Promethazine 12.5mg Tablets

Promethazine is a phenothiazine derivative that acts as a potent, first-generation H1-receptor antagonist. It competitively blocks histamine at H1 receptors, thereby preventing the effects of histamine on capillaries, bronchi, and GI smooth muscle. Its antiemetic effects are thought to be due to antagonism of dopamine D2 receptors in the chemoreceptor trigger zone (CTZ). It also possesses significant anticholinergic, sedative, and alpha-adrenergic blocking 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 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 potentially life-threatening condition, characterized by:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast heartbeat
+ Abnormal heartbeat
+ Excessive sweating
Severe breathing problems, including:
+ Slow, shallow, or troubled breathing
Low white blood cell counts, which may increase the risk of infection, characterized by:
+ Fever
+ Chills
+ Sore throat

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it is 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. Remember, this is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.

Reporting Side Effects

You can report any side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.

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 liver problems or a history of Reye's syndrome.

Please note that this is not an exhaustive list of all potential interactions between this medication and other health issues. Therefore, it is crucial to discuss all of your:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication and your individual health profile.

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 any activity that requires 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.

Before 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.

• MAO inhibitors (concurrent use or within 14 days of promethazine)
• Other drugs causing respiratory depression in children < 2 years

• CNS depressants (e.g., opioids, benzodiazepines, barbiturates, alcohol, tricyclic antidepressants, other antihistamines): Increased sedation, respiratory depression, hypotension.
• Anticholinergics (e.g., atropine, TCAs, benztropine): Increased anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation).
• QT-prolonging drugs (e.g., antiarrhythmics, certain antipsychotics, macrolide antibiotics): Increased risk of QT prolongation and torsades de pointes.
• Dopamine agonists (e.g., bromocriptine, cabergoline): Promethazine's antidopaminergic effects may antagonize their therapeutic effects.
• 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 risk of extrapyramidal symptoms (EPS).

• Not available (most interactions are moderate to major due to broad pharmacological effects)

• Excessive drowsiness
• Dizziness
• Blurred vision
• Dry mouth
• Urinary retention
• Constipation
• Confusion
• Disorientation
• Restlessness
• Agitation
• Extrapyramidal symptoms (rare, e.g., dystonia, akathisia, parkinsonism)
• Hypotension
• Tachycardia
• Respiratory depression

Category C. Promethazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Use in the third trimester may cause respiratory depression or withdrawal symptoms in the neonate.

L3 (Moderately safe). Promethazine is excreted into breast milk. Due to the potential for sedation, respiratory depression, and anticholinergic effects in the infant, use with caution. Monitor the infant for drowsiness, poor feeding, and respiratory issues. Avoid use in preterm or jaundiced infants.

Contraindicated in children younger than 2 years due to the risk of fatal respiratory depression. Use with extreme caution in children 2 years and older, using the lowest effective dose and avoiding concomitant use with other respiratory depressants. Children may be more susceptible to anticholinergic effects and paradoxical excitation.

Elderly patients are more susceptible to the sedative, hypotensive, and anticholinergic effects of promethazine. Use the lowest effective dose and monitor closely for confusion, dizziness, urinary retention, and constipation. Avoid in elderly patients with dementia-related psychosis due to increased mortality risk with antipsychotics (though promethazine is not an antipsychotic, it has similar properties). Consider Beers Criteria.

• Promethazine is a potent sedative; warn patients about impaired ability to drive or operate machinery.
• Due to its anticholinergic properties, it can worsen conditions like glaucoma, prostatic hypertrophy, and urinary retention.
• Avoid in children under 2 years due to severe respiratory depression risk (Black Box Warning).
• Oral route is preferred for safety; IV administration carries significant risk of tissue injury and is generally discouraged.
• Can cause paradoxical excitation (restlessness, agitation) in some children and elderly patients.
• May interfere with immunological pregnancy tests, causing false-negative or false-positive results.

• For allergies: Loratadine, Cetirizine, Fexofenadine (non-sedating antihistamines); Diphenhydramine (sedating antihistamine)
• For nausea/vomiting: Ondansetron, Metoclopramide, Prochlorperazine
• For sedation: Diphenhydramine, Hydroxyzine, Benzodiazepines (e.g., lorazepam)
• For motion sickness: Dimenhydrinate, Meclizine, Scopolamine (transdermal patch)

If your symptoms or health issues persist or worsen, it is 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 it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, do not 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 seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.