Cophylac (Normethadone and hydroxyephedrine) is a formulation containing normethadone which is a synthetic opioid and hydroxyehedrine that is a sympathetic stimulant. Cophylac is used primarily as an antitussive (cough suppressant).
Cophylac (Normethadone and hydroxyephedrine) Uses:
Note:
- Not approved in the US.
-
Cough:
- Associated with inflamed mucosa, treatment of cough in adults who do not respond to less potent therapies.
Cophylac Dose in Adults
Cophylac Dose in the treatment of Cough:
- P/O:
- 15 drops twice every 24 hours.
- Max dose:
- 30 drops in 24 hours.
Use in Children:
Not indicated for use in children.
Cophylac Pregnancy Risk Catogory: D
- Opioids can cross the placenta.
- [Canadian Boxed Warn]
- Pregnancy opioid withdrawal syndrome can be caused by prolonged maternal opioid use. This could potentially lead to death.
- Infants born in-utero to harmful substances are at high risk for developing life-threatening respiratory depression.
- Neonatal opioid withdrawal syndrome symptoms may include vomiting, diarrhea, vomiting and poor feeding/weight gain.
- Pregnant women should not use this product.
- Long-term opioid abuse can lead to infertility or sexual dysfunction.
Use of hydroxyephedrine and normethadone during lactation:
- Breast milk contains opiates.
- [Canadian Boxed Warn]
- Breastfeeding infants are at high risk for respiratory depression.
- According to the manufacturer, breastfeeding should be avoided
Cophylac Dose in Kidney Disease:
- No particular dosage modifications are mentioned in the manufacturer's labelling.
- Use cautiously.
Cophylac Dose in Liver Disease:
- No particular dosage modifications are mentioned in the manufacturer's labelling.
- Use cautiously.
Side effects of Cophylac (Normethadone and hydroxyephedrine):
-
Cardiovascular:
- Hypotension
- Syncope
-
Central Nervous System:
- Ataxia
- Dizziness
- Drowsiness
- Drug Abuse
- Drug Dependence
- Headache
- Insomnia
- Neonatal Withdrawal
-
Dermatologic:
- Diaphoresis
- Pruritus
-
Gastrointestinal:
- Constipation
- Decreased Appetite
- Nausea
- Vomiting
- Xerostomia
-
Neuromuscular & Skeletal:
- Asthenia
-
Ophthalmic:
- Visual Disturbance
-
Respiratory:
- Respiratory Depression
Contraindications to Cophylac (Normethadone and hydroxyephedrine):
- Hypersensitivity to normethadone or hydroxyephedrine, opioid analgesics, and any component of the formulation.
- Suspected mechanical GI obstruction
- Suspected surgical abdomen
- Acute or severe bronchial symptoms, chronic obstructive breathing, or status as asthmaticus.
- Acute respiratory depression.
- Hypercarbia.
- Cor pulmonale.
- Acute alcoholism.
- Delirium tremens.
- Convulsive disorders.
- Severe CNS depression.
- Elevated cerebrospinal and intracranial pressure
- Head injury
- MAOIs (concomitant or within 14 days after therapy)
- Women who are pregnant or during labor and birth.
- Breastfeeding
- There is relatively little information available on how opioids interact with allergens.
- Due to similarities in chemical structure and pharmacologic actions, cross-sensitivity is a possibility.
Warnings and precautions
-
CNS depression:
- CNS depression can lead to mental and physical impairments.
- It is important to warn patients about tasks that require mental alertness, such as driving or operating machinery.
-
Constipation
- Constipation can occur in patients with post-myocardial damage or unstable angina.
- To prevent constipation, take precautions like using a stool softener or consuming more fibre.
-
Head trauma
- Use is not recommended for patients suffering from head injuries or high intracranial or cerebrospinal pressures.
- If therapy is necessary and cannot be avoided, use extreme caution.
-
Hypotension
- Can cause severe hypotension (including syncope and orthostasis).
- In patients with reduced blood volume or taking concurrent CNS depressants, the risk is increased (eg, phenothiazines, general anesthetics).
- Patients with circulatory shock should not use this product.
-
Respiratory depression[Canadian Boxed Warn]
- It is possible to develop severe, life-threatening or fatal respiratory depression.
- Infants who are exposed to breast milk or in utero during pregnancy or delivery may develop life-threatening respiratory depression.
- You should be aware of respiratory depression, especially during dose escalation or initiation.
-
Conditions abdominales:
- Patients with acute abdominal conditions may not be diagnosed or treated appropriately.
-
Adrenocortical Insufficiency
- Patients with adrenocortical impairment, including Addison disease, should be cautious.
- Sometimes, dose adjustment is necessary.
