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PROMETHAZINE-PHENYLEPH-CODEINE (PROMETHAZINE/PHENYLEPHRINE HCL/CODEINE)
- Cold symptoms
- Cough
- Rhinorrhea
- Allergic rhinitis
- Nasal congestion
- Promethazine-phenylephrine-codeine Syrup
- Promethazine-phenylephrine-codeine Oral Syrup
- Phenyleph-promethazine-cod Syrup
- By Indication
promethazine-phenylephrine-codeine 6.25 mg-5 mg-10 mg/5 mL oral syrup
- 5 milliliters by oral route every 4-6 hours as needed, not to exceed 30 ml in 24 hours
promethazine-phenylephrine-codeine 6.25 mg-5 mg-10 mg/5 mL oral syrup
- 5 milliliters by oral route every 4-6 hours as needed, not to exceed 30 ml in 24 hours
promethazine-phenylephrine-codeine 6.25 mg-5 mg-10 mg/5 mL oral syrup
- 5 milliliters by oral route every 4-6 hours as needed, not to exceed 30 ml in 24 hours
Cold symptoms
- 5 milliliters by oral route every 4-6 hours as needed, not to exceed 30 ml in 24 hours
- 5 milliliters by oral route every 4 hours as needed, not to exceed 30 ml in 24 hours
- 5 milliliters by oral route every 6 hours as needed, not to exceed 30 ml in 24 hours
Cough
- 5 milliliters by oral route every 4-6 hours as needed, not to exceed 30 ml in 24 hours
- 5 milliliters by oral route every 4 hours as needed, not to exceed 30 ml in 24 hours
- 5 milliliters by oral route every 6 hours as needed, not to exceed 30 ml in 24 hours
Nasal congestion
- 5 milliliters by oral route every 4-6 hours as needed, not to exceed 30 ml in 24 hours
- 5 milliliters by oral route every 4 hours as needed, not to exceed 30 ml in 24 hours
- 5 milliliters by oral route every 6 hours as needed, not to exceed 30 ml in 24 hours
- Depade
- isocarboxazid
- Marplan
- Matulane
- methylene blue (antidote)
- naltrexone
- naltrexone microspheres
- Nardil
- Orap
- Parnate
- phenelzine
- pimozide
- procarbazine
- Revia
- tranylcypromine
- Vivitrol
Contraindicated
- Azilect
- bromocriptine
- cabergoline
- Cafergot
- Compound 347
- Cycloset
- D.h.e.45
- dihydroergotamine
- Eldepryl
- enflurane
- ergoloid
- Ergomar
- ergotamine tartrate
- ergotamine-caffeine
- Forane
- isoflurane
- linezolid
- methylergonovine
- Migergot
- Migranal
- Parlodel
- rasagiline
- selegiline HCl
- sevoflurane
- Sojourn
- Terrell
- Ultane
- Zelapar
- Zyvox
Severe
Moderate
- Alagesic Lq
- amobarbital
- Amytal
- Anaspaz
- Aplenzin
- Ascomp With Codeine
- Atropen
- atropine
- belladonna alkaloids-opium
- Belladonna-opium
- Belladonna-phenobarbital
- Bentyl
- benztropine
- Brisdelle
- Bupap
- Buprenex
- buprenorphine
- buprenorphine-naloxone
- Buproban
- bupropion HBr
- bupropion HCl
- butabarbital
- Butalbital Compound W/codeine
- Butalbital Compound-codeine
- butalbital-acetaminop-caf-cod
- butalbital-acetaminophen
- butalbital-acetaminophen-caff
- butalbital-aspirin-caffeine
- Butisol
- butorphanol tartrate
- Butrans
- Cantil
- Capacet
- chlordiazepoxide-clidinium
- chlorphen-pseudoeph-bellad alk
- codeine-butalbital-ASA-caff
- Cogentin
- Cuvposa
- dextromethorphan-quinidine
- dicyclomine
- diphenoxylate-atropine
- Ditropan Xl
- Donnatal
- Duodote
- Ed-spaz
- edrophonium Cl-atropine
- Enlon-plus
- Esgic
- Fanatrex
- Fioricet
- Fioricet With Codeine
- Fiorinal
- Fiorinal-codeine #3
- flavoxate
- fluoxetine
- Forfivo Xl
- gabapentin
- gabapentin enacarbil
- Gelnique
- Glycate
- glycopyrrolate
- Gralise
