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Drug overview for PRES GEN PEDIATRIC (guaifenesin/dextromethorphan hbr/phenylephrine):
Generic name: GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE
Drug class: Amphetamines/Anorexiants/Stimulants
Therapeutic class: Respiratory Therapy Agents
Dextromethorphan, a derivative of levorphanol, is an antitussive agent. Guaifenesin is an expectorant. Phenylephrine hydrochloride is an alpha1-adrenergic receptor agonist.
Dextromethorphan is used for the temporary relief of coughs caused by minor throat and bronchial irritation such as may occur with common colds or with inhaled irritants. Dextromethorphan is most effective in the treatment of chronic, nonproductive cough. The drug is a common ingredient in commercial cough mixtures available without prescription.
Although cough and cold preparations that contain cough suppressants (including dextromethorphan), nasal decongestants, antihistamines, and/or expectorants commonly are used in pediatric patients younger than 2 years of age, systematic reviews of controlled trials have concluded that nonprescription (over-the-counter, OTC) cough and cold preparations are not more effective than placebo in reducing acute cough and other symptoms of upper respiratory tract infection in these patients. Furthermore, adverse events, including deaths, have been (and continue to be) reported in pediatric patients younger than 2 years of age receiving these preparations. (See Cautions: Pediatric Precautions and see Acute Toxicity: Manifestations.) For information on abuse of dextromethorphan, see Cautions. For use of dextromethorphan hydrobromide in fixed combination with quinidine sulfate in the treatment of pseudobulbar affect (PBA), see Dextromethorphan Hydrobromide and Quinidine Sulfate 28:92.
Generic name: GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE
Drug class: Amphetamines/Anorexiants/Stimulants
Therapeutic class: Respiratory Therapy Agents
Dextromethorphan, a derivative of levorphanol, is an antitussive agent. Guaifenesin is an expectorant. Phenylephrine hydrochloride is an alpha1-adrenergic receptor agonist.
Dextromethorphan is used for the temporary relief of coughs caused by minor throat and bronchial irritation such as may occur with common colds or with inhaled irritants. Dextromethorphan is most effective in the treatment of chronic, nonproductive cough. The drug is a common ingredient in commercial cough mixtures available without prescription.
Although cough and cold preparations that contain cough suppressants (including dextromethorphan), nasal decongestants, antihistamines, and/or expectorants commonly are used in pediatric patients younger than 2 years of age, systematic reviews of controlled trials have concluded that nonprescription (over-the-counter, OTC) cough and cold preparations are not more effective than placebo in reducing acute cough and other symptoms of upper respiratory tract infection in these patients. Furthermore, adverse events, including deaths, have been (and continue to be) reported in pediatric patients younger than 2 years of age receiving these preparations. (See Cautions: Pediatric Precautions and see Acute Toxicity: Manifestations.) For information on abuse of dextromethorphan, see Cautions. For use of dextromethorphan hydrobromide in fixed combination with quinidine sulfate in the treatment of pseudobulbar affect (PBA), see Dextromethorphan Hydrobromide and Quinidine Sulfate 28:92.
DRUG IMAGES
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The following indications for PRES GEN PEDIATRIC (guaifenesin/dextromethorphan hbr/phenylephrine) have been approved by the FDA:
Indications:
Cold symptoms
Cough
Nasal congestion
Rhinitis
Rhinorrhea
Professional Synonyms:
Nasal stuffiness
Indications:
Cold symptoms
Cough
Nasal congestion
Rhinitis
Rhinorrhea
Professional Synonyms:
Nasal stuffiness
The following dosing information is available for PRES GEN PEDIATRIC (guaifenesin/dextromethorphan hbr/phenylephrine):
Dosages of dextromethorphan hydrobromide and dextromethorphan polistirex are expressed in terms of dextromethorphan hydrobromide.
The usual dosage of dextromethorphan hydrobromide for adults and children 12 years of age or older is 10-20 mg every 4 hours or 30 mg every 6-8 hours, not to exceed 120 mg daily, or as directed by a clinician. The usual dosage for children 6 to younger than 12 years of age is 5-10 mg every 4 hours or 15 mg every 6-8 hours, not to exceed 60 mg daily, or as directed by a clinician. Children 2 to younger than 6 years of age may receive 2.5-5
mg every 4 hours or 7.5 mg every 6-8 hours, not to exceed 30 mg daily, or as directed by a clinician. Dosage in children younger than 2 years of age must be individualized.
