Phenergan 25mg/ml Inj, 1ml

Promethazine is a phenothiazine derivative that acts as a potent, competitive H1-receptor antagonist. It also possesses significant anticholinergic, antidopaminergic, and weak alpha-adrenergic blocking activity. Its antiemetic effects are thought to be due to its central anticholinergic action and direct depression of the chemoreceptor trigger zone (CTZ). Its sedative effects are due to its antihistaminic and anticholinergic 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 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
+ Dizziness
+ Passing out
+ Changes in eyesight
Abnormal heartbeat (fast or slow)
Trouble controlling body movements, including:
+ Twitching
+ Changes in balance
+ Difficulty swallowing or speaking
Shakiness, difficulty moving around, or stiffness
Confusion
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 potentially life-threatening condition, which may cause:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast or irregular heartbeat
+ Excessive sweating
Severe breathing problems, including:
+ Slow or shallow breathing
+ Difficulty breathing
Low white blood cell counts, which may increase the risk of infection, including:
+ Fever
+ Chills
+ Sore throat

Other Possible Side Effects

Most people experience few or no side effects while taking this medication. However, if you notice 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
Blurred vision
Dry mouth
Upset stomach or vomiting
Trouble sleeping
Stuffy nose

Reporting Side Effects

This is not an exhaustive list of possible 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:

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 as a result of the allergy.
If you have respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), or sleep apnea, which involves breathing difficulties during sleep.
If you have liver problems or a history of Reye's syndrome, a rare but serious condition.

Please note that this list is not exhaustive, and it is crucial to discuss all your health concerns with your doctor.

To ensure safe treatment, it is vital to 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 all health problems

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so in conjunction with your other medications and health conditions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Before operating a vehicle or engaging in activities that require alertness and clear vision, wait until you understand how this medication affects you.

This drug may interfere with the accuracy of certain pregnancy tests. If you are pregnant or suspect you may be pregnant, consult your doctor.

If you have diabetes, it is crucial to closely monitor your blood sugar levels while taking this medication.

Prior to consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, discuss the potential risks with your doctor.

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 sun protection.

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 medication.

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

If you are 65 years or older, exercise caution when taking this medication, as you may be more prone to experiencing side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

• MAO inhibitors (concurrent use or within 14 days of MAOI discontinuation) - increased anticholinergic effects and CNS depression
• Other CNS depressants (e.g., opioids, barbiturates, benzodiazepines, alcohol) in children <2 years old

• CNS depressants (e.g., opioids, barbiturates, benzodiazepines, general anesthetics, tricyclic antidepressants, alcohol) - additive CNS depression, respiratory depression, profound sedation
• Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants) - additive anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation)
• QT-prolonging drugs (e.g., antiarrhythmics, certain antipsychotics, macrolide antibiotics) - theoretical risk of additive QT prolongation
• Dopamine agonists (e.g., bromocriptine, cabergoline) - promethazine's antidopaminergic effects may antagonize their action
• Epinephrine - promethazine may reverse the vasopressor effect of epinephrine, leading to hypotension

• Antihypertensives - additive hypotensive effects
• Cholinesterase inhibitors - antagonism of effects
• Drugs metabolized by CYP2D6 (e.g., fluoxetine, paroxetine, quinidine) - potential for altered metabolism of promethazine or co-administered drug
• Photosensitizing agents - additive photosensitivity

• Not available

• Respiratory depression (slow, shallow breathing, cyanosis)
• Excessive sedation/drowsiness
• Dizziness, lightheadedness
• Dry mouth, blurred vision, urinary retention, constipation (anticholinergic effects)
• Hypotension
• Extrapyramidal symptoms (dystonia, akathisia, parkinsonism) - rare but possible
• Neuroleptic Malignant Syndrome (NMS) - very rare but serious (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 only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. May cause respiratory depression in neonates if given close to delivery.

Promethazine is excreted into breast milk. The American Academy of Pediatrics considers it to be of 'concern' due to potential for sedation and respiratory depression in the infant. Use with caution, monitor infant for drowsiness, poor feeding, and respiratory issues. L3 (Moderately Safe).

Contraindicated in children younger than 2 years of age due to the risk of fatal respiratory depression. Use with extreme caution in children 2 years and older; use the lowest effective dose and avoid concomitant use with 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., confusion, urinary retention, constipation, dry mouth, blurred vision), sedation, and orthostatic hypotension. Start with lower doses and titrate slowly. Avoid in patients with dementia-related psychosis.

• **Black Box Warning:** Absolutely contraindicated in children <2 years due to fatal respiratory depression. Also carries a severe tissue injury warning for IV administration.
• **Preferred Route:** Deep intramuscular (IM) injection is the preferred route due to the risk of severe tissue damage (including gangrene requiring amputation) with IV administration.
• **IV Administration Precautions:** If IV administration is necessary, dilute to 25 mg/mL, administer via a large-bore, patent vein (preferably central line), at a rate not exceeding 25 mg/minute. Avoid IV push. Monitor injection site meticulously.
• **Extravasation Management:** If extravasation occurs, stop injection immediately, aspirate residual drug, infiltrate with hyaluronidase, apply warm compresses, and elevate the extremity. Consult plastic surgery if severe.
• **Anticholinergic Effects:** Be aware of significant anticholinergic side effects (dry mouth, blurred vision, urinary retention, constipation), especially in elderly patients or those on other anticholinergic medications.
• **Sedation:** Promethazine causes significant sedation. Advise patients to avoid driving or operating machinery.
• **Photosensitivity:** Patients should be advised to use sun protection as promethazine can cause photosensitivity.
• **Drug Interactions:** Potentiates CNS depressants (alcohol, opioids, benzodiazepines). Avoid concomitant use or reduce doses of other CNS depressants.

• For Nausea/Vomiting: Ondansetron (Zofran), Metoclopramide (Reglan), Prochlorperazine (Compazine), Dimenhydrinate (Dramamine)
• For Allergic Reactions: Diphenhydramine (Benadryl), Hydroxyzine (Vistaril, Atarax)
• For Sedation: Diphenhydramine, Hydroxyzine, Benzodiazepines (e.g., Midazolam, Lorazepam)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. 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 otherwise, avoid flushing medications down the toilet or pouring them down the 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, so be sure to check with your pharmacist. 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 call 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 occurred, as this will aid in prompt and effective treatment.