Prometh/pe 6.25-5mg/5ml Oral Soln

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 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.

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 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): A rare but potentially life-threatening condition called NMS may occur. Seek medical help right away 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 may cause severe and potentially life-threatening breathing problems. Seek medical help right away if you experience:
+ Slow, shallow, or difficulty breathing

Low White Blood Cell Count: 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 help right away 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 and 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. This will help determine whether it is safe to take this medication with your other medications and health conditions. 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, it is advisable to avoid driving and engaging in other activities that require alertness and 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 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, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, 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 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, and certain natural products or aids, consult with your doctor. This medication may increase the risk of seizures in some individuals, including 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.

• MAO inhibitors (MAOIs) or within 14 days of MAOI therapy (due to phenylephrine, risk of hypertensive crisis)
• Other phenothiazines (additive effects)
• Concomitant use in pediatric patients < 2 years of age (due to promethazine, risk of fatal respiratory depression)

• CNS depressants (e.g., alcohol, opioids, benzodiazepines, sedatives, hypnotics, tricyclic antidepressants): Increased sedation, respiratory depression, hypotension.
• Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants): Increased anticholinergic effects (dry mouth, urinary retention, blurred vision, constipation).
• Antihypertensives (e.g., beta-blockers, ACE inhibitors): Phenylephrine may reduce the hypotensive effects.
• QT-prolonging drugs (e.g., antiarrhythmics, certain antipsychotics, macrolide antibiotics): Promethazine may prolong QT interval, increasing risk of arrhythmias.
• Dopamine agonists (e.g., bromocriptine, cabergoline): Promethazine may antagonize effects.

• Sympathomimetics (e.g., pseudoephedrine, ephedrine, stimulants): Additive cardiovascular effects (increased blood pressure, tachycardia).
• Thyroid hormones: Increased risk of cardiovascular effects with phenylephrine.
• Digoxin: Increased risk of arrhythmias with phenylephrine.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): May increase promethazine levels.
• Antacids (containing aluminum or magnesium): May decrease phenylephrine absorption.

• Not specifically identified as minor, but general caution with any drug affecting CNS or cardiovascular system.

• Excessive drowsiness or sedation
• Dizziness or lightheadedness
• Dry mouth, nose, or throat
• Blurred vision
• Difficulty urinating or urinary retention
• Constipation
• Nervousness, restlessness, or insomnia (especially with phenylephrine)
• Increased heart rate or palpitations
• Increased blood pressure
• Paradoxical excitation (agitation, hallucinations, nightmares, especially in children)
• Difficulty breathing or shallow breathing (especially in young 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 and extrapyramidal symptoms in neonates when administered close to delivery. Phenylephrine has vasoconstrictive effects that could potentially reduce uterine blood flow.

L3 (Moderate Concern). Both promethazine and phenylephrine are excreted into breast milk. Promethazine can cause drowsiness, respiratory depression, and anticholinergic effects in the infant. Phenylephrine can cause irritability, sleep disturbances, and potentially reduce milk supply. Use with caution; consider alternative agents or monitor infant closely for adverse effects.

Contraindicated in children younger than 2 years due to the risk of fatal respiratory depression (Black Box Warning for promethazine). Use with extreme caution in children 2 years and older, as they may be more susceptible to paradoxical excitation, respiratory depression, and anticholinergic effects. Not generally recommended for cough/cold symptoms in children under 6 years of age by many professional organizations.

Increased sensitivity to the sedative, anticholinergic, and hypotensive effects of promethazine. Increased risk of cardiovascular effects (hypertension, tachycardia) with phenylephrine. Use with caution, starting with lower doses and titrating slowly. Monitor for confusion, urinary retention, constipation, and falls.

• This combination product carries a Black Box Warning for fatal respiratory depression in pediatric patients younger than 2 years of age. It should never be used in this age group.
• Caution should be exercised when administering to pediatric patients 2 years of age and older, and generally, cough/cold products are not recommended for children under 6 years.
• Patients should be advised about significant drowsiness and to avoid activities requiring mental alertness (e.g., driving, operating machinery).
• Avoid concomitant use with alcohol or other CNS depressants due to additive sedative effects.
• Monitor for anticholinergic side effects such as dry mouth, blurred vision, urinary retention, and constipation, especially in elderly patients or those with pre-existing conditions like glaucoma or benign prostatic hyperplasia (BPH).
• Phenylephrine can increase blood pressure and heart rate; use with caution in patients with hypertension, heart disease, or thyroid disorders.
• Patients should be instructed to contact a healthcare provider if symptoms do not improve or worsen after a few days of use.

• Single-ingredient antihistamines (e.g., diphenhydramine, loratadine, cetirizine)
• Single-ingredient decongestants (e.g., pseudoephedrine, oxymetazoline nasal spray)
• Cough suppressants (e.g., dextromethorphan, guaifenesin)
• Saline nasal sprays or rinses for congestion
• Non-pharmacological measures for cold/allergy symptoms (e.g., humidifiers, rest, fluids)

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 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 details about the medication taken, the amount, and the time it happened.