Nifedipine 90mg ER (xl/osm) Tablet
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
Aug 1989
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nifedipine is a medicine used to treat high blood pressure (hypertension) and chest pain (angina). It works by relaxing blood vessels, which helps blood flow more easily and reduces the workload on your heart. This extended-release tablet is designed to release 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, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely.
When taking your medication, swallow the tablet or capsule whole. Do not chew, break, or crush it, as this can affect how the medication works.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. It's essential to take the full course of treatment as directed.
If you need to stop taking your medication, do not stop suddenly without consulting your doctor. Stopping abruptly may increase your risk of side effects. Instead, your doctor will advise you on how to gradually taper off the medication.
Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult your pharmacist for guidance on the best way to take your specific medication.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, away from direct light and moisture. Avoid storing it in a bathroom, as the humidity can affect the medication.
Keep all medications 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 instructed to do so by your pharmacist. Instead, check with your pharmacist for the best disposal method or participate in a local drug take-back program.
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 a missed dose, as this can increase your risk of side effects.
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely.
When taking your medication, swallow the tablet or capsule whole. Do not chew, break, or crush it, as this can affect how the medication works.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. It's essential to take the full course of treatment as directed.
If you need to stop taking your medication, do not stop suddenly without consulting your doctor. Stopping abruptly may increase your risk of side effects. Instead, your doctor will advise you on how to gradually taper off the medication.
Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure, consult your pharmacist for guidance on the best way to take your specific medication.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, away from direct light and moisture. Avoid storing it in a bathroom, as the humidity can affect the medication.
Keep all medications 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 instructed to do so by your pharmacist. Instead, check with your pharmacist for the best disposal method or participate in a local drug take-back program.
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 a missed dose, as this can increase your risk of side effects.
Lifestyle & Tips
- Take the tablet whole; do not crush, chew, or divide it.
- Take with or without food, but consistently with one or the other.
- Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the amount of medicine in your body and cause side effects.
- Limit alcohol consumption, as it can increase the blood pressure-lowering effect.
- Maintain a healthy diet (low in sodium, saturated fats), regular exercise, and manage stress to help control blood pressure.
- Report any swelling in your ankles or feet, dizziness, or persistent headaches to your doctor.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
30-60 mg orally once daily, titrate as needed. Maximum 90 mg once daily.
Dose Range:
30 - 90 mg
Condition-Specific Dosing:
hypertension:
Initial: 30-60 mg orally once daily. Maintenance: 30-90 mg orally once daily.
chronic stable angina:
Initial: 30-60 mg orally once daily. Maintenance: 30-90 mg orally once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for routine use; specific indications (e.g., hypertrophic cardiomyopathy, pulmonary hypertension) may use immediate-release formulations with careful titration. ER formulation generally not recommended.
Adolescent:
Not established for routine use; specific indications may use immediate-release formulations with careful titration. ER formulation generally not recommended.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment generally needed.
Moderate:
No adjustment generally needed.
Severe:
No adjustment generally needed.
Dialysis:
Not dialyzable; no supplemental dose needed.
Hepatic Impairment:
Mild:
Consider lower initial dose and careful titration.
Moderate:
Consider lower initial dose (e.g., 30 mg once daily) and careful titration. Monitor closely.
Severe:
Use with caution; consider significant dose reduction or alternative therapy. Monitor closely.
Pharmacology
Mechanism of Action
Nifedipine is a dihydropyridine calcium channel blocker. It inhibits the transmembrane influx of calcium ions into vascular smooth muscle and myocardial 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 significant first-pass metabolism)
Tmax:
2.5-5 hours (for extended-release formulation)
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption for the extended-release formulation. Grapefruit juice significantly increases bioavailability due to CYP3A4 inhibition.
Distribution:
Vd:
0.77-1.7 L/kg
ProteinBinding:
>90% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-5 hours (terminal half-life for ER formulation can appear longer due to sustained absorption)
Clearance:
Approximately 0.5-1 L/kg/hr
ExcretionRoute:
Mainly renal (60-80% as inactive metabolites), fecal (15-20%)
Unchanged:
<1% (in urine)
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 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
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 if they bother you or do not go away:
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 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
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 if they bother you or do not go away:
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
- Chest pain that worsens or does not go away
- Significant swelling in the hands, ankles, or feet
- Unusual fatigue or weakness
- Shortness of breath
- Severe headache
- Irregular heartbeat
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 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 all potential interactions.
To ensure your safety, it is crucial to discuss all of your medications and health conditions with your doctor and pharmacist. This includes:
All prescription and OTC medications
Natural products
Vitamins
Health problems
Do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so with this medication.
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 all potential interactions.
To ensure your safety, it is crucial to discuss all of your medications and health conditions with your doctor and pharmacist. This includes:
All prescription and OTC medications
Natural products
Vitamins
Health problems
Do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so with this medication.
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 driving or engaging in activities that require alertness, as it may affect your ability to perform these tasks safely. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position and exercise caution when navigating stairs.
Although rare, this medication may increase the risk of new or worsening chest pain, which can be a sign of a heart attack. This risk may be 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 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.
