CoActifed (Triprolidine HCl – Codeine Phosphate – Pseudoephedrine HCl)

CoACTIFED® Preparations

Glaxo Wellcome

Triprolidine HCl – Codeine Phosphate – Pseudoephedrine HCl

Antihistamine – Antitussive – Decongestant

Indications And Clinical Uses: CoActifed Expectorant: To facilitate expectoration and control cough associated with inflamed mucosa and tenacious sputum.

CoActifed Syrup and Tablets: The treatment of cough associated with inflamed mucosa.

Contra-Indications: This drug should not be used in newborn or premature infants. Hypersensitivity to codeine phosphate or other narcotics, triprolidine hydrochloride, or other antihistamines of similar chemical structure or sympathomimetic amines including pseudoephedrine. Should not be administered to patients receiving MAO inhibitors or who have taken it within the preceding 2 weeks. Patients with severe hypertension or severe coronary artery disease.

Antihistamines should not be used to treat lower respiratory tract symptoms, including asthma.

Manufacturers’ Warnings In Clinical States: CoActifed should be used with considerable caution in patients with increased intraocular pressure (narrow angle glaucoma), stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, bladder neck obstruction, hypertension, diabetes mellitus, ischemic heart disease and hyperthyroidism. In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS effects, such as drowsiness, that may further obscure the clinical course of patients with head injuries. Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions.

Precautions: Before prescribing medication to suppress or modify cough, it is important to ascertain that the underlying cause of the cough is identified, that modification of the cough does not increase the risk of clinical or physiologic complications, and that appropriate therapy for the primary disease is provided.

In young children the respiratory centre is especially susceptible to the depressant action of narcotic cough suppressants. Benefit to risk ratio should be carefully considered especially in children with respiratory embarrassment, e.g., croup. Estimation of dosage relative to the child’s age and weight is of great importance.

CoActifed should be prescribed with caution for certain special risk patients such as the elderly and debilitated, for those with severe impairment of hepatic or renal function, gallbladder disease or gallstones, respiratory impairment, cardiac arrhythmias, history of bronchial asthma, prostate hypertrophy or urethral stricture, and in patients known to be taking other antitussive, antihistamine or decongestant medications. Patients’ self-medication habits should be looked into. CoActifed should not be used by patients intolerant to sympathomimetics used for the relief of nasal or sinus congestion. Such drugs include ephedrine, epinephrine, phenylpropanolamine and phenylephrine. Symptoms of intolerance include drowsiness, dizziness, weakness, difficulty in breathing, tenseness, muscle tremors or palpitations. Codeine may be habit forming when used over long periods or in high doses. Patients should take the drug only for as long, in the amounts, and as frequently as prescribed.

The dependence liability of codeine has been found to be too small to permit a full definition of its characteristics. Studies indicate that addiction to codeine is extremely uncommon and requires very high parenteral doses.

Occupational Hazards: Patients should be warned about engaging in activities requiring mental alertness such as driving a car, operating dangerous machinery or hazardous appliances.

Pregnancy: CoActifed should be given to a pregnant woman only if clearly needed.

Lactation: The components of CoActifed are excreted in breast milk in small amounts, but the significance of their effects on the nursing infant is unknown. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Geriatrics: CoActifed is more likely to cause adverse reactions in the elderly (approximately 60 years and older).

Children: CoActifed may elicit either mild stimulation or mild sedation. In infants and children, the ingredients, in overdosage, may produce hallucinations, convulsions and death. Symptoms of toxicity in children may include fixed dilated pupils, flushed face, dry mouth, fever, excitation, hallucinations, ataxia, incoordination, athetosis, tonic clonic convulsions, and postictal depression.

Drug Interactions: Precautions: CoActifed may enhance the effects of MAO inhibitors, other narcotic analgesics, tranquilizers, alcohol, general anesthetics, sedative-hypnotics, surgical skeletal muscle relaxants, or other CNS depressants. It may diminish the antihypertensive effects of guanethidine, bethanidine, methyldopa and reserpine.

Adverse Reactions: In some patients, drowsiness, dizziness, dry mouth, nausea and vomiting or mild stimulation may occur.

Symptoms And Treatment Of Overdose: Symptoms: Overdosage with codeine can cause transient euphoria, drowsiness, dizziness, weariness, diminution of sensibility, loss of sensation, vomiting, transient excitement in children and occasionally in adult women, miosis progressing to nonreactive pinpoint pupils, itching sometimes with skin rashes and urticaria, and clammy skin with mottled cyanosis. In more severe cases, muscular relaxation with depressed or absent superficial and deep reflexes and a positive Babinski sign may appear. Marked slowing of the respiratory rate with inadequate pulmonary ventilation and consequent cyanosis may occur. Terminal signs include shock, pulmonary edema, hypostatic or aspiration pneumonia and respiratory arrest, with death occurring within 6 to 12 hours following ingestion.