Suggested dosages for children younger than 2 years of age+ for some cough and cold preparations have been published in various references for prescribing and parenting. Using recommended dosages for adults and older children, some clinicians have extrapolated dosages for these preparations based on the weight or age of children younger than 2 years of age. However, these extrapolations were based on assumptions that pathology of the disease and pharmacology of the drugs are similar in adults and pediatric patients.
There currently are no specific dosage recommendations (i.e., approved by the US Food and Drug Administration (FDA)) for cough and cold preparations for this patient population. (See Cautions: Pediatric Precautions.)
The usual dosage of dextromethorphan hydrobromide as the extended-release oral suspension containing the polistirex for adults and children 12 years of age or older is 60 mg twice daily. The usual dosage as the extended-release oral suspension for children 6 to younger than 12 years of age is 30 mg twice daily; children 2 to younger than 6 years of age may receive 15 mg twice daily.
The usual dosage of dextromethorphan hydrobromide for adults and children 12 years of age or older is 10-20 mg every 4 hours or 30 mg every 6-8 hours, not to exceed 120 mg daily, or as directed by a clinician. The usual dosage for children 6 to younger than 12 years of age is 5-10 mg every 4 hours or 15 mg every 6-8 hours, not to exceed 60 mg daily, or as directed by a clinician. Children 2 to younger than 6 years of age may receive 2.5-5
mg every 4 hours or 7.5 mg every 6-8 hours, not to exceed 30 mg daily, or as directed by a clinician. Dosage in children younger than 2 years of age must be individualized.
Suggested dosages for children younger than 2 years of age+ for some cough and cold preparations have been published in various references for prescribing and parenting. Using recommended dosages for adults and older children, some clinicians have extrapolated dosages for these preparations based on the weight or age of children younger than 2 years of age. However, these extrapolations were based on assumptions that pathology of the disease and pharmacology of the drugs are similar in adults and pediatric patients.
There currently are no specific dosage recommendations (i.e., approved by the US Food and Drug Administration (FDA)) for cough and cold preparations for this patient population. (See Cautions: Pediatric Precautions.)
The usual dosage of dextromethorphan hydrobromide as the extended-release oral suspension containing the polistirex for adults and children 12 years of age or older is 60 mg twice daily. The usual dosage as the extended-release oral suspension for children 6 to younger than 12 years of age is 30 mg twice daily; children 2 to younger than 6 years of age may receive 15 mg twice daily.
Dextromethorphan preparations are administered orally. Lozenges containing dextromethorphan hydrobromide should not be used in children younger than 6 years of age and liquid-filled capsules containing the drug should not be used in children younger than 12 years of age, unless otherwise directed by a clinician. Guaifenesin is administered orally.
Mucinex(R) 600-mg extended-release tablets should not be broken, crushed, or chewed and should not be used in children younger than 12 years of age; the tablets should be kept out of reach of young children to avoid accidental swallowing and choking. Phenylephrine hydrochloride is administered by IV bolus or continuous IV infusion for the treatment of clinically important hypotension. The drug is available as a 10 mg/mL phenylephrine hydrochloride injection concentrate that must be diluted prior to administration and as a ready-to-use phenylephrine hydrochloride 100 mcg/mL (Immphentiv(R), Biorphen(R)) injection.
Ready-to-use phenylephrine hydrochloride 100 mcg/mL (Immphentiv(R), Biorphen(R)) injection should not be further diluted before IV bolus administration. For treatment of hypotension during anesthesia, the manufacturers recommend administration of phenylephrine hydrochloride as an IV bolus or continuous infusion; when used in the treatment of septic shock, the drug should be administered as a continuous IV infusion with no initial bolus dose. Phenylephrine hydrochloride injection should be stored at 20-25degreesC, but may be exposed to temperatures ranging from 15-30degreesC; single-dose and pharmacy bulk vials should be kept in their original carton until time of use and protected from light.
Commercially available phenylephrine hydrochloride injection concentrate must be diluted with a compatible IV solution prior to administration. Diluted solutions may be stored at room temperature for up to 4 hours or under refrigeration for up to 24 hours; any unused portions should be discarded. Commercially available phenylephrine hydrochloride bulk vials are intended for use in a pharmacy admixture program for preparation of single doses to be dispensed to multiple patients.
