Guaifenesin / Codeine Phosphate

Pronunciation: gwye-FEN-e-sin/KOE-deen FOS-fate
Class: Antitussive with expectorants

Trade Names

Allfen CD
- Tablets codeine 10 mg/guaifenesin 400 mg

Allfen CDX
- Tablets codeine 20 mg/guaifenesin 400 mg
- Liquid codeine 20 mg/guaifenesin 200 mg

Brontex
- Tablets codeine phosphate 10 mg/guaifenesin 300 mg

CGU WC
- Liquid codeine 6.3 mg/guaifenesin 100 mg per 5 mL

Cheratussin AC
- Syrup codeine 10 mg/guaifenesin 100 mg per 5 mL

Dex-Tuss
- Liquid codeine 10 mg/guaifenesin 300 mg

ExeClear-C
- Syrup codeine 10 mg/guaifenesin 200 mg per 5 mL

Gani-Tuss NR
- Liquid codeine 10 mg/guaifenesin 100 mg

M-Clear
- Capsules codeine 9 mg/guaifenesin 200 mg

M-Clear WC
- Liquid codeine 6.3 mg/guaifenesin 100 mg per 5 mL

Mar-Cof CG
- Syrup codeine phosphate 7.5 mg/guaifenesin 225 mg per 5 mL

Mytussin AC
- Syrup codeine phosphate 10 mg/guaifenesin 100 mg per 5 mL

Pro-Clear
- Capsules codeine 9 mg/guaifenesin 200 mg

Romilar AC
- Syrup codeine phosphate 10 mg/guaifenesin 100 mg per 5 mL

Tussi-Organidin NR
- Liquid codeine 10 mg/guaifenesin 300 mg

Tussi-Organidin-S NR
- Liquid codeine 10 mg/guaifenesin 300 mg

Tussiden C
- Liquid codeine 10 mg/guaifenesin 300 mg

Tusso-C
- Syrup codeine 10 mg/guaifenesin 200 mg

Pharmacology

Guaifenesin

May enhance output of respiratory tract fluid by reducing adhesiveness and surface tension, enhancing removal of viscous mucus, and making nonproductive coughs more productive and less frequent.

Slideshow: The Shocking Truth About Antibiotic Resistance

Codeine

Stimulates opiate receptors in CNS; also causes suppression of cough.

Indications and Usage

Temporary control of cough caused by minor throat and bronchial irritation as occurs with common cold or inhaled irritants; assists in loosening phlegm (mucus) and thins bronchial secretions to make cough more productive; for the treatment of lower respiratory tract symptoms, including asthma ( Allfen CDX liquid)

Contraindications

Hypersensitivity to any component of the product or morphine derivatives; asthma; pregnancy or breast feeding ( CGO WC , M-Clear WC ).

Dosage and Administration

Maximum dose
Adults

Codeine 120 mg/day; guaifenesin 2,400 mg/day.

Children 12 yr of age and older

Codeine 120 mg/day; guaifenesin 2,400 mg/day.

Children 6 to younger than 12 yr of age

Codeine 60 mg/day; guaifenesin 1,200 mg/day.

Children 5 years of age

Codeine 20 mg/day; guaifenesin 540 mg/day.

Children 4 years of age

Codeine 16 mg/day; guaifenesin 480 mg/day.

Children 3 years of age

Codeine 14 mg/day; guaifenesin 420 mg/day.

Children 2 years of age

Codeine 12 mg/day; guaifenesin 360 mg/day.

Adults

For specific dosing by product, refer to the individual manufacturer's prescribing information.

Cough Usual dosage

Codeine 7.5 to 20 mg every 4 to 6 h.

Maximum dose

Codeine 120 mg/day; guaifenesin 2,400 mg/day.

Children

For specific dosing by product, refer to the individual manufacturer's prescribing information.

Cough 12 yr of age and older Usual dosage

Codeine 7.5 to 20 mg every 4 to 6 h.

Maximum dose

Codeine 120 mg/day; guaifenesin 2,400 mg/day.

6 to younger than 12 yr of age Usual dosage

Codeine 3.75 to 10 mg every 4 to 6 h.

Maximum dose

Codeine 60 mg/day; guaifenesin 1,200 mg/day.

5 yr of age Usual dosage

Codeine 4.5 to 5 mg every 4 to 6 h.

Maximum dose

Codeine 20 mg/day; guaifenesin 540 mg/day.

4 yr of age Usual dosage

Codeine 2.5 to 4 mg every 4 to 6 h.

Maximum dose

Codeine 16 mg/day; guaifenesin 480 mg/day.

3 yr of age Usual dosage

Codeine 2.5 to 3.5 mg every 4 to 6 h.

Maximum dose

Codeine 14 mg/day; guaifenesin 420 mg/day.

2 yr of age Usual Dosage

Codeine up to 3 mg every 4 to 6 h.

Maximum dose

Codeine 12 mg/day; guaifenesin 360 mg/day.

Younger than 2 yr of age

Not recommended.

General Advice

  • Give with food or milk if GI upset occurs.
  • Administer with special measuring device for accurate dose
  • Use dosing spoon or syringe for pediatric patients.
  • Shake suspension/liquid well before use.

