Promethazine and codeine

Name: Promethazine and codeine

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Uses For promethazine and codeine

Promethazine and codeine combination is used to relieve cough, runny or stuffy nose, sneezing, or other symptoms caused by allergies or the common cold.

Promethazine is an antihistamine. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. It can sometimes close up the bronchial tubes (air passages of the lungs) and make breathing difficult. Codeine belongs to the group of medicine called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

promethazine and codeine is available only with your doctor's prescription.

Before Using promethazine and codeine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For promethazine and codeine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to promethazine and codeine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of promethazine and codeine combination is not recommended in children younger than 6 years of age because of the increased risk of respiratory depression.

Promethazine and codeine combination should not be used to relieve pain after surgery to remove tonsils and/or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of promethazine and codeine combination in the elderly. However, elderly patients are more likely to have unwanted effects (such as confusion, drowsiness) and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving promethazine and codeine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using promethazine and codeine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking promethazine and codeine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using promethazine and codeine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amifampridine
Amisulpride
Bepridil
Bromopride
Cisapride
Dronedarone
Furazolidone
Iproniazid
Isocarboxazid
Linezolid
Mesoridazine
Methylene Blue
Metoclopramide
Moclobemide
Nalmefene
Naltrexone
Nialamide
Phenelzine
Pimozide
Piperaquine
Procarbazine
Rasagiline
Safinamide
Saquinavir
Selegiline
Sodium Oxybate
Sparfloxacin
Terfenadine
Thioridazine
Toloxatone
Tranylcypromine
Ziprasidone

Using promethazine and codeine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acepromazine
Alfentanil
Alfuzosin
Almotriptan
Alprazolam
Amineptine
Amiodarone
Amisulpride
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Anagrelide
Anileridine
Apomorphine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Astemizole
Azithromycin
Baclofen
Benperidol
Benzphetamine
Bromazepam
Bromopride
Brompheniramine
Buprenorphine
Bupropion
Buserelin
Buspirone
Butabarbital
Butorphanol
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Chloral Hydrate
Chlordiazepoxide
Chloroquine
Chlorpheniramine
Chlorpromazine
Chlorzoxazone
Ciprofloxacin
Citalopram
Clarithromycin
Clobazam
Clomipramine
Clonazepam
Clorazepate
Clozapine
Cocaine
Codeine
Conivaptan
Crizotinib
Cyclobenzaprine
Dabrafenib
Darunavir
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Desmopressin
Deutetrabenazine
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diazepam
Dibenzepin
Dichloralphenazone
Difenoxin
Dihydrocodeine
Diphenhydramine
Diphenoxylate
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Doxylamine
Droperidol
Duloxetine
Efavirenz
Eletriptan
Enflurane
Erythromycin
Escitalopram
Estazolam
Eszopiclone
Ethchlorvynol
Ethopropazine
Ethylmorphine
Fentanyl
Fingolimod
Flecainide
Flibanserin
Fluconazole
Fluoxetine
Fluphenazine
Flurazepam
Fluspirilene
Fluvoxamine
Foscarnet
Fospropofol
Frovatriptan
Gatifloxacin
Gemifloxacin
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Halothane
Hexobarbital
Histrelin
Hydrocodone
Hydromorphone
Hydroxychloroquine
Hydroxytryptophan
Hydroxyzine
Ibutilide
Iloperidone
Imipramine
Isoflurane
Isradipine
Ivabradine
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Lapatinib
Leuprolide
Levofloxacin
Levomilnacipran
Levorphanol
Lisdexamfetamine
Lithium
Lofepramine
Lopinavir
Lorazepam
Lorcaserin
Loxapine
Lumefantrine
Meclizine
Mefloquine
Melitracen
Melperone
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaxalone
Methadone
Methamphetamine
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Metrizamide
Metronidazole
Midazolam
Mifepristone
Milnacipran
Mirtazapine
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Nafarelin
Nalbuphine
Naratriptan
Nefazodone
Netupitant
Nicomorphine
Nilotinib
Nitrazepam
Nitrous Oxide
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Olanzapine
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxazepam
Oxycodone
Oxymorphone
Paliperidone
Palonosetron
Panobinostat
Papaveretum
Paregoric
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenobarbital
Pimavanserin
Piperacetazine
Pipotiazine
Piritramide
Pitolisant
Posaconazole
Prazepam
Primidone
Procainamide
Procarbazine
Prochlorperazine
Promazine
Promethazine
Propafenone
Propofol
Protriptyline
Quazepam
Quetiapine
Quinine
Ramelteon
Ranolazine
Remifentanil
Remoxipride
Ribociclib
Rizatriptan
Salmeterol
Secobarbital
Sertindole
Sertraline
Sevoflurane
Sibutramine
Sodium Oxybate
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
St John's Wort
Sufentanil
Sulpiride
Sumatriptan
Sunitinib
Suvorexant
Tacrolimus
Tapentadol
Telavancin
Telithromycin
Temazepam
Tetrabenazine
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Tianeptine
Tilidine
Tiotropium
Tizanidine
Tolonium Chloride
Topiramate
Toremifene
Tramadol
Trazodone
Triazolam
Trifluoperazine
Trifluperidol
Triflupromazine
Trimeprazine
Trimipramine
Triptorelin
Tryptophan
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Vilazodone
Vinflunine
Voriconazole
Vortioxetine
Zaleplon
Ziprasidone
Zolmitriptan
Zolpidem
Zopiclone
Zotepine
Zuclopenthixol

Using promethazine and codeine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aminolevulinic Acid
Belladonna
Belladonna Alkaloids
Betel Nut
Evening Primrose
Midodrine
Phenylalanine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using promethazine and codeine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use promethazine and codeine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Indications and usage

Promethazine hydrochloride and codeine phosphate syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

Contraindications

The combination of promethazine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.

Codeine sulfate is contraindicated for post-operative pain management in children who have undergone tonsillectomy and/or adenoidectomy. (See WARNINGS - Death Related to Ultra- Rapid Metabolism of Codeine to Morphine). Codeine is contraindicated in patients with a known hypersensitivity to the drug.

Promethazine hydrochloride is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.

Antihistamines and codeine are both contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma.

Pharmacologic Category

Analgesic, Opioid
Antitussive
Histamine H1 Antagonist
Histamine H1 Antagonist, First Generation
Phenothiazine Derivative

Pharmacology

Codeine: Binds to opioid receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain; causes cough suppression by direct central action in the medulla; produces generalized CNS depression.

Promethazine: Phenothiazine derivative; blocks postsynaptic mesolimbic dopaminergic receptors in the brain; exhibits a strong alpha-adrenergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones; competes with histamine for the H1-receptor; muscarinic-blocking effect may be responsible for antiemetic activity; reduces stimuli to the brainstem reticular system.

Dosing Geriatric

Refer to adult dosing. Use with caution; consider using decreased dose.

Administration

Administer with an accurate measuring device; do not use a household teaspoon (overdosage may occur). May administer without regard to meals; administer with food or milk to decrease adverse GI effects.

Adverse Reactions

Also see individual agents.

Limited to important or life-threatening: Hypogonadism (Brennan 2013; Debono 2011)

Pregnancy Risk Factor C Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. See individual agents.