Tusicof

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of symptoms associated with colds, specifically nasal congestion and cough due to minor throat and bronchial irritation. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 1 teaspoon (5 mL) administered orally every 4 hours. It is imperative that no more than 6 doses are taken within a 24-hour period. For children under 12 years of age, the use of this medication is not advised.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. It is also advised to refrain from using 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 includes an MAOI.

Prior to use, patients should consult a healthcare provider if they have any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a cough that is productive of excessive phlegm. Additionally, individuals with a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema should seek medical advice before using this product.

Patients must adhere strictly to the recommended dosage and should not exceed the directed amount. If symptoms persist beyond seven days, worsen, or are accompanied by fever, it is imperative to discontinue use and consult a healthcare professional. Furthermore, if patients experience nervousness, dizziness, or sleeplessness, they should stop taking the product and seek medical advice. A cough that lasts more than seven days, recurs, or is accompanied by fever, rash, or persistent headache may indicate a serious underlying condition and warrants immediate medical evaluation.

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

In the event of an accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals with specific pre-existing conditions. It is contraindicated for use in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Patients are advised to consult a healthcare professional if they have diabetes, heart disease, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a cough that is productive of excessive phlegm or is chronic in nature, such as that associated with smoking, asthma, chronic bronchitis, or emphysema.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients should discontinue use and seek medical advice if these symptoms occur. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache, patients should also consult a healthcare provider, as these may indicate a serious underlying condition.

For pregnant or breastfeeding individuals, it is recommended to seek guidance from a health professional prior to use.

Drug Interactions

The concomitant use of TUSICOF with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. This combination may result in serious interactions that could pose significant health risks. It is advised that TUSICOF not be administered to patients currently taking an MAOI or within two weeks following the discontinuation of an MAOI. Monitoring for adverse effects is recommended in patients who may have recently stopped MAOI therapy before initiating TUSICOF.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 teaspoon (5 mL) every 4 hours, with a maximum of 6 doses in any 24-hour period. Caution is advised to ensure adherence to the dosing guidelines to prevent potential overdose.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 safe use during pregnancy and lactation.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. 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 immediate medical assistance or contact a Poison Control Center without delay. Prompt action 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 to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely for any signs of toxicity and initiate interventions as necessary. This may include administering activated charcoal if appropriate and ensuring the patient is stable while awaiting further medical evaluation.

In summary, immediate medical intervention is critical in cases of overdose, and healthcare professionals should be prepared to implement supportive measures tailored to the individual patient's needs.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to 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

Serious side effects have been reported voluntarily through various channels, including surveillance programs. Individuals are encouraged to report any serious adverse events to the designated phone number, which is available on weekdays from 8 AM to 4 PM AST.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with overdose. In the event of an accidental overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in packaging that includes a printed security seal. It is imperative that the product not be used if the security seal is torn, broken, or missing.

For optimal storage conditions, the product should be maintained at a controlled room temperature between 15-30°C (59-86°F). It is essential to avoid exposure to excessive heat or humidity to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)