Storage/Stability

Store at 59° to 86°F. Protect from light and moisture.

ExeClear-C syrup, M-Clear capsules, Pro-Clear capsules

Store at 68° to 77°F. Protect from light

Drug Interactions

Anticholinergics (eg, atropine, orphenadrine, scopolamine)

Risk of paralytic ileus may be increased.

Alcohol, antihistamines (eg, diphenhydramine), antidepressants (eg, MAOIs), psychotropics, sedatives (eg, barbiturates), tranquilizers (eg, benzodiazepines)

May cause increased drowsiness. Do not use concurrently with MAOIs or within 2 wk after stopping an MAOI.

Laboratory Test Interactions

May cause color interference with the vanillylmandelic acid test for catechols and may falsely elevate the level of 5-HIAA in certain serotonin metabolite chemical tests.

Adverse Reactions

Cardiovascular

Bradycardia; circulatory depression; faintness; orthostatic hypotension; palpitations; syncope; tachycardia.

CNS

CNS depression; convulsions; depression; disorientation; dizziness; drowsiness; dysphoria; euphoria; headache; light-headedness; sedation; transient hallucinations.

Dermatologic

Pruritus; rash; urticaria.

EENT

Visual disturbances; miosis.

GI

Abdominal pain; biliary tract spasm; constipation; increased colonic motility in patients with chronic ulcerative colitis; nausea; stomach pain; toxic dilation in patients with acute ulcerative colitis; vomiting.

Genitourinary

Antidiuretic effect; oliguria; urinary retention.

Hypersensitivity

Allergic reaction; anaphylactic reaction, angioedema, angioneurotic edema, laryngeal edema.

Respiratory

Respiratory depression; shortness of breath.

Miscellaneous

Facial flushing; sweating; weakness.

Precautions

Pregnancy

Category C .

Lactation

Codeine

Excreted in breast milk.

Guaifenesin

Undetermined.

Children

Not recommended for children younger than 2 yr of age.

Brontex

Not recommended for children younger than 12 yr of age.

M-Clear capsules and Pro-Clear capsules

Not recommended for children younger than 6 yr of age.

Elderly

Use with caution.

Renal Function

Use with caution.

Hepatic Function

Use with caution.

Special Risk Patients

Do not use in patients with heart diseases, high blood pressure, thyroid disease, diabetes, those with difficulty in urination caused by enlargement of the prostate gland, or in asthmatic patients. Use with caution in young, elderly, or debilitated patients and those with hepatic or renal impairment, atopic children, Addison disease, convulsive disorders, fever, hypothyroidism, prostatic hypertrophy, ulcerative colitis, severe head injury, increased intracranial pressure, acute abdominal condition, severe CNS depression, severe respiratory depression, or in patients prone to respiratory depression, acute alcoholism, or pulmonary disease, and patients with decreased respiratory reserve, or recent GI or urinary tract surgery.

Constipation

Codeine may cause or aggravate constipation.

Dependence

Codeine has abuse potential; may be habit forming.

Hypotension

Codeine may produce orthostatic hypotension in ambulatory patients.

Persistent cough

Persistent cough may be a sign of a serious condition. Consult health care provider for a cough of more than 1 wk duration or for a cough accompanied by fever, rash, or persistent headache. Do not use for chronic or persistent cough, cough accompanied by excessive phlegm (mucus), shortness of breath, or chronic pulmonary disease without consulting health care provider.

Phenylketonurics

Tusso-C contains phenylalanine, use with caution in patients with phenylketonuria.

Tartrazine

M-Clear capsules and Pro-Clear capsules contain tartrazine.

Ultra-rapid metabolizers of codeine

May experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing.

Unresponsiveness

The codeine dose should not be increased if cough fails to respond; unresponsive coughs should be reevaluated in 5 days or sooner for possible underlying pathology.

Overdosage

Symptoms

Apnea, bradycardia, cardiac arrest, Cheyne-Stokes respiration, circulatory collapse, cold and clammy skin, constricted pupils, death, delirium, delusions, double vision, dyspnea, excitement, extreme somnolence progressing to stupor and coma, hallucinations, hypotension, miosis (mydriasis may occur in terminal necrosis or hypoxia), restlessness, respiratory depression, skeletal muscle flaccidity, speech disturbances, vertigo.

Patient Information

  • Advise patient to take dose as prescribed and not to exceed that dose.
  • Advise patient to take with food or milk if GI upset occurs.
  • Advise patients to drink extra fluids.
  • Instruct patients or caregiver to obtain and use a dispensing device (eg, dropper calibrated for age or weight) to administer the drug to a child.
  • Advise patient that if a dose is missed to take as soon as remembered unless it is nearing time for the next dose. Caution patient to not double the dose to catch up.
  • Advise patient that if cough is not controlled, not to increase the dose of medication but to inform health care provider.
  • Caution patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Advise patient to avoid alcohol and other CNS depressants because of risk of excessive sedation.
  • Advise patient to avoid prolonged exposure to the sun.

Copyright © 2009 Wolters Kluwer Health.

Hide
(web3)