Overdoses of antihistamines may cause hallucinations, convulsions, or possibly death, especially in infants and children. Antihistamines are more likely to cause dizziness, sedation and hypotension in elderly patients. Overdosage with triprolidine may produce reactions varying from depression to stimulation of the CNS; the latter is particularly likely in children. Atropine-like signs and symptoms (dry mouth, fixed dilated pupils, flushing, tachycardia, hallucinations, convulsions, urinary retention, cardiac arrhythmias and coma) may occur.

Overdosage with pseudoephedrine can cause excessive CNS stimulation resulting in excitement, nervousness, anxiety, tremor, restlessness and insomnia. Other effects include tachycardia, hypertension, pallor, mydriasis, hyperglycemia and urinary retention. Severe overdosage may cause tachypnea or hyperpnea, hallucinations, 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 depletion of potassium. No organ damage or significant metabolic derangement is associated with pseudoephedrine overdosage.

Treatment: Therapy, if instituted within 4 hours of overdosage, is aimed at reducing further absorption of the drug. In the conscious patient, vomiting should be induced even though it may have occurred spontaneously. If vomiting cannot be induced, gastric lavage is indicated. Adequate precautions must be taken to protect against aspiration, especially in infants and children. Charcoal slurry or other suitable agents should be instilled into the stomach after vomiting or lavage. Saline cathartics or milk of magnesia may be of additional benefit.

In the unconscious patient, the airway should be secured with a cuffed endotracheal tube before attempting to evacuate the gastric contents. Intensive supportive and nursing care is indicated, as for any comatose patient. If breathing is significantly impaired, maintenance of an adequate airway and mechanical support of respiration is the most effective means of providing adequate oxygenation.

Hypotension is an early sign of impending cardiovascular collapse and should be treated vigorously.

Do not use CNS stimulants. Convulsions should be controlled by careful administration of diazepam or short-acting barbiturate, repeated as necessary. Physostigmine may be also considered for use in controlling centrally mediated convulsions.

Ice packs and cooling sponge baths, not alcohol, can aid in reducing the fever commonly seen in children.

For codeine, continuous stimulation that arouses, but does not exhaust, the patient is useful in preventing coma. Continuous or intermittent oxygen therapy is usually indicated, while naloxone is useful as a codeine antidote. Close nursing care is essential

Saline cathartics, such as milk of magnesia, help to dilute the concentration of the drugs in the bowel by draining water into the gut, thereby hastening drug elimination.

Adrenergic receptor blocking agents are antidotes to pseudoephedrine. In practice, the most useful is the betablocker propranolol, which is indicated when there are signs of cardiac toxicity.

There are no specific antidotes to triprolidine. Histamine should not be given.

Pseudoephedrine and codeine are theoretically dialyzable, but the procedures have not been clinically established.

In severe cases of overdosage, it is essential to monitor both the heart (by ECG) and plasma electrolytes and to give i.v. potassium as indicated by these continuous controls. Vasopressors may be used to treat hypotension, and excessive CNS stimulation may be counteracted with parenteral diazepam. Stimulants should not be used.

Dosage And Administration: Dosage should be individualized according to the needs and response of the patient.

Usual Dose: To be given every 4 to 6 hours. Do not exceed 4 doses in 24 hours. Adults and children 12 years of age and older: 1 tablet or 10 mL. Children 6 to under 12 years of age: 1/2 tablet or 5 mL. Children 2 to under 6 years of age: 2.5 mL.

Availability And Storage: Expectorant: Each 5 mL of clear, orange, syrupy liquid with a mixed fruit odor contains: triprolidine HCl 2 mg, pseudoephedrine HCl 30 mg, guaifenesin 100 mg and codeine phosphate 10 mg. Nonmedicinal ingredients: fruit flavor, glycerin, methylparaben, sodium benzoate, sucrose and sunset yellow FCF. Alcohol-free. Bottles of 100 mL and 2 L. Store between 15 to 30°C and protect from light. Do not refrigerate.

Syrup: Each 5 mL of clear, dark red syrupy liquid contains: tripolidine HCl 2 mg, pseudoephedrine HCl 30 mg and codeine phosphate 10 mg. Nonmedicinal ingredients: amaranth, fruit flavor, glycerin, methylparaben, sodium benzoate and sucrose. Alcohol-free. Bottles of 100 mL and 2 L. Store between 15 to 30°C and protect from light.

Tablets: Each white to off white, biconvex tablet, code number WELLCOME P4B on same side as score mark, contains: triprolidine HCl 4 mg, pseudoephedrine HCl 60 mg and codeine phosphate 20 mg. Nonmedicinal ingredients: cornstarch, lactose, gelatin, magnesium stearate and quinoline yellow WS. Each tablet is equivalent to 10 mL of syrup. If tablet is broken in half, it reveals a yellow core. Tartrazine-free. Bottles of 50. Store between 15 to 30°C. Protect from light and keep dry.

CoACTIFED® Preparations Glaxo Wellcome Triprolidine HCl – Codeine Phosphate – Pseudoephedrine HCl Antihistamine – Antitussive – Decongestant

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