Diltiazem 125mg/25ml Inj, 25ml

Diltiazem is a non-dihydropyridine calcium channel blocker. It inhibits the influx of extracellular calcium ions across the myocardial and vascular smooth muscle cell membranes through voltage-dependent L-type calcium channels. In the heart, this leads to decreased sinoatrial (SA) and atrioventricular (AV) nodal conduction, resulting in a negative chronotropic (decreased heart rate) and negative dromotropic (decreased AV conduction velocity) effect. In vascular smooth muscle, it causes peripheral and coronary vasodilation, leading to decreased systemic vascular resistance and blood pressure.

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 liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe dizziness or fainting
Slow heartbeat
New or worsening abnormal heartbeat
Worsening heart failure (if you have a history of heart failure, discuss this with your doctor). Seek immediate medical attention if you experience:
+ Shortness of breath
+ Significant weight gain
+ Swelling in the arms or legs
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions (sometimes fatal). Seek medical help immediately if you notice:
+ Red, swollen, blistered, or peeling skin
+ Other skin irritation (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes

Other Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Irritation at the injection site

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 symptoms you experienced.
Certain types of abnormal heart rhythms, as this medication is not suitable for individuals with specific heart rhythm disorders. If you are unsure, consult your doctor or pharmacist for guidance.
Existing health conditions, including:
+ Fluid accumulation in the lungs
+ Low blood pressure
+ Recent heart attack
Current medications, particularly:
+ Ivabradine
+ Rifampin

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist to ensure safe use. Before starting, stopping, or modifying the dosage of any medication, including this one, always consult 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.

When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.

As directed by your doctor, regularly monitor your blood pressure and heart rate. You may need to undergo an electrocardiogram (ECG) before initiating treatment and periodically while taking this medication. Discuss any concerns or questions with your doctor.

If you have high blood pressure, consult your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor. Additionally, talk to your doctor before consuming alcohol while taking this medication.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.

• Ivabradine (risk of severe bradycardia)
• Dantrolene (IV) (risk of cardiovascular collapse)
• Patients with sick sinus syndrome (without a pacemaker)
• Second- or third-degree AV block (without a pacemaker)
• Severe hypotension (systolic BP < 90 mmHg)
• Cardiogenic shock
• Acute myocardial infarction and pulmonary congestion (documented by X-ray or clinical signs)
• Wolff-Parkinson-White (WPW) syndrome or short PR syndrome associated with atrial fibrillation or flutter (risk of increased ventricular response)

• Beta-blockers (e.g., metoprolol, propranolol): Increased risk of bradycardia, AV block, and hypotension.
• Digoxin: Increased digoxin levels, leading to increased risk of toxicity (bradycardia, arrhythmias).
• Amiodarone: Increased risk of bradycardia, AV block, and hypotension.
• Statins (e.g., simvastatin, lovastatin, atorvastatin): Increased statin levels due to CYP3A4 inhibition, leading to increased risk of myopathy/rhabdomyolysis.
• Fentanyl: Increased fentanyl levels, leading to increased respiratory depression.
• Midazolam, Triazolam: Increased benzodiazepine levels, leading to increased sedation.
• Clonidine: Increased risk of bradycardia and AV block.
• Quinidine, Procainamide: Increased risk of QT prolongation and arrhythmias.

• Alpha-blockers (e.g., prazosin): Increased risk of hypotension.
• Other antihypertensives: Additive hypotensive effects.
• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, grapefruit juice): Increased diltiazem levels.
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Decreased diltiazem levels.
• Cyclosporine, Tacrolimus, Sirolimus: Increased immunosuppressant levels.
• Theophylline: Increased theophylline levels.
• Carbamazepine: Increased carbamazepine levels.
• Phenytoin: Increased phenytoin levels.

• Cimetidine: May increase diltiazem levels slightly.
• Ranitidine: No significant interaction.

• Dizziness
• Lightheadedness
• Fatigue
• Shortness of breath
• Chest pain
• Palpitations
• Swelling in ankles/feet
• Signs of heart failure exacerbation

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Diltiazem has been shown to be teratogenic in animal studies at doses higher than human therapeutic doses. Limited human data, but no clear evidence of harm.

Diltiazem is excreted in breast milk. The American Academy of Pediatrics considers it compatible with breastfeeding, but caution is advised. Monitor the infant for bradycardia, hypotension, and sedation.

Use with extreme caution, especially in infants and young children, due to increased risk of profound hypotension and bradycardia. Dosing is not well-established, and individual titration is critical. Not recommended for neonates.

Elderly patients may be more sensitive to the hypotensive and bradycardic effects of diltiazem due to age-related decreases in renal and hepatic function, and increased sensitivity of the cardiovascular system. Start with lower doses and titrate slowly. Monitor closely for adverse effects.

• Diltiazem IV is primarily used for rapid ventricular rate control in atrial fibrillation/flutter and for conversion of PSVT.
• Always administer IV bolus slowly over 2 minutes to minimize the risk of hypotension and bradycardia.
• Continuous ECG and blood pressure monitoring are essential during and after IV administration.
• Avoid in patients with wide complex tachycardia of unknown origin, as it may worsen ventricular arrhythmias if the rhythm is ventricular tachycardia.
• Exercise extreme caution or avoid in patients with pre-existing severe left ventricular dysfunction or heart failure, as it can worsen cardiac function.
• Calcium gluconate/chloride can be used as an antidote for severe diltiazem toxicity, though its efficacy is variable.

• Beta-blockers (e.g., metoprolol, esmolol) for rate control in AF/AFL or PSVT.
• Adenosine for PSVT conversion.
• Digoxin for rate control in AF/AFL (slower onset).
• Amiodarone for rate/rhythm control in AF/AFL (slower onset, more side effects).
• Electrical cardioversion for unstable arrhythmias.

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion or exposure. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities have drug take-back programs that provide a safe and responsible way to dispose of unwanted medications.

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 your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance and support.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time it was taken, to help healthcare providers deliver appropriate care and treatment.