Dolofin Infantil

Description

Dolofin Infantil is a pharmaceutical formulation designed for pediatric use. It is presented in a liquid dosage form, specifically as an oral solution. The active ingredient is paracetamol, which is utilized for its analgesic and antipyretic properties. The product is characterized by its clear, colorless appearance, ensuring ease of administration for children. The formulation includes various inactive ingredients that contribute to its stability and palatability. The precise molecular weight and chemical formula of paracetamol are 151.16 g/mol and C8H9NO2, respectively. Dolofin Infantil is indicated for the relief of mild to moderate pain and the reduction of fever in pediatric patients.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the temporary relief of minor aches and pains associated with conditions such as the common cold, influenza, headache, sore throat, and toothache.

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

Dosage and Administration

Shake the product well before use. Healthcare professionals should determine the appropriate dose based on the patient's weight whenever possible; if weight is not available, age may be used as a guide. The enclosed dosing cup, specifically designed for this product, must be utilized; no other dosing devices should be employed.

The following dosage chart provides guidance for administration:

• For patients weighing less than 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

• For patients weighing between 24-35 lb or aged 2-3 years, the recommended dose is 1 teaspoon (5 mL).

• For patients weighing between 36-47 lb or aged 4-5 years, the recommended dose is 1 1/2 teaspoons (7.5 mL).

• For patients weighing between 48-59 lb or aged 6-8 years, the recommended dose is 2 teaspoons (10 mL).

• For patients weighing between 60-71 lb or aged 9-10 years, the recommended dose is 2 1/2 teaspoons (12.5 mL).

• For patients weighing between 72-95 lb or aged 11 years, the recommended dose is 3 teaspoons (15 mL).

If necessary, the dose may be repeated every 4 hours while symptoms persist. However, it is important not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a physician.

Contraindications

Use is contraindicated in patients with liver disease due to the potential for exacerbating hepatic impairment. Additionally, caution is advised for children concurrently taking the anticoagulant warfarin; consultation with a healthcare professional is recommended to assess the risk of interactions.

Exceeding the recommended dose may lead to liver damage, and therefore, adherence to dosing guidelines is essential. Discontinue use and seek medical advice if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days.

Warnings and Precautions

Severe liver damage may occur in pediatric patients taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of five doses within a 24-hour period or if they concurrently use other medications containing acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to mitigate the risk of hepatotoxicity.

In cases of severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a physician promptly. These symptoms may indicate a more serious underlying condition that requires immediate medical evaluation.

Healthcare providers should emphasize the importance of avoiding overdose, as exceeding the recommended dosage can lead to significant liver damage. In the event of an accidental overdose, it is crucial to seek professional medical assistance or contact a Poison Control Center without delay, as timely intervention is essential even in the absence of overt symptoms.

Patients should be instructed to discontinue use and consult a healthcare professional if any new symptoms arise, if there is evidence of redness or swelling, if pain intensifies or persists beyond five days, or if fever worsens or lasts more than three days. These signs may suggest the presence of a serious medical condition that necessitates further investigation and management.

Side Effects

Patients may experience adverse reactions associated with the use of this product. Serious warnings include the potential for severe liver damage, particularly in cases where patients exceed the maximum daily dosage of five doses within a 24-hour period or when used concurrently with other medications containing acetaminophen. Additionally, a sore throat warning is in place; if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Patients are advised to stop use and seek medical attention if new symptoms arise, if there is any redness or swelling, if pain worsens or lasts longer than five days, or if fever intensifies or persists beyond three days, as these may indicate a serious condition.

Before using this product, it is important for patients to consult a doctor if they have a history of liver disease. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Dolofin Infantil (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be evaluated for liver disease prior to use. Additionally, consultation with a healthcare professional is advised if the child is concurrently taking the anticoagulant warfarin.

For dosing, it is recommended to use weight as the primary guide; if weight is not available, age may be used. The following dosing chart is provided:

• Under 24 lb (Under 2 years): Consult a doctor.

• 24-35 lb (2-3 years): 1 teaspoon (5 mL).

• 36-47 lb (4-5 years): 1 1/2 teaspoons (7.5 mL).

• 48-59 lb (6-8 years): 2 teaspoons (10 mL).

• 60-71 lb (9-10 years): 2 1/2 teaspoons (12.5 mL).

• 72-95 lb (11 years): 3 teaspoons (15 mL).

Pediatric patients should not exceed 5 doses within a 24-hour period, which is the maximum daily amount. Furthermore, treatment should not extend beyond 5 days unless directed by a healthcare provider.

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

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and should be informed of the absence of established safety data in pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the recommended dosage guidelines to minimize the risk of hepatotoxicity.

Specifically, patients must not exceed 5 doses within a 24-hour period, as this represents the maximum daily amount. Additionally, caution is advised when administering this product in conjunction with other medications that also contain acetaminophen, as this may further increase the risk of liver damage.

Healthcare providers should evaluate liver function regularly in patients with compromised liver function and adjust treatment plans accordingly to ensure safety and efficacy.

Overdosage

Severe liver damage may occur in pediatric patients who exceed the recommended dosage of this product, which contains acetaminophen. Specifically, healthcare professionals should be aware that administering more than five doses within a 24-hour period, which constitutes the maximum daily amount, poses a significant risk of hepatotoxicity.

Additionally, caution is advised when this product is used concurrently with other medications that also contain acetaminophen, as this can further increase the likelihood of overdose and subsequent liver injury.

In the event of suspected overdosage, it is imperative to monitor the patient closely for symptoms of liver damage, which may include nausea, vomiting, loss of appetite, confusion, jaundice, and abdominal pain. Immediate medical intervention is recommended, and healthcare providers should consider the administration of N-acetylcysteine as an antidote, particularly if the overdose is identified within a critical time frame.

Prompt recognition and management of acetaminophen overdosage are essential to mitigate the risk of severe hepatic injury and ensure patient safety.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion. It is important to communicate the overdose warning clearly; patients should be informed that taking more than the recommended dose may lead to liver damage. In the event of an accidental overdose, patients must seek professional assistance or contact a Poison Control Center immediately, as prompt medical attention is critical even if no signs or symptoms are present.

Patients should be instructed to stop using the medication and consult a doctor if they experience new symptoms, or if redness or swelling occurs. Additionally, they should be advised to seek medical advice if pain worsens or persists for more than five days, or if fever intensifies or lasts longer than three days, as these may indicate a serious condition.

While using this product, patients must not exceed the recommended dose, and they should be reminded of the overdose warning. It is also essential to ask a doctor before use if their child has liver disease. Furthermore, patients should consult a doctor or pharmacist before use if their child is taking the blood-thinning medication warfarin, to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at controlled room temperature, ensuring that it is kept within the recommended temperature range. For proper identification, the lot number and expiration date are located on the bottom panel of the packaging. Special handling requirements are not specified; however, standard precautions should be observed to maintain product integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)