Promethazine 50mg Suppositories

Promethazine is a phenothiazine derivative that acts as a potent, competitive H1-receptor antagonist, blocking the effects of histamine. It also possesses significant anticholinergic (muscarinic), antidopaminergic, and weak alpha-adrenergic blocking activity. Its antiemetic effects are thought to be due to its anticholinergic and central nervous system depressant effects, including antagonism of D2 dopamine receptors in the chemoreceptor trigger zone (CTZ). Its sedative effects are due to its ability to cross the blood-brain barrier and block H1 receptors in the brain.

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 experience 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 or 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 or 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 potentially life-threatening condition, characterized by:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast heartbeat or irregular heartbeat
+ Excessive sweating
Severe breathing problems, including:
+ Slow, shallow, or difficulty breathing
Low white blood cell counts, which may increase the risk of infection, characterized by:
+ Fever
+ Chills
+ Sore throat

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. 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

This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
If you have respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), or sleep apnea, which involves breathing difficulties during sleep.
If you have a history of liver problems or Reye's syndrome, a rare but serious condition.

Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Discuss your health problems with your doctor to verify that it is safe to take this medication in conjunction with your other medications and health conditions.
Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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.

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

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 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 spending time outdoors.

This medication may increase the risk of seizures, particularly in individuals with 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, use 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, inform your doctor. It is essential 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 (e.g., opioids, barbiturates, benzodiazepines) in children < 2 years old due to risk of respiratory depression.

• CNS depressants (e.g., opioids, benzodiazepines, barbiturates, tricyclic antidepressants, alcohol): Increased sedation, respiratory depression, hypotension.
• Anticholinergics (e.g., atropine, scopolamine, TCAs, some antipsychotics): Increased anticholinergic side effects (dry mouth, blurred vision, urinary retention, constipation).
• Dopamine agonists (e.g., bromocriptine, cabergoline): Promethazine's antidopaminergic effects may antagonize their therapeutic effects.
• QT-prolonging drugs (e.g., antiarrhythmics, some antipsychotics, macrolide antibiotics): Potential for additive QT prolongation, though promethazine's effect is generally minor.
• Epinephrine: Promethazine may reverse the pressor effect of epinephrine, leading to further blood pressure decrease.

• Antihypertensives: Additive hypotensive effects.
• Cholinergic inhibitors (e.g., donepezil, rivastigmine): Promethazine's anticholinergic effects may reduce their efficacy.
• Metoclopramide: Additive CNS depression and extrapyramidal symptoms.
• Phenytoin: Promethazine may alter phenytoin metabolism.

• Not specifically categorized as minor, but general caution with any drug that causes sedation or anticholinergic effects.

• Excessive sedation
• Difficulty breathing or shallow breathing
• Dizziness or lightheadedness (especially when standing)
• Blurred vision
• Dry mouth
• Difficulty urinating
• Constipation
• Involuntary muscle movements (extrapyramidal symptoms)
• Confusion or disorientation
• Hallucinations
• Seizures

Use during pregnancy should be avoided unless the potential benefits outweigh the potential risks to the fetus. Promethazine has been associated with a potential for increased risk of extrapyramidal symptoms in neonates when used late in pregnancy.

Promethazine is excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants (e.g., sedation, respiratory depression, paradoxical excitation), use is generally not recommended. If use is necessary, monitor infant closely for sedation or irritability.

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 of age and older; use the lowest effective dose and avoid concomitant use of other respiratory depressants. May cause paradoxical excitation in some children.

Elderly patients are more susceptible to the anticholinergic effects (e.g., confusion, urinary retention, constipation, dry mouth, blurred vision) and sedative effects of promethazine. Use with caution, starting with lower doses and titrating slowly. Increased risk of falls due to sedation and orthostatic hypotension.

• Promethazine suppositories are useful when oral administration is not feasible due to severe nausea/vomiting.
• Always confirm patient age before administering promethazine, especially in pediatric populations, due to the black box warning for children under 2 years.
• Educate patients about significant sedation and anticholinergic side effects, and advise against driving or operating machinery.
• Monitor for signs of respiratory depression, particularly in patients with underlying respiratory conditions or those receiving other CNS depressants.
• Be aware of the potential for paradoxical excitation (restlessness, agitation) in some pediatric and geriatric patients.
• Rectal absorption can be variable; if efficacy is not achieved, consider alternative antiemetics or routes of administration if appropriate.

• Ondansetron (oral, ODT, IV)
• Granisetron (oral, IV, transdermal)
• Dimenhydrinate (oral, IV, IM)
• Diphenhydramine (oral, IV, IM)
• Prochlorperazine (oral, rectal, IV, IM)
• Metoclopramide (oral, IV, IM)
• Scopolamine (transdermal patch for motion sickness)

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 your 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 occurred.