Dihydrocodeine Bitartrate / Phenylephrine Hydrochloride / Guaifenesin

Pronunciation: dye-HYE-droe-KOE-deen bye-TAR-trate/FEN-il-EF-rin HYE-droe-KLOR-ide/gwye-FEN-e-sin
Class: Antitussive, Decongestant, Expectorant

Trade Names

Donatuss DC
- Syrup dihydrocodeine bitartrate 7.5 mg/phenylephrine hydrochloride 7.5 mg/guaifenesin 50 mg per 5 mL

Pharmacology

Dihydrocodeine

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

Guaifenesin

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

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Phenylephrine

Stimulates postsynaptic alpha-receptors, resulting in vasoconstriction, which reduces congestion.

Indications and Usage

Temporary relief of nasal congestion and dry, nonproductive cough associated with upper respiratory tract infections and allergies.

Contraindications

Hypersensitivity to dihydrocodeine, codeine, or any component of the product; significant respiratory depression in unmonitored settings or in the absence of resuscitation equipment; acute or bronchial asthma or hypercapnia; paralytic ileus; severe hypertension; severe coronary artery disease; narrow-angle glaucoma; urinary retention; peptic ulcer; pregnancy.

Dosage and Administration

Maximum dose
Adults and Children 12 yr of age and older

Dihydrocodeine 90 mg/day; guaifenesin 600 mg/day; phenylephrine 90 mg/day.

Children 6 to younger than 12 yr of age

Dihydrocodeine 45 mg/day; guaifenesin 300 mg/day; phenylephrine 45 mg/day.

Adults

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

Cough and upper respiratory tract symptoms Usual dosage

5 to 10 mL every 4 to 6 h as needed.

Maximum dose

Dihydrocodeine 90 mg/day; guaifenesin 600 mg/day; phenylephrine 90 mg/day.

Children

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

Cough and upper respiratory tract symptoms Children 12 yr of age and older Usual dosage

5 to 10 mL every 4 to 6 h as needed.

Maximum dose

Dihydrocodeine 90 mg/day; guaifenesin 600 mg/day; phenylephrine 90 mg/day.

Children 6 to younger than 12 yr of age Usual dosage

2.5 to 5 mL every 4 to 6 h as needed.

Maximum dosage

Dihydrocodeine 45 mg/day; guaifenesin 300 mg/day; phenylephrine 45 mg/day.

Elderly

Use with caution; patients 60 yr of age and older are more likely to exhibit adverse reactions.

Renal function impairment

Use with caution and at a reduced dosage.

Hepatic function impairment

Use with caution.

General Advice

  • Administer without regard to meals. Administer with food if GI upset occurs.
  • A dispensing device (eg, dropper calibrated for age or weight) should be used to administer the drug to a child.
  • Administer with a full glass of water to help loosen mucus in the lungs.

Storage/Stability

Store at 59° to 86°F.

Drug Interactions

Anticholinergics (eg, atropine, orphenadrine, scopolamine)

Risk of paralytic ileus may be increased.

CNS depressants (eg, alcohol, centrally acting antiemetics, general anesthetics, hypnotics, muscle relaxants, phenothiazines, sedatives, tranquilizers)

May cause increased drowsiness.

Beta-adrenergic blockers, MAOIs

May potentiate the pressor effect of phenylephrine.

Guanethidine, mecamylamine, methyldopa, reserpine, veratrum alkaloids

Hypotensive effects of these agents may be reduced.

Laboratory Test Interactions

May cause color interference with the vanillylmandelic acid test for catechols. Guaifenesin may interfere with the interpretation of the test for urinary 5-hydroxyindoleacetic acid.

Adverse Reactions

Cardiovascular

Flushing; orthostatic hypotension; palpitations.

CNS

Confusion; dizziness; drowsiness; fatigue; giddiness; hallucinations; headache; increased irritability or excitement; lassitude; light-headedness; physical/psychological dependence; sedation; vivid dreams.

Dermatologic

Pruritus; skin reactions; sweating.

EENT

Blurred vision; miosis.

GI

Abdominal pain; anorexia; biliary tract spasm; constipation; diarrhea; dry mouth; indigestion; nausea; vomiting.

Genitourinary

Acute renal failure; granulomatous interstitial nephritis; urinary retention.

Hypersensitivity

Hypersensitivity reactions, including anaphylactic reaction.

Respiratory

Respiratory depression.

Miscellaneous

Severe narcosis.

Precautions

Pregnancy

Category C .

Lactation

Dihydrocodeine

Excreted in breast milk.

Guaifenesin

Undetermined.

Phenylephrine

Excreted in breast milk.

Children

Not recommended for children younger than 6 yr of age.

Elderly

Use with caution; patients 60 years of age and older are more likely to exhibit adverse reactions.

Renal Function

Use with caution and at a reduced dosage.

Hepatic Function

Use with caution.

Special Risk Patients

Use with caution in debilitated patients and those with acute abdominal condition, adrenocortical insufficiency (eg, Addison disease), biliary tract disease (including pancreatitis), circulatory shock, CNS depression, coma, convulsive disorders, delirium tremens, diabetes, fever, head injury, hypertension, hypothyroidism or hyperthyroidism, increased intracranial pressure, increased IOP, ischemic heart disease, obesity myxedema, prostatic hypertrophy, recent GI or urinary tract surgery, toxic psychosis, ulcerative colitis, or urethral structure.

Dependence

Dihydrocodeine has abuse potential; may be habit forming.

Hypotension

May occur, especially in patients who are volume depleted or who received concurrent therapy with drugs such as phenothiazine or other agents that compromise vasomotor tone. Orthostatic hypotension may occur in ambulatory patients.

Respiratory depression

Occurs more frequently in elderly or debilitated patients, when given in combination with other agents that depress respiration, or after large initial doses in nontolerant patients. Use with caution in patients with COPD, emphysema, kyphoscoliosis, or cor pulmonale, and in patients with substantially decreased respiratory reserve, hypercapnia, hypoxia, or respiratory depression.

Overdosage

Symptoms

Cold and clammy skin, convulsions, CV collapse, extreme somnolence progressing to stupor or coma, pinpoint pupils, respiratory depression, skeletal muscle flaccidity.

Patient Information

  • Advise patient to take prescribed dose every 4 to 6 h as needed.
  • 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 not to adjust the dose without consulting their 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 women of childbearing potential who become or are planning to become pregnant to consult their health care provider.

Copyright © 2009 Wolters Kluwer Health.

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