- Long-term opioid abuse can lead to secondary hypogonadism. This could cause infertility, sexual dysfunction, mood disorders, and osteoporosis.
-
Prostatic hyperplasia, urinary stricture
- Patients with prostatic hyperplasia and urinary stricture should be cautious.
- Sometimes, dose adjustment is necessary.
-
Psychosis:
- Patients with toxic psychosis should be treated cautiously
-
Respiratory disease
- Patients with impaired respiratory function should not use this medication.
- It is also contraindicated in patients suffering from acute respiratory depression, chronic obstruction of the airway, hypercarbia, and status asthmaticus.
-
Thyroid dysfunction:
- When treating someone with thyroid problems, exercise cautious.
Normethadone and hydroxyephedrine (United States: Not available): Drug Interaction
|
Risk Factor C (Monitor therapy) |
|
|
Alizapride |
May enhance the CNS depressant effect of CNS Depressants. |
|
Amphetamines |
Opioid agonists' analgesic effects might be improved. |
|
Anticholinergic Agents |
Opioid agonists' negative or toxic effects might be heightened. In particular, this combination may raise the risk for constipation and bladder retention. |
|
Brimonidine (Topical) |
May enhance the CNS depressant effect of CNS Depressants. |
|
Bromopride |
May enhance the CNS depressant effect of CNS Depressants. |
|
Cannabidiol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Cannabis |
May enhance the CNS depressant effect of CNS Depressants. |
|
Chlorphenesin Carbamate |
May enhance the adverse/toxic effect of CNS Depressants. |
|
Desmopressin |
Opioid Agonists may enhance the adverse/toxic effect of Desmopressin. |
|
Dimethindene (Topical) |
May enhance the CNS depressant effect of CNS Depressants. |
|
Diuretics |
Opioid Agonists may enhance the adverse/toxic effect of Diuretics. Opioid Agonists may diminish the therapeutic effect of Diuretics. |
|
Dronabinol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Gastrointestinal Agents (Prokinetic) |
Opioid Agonists may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). |
|
Kava Kava |
May enhance the adverse/toxic effect of CNS Depressants. |
|
Lofexidine |
CNS depressants may have an enhanced CNS depressant impact. Management: Separate drug interaction monographs go into further detail about the medications indicated as exceptions to this book. |
|
Magnesium Sulfate |
May enhance the CNS depressant effect of CNS Depressants. |
|
MetyroSINE |
CNS Depressants may enhance the sedative effect of MetyroSINE. |
|
Minocycline |
May enhance the CNS depressant effect of CNS Depressants. |
|
Nabilone |
May enhance the CNS depressant effect of CNS Depressants. |
|
Pegvisomant |
Opioid Agonists may diminish the therapeutic effect of Pegvisomant. |
|
Piribedil |
CNS Depressants may enhance the CNS depressant effect of Piribedil. |
|
Pramipexole |
The sedative effects of pramipexole might be enhanced by CNS depressants. |
|
Ramosetron |
Ramosetron's tendency to induce constipation may be increased by opioid agonists. |
|
ROPINIRole |
The sedative effects of CNS depressants may increase those of ROPINIRole. |
|
Rotigotine |
Rotigotine's sedative effects may be boosted by CNS depressants. |
|
Rufinamide |
CNS depressants' harmful or toxic effects could be increased. Particularly, drowsiness and lightheadedness could be worsened. |
|
Selective Serotonin Reuptake Inhibitors |
CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. |
|
Serotonin Modulators |
Opioid Agonists may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Exceptions: Nicergoline. |
|
Succinylcholine |
May enhance the bradycardic effect of Opioid Agonists. |
|
Tetrahydrocannabinol |
CNS depressants may have an enhanced CNS depressant impact. |
|
Tetrahydrocannabinol and Cannabidiol |
CNS depressants may have an enhanced CNS depressant impact. |
|
Risk Factor D (Consider therapy modification) |
|
|
Alvimopan |
Opioid Agonists may enhance the adverse/toxic effect of Alvimopan. This is most notable for patients receiving long-term (i.e., more than 7 days) opiates prior to alvimopan initiation. Management: Alvimopan is contraindicated in patients receiving therapeutic doses of opioids for more than 7 consecutive days immediately prior to alvimopan initiation. |
|
Blonanserin |
CNS Depressants may enhance the CNS depressant effect of Blonanserin. |
|
Chlormethiazole |
CNS depressants may have an enhanced CNS depressant impact. Management: Keep a close eye out for signs of severe CNS depression. If such a combination is required, it should be taken at a dose that has been suitably lowered, according to the instructions for chlormethiazole. |
|
CNS Depressants |
May intensify opioid agonists' CNS depressive effects. Management: When at all possible, refrain from using benzodiazepines or other CNS depressants concurrently with opioid agonists. Only in the event that other treatment choices are insufficient should these medications be combined. Limit the duration and dosage of each medicine when used together. |
|
Droperidol |
