidental ingestion of Tussilon, particularly by children younger than 10 years, with symptoms and death occurring within 15 to 20 minutes of ingestion. Tussilon must be stored securely and kept out of the reach and sight of children at all times, and any accidental ingestion requires immediate emergency medical attention (see Overdose).

• Capsules of Tussilon must be swallowed whole; chewing, sucking, or breaking the capsule can numb the mouth and throat and cause choking or aspiration.
• Tussilon may cause central nervous system effects such as dizziness and sedation; use caution when driving or operating machinery until the individual effect is known.
• Tussilon provides only symptomatic relief and does not treat the underlying cause of cough; persistent, severe, or worsening cough, or cough accompanied by fever, rash, or difficulty breathing, should be medically evaluated.
• Elderly patients may be more susceptible to central nervous system effects of Tussilon, including confusion or hallucinations.

Overdose of Tussilon, including accidental ingestion by children, is a medical emergency. Onset of symptoms can occur within 15 to 20 minutes and may include restlessness and tremors progressing to convulsions, central nervous system depression, coma, cardiac arrhythmia, and cardiac arrest, which can be fatal. There is no specific antidote for Tussilon overdose. Anyone who has taken, or is suspected of having taken, more than the prescribed amount of Tussilon, or any amount in a child, should seek immediate emergency medical attention or contact a poison control center right away; treatment is supportive and should be provided by medical professionals.

Store at room temperature (below 30°C), away from light and moisture. Keep Tussilon in a secure location out of the reach and sight of children, as accidental ingestion can be fatal.

Pediatric use: Tussilon is contraindicated in children 10 years of age or younger (see Contraindications); safety and efficacy have not been established in this age group, and serious, sometimes fatal, poisoning has occurred after accidental ingestion.

Geriatric use: Elderly patients may be more sensitive to the central nervous system effects of Tussilon, such as dizziness, confusion, or hallucinations; use with caution.

Renal/hepatic impairment: Specific dosage adjustment data for Tussilon are not well established; use with caution and physician supervision.

Tussilon is intended for short-term, symptomatic treatment of cough for the duration of the acute illness. If cough persists beyond about one week, recurs, or is accompanied by fever, rash, or persistent headache, treatment with Tussilon should be reassessed by a physician rather than continued indefinitely.

Non-opioid, peripherally-acting antitussive (cough suppressant).

Benzonatate anesthetizes the stretch receptors located in the respiratory passages, lungs, and pleura, interrupting the peripheral (afferent) arc of the cough reflex rather than acting on the cough center in the brain. See Pharmacology for further detail.

C

Tussilon is not indicated and is contraindicated in children 10 years of age or younger. In children older than 10 years, the adult dose of Tussilon (100–200 mg three times daily as needed) may be used. Caregivers must store Tussilon capsules securely out of children's reach, as accidental ingestion — even of a single capsule — has caused serious, sometimes fatal, poisoning in young children (see Contraindications and Overdose).