Promethazine VC Plain Syrup

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

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

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
+ Changes in eyesight
Fast or slow heartbeat
Difficulty urinating
Hallucinations (seeing or hearing things that are not there)
Mood changes
Feeling confused
Ringing in the ears
Seizures
Unexplained bruising or bleeding
Trouble controlling body movements, twitching, changes in balance, trouble swallowing or speaking
Shakiness
Restlessness
Changes in eyesight
* Yellow skin or eyes

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

Breathing Problems: This medication can 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 can cause a decrease in white blood cell count, which can increase the risk of infection. 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, but some may occur. 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
+ Excitability
+ Dry mouth
+ Upset stomach or vomiting
+ Trouble sleeping

Reporting Side Effects

If you have questions about side effects or experience any side effects not listed here, 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 symptoms you experienced.
Certain health conditions, including:
+ Respiratory problems like asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing difficulties
+ High blood pressure
+ Poor blood circulation to the legs
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications can lead to severely high blood pressure.
If you are currently taking:
+ Linezolid
+ Methylene blue
Note: This is not an exhaustive list of interacting medications.

To ensure your safety, it is crucial to discuss all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems

with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing health conditions and medications. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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 or clear vision. Be aware that this medication may interfere with 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 vital 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 sunlight, 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 you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOIs due to risk of hypertensive crisis with phenylephrine)
• Other CNS depressants (e.g., alcohol, sedatives, hypnotics, tranquilizers, opioids) in children < 2 years due to additive respiratory depression risk with promethazine

• Other anticholinergic drugs (e.g., tricyclic antidepressants, atropine, benztropine) due to additive anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation)
• QT-prolonging drugs (e.g., antiarrhythmics, certain antipsychotics, macrolide antibiotics) due to potential for additive QT prolongation with promethazine
• Sympathomimetics (e.g., pseudoephedrine, ephedrine, stimulants) due to additive adrenergic effects (hypertension, tachycardia)
• Antihypertensives (e.g., beta-blockers, ACE inhibitors) due to potential reduction in their effect by phenylephrine

• Dopamine agonists (e.g., bromocriptine, cabergoline) due to potential antagonism by promethazine
• Metoclopramide (due to potential antagonism of its effects by promethazine)
• Antacids (may reduce absorption of phenylephrine)

• None typically classified as minor for this combination with significant clinical impact.

• Drowsiness
• Dizziness
• Dry mouth
• Blurred vision
• Urinary retention
• Constipation
• Nervousness
• Insomnia
• Palpitations
• Increased blood pressure
• Nausea
• Vomiting
• Rash
• 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 has vasoconstrictive effects that could theoretically reduce uterine blood flow.

L3 (Moderate risk). Both promethazine and phenylephrine are excreted into breast milk. Promethazine can cause drowsiness, irritability, and respiratory depression in infants, especially newborns or premature infants. Phenylephrine can cause irritability and may reduce milk supply.

Contraindicated in children younger than 2 years due to the risk of fatal respiratory depression with promethazine. Use with extreme caution in children 2 to 6 years of age, and generally not recommended. Older children (6-12 years) should receive reduced doses. Adolescents (12 years and older) can receive adult doses. Children are more susceptible to the anticholinergic and CNS effects.

Elderly patients are more susceptible to the anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation), sedative effects (drowsiness, dizziness), and adrenergic effects (e.g., increased blood pressure, tachycardia) of this combination. Use with caution, starting with lower doses and titrating slowly. Avoid in patients with conditions exacerbated by anticholinergics (e.g., glaucoma, BPH) or sympathomimetics (e.g., hypertension, cardiovascular disease).

• Always confirm patient age; Promethazine is contraindicated in children < 2 years due to fatal respiratory depression risk.
• Counsel patients on significant sedative effects and the importance of avoiding alcohol and other CNS depressants.
• Advise patients about anticholinergic side effects (dry mouth, blurred vision, constipation, urinary retention) and adrenergic side effects (nervousness, insomnia, palpitations).
• Warn patients about potential for paradoxical excitation, especially in children.
• Monitor blood pressure in patients with hypertension due to phenylephrine component.
• Avoid in patients with narrow-angle glaucoma or prostatic hypertrophy due to anticholinergic effects.
• Caution in patients with cardiovascular disease, diabetes, or hyperthyroidism due to phenylephrine.

• Single-agent antihistamines (e.g., loratadine, fexofenadine, cetirizine for non-sedating options; diphenhydramine for sedating)
• Single-agent decongestants (e.g., pseudoephedrine, oxymetazoline nasal spray)
• Nasal saline irrigation
• Cough suppressants (e.g., dextromethorphan) or expectorants (e.g., guaifenesin) if cough is primary symptom

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.