Presgen Pediatric

Description

No description information is available for the 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

Adults and children aged 12 years and over are advised to administer 4 teaspoons (20 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 2 teaspoons (10 mL) every 4 hours, also with a maximum of 6 doses in a 24-hour period. In children aged 2 to under 6 years, the dosage is 1 teaspoon (5 mL) every 4 hours, adhering to the same limit of 6 doses per day. It is important to note that this medication is not recommended for children under 2 years of age.

Healthcare professionals should ensure that patients are aware of the dosing intervals and the maximum daily limit to prevent potential overdose.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of an accidental overdose, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

The use of this product is contraindicated in children under 2 years of age. Additionally, it should not be administered to children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Healthcare professionals should advise caregivers to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription.

Before recommending this product, healthcare professionals should inquire about the patient's medical history, particularly if the patient has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Furthermore, caution is advised in patients with a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

It is imperative that patients adhere to the recommended dosage and not exceed it.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: the child experiences nervousness, dizziness, or sleeplessness; 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 accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition.

For pregnant or breastfeeding individuals, consultation with a healthcare professional is recommended prior to use.

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 several important warnings and adverse reactions associated with the use of this medication. It is contraindicated in children under 2 years of age and should not be used in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment.

Before using this medication, patients should consult a healthcare professional if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Additionally, individuals with a chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use.

Patients are advised to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, 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, medical attention should be sought, as these may indicate a serious condition.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before using this medication. In the event of an accidental overdose, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Drug Interactions

There are currently no documented drug interactions associated with 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 Presgen Pediatric (guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not be administered this medication. For children aged 2 to under 6 years, the recommended dosage is 1 teaspoon (5 mL) every 4 hours. In children aged 6 to under 12 years, the dosage increases to 2 teaspoons (10 mL) every 4 hours. For adolescents aged 12 years and over, the dosage is 4 teaspoons (20 mL) every 4 hours. Care should be taken to adhere to these dosing guidelines to ensure safety and efficacy in pediatric populations.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of specific data and the potential for variability in response among this population. Regular monitoring and assessment of therapeutic outcomes may be warranted to ensure safety and efficacy in elderly patients.

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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for 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 intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that the 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. 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 clinical scenario.

It is vital for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These events have been documented in the context of routine pharmacovigilance activities.

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 accidental overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the potential seriousness of an overdose and the importance of prompt action in such situations.

Storage and Handling

The product is supplied in packaging that includes a 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 and humidity to ensure the integrity and efficacy of the product.

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 essential to keep the medication out of reach of children, and in the event of an accidental overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

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