Giltuss Diabetic

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation associated with common colds or inhaled irritants. It is effective in reducing the intensity of coughing and decreasing the impulse to cough, thereby facilitating sleep. Additionally, this drug aids in loosening phlegm (mucus) and thinning bronchial secretions, which enhances the productivity of coughs and promotes drainage of the bronchial tubes. It also provides relief from cough and cold symptoms, including chest congestion, by liquefying and loosening phlegm and mucus.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to administer 10 mL every 4 hours, not exceeding 6 doses within a 24-hour period.

For children aged 6 to under 12 years, the recommended dosage is 5 mL every 4 hours, also adhering to the maximum limit of 6 doses in a 24-hour timeframe.

Children aged 2 to under 6 years should receive 2.5 mL every 4 hours, with the same restriction on the total number of doses per day.

It is important to note that this product is not recommended for use in children under 2 years of age.

Healthcare professionals should ensure that the dosing cup is retained with the product for accurate measurement and administration.

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.

Exceeding the recommended dosage is also contraindicated while using this product.

Warnings and Precautions

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. Additionally, this product should not be used for at least two weeks after discontinuing an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

When utilizing this product, it is essential to adhere strictly to the recommended dosage and not exceed the directed amount. Healthcare professionals should advise patients to seek medical guidance before use if they experience a cough accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema.

Patients are instructed to discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

In the event of an accidental overdose, it is critical to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt action is necessary to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious warnings include the contraindication of use in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Patients uncertain about whether their prescription contains an MAOI are advised to consult a healthcare professional prior to using this product.

Patients are also instructed to stop use and seek medical advice if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or headache, as these symptoms may indicate a serious underlying condition.

Before using this product, patients should consult a healthcare provider if they have a cough that produces excessive phlegm (mucus) or if they experience a persistent or chronic cough, which may be associated with smoking, asthma, chronic bronchitis, or emphysema.

In the event of an accidental overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center.

Drug Interactions

The concomitant use of Giltuss Diabetic Cough and Cold with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use Giltuss Diabetic Cough and Cold while taking an MAOI or for a period of two weeks following the discontinuation of an MAOI. This combination may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for Giltuss Diabetic Cough and Cold. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the contraindication with MAOIs.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may be administered 10 mL every 4 hours. For children aged 6 to under 12 years, the recommended dosage is 5 mL every 4 hours. In children aged 2 to under 6 years, the dosage is 2.5 mL every 4 hours. This medication is not recommended for use in children under 2 years of age.

Healthcare professionals should ensure that this medication is kept out of reach of children. In the event of an accidental overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of detailed information necessitates careful clinical judgment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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

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

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 substance involved and the clinical scenario.

It is essential for healthcare providers to remain vigilant and prepared to implement appropriate interventions to ensure patient safety and optimal outcomes following an overdose incident.

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 associated with the use of the product. Commonly reported events include dizziness, nausea, vomiting, and rash. Additionally, there have been reports of allergic reactions, including anaphylaxis.

Serious adverse events have been linked to the misuse and abuse of dextromethorphan. Cases of serotonin syndrome have been documented in patients taking dextromethorphan in conjunction with other serotonergic medications. Respiratory depression has been particularly noted in pediatric patients.

Some individuals have reported experiencing confusion and hallucinations. Furthermore, there have been observations of increased blood pressure and heart rate in certain patients. Isolated cases of hepatotoxicity associated with guaifenesin use have also been reported.

The safety profile of this product continues to be monitored through ongoing postmarketing surveillance.

Patient Counseling

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

Patients should be informed that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

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

It is important to remind patients to adhere to the recommended dosage and not exceed the directed amount while using this product. Additionally, patients should be advised to consult a doctor before use 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, maintaining a range between 15°- 30°C (59°- 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 and further information.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)