Phenergan Syrup W/dm

Promethazine is a phenothiazine derivative that acts as an H1-receptor antagonist, blocking histamine's effects. It also has significant anticholinergic, sedative, and antiemetic properties. Dextromethorphan is a non-opioid antitussive that acts centrally by elevating the cough threshold, likely through agonism of sigma opioid receptors and antagonism of NMDA receptors.

Urgent Side Effects: Seek Medical Help Right Away

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 immediate medical attention:

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 problems
Trouble controlling body movements, including:
+ Twitching
+ Changes in balance
+ Difficulty swallowing or speaking
Shakiness
Hallucinations (seeing or hearing things that are not there)
Mood changes
Ringing in the ears
Seizures
Unexplained bruising or bleeding
Changes in eyesight
Feeling nervous and excitable
Trouble sleeping
* Yellowing of the skin or eyes

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

Breathing Problems: This medication may cause severe and potentially life-threatening breathing problems. Seek immediate medical attention 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 attention if you experience:
+ Fever
+ Chills
+ Sore throat

Other Side Effects

Most people experience no side effects or only mild side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
+ Dizziness
+ Drowsiness
+ Fatigue
+ Weakness
+ Dry mouth
+ Upset stomach or vomiting

Reporting Side Effects

This is not an exhaustive list of potential 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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, other medications, foods, or substances. Be sure to describe the allergic reaction and its symptoms.
Respiratory health issues, such as:
+ Asthma
+ Chronic obstructive pulmonary disease (COPD)
+ Sleep apnea (breathing difficulties during sleep)
Coughs accompanied by excessive mucus production, long-term coughs caused by smoking or exposure to smoke, or lung conditions like:
+ Asthma
+ Emphysema
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (as this may lead to severely high blood pressure)
* Concurrent use of:
+ Linezolid
+ Methylene blue

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

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, exercise caution when driving or engaging in activities that require alertness. Be aware that this drug may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this medication.

If you have diabetes (high blood sugar), it is vital to monitor your blood sugar levels closely while taking this medication. Furthermore, be aware that this medication may cause false results in some pregnancy tests, so it is recommended that you consult with your doctor.

Before consuming alcohol, using marijuana or other forms of cannabis, or taking prescription or over-the-counter drugs that may cause drowsiness, discuss the potential risks with your doctor. You may be more susceptible to sunburn while taking this medication, so it is advised to avoid exposure to the sun, sunlamps, and tanning beds, and to use sunscreen and protective clothing and eyewear when going outside.

This medication may increase the risk of seizures in certain individuals, particularly those with a history of seizures. Consult with your doctor to assess your personal risk of seizures while taking this medication. If you are 65 years or older, use this medication with caution, as you may be more prone to experiencing side effects.

It is essential to inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks of taking this medication to both you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOIs due to risk of serotonin syndrome with dextromethorphan and enhanced anticholinergic/CNS depressant effects with promethazine)
• Other CNS depressants (e.g., opioids, benzodiazepines, barbiturates, alcohol) in children younger than 2 years due to severe respiratory depression risk

• Other CNS depressants (e.g., opioids, benzodiazepines, barbiturates, alcohol) in adults and children >2 years (additive CNS depression, respiratory depression)
• Anticholinergic drugs (e.g., tricyclic antidepressants, atropine, benztropine) (additive anticholinergic effects, increased risk of paralytic ileus, urinary retention, severe constipation)
• QT-prolonging drugs (e.g., antiarrhythmics, certain antipsychotics, macrolide antibiotics) (promethazine may prolong QT interval, increasing risk of torsades de pointes)
• Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, St. John's Wort) (increased risk of serotonin syndrome with dextromethorphan)
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, amiodarone) (can significantly increase dextromethorphan and dextrorphan levels, increasing risk of toxicity and serotonin syndrome)

• Antihypertensives (promethazine may cause orthostatic hypotension)
• Dopamine agonists (promethazine has antidopaminergic effects)
• Epinephrine (promethazine may reverse pressor effect of epinephrine, leading to hypotension)
• Phenytoin (promethazine may alter phenytoin metabolism)

• Not available

• Drowsiness
• Dizziness
• Dry mouth
• Blurred vision
• Constipation
• Urinary retention
• Nausea/vomiting
• Paradoxical excitation (especially in children)
• Respiratory depression
• Confusion
• Hallucinations
• Serotonin syndrome symptoms (agitation, hyperthermia, rigidity, myoclonus, hyperreflexia, tachycardia, labile blood pressure)

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Promethazine has been associated with potential for respiratory depression and extrapyramidal symptoms in neonates if used near term. Dextromethorphan has limited human data but is generally considered low risk.

L3 (Moderate Risk). Both promethazine and dextromethorphan are excreted into breast milk. Promethazine can cause sedation, irritability, and respiratory depression in infants, and may decrease milk supply due to its anticholinergic effects. Dextromethorphan's effects on infants are not well studied but theoretical CNS effects are possible. Use with caution; consider alternative or monitor infant closely for sedation, poor feeding, or respiratory issues.

Contraindicated in children younger than 2 years of age due to the risk of fatal respiratory depression (Black Box Warning). Use with extreme caution in children 2 years and older, especially those with respiratory conditions (e.g., asthma, sleep apnea) or a family history of SIDS. Children are more susceptible to paradoxical excitation and anticholinergic effects.

Increased susceptibility to adverse effects, particularly sedation, dizziness, confusion, orthostatic hypotension, and anticholinergic effects (e.g., dry mouth, urinary retention, constipation). Use lower initial doses and titrate slowly. Avoid in elderly patients with dementia or cognitive impairment due to increased risk of falls and delirium (BEERS criteria).

• Always check the patient's age; this product is contraindicated in children under 2 years due to the risk of fatal respiratory depression.
• Educate patients about the significant sedative effects and the importance of avoiding alcohol and other CNS depressants.
• Advise patients to avoid driving or operating machinery until they know how the medication affects them.
• Monitor for signs of anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation), especially in the elderly.
• Be aware of the potential for serotonin syndrome when co-administered with other serotonergic drugs or MAOIs (contraindicated).
• This combination is for symptomatic relief of cough and cold symptoms; it does not treat the underlying cause.

• Single-agent antihistamines (e.g., diphenhydramine, loratadine, cetirizine)
• Single-agent antitussives (e.g., dextromethorphan, benzonatate)
• Expectorants (e.g., guaifenesin)
• Nasal decongestants (e.g., pseudoephedrine, phenylephrine)
• Non-pharmacological measures (e.g., hydration, humidifiers, saline nasal sprays, honey for cough)

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 information. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.