POLY HIST DHC

POLY HIST DHC- dihydrocodeine bitartrate, phenylephrine hydrochloride and pyrilamine maleate liquid
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 HIST DHC Liquid

CIII
NDC 50991-521-16
Rx Only
DESCRIPTION:
Each 5 mL (one teaspoonful) for oral administration contains:
Dihydrocodeine Bitartrate*…………………….. 7.5 mg
(*WARNING — May be habit forming)
Phenylephrine HCl……………………………… 5 mg
Pyrilamine Maleate…………………………….. 7.5 mg
POLY HIST DHC Liquid also contains: Citric Acid, Glycerin, Fruit Gum Flavor, Propylene Glycol,
Sorbitol, Purified Water, Sodium Citrate, Sodium Saccharin.
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) 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6α-ol (+)-tartrate (salt).
It has the following structural formula:
Dihydrocodeine Bitartrate Chemical Structure
Phenylephrine hydrochloride is an orally effective nasal decongestant. Chemically it is Benzenemethanol,
3-hydroxy-α-[(methylamino)methyl]-,hydrochloride (R)-, (-)-m -Hydroxy-α- [(methylamino)methyl]benzyl alcohol
hydrochloride. Its chemical structure is as follows:
Phenylephrine Hydrochloride Chemical Structure
Pyrilamine Maleate is an antihistamine having the chemical name 1,2-Ethanediamine, N-[(4-methoxyphenyl)methyl]-N’,
N’-dimethyl-N-2-pyridinyl-, (Z)-2-butenedioate (1:1) 2-[[2-Dimethylamino)ethyl](p -methoxybenzyl)amino] pyridine
maleate (1:1); Its structural formula is as follows:
Pyrilamine Maleate Chemical StructureDihydrocodeine Bitartrate Chemical StructurePhenylephrine Hydrochloride Chemical StructurePyrilamine Maleate Chemical Structure

CLINICAL PHARMACOLOGY

Dihydrocodeine is a semi-synthetic narcotic analgesic 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.

Pyrilamine Maleate is an antihistamine used in suppressing symptoms of allergic rhinitis. However, it

is more prone to cause drowsiness than some other antihistamines.

POLY HIST DHC Indications and Usage

POLY HIST DHC Liquid is indicated to control cough and provide for temporary relief from

congestion associated with the upper respiratory tract.

CONTRAINDICATIONS

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

codeine, or any of the active and 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. Antihistamines and sympathomimetics are contraindicated in patients receiving

antihypertensive or antidepressant drugs containing monoamine oxidase (MAO) inhibitors.

Antihistamines should not be used to treat lower respiratory tract symptoms or be given to

premature or newborn infants. 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 asthma 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. Antihistamines may

cause excitability, especially in children. At dosages higher than the recommended dose, nervousness,

dizziness, or sleeplessness may occur.

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

depression occurs most frequently in elderly more 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.

Hypotensive 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

receive concurrent therapy with drugs such as phenothiazines or other agents which compromise

vasomotor tone. POLY HIST DHC Liquid may produce orthostatic hypotension in ambulatory patients.

This combination product should be administered with caution to patients in 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 stricture; and

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

and in those with a history of 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: Sympathomimetics may reduce the antihypertensive effects of methyldopa,

mecamylamine, reserpine and veratrum alkaloids.

Other Central Nervous System 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 combination product

may exhibit additive depressant effects on the central nervous system. When such combined

therapy is contemplated, the dose of one or both agents should be reduced. Concomitant use

of dihydrocodeine and antihistamines 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. They may also prolong

and intensify the anticholinergic effects of antihistamines.

Information for Patient/Caregivers:

Patients receiving POLY HIST DHC Liquid should be given the following information:

1. Patients should be advised that POLY HIST DHC Liquid may impair the mental or

physical abilities required for the performance of potentially hazardous tasks such

as driving a car or operating machinery.

2. Patients should be advised to report adverse experiences occurring during therapy.

3. Patients should be advised not to adjust the dose of POLY HIST DHC Liquid without

consulting the prescribing professional.

4. Patients should not combine POLY HIST DHC Liquid with alcohol or other central

nervous system stimulants.

5. 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 POLY HIST DHC Liquid is a potential drug of abuse. They

should protect if from theft, and it should never be given to anyone other than the individual

for whom it was prescribed.

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