Antitussives /Expectorants

INDICATIONS AND USAGE
Benzonatate capsules are indicated for the symptomatic relief of cough.

CONTRAINDICATIONS
Hypersensitivity to benzonatate or related compounds.

WARNINGS
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.

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

Dosage
Children >10 years and Adults: Oral: 100 mg 3 times/day or every 4 hours up to 600 mg/day

Supplied
Capsule: 100 mg
Tessalon®: 100 mg, 200 mg

Children >12 years and Adults:
Suspension: (guaifenesin 100 mg/5 ml): 200-400 mg (2 to 4 teaspoonfuls) orally every 4 hours as needed. Maximum of 24 teaspoonfuls per day.

Humabid LA (600mg tabs): 1-2 tabs every 12 hours. Maximum 4 tabs/day.

Regular release- (200 mg tabs): Adults and children 12 years of age and older: One to 2 tablets (200 mg to 400 mg) every four hours, not to exceed 2400 mg (12 tablets) in 24 hours.

Initial U.S. Approval:  2014

Mechanism of Action: Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone will depress respiration. Hydrocodone can produce miosis, euphoria, and physical and physiological dependence.

Guaifenesin is an expectorant the action of which promotes or facilitates the removal of secretions from the respiratory tract. The precise mechanism of action of guaifenesin is not known; however, it is thought to act as an expectorant by increasing the volume and reducing the viscosity of secretions in the trachea and bronchi. In turn, this may increase the efficiency of the cough reflex and facilitate removal of the secretions.

INDICATIONS AND USAGE:  OBREDON Oral Solution is a combination product containing an opioid antitussive and expectorant indicated for:
Symptomatic relief of cough and to loosen mucus associated with the common cold.

Important Limitations of Use:
Not indicated for pediatric patients under 18 years of age.

HOW SUPPLIED: Oral Solution: Each 5 mL contains hydrocodone bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg.

Children 6 to under 12 years: 1 teaspoonful every 4 hours, not to exceed 6 teaspoonfuls in a 24-hour period.

Supplied: Each teaspoonful (5 ml) contains: Guaifenesin 100 mg, Codeine Phosphate 10 mg.

Supplied: Each teaspoonful (5 ml) contains: Guaifenesin 100 mg, Dextromethorphan Hydrobromide 10 mg.

Supplied: Each teaspoonful (5 ml) contains: Guaifenesin 100 mg, Pseudoephedrine hcl 30 mg, Dextromethorphan Hydrobromide 10 mg.

Supplied: Each teaspoonful (5 ml) contains: Guaifenesin 100 mg, Pseudoephedrine HCl 30 mg.

Initial U.S. Approval:  2015

Mechanism of Action:
Codeine is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of morphine. The precise mechanism of action of codeine and other opiates is not known; however, codeine is believed to act centrally on the cough center. In excessive doses, codeine will depress respiration. Codeine can produce miosis, euphoria, and physical and physiological dependence.

Chlorpheniramine is a propylamine derivative antihistamine drug (H1 receptor antagonist) that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.

INDICATIONS AND USAGE:
TUZISTRA XR is a combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1 (H1) receptor antagonist indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold. (1.1)
Limitation of Use:
Not indicated for pediatric patients under 18 years of age.

HOW SUPPLIED:: Extended-release oral suspension contains: an antitussive – codeine polistirex, which contains 14.7 mg of codeine (equivalent to 20 mg codeine phosphate), and an antihistamine – chlorpheniramine polistirex, which contains 2.8 mg of chlorpheniramine (equivalent to 4 mg chlorpheniramine maleate) per 5 mL.

Initial U.S. Approval:  2013

Mechanism of Action: Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone will depress respiration. Hydrocodone can produce miosis, euphoria, and physical and physiological dependence.

Chlorpheniramine is an antihistamine drug (H1 receptor antagonist) that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.

INDICATIONS AND USAGE:  Vituz® Oral Solution is a combination of hydrocodone bitartrate, an antitussive, and chlorpheniramine maleate, a histamine-1 (H1) receptor antagonist, indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold;
 Limitations of Use:  Not indicated for pediatric patients under 18 years of age

HOW SUPPLIED: Each 5 mL of Vituz Oral Solution contains: hydrocodone bitartrate, USP, 5 mg and chlorpheniramine maleate, USP, 4 mg