Nifedipine 30mg ER (xl/osm) Tablets
It is used to treat some types of chest pain (angina).It is used to treat high blood pressure.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antihypertensive, Antianginal
Pharmacologic Class
Calcium Channel Blocker, Dihydropyridine
Pregnancy Category
Category C
FDA Approved
Sep 1989
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nifedipine ER is a medication used to treat high blood pressure (hypertension) and chest pain (angina). It works by relaxing blood vessels, which allows blood to flow more easily and reduces the workload on your heart. This is an extended-release tablet, meaning it releases the medicine slowly over 24 hours, so you only need to take it once a day.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your medication and follow the instructions closely. When taking your medication, swallow the tablet whole - do not chew, break, or crush it.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well. It's crucial not to stop taking your medication suddenly without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking your medication, your doctor will advise you on how to gradually discontinue it.
Some medications may need to be taken with food or on an empty stomach, while others may not have specific requirements. Consult with your pharmacist to determine the best way to take your medication.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing your medication in a bathroom. Keep all medications in a secure location, out of the reach of children and pets.
When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your medication and follow the instructions closely. When taking your medication, swallow the tablet whole - do not chew, break, or crush it.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well. It's crucial not to stop taking your medication suddenly without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking your medication, your doctor will advise you on how to gradually discontinue it.
Some medications may need to be taken with food or on an empty stomach, while others may not have specific requirements. Consult with your pharmacist to determine the best way to take your medication.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing your medication in a bathroom. Keep all medications in a secure location, out of the reach of children and pets.
When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take the tablet whole; do not crush, chew, or divide it.
- Take at approximately the same time each day.
- You may see a 'ghost tablet' (empty shell) in your stool; this is normal and means the medication has been absorbed.
- Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the amount of nifedipine in your body and lead to side effects.
- Limit alcohol consumption, as it can increase the blood pressure-lowering effect.
- Maintain a healthy diet (e.g., low sodium, low fat).
- Engage in regular physical activity as advised by your doctor.
- Manage stress.
- Quit smoking if applicable.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
30 mg or 60 mg orally once daily
Dose Range:
30 - 120 mg
Condition-Specific Dosing:
hypertension:
Initial dose 30 mg or 60 mg once daily. Titrate over 7-14 days to a maximum of 90 mg or 120 mg once daily based on patient response and tolerability.
chronicStableAngina:
Initial dose 30 mg or 60 mg once daily. Titrate over 7-14 days to a maximum of 90 mg or 120 mg once daily based on patient response and tolerability.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment typically required.
Moderate:
No dosage adjustment typically required.
Severe:
No dosage adjustment typically required, but use with caution.
Dialysis:
Nifedipine is not dialyzable. No specific adjustment needed for dialysis patients, but monitor blood pressure closely.
Hepatic Impairment:
Mild:
Initiate with caution, consider lower starting doses (e.g., 30 mg once daily) and titrate slowly.
Moderate:
Initiate with caution, consider lower starting doses (e.g., 30 mg once daily) and titrate slowly. Close monitoring for adverse effects.
Severe:
Contraindicated or use with extreme caution. Significant reduction in clearance expected. Consider alternative therapies.
Pharmacology
Mechanism of Action
Nifedipine is a dihydropyridine calcium channel blocker. It inhibits the transmembrane influx of calcium ions into cardiac muscle and smooth muscle cells. This action leads to peripheral arterial vasodilation, reducing systemic vascular resistance and blood pressure. It also causes coronary vasodilation, increasing myocardial oxygen supply. The extended-release formulation provides a sustained release of nifedipine, maintaining therapeutic plasma concentrations over 24 hours.
Pharmacokinetics
Absorption:
Bioavailability:
45-70% (due to extensive first-pass metabolism, though ER formulation can improve consistency)
Tmax:
6-12 hours (for ER formulation)
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption for the ER formulation. Can be taken with or without food.
Distribution:
Vd:
0.77 L/kg
ProteinBinding:
>90%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-5 hours (terminal half-life for immediate release, but ER provides sustained release)
Clearance:
Approximately 0.5-1 L/kg/hr
ExcretionRoute:
Renal (60-80% as inactive metabolites), Fecal (15-20%)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Gradual (hours for ER formulation)
PeakEffect:
6-12 hours (for ER formulation)
DurationOfAction:
24 hours (for ER formulation)
Safety & Warnings
Side Effects
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 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
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 that bother you or do not go away, contact your doctor:
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.
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
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 that bother you or do not go away, contact your doctor:
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.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting (signs of low blood pressure)
- Swelling of the ankles, feet, or hands that is severe or bothersome
- New or worsening chest pain
- Shortness of breath
- Unusual fatigue or weakness
- Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems)
Before Using This Medicine
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.
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 other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting 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.
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 other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
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, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.
Although rare, this medication may cause new or worsening chest pain, potentially leading to a heart attack, especially in individuals with severe heart blood vessel disease. Consult your doctor to discuss this risk.
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.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.
Although rare, this medication may cause new or worsening chest pain, potentially leading to a heart attack, especially in individuals with severe heart blood vessel disease. Consult your doctor to discuss this risk.
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.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Profound hypotension (very low blood pressure)
- Bradycardia (slow heart rate)
- Tachycardia (fast heart rate)
- Dizziness
- Fainting
- Flushing
- Hyperglycemia (high blood sugar)
- Metabolic acidosis
- Cardiogenic shock with pulmonary edema
- Loss of consciousness
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management typically involves supportive care, including intravenous fluids for hypotension, vasopressors, calcium gluconate/chloride, and potentially glucagon or high-dose insulin therapy. Activated charcoal may be considered if ingestion is recent.
