Pseudoephedrine hydrochloride

Description

Pseudoephedrine HCl Extended-Release Tablets, USP, contain 120 mg of pseudoephedrine hydrochloride, a long-acting nasal decongestant. These tablets are indicated for the relief of nasal and sinus congestion associated with colds and allergies, as well as for alleviating sinus pressure. The formulation is designed for maximum strength efficacy. The product is manufactured by Ohm Laboratories Inc.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, and upper respiratory allergies. It is designed to restore freer breathing through the nose and promote nasal and/or sinus drainage. Additionally, it temporarily alleviates 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 dosage should not exceed 2 tablets within a 24-hour period. For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

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 a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease, should not use this product. This restriction applies during the course of MAOI treatment and for a period of two weeks following the cessation of the MAOI. If there is uncertainty regarding whether a prescription medication 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, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland. These conditions may increase the risk of adverse effects and warrant careful consideration before initiating treatment.

In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay to ensure appropriate management.

Patients are advised to discontinue use and consult a healthcare provider if symptoms do not improve within seven days, if symptoms are accompanied by a fever, or if they experience feelings of nervousness, dizziness, or sleeplessness. These symptoms may indicate a need for reevaluation of the treatment plan.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to stop use and consult a healthcare professional if symptoms do not improve within 7 days, if symptoms are accompanied by a fever, or if they experience feelings of nervousness, dizziness, or sleeplessness.

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

Additionally, the product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients must refrain from using this product while taking an MAOI and for at least 2 weeks after discontinuing the MAOI. If there is uncertainty regarding the presence of an MAOI in their prescription medication, patients should consult a doctor or pharmacist prior to use.

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 medication contains 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 consult a healthcare professional before use. For adolescents 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

Elderly patients may not require specific dosage adjustments when receiving this medication, as there are no safety concerns noted in the provided information. However, healthcare providers should remain vigilant in monitoring this population for any potential adverse effects, given the general considerations associated with geriatric patients. It is advisable to assess the overall health status and comorbidities of elderly patients to ensure optimal therapeutic outcomes.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure informed decision-making regarding the risks and benefits associated with this medication during pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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

Patients with renal impairment have not been specifically addressed in the drug insert 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 absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 aware that the specific symptoms of an overdose may vary depending on the 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 the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the event of an overdose to ensure optimal patient outcomes.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. In cases where symptoms do not improve within 7 days or are accompanied by a fever, it is recommended to discontinue use and seek medical advice. Users may experience nervousness, dizziness, or sleeplessness.

No relevant information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, sleeplessness, increased blood pressure, palpitations, tachycardia, nausea, vomiting, rash, and allergic reactions, including anaphylaxis. Additionally, other unspecified reactions have been reported. It is important to note that these reactions may not be listed in the product labeling.

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

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

Healthcare providers should emphasize the importance of adhering to the recommended dosage and not exceeding the directed amount when using this product. It is also essential to advise patients to consult a doctor before use if they have any of the following conditions: heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in tamper-evident blister units. It is essential to inspect the packaging prior to use; do not utilize any blister units that are torn, broken, or exhibit signs of tampering.

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

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. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

There is no additional information 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)