Each vial should be penetrated only one time with a suitable sterile transfer device or dispensing set. Dispensing from a pharmacy bulk vial should be completed within 4 hours after the vial is penetrated. Prior to administration, phenylephrine hydrochloride solutions should be inspected visually for particulate matter and discoloration; the drug should be discarded if the solution is colored, cloudy, or contains any particulate matter. Care should be taken to avoid extravasation and the infusion site should be checked for free flow.
Mucinex(R) 600-mg extended-release tablets should not be broken, crushed, or chewed and should not be used in children younger than 12 years of age; the tablets should be kept out of reach of young children to avoid accidental swallowing and choking. Phenylephrine hydrochloride is administered by IV bolus or continuous IV infusion for the treatment of clinically important hypotension. The drug is available as a 10 mg/mL phenylephrine hydrochloride injection concentrate that must be diluted prior to administration and as a ready-to-use phenylephrine hydrochloride 100 mcg/mL (Immphentiv(R), Biorphen(R)) injection.
Ready-to-use phenylephrine hydrochloride 100 mcg/mL (Immphentiv(R), Biorphen(R)) injection should not be further diluted before IV bolus administration. For treatment of hypotension during anesthesia, the manufacturers recommend administration of phenylephrine hydrochloride as an IV bolus or continuous infusion; when used in the treatment of septic shock, the drug should be administered as a continuous IV infusion with no initial bolus dose. Phenylephrine hydrochloride injection should be stored at 20-25degreesC, but may be exposed to temperatures ranging from 15-30degreesC; single-dose and pharmacy bulk vials should be kept in their original carton until time of use and protected from light.
Commercially available phenylephrine hydrochloride injection concentrate must be diluted with a compatible IV solution prior to administration. Diluted solutions may be stored at room temperature for up to 4 hours or under refrigeration for up to 24 hours; any unused portions should be discarded. Commercially available phenylephrine hydrochloride bulk vials are intended for use in a pharmacy admixture program for preparation of single doses to be dispensed to multiple patients.
Each vial should be penetrated only one time with a suitable sterile transfer device or dispensing set. Dispensing from a pharmacy bulk vial should be completed within 4 hours after the vial is penetrated. Prior to administration, phenylephrine hydrochloride solutions should be inspected visually for particulate matter and discoloration; the drug should be discarded if the solution is colored, cloudy, or contains any particulate matter. Care should be taken to avoid extravasation and the infusion site should be checked for free flow.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for PRES GEN PEDIATRIC (guaifenesin/dextromethorphan hbr/phenylephrine):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for PRES GEN PEDIATRIC (guaifenesin/dextromethorphan hbr/phenylephrine):
Drug contraindication overview.
*Known hypersensitivity to phenylephrine or to any ingredient in the respective formulation.
*Known hypersensitivity to phenylephrine or to any ingredient in the respective formulation.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Severe uncontrolled hypertension |
There are 5 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Benign prostatic hyperplasia |
| Coronary artery disease |
| Hypertension |
| Hyperthyroidism |
| Systemic mastocytosis |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Chronic heart failure |
| No disease contraindications |
The following adverse reaction information is available for PRES GEN PEDIATRIC (guaifenesin/dextromethorphan hbr/phenylephrine):
Adverse reaction overview.
The most commonly reported adverse effects in patients receiving IV phenylephrine hydrochloride were nausea, vomiting, and headache.
The most commonly reported adverse effects in patients receiving IV phenylephrine hydrochloride were nausea, vomiting, and headache.
There are 10 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Cardiac arrhythmia Dizziness Headache disorder Hyperhidrosis Insomnia Nervousness Pallor Tachycardia Tremor Vomiting |
There are 7 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Abdominal pain with cramps Anticholinergic toxicity Dizziness Drowsy Gastrointestinal irritation Nausea Vomiting |
The following precautions are available for PRES GEN PEDIATRIC (guaifenesin/dextromethorphan hbr/phenylephrine):
The manufacturers state that safety and efficacy of parenteral preparations of phenylephrine hydrochloride have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Data from randomized trials and meta-analyses with phenylephrine injection in pregnant women undergoing Cesarean section have not established a drug-associated risk of major birth defects or miscarriage. Additionally, the data did not identify adverse effects on maternal outcomes or infant Apgar scores. At recommended doses, phenylephrine does not appear to significantly affect fetal heart rate or fetal heart rate variability.