Drug Interactions
Contraindicated Interactions
- Rifampin (strong CYP3A4 inducer, significantly reduces nifedipine levels)
- St. John's Wort (strong CYP3A4 inducer, significantly reduces nifedipine levels)
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nefazodone, grapefruit juice): May significantly increase nifedipine plasma concentrations, leading to increased hypotensive effects and adverse reactions.
- Beta-blockers: May cause excessive hypotension or exacerbate heart failure in susceptible patients. Close monitoring required.
- Quinidine: May decrease quinidine levels or increase nifedipine levels.
- Magnesium sulfate (parenteral): Increased risk of severe hypotension and neuromuscular blockade, especially in pre-eclampsia.
Moderate Interactions
- Cimetidine: May increase nifedipine levels.
- Digoxin: May increase digoxin levels.
- Phenytoin, Carbamazepine, Phenobarbital (CYP3A4 inducers): May decrease nifedipine levels.
- Fentanyl: Severe hypotension has been reported with concomitant use.
- Theophylline: May alter theophylline levels.
- Tacrolimus: May increase tacrolimus levels, requiring dose adjustment.
Minor Interactions
- Warfarin: No significant interaction, but monitor INR.
- Non-steroidal anti-inflammatory drugs (NSAIDs): May reduce the antihypertensive effect of nifedipine.
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation of therapy.
Heart Rate (HR)
Rationale: To establish baseline and monitor for reflex tachycardia or bradycardia.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs)
Rationale: Nifedipine is extensively metabolized by the liver; baseline assessment is important, especially in patients with suspected hepatic impairment.
Timing: Prior to initiation, especially if hepatic impairment is suspected.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially during dose titration (e.g., weekly to bi-weekly) and then periodically (e.g., every 3-6 months) once stable.
Target: <130/80 mmHg (or individualized target based on guidelines and patient comorbidities)
Action Threshold: If BP remains above target, consider dose increase or add-on therapy. If BP is too low (<90/60 mmHg or symptomatic hypotension), consider dose reduction.
Heart Rate (HR)
Frequency: Regularly, especially during dose titration and then periodically.
Target: 60-100 bpm (or individualized)
Action Threshold: If persistent tachycardia (>100 bpm) or symptomatic bradycardia (<60 bpm), investigate cause and consider dose adjustment or alternative.
Peripheral Edema
Frequency: Regularly, especially during dose titration and then periodically.
Target: Absence of significant edema
Action Threshold: If significant or bothersome peripheral edema develops, consider dose reduction, diuretic, or alternative therapy.
Symptom Monitoring
- Headache
- Dizziness
- Flushing
- Palpitations
- Peripheral edema (swelling of ankles/feet)
- Fatigue
- Nausea
- Gastrointestinal upset
- Chest pain (worsening or new onset)
- Shortness of breath
Special Patient Groups
Pregnancy
Nifedipine is Pregnancy Category C. Studies in animals have shown adverse effects on the fetus. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is sometimes used off-label for preterm labor or severe pre-eclampsia, but this should be done under strict medical supervision.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies (skeletal abnormalities, digital anomalies). Human data are limited and conflicting, but generally, first-trimester exposure is avoided if possible.
Second Trimester:
Generally considered safer than first trimester if clinically indicated for conditions like severe hypertension. Monitor for maternal hypotension and fetal well-being.
Third Trimester:
Used in some cases for severe hypertension or preterm labor. Risk of maternal hypotension and potential for decreased uteroplacental perfusion. Monitor for adverse effects in mother and fetus.
Lactation
Nifedipine is excreted into breast milk in small amounts. The American Academy of Pediatrics considers nifedipine compatible with breastfeeding. Monitor the infant for signs of adverse effects such as lethargy, poor feeding, or hypotension, though these are rare.
Infant Risk:
Low risk. Monitor for potential effects on infant blood pressure or feeding.
Pediatric Use
Safety and effectiveness of nifedipine extended-release tablets in pediatric patients have not been established. Use is generally not recommended.
Geriatric Use
Geriatric patients may be more sensitive to the hypotensive effects of nifedipine. Initiate therapy with the lowest effective dose (e.g., 30 mg once daily) and titrate slowly. Monitor closely for dizziness, orthostatic hypotension, and peripheral edema.
Clinical Information
Clinical Pearls
- Nifedipine ER (XL/OSM) utilizes an osmotic pump system, which means the tablet shell may be excreted intact in the stool ('ghost tablet'). This is normal and does not mean the medication was not absorbed.
- Always swallow the extended-release tablets whole; do not crush, chew, or break them, as this can lead to rapid release of the drug and potentially dangerous hypotension.
- Avoid grapefruit and grapefruit juice due to significant CYP3A4 interaction, which can lead to increased nifedipine levels and adverse effects.
- Peripheral edema is a common side effect, often dose-dependent. It is due to precapillary vasodilation and can sometimes be managed with diuretics or by switching to another class of antihypertensive.
- Nifedipine ER is generally preferred over immediate-release nifedipine for chronic conditions due to its smoother blood pressure control and lower risk of reflex tachycardia and acute hypotensive episodes.
Alternative Therapies
- Other dihydropyridine calcium channel blockers (e.g., amlodipine, felodipine, nicardipine ER)
- Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem)
- ACE inhibitors (e.g., lisinopril, enalapril)
- Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
- Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone)
- Beta-blockers (e.g., metoprolol, carvedilol)
- Alpha-blockers (e.g., prazosin, doxazosin)
- Direct vasodilators (e.g., hydralazine, minoxidil)
Cost & Coverage
Average Cost:
$20 - $100+ per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.