POLY-TUSSIN EX

POLY-TUSSIN EX- dihydrocodeine bitartrate, phenylephrine hydrochloride and guaifenesin syrup
Poly Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Poly-Tussin EX Syrup

Rx Only
CIII
DESCRIPTION
Each 5 mL (one teaspoonful) for oral administration contains:
Dihydrocodeine Bitartrate……………… 7.5 mg
(WARNING — May be habit forming)
Phenylephrine HCl……………………….. 5 mg
Guaifenesin………………………………. 50 mg
This product contains the following inactive ingredients:
Purified Water, Propylene Glycol, Citric Acid, Sodium Citrate, Sodium Saccharin, Glycerin, Sorbitol,
Grape Flavor, Bitter Mask.
This product contains ingredients of the following therapeutic classes: Antitussive, Decongestant and
Expectorant.
Dihydrocodeine Bitartrate is an antitussive with the chemical name Morphinan-6-ol,4,5-epoxy-3-methoxy-
17-methyl-, (5α, 6α)-2,3-dihydroxybutanedioate (1:1) (salt). It has the following structural formula:
POLY-TUSSIN EX Packaging
Phenylephrine hydrochloride is an orally effective nasal decongestant. Chemically it is benzenemethanol,
3-hydroxy-α-[(methylamino)methyl]-, hydrochloride (R)-. Its chemical structure is as follows:
POLY-TUSSIN EX Packaging
Guaifenesin is an expectorant with the chemical name 1, 2-Propanediol, 3-(2-methoxyphenoxy)-(±)-. It has
the following structural formula:
POLY-TUSSIN EX PackagingPOLY-TUSSIN EX PackagingPOLY-TUSSIN EX PackagingPOLY-TUSSIN EX Packaging

CLINICAL PHARMACOLOGY

Dihydrocodeine is a semisynthetic narcotic analgesic/antitussive related to codeine, with multiple

actions qualitatively similar to those of codeine: the most prominent of these involve the central

nervous system and organs with smooth muscle components.

Phenylephrine HCl is a sympathomimetic, which acts predominately on alpha-receptors and has

little action on beta-receptors. It therefore functions as an oral nasal decongestant with minimal

CNS stimulation.

Guaifenesin is an expectorant, which increases respiratory tract fluid secretions and helps to

loosen phlegm and bronchial secretions. By reducing the viscosity of secretions, guaifenesin

increases the efficiency of the cough reflex and of ciliary action in removing accumulated

secretions from the trachea and bronchi.

POLY-TUSSIN EX Indications and Usage

This product is indicated for the temporary relief of nasal congestion and dry, non-productive

cough associated with upper respiratory tract infections and allergies.

CONTRAINDICATIONS

This combination product is contraindicated in patients with hypersensitivity to dihydrocodeine,

codeine, or any of the active or inactive components listed above, or in any situation where

opioids are contraindicated including significant respiratory depression (in unmonitored settings

or in the absence of resuscitation equipment), acute or severe bronchial asthma or hypercapnia,

and paralytic ileus. Sympathomimetic agents are contraindicated in patients with severe

hypertension, severe coronary artery disease, patients with narrow angle glaucoma, bronchial

asthma, urinary retention, peptic ulcer, and during an asthmatic attack. This product is

contraindicated in women who are pregnant.

WARNINGS

General: Considerable caution should be exercised in patients with hypertension, diabetes mellitus,

ischemic heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy.

The elderly (60 years and older) are more likely to exhibit adverse reactions.

Usage in Ambulatory Patients: Dihydrocodeine may impair the mental and/or physical abilities

required for the performance of potentially hazardous tasks such as driving a car or operating

machinery.

