Promethegan 25mg Suppositories

Promethazine is a phenothiazine derivative that acts as a potent H1-receptor antagonist. It also possesses significant anticholinergic, antidopaminergic, and moderate 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.

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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Fainting or changes in vision
Abnormal heart rhythms, such as a fast or slow heartbeat
Neurological symptoms, including:
+ Difficulty controlling body movements or twitching
+ Changes in balance or coordination
+ Trouble swallowing or speaking
+ Shakiness, stiffness, or difficulty moving around
Confusion or feelings of nervousness and excitability
Hallucinations (seeing or hearing things that are not there)
Mood changes or ringing in the ears
Seizures
Unexplained bruising or bleeding
Yellowing of the skin or eyes (jaundice)
Changes in vision
Neuroleptic malignant syndrome (NMS), a rare but potentially life-threatening condition, characterized by:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness or severe headache
+ Confusion or changes in thinking
+ Fast or irregular heartbeat
+ Excessive sweating
Respiratory problems, including slow, shallow, or difficult breathing
Low white blood cell counts, which can increase the risk of infection; seek medical attention 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, or weakness
Blurred vision
Dry mouth
Upset stomach or vomiting
Difficulty sleeping
Stuffy nose

If you experience any of these side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for guidance.

Reporting Side Effects

If you have questions or concerns about side effects, you can:

Contact your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
* Submit a report 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 respiratory conditions, such as 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 that can cause liver and brain damage.

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

Before starting, stopping, or changing the dosage of any medication, including this one, you must consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all 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 medication 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 cause drowsiness, 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 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 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 necessary to discuss the potential benefits and risks of this medication to both you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation)
• Other CNS depressants in children < 2 years of age

• CNS depressants (e.g., opioids, benzodiazepines, barbiturates, alcohol, tricyclic antidepressants) - increased sedation and respiratory depression
• Anticholinergic drugs (e.g., atropine, scopolamine, other antihistamines) - 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
• Dopamine antagonists (e.g., metoclopramide, antipsychotics) - increased risk of extrapyramidal symptoms

• Antihypertensives - additive hypotensive effects
• Ototoxic drugs (e.g., aminoglycoside antibiotics, loop diuretics) - promethazine may mask symptoms of ototoxicity (tinnitus, dizziness, vertigo)
• Epinephrine - promethazine may reverse the pressor effect of epinephrine, leading to further blood pressure decrease

• Not specifically identified for minor interactions, but general caution with any drug affecting CNS or anticholinergic activity.

• Excessive drowsiness or sedation
• Difficulty breathing or shallow breathing
• Confusion or disorientation
• Hallucinations
• Unusual muscle movements or stiffness (extrapyramidal symptoms)
• Dry mouth
• Blurred vision
• Difficulty urinating
• Constipation
• Dizziness or lightheadedness (especially when standing up)
• Restlessness or agitation (paradoxical reaction)

Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data suggest no increased risk of major birth defects, but some studies suggest a possible association with congenital malformations when used in the first trimester. Use with caution, especially in the third trimester due to potential for neonatal effects (e.g., irritability, tremors).

L3 (Moderately Safe). Promethazine is excreted in breast milk. Use with caution. Monitor breastfed infant for sedation, irritability, poor feeding, or respiratory depression.

Contraindicated in children less 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. Children are more susceptible to paradoxical excitation and extrapyramidal symptoms.

Increased risk of sedation, confusion, anticholinergic effects (e.g., dry mouth, constipation, urinary retention, blurred vision), and orthostatic hypotension. Start with the lowest effective dose and titrate slowly. Avoid use in elderly patients with dementia-related psychosis.

• Promethazine suppositories are useful for patients who cannot tolerate oral medications due to severe nausea/vomiting.
• Always confirm patient's age; contraindicated in children under 2 years due to severe respiratory depression risk.
• Warn patients about significant sedation and anticholinergic side effects (dry mouth, blurred vision, urinary retention, constipation).
• Advise against driving or operating machinery while taking this medication.
• Monitor for paradoxical reactions (e.g., restlessness, agitation, nightmares) which can occur, especially in children.
• May mask symptoms of ototoxicity (e.g., tinnitus, dizziness) from other medications.

• For Nausea/Vomiting: Ondansetron (oral, ODT, IV), Metoclopramide (oral, IV), Prochlorperazine (oral, rectal, IV), Dimenhydrinate (oral, IV, rectal).
• For Allergy: Diphenhydramine (oral, IV), Cetirizine (oral), Loratadine (oral).
• For Sedation: Diphenhydramine (oral), Benzodiazepines (e.g., lorazepam, midazolam - for specific indications).

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.