Nifedipine 60mg ER (xl/os) Tablets

Nifedipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into cardiac muscle and smooth muscle cells. This action leads to relaxation of vascular smooth muscle, resulting in peripheral arterial vasodilation and reduction in peripheral vascular resistance. This reduces afterload, leading to a decrease in blood pressure and myocardial oxygen demand. It also dilates coronary arteries and arterioles, increasing myocardial oxygen supply.

Serious 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 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
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, contact your doctor or seek medical attention if they bother you or persist:

Dizziness, tiredness, or weakness
Headache
Flushing
Heartburn
Upset stomach
* Feeling nervous and excitable

Note: For some brands, you may notice the tablet shell in your stool. This is a normal occurrence and not a cause for concern. If you have questions, consult your doctor.

Reporting Side Effects

This list is not exhaustive, and you may experience other 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.
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.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing treatments and health status.

Remember, do not start, stop, or change the dosage 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, get up slowly from a sitting or lying position, and exercise caution when navigating stairs.

Although rare, this medication can increase the risk of new or worsening chest pain, which may be a sign 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, follow your doctor's instructions for scheduled blood tests to ensure your safety while taking this medication.

Avoid consuming grapefruit and grapefruit juice during treatment with this medication. If you have high blood pressure, consult your doctor before taking any 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.

Be aware that a long-acting form of this medication has been associated with severe stomach and bowel problems, including blockages 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. Your doctor will help you weigh the benefits and risks of this medication for both you and your baby.

• Rifampin (strong CYP3A4 inducer, significantly reduces nifedipine levels)
• St. John's Wort (strong CYP3A4 inducer, significantly reduces nifedipine levels)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, saquinavir, nefazodone): May significantly increase nifedipine plasma concentrations, leading to increased hypotensive effects and peripheral edema.
• Grapefruit juice: Inhibits CYP3A4, significantly increases nifedipine plasma concentrations and effects. Avoid concomitant use.
• Beta-blockers: May cause excessive hypotension, bradycardia, or heart failure, especially in patients with impaired ventricular function. Monitor closely.
• Digoxin: Nifedipine may increase digoxin plasma concentrations. Monitor digoxin levels.
• Quinidine: Nifedipine may decrease quinidine levels or, rarely, increase them. Monitor quinidine levels.
• Magnesium sulfate (parenteral, in pregnancy): Increased risk of severe hypotension and neuromuscular blockade.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil): May increase nifedipine levels. Monitor for increased effects.
• Cimetidine: May increase nifedipine plasma concentrations. Monitor for increased effects.
• Phenytoin, Carbamazepine, Phenobarbital (CYP3A4 inducers): May decrease nifedipine plasma concentrations. Monitor for reduced efficacy.
• Fentanyl: Severe hypotension has been reported with concomitant use of beta-blockers and calcium channel blockers. Use with caution during surgery.
• Theophylline: Nifedipine may increase theophylline levels.

• NSAIDs: May reduce the antihypertensive effect of nifedipine.
• Alpha-blockers (e.g., prazosin): May cause additive hypotensive effects, especially orthostatic hypotension.

• Headache
• Dizziness/Lightheadedness
• Flushing
• Peripheral edema (swelling of ankles/feet)
• Palpitations
• Chest pain (worsening or new onset)
• Shortness of breath
• Gingival hyperplasia (long-term)

Nifedipine is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It has been used off-label for the management of preterm labor and severe preeclampsia/eclampsia.

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 or poor feeding, though these are rare.

Safety and efficacy have not been established in pediatric patients for routine hypertension or angina. Use is generally not recommended. Limited data exist for specific conditions, but it should be used with extreme caution and under specialist supervision.

Geriatric patients may be more sensitive to the hypotensive effects of nifedipine. Initiate therapy with the lowest effective dose and titrate slowly. Monitor blood pressure and heart rate closely. Increased risk of peripheral edema.

• Nifedipine ER tablets must be swallowed whole; crushing, chewing, or dividing them can lead to rapid release of the drug and potentially dangerous hypotension.
• The tablet shell may be excreted in the stool; this is normal and does not mean the medication was not absorbed.
• Peripheral edema (ankle swelling) is a common side effect, especially at higher doses, and is due to vasodilation rather than fluid retention. It may be managed by elevating legs or, if severe, by dose reduction or adding an ACE inhibitor/ARB.
• Avoid abrupt discontinuation, especially in patients with coronary artery disease, as it may lead to rebound angina or hypertension.
• Educate patients about the importance of avoiding grapefruit juice due to significant interaction.
• Nifedipine ER is generally preferred over immediate-release formulations for chronic conditions due to smoother blood pressure control and reduced risk of reflex tachycardia.

• 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., losartan, valsartan)
• Beta-blockers (e.g., metoprolol, carvedilol)
• Thiazide diuretics (e.g., hydrochlorothiazide)
• Other classes of antihypertensives depending on patient comorbidities and indications.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 consult with your pharmacist. 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.