All doses of opioids carry an inherent risk of fatal or non-fatal adverse events. This risk is increased with higher doses. TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups should not be administered for more than 3 days. The maximum recommended daily dose of TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups is 40 mL (12 morphine milligram equivalent) for adults over the age of 18 years.
Each patient should be assessed for their risk prior to prescribing TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups as the likelihood of experiencing serious adverse events can depend upon the type of opioid and duration of treatment, as well as the patient’s own level of tolerance.
In addition, the coughing should be assessed routinely to confirm the most appropriate dose and the need for further use of TEVA-COTRIDIN and TEVA- COTRIDIN EXPECTORANT Syrups. Dosing Considerations TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups should be avoided in patients known or suspected to be ultrarapid CYP2D6 metabolizers.
Patients should be advised to seek medical advice if symptoms persist for more than 3 days. Do not increase the dose or the frequency of dosing. Avoid use with other decongestants, anti-histamine-containing or other codeine containing products, including cough and cold medicines (see WARNINGS AND PRECAUTIONS).
Recommended Dose and Dosage Adjustment Adults Take 10 mL of syrup every 6-8 hours as required. Do not exceed 4 doses in a day (24 hours). Minimum time between doses: 6 hours. TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups are contraindicated in patients less than 18 years old.
Codeine, including TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups, should be prescribed at the lowest effective dose for the shortest period of time. Dosing should be as needed and not on scheduled intervals.
Patients with Hepatic Impairment:
Experience with the use of the product suggests that normal adult dosage is appropriate in the presence of mild to moderate hepatic impairment. TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups are contraindicated in patients with severe hepatic impairment (see CONTRAINDICATIONS).
There have been no specific studies of triprolidine, pseudoephedrine, guaifenesin, or codeine in hepatic impairment.
Patients with Renal Impairment:
Page 16 or 35 Caution should be exercised when administering TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups to patients with mild to moderate renal impairment, particularly if accompanied by cardiovascular disease (see CONTRAINDICATIONS section).
TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups are contraindicated in patients with severe renal impairment (see CONTRAINDICATIONS). There have been no specific studies of triprolidine, pseudoephedrine, guaifenesin, or codeine in renally impaired patients.
Geriatrics:
Respiratory depression has occurred in the elderly following administration of large initial doses of opioids to patients who were not opioid-tolerant or when opioids were co-administered with other agents that can depress respiration.
TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups should be initiated at a low dose and slowly titrated to effect (see WARNINGS AND PRECAUTIONS and ACTION AND CLINICAL PHARMACOLOGY). Although there have been no specific studies done on combination products of Triprolidine hydrochloride-Pseudoephedrine hydrochloride-Codeine phosphate and Triprolidine hydrochloride-Pseudoephedrine hydrochloride-Guaifenesin-Codeine phosphate in this group of patients, it may be anticipated that the elderly may be more susceptible to adverse effects.
Therefore, reduced dosage and careful monitoring is advised, particularly in cases where there is impairment of renal, hepatic or mental status (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION).
Adjustment or Reduction of Dosage:
Physical dependence with or without psychological dependence tends to occur with chronic administration of opioids, including TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT. Withdrawal (abstinence) symptoms may occur following abrupt discontinuation of prolonged therapy.
These symptoms may include body aches, diarrhea, gooseflesh, loss of appetite, nausea, nervousness or restlessness, runny nose, sneezing, tremors or shivering, stomach cramps, tachycardia, trouble with sleeping, unusual increase in sweating, palpitations, unexplained fever, weakness and yawning.
Missed Dose As there is no strictly scheduled dosing (see Recommended Dose and Dosage Adjustment; Adults), TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups should be administered as needed for cough or to loosen phlegm and should not exceed 4 doses in a day (24 hours).
If the patient forgets to take one or more doses, they should ensure the next dose does not exceed the normal amount. Disposal TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups should be kept in a safe place, out of the sight and reach of children before, during and after use.
TEVA-COTRIDIN and TEVA- COTRIDIN EXPECTORANT Syrups should not be used in front of children, since they may copy these actions. Page 17 or 35 TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups should never be disposed of in household trash.
Disposal via a pharmacy take back program is recommended. Unused or expired TEVA-COTRIDIN and TEVA-COTRIDIN EXPECTORANT Syrups should be properly disposed of as soon as it is no longer needed to prevent accidental exposure to others, including children or pets.
If temporary storage is required before disposal, a sealed child-proof container, such as a biohazard waste container or lockable medication box could be obtained from a pharmacy. OVERDOSAGE For management of a suspected overdose, contact your regional Poison Control Centre immediately.
Symptoms In 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, […]