Novalgina Pediatrico Cough and Cold

Description

No specific information related to the Description section for SPL code 34089-3 is provided in the text.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider this information when evaluating treatment options for their patients.

Dosage and Administration

The recommended dosage must not be exceeded, and it is essential to measure the dose using the provided dosage device to ensure accuracy.

For children aged 6 to under 12 years, the recommended dose is 2 ml administered every 6 to 8 hours as needed. For children aged 2 to under 6 years, the dosage is 1 ml every 6 to 8 hours as required.

For children under 2 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in children who are currently taking prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such medication. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription, consultation with a healthcare professional is advised prior to administration of this product.

Additionally, exceeding the recommended dosage is contraindicated during the use of this product.

Warnings and Precautions

Do not administer this product to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Before using this product, it is advisable to consult a healthcare provider if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, persistent or chronic cough (such as that associated with asthma), or a cough accompanied by excessive phlegm (mucus). These conditions may necessitate special consideration or alternative treatment options.

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

Parents or caregivers should discontinue use and contact a healthcare provider if the child experiences nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they are accompanied by fever, or if a cough persists for more than 7 days, recurs, or occurs with fever, rash, or a persistent headache, these may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. It is important for patients to monitor their symptoms and seek medical advice if certain conditions arise.

In the event of nervousness, dizziness, or sleeplessness, patients are advised to discontinue use and consult a healthcare professional if these symptoms do not improve within 7 days. Additionally, if these symptoms are accompanied by fever, a cough lasting more than 7 days, a recurrence of symptoms, or the presence of a rash or persistent headache, it may indicate a serious underlying condition that requires immediate medical attention.

Before initiating treatment, it is recommended that patients consult a healthcare provider if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or a persistent or chronic cough, such as that associated with asthma. Furthermore, patients with a cough that produces excessive phlegm (mucus) should also seek medical advice prior to use.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated in pediatric patients. MAOIs are typically prescribed for the treatment of depression, psychiatric disorders, emotional conditions, or Parkinson's disease. It is essential to avoid administering this product to a child who is currently taking an MAOI or has discontinued MAOI therapy within the past two weeks.

Healthcare professionals should ensure that caregivers are informed about the presence of MAOIs in any prescription medications their child may be taking. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is advisable to consult a physician or pharmacist prior to the administration of this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 2 ml every 6-8 hours, while those aged 2 to under 6 years should receive 1 ml every 6-8 hours. For children under 2 years of age, consultation with a healthcare professional is advised prior to use.

Caution is warranted in pediatric patients who are taking prescription monoamine oxidase inhibitors (MAOIs) or have taken them within the past two weeks, as the medication should not be used in these cases. Additionally, it is recommended to consult a healthcare provider before use if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, persistent or chronic cough (such as that associated with asthma), or cough accompanied by excessive phlegm (mucus).

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, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Use is contraindicated in pregnancy due to potential risks to the fetus. There may be risks associated with the use of this medication during pregnancy; therefore, it is essential for healthcare providers to be consulted for advice regarding its use.

Dosage modifications may be necessary for pregnant individuals, and specific recommendations should be obtained from a healthcare provider. Pregnant women are advised to discuss the use of this product with their healthcare provider prior to use to ensure informed decision-making regarding potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of Novalgina Pediatrico Cough and Cold in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of specific guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an 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 the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose situation.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product, including nervousness, dizziness, and sleeplessness. Additionally, it is noted that symptoms which do not improve within 7 days, or that occur alongside fever, a cough lasting more than 7 days, returning symptoms, or symptoms accompanied by fever, rash, or persistent headache, may indicate the presence of a serious condition.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that this product should not be used in children who are currently taking prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of stopping such medication. If patients are uncertain whether their child's prescription includes an MAOI, they should be encouraged to consult a doctor or pharmacist prior to administering this product.

Patients should be made aware of the potential side effects, including nervousness, dizziness, or sleeplessness. If these symptoms do not improve within seven days, or if they occur alongside a fever or a cough that lasts more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, patients should be instructed to seek medical attention, as these may indicate a serious condition.

It is important to emphasize that patients must not exceed the recommended dosage when using this product. Additionally, healthcare providers should recommend that patients consult a doctor before use if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, persistent or chronic cough (such as that associated with asthma), or a cough that produces excessive phlegm (mucus).

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit) to maintain its efficacy.

Healthcare professionals should ensure that the product is not used if there is any evidence of tampering, as this may compromise safety and effectiveness. Proper handling and storage conditions are critical to preserving the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)