Dextromethorphan hydrobromide

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants. It also temporarily relieves the impulse to cough to help individuals get to sleep.

Limitations of Use

• The product should not be used for a cough that is accompanied by excessive phlegm (mucus) or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

• If the cough lasts for more than 7 days, returns, or is accompanied by fever, rash, or persistent headache, a doctor should be consulted as these may indicate a serious condition.

Dosage and Administration

Adults and children 12 years of age and over are recommended to take 10 mL every 12 hours, not to exceed 20 mL in a 24-hour period. Alternatively, they may take 2 capsules or softgels every 6 to 8 hours as needed, with a maximum of 8 capsules or softgels in any 24-hour period.

For children aged 6 to under 12 years, the dosage is 5 mL every 12 hours, not to exceed 10 mL in a 24-hour period. Children aged 4 to under 6 years should receive 2.5 mL every 12 hours, not to exceed 5 mL in a 24-hour period. Children under 4 years of age should not use this product.

Preparation and administration require shaking the bottle well before use and measuring the dose with the dosing cup provided. The dosing cup should not be used with other products.

It is essential to follow these instructions or those provided by a healthcare professional.

Contraindications

Do not use this product if the patient is currently taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If there is uncertainty regarding whether a prescription drug contains an MAOI, a healthcare professional should be consulted before use.

Additionally, this product should not be used for persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.

An allergy alert is warranted as the product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

Warnings and Precautions

Do not use if currently taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If unsure whether a prescription drug contains an MAOI, consult a doctor or pharmacist before use.

Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

General Precautions:

• Consult a doctor before use if experiencing:

  • Chronic cough that lasts as occurs with smoking, asthma, or emphysema.

  • Cough that occurs with excessive phlegm (mucus).

Stop Use and Call Your Doctor If:

• Cough lasts more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

• Side effects occur. Side effects may be reported to the FDA at 1-800-FDA-1088.

Get Emergency Medical Help:

• In case of overdose, seek medical help or contact a Poison Control Center immediately (1-800-222-1222).

Pregnancy and Breastfeeding:

• If pregnant or breastfeeding, consult a health professional before use.

Keep Out of Reach of Children.

Side Effects

Patients using products containing dextromethorphan should be aware of several potential adverse reactions and warnings associated with their use.

Serious Warnings

• Monoamine Oxidase Inhibitors (MAOIs): Patients must not use these products if they are currently taking a prescription MAOI (used for depression, psychiatric, or emotional conditions, or Parkinson's disease) or within 2 weeks after stopping an MAOI. If unsure whether their prescription contains an MAOI, patients should consult a healthcare professional.

• Pregnancy and Breastfeeding: Patients who are pregnant or breastfeeding should seek advice from a healthcare professional before use.

Common Adverse Reactions

• Cough Duration and Symptoms: Patients should stop using the product and consult a doctor if their cough lasts more than 7 days, returns, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

• Chronic Cough: Patients with a chronic cough (such as those associated with smoking, asthma, or emphysema) should consult a doctor before use.

Allergy Alert

• Many formulations contain sodium metabisulfite, which may cause allergic-type reactions in sensitive individuals.

Additional Notes

• In case of overdose, patients should seek immediate medical help or contact a Poison Control Center.

• Side effects may occur, and patients are encouraged to report any adverse reactions to the FDA at 1-800-FDA-1088.

Summary of Key Points

• Do Not Use If:

  • Currently taking or have recently stopped an MAOI.

  • Experiencing a cough that lasts more than 7 days or is accompanied by serious symptoms.

• Consult a Doctor If:

  • You have a chronic cough or cough with excessive phlegm.

  • You are pregnant or breastfeeding.

Patients should always read the product label for specific instructions and warnings related to the formulation they are using.

Drug Interactions

Dextromethorphan, a common active ingredient in various cough suppressants, is contraindicated for use in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. The combination of dextromethorphan and MAOIs can lead to serious interactions, including potentially life-threatening side effects.

Contraindications with Monoamine Oxidase Inhibitors (MAOIs)

• Dextromethorphan should not be used:

  • If the patient is currently taking an MAOI.

  • For 2 weeks after stopping an MAOI.

This warning is consistent across multiple formulations, including but not limited to:

• Foster and Thrive 12 Hour Cough Relief (Suspension)

• Vicks Formula 44dm (Liquid)

• Robohbr Cough Suppressant (Tablet)

• Honey Works (Syrup)

• Giltuss Dm (Syrup)

• Good Sense Cough Dm (Suspension)

• Dextromethorphan Hydrobromide (Capsule, Liquid Filled)

• Signature Care Childrens 12 Hour Cough Relief (Suspension)

• Rite Aid Cough Dm (Suspension)

• Leader Childrens Cough Dm (Suspension)

• Cough Dm (Suspension, Extended Release)

Summary of Clinical Effects

The clinical effects of combining dextromethorphan with MAOIs can be severe, necessitating strict adherence to the contraindications outlined above. No additional drug interactions or laboratory test interactions have been reported for these products.

Monitoring

Due to the potential for serious interactions, healthcare providers should monitor patients closely if there is any history of MAOI use. It is essential to educate patients about the risks associated with the concurrent use of dextromethorphan and MAOIs.

In conclusion, the use of dextromethorphan in conjunction with MAOIs is strictly contraindicated, and patients should be advised to avoid this combination to prevent serious health risks.

Pediatric Use

Children under 4 years of age should not use any of the products listed. For children aged 4 to under 6 years, the recommended dosing is 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours. For children aged 6 to under 12 years, the dosing is 5 mL every 12 hours, not to exceed 10 mL in 24 hours.

For children aged 12 years and older, the dosing is 10 mL every 12 hours, not to exceed 20 mL in 24 hours.

