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TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES AND CODEINE PHOSPHATE SYRUP
Overview
What is Triacin-C?
Each 5 mL (one teaspoonful) of syrup for oral administration contains:
Codeine Phosphate……10 mg
WARNING:
Triprolidine Hydrochloride……1.25 mg
Pseudoephedrine Hydrochloride……30 mg
Alcohol 4.3%.
Inactive ingredients:
Triacin-C produces antitussive, antihistaminic and nasal decongestant effects. The components have the following chemical names and structural formulas:
Codeine Phosphate, USP
7,8-didehydro-4,5 α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate
Triprolidine Hydrochloride, USP
(E)-2-[3(1-Pyrrolidinyl)-1-p-tolylpropenyl]pyridine monohydrochloride monohydrate
Pseudoephedrine Hydrochloride, USP
Benzenemethanol, α-[1-(methylamino)ethyl]-,[S-(R*, R*)]- hydrochloride
What does Triacin-C look like?
What are the available doses of Triacin-C?
Sorry No records found.
What should I talk to my health care provider before I take Triacin-C?
Sorry No records found
How should I use Triacin-C?
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT.
What interacts with Triacin-C?
Sorry No Records found
What are the warnings of Triacin-C?
Sorry No Records found
What are the precautions of Triacin-C?
Sorry No Records found
What are the side effects of Triacin-C?
(The most frequent adverse reactions are underlined.)
General:
Dryness of mouth
dryness of nose
dryness of throat
Cardiovascular System
Hematologic System
Nervous System
Sedation
sleepiness
dizziness
disturbed coordination
G.I. System
G.U. System
Respiratory System
What should I look out for while using Triacin-C?
What might happen if I take too much Triacin-C?
Since Triacin-C is comprised of three pharmacologically different compounds, it is difficult to predict the exact manifestation of symptoms in a given individual. Reaction to an overdosage of this product may vary from CNS depression to stimulation. A detailed description of symptoms which are likely to appear after ingestion of an excess of the individual components follows:
Overdosage with codeine can cause transient euphoria, drowsiness, dizziness, weariness, diminution of sensitivity, 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 6-12 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 Central Nervous System (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.
The toxic plasma concentration of codeine is not known with certainty. Experimental production of mild to moderate CNS depression in healthy, nontolerant subjects occurs at plasma concentrations of 0.5-1.9µg/mL when codeine is given by intravenous infusion. The single lethal dose of codeine in adults is estimated to be from 0.5 to 1.0 gram. It is also estimated that 5 mg/kg could be fatal in children.
The LD (single, oral dose) of triprolidine is 163 to 308 mg/kg in the mouse (depending upon strain) and 840 mg/kg in the rat.
Insufficient data are available to estimate the toxic and lethal doses of triprolidine in humans. No reports of acute poisoning with triprolidine have appeared.
The LD (single, oral dose) of pseudoephedrine is 726 mg/kg in the mouse, 2206 mg/kg in the rat and 1177 mg/kg in the rabbit. The toxic and lethal concentrations in human biologic fluids are not known. Excretion rates increase with urine acidification and decrease with alkalinization. Few reports of toxicity due to pseudoephedrine have been published and no case of fatal overdosage is known.
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 drawing water into the gut, thereby hastening drug elimination.
Adrenergic receptor blocking agents are antidotes to pseudoephedrine. In practice, the most useful is the beta-blocker 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 electrocardiograph) and plasma electrolytes and to give intravenous 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.
How should I store and handle Triacin-C?
Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.Silver Nitrate Solution is supplied in a 1 oz. Amber Glass Bottle.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Codeine:
Codeine is readily absorbed from the gastrointestinal tract, with a therapeutic dose reaching peak antitussive effectiveness in about 2 hours and persisting for 4 to 6 hours. Codeine is rapidly distributed from blood to body tissues and taken up preferentially by parenchymatous organs such as liver, spleen and kidney. It passes the blood brain barrier and is found in fetal tissue and breast milk.
The drug is not bound by plasma proteins nor is it accumulated in body tissues. Codeine is metabolized in the liver to morphine and norcodeine, each representing about 10 percent of the administered codeine dose. About 90 percent of the dose is excreted within 24 hours, primarily through the kidneys. Urinary excretion products are free and glucuronide-conjugated codeine (about 70%), free and conjugated norcodeine (about 10%), free and conjugated morphine (about 10%), normorphine (under 4%) and hydrocodone (<1%). The remainder of the dose appears in the feces.
Triprolidine:
Animal distribution studies have shown localization of triprolidine in lung, spleen and kidney tissue. Liver microsome studies have revealed the presence of several metabolites with an oxidized product of the toluene methyl group predominating.
Pseudoephedrine:
Pseudoephedrine is rapidly and almost completely absorbed from the gastrointestinal tract. Considerable variation in half-life has been observed (from about 4½ to 10 hours), which is attributed to individual differences in absorption and excretion. Excretion rates are also altered by urine pH, increasing with acidification and decreasing with alkalinization. As a result, mean half-life falls to about 4 hours at pH 5 and increases to 12 to 13 hours at pH 8.
After administration of a 60 mg tablet, 87 to 96% of the pseudoephedrine is cleared from the body within 24 hours. The drug is distributed to body tissues and fluids, including fetal tissue, breast milk and the central nervous system (CNS). About 55 to 75% of an administered dose is excreted unchanged in the urine; the remainder is apparently metabolized in the liver to inactive compounds by N-demethylation, parahydroxylation and oxidative deamination.
Non-Clinical Toxicology
GeneralInformation For Patients
This product should not be used by persons intolerant to sympathomimetics used for the relief of nasal or sinus congestion. Such drugs include ephedrine, epinephrine, phenylephrine and phenylpropanolamine. 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.
Drug Interactions
1. Monoamine oxidase (MAO) inhibitors;2. other narcotic analgesics, alcohol, general anesthetics, tranquilizers, sedative-hypnotics, surgical skeletal muscle relaxants, or other CNS depressants, by causing increased CNS depression.
This product may diminish the antihypertensive effects of guanethidine, bethanidine, methyldopa and reserpine.
Drug/Laboratory Test Interactions
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Pregnancy
Teratology studies have been conducted with the three ingredients of Triacin-C. Pseudoephedrine studies were conducted in rats at doses up to 150 times the human dose; triprolidine was studied in rats and rabbits at doses up to 125 times the human dose, and codeine studies were conducted in rats and rabbits at doses up to 150 times the human dose. No evidence of teratogenic harm to the fetus was revealed in any of these studies. However, overt signs of toxicity were observed in the dams which received pseudoephedrine. This was reflected in reduced average weight and length and rate of skeletal ossification in their fetuses.
Nursing Mothers:
Pediatric Use:
As in adults, the combination of an antihistamine, sympathomimetic amine and codeine can elicit either mild stimulation or mild sedation in pediatric patients. In pediatric patients particularly, the ingredients in this drug product in overdosage may produce hallucinations, convulsions and death. Symptoms of toxicity in pediatric patients may include fixed dilated pupils, flushed face, dry mouth, fever, excitation, hallucinations, ataxia, incoordination, athetosis, tonic clonic convulsions and postictal depression, (see CONTRAINDICATIONS and OVERDOSAGE sections).
Use In Elderly (Approximately 60 Years Or Older): The ingredients in Triacin-C are more likely to cause adverse reactions in elderly patients.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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