Promethazine 6.25mg/5ml Syrup

Promethazine is a phenothiazine derivative that acts as a potent, competitive H1-receptor antagonist. It also possesses significant anticholinergic (muscarinic receptor blockade), sedative, antiemetic, and weak alpha-adrenergic blocking and dopamine blocking properties. Its antiemetic effect is thought to be due to central anticholinergic action and direct depression of the chemoreceptor trigger zone (CTZ). The sedative effect is due to its ability to cross the blood-brain barrier and block H1 receptors in the CNS.

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 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 symptoms, 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 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 due to low white blood cell counts. Seek medical help immediately if you experience:
+ Fever
+ Chills
+ Sore throat

Other Side Effects

While many people may not experience side effects or only have mild side effects, it is essential to be aware of the following possible side effects:
Feeling dizzy, sleepy, tired, or weak
Blurred vision
Dry mouth
Upset stomach or vomiting
Trouble sleeping
* Stuffy nose

If any of these side effects or any other symptoms bother you or do not go away, contact your doctor or seek medical attention. 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 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 a history of liver problems or Reye's syndrome.

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

To ensure your safety, please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
All your health problems

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.

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 (high blood sugar), it is crucial to monitor your blood sugar levels closely while taking this medication.

Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter drugs that may impair your reactions, consult with your doctor.

You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to sunlight, sunlamps, and tanning beds. Use protective measures such as sunscreen, clothing, and eyewear that shield you from the sun.

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 drug.

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.

• MAO inhibitors (concurrent use or within 14 days of MAOI discontinuation) - risk of increased anticholinergic effects and CNS depression.
• Other CNS depressants (e.g., opioids, benzodiazepines, alcohol) in children < 2 years due to increased risk of respiratory depression.

• CNS depressants (e.g., opioids, benzodiazepines, barbiturates, general anesthetics, tricyclic antidepressants, alcohol) - additive CNS depression, respiratory depression, profound sedation.
• Anticholinergics (e.g., atropine, scopolamine, tricyclic antidepressants) - additive 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 dopamine blocking effects may antagonize their therapeutic effects.
• Epinephrine - promethazine may reverse the pressor effect of epinephrine, leading to hypotension.

• Antihypertensives - additive hypotensive effects.
• Cholinesterase inhibitors (e.g., donepezil) - promethazine's anticholinergic effects may antagonize their therapeutic effects.
• Metoclopramide - additive risk of extrapyramidal symptoms.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - may increase promethazine levels, though clinical significance is often minor due to multiple metabolic pathways.

• Herbal supplements with sedative properties (e.g., valerian, kava, chamomile) - additive sedation.

• Excessive drowsiness or sedation
• Difficulty breathing or shallow breathing
• Confusion or disorientation
• Hallucinations
• Seizures
• Unusual muscle movements (dystonia, akathisia)
• Blurred vision
• Dry mouth
• Difficulty urinating
• Constipation
• Dizziness or lightheadedness upon standing
• Skin rash or itching

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Promethazine has been used for nausea and vomiting of pregnancy, but data are limited and conflicting regarding safety. Avoid use near term due to potential for neonatal effects (e.g., irritability, tremors, respiratory depression).

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 infants for drowsiness, poor feeding, and respiratory issues. Avoid use in preterm or jaundiced infants.

Contraindicated in children less than 2 years of age due to the risk of fatal respiratory depression. Use with extreme caution and at the lowest effective dose in children 2 years of age and older. Avoid concomitant use with other respiratory depressants. Children are more susceptible to extrapyramidal reactions and paradoxical excitation.

Use with caution in elderly patients. They are more susceptible to anticholinergic effects (e.g., confusion, urinary retention, constipation), sedation, and orthostatic hypotension. Start with lower doses and titrate slowly. Avoid in patients with dementia-related psychosis due to increased mortality risk with antipsychotics (though promethazine is not a typical antipsychotic, it has some similar properties).

• Promethazine syrup has a bitter taste; it can be mixed with fruit juice or water to mask the taste.
• Due to its sedative effects, it's often preferred for nighttime use for allergic symptoms or as a sleep aid.
• Always confirm patient age before prescribing, especially for pediatric patients, due to the Black Box Warning for those under 2 years.
• Counsel patients on the risk of drowsiness and to avoid activities requiring mental alertness.
• Advise patients about anticholinergic side effects and strategies to manage them (e.g., sugar-free candy for dry mouth).
• Promethazine can cause photosensitivity; advise patients to use sunscreen and protective clothing.
• Avoid subcutaneous or intra-arterial administration due to severe tissue injury risk (though this applies more to injectable forms, it highlights the drug's irritant nature).

• For Allergic Conditions: Other H1-antihistamines (e.g., diphenhydramine, cetirizine, loratadine, fexofenadine)
• For Motion Sickness: Dimenhydrinate, scopolamine (transdermal patch)
• For Nausea/Vomiting: Ondansetron, metoclopramide, prochlorperazine
• For Sedation/Insomnia: Diphenhydramine, doxylamine, zolpidem (prescription)
• For Cough: Dextromethorphan, guaifenesin, codeine (alone or in other combinations)

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.