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Brand Name :
Codeine Phosphate-Promethazine HCl, Phenergan with Codeine
Synonyms :
promethazine and codeine
Class :
Antitussives, Narcotic Combos
Dosage Forms & Strengths
oral liquid: Schedule V
(6.25mg/10mg)/5ml
Dosage Forms & Strengths
oral liquid: Schedule V
(6.25mg/10mg)/5ml
[promethazine(6.25mg)/codeine(10mg)]/5ml
Refer to adult dosing
Actions and Spectrum:
The action of this combination drug is to relieve coughing and other respiratory symptoms. As an antihistamine, promethazine helps to lessen inflammation and allergic reactions that can lead to coughing. codeine acts on the cough centre in the brain, suppressing coughing and making it easier to breathe.
In terms of spectrum, the combination of promethazine and codeine has a broad spectrum of action. It works well to treat a range of coughs and respiratory symptoms brought on by colds, allergies, and other respiratory ailments.
Frequency Defined
>10% (Codeine)
Drowsiness
Constipation
Frequency not defined (for codeine)
False feeling of well being
Vomiting
Urination decreased
LFT’s increased
Histamine release
Xerostomia
Rash
Urticaria
Headache
Respiratory depression
Paradoxical CNS stimulation
Restlessness
Lightheadedness
Confusion
Dizziness
Malaise
Weakness
Tachycardia
Ureteral spasm
Bradycardia
Blurred vision
Anaphylactoid reaction
Seizure (with excessive doses)
Hypotension (especially with intravenous use)
Dyspnea
Anorexia
Nausea
Frequency not defined (for promethazine)
Sedation (common)
Adverse anticholinergic effects (dry mouth, blurred vision)
Leukopenia (rare)
Agranulocytosis (rare)
Obstructive jaundice
Photosensitivity
Confusion (common)
Tachycardia
Bradycardia
Disorientation (common)
EPS
Black Box Warning
The warning indicates that the medicine should not be taken in children younger than 12 years of age, as it may cause significant and perhaps life-threatening respiratory issues. The warning advises that the medication should be used only for short-term treatment of respiratory symptoms and cough.
The black box warning clearly stresses the risk for misuse and addiction with this drug. Since codeine is an opioid, it has the potential to become addictive or cause overdose.
Contraindication/Caution:
Contraindication:
Caution:
Pregnancy warnings:
Pregnancy category: N/A
Lactation: Excretion into human milk is known
Pregnancy Categories:
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.
Category B: There were lack of studies on pregnant women and no evidence of risk to the foetus in animal experiments.
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 available 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
promethazine is a medication that works by blocking the action of histamine, a chemical that is released in response to allergens and other triggers. This reduces inflammation and allergic reactions, which can help relieve coughing and other respiratory symptoms.
codeine is an opioid that helps to reduce pain and suppress coughing. It is metabolized in the liver and converted into morphine, which is the most active form of the medication.
Pharmacodynamics
The pharmacology of promethazine and codeine is complicated, but it involves how the two active ingredients interact with the body. promethazine works by blocking histamine receptors in the body, while codeine works by activating opioid receptors in the brain and spinal cord.
promethazine and codeine are both medications that are used to treat cough and respiratory symptoms. Together, they are more effective than either medication alone. The antihistamine properties of promethazine help reduce inflammation and allergic reactions, while the opioid properties of codeine suppress coughing and reduce pain.
Pharmacokinetics
Absorption
promethazine and codeine are taken orally in tablet or syrup form. The medication is well-absorbed in the gastrointestinal tract, and peak plasma concentrations are reached within 1-2 hours after oral administration.
Distribution
The medicine is in the bloodstream and it works to improve your cough and breathing problems. promethazine and codeine are both very tightly bound to proteins in the blood.
Metabolism
promethazine is metabolized by the liver. codeine is metabolized by the liver into its active form, morphine, through the CYP2D6 enzyme pathway. The metabolites of both drugs can be further metabolized by glucuronidation and other pathways.
Elimination and excretion
promethazine and its metabolites are eliminated from the body over a period of about 7 to14 hours, while codeine and its metabolites are eliminated over a period of about 2 to 4 hours. The active metabolite of codeine, morphine, is eliminated over a period of about 2 to 4 hours.
Administration:
promethazine and codeine both the medicine that can be taken in tablet and syrup forms. It should be taken as directed by a healthcare provider, and the dosage may vary depending on the patient’s age, weight, and medical condition.
For adults, the recommended dose is one tablet or teaspoonful (5 ml) of syrup every 4 to 6 hours, as needed for pain and cough relief. Some people may need more than this, while others may need less.
When you take promethazine and codeine together, it is important to take them with food or milk to help reduce stomach upset. You should not crush or chew the tablets, and you should swallow them whole with a full glass of water.
Patient information leaflet
Generic Name: promethazine and codeine
Why do we use promethazine and codeine?
promethazine and codeine are a blend of medicines that are employed to ease cough and other indications linked with allergies, common colds, and upper respiratory tract infections. This medication is accessible only with a prescription and is meant for limited-time use.