Phenergan 12.5mg Suppositories
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use the suppository rectally, as directed. Before and after handling the suppository, wash your hands thoroughly. If the suppository is soft, you can chill it in the refrigerator or run it under cold water to firm it up. Remove the foil wrapper and insert the suppository into the rectum with gentle pressure, pointed end first. Avoid handling the suppository excessively.
Storing and Disposing of Your Medication
Store the suppositories in the refrigerator, but do not freeze them. Keep all medications in a safe and secure location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to inquire about drug take-back programs in your area.
Missing a Dose
If you take this medication on a regular schedule, take the missed dose as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Avoid alcohol and other medications that cause drowsiness, as this can increase sedation and respiratory depression.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause significant drowsiness and dizziness.
- Avoid prolonged exposure to sunlight or tanning beds, as promethazine can increase sensitivity to the sun.
- Stay hydrated to help manage dry mouth, a common side effect.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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 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 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 or irregular heartbeat
+ Excessive sweating
Severe breathing problems, including:
+ Slow, shallow, or labored 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:
Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Dry mouth
Upset stomach or vomiting
Trouble sleeping
* Stuffy nose
If you experience any of these side effects or any other unusual symptoms, contact your doctor or seek medical attention. Not all side effects are listed here, so if you have concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects
You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor is also available to provide guidance on managing side effects and answering any questions you may have.
Seek Immediate Medical Attention If You Experience:
- Severe drowsiness or dizziness
- Difficulty breathing or slow, shallow breathing
- Unusual muscle movements or stiffness (e.g., tremors, difficulty speaking, shuffling walk)
- Hallucinations or confusion
- Yellowing of the skin or eyes (jaundice)
- Unusual bleeding or bruising
- Seizures
- Severe rash or allergic reaction (swelling of face/tongue, severe dizziness)
Before Using This Medicine
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 been diagnosed with:
+ Liver problems
+ Reye's syndrome
Please note that this is not an exhaustive list of all potential interactions between this medication and other health conditions or drugs. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems you are experiencing
To ensure your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in conjunction with your other medications and health conditions.
Precautions & Cautions
Before operating a vehicle or engaging in any activity that requires 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 undergoing pregnancy testing, consult with your doctor.
If you have diabetes (high blood sugar), 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 protection against the sun.
This medication may increase the risk of seizures, particularly in individuals with a history of seizure disorders. Consult with your doctor to determine if you are at a higher risk of experiencing 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 breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe drowsiness or coma
- Severe respiratory depression (slow, shallow breathing)
- Hypotension (low blood pressure)
- Tachycardia (fast heart rate)
- Arrhythmias
- Seizures
- Dilated pupils
- Dry mouth
- Flushing
- Agitation, restlessness, or hallucinations (especially in children)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, including maintaining airway, breathing, and circulation.
Drug Interactions
Contraindicated Interactions
- MAO inhibitors (concurrent use or within 14 days of MAOI discontinuation)
- Other CNS depressants (in children < 2 years old)
Major Interactions
- 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 antidopaminergic effects may antagonize their action
- Epinephrine - promethazine may reverse the vasopressor effect of epinephrine, leading to a further decrease in blood pressure
Moderate Interactions
- Antihypertensives - additive hypotensive effects
- Metoclopramide - additive extrapyramidal symptoms
- Phenytoin - promethazine may increase phenytoin levels
- Antidiabetic agents - promethazine may mask symptoms of hypoglycemia
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To identify contraindications or potential hypersensitivity reactions.
Timing: Prior to first dose
Rationale: To assess for baseline sedation and monitor for excessive CNS depression.
Timing: Prior to first dose
Rationale: To assess for baseline respiratory function, especially important in pediatric patients.
Timing: Prior to first dose
Routine Monitoring
Frequency: Periodically, especially after initial doses or dose changes
Target: Appropriate for indication (e.g., mild sedation for sleep, alert for allergy)
Action Threshold: Excessive drowsiness, somnolence, difficulty arousing
Frequency: Periodically, especially in children and patients with respiratory compromise
Target: Age-appropriate normal range
Action Threshold: Bradypnea, shallow breathing, signs of respiratory distress
Frequency: Periodically, especially in patients prone to hypotension or with cardiovascular disease
Target: Within patient's normal range
Action Threshold: Significant hypotension, tachycardia, or bradycardia
Frequency: As reported by patient or observed
Target: Minimal to tolerable
Action Threshold: Severe or intolerable symptoms requiring intervention
Symptom Monitoring
- Excessive drowsiness
- Dizziness
- Confusion
- Difficulty breathing
- Dry mouth
- Blurred vision
- Urinary retention
- Constipation
- Restlessness
- Involuntary muscle movements (extrapyramidal symptoms)
Special Patient Groups
Pregnancy
Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data, but animal studies show some adverse effects. Use near term may cause respiratory depression or extrapyramidal symptoms in the neonate.
Trimester-Specific Risks:
Lactation
Excreted into breast milk. Use with caution. The American Academy of Pediatrics considers promethazine to be compatible with breastfeeding, but monitor infant for sedation, irritability, or poor feeding. Avoid use in preterm infants or those with respiratory issues.
Pediatric 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 of age and older, and avoid in those with a history of sleep apnea, family history of SIDS, or acute illness (e.g., asthma, pneumonia) that could compromise respiratory function. Lower doses and careful monitoring are essential.
Geriatric Use
Elderly patients are more susceptible to the anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation) and CNS effects (e.g., sedation, confusion, dizziness, orthostatic hypotension) of promethazine. Use lower initial doses and titrate carefully. Avoid in patients with dementia or cognitive impairment.
Clinical Information
Clinical Pearls
- Promethazine suppositories are useful when oral administration is not feasible due to severe nausea/vomiting.
- Due to the risk of severe respiratory depression, promethazine is contraindicated in children younger than 2 years of age.
- Exercise extreme caution when administering promethazine to pediatric patients 2 years of age and older, and avoid in those with compromised respiratory function.
- Warn patients about significant sedation and advise against driving or operating machinery.
- Advise patients to avoid alcohol and other CNS depressants due to additive effects.
- Monitor for anticholinergic side effects, especially in elderly patients.
- Promethazine can cause photosensitivity; advise patients to use sun protection.
- Rectal administration may cause local irritation.
Alternative Therapies
- For nausea/vomiting: Ondansetron, Granisetron, Dimenhydrinate, Metoclopramide
- For allergy: Diphenhydramine, Loratadine, Cetirizine, Fexofenadine
- For sedation: Diphenhydramine, Hydroxyzine, Benzodiazepines (e.g., lorazepam, midazolam)