Altidesp

Description

Altidesp is presented in a media type of image/jpeg, with the corresponding image reference being Altidesp.jpg.

Uses and Indications

This drug is indicated for the loosening of phlegm (mucus) and thinning of bronchial secretions, facilitating drainage of the bronchial tubes and enhancing the productivity of coughs. It also provides temporary relief from nasal congestion associated with hay fever or other upper respiratory allergies (allergic rhinitis) and alleviates cough resulting from minor throat and bronchial irritation, which may occur with the common cold.

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

Dosage and Administration

Healthcare professionals are advised to adhere to the following dosage and administration guidelines.

For children aged 2 years to under 6 years, the recommended dosage is 1 mL administered every 4 hours as needed. It is imperative that no more than 6 doses are given within a 24-hour period to avoid potential overdose.

For children under 2 years of age, it is essential to consult a physician prior to administration to determine the appropriate dosage.

The medication should be measured using the dosage device provided with the product. It is crucial not to use any other measuring device to ensure accurate dosing.

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 without delay.

Warnings and Precautions

Patients should adhere strictly to the recommended dosage to avoid potential adverse effects. In the event of nervousness, dizziness, or sleeplessness, it is imperative to discontinue use and consult a healthcare professional. Should these symptoms persist beyond seven days or occur alongside fever, medical advice must be sought promptly.

This product is not indicated for use in cases of persistent or chronic cough, such as that associated with asthma, or if the cough is accompanied by excessive phlegm (mucus), unless specifically directed by a healthcare provider.

Particular caution is warranted when administering this product to children who are currently taking a prescription Monoaminooxidase Inhibitor (MAOI) or have done so within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric, or emotional conditions, as well as for Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, consultation with a doctor or pharmacist is essential prior to administration.

This product should not be given to children with underlying health conditions such as heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a healthcare professional.

Healthcare providers should advise patients to stop use and seek medical advice if a persistent cough is present, as this may indicate a serious underlying condition. Additionally, if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache, consultation with a healthcare provider is necessary.

In the case of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. It is crucial to adhere to the recommended dosage to minimize the risk of adverse effects.

In clinical trials and postmarketing experiences, serious adverse reactions have been noted, including nervousness, dizziness, and sleeplessness. Should any of these symptoms occur, patients are advised to discontinue use and consult a healthcare professional. If symptoms do not improve within seven days or are accompanied by fever, medical consultation is also recommended.

This product is contraindicated for use in patients with certain conditions. Specifically, it should not be used for persistent or chronic coughs, such as those associated with asthma, or if the cough is accompanied by excessive phlegm (mucus), unless directed by a healthcare provider. Additionally, it is not recommended for children who are taking a prescription Monoaminooxidase Inhibitor (MAOI) or for two weeks following the cessation of such medication. Parents should verify whether their child's prescription includes an MAOI by consulting a doctor or pharmacist.

Furthermore, this product should not be administered to children with heart disease, high blood pressure, thyroid disease, or diabetes unless specifically directed by a healthcare professional. Patients should also be vigilant and seek medical advice if a persistent cough may indicate a serious condition, if the cough lasts more than one week, recurs, or is accompanied by fever, rash, or persistent headache.

Drug Interactions

In pediatric patients who are prescribed a Monoaminooxidase Inhibitor (MAOI) for the treatment of depression, psychiatric disorders, or Parkinson's disease, caution is advised when considering the administration of this product. The potential for significant drug interactions exists if the MAOI is taken concurrently or within two weeks of discontinuation.

Healthcare professionals should ensure that they verify whether the child's prescription includes an MAOI. If there is any uncertainty regarding the presence of an MAOI in the child's medication regimen, it is imperative to consult with a physician or pharmacist prior to the administration of this product. Monitoring for adverse effects is recommended during this period to mitigate any potential risks associated with the interaction.

Packaging & NDC

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

Pediatric Use

Pediatric patients with heart disease, high blood pressure, thyroid disease, or diabetes should not receive this product unless specifically directed by a healthcare professional.

For children aged 2 years to under 6 years, the recommended dosage is 1 mL every 4 hours. For infants and children under 2 years of age, consultation with a doctor is necessary prior to administration.

Caution is advised for pediatric patients who are currently taking a prescription Monoaminooxidase Inhibitor (MAOI) or have taken one within the past two weeks. It is important to verify with a healthcare provider or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication before administering this product.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 these patients to ensure safety and 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

Overdosage of the medication can lead to serious health consequences. It is imperative that healthcare professionals adhere strictly to the recommended dosage guidelines to mitigate the risk of overdosage.

In the event of suspected overdosage, it is crucial to monitor the patient closely for any potential symptoms that may arise. Symptoms of overdosage can vary depending on the specific medication involved and may include a range of physiological and psychological effects.

Management of overdosage should be initiated promptly. Healthcare professionals are advised to provide supportive care and symptomatic treatment as necessary. In cases where the overdosage is significant, further medical intervention may be required, including the possibility of activated charcoal administration if appropriate and within the recommended time frame post-ingestion.

It is essential to consult local poison control centers or relevant medical authorities for guidance on specific management protocols tailored to the medication in question. Continuous assessment and monitoring of the patient’s condition are vital to ensure optimal outcomes following an overdosage incident.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in packaging that ensures integrity and safety. It must be stored at room temperature, specifically within the range of 15°C to 30°C (59°F to 86°F).

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the seal is torn, broken, or missing, as this may compromise the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)