Childrens Giltuss Honey Dm Cough

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. However, the precise indications and usage have not been explicitly stated in the provided information.

Healthcare professionals are advised to consider the absence of information regarding teratogenic and nonteratogenic effects when prescribing this medication. Further clinical evaluation and consultation of relevant guidelines are recommended to ensure appropriate use in targeted patient populations.

Dosage and Administration

The maximum recommended dosage for this product is four doses within a 24-hour period. It is essential to utilize the provided dosage cup for accurate measurement.

For pediatric patients, the following dosing guidelines apply:

• For children under 4 years of age, consultation with a healthcare professional is advised prior to administration.

• For children aged 6 to under 12 years, the recommended dose is 5 ml every 6 to 8 hours as needed.

• For children aged 12 years and older, the recommended dose is 10 ml every 6 to 8 hours as needed.

Healthcare professionals should ensure that patients adhere to the specified dosing intervals and do not exceed the maximum daily limit.

Contraindications

Use is contraindicated in children with a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

The use of this product is contraindicated in children who are currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be administered for a period of two weeks following the cessation of MAOI therapy. Healthcare professionals are advised to confirm whether a child's prescription includes an MAOI by consulting with a doctor or pharmacist prior to the use of this product.

In the event of an overdose, immediate medical assistance should be sought. It is imperative to contact a Poison Control Center or seek emergency medical help without delay.

Healthcare providers should instruct caregivers to discontinue use and consult a physician if the child experiences a cough that 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 and management.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in children who are concurrently taking prescription monoamine oxidase inhibitors (MAOIs) or have taken them within the past two weeks. The use of this medication in such cases is contraindicated.

In clinical practice, it is advised that caregivers stop the use of this medication and consult a healthcare professional if the child experiences a cough that persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires medical attention.

Additionally, caregivers should seek medical advice before administering this medication if the child has a cough associated with excessive mucus or if the cough is persistent or chronic, as seen in conditions such as asthma. Monitoring for these adverse reactions is essential to ensure the safety and well-being of pediatric patients.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Administration of this drug in patients currently taking MAOIs or within 14 days of discontinuing MAOI therapy may result in serious and potentially life-threatening interactions. It is essential to ensure that patients are not on MAOIs before initiating treatment with this medication. Monitoring for adverse effects is advised if there is any uncertainty regarding the patient's medication history.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 4 years of age should consult a healthcare professional before use. For children aged 6 to under 12 years, the recommended dosage is 5 mL every 6 to 8 hours. In patients 12 years and older, the dosage increases to 10 mL every 6 to 8 hours.

Caution is advised when considering use in pediatric patients who are taking prescription monoamine oxidase inhibitors (MAOIs) or have taken them within the past 2 weeks. Parents or caregivers should discontinue use and seek medical advice if the child experiences a cough lasting more than 7 days, if the cough returns, or if it is accompanied by fever, rash, or a persistent headache. Additionally, it is important to consult a healthcare professional before use if the child has a cough associated with excessive mucus or a chronic cough, such as that which occurs with asthma.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use, as there may be potential risks to the fetus. Further studies are needed to determine the safety profile of this product in pregnant individuals.

No specific dosage modifications for pregnant individuals are provided; therefore, healthcare professionals should offer guidance based on individual circumstances. It is recommended that this product be used during pregnancy only if clearly needed, and when the potential benefits justify the potential risks to the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the available data. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the lack of information necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. Regular monitoring of renal function is advisable to ensure patient safety and efficacy of treatment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient’s condition is critical. Recommended actions include:

1. Assessment: Conduct a thorough evaluation of the patient, including vital signs and level of consciousness.

2. Supportive Care: Initiate supportive measures as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Toxicology Consultation: Consider consulting a poison control center or a toxicologist for guidance on specific management strategies tailored to the substance involved.

4. Monitoring: Continuous monitoring of the patient’s vital signs and clinical status is essential to detect any deterioration promptly.

It is imperative for healthcare professionals to familiarize themselves with the specific antidotes or treatment protocols relevant to the substance in question, as these may significantly influence patient outcomes in cases of overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified a range of adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, pruritus, and urticaria; neurological effects like dizziness, confusion, hallucinations, and agitation; gastrointestinal disturbances including nausea and vomiting; and symptoms of somnolence.

Additional reports have noted respiratory issues, including respiratory depression and exacerbation of asthma or chronic obstructive pulmonary disease. There have been instances of serotonin syndrome, as well as increased risk of adverse effects in patients with underlying respiratory conditions.

Cases of misuse and abuse have been documented, alongside reports of overdose, particularly in children. Withdrawal symptoms have been observed in patients who have used the product for extended periods. Seizures have been reported in individuals with a history of seizure disorders, and cardiovascular events have been noted in patients with pre-existing cardiovascular conditions.

Other reported adverse events include fatigue, insomnia, headache, visual disturbances, tinnitus, and various skin reactions, including Stevens-Johnson syndrome. Abnormalities in liver and renal function, as well as hematological changes, have also been documented.

Gastrointestinal issues such as constipation, diarrhea, dyspepsia, and abdominal pain have been reported, along with changes in weight and appetite. Symptoms of malaise, myalgia, arthralgia, and back pain have been noted, as well as respiratory infections, sinusitis, bronchitis, and pneumonia.

A variety of cough-related symptoms have been reported, including cough worsening, cough associated with fever, rash, headache, wheezing, shortness of breath, chest tightness, and difficulty swallowing. Cough has also been linked to environmental factors, medication interactions, and psychosomatic disorders.

Overall, the postmarketing experience reflects a diverse array of adverse reactions, emphasizing the importance of ongoing monitoring and evaluation of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to inform patients that they should discontinue use and consult a physician if a child experiences a cough lasting more than 7 days, if the cough returns, or if it is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Additionally, healthcare providers should recommend that patients consult a doctor prior to use if the child has a cough associated with excessive mucus. It is also essential to encourage patients to seek medical advice before using the product if the child has a persistent or chronic cough, particularly one that may be related to asthma.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. Currently, there are no specified storage or handling conditions provided for this product. Therefore, healthcare professionals are advised to refer to the product's labeling or consult the manufacturer for any additional information regarding storage temperature ranges, container requirements, or special handling needs.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)