Giltuss Dm

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 associated with a common cold or inhaled irritants. It is effective in reducing the intensity of coughing and alleviating the impulse to cough, thereby facilitating sleep.

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

Dosage and Administration

The recommended dosage for adults and children over 12 years is 10 mL administered every 8 hours. For children aged 6 years to under 12 years, the dosage is 5 mL every 8 hours. Children aged 4 years to under 6 years should receive 2.5 mL every 8 hours, utilizing an appropriate measuring syringe or measuring cup for accuracy.

It is imperative that the total dosage does not exceed 4 doses within any 24-hour period. For all patients, the enclosed dosing cup should be used to ensure proper measurement. The product is not recommended for use in children under 4 years of age.

Healthcare professionals should advise patients to adhere strictly to the recommended dosages and intervals to avoid potential overdose.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI. Additionally, it is contraindicated to exceed the recommended dosage while using this product.

Warnings and Precautions

The 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 not to use this product for at least 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.

When administering this product, it is imperative to adhere strictly to the recommended dosage. Exceeding the directed amount may lead to adverse effects.

Healthcare providers should advise patients to consult a physician prior to use if they present with a cough that produces excessive phlegm (mucus) or if they have a persistent or chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. These symptoms may indicate underlying health issues that require further evaluation.

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

Patients should be instructed to discontinue use and consult a healthcare professional if their cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These signs may indicate a more serious medical condition that necessitates further investigation.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, and it is advised to stop use and consult a healthcare professional if a cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious underlying condition.

Additionally, patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Use of this product is contraindicated during the course of MAOI treatment and for at least 2 weeks after discontinuation of the MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should seek guidance from a healthcare provider or pharmacist prior to using this product.

It is also important for patients to adhere strictly to the recommended dosage and not exceed the directed use, as misuse may lead to additional adverse effects.

Drug Interactions

The concomitant use of dextromethorphan with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. This combination can result in serious interactions, and it is advised that dextromethorphan not be used while taking an MAOI or for a period of two weeks following the discontinuation of an MAOI.

No additional drug interactions or drug and laboratory test interactions have been identified.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 years to under 6 years, the recommended dosage is 2.5 mL every 8 hours. In children under 12 years, the dosage increases to 5 mL every 8 hours. For adolescents and adults over 12 years, the dosage is 10 mL every 8 hours. It is essential to use an appropriate measuring syringe or measuring cup for accurate dosing.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, 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 the safety of both the mother and the developing fetus.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 medication. Consequently, there are no established 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 specific symptoms of an 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 the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure optimal patient outcomes.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include dizziness, nausea, vomiting, somnolence, confusion, hallucinations, agitation, rash, pruritus, urticaria, and anaphylaxis. It is important to note that these reactions were reported during the postmarketing experience and may not be directly related to the use of Giltuss DM.

Patient Counseling

Healthcare providers should advise patients to keep this product 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 should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. It is important for patients to consult with their doctor or pharmacist if they are unsure whether their prescription medication contains an MAOI.

When using this product, patients must be cautioned to adhere strictly to the recommended dosage and not exceed the directed amount. They should be advised to discontinue use and consult a doctor if their cough persists for more than seven days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a more serious condition.

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

Storage and Handling

The product is supplied in a configuration that includes an NDC number, which should be referenced for identification. It is essential to store the product at room temperature, specifically within the range of 15° to 30°C (59° to 86°F).

To ensure the integrity of the product, the cap must be closed tightly after each use. Additionally, it is recommended to save the carton for complete drug facts, which may be necessary for future reference.

Additional Clinical Information

For patients aged 12 years and older, the recommended administration is 10 mL every 8 hours. For children under 12 years, the dosage is 5 mL every 8 hours, while children aged 4 to under 6 years should receive 2.5 mL every 8 hours. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)