Pseudoephedrine hydrochloride

Description

Pseudoephedrine HCl is a long-acting nasal decongestant available in an extended-release tablet formulation, with each tablet containing 120 mg of the active ingredient. This product is designed to provide relief from sinus pressure and congestion for up to 12 hours. The dosage form consists of 20 coated capsule-shaped tablets, ensuring ease of administration.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief from sinus congestion and pressure.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 tablet every 12 hours. The maximum allowable dosage is 2 tablets within a 24-hour period.

This product is not recommended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage while using this product is also contraindicated.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

It is crucial that patients adhere to the recommended dosage and not exceed it. In the event of experiencing nervousness, dizziness, or sleeplessness, patients should discontinue use and consult a healthcare provider. Furthermore, if symptoms do not improve within seven days or are accompanied by a fever, medical advice should be sought.

This product must be kept out of reach of children. In the case of an overdose, immediate medical assistance should be obtained, or contact with a Poison Control Center should be made without delay (1-800-222-1222).

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious warnings include the contraindication of use in individuals 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, and Parkinson's disease. Patients uncertain about whether their prescription contains an MAOI are advised to consult a healthcare professional prior to use.

Common adverse reactions may include nervousness, dizziness, and sleeplessness. Patients experiencing these symptoms should discontinue use and seek medical advice. Additionally, if symptoms do not improve within 7 days or are accompanied by a fever, it is recommended that patients consult a healthcare provider.

Before using this product, patients with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice.

In the event of an overdose, immediate medical assistance should be sought, or patients should contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson's disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Pseudoephedrine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For adolescents and adults aged 12 years and older, the recommended dosage is 1 tablet every 12 hours, with a maximum of 2 tablets in a 24-hour period.

Geriatric Use

There is no specific geriatric use information provided in the prescribing information. Consequently, there are no 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 individual health status and potential comorbidities that may affect treatment outcomes. Regular monitoring and assessment may be warranted to ensure the safety and efficacy of the therapy in 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed 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 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 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. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and specific interventions based on the substance involved. It is vital for healthcare providers to remain vigilant and prepared to implement necessary measures to ensure patient safety and recovery.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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 revealed reports of various adverse reactions associated with the use of the product. These include nervousness, dizziness, and sleeplessness. Cardiovascular effects such as increased blood pressure, palpitations, and tachycardia have also been reported. Gastrointestinal disturbances, including nausea and vomiting, were noted among users. Additionally, allergic reactions have been documented, which encompass rash, pruritus, and angioedema. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should counsel patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the product and seek medical advice if their symptoms do not improve within 7 days or if they experience symptoms accompanied by a fever.

It is important to remind patients not to exceed the recommended dosage while using this product. Furthermore, healthcare providers should recommend that patients consult a doctor before use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in blister packaging, which is designed to ensure tamper evidence. It is imperative that the blister units are inspected prior to use; any units that are torn, broken, or exhibit signs of tampering should not be used.

For optimal storage, the product must be kept in a dry place at a temperature range of 59° to 77° F. Additionally, it is essential to protect the product from light exposure to maintain its integrity.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every 12 hours, with a maximum of two tablets within a 24-hour period. It is contraindicated for use in children under 12 years of age. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)