Professional Information

Hydrocodone Bitartrate / Potassium Guaiacolsulfonate

Pronouncation: (hye-droe-KOE-done bye-TAR-trate/po-TAS-ee-um GWYE-a-klo-sul-FON-ate)
Class: Upper respiratory combination

Trade Names:
Entuss Expectorant
- Liquid 5 mg Hydrocodone Bitartrate/300 mg Potassium Guaiacolsulfonate per 5 mL

Trade Names:
Hydron EX
- Liquid 2.5 mg Hydrocodone Bitartrate/120 mg Potassium Guaiacolsulfonate per 5 mL

Trade Names:
Hydron KGS
- Liquid 5 mg Hydrocodone Bitartrate/300 mg Potassium Guaiacolsulfonate per 5 mL

Trade Names:
Jaycof CIII Expectorant
- Liquid 5 mg Hydrocodone Bitartrate/350 mg Potassium Guaiacolsulfonate per 5 mL

Trade Names:
M-Clear
- Liquid 5 mg Hydrocodone Bitartrate/400 mg Potassium Guaiacolsulfonate per 5 mL

Trade Names:
Marcof Expectorant
- Liquid 5 mg Hydrocodone Bitartrate/350 mg Potassium Guaiacolsulfonate per 5 mL

Trade Names:
MC Cough Syrup
- Liquid 5 mg Hydrocodone Bitartrate/400 mg Potassium Guaiacolsulfonate per 5 mL

Trade Names:
MCJR Cough Syrup
- Liquid 2.5 mg Hydrocodone Bitartrate/175 mg Potassium Guaiacolsulfonate per 5 mL

Trade Names:
Mintuss NX
- Liquid 3 mg Hydrocodone Bitartrate/150 mg Potassium Guaiacolsulfonate per 5 mL

Trade Names:
Pro-Clear Antitussive/Expectorant
- Liquid 3 mg Hydrocodone Bitartrate/350 mg Potassium Guaiacolsulfonate per 5 mL

Trade Names:
Prolex DH
- Liquid 4.5 mg Hydrocodone Bitartrate/300 mg Potassium Guaiacolsulfonate per 5 mL

Indications and Usage

Temporary relief of dry, nonproductive cough due to colds, pertussis, or influenza.

Contraindications

Hypersensitivity to any component of the product; hypersensitivity to opioids; intracranial lesion associated with increased intracranial pressure; depressed ventilatory function.

Dosage and Administration

Adults and Children 12 yr of age and older

Entuss , Hydron KGS , Jaycof , Prolex DH

5 to 7.5 mL up to 4 times daily.

Hydron EX , Mintuss NX

10 to 15 mL every 4 to 6 h (max, 4 doses [60 mL] in 24 h).

M-Clear , MC Cough Syrup

5 mL every 4 to 6 h (max, 30 mL in 24 h).

Marcof Expectorant

5 mL after meals and at bedtime, at least 4 h apart (max, 30 mL in 24 h).

MCJR Cough Syrup

5 to 10 mL up to 4 times daily.

Pro-Clear

5 to 10 mL every 4 to 6 h (max, 4 doses in 24 h).

Children 6 to 12 yr of age

Entuss , Hydron KGS , Jaycof , MCJR Cough Syrup , Prolex DH

2.5 to 5 mL up to 4 times daily.

Hydron EX

5 to 10 mL every 4 to 6 h (max, 40 mL in 24 h).

M-Clear , MC Cough Syrup

2.5 mL every 4 to 6 h (max, 15 mL in 24 h).

Marcof Expectorant

2.5 mL after meals and at bedtime, at least 4 h apart (max, 15 mL in 24 h).

Mintuss NX

5 to 7.5 mL every 4 to 6 h (max, 4 doses in 24 h).

Pro-Clear

5 mL every 4 to 6 h (max, 4 doses in 24 h).

Children 3 to 6 yr of age

Entuss , Hydron KGS , Jaycof , MCJR Cough Syrup , Prolex DH

1.25 to 2.5 mL up to 4 times daily.

Hydron EX (2 to 6 yr of age)

2.5 to 5 mL every 4 to 6 h (max, 20 mL in 24 h).

Mintuss NX (2 to 6 yr of age)

2.5 to 5 mL every 4 to 6 h (max, 4 doses in 24 h).

Pro-Clear (2 to 6 yr of age)

2.5 mL every 4 to 6 h (max, 4 doses in 24 h).

General Advice

Dose in children younger than 12 yr of age should be based on hydrocodone 0.6 mg/kg/day in equally divided doses, 4 times daily.

Storage/Stability

Store at 59° to 86°F.

Drug Interactions

General anesthetics, other narcotics, phenothiazines or other tranquilizers, sedative-hypnotics or other CNS depressants

Additive CNS depression; dosage adjustments may be needed.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypertension, palpitations, postural hypotension.

CNS

Anxiety, dizziness, drowsiness, dysphoria, fear, giddiness, impaired mental and physical performance, lassitude, lethargy, mental clouding, mood changes, psychic dependence, sedation.

EENT

Blurred vision.

GI

Constipation, nausea, vomiting.

Genitourinary

Spasm of vesical sphincters, ureteral spasm, urinary retention.

Respiratory

Dose-related respiratory depression.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Not recommended for use in children younger than 3 yr of age (2 yr of age for Hydron EX , Mintuss NX , and Pro-Clear ).

Marcof Expectorant

Safety and efficacy not established in children younger than 6 yr of age.

Acute abdominal conditions

Diagnosis may be obscured.

Dependence

Hydrocodone has abuse potential; may be habit-forming.

Head injury and increased intracranial pressure

Narcotic adverse reactions may obscure the clinical course of patients with head injuries; respiratory depression properties and the capacity of hydrocodone to elevate CSF pressure may be obscured.

Nonteratogenic effects

Babies born to mothers who have been taking hydrocodone regularly prior to delivery will be physically dependent.

Respiratory depression

Dose-related respiratory depression occurs.

Special risk patients

Use with caution in elderly or debilitated patients, and in those with hepatic or renal function impairment.

Overdosage

Symptoms

Apnea, bradycardia, cardiac arrest, circulatory collapse, cold and clammy skin, death, extreme somnolence progressing to stupor or coma, hypotension, respiratory depression, skeletal muscle flaccidity.

Patient Information

Advise the patient that drug may cause drowsiness, or impaired judgment or thinking and to use caution while driving, riding a bike, or performing other tasks requiring alertness until tolerance is determined.