Nifedipine 60mg ER (cc) Tablets

Nifedipine is a dihydropyridine calcium channel blocker. It inhibits the transmembrane influx of calcium ions into cardiac muscle and vascular smooth muscle cells. This inhibition leads to relaxation of vascular smooth muscle, resulting in peripheral arterial vasodilation and reduction in peripheral vascular resistance, which lowers blood pressure. In the heart, it reduces myocardial oxygen demand by decreasing afterload and, to a lesser extent, by reducing heart rate (reflex tachycardia may occur). It also dilates coronary arteries, increasing myocardial oxygen supply.

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 experience 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
Severe dizziness or fainting
New or worsening chest pain
Abnormal heartbeat
Mood changes
Shortness of breath, significant weight gain, or swelling in the arms or legs
Muscle pain or cramping
Shakiness
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Dizziness, tiredness, or weakness
Headache
Flushing
Heartburn
Upset stomach
Feeling nervous and excitable
For some brands, you may notice the tablet shell in your stool, which is normal and not a cause for concern

Reporting Side Effects

If you have questions or concerns about side effects, talk to 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.
If you have been diagnosed with intolerance to certain sugars, including lactose, glucose, or galactose. Some formulations of this medication may contain lactose.
If you have recently had a heart attack.
If you are taking any medications, including prescription and over-the-counter (OTC) drugs, natural products, or vitamins, that may interact with this medication. Specifically, certain medications used to treat HIV, infections, seizures, and other conditions should not be taken with this drug. However, this is not an exhaustive list of interacting medications.

To ensure your safety, it is crucial to discuss all of your medications (prescription and OTC), natural products, vitamins, and health problems with your doctor and pharmacist. This will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

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, be cautious when performing tasks that require alertness, such as driving, until you understand how it affects you. To minimize the risk of dizziness or fainting, rise slowly from a seated or lying position, and exercise caution when navigating stairs.

Although rare, new or worsening chest pain can occur after initiating this medication or increasing the dose, which may increase the risk of a heart attack. This risk is particularly higher in individuals with severe heart blood vessel disease. It is crucial to discuss this with your doctor.

Regularly monitor your blood pressure as directed by your healthcare provider. Additionally, adhere to the schedule for blood work as advised by your doctor and discuss any concerns or results with them.

Avoid consuming grapefruit and grapefruit juice while taking this medication. If you have high blood pressure, consult your doctor before using over-the-counter (OTC) products that may elevate 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.

Be aware that a long-acting form of this medication has been associated with severe stomach and bowel problems, including blockage and ulcers, which may require hospitalization. Discuss these potential risks with your doctor.

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

It is vital to inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding, as you will need to discuss the benefits and risks of this medication to both you and your baby.

• Rifampin (significant reduction in nifedipine efficacy)
• St. John's Wort (significant reduction in nifedipine efficacy)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nefazodone): May significantly increase nifedipine levels, leading to hypotension, bradycardia, or edema.
• Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, phenobarbital): May significantly decrease nifedipine levels, leading to loss of efficacy.
• Grapefruit juice: May increase nifedipine plasma concentrations and enhance hypotensive effects.
• Beta-blockers: Increased risk of hypotension, bradycardia, and heart failure (especially in patients with impaired ventricular function).

• Digoxin: May increase digoxin levels (monitor digoxin levels).
• Cimetidine: May increase nifedipine levels.
• Quinidine: May decrease quinidine levels.
• Fentanyl: Severe hypotension has been reported with concomitant use.
• Magnesium sulfate (parenteral): Enhanced hypotensive effects.

• Theophylline: May alter theophylline levels (monitor).

• Headache
• Dizziness
• Flushing
• Peripheral edema (swelling of ankles/feet)
• Palpitations
• Fatigue
• Gingival hyperplasia (rare, long-term)
• Chest pain (if worsening or new onset)

Nifedipine is Pregnancy Category C. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. It has been used for severe hypertension in pregnancy and preterm labor, but its use for chronic hypertension during pregnancy requires careful consideration.

Nifedipine is excreted into breast milk in small amounts. The American Academy of Pediatrics considers it compatible with breastfeeding. Monitor the infant for potential adverse effects such as lethargy, poor feeding, or bradycardia, though significant effects are unlikely with typical maternal doses.

Safety and efficacy of extended-release nifedipine have not been established in pediatric patients. Not generally recommended for routine pediatric use, especially for hypertension.

Start with lower doses and titrate slowly due to increased sensitivity to hypotensive effects and potential for reduced drug clearance. Monitor closely for dizziness, orthostatic hypotension, and peripheral edema.

• Nifedipine extended-release tablets (e.g., Adalat CC, Procardia XL) are designed for once-daily dosing and should be swallowed whole; do not crush, chew, or divide, as this can lead to rapid release of the drug and potentially severe hypotension.
• Patients may notice an intact tablet shell (ghost tablet) in their stool, which is normal and indicates the medication has been released.
• Avoid immediate-release nifedipine for acute hypertensive emergencies due to unpredictable and rapid blood pressure drops, which can lead to adverse cardiovascular events.
• Peripheral edema is a common dose-dependent side effect, often managed by adding a diuretic or switching to another class of antihypertensive.
• Gingival hyperplasia (gum overgrowth) is a rare but known side effect with long-term use; good oral hygiene is important.

• Other Dihydropyridine Calcium Channel Blockers (e.g., Amlodipine, Felodipine, Nicardipine)
• Non-Dihydropyridine Calcium Channel Blockers (e.g., Verapamil, Diltiazem)
• ACE Inhibitors (e.g., Lisinopril, Enalapril)
• Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
• Thiazide Diuretics (e.g., Hydrochlorothiazide, Chlorthalidone)
• Beta-blockers (e.g., Metoprolol, Atenolol)

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 your 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.