PEDIACOF®	Prescribing Information

DESCRIPTION  |  CLINICAL PHARMACOLOGY  | 
INDICATIONS AND USAGE |  CONTRAINDICATIONS
WARNINGS  |   PRECAUTIONS 
ADVERSE REACTIONS  |  OVERDOSAGE
DOSAGE AND ADMINISTRATION  |   HOW SUPPLIED

DESCRIPTION

Each teaspoon (5 mL) contains:

with sodium benzoate 0.2% as preservative and alcohol 5%.

PEDIACOF is a pleasant-tasting, raspberry-flavored cough syrup. It contains four active ingredients in proper proportion for children. Codeine phosphate is a white crystalline, odorless powder which is freely soluble in water. It is a narcotic analgesic.

Codeine phosphate is 7,8-Didehydro-4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol phosphate, and has the following structural formula:

Phenylephrine hydrochloride is a vasoconstrictor and pressor drug chemically related to epinephrine and ephedrine. It is a synthetic sympathomimetic agent. Chemically, phenylephrine hydrochloride is (—)-m-Hydroxy--[(methylamino) methyl]-benzyl alcohol hydrochloride, and has the following structural formula:

Chlorpheniramine maleate is an alkylamine H₁-blocking agent (antihistamine) which is chemically 2-Pyridinepropanamine, -(4-chlorphenyl)- N,N-dimethyl-,(Z) - 2-butenedioate with the following structural formula:

Potassium iodide is an expectorant.

Inactive Ingredients: Alcohol, Citric Acid, FD&C Red #40, Flavor, Glycerin, Liquid Glucose, Purified Water, Saccharin Sodium, Sodium Benzoate.
 

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CLINICAL PHARMACOLOGY

Codeine phosphate is an antitussive that is well recognized not only because of its efficiency and rapidity of action but also because of its relative safety in clinical use. Thus, irritating, nonproductive cough is suppressed by codeine. The codeine content of PEDIACOF is reduced to the proportion that is most suitable for children. When codeine is combined with the expectorant potassium iodide, which tends to increase bronchial secretion, coughing, although minimized, is more productive when it does occur. The continuous fatiguing effect of useless coughing is thereby avoided. Codeine is a narcotic analgesic and antitussive which resembles morphine pharmacologically. Codeine is metabolized by the liver and excreted chiefly in the urine, largely in inactive forms. A small fraction (10%) of administered codeine is demethylated to form morphine, and both free and conjugated morphine can be found in the urine after therapeutic doses of codeine. When administered subcutaneously, 120 mg of codeine is approximately equivalent to 10 mg of morphine. The abuse liability of codeine is generally considered to be much lower than that of morphine.

The half-life of codeine in plasma is 2.5 to 3.0 hours.

Codeine has diverse additional actions. It depresses the respiratory center, stimulates the vomiting center, depresses the cough reflex, constricts the pupils, increases the tone of the gastrointestinal and genitourinary tracts, and produces mild vasodilation.

Neo-Synephrine® , brand of phenylephrine hydrochloride, produces effective decongestion of the mucous membranes of the respiratory tract via its powerful postsynaptic -receptor stimulant action. It has little effect on cardiac -receptors. Most of its effects are due to direct action on receptors and only a small part is due to norepinephrine release. Central stimulant activity is minimal.

Chlorpheniramine maleate helps control allergic coughs and mucosal congestion. The mild anticholinergic action of chlorpheniramine maleate may aid in reducing rhinorrhea, and its mild sedative action may also be beneficial to patients whose excessive coughing has caused them to lose sleep.

Clinical experience with PEDIACOF has shown it to be a dependable medication for the relief of cough and the reduction of nasal congestion in children.

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INDICATIONS AND USAGE

Coughs due to colds as well as coughs and congestive symptoms associated with upper respiratory tract infections such as tracheobronchitis or laryngobronchitis, croup, pharyngitis, allergic bronchitis, and infectious bronchitis, when accompanied by disturbing and fatiguing cough, have been treated successfully with PEDIACOF in children.

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CONTRAINDICATIONS

PEDIACOF is contraindicated in patients who are hypersensitive to any of its ingredients. Due to the component phenylephrine, PEDIACOF is contraindicated in patients with ventricular tachycardia or severe hypertension.

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WARNINGS

Respiratory Depression: Codeine produces dose-related respiratory depression by acting directly on brain stem respiratory centers. Codeine also affects centers that control respiratory rhythm and may produce irregular and periodic breathing. If significant respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride. (See OVERDOSAGE.)

Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure. Furthermore, narcotics can produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

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PRECAUTIONS

Caution should be exercised if PEDIACOF is administered to patients with cardiac disorders other than ventricular tachycardia, in which it is contraindicated; mild hypertension and hyperthyroidism.

Special Risk Patients:

Codeine should be used with caution in patients with impaired renal or hepatic function, hypothyroidism, Addison’s disease, or urethral stricture.

In asthma, the indiscriminate use of codeine may, due to its drying action upon the mucosa of the respiratory tract, precipitate severe respiratory insufficiency resulting from increased viscosity of the bronchial secretions and suppression of the cough reflex. As with any narcotic analgesic agent, the usual precautions should be observed and the possibility of respiratory depression should be kept in mind.

