Phenergan VC Plain Syrup

Promethazine is a phenothiazine derivative that acts as an H1-receptor antagonist, blocking the effects of histamine. It also has significant anticholinergic, sedative, antiemetic, and local anesthetic properties. Phenylephrine is a direct-acting sympathomimetic amine that primarily acts as an alpha-1 adrenergic agonist, causing vasoconstriction in the nasal mucosa, leading to decongestion.

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out or changes in eyesight
Abnormal heart rhythms, such as:
+ Fast or slow heartbeat
Urination difficulties
Hallucinations (seeing or hearing things that are not there)
Mood changes
Confusion
Ringing in the ears
Seizures
Unexplained bruising or bleeding
Trouble controlling body movements, twitching, changes in balance, or difficulty swallowing or speaking
Shakiness
Restlessness
Changes in eyesight
* Yellowing of the skin or eyes

Neuroleptic Malignant Syndrome (NMS): A rare but potentially life-threatening condition called NMS may occur. Seek medical help immediately if you experience:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast or irregular heartbeat
+ Excessive sweating

Respiratory Problems: This medication may cause severe and potentially life-threatening breathing problems. Seek medical help immediately if you experience:
+ Slow, shallow, or difficulty breathing

Low White Blood Cell Count: This medication may increase the risk of infection due to a low white blood cell count. If you have a history of low white blood cell count, inform your doctor. Seek medical help immediately if you experience:
+ Signs of infection, such as:
- Fever
- Chills
- Sore throat

Other Side Effects

Most people do not experience severe side effects, and some may only have minor side effects. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
+ Dizziness
+ Drowsiness
+ Fatigue
+ Weakness
+ Nervousness or excitability
+ Dry mouth
+ Upset stomach or vomiting
+ Sleep disturbances

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems, such as asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing difficulties
+ High blood pressure
+ Poor blood flow to the legs
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure
Current use of certain medications, such as linezolid or methylene blue, as these may interact with this medication

To ensure safe treatment, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have

Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the dosage instructions provided by your doctor, as taking more than prescribed may increase your risk of experiencing severe side effects. Additionally, do not take this medication for a longer duration than recommended by your doctor.

Until you are aware of how this medication affects you, it is advisable to avoid driving and engaging in activities that require alertness and clear vision. Be aware that this medication may influence the results of certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.

If you have diabetes (high blood sugar), it is necessary to monitor your blood sugar levels closely while taking this medication. Furthermore, this medication may cause false results in some pregnancy tests, so it is important to discuss this with your doctor.

Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter (OTC) medications that may impair your reactions, consult with your doctor. You may be more susceptible to sunburn while taking this medication, so it is recommended to avoid exposure to the sun, sunlamps, and tanning beds, and to use sunscreen and protective clothing and eyewear.

Prior to using any OTC products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products or aids, consult with your doctor. This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures, so it is essential to discuss your risk with your doctor.

If you are 65 years or older, exercise caution when taking this medication, as you may be more prone to experiencing side effects. It is also important to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to both you and your baby.

• MAO inhibitors (MAOIs) or within 14 days of MAOI therapy (due to phenylephrine, risk of hypertensive crisis)
• Other phenothiazines (additive effects)
• Children younger than 2 years (due to promethazine, risk of fatal respiratory depression)

• CNS depressants (e.g., alcohol, opioids, benzodiazepines, sedatives, hypnotics, tricyclic antidepressants) - additive sedation and respiratory depression
• Anticholinergic drugs (e.g., atropine, scopolamine, certain antidepressants) - additive anticholinergic effects (dry mouth, urinary retention, blurred vision)
• Antihypertensive drugs (e.g., beta-blockers, ACE inhibitors) - phenylephrine may reduce their effect
• QT-prolonging drugs (e.g., certain antiarrhythmics, antipsychotics) - promethazine may prolong QT interval

• Dopamine agonists (e.g., bromocriptine, cabergoline) - promethazine may antagonize their effects
• Metoclopramide - promethazine may antagonize its effects
• Ephedrine, pseudoephedrine, other sympathomimetics - additive pressor effects with phenylephrine
• Digoxin - phenylephrine may increase risk of arrhythmias

• Antacids (containing aluminum or magnesium) - may reduce absorption of phenylephrine (separate administration)
• Food - may delay absorption but not significantly affect extent

• Drowsiness
• Dizziness
• Dry mouth
• Blurred vision
• Urinary retention
• Constipation
• Nervousness
• Insomnia
• Palpitations
• Increased blood pressure
• Difficulty breathing (especially in children)

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Promethazine has been associated with potential for respiratory depression in neonates if used near term. Phenylephrine use in pregnancy is generally discouraged due to vasoconstrictive effects.

L3 (Moderately Safe). Promethazine is excreted into breast milk and can cause sedation, irritability, or respiratory depression in the infant, and may decrease milk supply. Phenylephrine is also excreted into breast milk and may cause irritability or tachycardia in the infant, and may decrease milk supply. Use with caution; consider alternative or monitor infant closely.

Contraindicated in children younger than 2 years due to the risk of fatal respiratory depression with promethazine. Use with extreme caution and at the lowest effective dose in children 2 years and older. Children may be more susceptible to anticholinergic effects and paradoxical excitation.

Elderly patients are more susceptible to the anticholinergic effects (e.g., dry mouth, urinary retention, constipation, blurred vision) and CNS depressant effects (e.g., sedation, dizziness, confusion) of promethazine. They are also more susceptible to the cardiovascular effects (e.g., increased blood pressure, tachycardia) of phenylephrine. Use with caution, starting with lower doses and monitoring closely.

• Promethazine has significant sedative and anticholinergic effects; counsel patients on these side effects and avoidance of activities requiring mental alertness.
• The black box warning for respiratory depression in children under 2 years old is critical and must be strictly adhered to.
• Phenylephrine, while less potent than pseudoephedrine, can still cause cardiovascular effects; caution in patients with hypertension, heart disease, or hyperthyroidism.
• Advise patients to avoid alcohol and other CNS depressants due to additive effects.
• This combination is for symptomatic relief of cold/allergy symptoms and does not treat the underlying cause.
• Patients should be advised to contact their healthcare provider if symptoms do not improve within 3-5 days or worsen.

• Single-agent antihistamines (e.g., loratadine, cetirizine for allergies)
• Single-agent decongestants (e.g., pseudoephedrine, oxymetazoline nasal spray)
• Cough suppressants (e.g., dextromethorphan, guaifenesin)
• Saline nasal sprays for congestion

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more details. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.