TESSALON Capsule (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Pfizer Laboratories Div Pfizer Inc

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1. Description

TESSALON, 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. Each TESSALON Perle contains: Benzonatate, ...

2. Clinical Pharmacology

TESSALON 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. ...

3. Indications and Usage

TESSALON is indicated for the symptomatic relief of cough.

4. Contraindications

Hypersensitivity to benzonatate or related compounds.

5. 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 ...

6. 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 ...

6.2. Information for Patients

Swallow TESSALON Perles whole. Do not break, chew, dissolve, cut, or crush TESSALON Perles. Release of TESSALON from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

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

6.7. Pregnancy

Animal reproduction studies have not been conducted with TESSALON. It is also not known whether TESSALON can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ...

6.9. 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 is administered to a nursing woman.

6.10. 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.

7. Adverse Reactions

Potential Adverse Reactions to TESSALON may include: <u>Hypersensitivity reactions:</u> including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or ...

9. Overdosage

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 ...

10. Dosage and Administration

Adults and Children over 10 years of age Usual dose is one 100 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. ...

11. How Supplied

Perles, 100 mg (yellow); bottles of 100 NDC 0069 0122 01 Imprint: T. Mfd. by: Catalent Pharma Solutions, St. Petersburg, Florida 33716 Dist. by: Pfizer, Madison, New Jersey 07940

12. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT. Dispense in tight (USP), child-resistant containers.