Respiratory Depression: Respiratory depression is the most dangerous acute reaction produced by

opioid agonist preparations, although it is rarely severe with usual doses. Opioids decrease the

respiratory tidal volume, minute ventilation, and sensitivity to carbon dioxide. Respiratory depression

occurs most frequently in elderly or debilitated patients, usually after large initial doses in

non-tolerant patients, or when opioids are given in conjunction with other agents that depress

respiration. This combination product should be used with caution in patients with significant chronic

obstructive pulmonary disease or cor pulmonale and in patients with a substantially decreased

respiratory reserve, hypoxia, hypercapnia, or respiratory depression.

Hypertensive Effect: Dihydrocodeine, like all opioid analgesics, may cause hypotension in patients

whose ability to maintain blood pressure has been compromised by a depleted blood volume or who

received concurrent therapy with drugs such as phenothiazine or other agents which compromise

vasomotor tone. This product may produce orthostatic hypotension in ambulatory patients. This

combination product should be administered with caution to patients with circulatory shock since

vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Dependence: Dihydrocodeine can produce drug dependence of the codeine type and has the

potential of being abused. This product should be prescribed and administered with the appropriate

degree of caution (See Drug Abuse and Dependence section).

PRECAUTIONS

General: This combination product should be used with caution in elderly or debilitated patients

or those with any of the following conditions: adrenocortical insufficiency (e.g., Addison’s disease);

asthma; central nervous system depression or coma; chronic obstructive pulmonary disease;

decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or

kyphoscoliosis); delirium tremens; diabetes, head injury; hypotension; hypertension; increased

intracranial pressure; myxedema or hypothyroidism; prostatic hypertrophy or urethral structure;

and toxic psychosis. The benefits and risks of opioids in patients taking monoamine oxidase

inhibitors and in those with a history or drug abuse should be carefully considered. This

combination product may aggravate convulsions in patients with convulsive disorders, and like

all opioids, may induce or aggravate seizures in some clinical settings.

Drug Interactions:

General: Sympathomimetic amines may reduce the antihypertensive effects of methyldopa,

mecamylamine, reserpine, and veratrum alkaloids.

Other CNS Depressants: Patients receiving other opioid analgesics, sedatives or hypnotics,

muscle relaxants, general anesthetics, centrally acting anti-emetics, phenothiazines or other

tranquilizers, or alcohol concomitantly with this product may exhibit additive depressant

effects on the central nervous system. When such combination therapy is contemplated, the

dose of one or both agents should be reduced. Concomitant use of dihydrocodeine with alcohol

and other CNS depressants may have an additive effect.

Monoamine Oxidase Inhibitors: Dihydrocodeine, like all opioids, interact with monoamine

oxidase inhibitors causing central nervous system excitation and hypertension. MAO inhibitors

and beta-adrenergic blockers increase the effects of sympathomimetics.

Information for Patients:

Patients receiving this product should be given the following information:

  • This product may inhibit mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
  • Report any adverse experiences occurring during therapy.
  • Do not adjust the dose of this product without consulting the prescribing professional.
  • Do not combine this product with alcohol or other central nervous system depressants.
  • Women of childbearing potential who become, or are planning to become pregnant should be advised to consult their physician regarding the effects of opioids and other drug use during pregnancy on themselves and their unborn child.
Patients should be advised that this product is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.

Pregnancy:

Teratogenic Effects — Pregnancy Category C: Animal reproduction studies have not been conducted

with this product. It is also not known whether this combination product can cause fetal harm when

administered to pregnant women or can effect reproduction capacity in males and females. This

combination product should be given to a pregnant woman only if clearly needed, especially during

the first trimester.

Nonteratogenic Effects:

Babies born to mothers who have been taking opioids regularly prior to delivery will be physically

dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes,

increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of

the syndrome does not always correlate with the duration of the maternal opioid use or dose. There is

no consensus on the best method of managing withdrawal. Chlorpromazine 0.7-1.0 mg/kg q6h,

phenobarbital 2 mg/kg q6h, and paregoric 2-4 drops/kg q4h, have been used to treat withdrawal

symptoms in infants. The duration of therapy is 4 to 28 days, with dosages decreased as tolerated.

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