CNS depressants may have an enhanced CNS depressant impact. Consider lowering the dosage of droperidol or other CNS drugs (such as opioids or barbiturates) when they are used concurrently. In separate drug interaction monographs, exceptions to this monograph are covered in more detail. |
|
Flunitrazepam |
Flunitrazepam's CNS depressing effects may be enhanced by other CNS depressants. |
|
HYDROcodone |
The CNS depressive action of HYDROcodone may be enhanced by CNS depressants. Management: Whenever feasible, refrain from using hydrocodone and benzodiazepines or other CNS depressants concurrently. Only in the event that other treatment choices are insufficient should these medications be combined. Limit the duration and dosage of each medicine when used together. |
|
Methotrimeprazine |
The CNS depressing action of methotrimeprazine may be enhanced by CNS depressants. The CNS depressant action of CNS Depressants may be strengthened by methotrimeprazine. Management: Start concurrent methotrimeprazine therapy while reducing the adult dose of CNS depressants by 50%. Only once a clinically effective dose of methotrimeprazine has been established should additional CNS depressant dosage modifications be made. |
|
Nalmefene |
May lessen opioid agonists' therapeutic efficacy. Management: Avoid taking nalmefene and opioid agonists together. One week before any anticipated use of opioid agonists, stop taking nalmefene. Larger doses of opioid agonists will probably be needed if they are combined. |
|
Naltrexone |
May lessen opioid agonists' therapeutic efficacy. Management: Look for therapeutic opioid substitutes. For comprehensive suggestions, consult the entire medication interaction monograph. |
|
Opioid Agonists |
CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
OxyCODONE |
The CNS depressing effects of OxyCODONE may be enhanced by CNS depressants. Management: Whenever feasible, refrain from using oxycodone and benzodiazepines or other CNS depressants concurrently. Only in the event that other treatment choices are insufficient should these medications be combined. Limit the duration and dosage of each medicine when used together. |
|
Perampanel |
CNS depressants may have an enhanced CNS depressant impact. Treatment: Until they have experience using the combination, patients taking perampanel along with any other medication that has CNS depressive effects should avoid complex and high-risk activities, especially those like driving that call for awareness and coordination. |
|
Sincalide |
The therapeutic benefit of Sincalide may be reduced by medications that affect gallbladder function. Prior to using sincalide to induce gallbladder contraction, you should think about stopping any medications that can impair gallbladder motility. |
|
Sodium Oxybate |
CNS depressants may have an enhanced CNS depressant impact. Management: Take into account substitutes for combined use. Reduce the doses of one or more medications when simultaneous use is necessary. It is not advised to use sodium oxybate with alcoholic beverages or hypnotic sedatives. |
|
Suvorexant |
CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. |
|
Tapentadol |
May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. |
|
Zolpidem |
CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. |
|
Risk Factor X (Avoid combination) |
|
|
Azelastine (Nasal) |
CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). |
|
Bromperidol |
May enhance the CNS depressant effect of CNS Depressants. |
|
Eluxadoline |
Opioid Agonists may enhance the constipating effect of Eluxadoline. |
|
Opioids (Mixed Agonist / Antagonist) |
May lessen opioid agonists' analgesic effects. Management: If patients are given mixed agonist/antagonist opioids instead of pure opioid agonists, look for alternatives and keep an eye out for withdrawal symptoms in patients who are opioid-dependent or signs of therapeutic failure/high dose requirements. |
|
Orphenadrine |
The CNS depressing action of orphenadrine may be enhanced by CNS depressants. |
|
Oxomemazine |
May enhance the CNS depressant effect of CNS Depressants. |
|
Paraldehyde |
CNS Depressants may enhance the CNS depressant effect of Paraldehyde. |
|
Thalidomide |
CNS Depressants may enhance the CNS depressant effect of Thalidomide. |
Monitoring Parameters:
- Relief of symptoms.
- Respiratory and mental status.
- Bowel function,
- Signs/symptoms of addiction, abuse, or misuse
How to administer Cophylac (Normethadone and hydroxyephedrine)?
P/O:
- Invert dispensing bottle to dispense drops.
- After breakfast and at bedtime, administer preferably.
- May be taken plain with sugar or added to any beverage.
- For disposal instructions, refer to the manufacturer's labeling.
Mechanism of action of Cophylac (Normethadone and hydroxyephedrine):
- It acts centrally to suppress the cough center in the medulla.
International Brands of Normethadone and hydroxyephedrine:
- Cophylac
Normethadone and hydroxyephedrine Brand Names in Pakistan:
No Brands Available in Pakistan.
 Injection.webp)