Entex (Phenylpropanolamine HCI – Guaifenesin)

ENTEX® LA

Purdue Frederick

Phenylpropanolamine HCI – Guaifenesin

Decongestant – Expectorant

Action And Clinical Pharmacology: Phenylpropanolamine is an alpha-adrenergic receptor agonist (sympathomimetic) which produces vasoconstriction by stimulating alpha-receptors within the mucosa of the respiratory tract. Clinically, phenylpropanolamine shrinks swollen mucous membranes, reduces tissue hyperemia, edema and nasal congestion, and increases nasal airway patency.

Guaifenesin promotes lower respiratory tract drainage by thinning bronchial secretions, lubricates irritated respiratory tract membranes through increased mucus flow, and facilitates removal of viscous, inspissated mucus. As a result of these combined actions, sinus and bronchial drainage is improved, and dry, nonproductive coughs become more productive.

Indications And Clinical Uses: Reduces swelling of nasal passages, helps decongest sinus openings and promote nasal and/or sinus drainage. Helps drain bronchial tubes by thinning mucus and relieves irritated membranes in the respiratory passageways by preventing dryness through increased mucus flow.

Contra-Indications: Known hypersensitivity to sympathomimetics, severe hypertension, or in patients receiving MAO inhibitors.

Manufacturers’ Warnings In Clinical States: Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy.

Precautions: Should not be taken by persons who have high blood pressure, heart or thyroid disease, diabetes, persistent/chronic cough; or by pregnant/nursing women; or by persons taking high blood pressure medication or an antidepressant containing a monoamine oxidase inhibitor, except under the advice and supervision of a physician. Consult your physician if symptoms do not improve within 7 days, if cough worsens or is accompanied by high fever, if you have peripheral vascular disease, glaucoma, or prostate disease. Do not exceed recommended dosage. Keep all medicines out of the reach of children. Do not crush or chew tablets.

Drug Interactions: Do not use in patients taking other sympathomimetics or MAO inhibitors.

Drug/Laboratory Test Interactions : Guaifenesin has been reported to interfere with clinical laboratory determinations of urinary 5-hydroxyindole- acetic acid (5-HIAA) and urinary vanillylmandelic acid (VMA).

Pregnancy: It is not known whether Entex LA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Should not be used in pregnancy unless the potential benefits outweigh the possible risks.

Lactation: Not known whether the drugs in Entex LA are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the product, taking into account the importance of the drug to the mother.

Children: Not recommended for children under 6 years of age.

Adverse Reactions: Possible adverse effects include nervousness, insomnia, restlessness, dizziness, headache, nausea, or gastric irritation. These reactions rarely, if ever, require discontinuation of therapy. Chest tightness has been reported on occasion. Urinary retention may occur in patients with prostatic hypertrophy.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Provide symptomatic and supportive care. If the amount ingested is considered dangerous or excessive, induce vomiting with ipecac syrup unless the patient is convulsing, comatose, or has lost the gag reflex, in which case perform gastric lavage using a large-bore tube. If indicated, follow with activated charcoal and saline cathartic. Since the effects of Entex LA may last up to 12 hours, continue treatment for at least that length of time.

Dosage And Administration: Adults and children 12 years of age and over: 1 tablet twice daily (every 12 hours).

Children 6 to under 12 years of age: 1/2 a tablet twice daily (every 12 hours). Not recommended for children under 6 years of age.

Tablets may be broken in half for ease of administration without affecting release of medication but should not be crushed or chewed prior to swallowing.

Availability And Storage: Each blue, scored tablet, imprinted “PF”, contains: phenylpropanolamine HCl 75 mg and guaifenesin 600 mg, in a special base to provide a prolonged therapeutic effect. Nonmedicinal ingredients: FD&C Blue #1, carbomer 934P, compressible sugar, stearic acid and zinc stearate. Bisulfite-, gluten-, lactose-, paraben-, sodium- and tartrazine-free. Bottles of 100 and boxes of 12 individually foil-packed tablets. Store below 30°C protected from moisture.

ENTEX® LA Purdue Frederick Phenylpropanolamine HCI – Guaifenesin Decongestant – Expectorant

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