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 this risk 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, plan to become pregnant, or are 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 driving or engaging in activities that require alertness, as it may affect your ability to perform these tasks safely. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position and exercise caution when navigating stairs.
Although rare, this medication may increase the risk of new or worsening chest pain, which can be a sign of a heart attack. This risk may be 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 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.
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 this risk 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, plan to become pregnant, or are 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, reflex)
- Dizziness, lightheadedness, fainting
- Flushing
- Nausea, vomiting
- Metabolic acidosis
- Hyperglycemia
- Cardiogenic shock
- Loss of consciousness
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and may include IV fluids, vasopressors, calcium gluconate, glucagon, and atropine.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nefazodone) - may significantly increase nifedipine levels, leading to hypotension and edema.
- Grapefruit juice - significantly increases nifedipine levels due to CYP3A4 inhibition.
- Rifampin - strong CYP3A4 inducer, significantly decreases nifedipine levels, leading to loss of efficacy.
Moderate Interactions
- Beta-blockers - may cause excessive hypotension or exacerbate angina (rarely, paradoxical increase in angina).
- Digoxin - nifedipine may increase digoxin plasma concentrations.
- Theophylline - nifedipine may increase theophylline plasma concentrations.
- Cimetidine - may increase nifedipine bioavailability.
- Phenytoin, Carbamazepine, Phenobarbital - CYP3A4 inducers, may decrease nifedipine levels.
- Magnesium sulfate (parenteral) - increased risk of hypotension and neuromuscular blockade.
- Quinidine - may decrease quinidine levels or, rarely, increase nifedipine levels.
Minor Interactions
- NSAIDs - may reduce the antihypertensive effect of nifedipine.
- Alpha-blockers - additive hypotensive effects.
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.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs)
Rationale: Nifedipine is extensively metabolized by the liver; baseline assessment is prudent, especially in patients with suspected hepatic impairment.
Timing: Prior to initiation, if clinically indicated.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then monthly to quarterly).
Target: Individualized, typically <130/80 mmHg for hypertension.
Action Threshold: Persistent hypotension (<90/60 mmHg) or inadequate BP control.
Heart Rate (HR)
Frequency: Regularly, especially during dose titration and periodically thereafter.
Target: 60-100 bpm (unless otherwise indicated).
Action Threshold: Persistent bradycardia (<50 bpm) or significant reflex tachycardia (>100 bpm).
Peripheral Edema
Frequency: Regularly, especially during dose titration and periodically thereafter.
Target: Absence of significant edema.
Action Threshold: Development of significant or bothersome ankle/leg edema.
Symptoms of Angina (if applicable)
Frequency: Regularly.
Target: Reduction or elimination of angina episodes.
Action Threshold: Increased frequency or severity of angina.
Symptom Monitoring
- Headache
- Dizziness
- Flushing
- Peripheral edema (swelling of ankles/feet)
- Palpitations
- Fatigue
- Gastrointestinal upset (nausea, constipation)
- Gingival hyperplasia (long-term use)
Special Patient Groups
Pregnancy
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 for management of preterm labor and severe preeclampsia, but its use for chronic hypertension in pregnancy requires careful consideration.
Trimester-Specific Risks:
First Trimester:
Limited data; animal studies show teratogenicity at high doses. Use with caution.
Second Trimester:
Used for management of preterm labor and severe hypertension/preeclampsia, generally considered safer than in first trimester.
Third Trimester:
Used for management of preterm labor and severe hypertension/preeclampsia. Monitor for maternal hypotension and fetal effects.
Lactation
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 significant effects are unlikely with typical maternal doses.
Infant Risk:
Low risk; monitor for drowsiness or feeding issues.
Pediatric Use
Safety and efficacy of nifedipine extended-release in pediatric patients have not been established. Use in children for hypertension is generally not recommended as first-line therapy. If used for specific indications (e.g., hypertrophic cardiomyopathy, pulmonary hypertension), immediate-release formulations are typically preferred with careful titration and monitoring.
Geriatric Use
Elderly patients may be more sensitive to the hypotensive effects of nifedipine. Start with lower doses (e.g., 30 mg once daily) and titrate slowly. Monitor blood pressure and heart rate closely to avoid excessive hypotension and reflex tachycardia.
Clinical Information
Clinical Pearls
- Nifedipine ER (XL/OSM) is an osmotic pump tablet; patients may notice an intact 'ghost tablet' in their stool, which is normal and does not mean the medication was not absorbed.
- Unlike immediate-release nifedipine, the extended-release formulation is suitable for chronic management of hypertension and angina and should not be used for acute hypertensive emergencies due to its slow onset.
- Patients should be advised to avoid grapefruit and grapefruit juice due to significant drug interaction via CYP3A4 inhibition.
- Peripheral edema is a common side effect of dihydropyridine calcium channel blockers like nifedipine, often dose-dependent. It is due to precapillary vasodilation and not fluid retention. It can sometimes be managed by adding an ACE inhibitor or ARB.
- Gingival hyperplasia can occur with long-term use; good oral hygiene is important.
Alternative Therapies
- 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)
- Alpha-blockers (e.g., Doxazosin, Terazosin)
Cost & Coverage
Average Cost:
$10 - $50 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'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.