Promethazine 25mg Suppositories

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 effects. Its antiemetic action is thought to be due to its effects on the chemoreceptor trigger zone (CTZ) in the medulla.

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 problems, including:
+ Trouble controlling body movements
+ Twitching
+ Changes in balance
+ Difficulty swallowing or speaking
+ Shakiness
+ Trouble moving around
+ Stiffness
Confusion or disorientation
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 medical help immediately 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 medical help immediately if you experience:
+ Slow or shallow breathing
+ Difficulty breathing

Low White Blood Cell Count: This medication may increase the risk of infection. Seek medical help immediately if you experience:
+ Fever
+ Chills
+ Sore throat

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical help 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 and its symptoms.
Certain health conditions, including:
+ Respiratory problems, such as 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 problems with your doctor.

Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking.
Any natural products, vitamins, or supplements you are using.
All your health problems, as this information is necessary to ensure safe treatment.

Remember, before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so in relation to 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 engaging in activities that require alertness or clear vision, such as driving, wait until you understand how this drug affects you.

Be aware that this medication may interfere with the accuracy of certain pregnancy tests. If you are concerned about this, discuss it with your doctor.

If you have diabetes (high blood sugar), 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 drugs that may cause drowsiness, consult 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 sunscreen and wear protective clothing and eyewear when going outside.

This drug may increase the risk of seizures, particularly in individuals who have a history of seizure disorders. Discuss your individual risk with your doctor to determine if you are more likely to experience seizures while taking this medication.

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

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is necessary 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 promethazine)
• Other CNS depressants (in children < 2 years)

• Other CNS depressants (e.g., opioids, benzodiazepines, alcohol, barbiturates, tricyclic antidepressants) - increased sedation and respiratory depression
• Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants) - increased 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 weak dopamine blocking effects may antagonize their action
• Epinephrine - promethazine may reverse the vasopressor effect of epinephrine, leading to a further decrease in blood pressure

• Antihypertensives - additive hypotensive effects
• Anticonvulsants - may lower seizure threshold
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - may increase promethazine levels
• Cholinesterase inhibitors (e.g., donepezil) - anticholinergic effects may antagonize their action

• Not available

• Excessive drowsiness or sedation
• Dizziness or lightheadedness
• Blurred vision
• Dry mouth
• Difficulty urinating
• Constipation
• Restlessness or agitation (paradoxical reaction, especially in children)
• Involuntary muscle movements (extrapyramidal symptoms, rare)
• Signs of respiratory depression (slow, shallow breathing, cyanosis)

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 adequate and well-controlled studies are lacking. May cause respiratory depression in neonates if used close to delivery.

L3 (Moderately safe). Promethazine is excreted into breast milk. While generally considered compatible with breastfeeding for short-term use, monitor the infant for sedation, irritability, or poor feeding. Avoid prolonged or high-dose use.

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, and only when clearly indicated. May cause paradoxical excitation (restlessness, agitation) in some children. Lower seizure threshold.

Increased sensitivity to anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation) and sedative effects (dizziness, confusion, falls). Use lower initial doses and titrate carefully. Avoid in elderly patients with dementia-related psychosis due to increased mortality risk (though promethazine is not an antipsychotic, it has some dopamine blocking effects).

• Promethazine suppositories are useful when oral administration is not feasible due to severe nausea/vomiting or patient inability to swallow.
• Always confirm the patient's age before administering promethazine, especially in pediatric patients, due to the Black Box Warning for children under 2 years.
• Advise patients about significant sedation and anticholinergic side effects. Warn against driving or operating machinery.
• Due to the risk of severe tissue injury, ensure proper administration technique for suppositories and avoid other routes if possible.
• Consider alternative antiemetics or antihistamines in patients where promethazine's sedative or anticholinergic effects are undesirable or contraindicated.

• For nausea/vomiting: Ondansetron, Metoclopramide, Prochlorperazine, Dimenhydrinate
• For allergies: Diphenhydramine, Loratadine, Cetirizine, Fexofenadine
• For sedation: Diphenhydramine, Hydroxyzine, Benzodiazepines (for short-term use)

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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.