normethadone/hydroxyephedrine

Action and Spectrum

Actions and Spectrum 

normethadone/hydroxyephedrine acts centrally to suppress the cough center in the medulla region.  

The action of levomethadone involves providing analgesia and reducing opioid withdrawal symptoms. 

hydroxyephedrine acts on adrenergic receptors, specifically as an agonist of alpha and beta receptors in the sympathetic nervous system.

Drug Interaction

Adverse Reaction

Frequency not defined  

Drowsiness, drug abuse  

Hypotension, syncope 

Ataxia, dizziness 

Diaphoresis, pruritus 

Drug dependence, headache, insomnia 

Visual disturbance 

Respiratory depression  

Nausea, vomiting, xerostomia 

Asthenia 

Constipation, decreased appetite 

Black Box Warning

Black Box Warning 

None

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• Hypersensitivity to normethadone/ hydroxyephedrine or any component of the formulation.  

Caution: 

• Patients should be cautioned about performing tasks which require mental alertness such as operating machinery or driving vehicle.  
• It may cause constipation which may be harmful in patients with unstable angina and patients’ post-myocardial infarction.  
• Consider preventive measures to reduce the potential for constipation. 

Pregnancy / Lactation

Pregnancy consideration: 

Pregnancy category: N/A 

Lactation: Excretion into human milk is unknown  

Pregnancy Categories:         

Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 

<b>Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.  

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women. 

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 

Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology  

levomethadone is a synthetic opioid analgesic and an isomer of methadone. Methadone is a mu-opioid receptor agonist, which means it binds to and activates these receptors in the central nervous system. 

hydroxyephedrine is a sympathomimetic amine with both alpha- and beta-adrenergic agonist properties. It acts as a direct and indirect stimulant of the sympathetic nervous system.  

Pharmacodynamics 

Limited information available  

Pharmacokinetics 

Limited information available on ADME

Adminstartion

Administration 

normethadone/hydroxyephedrine usually administered orally and it is available in solution (syrup) form.

Patient Information Leaflet

Patient information leaflet 

Generic Name: normethadone/ hydroxyephedrine 

Why do we use normethadone/ hydroxyephedrine? 

normethadone/hydroxyephedrine is combination drug indicated for treatment of cough associated with inflamed mucosa in adults.   

normethadone may be used as pain relief or treatment for opioid dependence.  

hydroxyephedrine is commonly used as a decongestant to relieve nasal congestion.