Data are not available on phenylephrine use during the first or second trimester. Untreated hypotension in pregnant women undergoing Cesarean delivery with neuraxial anesthesia has been associated with increased maternal nausea and vomiting. A sustained decrease in uterine blood flow caused by maternal hypotension has also been associated with fetal bradycardia and acidosis.
No data are available on the safety of phenylephrine injection during the period of organogenesis; therefore, conclusions cannot be drawn regarding the risk of birth defects from drug exposure. In addition, no data are available on the risk of miscarriage following fetal exposure to phenylephrine injection. In animal studies, fetal malformations were observed following phenylephrine infusion over 1 hour during the period of organogenesis at a dosage of 1.2
times the human daily dosage. Decreased pup weight was also observed in offspring of pregnant rats who received 2.9 times the human daily dose of phenylephrine. If a vasopressor is used in conjunction with oxytocic drugs, the vasopressor effect is potentiated and may result in serious adverse effects.
Data are not available on phenylephrine use during the first or second trimester. Untreated hypotension in pregnant women undergoing Cesarean delivery with neuraxial anesthesia has been associated with increased maternal nausea and vomiting. A sustained decrease in uterine blood flow caused by maternal hypotension has also been associated with fetal bradycardia and acidosis.
No data are available on the safety of phenylephrine injection during the period of organogenesis; therefore, conclusions cannot be drawn regarding the risk of birth defects from drug exposure. In addition, no data are available on the risk of miscarriage following fetal exposure to phenylephrine injection. In animal studies, fetal malformations were observed following phenylephrine infusion over 1 hour during the period of organogenesis at a dosage of 1.2
times the human daily dosage. Decreased pup weight was also observed in offspring of pregnant rats who received 2.9 times the human daily dose of phenylephrine. If a vasopressor is used in conjunction with oxytocic drugs, the vasopressor effect is potentiated and may result in serious adverse effects.
There are no data on whether phenylephrine or its metabolite is distributed into human or animal milk following parenteral administration. The effects on the breast-fed infant and milk production are not known. The developmental and health benefits of breast-feeding should be weighed along with the mother's clinical need for the drug and any potential adverse effects on the breast-fed infant from phenylephrine or from the underlying maternal condition.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Dextromethorphan | Excreted.This drug is known to be excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Low levels excreted, no adverse effects in infants expected |
| Guaifenesin | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Insuff data avail; avoid products with high alcohol content |
| Phenylephrine | Excreted.This drug is known to be excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Oral bioavailability low; infant exposure may be minimal |
Clinical studies of phenylephrine hydrochloride did not include sufficient numbers of patients >=65 years of age to determine whether geriatric patients respond differently than younger patients. Clinical experience to date has not identified any differences in response between geriatric and younger patients. If phenylephrine is used in geriatric patients, dosage should be selected carefully, usually starting at the low end of the dosage range, since renal, hepatic, and cardiovascular dysfunction and concomitant disease or other drug therapy are more common in this age group.
Precaution Exists
Geriatric management or monitoring precaution exists.
Precaution Exists
Geriatric management or monitoring precaution exists.
| Drug Name | Narrative | REN | HEP | CARDIO | NEURO | PULM | ENDO |
|---|---|---|---|---|---|---|---|
| Phenylephrine | Cardiovascular-Elderly are more sensitive to tachycardia and hypertensive effects. May exacerbate symptomatic coronary insufficiency. Genitourinary-May cause urinary retention. Neuro/Psych-May worsen cognitive impairment in some elderly with dementia. Insomnia risk. | N | N | Y | Y | N | N |
The following prioritized warning is available for PRES GEN PEDIATRIC (guaifenesin/dextromethorphan hbr/phenylephrine):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for PRES GEN PEDIATRIC (guaifenesin/dextromethorphan hbr/phenylephrine)'s list of indications:
| Cold symptoms | |
| J00 | Acute nasopharyngitis [common cold] |
| Cough | |
| R05 | Cough |
| R05.1 | Acute cough |
| R05.2 | Subacute cough |
| R05.3 | Chronic cough |
| R05.9 | Cough, unspecified |
| Nasal congestion | |
| R09.81 | Nasal congestion |
| Rhinitis | |
| J30 | Vasomotor and allergic rhinitis |
| J30.0 | Vasomotor 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 |
| J31.0 | Chronic rhinitis |
| Rhinorrhea | |
| R09.82 | Postnasal drip |
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