- Gralise 30-day Starter Pack
- Horizant
- Hydrocodone Compound
- hydrocodone-homatropine
- Hydromet
- Hyophen
- hyoscyamine sulfate
- Hyosyne
- Levbid
- Levsin
- Levsin/sl
- Librax (with Clidinium)
- Lomotil
- Luminal
- Margesic
- Marten-tab
- mepenzolate bromide
- methen-hyos-me blue-ba-salicyl
- methen-hyosc-m.blue-sal-naphos
- methen-sod phos-meth blue-hyos
- methscopolamine
- methyldopa
- methyldopa-hydrochlorothiazide
- methyldopate
- mth-me blue-sod phos-phsal-hyo
- Mysoline
- nalbuphine
- Nembutal Sodium
- Neurontin
- Nuedexta
- Nulev
- olanzapine-fluoxetine
- Oscimin
- Oscimin Sl
- Oscimin Sr
- oxybutynin
- oxybutynin chloride
- Oxytrol
- Oxytrol For Women
- Pamine
- Pamine Forte
- paroxetine HCl
- paroxetine mesylate
- Paxil
- Paxil Cr
- pentobarbital sodium
- Pexeva
- phenobarb-hyoscy-atropine-scop
- phenobarbital
- phenobarbital sodium
- Phosphasal
- pralidoxime-atropine
- primidone
- propantheline
- Prosed/ds (atropine Free)
- Prozac
- Prozac Weekly
- quinidine gluconate
- quinidine sulfate
- reserpine
- Respa-ar
- Robinul
- Robinul Forte
- Sarafem
- scopolamine base
- scopolamine HBr
- secobarbital sodium
- Seconal Sodium
- Suboxone
- Symax Duotab
- Symax Fastabs
- Symax-sl
- Symax-sr
- Symbyax
- Tencon
- Transderm-scop
- trihexyphenidyl
- Tussigon
- Ur N-c
- Urelle
- Uretron D-s
- Uribel
- Urimar-t
- Urin Ds
- Urogesic-blue
- Uryl
- Ustell
- Uta
- Wellbutrin
- Wellbutrin Sr
- Wellbutrin Xl
- Zebutal
- Zubsolv
- Zyban
- Acute myocardial infarction
- Adenoidectomy in pediatric patient
- Arterial thrombosis
- Coma
- Congenital long QT syndrome
- Lactating mother
- Neuroleptic malignant syndrome
- Respiratory depression
- Severe uncontrolled hypertension
- Sleep apnea
- Tonsillectomy in pediatric patient
- Torsades de pointes
- Ventricular tachycardia
Contraindicated
- Acute asthma attack
- Acute hepatitis
- Acute pancreatitis
- Angle-closure glaucoma
- Asthma
- Benign prostatic hyperplasia
- Bladder outflow obstruction
- Bradycardia
- Chronic idiopathic constipation
- Chronic obstructive pulmonary disease
- Coronary artery disease
- CYp2d6 poor metabolizer
- CYp2d6 ultrarapid metabolizer
- Drug abuse
- Gastrointestinal obstruction
- History of opioid overdose
- Hypertension
- Hyperthyroidism
- Incomplete AV heart block
- Intracranial hypertension
- Kidney disease with likely reduction in GFR
- Obstructive sleep apnea syndrome
- Parkinsonism
- Prolonged QT interval
- Pyloroduodenal obstruction
- Respiratory depression
- Severe arteriosclerotic vascular disease
- Shock
- Sleep apnea
- Stenosing peptic ulcer
- Systemic mastocytosis
Severe
Moderate
- Acidosis
- Adrenal cortical insufficiency
- Alcohol intoxication
- Biliary tract disorder
- Bone marrow depression
- Chronic heart failure
- Constipation
- Cor pulmonale
- Debilitation
- Disease of liver
- Gastrointestinal obstruction
- Hyperbilirubinemia
- Hypotension
- Hypoxia
- Lower seizure threshold
- Seizure disorder
- Severe hepatic disease
- Untreated hypothyroidism
- Urinary retention
PROMETHAZINE-PHENYLEPH-CODEINE (PROMETHAZINE/PHENYLEPHRINE HCL/CODEINE)
- Cold symptoms
- Cough
- Rhinorrhea
- Allergic rhinitis
- Nasal congestion
- Hypotension
- Tachycardia
- Abdominal pain with cramps
- Acute confusion
- Blurred vision
- Constipation
- Dizziness
- Drowsy
- Excitement
- Irritability
