Loading…
DALMACOL is a brand name for Sodium Citrate, supplied as a syrup. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Seldom occurrences of adverse effects of DALMACOL are drowsiness, dizziness, nausea, nervousness, palpitation or increased blood pressure.
Androgen deficiency:
Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date.
Patients presenting with symptoms of androgen deficiency should undergo laboratory evaluation. g. other opioids, sedatives/hypnotics, antidepressants, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, phenothiazines, neuroleptics, antihistamines, antiemetics, and alcohol) and beta-blockers, increases the risk of respiratory depression, profound sedation, coma, and death and should be avoided (see WARNINGS AND PRECAUTIONS, Neurologic, Interactions with Central Nervous System Depressants (including benzodiazepines and alcohol) and Psychomotor Impairment).
DALMACOL should not be consumed with alcohol as it may increase the chance of experiencing dangerous side effects.
Drug-Drug Interactions Monoamine Oxidase Inhibitors:
DALMACOL is contraindicated in patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy) (see CONTRAINDICATIONS).
Serotonergic Agents:
Coadministration of hydrocodone bitartrate with a serotonergic agent, such as a Selective Serotonin Re-uptake Inhibitor or a Serotonin Norepinephrine Re-uptake Inhibitor, may increase the risk of serotonin syndrome, a potentially life-threatening condition (see WARNINGS AND PRECAUTIONS, Neurologic).
g. , ritonavir), can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of DALMACOL and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of DALMACOL is achieved.
• Children younger than 6 years of age. • Patients who are hypersensitive to the active substances, including hydrocodone bitartrate or other opioid analgesics, or to any ingredient in the formulation. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.
, ileus of any type). , acute appendicitis or pancreatitis). • Patients with acute or severe bronchial asthma, chronic obstructive airway, or status asthmaticus. • Patients with acute respiratory depression, elevated carbon dioxide levels in the blood and cor pulmonale.
• Patients with acute alcoholism, delirium tremens, and convulsive disorders. • Patients with severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury. • Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy).
• Women who are breast-feeding, and during pregnancy, or during labour and delivery. (see SERIOUS WARNINGS AND PRECAUTIONS, and WARNINGS AND PRECAUTIONS) WARNINGS AND PRECAUTIONS SERIOUS WARNINGS AND PRECAUTIONS Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the risks of overdose and death with immediate release opioid formulations, DALMACOL (which includes hydrocodone bitartrate) should only be used in patients for whom alternative non-opioid treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide appropriate cough management (see DOSAGE AND ADMINISTRATION).
Addiction, Abuse, and Misuse DALMACOL poses risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Each patient’s risk should be assessed prior to prescribing DALMACOL, and all patients should be monitored regularly for the development of these behaviors or conditions (see WARNINGS AND PRECAUTIONS, Abuse and Misuse).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Sodium Citrate in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
DALMACOL Page 12 of 25 Avoid the use of DALMACOL while taking a CYP3A4 or CYP2D6 inhibitor. If concomitant use is necessary, monitor patients for respiratory depression and sedation at frequent intervals. Drug-Lifestyle Interactions Patients should be cautioned not to operate vehicles or hazardous machinery until their response to the drug has been determined.
The concomitant use of alcohol should be avoided (see WARNINGS AND PRECAUTIONS, General).
DOSAGE AND ADMINISTRATION Pediatrics (<18 years of age):
DALMACOL is not indicated for use in patients younger than 18 years of age because of the risk of opioid toxicity due to the variable and unpredictable metabolism of hydrocodone to hydromorphone and because of the benefits of symptomatic treatment of cough do not outweigh the risks for use of hydrocodone in these patients.
DALMACOL is contraindicated in children younger than 6 years of age. Increasing Risk with Higher Doses All doses of opioids carry an inherent risk of fatal or non-fatal adverse events. This risk is increased with higher doses. The maximum recommended daily dose of DALMACOL is 30 mL (10 morphine milligram equivalent (MME)).
Each patient should be assessed for their risk prior to prescribing DALMACOL, 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 DALMACOL. Dosing Considerations DALMACOL may be taken with or without food, with a glass of water. Recommended Dose and Dosage Adjustment Adults: 5 mL every 3 to 5 hours but not more than 30 mL in any 24-hour period.
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.
DALMACOL should be initiated at a low dose and slowly titrated to effect (see WARNINGS AND PRECAUTIONS).
Adjustment or Reduction of Dosage:
Physical dependence with or without psychological dependence tends to occur with chronic administration of opioids, including DALMACOL. Withdrawal (abstinence) symptoms may occur following abrupt discontinuation of therapy. DALMACOL Page 13 of 25 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 If the patient forgets to take one or more doses, they should take their next dose at the next scheduled time and in the normal amount. Disposal DALMACOL should be kept in a safe place, out of the sight and reach of children before, during and after use.
DALMACOL should not be used in front of children, since they may copy these actions. DALMACOL should never be disposed of in household trash. Disposal via a pharmacy take back program is recommended. Unused or expired DALMACOL 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 […]
DALMACOL should be stored securely to avoid theft or misuse.
DALMACOL Page 5 of 25 Life-threatening Respiratory Depression:
OVERDOSE Serious, life-threatening, or fatal respiratory depression may occur with use of DALMACOL. Infants exposed in-utero or through breast milk are at risk of life- threatening respiratory depression upon delivery or when nursed.
Patients should be monitored for respiratory depression, especially during initiation of DALMACOL or following a dose increase. Further, instruct patients of the hazards related to taking opioids including fatal overdose. Accidental Exposure Accidental exposure to DALMACOL, especially by children, can result in a fatal overdose of hydrocodone bitartrate (see DOSAGE AND ADMINISTRATION, Disposal, for instructions on proper disposal).
Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of DALMACOL during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening (see WARNINGS AND PRECAUTIONS, Neonatal Opioid Withdrawal Syndrome (NOWS)).
Interaction with Alcohol The co-ingestion of alcohol with DALMACOL should be avoided as it may result in dangerous additive effects, causing serious injury or death (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS). Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death (see WARNINGS AND PRECAUTIONS, Neurologic and DRUG INTERACTIONS).
• Reserve concomitant prescribing of DALMACOL and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation.
General 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 physiological complications, and that appropriate therapy for the primary disease is provided.
Accidental ingestion, especially by children can result in a fatal overdose of hydrocodone bitartrate (see DOSAGE AND ADMINISTRATION, disposal, for instructions on proper disposal). DALMACOL Page 6 of 25 Patients should be instructed not to give DALMACOL (which includes hydrocodone bitartrate) to anyone other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.
DALMACOL should be stored securely to avoid theft or misuse. Patients should be cautioned not to consume alcohol while taking DALMACOL as it may increase the chance of experiencing serious adverse events, including death. Abuse and Misuse Like all opioids, DALMACOL is a potential drug of abuse and misuse, which can lead to overdose and death.
Therefore, DALMACOL should be prescribed and handled with caution. Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse and abuse.
Use in Drug and Alcohol Addiction:
DALMACOL is an opioid with no approved use in the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission is for the management of cough requiring opioids. Patients with a history of addiction to drugs or alcohol may be at higher risk of becoming addicted to DALMACOL; extreme caution and awareness is warranted to mitigate the risk.
Cardiovascular Hydrocodone bitartrate administration may result in hypotension and dizziness. Dependence/Tolerance As with other opioids, tolerance and physical dependence may […]