Gentex HC Liquid

RX only

DESCRIPTION
Antitussive
Nasal Decongestant
Expectorant
Each 5 mL(teaspoonful) of Gentex HC Liquid contains:
Hydrocodone*
Bitartrate….............. 2.5 mg
*(Warning: May be habit forming)
Phenylephrine
Hydrochloride......... 7.5 mg
Guaifenesin........... 100 mg

Hydrocodone Bitartrate is an opioid analgesic and antitussive. It occurs as fine white crystals or crystalline powder. It is affected by light. The chemical name is 4,5?-Epoxy-3-methoxy-17- methylmorphinan- 6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

C18H21NO3 o C4H6O6 o 2½H2O
M.W. 494.50

Phenylephrine hydrochloride is a sympathomimetic amine and occurs as bitter, white crystals. Its chemical name is Benzenemethanol, 3-hydroxy-?-[(methylamino)methyl]-,hydrochloride (R)-.
It has the following structural formula:

C9H13NO2 o HCl M.W. 203.67

Guaifenesin is an expectorant. Its chemical name is 3-(2-Methoxyphenoxy)-1,2-propanediol. It has the following structural formula:

C10H14O4 M.W. 198.22

In addition, Gentex HC Liquid contains the following as inactive ingredients: citric acid, edetate disodium, glycerin, methylparaben, propylparaben, propylene glycol, saccharin sodium, sodium citrate, sorbitol, water, FD&C red 40, artificial cherry flavor.

CLINICAL PHARMACOLOGY:
Hydrocodone Bitartrate is a potent antitussive which causes suppression of the cough reflex by direct action on the cough center of the brain. It exerts agonist activity primarily at the µ receptor. It is approximately three to eight times as potent as codeine on a weight basis and has a higher addiction potential.
Phenylephrine HCl is a sympathomimetic amine which acts predominantly on ?-receptors and has little action on ß-receptors. It therefore acts as an oral nasal decongestant with minimal CNS stimulation.
Guaifenesin has an expectorant action which increases the output of respiratory tract fluid by reducing adhesiveness and surface tension. The increased flow of less viscous secretions promotes
ciliary action and facilitates the removal of mucus. This changes a dry, non-productive cough to a cough that is more productive and less frequent.

INDICATIONS AND USAGE:
Gentex HC Liquid is indicated for the temporary relief of cough, nasal congestion, and other symptoms associated with colds or seasonal or perennial allergic vasomotor rhinitis (hay fever).

CONTRAINDICATIONS:
Gentex HC Liquid is contraindicated in patients with respiratory depression, severe hypertension, severe coronary artery disease, and in patients on monoamine oxidase inhibitor (MAOI) therapy. Gentex HC Liquid is also contraindicated in patients with urinary retention, peptic ulcer, or in patients with hypersensitivity to any of its ingredients. This medication should not be used in patients with diarrhea caused by poisoning, until toxic material has been eliminated from the gastrointestinal tract (opioids may slow elimination of toxic material, thereby worsening and prolonging the diarrhea).

WARNINGS:
Caution should be exercised in patients with severe hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure and prostatic hypertrophy. The elderly (60 years or older) are more likely to exhibit adverse reactions to this product.
Hydrocodone can produce drug dependence, and, therefore, has the potential for being abused (see Drug Abuse and Dependence section).