- Nausea
- Nervousness
- Nightmares
- Sedation
- Skin photosensitivity
- Skin rash
- Thick bronchial secretions
- Tinnitus
- Visual changes
- Xerostomia
More Frequent
Severe
Less Severe
- Atelectasis
- CNS depression
- Dyspnea
- Orthostatic hypotension
- Respiratory depression
- Sedation
- Acute confusion
- Anorexia
- Dizziness
- Dysphoric mood
- General weakness
- Headache disorder
- Hyperhidrosis
- Hypotension
- Nasal congestion
- Nervousness
- Oliguria
- Palpitations
- Pruritus of skin
- Skin rash
- Syncope
- Urticaria
- Visual changes
- Vomiting
- Xerostomia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Acute respiratory insufficiency
- Adrenal cortical insufficiency
- Agranulocytosis
- Anaphylaxis
- Androgen deficiency
- Angioedema
- Apnea
- Asthma
- Bradycardia
- Cardiac arrest
- Cardiac arrhythmia
- Circulatory depression
- Delirium
- Dissociative disorder
- Dizziness
- Extrapyramidal disease
- Hallucinations
- Headache disorder
- Hyperhidrosis
- Hypertension
- Ileus
- Insomnia
- Jaundice
- Leukopenia
- Lower seizure threshold
- Nervousness
- Neuroleptic malignant syndrome
- Obstructive hyperbilirubinemia
- Opioid dependence
- Pallor
- Pancreatitis
- Respiratory depression
- Seizure disorder
- Shock
- Sleep apnea
- Tachycardia
- Thrombocytopenic disorder
- Thrombotic thrombocytopenic purpura
- Tremor
- Urticaria
Less Severe
- Anorexia
- Ataxia
- Biliary spasm
- Diarrhea
- Diplopia
- Dysuria
- Erectile dysfunction
- Euphoria
- Fatigue
- Flushing
- Gastrointestinal irritation
- Infertility
- Insomnia
- Libido changes
- Nausea
- Skin inflammation
- Symptoms of anxiety
- Tremor
- Vertigo
- Vomiting
Contraindicated
Codeine (cough_cold)
Not indicated for symptoms of cough and cold in pediatrics. Risk of slowed or difficult breathing and respiratory depression. Death reported in CYP2D6 ultra-rapid metabolizers post tonsillectomy or adenoidectomy.
Risk of CNS excitation. Do not use age <6 years without clinician consult.
Potential for fatal respiratory depression age < 2 years. Avoid use.
- 1 Day – 18 Years
- 1 Not indicated for symptoms of cough and cold in pediatrics. Risk of slowed or difficult breathing and respiratory depression. Death reported in CYP2D6 ultra-rapid metabolizers post tonsillectomy or adenoidectomy.
- 1 Day – 6 Years
- 1 Not indicated for symptoms of cough and cold in pediatrics. Risk of slowed or difficult breathing and respiratory depression. Death reported in CYP2D6 ultra-rapid metabolizers post tonsillectomy or adenoidectomy.
- 1 Day – 2 Years
- 1 Not indicated for symptoms of cough and cold in pediatrics. Risk of slowed or difficult breathing and respiratory depression. Death reported in CYP2D6 ultra-rapid metabolizers post tonsillectomy or adenoidectomy.
Phenylephrine (oral)
Not indicated for symptoms of cough and cold in pediatrics. Risk of slowed or difficult breathing and respiratory depression. Death reported in CYP2D6 ultra-rapid metabolizers post tonsillectomy or adenoidectomy.
Risk of CNS excitation. Do not use age <6 years without clinician consult.
Potential for fatal respiratory depression age < 2 years. Avoid use.
- 1 Day – 18 Years
- 1 Risk of CNS excitation. Do not use age <6 years without clinician consult.
- 1 Day – 6 Years
- 1 Risk of CNS excitation. Do not use age <6 years without clinician consult.
