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This document provides essential safety and warning information regarding the use of Promethazine VC (promethazine/phenylephrine), emphasizing potential risks, necessary precautions, and specific instructions for different populations. Please review the following points carefully and consult with your healthcare provider if you have any questions or concerns:

• Risks of Slowed Breathing: Promethazine can cause life-threatening slowed breathing, particularly in children, individuals with breathing issues (such as COPD, sleep apnea, asthma), and those on medications that may affect breathing (like opioids or benzodiazepines). It is crucial to use the lowest possible dose for the shortest duration. Disclose all your medical conditions and medications to ensure safety.

• Pediatric Use: Promethazine is not recommended for children under 2 due to the risk of severe breathing issues. For children over 2, monitor closely for any signs of breathing difficulty or other side effects like seizures and hallucinations. Seek medical attention immediately if any issues arise.

• Cognitive and Sedative Effects: Promethazine may cause extreme drowsiness and impair concentration. This risk increases with concurrent use of other sedative medications, in older adults (65+), or with alcohol. Be cautious when engaging in activities requiring alertness, such as driving.

• Seizure Risk: There is an increased risk of seizures for individuals with a history of seizure disorders or those taking medications that reduce the seizure threshold. Notify your healthcare provider if seizures become more frequent.

• Neuroleptic Malignant Syndrome (NMS): Although rare, promethazine may induce NMS, a serious condition characterized by symptoms like fever, muscle stiffness, and irregular heartbeat. Immediate medical intervention is necessary if symptoms occur.

• Involuntary Movements: Promethazine may lead to uncontrollable muscle movements, especially in dehydrated individuals or those on antipsychotic medications. Contact your healthcare provider if such movements develop.

• Blood Cell Counts: Promethazine can lower white blood cell counts, increasing infection risk. Report any persistent symptoms of infection, such as fever or fatigue, to your healthcare provider.

• Cardiovascular Effects: Phenylephrine may elevate heart rate and blood pressure, posing a risk for individuals with heart conditions or hypertension. Discontinue use and seek medical care if severe symptoms like chest pain or irregular heartbeat occur.

• Exacerbation of Medical Conditions: Promethazine VC may worsen conditions such as heart disease, thyroid disorders, diabetes, or prostate issues. Ensure your healthcare provider is informed of your complete medical history.

• Contraindications: Do not use Promethazine VC if you have an allergy to promethazine or phenothiazines, suffer from lower respiratory issues, high blood pressure, have taken MAOIs recently, or have poor blood circulation in the legs. Always consult your healthcare provider before starting treatment if these apply to you.

This information is intended to guide safe use and help prevent serious health risks associated with Promethazine VC. Always adhere to your healthcare provider’s instructions and report any concerning symptoms promptly.

When taking this medication, you may experience some common side effects such as drowsiness, dizziness, headache, upset stomach, nausea, constipation, or dry mouth. These are generally mild, but if they persist or worsen, it is advisable to consult your healthcare provider for guidance.

In some cases, individuals may also feel nervousness, restlessness, or confusion, and encounter vision changes like blurred or double vision. While these effects are less common, they should not be ignored, particularly if they become severe.

More serious side effects, although rare, require immediate medical attention. These include symptoms like dangerously slow or shallow breathing, seizures, and extreme sleepiness. A rare but critical condition known as neuroleptic malignant syndrome (NMS) can occur, characterized by fever, muscle stiffness, severe confusion, and an irregular heartbeat. Additionally, symptoms such as easy bruising or bleeding, uncontrolled movements, and signs of low blood cell counts like pale skin and lightheadedness should be promptly addressed.

Moreover, while very serious allergic reactions to this medication are rare, seek urgent medical help if you notice symptoms such as rash, severe dizziness, trouble breathing, or swelling of the face, tongue, or throat. Always stay vigilant for any other effects not listed here and consult your healthcare provider if you observe any unusual symptoms.

Certain products and drugs can interact with this medication. These include topical antihistamines (like diphenhydramine cream, ointment, or spray), cabergoline, metoclopramide, and pergolide. Additionally, taking this medication with MAO inhibitors can lead to a serious and potentially fatal interaction. It is important to avoid MAO inhibitors such as isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, and tranylcypromine during treatment. Most MAO inhibitors should also be avoided for two weeks before starting this medication. Consult your doctor about when to begin or discontinue use.

Combining this medication with other products that cause drowsiness or breathing difficulties may increase the risk of severe side effects, such as slow or shallow breathing and extreme drowsiness or dizziness. Inform your doctor or pharmacist if you are using opioid painkillers or cough suppressants (e.g., codeine, hydrocodone), alcohol, marijuana (cannabis), sleep or anxiety medications (e.g., alprazolam, lorazepam, zolpidem), muscle relaxants (e.g., carisoprodol, cyclobenzaprine), or other antihistamines (e.g., cetirizine, diphenhydramine).

Review the labels on all your medications, including those for allergies or colds, as they might contain ingredients that induce drowsiness. Consult your pharmacist to ensure safe usage of these products.

This medication may affect certain laboratory tests, such as pregnancy and blood sugar tests, as well as allergy skin tests, potentially causing inaccurate results. Ensure that all laboratory personnel and your healthcare providers are aware of your medication use.