Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 21 February 2017
CONTRAINDICATIONS Triacin-C is contraindicated under the following conditions: Codeine sulfate is contraindicated for postoperative
Use In Newborn or
Hypersensitivity To (1) codeine phosphate or other
Sympathomimetic amines are contraindicated in
PRECAUTIONS General: Triacin-C should be prescribed with
Patients ' self-medication habits should be investigated to determine their use of such medications.
Triacin-C is intended for
Information For Patients: Advise patients that some people have a genetic variation that results in codeine changing into morphine more rapidly and completely than other people.
These higher-than-normal levels of morphine in the
Children with this genetic variation who were prescribed codeine after tonsillectomy and/or
As a result, codeine is contraindicated in all children who undergo tonsillectomy and/or adenoidectomy.
Advise caregivers of children receiving codeine for other reasons to monitor for signs of respiratory
Patients with a history of glaucoma, peptic ulcer,
Patients should be told not to take alcohol, sleeping pills, sedatives or tranquilizers while taking Triacin-C. 4.
Antihistamines may cause dizziness, drowsiness, dry mouth,
Patients should be told to store this medicine in a
Nursing Mothers - refer to following section titled “Nursing Mothers.” (see WARNINGS -
This product should not be used by persons intolerant to sympathomimetics used for the
Such drugs include ephedrine, epinephrine, phenylephrine and phenylpropanolamine.
Codeine may be habit-forming when used over long periods or in
Patients should take the drug only for as long, in the amounts, and as frequently as prescribed.
Monoamine oxidase (MAO) inhibitors; 2.
other narcotic analgesics, alcohol, general anesthetics, tranquilizers, sedative-hypnotics, surgical skeletal muscle relaxants, or other CNS depressants, by causing
Drug/Laboratory Test Interactions: Codeine:
Pregnancy: Teratogenic Effects - Pregnancy category C. Animal reproduction studies have not been conducted with Triacin-C.
It is also not known whether this product can cause fetal
This product should be given to a pregnant woman only if clearly needed.
Teratology studies have been conducted with the three ingredients of Triacin-C. Pseudoephedrine studies were conducted in
However, overt signs of toxicity were observed in the dams which received pseudoephedrine.
This was reflected in
Nursing Mothers: The components of Triacin-C are excreted in breast milk in
Because of the
(see WARNINGS -
Pediatric Use: Respiratory
Codeine is contraindicated for post-operative
In pediatric patients particularly, the ingredients in this drug product in overdosage may produce
Symptoms of toxicity in pediatric patients may include fixed dilated pupils,
Use In Elderly (Approximately 60 Years Or Older): The ingredients in Triacin-C are more likely to cause
General: Dryness of mouth, dryness of nose, dryness of throat, urticaria, drug rash, anaphylactic
Cardiovascular System: Hypotension,
Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.
G.I. System: Epigastric
G.U. System: Urinary frequency,
Respiratory System: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness, respiratory
DOSAGE AND ADMINISTRATION DOSAGE SHOULD BE INDIVIDUALIZED
Children 6 to under 12 years 1 teaspoonful (5 mL) every 4 to 6 hours, not to
Children 2 to under 6 years?
teaspoonful (2.5 mL) every 4 to 6 hours, not to
|Date Last Revised||28-07-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||STI Pharma LLC|
|Warnings||WARNING: Death Related to Ultra-Rapid Metabolism of Codeine to Morphine Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism (see WARNINGS - Codeine Phosphate - Death Related to Ultra-Rapid Metabolism of Codeine to Morphine).|