Hycotuss expectorant syrup

HYCOTUSS Expectorant Syrup contains hydrocodone (dihydrocodeinone) bitartrate, a semi-synthetic centrally-acting opioid antitussive and guaifenesin, an expectorant for oral administration.

HYCOTUSS Expectorant Syrup also contains: artificial butterscotch flavor, FD&C Red 40, FD&C Yellow 6, glycerin, liquid sugar, methylparaben, propylparaben, saccharin sodium, and sorbitol solution.

HYCOTUSS (hydrocodone bitartrate and guaifenesin) Expectorant Syrup is indicated for the symptomatic relief of irritating non-productive cough associated with upper and lower respiratory tract congestion.

May be habit forming. Hydrocodone can produce drug dependence of the morphine type and therefore has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of HYCOTUSS Expectorant Syrup and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs (See DRUG ABUSE AND DEPENDENCE ).

Respiratory Depression:   HYCOTUSS Expectorant Syrup produces dose-related respiratory depression by directly acting on the brain stem respiratory centers. If respiratory depression occurs, it may be antagonized by the use of NARCAN (naloxone hydrochloride) and other supportive measures when indicated.

Head Injury and Increased Intracranial Pressure: The respiratory depressant properties of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions:   The administration of HYCOTUSS Expectorant Syrup or other opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Respiratory System:   Hydrocodone produces dose-related respiratory depression by acting directly on brain stem respiratory centers.

Cardiovascular System:   Hypertension, postural hypotension and palpitations.

Genitourinary System:   Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates.

Central Nervous System:   Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes and blurred vision.

Gastrointestinal System:   Nausea and vomiting occur more frequently in ambulatory than in recumbent patients.

DRUG ABUSE AND DEPENDENCE

Special care should be exercised in prescribing hydrocodone for emotionally unstable patients and for those with a history of drug misuse. Such patients should be closely supervised when long-term therapy is contemplated.

HYCOTUSS Expectorant Syrup is a Schedule III opioid. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of opioids; therefore, HYCOTUSS Expectorant Syrup should always be prescribed and administered with caution. Physical dependence is the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome.

Patients physically dependent on opioids will develop an abstinence syndrome upon abrupt discontinuation of the opioid or following the administration of a opioid antagonist. The character and severity of the withdrawal symptoms are related to the degree of physical dependence. Manifestations of opioid withdrawal are similar to but milder than that of morphine and include lacrimation, rhinorrhea, yawning, sweating, restlessness, dilated pupils, anorexia, gooseflesh, irritability and tremor. In more severe forms, nausea, vomiting, intestinal spasm and diarrhea, increased heart rate and blood pressure, chills, and pains in bones and muscles of the back and extremities may occur. Peak effects will usually be apparent at 48 to 72 hours.

Treatment of withdrawal is usually managed by providing sufficient quantities of an opioid to suppress severe withdrawal symptoms and then gradually reducing the dose of opioid over a period of several days.

Usual Adult Dose:   One teaspoonful (5 mL) after meals and at bedtime, not less than 4 hours apart (not to exceed 6 teaspoonsful in a 24 hour period). Treatment should be initiated with one teaspoonful and subsequent doses, up to a maximum single dose of 3 teaspoonsful, adjusted if required.

Usual Children's Dose:

Over 12 years: Initial dose 1 teaspoonful; maximum single dose, 2 teaspoonsful.

6 to 12 years: Initial dose 1 / 2 teaspoonful; maximum single dose, 1 teaspoonful.