Promethazine 25mg/ml Inj 1ml Amps

Promethazine is a phenothiazine derivative that acts as a potent, competitive H1-receptor antagonist. It also possesses significant anticholinergic (muscarinic), antidopaminergic, and alpha-adrenergic blocking activity. Its antiemetic effects are thought to be due to central anticholinergic actions and direct depression of the chemoreceptor trigger zone (CTZ). Its sedative effects are due to its antihistaminic and anticholinergic properties.

Serious Side Effects: Seek Medical Help Immediately

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 right away:

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
+ 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 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 rare but potentially life-threatening condition called NMS may occur. Seek medical help immediately if you experience:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast heartbeat
+ Abnormal heartbeat
+ Excessive sweating

Respiratory Problems: This medication may cause severe and potentially life-threatening breathing problems. Seek medical help immediately if you experience:
+ Slow, shallow, or 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:
+ Signs of infection, such as:
- Fever
- Chills
- Sore throat

Other Side Effects

Most people do not experience serious side effects, and many side effects are mild and temporary. However, 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

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 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. 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
Any health problems you have

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is vital to verify that this medication is compatible 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 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 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, and use protective measures such as sunscreen, clothing, and eyewear.

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 have a sulfite allergy, inform your doctor, as some formulations of this medication may contain sulfites.

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, discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

• MAO inhibitors (concurrent use or within 14 days of promethazine)

• CNS depressants (e.g., opioids, benzodiazepines, alcohol, other sedatives): Increased sedation, respiratory depression.
• Anticholinergics (e.g., atropine, tricyclic antidepressants): 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 arrhythmias.
• 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 hypotension.

• Antihypertensives: Additive hypotensive effects.
• Anticonvulsants: May lower seizure threshold.
• Metoclopramide: Additive extrapyramidal symptoms.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): May increase promethazine levels.

• Antacids: May reduce absorption of oral promethazine (not relevant for injection).

• Excessive sedation
• Respiratory depression (slow, shallow breathing)
• Hypotension
• Dizziness
• Confusion
• Dry mouth
• Blurred vision
• Urinary retention
• Constipation
• Extrapyramidal symptoms (tremor, rigidity, dystonia, akathisia)
• Signs of tissue injury/extravasation at injection site (pain, burning, redness, swelling, blistering, necrosis)

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data; animal studies show some adverse effects. Avoid use near term due to potential for neonatal respiratory depression and extrapyramidal symptoms.

L3 (Moderately safe). Promethazine is excreted into breast milk. Potential for sedation, irritability, or paradoxical excitation in the infant. Use with caution, monitor infant for adverse effects, especially in neonates or preterm infants.

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, using the lowest effective dose. Avoid in children with signs of Reye's syndrome or other hepatic encephalopathy due to risk of hepatotoxicity.

Increased susceptibility to anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation), sedation, confusion, and orthostatic hypotension. Use lower initial doses and titrate slowly. Monitor closely for adverse effects.

• Promethazine injection should be administered via deep intramuscular (IM) injection as the preferred route due to the risk of severe tissue injury with intravenous (IV) administration.
• If IV administration is absolutely necessary, it must be done with extreme caution: use a large-bore, patent vein (preferably central line), dilute to a concentration not exceeding 25 mg/mL, and administer slowly at a rate not exceeding 25 mg/minute. Avoid extravasation at all costs.
• Never administer promethazine via intra-arterial or subcutaneous routes due to the risk of severe tissue damage, including gangrene requiring amputation.
• Contraindicated in children under 2 years of age due to the risk of fatal respiratory depression.
• Patients should be monitored closely for respiratory depression, especially when co-administered with other CNS depressants.
• Be aware of significant anticholinergic side effects, particularly in elderly patients.
• May cause false-positive or false-negative pregnancy tests and interfere with glucose tolerance tests.

• For nausea/vomiting: Ondansetron, Metoclopramide, Prochlorperazine, Dimenhydrinate.
• For allergic reactions: Diphenhydramine, Hydroxyzine, Cetirizine, Loratadine.
• For sedation: Diphenhydramine, Hydroxyzine, Benzodiazepines (e.g., Lorazepam, Midazolam).

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.

All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or the medication's packaging. If you are unsure about the proper disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices and inform you about potential drug take-back programs in your area.

Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid healthcare professionals in providing appropriate treatment.