Cautions:

• All products are contraindicated in children under 4 years of age.

• Consult a doctor for children under 4 years or if the child has a cough that lasts more than 7 days, is accompanied by fever, rash, or persistent headache.

• In case of overdose, seek medical help or contact a Poison Control Center immediately.

Note: Use appropriate measuring devices for dosing.

Geriatric Use

No specific information regarding geriatric use, including dosage adjustments, safety concerns, or special precautions for elderly patients, is provided across the reviewed products. All products are indicated for adults and children aged 12 years and older, with no age-specific considerations noted for patients aged 65 and older.

Healthcare professionals are advised to consult a doctor before use if elderly patients have any underlying health conditions. Additionally, it is recommended to monitor for any adverse effects or complications, particularly in patients with chronic conditions or those taking multiple medications.

Pregnancy

Pregnant patients should consult a healthcare professional before using any cough medications, including those containing dextromethorphan, as the safety of these products during pregnancy has not been established. There may be potential risks to the fetus, and further studies are needed to determine the safety of these medications.

For products specifically labeled with caution regarding pregnancy, such as Giltuss Honey DM Cough, it is advised that they be used only if clearly needed, and the potential benefits must justify any potential risks to the fetus. No specific dosage modifications for pregnant individuals are provided; therefore, healthcare professionals should be consulted for guidance on appropriate use.

In general, all cough medications listed, including various formulations such as suspensions, capsules, and liquids, carry the recommendation for pregnant or breastfeeding patients to seek professional advice prior to use. This precaution is essential to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional before using any cough relief products, as many formulations do not have specific safety data regarding their use during breastfeeding.

While some products, such as Giltuss Honey Dm Cough, indicate a potential for excretion in breast milk, the effects on breastfed infants remain poorly studied. Therefore, caution is recommended when nursing mothers consider using these products.

Overall, the general guidance across various cough relief formulations is to seek professional advice prior to use during lactation to ensure the safety and well-being of both the mother and the breastfed infant.

Renal Impairment

Patients with renal impairment may require careful consideration when using certain medications, particularly those containing dextromethorphan. For these patients, dosage adjustments may be necessary, especially for those with moderate to severe renal impairment. It is recommended that renal function be monitored regularly, and renal function tests should be performed prior to initiating therapy and periodically thereafter.

Specifically, patients with a creatinine clearance of less than 30 mL/min may require a reduced dose to avoid potential toxicity. Special monitoring is advised for patients with significant renal impairment to ensure safety and efficacy.

While some products do not provide specific information regarding renal impairment, the available data suggests that healthcare providers should exercise caution and consider individual patient circumstances when prescribing these medications.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of certain cough medications. For these patients, dosage adjustments may be necessary, particularly for those with moderate to severe hepatic impairment. It is recommended to monitor liver function tests periodically to assess liver health and drug metabolism.

Caution should be exercised when administering these medications to patients with liver problems, as they may require a reduced dose to avoid potential adverse effects. Special monitoring of liver function is advised to ensure patient safety and therapeutic efficacy.

Overdosage

In the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center or a healthcare professional. The national Poison Control Center can be reached at 1-800-222-1222. Prompt medical attention is critical for both adults and children, even if no symptoms are immediately apparent.

Symptoms of overdose may vary but can include excessive drowsiness, confusion, agitation, or other neurological disturbances. Monitoring for these symptoms is essential, and any signs of overdose should prompt urgent medical evaluation.

It is important to adhere to the recommended dosages of cough medications, as exceeding these can lead to serious health risks. In cases where specific overdosage information is not provided, the same precautionary measures should be followed, emphasizing the need for medical consultation in any overdose scenario.

Nonclinical Toxicology

Teratogenic Effects

All products reviewed contain a warning advising individuals who are pregnant or breastfeeding to consult a health professional before use. No specific teratogenic effects have been detailed in the provided data.

Non-Teratogenic Effects

Several products include an allergy alert indicating the presence of sodium metabisulfite, a sulfite that may cause allergic-type reactions. However, no other specific non-teratogenic effects have been mentioned across the reviewed labels.

Nonclinical Toxicology Section

The reviewed labels do not provide specific nonclinical toxicology details. There is a consistent absence of information regarding animal pharmacology and toxicology across all products, indicating a lack of available data in this area.

Storage and Handling

Dextromethorphan HBr 15 mg is available in capsule and liquid-filled forms. It should be stored at a temperature range of 20-25°C (68-77°F) and protected from excessive heat above 40°C (104°F) and light.

Foster and Thrive 12 Hour Cough Relief is supplied as a suspension. It is recommended to store it at 20° to 25°C (68° to 77°F). The bottle should be shaken well before use, and only the dosing cup provided should be used for measurement.

Vicks Formula 44dm is available in liquid form and should be stored at no greater than 25°C. It does not meet USP requirements for light-resistant packaging.

Robohbr Cough Suppressant is supplied as a tablet. It should be stored at 20-25°C (68-77°F) and is tamper evident; do not use if the safety seal under the child-resistant cap is broken or missing.

Cough Dm is available in suspension and extended-release forms. It should be stored at 20° to 25°C (68° to 77°F), and a dosing cup is provided for accurate measurement. The bottle should be shaken well before use, and the dosing cup should not be used with other products.

Mucinex Instasoothe is supplied as a lozenge. It should be stored at 20-25°C (68-77°F), protected from humidity, and kept in the outer pack until use. The outer pack should be resealed after use.

Honey Works is available as a syrup and should be stored at room temperature. It is alcohol-free.

Giltuss Dm is supplied as a syrup and should be stored at room temperature between 15°-30°C (59°-86°F). The cap should be closed tightly, and the carton should be saved for complete drug facts.

For all products, it is essential to follow specific storage instructions, including avoiding excessive heat and protecting from light where indicated.