PRECAUTIONS:
General: Caution should be exercised in patients with high blood pressure, heart disease, diabetes, or thyroid disease. The hydrocodone in Gentex HC Liquid may exhibit additive effects with other CNS depressants, including alcohol.
Information for patients: This product may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly. Patient consultation should include the following information regarding the proper use of this medication:
o Do not take more medication than the amount recommended.
o Do not drive or operate heavy machinery if drowsiness or dizziness occurs.
o Do not ingest alcoholic beverages, MAOIs, or CNS depression-producing medications (hypnotics, sedatives, tranquilizers) while taking this product.
o If a dose is missed, the medication should be taken as soon as possible unless almost time for the next dose, do not double doses.
Drug Interactions: MAOIs and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Concomitant use of hydrocodone with alcohol and other CNS depressants may have additive effects.
Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term studies have been conducted to evaluate the carcinogenic or mutagenic potential of Gentex HC Liquid.
Pregnancy Category C: It is not known whether Gentex HC Liquid can cause fetal harm when administered to a pregnant woman. Risk-benefit must be considered because hydrocodone bitartrate crosses the placental barrier. The use of phenylephrine during late pregnancy may cause fetal anoxia and bradycardia by increasing contractility of the uterus and decreasing uterine blood flow.
Labor and Delivery : Opioids readily enter the fetal circulation when used during labor and may cause respiratory depression in the neonate, especially those that are premature. Hydrocodone bitartrate, like other opioids, may prolong labor.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Gentex HC Liquid is administered to a nursing woman.
Pediatrics: Children up to 2 years of age may be more susceptible to the respiratory depressant effects of hydrocodone. Paradoxical excitation is especially likely to occur in pediatric patients receiving opioids.
Geriatrics: The elderly (over 60 years of age) may be more susceptible to the respiratory depressant effects of hydrocodone. Elderly patients are more likely to have prostatic hypertrophy or obstruction and age-related renal function impairment, and are therefore more likely to be adversely affected by opioid-induced urinary retention. In addition, elderly patients may metabolize or eliminate this medication more slowly than younger adults. Lower doses or longer dosing intervals than those usually recommended for adults may be required.

ADVERSE REACTIONS:
Adverse reactions to Gentex HC Liquid may include drowsiness, lassitude, nausea, giddiness, gastrointestinal upset, and constipation.

DRUG ABUSE AND DEPENDENCE:
Gentex HC Liquid is a schedule III controlled substance. Because of the hydrocodone content, some abuse may be experienced. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration. It should be prescribed and administered with the degree of caution appropriate for this type of product.

OVERDOSE:
Signs and Symptoms:
Treatment for Gentex HC Liquid overdose would probably be based upon treating the patient for hydrocodone and/or phenylephrine toxicity. Signs and symptoms of overdose indicating need for prompt medical attention include the following:
o Cold, clammy skin
o Confusion
o Convulsions
o Dizziness, severe
o Drowsiness, severe
o Hypotension
o Hypertension
o Nervousness or restlessness, severe
o Pinpoint pupils of eyes
o Slow heartbeat
o Slow or troubled breathing
o Weakness, severe
o Chest pain
o Fast, irregular heartbeat
o Sensation of fullness in the head
o Tingling of hands or feet
o Vomiting
o Unconsciousness
Recommended treatment:
Treatment for Gentex HC Liquid overdose consists of the following:
o Empty the stomach via induction of emesis or gastric lavage.
o Administration of naloxone (400 mcg [0.4 mg] to 2 mg as a single dose, preferably intravenously).
o Administration of intravenous fluids
o For excessive hypertensive effect that may follow phenylephrine overdose, an alpha-adrenergic blocker such as phentolamine, may be administered.

DOSAGE AND ADMINISTRATION:
Adults and children 12 years and older: 2 teaspoonsful (10 mL). Children 6 to under 12 years of age: 1 teaspoonful (5 mL). Children 3 to under 6 years of age: 1/2 teaspoonful (2.5 mL). Doses may be repeated every 4 to 6 hours as required. Not to exceed 6 doses in 24 hours.
[Children under 3 years, at discretion of physician, however, dosage based on 0.3 mg/kg/24 hours divided into four equal doses have been suggested.]
NOTE: Under 2 years of age: Narcotic antitussives are not recommended for use in children under 2 years of age. Children under 2 years may be more susceptible to the respiratory depressant effect of narcotics, including respiratory arrest, coma, and death.

HOW SUPPLIED:
Gentex HC Liquid is supplied as a red, cherry flavored liquid in bottles of 16 oz.
(NDC 15014-003-16).

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFFESIONAL ASSISTANCE OR CONTACT A POISON
CONTROL CENTER IMMEDIATELY.

Store at controlled room temperature 59°- 86°F (15°- 30°C).
Dispense in tight, light resistant containers as defined in USP/NF with a child-resistant closure.

Manufactured for:
Gentex Pharma
Madison, MS 39110

500276 Iss. 10/2005

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