Altituss

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the loosening of phlegm (mucus) and thinning of bronchial secretions to facilitate drainage of the bronchial tubes. It also provides 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

The recommended dosage for adults and children aged 12 years and older is 10 ml (2 teaspoons) administered every 4 hours, not to exceed 6 doses within a 24-hour period. For children aged 6 years to under 12 years, the dosage is 5 ml (1 teaspoon) every 4 hours, also limited to a maximum of 6 doses in a 24-hour period.

For children aged 2 years to under 6 years, the appropriate dosage is 2.5 ml (1/2 teaspoon) every 4 hours, adhering to the same 6-dose maximum within 24 hours.

It is imperative that healthcare professionals advise parents or guardians to consult a doctor before administering this medication to children under 2 years of age.

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 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 a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for a period of two weeks following the cessation of an MAOI. Patients uncertain about their medication should consult their healthcare provider or pharmacist prior to use.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have a cough associated with excessive phlegm (mucus) or if they experience a chronic cough, which may be indicative of underlying conditions such as smoking, asthma, chronic bronchitis, or emphysema.

It is imperative that patients adhere strictly to the recommended dosage and not exceed the directed amount when using this product.

Patients should 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, as these may signal a more serious health issue.

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

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). The use of this product is contraindicated in such cases, and patients are advised to consult their healthcare provider if they are uncertain about their medication status regarding MAOIs.

Common adverse reactions may include cough that persists for more than 7 days, returns after resolution, or is accompanied by fever, rash, or persistent headache. These symptoms could indicate a serious underlying condition, and patients should seek medical advice if they experience any of these signs.

Additionally, patients with a cough that produces excessive phlegm or those with chronic cough conditions, such as smoking-related cough, asthma, chronic bronchitis, or emphysema, should consult a healthcare professional before using this product. It is crucial for patients to adhere to the recommended dosage and not exceed the directed use to minimize the risk of adverse reactions.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may be administered 10 ml (2 teaspoons) every 4 hours. For children aged 6 years to under 12 years, the recommended dosage is 5 ml (1 teaspoon) every 4 hours. In children aged 2 years to under 6 years, the dosage is 2.5 ml (1/2 teaspoon) every 4 hours. For children under 2 years of age, it is advised to consult a doctor prior to administration.

Healthcare professionals should ensure that the product is kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for further guidance on the management of overdose cases.

In summary, while specific overdosage data is not available, healthcare professionals should exercise caution and be prepared to act swiftly in the event of an overdose, ensuring that appropriate interventions are implemented based on the patient's condition.

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 the following adverse reactions reported voluntarily or through surveillance programs: dizziness, nausea, vomiting, and allergic reactions, which include rash, itching, and swelling.

Patient Counseling

Healthcare providers should advise patients to keep the 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 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 a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is important to keep the medication out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)