Pentrexcilina

Description

Pentrexcilina is presented in a dosage form of tablets, with each pouch containing two tablets.

Uses and Indications

This drug is indicated for the relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies. It effectively alleviates sinus congestion and pressure, facilitating the decongestion of sinus openings and passages, thereby restoring freer breathing.

Additionally, this drug aids in loosening bothersome mucus, promoting drainage of the bronchial tubes, and enhancing the productivity of coughs. It also serves to suppress coughs resulting from minor throat and bronchial irritation due to colds or inhaled irritants.

Furthermore, this drug temporarily relieves minor aches, pains, and fever associated with conditions such as headaches, the common cold, toothaches, backaches, muscular aches, and menstrual cramps.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

Adults and children 12 years of age and older are advised to take 2 tablets every 6 to 8 hours as needed. The total daily dosage should not exceed 8 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor prior to administration to determine the appropriate dosage and administration guidelines.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other product containing acetaminophen is prohibited due to the risk of exceeding the recommended dose, which may lead to serious health concerns.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks should not use this product. Consultation with a healthcare professional is advised if there is uncertainty regarding the presence of an MAOI in the prescription medication.

• This product should not be used for persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or when cough is accompanied by excessive phlegm, unless directed by a healthcare provider.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage under certain conditions. Healthcare professionals should advise patients to avoid exceeding 8 tablets within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen, whether prescription or over-the-counter. Patients should be encouraged to consult a healthcare provider or pharmacist if there is any uncertainty regarding the use of multiple acetaminophen-containing products. Furthermore, consumption of 3 or more alcoholic drinks daily while using this product may also increase the risk of liver damage.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must discontinue use immediately and seek medical assistance. It is also important to note that a persistent cough may indicate a serious underlying condition, warranting further evaluation.

Patients should be instructed to stop use and consult a healthcare professional if symptoms do not improve, if pain or fever persists or worsens, if new symptoms arise, or if redness or swelling is observed. Symptoms that do not improve within 7 days, or that are accompanied by fever, require medical attention. Additionally, a cough that persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache should be evaluated by a healthcare provider.

In the event of an overdose, immediate medical assistance is crucial. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of more than 8 tablets in a 24-hour period, use the product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients are advised to discontinue use and consult a healthcare professional if symptoms do not improve, if pain or fever persists or worsens, if new symptoms arise, or if there is the presence of redness or swelling. Additionally, if symptoms do not improve within 7 days, are accompanied by fever, or if a cough persists for more than one week, tends to recur, or is associated with fever, rash, or a persistent headache, medical advice should be sought. A persistent cough may indicate a serious underlying condition.

Before using this product, patients should consult a healthcare provider if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate gland enlargement, or liver disease. Furthermore, individuals 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 before using this medication in conjunction with other drugs, particularly if they are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. It is advised to wait at least two weeks after stopping an MAOI before initiating treatment with this medication.

Additionally, individuals taking the anticoagulant warfarin should seek guidance from a healthcare provider prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe and effective use.

Packaging & NDC

Below are the non-prescription pack sizes of Pentrexcilina (acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 6 to 8 hours as needed, with a maximum of 8 tablets in a 24-hour period, unless otherwise 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.

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 the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 drug 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 information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the following limits:

• More than 8 tablets in a 24-hour period.

• Concurrent use with other medications containing acetaminophen, whether prescription or nonprescription. Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, before combining this product with any other drugs to ensure safety.

Additionally, patients should be aware that consuming 3 or more alcoholic drinks daily while using this product may increase the risk of liver damage. Therefore, it is recommended that patients with compromised liver function limit alcohol intake and adhere strictly to the dosage guidelines to mitigate potential risks. Regular monitoring of liver function may be warranted in patients with significant hepatic impairment to ensure safety and efficacy.

Overdosage

Severe liver damage may occur with the ingestion of this product, which contains acetaminophen, if the following conditions are met:

• Consumption of more than 8 tablets within a 24-hour period.

• Concurrent use with other medications that also contain acetaminophen, whether prescription or nonprescription. Healthcare professionals are advised to consult with a doctor or pharmacist if there is uncertainty regarding the use of other medications containing acetaminophen.

• Daily intake of 3 or more alcoholic beverages while using this product.

It is imperative to avoid the use of any additional products containing acetaminophen, as this can lead to exceeding the recommended dosage and result in serious health complications.

Healthcare professionals should emphasize the importance of adhering to the recommended dosage guidelines. Specifically, patients should not exceed the recommended dose and should refrain from using the product for more than 10 days for pain management unless directed by a physician. Similarly, the product should not be used for more than 3 days for fever unless advised by a healthcare provider.

In the event of suspected overdosage, immediate medical attention is warranted. Monitoring liver function and providing supportive care are critical components of management.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center in the event of an overdose, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this product in conjunction with any other product containing acetaminophen, as this could lead to an overdose and serious health concerns. It is essential to adhere strictly to the recommended dosage and to avoid using the product for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional.

When using this product, patients must not exceed the recommended dose. Additionally, if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks, they should consult a doctor or pharmacist before using this product.

Patients should be cautioned against using this product for persistent or chronic coughs associated with smoking, asthma, chronic bronchitis, or emphysema, especially if accompanied by excessive phlegm, unless directed by a healthcare provider.

Healthcare providers should instruct patients to stop using the product and consult a doctor if symptoms do not improve, if pain or fever persists or worsens, if new symptoms arise, or if redness or swelling occurs. Patients should also be advised to seek medical attention if symptoms do not improve within 7 days, if a cough persists for more than one week, or if it tends to recur, especially if accompanied by fever, rash, or a persistent headache, as a persistent cough may indicate a serious condition.

Patients should be made aware that acetaminophen can cause severe skin reactions, which may present as skin reddening, blisters, or rash. If any skin reaction occurs, they should stop using the product and seek medical help immediately.

Finally, healthcare providers should encourage patients to consult a doctor before use if they have any underlying health conditions such as heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate enlargement, or liver disease. Patients taking the blood-thinning medication warfarin should also be advised to consult a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to inspect the packaging prior to use; do not utilize the product if the packet is torn, cut, or opened.

For optimal storage, the product should be maintained at a controlled room temperature between 15° to 30°C (59° to 86°F). It is crucial to avoid exposure to excessive heat and humidity to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 tablets orally every 6 to 8 hours as needed, with a maximum of 8 tablets in a 24-hour period, unless otherwise directed by a healthcare professional. For children under 12 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. In the event of an overdose, it is crucial to obtain medical assistance or contact a Poison Control Center immediately, as prompt attention is essential for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

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

View product document (PDF)