Promethazine DM Oral Solution

Promethazine is a phenothiazine derivative that acts as a potent H1-receptor antagonist, blocking the effects of histamine. It also possesses significant anticholinergic, sedative, antiemetic, and mild local anesthetic properties. Dextromethorphan is a non-opioid antitussive that acts centrally on the cough center in the medulla to elevate the cough threshold. Its mechanism is thought to involve agonism at sigma-1 receptors and antagonism at NMDA receptors. It also has weak serotonin reuptake inhibition properties.

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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Fainting or changes in vision
Abnormal heart rhythms, such as a fast or slow heartbeat
Urination problems
Difficulty controlling body movements, twitching, or changes in balance
Trouble swallowing or speaking
Shakiness or tremors
Hallucinations (seeing or hearing things that are not there)
Mood changes
Ringing in the ears (tinnitus)
Seizures
Unexplained bruising or bleeding
Changes in vision
Feeling nervous, excitable, or restless
Sleep disturbances
Yellowing of the skin or eyes (jaundice)

Neuroleptic Malignant Syndrome (NMS): A Rare but Serious Condition

NMS is a potentially life-threatening condition that may occur with this medication. Seek immediate medical attention if you experience any of the following symptoms:
Fever
Muscle cramps or stiffness
Dizziness
Severe headache
Confusion or changes in thinking
Fast or irregular heartbeat
Excessive sweating

Respiratory Problems: A Rare but Serious Side Effect

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: A Rare but Serious Side Effect

This medication may 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 attention if you experience:
Fever
Chills
Sore throat

Other Side Effects

Most people do not experience significant 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 resolve:
Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Upset stomach or vomiting

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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Respiratory health issues, including:
+ Asthma
+ Chronic obstructive pulmonary disease (COPD)
+ Sleep apnea (breathing difficulties during sleep)
+ Coughs that produce excessive mucus
+ Long-term coughs caused by smoking or exposure to smoke
+ Lung conditions like emphysema
Recent use of certain 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)
Concurrent use of:
+ Linezolid
+ Methylene blue

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. Your doctor and pharmacist need this information to assess potential interactions and ensure safe treatment. Never start, stop, or adjust the dosage of any medication without 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, exercise caution when engaging in activities that require alertness, such as driving. 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, 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, and consult your doctor if you have any concerns.

Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications 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 recommended to avoid direct sunlight, sunlamps, and tanning beds, and to use protective measures such as sunscreen, clothing, and eyewear.

This medication may increase the risk of seizures in certain individuals, particularly those with a history of seizures. Consult your doctor to assess your personal risk. 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 discuss your pregnancy status or plans with your doctor, as well as any breastfeeding intentions, to carefully weigh the benefits and risks of taking this medication to both you and your baby.

• MAO inhibitors (concurrent use or within 14 days of stopping MAOIs due to risk of serotonin syndrome with dextromethorphan and prolonged/intensified anticholinergic/CNS depressant effects with promethazine)
• Other CNS depressants (e.g., opioids, benzodiazepines, barbiturates, alcohol) in children < 2 years due to risk of fatal respiratory depression with promethazine

• Other CNS depressants (e.g., alcohol, opioids, benzodiazepines, sedatives, hypnotics, tricyclic antidepressants, general anesthetics): Increased CNS depression, respiratory depression, profound sedation.
• Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants, some antipsychotics): Increased anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation, paralytic ileus).
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, amiodarone, celecoxib): Can significantly increase dextromethorphan levels, leading to increased adverse effects (serotonin syndrome risk, CNS effects).
• Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, linezolid, tramadol, St. John's Wort): Increased risk of serotonin syndrome with dextromethorphan.
• Epinephrine: Promethazine may reverse the vasopressor effect of epinephrine, leading to a further decrease in blood pressure.

• Antihypertensives: May enhance hypotensive effects.
• Dopamine agonists (e.g., bromocriptine, cabergoline): Promethazine's dopamine blocking effects may antagonize their action.
• Phenytoin: Promethazine may alter phenytoin metabolism.
• Metoclopramide: Additive CNS depression.

• Antacids: May reduce absorption of promethazine (separate administration).
• Charcoal: May reduce absorption.

• Excessive drowsiness or sedation
• Dizziness or lightheadedness
• Difficulty breathing or shallow breathing
• Confusion or disorientation
• Hallucinations (especially with overdose or high doses of dextromethorphan)
• Dry mouth, blurred vision, urinary retention, constipation
• Rash or allergic reaction

Use during pregnancy should be avoided unless the potential benefits outweigh the potential risks to the fetus. Promethazine is Category C, and Dextromethorphan is Category C. Promethazine has been associated with potential for respiratory depression and extrapyramidal symptoms in neonates when administered to the mother close to delivery.

Not recommended during breastfeeding. Both promethazine and dextromethorphan (and its active metabolite dextrorphan) are excreted into breast milk. Promethazine can cause sedation, respiratory depression, and anticholinergic effects in the infant. Dextromethorphan's effects on infants are less clear but potential for CNS effects exists.

Contraindicated in children younger than 2 years due to the risk of fatal respiratory depression with promethazine. Use with extreme caution and at reduced doses in children 2 years and older. Not recommended for children 2 to < 6 years due to safety concerns. Always use an age-appropriate formulation and dose. Over-the-counter cough and cold products are generally not recommended for children under 6 years.

Elderly patients are more susceptible to the sedative, anticholinergic, and hypotensive effects of promethazine. Use with caution, starting with lower doses and titrating slowly. Monitor closely for confusion, urinary retention, constipation, and falls. Dextromethorphan metabolism may be slower in some elderly individuals.

• Promethazine DM is contraindicated in children under 2 years of age due to the risk of fatal respiratory depression.
• Exercise extreme caution when prescribing to children 2 years and older; consider alternative antitussives/antihistamines first.
• Warn patients about significant sedation and impaired judgment; advise against driving or operating machinery.
• Avoid concomitant use with alcohol or other CNS depressants.
• Be aware of the potential for serotonin syndrome when co-administered with other serotonergic drugs, especially due to dextromethorphan's interaction with CYP2D6 inhibitors.
• Monitor for anticholinergic side effects, particularly in elderly patients or those with pre-existing conditions like glaucoma or prostatic hypertrophy.

• Single-agent antitussives (e.g., Dextromethorphan, Guaifenesin)
• Single-agent antihistamines (e.g., Diphenhydramine, Chlorpheniramine, Loratadine, Fexofenadine)
• Nasal decongestants (e.g., Pseudoephedrine, Phenylephrine)
• Non-pharmacological measures (e.g., humidifiers, saline nasal sprays, honey for cough)

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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.