Chlophedianol (Systemic)
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VA CLASSIFICATION
Primary: RE302
Commonly used brand name(s): Ulone.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
*Not commercially available in the U.S.
Category:
Antitussive—
Indications
Accepted
Cough (treatment)—Indicated for the symptomatic relief of nonproductive cough. Chlophedianol is used to provide relief of acute cough due to minor throat and bronchial irritation occurring with colds or inhaled irritants. {01} {02} {07} {08}
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Molecular weight—
326.26
Mechanism of action/Effect:
Suppresses the cough reflex by a direct effect on the cough center in the medulla of the brain. {01} {02} {06}
Other actions/effects:
It may also possess moderate local anesthetic effect and some anticholinergic action. {07}
Biotransformation:
Hepatic. {09}
Time to peak effect:
Slower than narcotic antitussives. {01} {03} {07}
Duration of action:
Longer than narcotic antitussives. {01} {03} {07}
Elimination:
Renal. {09}
Precautions to Consider
Pregnancy/Reproduction
Pregnancy—
Studies have not been done in humans.
Studies have not been done in animals. {01}
Breast-feeding
It is not known whether chlophedianol is distributed into breast milk. However, problems in humans have not been documented.
Pediatrics
Appropriate studies on the relationship of age to the effects of chlophedianol have not been performed in children up to 2 years of age. {01} {07}
Geriatrics
No information is available on the relationship of age to the effects of chlophedianol in geriatric patients.
Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):
Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.
Central nervous system (CNS) depression–producing medications (see Appendix II ) or
Monoamine oxidase (MAO) inhibitors, including furazolidone and procarbazine (concurrent use may potentiate CNS depressant effects of either these medications or chlophedianol {01} {07})
CNS stimulation–producing medications (see Appendix II ) (concurrent use may potentiate CNS stimulant effects of chlophedianol {01} {07})
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Except under special circumstances, this medication should not be used when the following medical problems exist:
» Cough, productive (inhibition of cough reflex may lead to retention of secretions {01} {07})
Sensitivity to chlophedianol
Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention
Incidence rare
CNS stimulant effects {01}{02}{05}{06}(hallucinations; nightmares; unusual excitement or irritability)
hypersensitivity {01}{02}{05}{06}(skin rash; hives)
With large doses
Anticholinergic effects {01}{02}{05}{06}(blurred vision; dizziness; drowsiness; dryness of the mouth; nausea; vomiting)
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Chlophedianol (Systemic).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Sensitivity to chlophedianol
Other medical problems, especially a productive cough
Proper use of this medication
Not taking liquids immediately after taking medication
» Importance of not taking more medication than the amount prescribed
» Proper dosing
Missed dose (if on regular dosing schedule): Taking as soon as possible; not taking if almost time for next dose; not doubling doses
» Proper storage
Precautions while using this medication
Checking with physician if cough persists after medication has been used for 7 days or if high fever, skin rash, or continuing headache is present with cough
» Avoiding use of alcohol or other CNS depressants
» Caution in taking appetite suppressants or drinking large amounts of xanthine-containing beverages during therapy
» Caution if drowsiness occurs
Side/adverse effects
Signs of potential side effects, especially CNS stimulant effects, hypersensitivity, or anticholinergic effects (with large dose)
General Dosing Information
Liquids should not be taken immediately after the syrup is taken because soothing effects will be decreased. {04}
Reduced dosage may be necessary in sedated or debilitated patients since excessive depression of the cough reflex might be undesirable in these patients. {01}
Oral Dosage Forms
CHLOPHEDIANOL HYDROCHLORIDE SYRUP
Usual adult and adolescent dose
Antitussive
Oral, 25 mg every six to eight hours as needed. {01} {05} {07}
Usual pediatric dose
Antitussive
Children up to 2 years of age: Dosage has not been established. {01} {07}
Children 2 to 6 years of age: Oral, 12.5 mg every six to eight hours as needed. {01} {07}
Children 6 to 12 years of age: Oral, 12.5 to 25 mg every six to eight hours as needed. {01} {07}
Usual geriatric dose
See Usual adult and adolescent dose .
Strength(s) usually available
U.S.—
Not commercially available.
Canada—
25 mg per 5 mL (OTC) [Ulone]
Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a light-resistant container, unless otherwise specified by manufacturer. Protect from freezing.
Auxiliary labeling:
• May cause drowsiness.
• Avoid alcoholic beverages.
Revised: 02/23/1994
References
- Ulo package insert (Riker—US), Rev 8/80.
- McEvoy GK, editor. AHFS Drug information. Bethesda, MD: American Society of Hospital Pharmacists, 1963.
- Drugs of Choice 1980-81: 459.
- Medication Guide for Patient Counseling, pp 166.
- Federal Register 09/15/88; 53(179): 35089.
- Diwan J, Dhand R, Jindal SK, et al. A comparative randomized double-blind clinical trial of isoaminile citrate and chlophedianol hydrochloride as antitussive agents. Int J Clin Pharmacol Ther Toxicol 1982; 20(8): 373-5.
- Ulone package insert (3M Pharmaceuticals, Canada). In: Compendium of Pharmaceuticals and Specialties 1993: 1281.
- Irwin RS, Curley FJ, Bennett FM. Appropriate use of antitussives and protussives. Drugs 1993; 46(1): 80-91.
- Letter from manufacturer (Riker), Rec 10/27/82.
- Irwin RS, Curley FJ, Pratter MR. The effects of drugs on cough. Eur J Respir Dis Suppl 1987; 153: 173-81.
- Irwin RS, Curley FJ, Bennett FM. Appropriate use of antitussives and protussives. Drugs 1993; 46(1): 80-91.
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