Altipres Pediatric

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritations, which may occur with the common cold. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes. Additionally, this drug provides temporary relief of nasal congestion due to the common cold.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying causes of cough or nasal congestion.

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 4 teaspoonfuls (20 mL) every 4 hours, not to exceed 6 doses within a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 2 teaspoonfuls (10 mL) every 4 hours, also adhering to the maximum limit of 6 doses in a 24-hour period. In children aged 2 to under 6 years, the dosage is 1 teaspoonful (5 mL) every 4 hours, with the same restriction on the total number of doses. This medication is not recommended for use in children under 2 years of age.

Healthcare professionals should ensure that patients are aware of the dosing intervals and the importance of not exceeding the maximum daily limit to avoid potential adverse effects.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

The use of this product is contraindicated in children who are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI) or have discontinued such medication within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Healthcare professionals should advise parents to consult with their doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their child's prescription medication.

Before administering this product, it is essential to consult a healthcare provider if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate gland enlargement, or a cough associated with excessive phlegm. Additionally, caution is warranted in cases of chronic cough, which may be indicative of underlying conditions such as smoking-related issues, asthma, chronic bronchitis, or emphysema.

While using this product, it is critical to adhere to the recommended dosage and not exceed it. Parents should be vigilant and discontinue use if the child experiences nervousness, dizziness, or insomnia. Furthermore, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists beyond seven days, recurs, or is associated with fever, rash, or a persistent headache, it is imperative to seek medical attention, as these may be signs of a serious condition.

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

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 a prescription Monoamine Oxidase Inhibitor (MAOI) or have taken one within the past two weeks. The use of this medication in such cases is contraindicated.

Before administering this medication to a child, it is advisable to consult a healthcare professional if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate gland enlargement, or a cough that is productive with excessive phlegm. Additionally, caution is warranted if the child has a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Parents and caregivers should monitor for specific symptoms that may necessitate discontinuation of the medication and consultation with a healthcare provider. These symptoms include increased nervousness, dizziness, or sleeplessness. If the child's symptoms do not improve within seven days, or if they are accompanied by fever, it is important to seek medical advice. Furthermore, if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, these may indicate a serious condition requiring immediate medical attention.

Drug Interactions

The use of this medication is contraindicated in pediatric patients who are concurrently taking a prescription Monoamine Oxidase Inhibitor (MAOI) or have discontinued an MAOI within the past two weeks. Co-administration in these circumstances may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the stated contraindication.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not use this product if they are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Prior to use, it is advised to consult a healthcare professional if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate gland enlargement, or a cough associated with excessive phlegm. Additionally, caution is warranted for children with chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema.

Recommended dosages for this product are as follows: children aged 6 to under 12 years should take 2 teaspoonfuls (10 mL) every 4 hours, while children aged 2 to under 6 years should take 1 teaspoonful (5 mL) every 4 hours. This product is not recommended for children under 2 years of age.

Parents and caregivers should ensure that the recommended dosage is not exceeded. If a child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or are accompanied by fever, use should be discontinued and a doctor consulted. Furthermore, if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, medical advice should be sought.

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 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

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 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, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

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 specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

Nonclinical Toxicology

If pregnant or breast-feeding, 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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, and sleeplessness. Additionally, serious conditions associated with cough have been noted, particularly when the cough lasts more than 7 days, returns, or is accompanied by fever, rash, or persistent headache.

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 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, any unused portion 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 also important to instruct patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an accidental overdose.

Drug Information (PDF)

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

View product document (PDF)