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Tessalon
Overview
What is Tessalon?
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, USP 100 mg
TESSALON Perles (capsules) also contain: D&C Yellow 10, gelatin, glycerin, methylparaben and propylparaben.
What does Tessalon look like?
What are the available doses of Tessalon?
Sorry No records found.
What should I talk to my health care provider before I take Tessalon?
Sorry No records found
How should I use Tessalon?
TESSALON is indicated for the symptomatic relief of cough.
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. TESSALON Perles are not to be broken, chewed, dissolved, cut or crushed.
What interacts with Tessalon?
Hypersensitivity to benzonatate or related compounds.
What are the warnings of Tessalon?
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 in combination with other prescribed drugs.
Accidental Ingestion and Death in Children
Keep TESSALON out of reach of children. Accidental ingestion of TESSALON 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 ).
What are the precautions of Tessalon?
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.
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 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 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, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of TESSALON at one time.
Usage in 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. TESSALON 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 is administered to a nursing woman.
Carcinogenesis, mutagenesis, impairment of fertility
Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with TESSALON.
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.
What are the side effects of Tessalon?
Potential Adverse Reactions to TESSALON may include:
Hypersensitivity reactions
CNS:
GI:
Dermatologic:
Other:
Deliberate or accidental overdose has resulted in death, particularly in children.
What should I look out for while using Tessalon?
Hypersensitivity to benzonatate or related compounds.
What might happen if I take too much Tessalon?
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.
How should I store and handle Tessalon?
Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. Reconstituted ZYPREXA IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP] for up to 1 hour if necessary. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Protect ZYPREXA tablets and ZYPREXA ZYDIS from light and moisture. Protect ZYPREXA IntraMuscular from light, do not freeze.Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. Reconstituted ZYPREXA IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP] for up to 1 hour if necessary. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Protect ZYPREXA tablets and ZYPREXA ZYDIS from light and moisture. Protect ZYPREXA IntraMuscular from light, do not freeze.Perles, 100 mg (yellow);bottles of 100NDC 0069 0122 01Imprint: T.Perles, 100 mg (yellow);bottles of 100NDC 0069 0122 01Imprint: T.Perles, 100 mg (yellow);bottles of 100NDC 0069 0122 01Imprint: T.Perles, 100 mg (yellow);bottles of 100NDC 0069 0122 01Imprint: T.
Clinical Information
Chemical Structure
No Image foundClinical 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. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. TESSALON has no inhibitory effect on the respiratory center in recommended dosage.
Non-Clinical Toxicology
Hypersensitivity to benzonatate or related compounds.Potassium-depleting are a major contributing factor to digitalis toxicity. particularly if administered rapidly by the intravenous route, may produce serious arrhythmias in digitalized patients. and raise the serum digoxin concentration due to a reduction in clearance and/or in volume of distribution of the drug, with the implication that digitalis intoxication may result. and (and possibly other ) and may increase digoxin absorption in patients who inactivate digoxin by bacterial metabolism in the lower intestine, so that digitalis intoxication may result (see ). and by decreasing gut motility, may increase digoxin absorption. certain and may interfere with intestinal digoxin absorption, resulting in unexpectedly low serum concentrations. may decrease serum digoxin concentration, especially in patients with renal dysfunction, by increasing the non-renal clearance of digoxin. There have been inconsistent reports regarding the effects of other drugs [e.g., ] on serum digoxin concentration. administration to a digitalized, hypothyroid patient may increase the dose requirement of digoxin. Concomitant use of digoxin and increases the risk of cardiac arrhythmias. may cause a sudden extrusion of potassium from muscle cells, and may thereby cause arrhythmias in digitalized patients. Although beta-adrenergic blockers or calcium channel blockers and digoxin may be useful in combination to control atrial fibrillation, their additive effects on AV node conduction can result in advanced or complete heart block.
Due to the considerable variability of these interactions, the dosage of digoxin should be individualized when patients receive these medications concurrently. Furthermore, caution should be exercised when combining digoxin with any drug that may cause a significant deterioration in renal function, since a decline in glomerular filtration or tubular secretion may impair the excretion of digoxin.
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.
Potential Adverse Reactions to TESSALON may include:
Hypersensitivity reactions
CNS:
GI:
Dermatologic:
Other:
Deliberate or accidental overdose has resulted in death, particularly in children.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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