Poly Hist PD

Name: Poly Hist PD

Indications and usage

Poly Hist PD is indicated for symptomatic relief of seasonal and perennial allergic rhinitis, and vasomotor rhinitis.

Warnings

Pyrilamine Maleate and Chlorpheniramine Maleate:
Antihistamines should be used with considerable caution in patients with narrow angle glaucoma, stenosing peptic
ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction. In infants and
children especially, antihistamine overdosage may cause hallucinations, convulsions or death. As in adults,
antihistamines may diminish mental alertness in children. Chlorpheniramine Maleate has additional effects with
alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers) Patients should be warned about engaging
in activities requiring mental alertness, such as driving a car or operating appliances, machinery, etc.

Phenylephrine Hydrochloride:
Sympathomimetic amines should be used with considerable caution in patients with hypertension, ischemic heart
disease, diabetes mellitus, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy.
Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse
with accompanying hypotension. DO NOT EXCEED RECOMMENDED DOSAGE. Hypertensive crisis could occur
with concurrent use of phenylephrine and monoamine oxidase (MAO) inhibitors, indomethacin or with beta blockers
and methyldopa. If a hypertensive crisis occurs, this drug should be discontinued immediately and therapy to lower
blood pressure should be instituted. Fever should be managed by means of external cooling. The elderly
(approximately sixty years or older) are more likely to have adverse reactions to sympathomimetics. Overdosage of
sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death. Therefore,
safe use of a short-acting sympathomimetic should be demonstrated in the individual elderly patient before
considering the use of a sustained-release formulation. Discontinue use if adverse reaction(s) occur.

Pediatric Use

In infants and children especially, antihistamines in overdosage may cause hallucination, convulsions or death.
As in adults, antihistamines may diminish mental alertness in children. In the young child particularly, they may
produce excitation.

Geriatric Use

The elderly (60 years and older) are more likely to experience adverse reactions from sympathomimetics and
antihistamines. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions,
CNS depression and death.

Overdosage

Signs and symptoms:
Pyrilamine Maleate and Chlorpheniramine Maleate:
Manifestations of antihistamine overdosage may vary from central nervous system depression (sedation, apnea,
cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors or convulsions). Other signs and
symptoms may be dizziness, tinnitus, ataxia, blurred vision and hypotension. Stimulation is particularly likely
in children, as are atropine-like signs and symptoms (dry mouth, fixed dilated pupils, flushing, hypothermia and
gastrointestinal symptoms.

Phenylephrine Hydrochloride:
May cause hypertension, headache, convulsions, cerebral hemorrhage and vomiting. Ventricular premature beats
and short paroxysms of ventricular tachycardia may also occur. Headache may be a symptom of hypertension.
Bradycardia may also be seen early in phenylephrine overdosage through stimulation of baroreceptors. Excessive
CNS stimulation may result in excitement, tremor, restlessness and insomnia. Other effects may include pallor,
mydriasis, hyperglycemia and urinary retention. Severe overdosage may cause tachypnea or hyperpnea,
hallucination, convulsions or delirium but in some individuals, there may be CNS depression with somnolence,
stupor or respiratory depression. Arrhythmias (including ventricular fibrillation) may lead to hypotension and
circulatory collapse. Severe hypokalemia can occur, probably due to compartmental shift rather than a depletion
of potassium.

Treatment:
The patient should be induced to vomit even if emesis has occurred spontaneously. Pharmacologic vomiting by
the administration of ipecac is facilitated by physical activity and by the administration of eight to twelve ounces
of water. If emesis does not occur within fifteen minutes, the dose of ipecac should be repeated.
Precautions against aspiration must be taken especially in infants and children. Following emesis, any drug remaining
in the stomach may be absorbed by activated charcoal administered as a slurry with water. If vomiting is unsuccessful
or contraindicated, gastric lavage should be performed. Isotonic and one-half isotonic saline are the lavage solution of
choice. Saline cathartics, such as milk of magnesia, draw water into the bowel by osmosis and therefore, may be
valuable for their action in rapid dilution of bowel content. After emergency treatment, the patient should continue to
be medically monitored. Treatment of the signs and symptoms of overdosage is symptomatic and supportive.

Storage

Store at controlled room temperature, 15o-30oC (59o-86oF).

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER WITH A CHILD-RESISTANT
CLOSURE AS DESCRIBED IN THE USP/NF.

CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION.

Manufactured by:
Great Southern Laboratories,
Houston, TX 77099

Distributed by:
Poly Pharmaceuticals, Inc.,
Mobile, AL 36619

Rev. 11/09

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Poly-Hist PD?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling sleepy.
  • Feeling nervous and excitable.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Poly-Hist PD?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
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