TESSALON 100 mg Perles 200 mg Capsules
(benzonatate, USP)
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.
CH3(CH2)2CH2NH COOCH2CH2(OCH2CH2)n OCH3
Each TESSALON Perle contains: Benzonatate, USP 100 mg
C30H53NO11
Each TESSALON Capsule contains:
Benzonatate, USP 200 mg
TESSALON Capsules also contain: D&C Yellow 10, gelatin, glycerin, methylparaben and propylparaben.
CLINICAL PHARMACOLOGY
TESSALON acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampe读后感格式范文
ning 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.
INDICATIONS AND USAGE
TESSALON is indicated for the symptomatic relief of cough.
CONTRAINDICATIONS
Hypernsitivity to benzonatate or related compounds.
WARNINGS
Hypernsitivity
Severe hypernsitivity reactions (including bronchospasm, laryngospasm and cardiovascular collap) 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 othe故事分享
r 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 overdo have been reported within
15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, ek medical attention immediately (e
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 adver CNS effects possibly related to a prior nsitivity to related agents or interaction with concomitant medication.
Information for patients:
Swallow TESSALON Capsules and Perles whole. Do not break, chew, dissolve, cut, or crush TESSALON Capsules and Perles. Relea of TESSALON from the capsule in the mouth can produce a temporary local anesthesia of the
Reference ID: 2893337
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 worn or persist, ek medical attention.
Keep TESSALON out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdo 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, ek medical attention immediately.
Overdosage resulting in death may occur in adults.
Do not exceed a single do of 200 mg and a total daily dosage of 600 mg. If you miss a do of TESSALON, skip that do and take电视背景墙怎么做
the next do at the next scheduled time. Do not take 2 dos of TESSALON at one time.
Usage in Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducte
d with TESSALON. It is also not known whether TESSALON can cau 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. Becau many drugs are excreted in human milk caution should be exercid 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 U: Safety and effectiveness in children below the age of 10 have not been establish提前转正申请
ed. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.
ADVERSE REACTIONS
Potential Adver Reactions to TESSALON may include:
Hypernsitivity reactions including bronchospasm, laryngospasm, cardiovascular collap possib
ly related to local anesthesia from chewing or sucking the capsule.
CNS: dation; headache; dizziness; mental confusion; visual hallucinations.
GI: constipation; naua; GI upt.
Dermatologic: pruritus; skin eruptions.
Other: nasal congestion; nsation of burning in the eyes; vague “chilly” nsation; numbness of the chest; hypernsitivity.
Deliberate or accidental overdo has resulted in death, particularly in children.
