Promethazine 25mg/ml Inj 1ml Vial

Promethazine is a phenothiazine derivative that acts as a potent, competitive H1-receptor antagonist. It also possesses significant anticholinergic (muscarinic), antidopaminergic, and alpha-adrenergic blocking activity. Its antiemetic effects are thought to be due to its anticholinergic and antidopaminergic actions, particularly blocking dopamine D2 receptors in the chemoreceptor trigger zone (CTZ). Its sedative effects are due to its H1-blocking 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 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 heart rhythms, such as:
+ Fast or slow heartbeat
Neurological symptoms, including:
+ Trouble controlling body movements
+ Twitching
+ Changes in balance
+ Difficulty swallowing or speaking
+ Shakiness
+ Trouble moving around
+ Stiffness
Confusion or altered mental state
Feeling nervous or 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 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

Respiratory Problems: This medication may cause severe and potentially life-threatening breathing problems. Seek immediate medical attention if you experience:
+ Slow or shallow breathing
+ Difficulty breathing

Low White Blood Cell Count: This medication may increase the risk of infection due to a low white blood cell count. Seek immediate medical attention if you experience:
+ Fever
+ Chills
+ Sore throat

Other Side Effects

Most people do not experience severe side effects, and many may have only minor or no side effects at all. However, 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
+ Blurred vision
+ Dry mouth
+ Upset stomach or vomiting
+ Trouble sleeping
+ Stuffy nose

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:

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 you experienced, including any symptoms that occurred.
If you have a history of respiratory problems, including:
+ Asthma
+ Chronic obstructive pulmonary disease (COPD)
+ Sleep apnea (breathing difficulties during sleep)
If you have a history of liver problems or Reye's syndrome.

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

To ensure safe treatment, 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 you have or have had

Do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.

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

Before 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 shield you from 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 medication.

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

Individuals 65 years or 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, it is essential to 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 promethazine)
• Other CNS depressants (in children < 2 years due to increased risk of respiratory depression)
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics, fluoroquinolones) - theoretical risk of additive QT prolongation

• CNS depressants (opioids, benzodiazepines, barbiturates, alcohol, other antihistamines, general anesthetics): Additive CNS depression, respiratory depression, profound sedation.
• Anticholinergic drugs (e.g., tricyclic antidepressants, atropine, benztropine): Additive anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation, paralytic ileus).
• Dopamine agonists (e.g., bromocriptine, cabergoline): Promethazine's antidopaminergic effects may antagonize their therapeutic effects.
• Epinephrine: Promethazine may reverse the vasopressor effect of epinephrine, leading to a further decrease in blood pressure (paradoxical effect).

• Antihypertensives: May cause additive hypotensive effects.
• Metoclopramide: Additive risk of extrapyramidal symptoms.
• Phenytoin: Promethazine may alter phenytoin metabolism.
• QT-prolonging drugs: Theoretical additive risk of QT prolongation, though promethazine's effect is generally minor.

• Not available

• Excessive sedation or drowsiness
• Dizziness or lightheadedness
• Dry mouth
• Blurred vision
• Urinary retention
• Constipation
• Confusion or disorientation
• Restlessness or agitation (paradoxical reaction)
• Extrapyramidal symptoms (rare, e.g., dystonia, akathisia, parkinsonism)
• Signs of respiratory depression (slow, shallow breathing, cyanosis)
• Signs of tissue injury at injection site (pain, swelling, redness, blistering, necrosis)

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Promethazine has been used in pregnancy for nausea and vomiting, but data are limited. Avoid use in late third trimester due to potential for platelet aggregation inhibition in the newborn and risk of respiratory depression.

L3 (Moderately safe). Promethazine is excreted into breast milk. While generally considered compatible with breastfeeding with caution, monitor the infant for sedation, irritability, or poor feeding. Avoid use in preterm infants or those with respiratory issues. Consider alternative agents if possible, especially with prolonged use.

Contraindicated in children less than 2 years of age due to the risk of fatal respiratory depression. Use with extreme caution and at lower doses in children 2 years of age and older. Avoid concomitant use with other respiratory depressants. Risk of paradoxical excitation (restlessness, agitation) in some children.

Use with caution 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 elderly patients with dementia-related psychosis.

• Always confirm the route of administration: IM is preferred for injection due to the risk of severe tissue injury with IV extravasation. If IV, use a large, patent vein (preferably central line), dilute to 25 mg/mL, and administer slowly (no faster than 25 mg/minute). Avoid hand/wrist veins.
• Promethazine is contraindicated in children under 2 years due to the risk of fatal respiratory depression. This is a critical Black Box Warning.
• Be aware of the significant sedative and anticholinergic effects. Counsel patients to avoid driving or operating machinery and to avoid alcohol or other CNS depressants.
• Monitor for paradoxical reactions (e.g., restlessness, agitation, nightmares) which can occur, especially in pediatric patients.
• Promethazine can interfere with immunological pregnancy tests, causing false-negative or false-positive results.
• May cause photosensitivity; advise patients to use sun protection.

• For nausea/vomiting: Ondansetron, Granisetron, Metoclopramide, Dimenhydrinate, Diphenhydramine
• For allergic reactions: Diphenhydramine, Loratadine, Cetirizine, Fexofenadine
• For sedation: Diphenhydramine, Hydroxyzine, Benzodiazepines (e.g., Lorazepam, Midazolam)
• For motion sickness: Scopolamine, Dimenhydrinate

If your symptoms or health problems persist or worsen, 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 for 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 pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for guidance. Many communities have 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 to see if this applies to your prescription. 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.