Dextromethorphan hydrobromide/Guaifenesin

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with a cold. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby making cough more productive.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 2 teaspoonfuls administered every 4 hours, not to exceed 6 doses within a 24-hour period. For children aged 6 years to under 12 years, the dosage is 1 teaspoonful every 4 hours, while children aged 2 years to under 6 years should receive 1/2 teaspoonful every 4 hours. For children under 2 years of age, it is advised to consult a doctor prior to administration.

Healthcare professionals should ensure that the dosing schedule is adhered to and that patients are informed not to exceed the maximum dosage limit within a 24-hour timeframe.

Contraindications

Use is contraindicated in patients who experience a cough lasting more than 7 days, a cough that returns, or a cough associated with fever, rash, or persistent headache. A persistent cough may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

Use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it is advised to refrain from using this product for a minimum of two weeks following the discontinuation of an MAOI. Healthcare professionals should counsel patients to verify with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

General precautions should be observed in patients with chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema. Caution is also warranted in cases where the cough is accompanied by excessive phlegm (mucus), as this may indicate an underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be advised to discontinue use and consult their healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. A persistent cough may signify a serious underlying condition that necessitates further investigation and management.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly in individuals who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this product is contraindicated in patients taking MAOIs or within 2 weeks of stopping such medication. Patients are advised to consult a healthcare professional if they are uncertain whether their prescription includes an MAOI.

Common adverse reactions may include a persistent cough. Patients should stop using the product and seek medical advice if their cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Additionally, patients with a chronic cough due to smoking, asthma, chronic bronchitis, or emphysema should consult a healthcare provider before using this product. It is also recommended that patients with a cough accompanied by excessive phlegm (mucus) seek medical advice prior to use.

Drug Interactions

The use of Sorbutuss is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI. Co-administration may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for Sorbutuss. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the aforementioned contraindication.

Packaging & NDC

Below are the non-prescription pack sizes of Sorbutuss. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years to under 6 years are recommended to receive 1 teaspoonful every 4 hours. For children aged 2 years to 6 years, the appropriate dosage is 1/2 teaspoonful every 4 hours. In infants and children under 2 years of age, it is advised to consult a doctor before administration.

Geriatric Use

Elderly patients may not have specific information regarding the use of Sorbutuss NR, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted in these patients to ensure safety and therapeutic effectiveness.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety. If symptoms of overdosage are observed, appropriate interventions should be implemented based on the clinical presentation.

Healthcare professionals are encouraged to report any cases of suspected overdosage to the relevant authorities to contribute to the understanding of the medication's safety profile.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, the assessment of potential risks related to these aspects remains incomplete.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of Sorbutuss. Reports received through voluntary reporting and surveillance programs have included dizziness, nausea, and vomiting. Additionally, skin reactions such as rash and allergic reactions, including anaphylaxis, have been documented.

Neuropsychiatric events such as hallucinations, confusion, and agitation were also reported. Cardiovascular effects, including increased heart rate, and respiratory depression have been noted in the postmarketing data. These events reflect the range of adverse reactions observed following the use of Sorbutuss in the postmarketing setting.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important for patients to discontinue use and consult a healthcare provider if their cough persists for more than 7 days, returns after resolution, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Patients should also be encouraged to consult with their healthcare provider prior to use if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should be advised to seek medical advice if their cough is accompanied by excessive phlegm (mucus). This proactive communication can help ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in a configuration that includes a safety seal around the bottle cap. It is essential to inspect this seal prior to use; the product should not be accepted if the safety seal is broken or missing.

For optimal storage, the product must be kept at room temperature, within the range of 15º to 30º C (59º to 86º F). Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Sorbutuss, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)