Phenylephrine hydrochloride should be employed only with extreme caution in patients with hyperthyroidism, bradycardia, partial heart block, and myocardial disease.

Chlorpheniramine maleate should be used with considerable caution in patients with narrow angle glaucoma, pyloroduodenal obstruction, and bladder neck obstruction. Chlorpheniramine maleate has an atropine-like action and therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease, and hypertension.

Drug Interactions: Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, tranquilizers, sedative-hypnotics, MAO inhibitors, tricyclic antidepressants, or other CNS depressants (including alcohol) concomitantly with codeine may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No long-term animal studies have been performed to evaluate the potential of PEDIACOF in these areas.

Nonteratogenic Effects: Dependence has been reported in newborns whose mothers received opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. Signs usually appear during the first few days of life.

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ADVERSE REACTIONS

The only significant untoward effects that have occurred are mild anorexia and an occasional tendency to constipation. However, discontinuance of PEDIACOF has seldom been required. Mild drowsiness occurs in some patients but, when cough is relieved, the quieting effect of PEDIACOF is considered beneficial in many instances. Because of its iodide content, PEDIACOF may cause elevation of the protein-bound iodine. Adverse reactions to codeine include: Central Nervous System: Sedation, drowsiness, mental clouding, dizziness, lethargy, impairment of mental and physical performance, anxiety, convulsions, fear, miosis, dysphoria, psychic dependence, mood changes, and respiratory depression. Gastrointestinal System: Nausea, vomiting, increased pressure in the biliary tract, and constipation. Cardiovascular System: Orthostatic hypotension, fainting, and tachycardia. Genitourinary System: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported. Other: Flushing, sweating, pruritus, allergic reactions, and suppressed cough reflex. Adverse reactions to phenylephrine hydrochloride include headache, reflex bradycardia, excitability, restlessness, and, rarely, arrhythmias.

Adverse reactions to chlorpheniramine maleate include slight to moderate drowsiness. Other possible side effects common to antihistamines in general include: General: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose, and throat. Cardiovascular System: Hypotension, headache, palpitations, tachycardia, and extrasystoles. Hematologic System: Hemolytic anemia, thrombocytopenia, and agranulocytosis. Nervous System: Sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, and convulsions. Gastrointestinal System: Epigastric distress, anorexia, nausea, vomiting, diarrhea, and constipation. Genitourinary System: Urinary frequency, difficult urination, urinary retention, and early menses. Respiratory System: Thickening of bronchial secretions, tightness of chest and wheezing, and nasal stuffiness.

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OVERDOSAGE

Codeine

Signs and Symptoms: Overdosage with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), pinpoint pupils, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur.

Treatment: Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Naloxone hydrochloride is a specific and effective antagonist for respiratory depression which may result from overdosage. If the desired degree of counteraction and improvement in respiratory function is not obtained immediately following IV administration, it may be repeated intravenously at 2 to 3 minute intervals. Failure to obtain significant improvement after 2 or 3 doses suggests that the condition may be due partly or completely to other disease processes or nonopioid drugs. The usual initial pediatric dose is 0.01 mg/kg body weight given IV, IM, or SC. If necessary, naloxone can be diluted with Sterile Water for Injection, USP. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated.

Oral LD₅₀ in the mouse is 693 mg/kg. Codeine is not dialyzable.

Phenylephrine hydrochloride

Signs and Symptoms: Overdosage may induce ventricular extrasystoles and short paroxysms of ventricular tachycardia, a sensation of fullness in the head, and tingling of the extremities.

Treatment: Should an excessive elevation of blood pressure occur, it may be immediately relieved by an a-adrenergic blocking agent, e.g., phentolamine. The oral LD₅₀ in the rat: 350 mg/kg; mouse: 120 mg/kg.

Chlorpheniramine maleate

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

Treatment: Emergency treatment should be started immediately. Vomiting should be induced, even if it has occurred spontaneously. Vomiting by the administration of ipecac syrup is preferred. Vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of eight to twelve fluid 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 solutions 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.

Stimulants (analeptic agents) should not be used. Vasopressors may be used to treat hypotension. Short-acting barbiturates, diazepam, or paraldehyde may be administered to control seizures. Hyperpyrexia, especially in children, may require treatment with tepid water sponge baths or a hypothermic blanket. Apnea is treated with ventilatory support.

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DOSAGE AND ADMINISTRATION

PEDIACOF should be given in accordance with the needs and age of the patient. Frequency of administration may be adjusted as cough is brought under control. The following doses, to be given at 4 to 6 hour intervals, are suggested for patients under 12 years of age: from 6 months to 1 year, 1/4 teaspoon; from 1 to 3 years, ½ to 1 teaspoon; from 3 to 6 years, 1 to 2 teaspoons; and from 6 to 12 years, 2 teaspoons.

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HOW SUPPLIED

Raspberry flavored syrup
Bottle of 16 fl oz (NDC 0024-1509-06)
Store at room temperature up to 25° C (77° F).

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Manufactured for Sanofi-Synthelabo Inc.
New York, NY 10016
by Bayer Corporation
Myerstown, PA 17067