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Anti-tussives / Expectorants:

Benzonatate ( Tessalon ®) guaifenesin ( Robitussin ®)
OBREDON ™  (hydrocodone bitartrate and guaifenesin) --
Robitussin AC ® Robitussin DM ®
Robitussin CF ® Robitussin PE ®
TUZISTRA XR™ (codeine polistirex and chlorpheniramine polistirex) VITUZ® (hydrocodone bitartrate and chlorpheniramine maleate)
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Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.    [  Read the disclaimer    |   <<Back     ]

Benzonatate ( Tessalon ®)  top of page

CLINICAL PHARMACOLOGY
Benzonatate 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. Benzonatate capsules have no inhibitory effect on the respiratory center in recommended dosage.


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

guaifenesin ( Robitussin ®)  top of page

Use: helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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.

OBREDON ™  (hydrocodone bitartrate and guaifenesin)  top of page

Drug UPDATES:  OBREDON ™  (hydrocodone bitartrate and guaifenesin) Oral Solution for oral administration CII
[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

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.

Robitussin AC ®  top of page

Adults and children 12 years of age and over: 2 teaspoonfuls every 4 hours, not to exceed 12 teaspoonfuls in a 24-hour period.

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.

Robitussin DM ®  top of page

Adults and children 12 years and over: 2 teaspoonfuls orally every 4 hours, up to a maximum of 6 doses each 24 hours. (Maximum 12 teaspoonfuls /day).

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

Robitussin CF ®  top of page

Adult dose: 2 teaspoonfuls every 4 hrs. Do not take more than 4 doses in any 24 hour period.

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

Robitussin PE ®  top of page

Adult dose (and children 12 years and over): 2 teaspoonfuls every 4 hrs. Do Not Exceed 4 Doses in any 24-Hour Period.

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

TUZISTRA XR™ (codeine polistirex and chlorpheniramine polistirex)  top of page


Drug UPDATES:  TUZISTRA XR™ (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII Initial U.S. Approval: 1985
[Drug information  /  PDFled   Click link for the latest monograph
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

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.

VITUZ® (hydrocodone bitartrate and chlorpheniramine maleate)  top of page

Drug UPDATES:  VITUZ (hydrocodone bitartrate and chlorpheniramine maleate) Oral Solution, CII.
[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)

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

®  top of page

 
 

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Disclaimer

Listed dosages are for - Adult patients ONLY. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. GlobalRPH does not directly or indirectly practice medicine or provide medical services and therefore assumes no liability whatsoever of any kind for the information and data accessed through the Service or for any diagnosis or treatment made in reliance thereon.

David F. McAuley, Pharm.D., R.Ph.  GlobalRPh Inc.
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