Phenergan 50mg/ml Inj, 1ml

Promethazine is a phenothiazine derivative that acts as a potent, competitive H1-receptor antagonist. It also possesses significant anticholinergic, sedative, antiemetic, and weak dopamine receptor blocking (D2) properties. Its antiemetic effect is thought to be due to central anticholinergic action and direct inhibition of the chemoreceptor trigger zone (CTZ).

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
+ Dizziness
+ Passing out
+ Changes in eyesight
Abnormal heartbeat (fast or slow)
Trouble controlling body movements, twitching, or changes in balance
Difficulty swallowing or speaking
Shakiness, trouble moving around, or stiffness
Feeling confused
Feeling nervous and excitable
Hallucinations (seeing or hearing things that are not there)
Mood changes
Ringing in the ears
Seizures
Unexplained bruising or bleeding
Yellowing of the skin or eyes
Changes in eyesight
Neuroleptic malignant syndrome (NMS), a rare but potentially life-threatening condition, characterized by:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast heartbeat
+ Abnormal heartbeat
+ Excessive sweating
Severe breathing problems, including:
+ Slow, shallow, or troubled breathing
Low white blood cell counts, which may increase the risk of infection; seek medical help if you experience:
+ Fever
+ Chills
+ Sore throat

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:

Feeling dizzy, sleepy, tired, or weak
Blurred vision
Dry mouth
Upset stomach or vomiting
Trouble sleeping
Stuffy nose

If any of these side effects or other concerns bother you or persist, contact your doctor or seek medical attention. Remember to report any side effects to your doctor or the FDA (1-800-332-1088 or 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 and its symptoms.
Certain health conditions, including:
+ Respiratory problems like asthma, chronic obstructive pulmonary disease (COPD), or sleep apnea (breathing difficulties during sleep).
+ Liver problems or a history of Reye's syndrome.

This list is not exhaustive, and it is crucial to discuss all your health concerns with your doctor.

To ensure safe treatment, please 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.

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness and clear vision, such as driving, wait until you understand how this drug affects you.

This medication may interfere with the accuracy of certain pregnancy tests. If you are pregnant or suspect you may be pregnant, consult your doctor to discuss the potential implications.

If you have diabetes, it is crucial to closely monitor your blood sugar levels while taking this medication. Additionally, before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter drugs that may cause drowsiness, consult your doctor to discuss potential interactions.

You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use protective measures such as sunscreen, clothing, and eyewear that provide adequate protection against the sun.

This medication may increase the risk of seizures, particularly in individuals with a history of seizure disorders. Consult your doctor to determine if you are at a higher risk of experiencing seizures while taking this drug.

If you have a sulfite allergy, inform your doctor, as some formulations of this medication may contain sulfites.

Older adults (65 years and older) should exercise caution when taking this medication, as they may be more prone to experiencing side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.

• MAO inhibitors (concurrent use or within 14 days of MAOI discontinuation)
• Other CNS depressants (e.g., opioids, barbiturates, benzodiazepines) in pediatric patients < 2 years

• CNS depressants (e.g., opioids, benzodiazepines, barbiturates, alcohol, tricyclic antidepressants, general anesthetics) - increased sedation, respiratory depression, hypotension
• Anticholinergic drugs (e.g., atropine, TCAs, other antihistamines) - increased anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation)
• Dopamine agonists (e.g., bromocriptine, cabergoline) - promethazine's dopamine blocking effects may antagonize their effects
• QT-prolonging drugs (e.g., antiarrhythmics, some antipsychotics, macrolide antibiotics) - theoretical risk of additive QT prolongation
• Epinephrine (paradoxical fall in blood pressure with promethazine in overdose)

• Antihypertensives - additive hypotensive effects
• Cholinesterase inhibitors (e.g., donepezil) - promethazine's anticholinergic effects may antagonize their effects
• Metoclopramide - additive risk of extrapyramidal symptoms
• Phenytoin - promethazine may alter phenytoin metabolism

• Not available

• Excessive sedation
• Respiratory depression (slow, shallow breathing)
• Dizziness
• Confusion
• Dry mouth
• Blurred vision
• Urinary retention
• Constipation
• Extrapyramidal symptoms (rare: dystonia, akathisia, parkinsonism)
• Neuroleptic Malignant Syndrome (rare: fever, muscle rigidity, altered mental status, autonomic instability)
• Injection site pain, burning, swelling, redness, blistering, tissue necrosis (especially with IV administration)

Promethazine is Pregnancy Category C. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Limited human data suggest no increased risk of major birth defects, but some studies suggest a possible association with congenital malformations when used in the first trimester. Use near term may cause respiratory depression or extrapyramidal symptoms in the neonate.

Promethazine is excreted into breast milk. The American Academy of Pediatrics considers it to be of 'concern' due to potential for sedation and anticholinergic effects in the infant. Use with caution, monitor infant for drowsiness, irritability, or poor feeding. Avoid in preterm or jaundiced infants.

Contraindicated in patients less than 2 years of age due to the risk of fatal respiratory depression. Use with extreme caution in pediatric patients 2 years of age and older; use the lowest effective dose and avoid concomitant use of other respiratory depressants. Risk of extrapyramidal symptoms and paradoxical excitation (restlessness, agitation) is higher in pediatric patients.

Use with caution in elderly patients due to increased susceptibility to anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation), sedation, dizziness, and hypotension. Start with lower doses and titrate slowly. Increased risk of falls. May exacerbate underlying conditions like glaucoma or prostatic hypertrophy.

• **Black Box Warning:** Absolutely contraindicated in children < 2 years due to fatal respiratory depression. Use extreme caution in children ≥ 2 years.
• **IV Administration:** The preferred route is deep IM injection. IV administration carries a black box warning for severe tissue injury (gangrene, necrosis) due to extravasation or intra-arterial injection. If IV is necessary, use a large, patent vein, dilute to ≤ 25 mg/mL, administer slowly (no faster than 25 mg/min), and ensure the patient reports any pain or burning immediately.
• **Sedation:** Promethazine is a potent sedative. Warn patients about impaired ability to drive or operate machinery. Avoid concomitant use with alcohol or other CNS depressants.
• **Anticholinergic Effects:** Be mindful of anticholinergic side effects, especially in elderly patients or those with pre-existing conditions like glaucoma, BPH, or bowel obstruction.
• **Extrapyramidal Symptoms (EPS):** While less common than with typical antipsychotics, promethazine can cause EPS, especially at higher doses or in susceptible individuals (e.g., children).
• **Photosensitivity:** Advise patients to use sun protection as promethazine can cause photosensitivity.

• For nausea/vomiting: Ondansetron, Metoclopramide, Prochlorperazine, Dimenhydrinate
• For allergic reactions: Diphenhydramine, Hydroxyzine, Cetirizine, Loratadine
• For sedation: Diphenhydramine, Hydroxyzine, Benzodiazepines (e.g., Lorazepam, Midazolam)
• For adjunct to analgesia: Hydroxyzine

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.