- 1 Day – 2 Years
- 1 Risk of CNS excitation. Do not use age <6 years without clinician consult.
Promethazine
Not indicated for symptoms of cough and cold in pediatrics. Risk of slowed or difficult breathing and respiratory depression. Death reported in CYP2D6 ultra-rapid metabolizers post tonsillectomy or adenoidectomy.
Risk of CNS excitation. Do not use age <6 years without clinician consult.
Potential for fatal respiratory depression age < 2 years. Avoid use.
- 1 Day – 18 Years
- 1 Potential for fatal respiratory depression age < 2 years. Avoid use.
- 1 Day – 6 Years
- 1 Potential for fatal respiratory depression age < 2 years. Avoid use.
- 1 Day – 2 Years
- 1 Potential for fatal respiratory depression age < 2 years. Avoid use.
Severe Precaution
Promethazine
Caution:use the lowest effective dose due to risk of respiratory depression.
- 2 Years – 18 Years
- Caution:use the lowest effective dose due to risk of respiratory depression.
Management or Monitoring Precaution
None
Codeine
- Severity Level:
C
- Additional Notes: Neonatal withdrawal/resp.depress. w/chronic or high dose; small teratogenic risk
Phenylephrine
- Severity Level:
2
- Additional Notes: Insufficient human data available.
Promethazine Hydrochloride
- Severity Level:
C
- Additional Notes: Caution with use; risk of platelet aggregation in newborn
Contraindicated
Codeine
Cns/respiratory depression,apnea possible;Caution w/ fast cyp2D6 metabolizer
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Excreted | Drug shown to have adverse effect | Cns/respiratory depression,apnea possible;Caution w/ fast cyp2D6 metabolizer |
Precaution Exists
Phenylephrine
Oral bioavailability low; infant exposure may be minimal
Limited amount may be excreted due to low mw; monitor infant for resp depress
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Excreted | Not known; no or inclusive data | Oral bioavailability low; infant exposure may be minimal |
Promethazine
Oral bioavailability low; infant exposure may be minimal
Limited amount may be excreted due to low mw; monitor infant for resp depress
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Limited amount may be excreted due to low mw; monitor infant for resp depress |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- This medication has a risk for abuse and addiction, which can lead to overdose and death. This medication may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose that works, and take it for the shortest possible time.<br /><br />See also How to Use section for more information about addiction. The risk for severe breathing problems is higher when you start this medication, or if you take the wrong dose or take more of this medication than prescribed. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death.<br /><br /> Also, other medications can affect the removal of this product from your body, which may affect how it works. Be sure you know how to take this product and what other drugs you should avoid taking with it. See also Drug Interactions section.<br /><br />Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up. Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this drug, get medical help right away.<br /><br /> Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or think you may be pregnant. During pregnancy, this medication is not recommended.<br /><br />It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time.<br /><br />Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as crying that doesn't stop, slow/shallow breathing, irritability, shaking, vomiting, diarrhea, poor feeding, or difficulty gaining weight.
| Allergic rhinitis | |
| J30.1 | Allergic rhinitis due to pollen |
| J30.2 | Other seasonal allergic rhinitis |
| J30.5 | Allergic rhinitis due to food |
| J30.8 | Other allergic rhinitis |
| J30.81 | Allergic rhinitis due to animal (cat) (dog) hair and dander |
| J30.89 | Other allergic rhinitis |
| J30.9 | Allergic rhinitis, unspecified |
| Cold symptoms | |
| J00 | Acute nasopharyngitis [common cold] |
| Cough | |
| R05 | Cough |
| Nasal congestion | |
| R09.81 | Nasal congestion |
| Rhinorrhea | |
| R09.82 | Postnasal drip |
| 0-9 | A-Z |
|---|---|
| J00 | Acute nasopharyngitis [common cold] |
| J30.1 | Allergic rhinitis due to pollen |
| J30.2 | Other seasonal allergic rhinitis |
| J30.5 | Allergic rhinitis due to food |
| J30.8 | Other allergic rhinitis |
| J30.81 | Allergic rhinitis due to animal (cat) (dog) hair and dander |
| J30.89 | Other allergic rhinitis |
| J30.9 | Allergic rhinitis, unspecified |
| R05 | Cough |
| R09.81 | Nasal congestion |
| R09.82 | Postnasal drip |
Formulary Reference Tool