Dextromethorphan Hbr 15 mg

Description

Dextromethorphan HBr Capsules contain 15 mg of dextromethorphan hydrobromide per capsule. This product is supplied in a bulk quantity of 12,000 capsules, identified by NDC No. 53345-011-01. Upon receipt, immediate inspection is required to ensure product integrity. These capsules are intended solely for further manufacturing, processing, or repacking. It is essential to protect the capsules from heat, humidity, and light, and refrigeration is not recommended.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold.

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

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 2 capsules every 6 to 8 hours as needed. It is essential not to exceed a total of 8 capsules within a 24-hour period. This product is not intended for use in children under 12 years of age; therefore, administration in this population is contraindicated.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use of this product is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to discontinue use and seek medical advice if a cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate the presence of a serious underlying condition that requires further evaluation.

It is essential to keep this product out of the reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

For individuals who are pregnant or breastfeeding, it is crucial to consult a healthcare professional before using this product to ensure safety for both the mother and the child.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this medication.

Serious adverse reactions may occur, particularly in patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this medication is contraindicated in such cases, as it may lead to significant health risks.

Patients are advised to consult a healthcare professional before using this medication if they have a cough that produces excessive phlegm or if they have a chronic cough related to conditions such as smoking, asthma, or emphysema.

It is important for patients to discontinue use and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additional considerations include the need for pregnant or breastfeeding individuals to consult a healthcare professional prior to use. Furthermore, this medication should be kept out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson's disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Dextromethorphan Hbr 15 mg (dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. The safety and efficacy of this medication have not been established in children younger than 12, and its use in this population is contraindicated.

Geriatric Use

Elderly patients may use this adult product, which is not intended for children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 2 capsules every 6 to 8 hours, as needed.

While no specific dosage adjustments or safety concerns for geriatric patients are mentioned in the provided information, it is advisable for healthcare providers to monitor elderly patients closely due to the potential for altered pharmacokinetics and increased sensitivity to medications in this population. Caution should be exercised when prescribing this product to elderly patients, and any adverse effects should be promptly addressed.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined 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 prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. The following events have been documented: dizziness, nausea, vomiting, somnolence, confusion, hallucinations, agitation, rash, pruritus, urticaria, and anaphylaxis.

These reactions were reported during the postmarketing experience and may not be directly related to the use of the product.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. It is important for patients to consult with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Healthcare providers should also counsel patients to discontinue use and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition.

Additionally, patients should be encouraged to seek medical advice before using the medication if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, or emphysema.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20-25°C (68-77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Additionally, the product must be protected from light to maintain its integrity and efficacy.

Additional Clinical Information

The product is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 capsules every 6 to 8 hours as needed. It is important to note that this product is not intended for use in children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using the product. Additionally, patients should be advised to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately in the event of an overdose.

Drug Information (PDF)

This file contains official product information for Dextromethorphan Hbr 15 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)