Nifedipine 60mg ER (xl/os) 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
Dihydropyridine Calcium Channel Blocker
Pregnancy Category
Category C
FDA Approved
Sep 1989
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nifedipine is a medicine that helps relax your blood vessels. This makes it easier for your heart to pump blood, which lowers your blood pressure and can help with chest pain (angina). The 'ER' or 'XL/OS' means it's an extended-release tablet, designed to release the medicine slowly over 24 hours, so you usually take it only once a day.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take your medication as directed by your doctor or healthcare provider.
Swallow the medication whole, without chewing, breaking, or crushing it.
Continue taking your medication even if you start feeling well, unless your doctor instructs you to stop.
Do not 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.
Special Instructions for Taking Your Medication
Some medications should be taken with food, while others should be taken on an empty stomach. Check 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.
Keep it in a dry place, away from the bathroom.
Store all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, or look into local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take your medication as directed by your doctor or healthcare provider.
Swallow the medication whole, without chewing, breaking, or crushing it.
Continue taking your medication even if you start feeling well, unless your doctor instructs you to stop.
Do not 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.
Special Instructions for Taking Your Medication
Some medications should be taken with food, while others should be taken on an empty stomach. Check 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.
Keep it in a dry place, away from the bathroom.
Store all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, or look into local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily. Do not chew, crush, or divide the tablet.
- Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the amount of medicine in your body and cause more side effects.
- Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.
- Monitor your blood pressure regularly at home if advised by your doctor.
- Limit alcohol intake, as it can increase the blood pressure-lowering effect.
- Maintain a healthy diet (low in sodium, rich in fruits/vegetables), regular exercise, and manage stress to help control blood pressure.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
30 mg or 60 mg 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. Max 90 mg or 120 mg once daily.
chronic stable angina:
Initial dose 30 mg or 60 mg once daily. Titrate over 7-14 days. Max 90 mg or 120 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment typically required.
Moderate:
No dose adjustment typically required.
Severe:
No dose adjustment typically required, but monitor blood pressure closely.
Dialysis:
Not dialyzable. No supplemental dose needed after dialysis.
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 lower initial dose and careful titration. Monitor closely.
Pharmacology
Mechanism of Action
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, which lowers blood pressure. It also dilates coronary arteries and arterioles, increasing myocardial oxygen supply.
Pharmacokinetics
Absorption:
Bioavailability:
86% (relative to immediate release)
Tmax:
6-12 hours (for ER formulations)
FoodEffect:
Food does not significantly alter the absorption of Nifedipine ER tablets. Can be taken with or without food.
Distribution:
Vd:
0.77-1.1 L/kg
ProteinBinding:
>92-98%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 6-11 hours (for ER formulations)
Clearance:
Approximately 0.5-1.0 L/hr/kg
ExcretionRoute:
Mainly renal (60-80% as inactive metabolites), fecal (15-20%)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Approximately 6 hours (for ER formulations)
PeakEffect:
Approximately 6-12 hours (for ER formulations)
DurationOfAction:
24 hours (for ER formulations)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
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 help 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 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.
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 help 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 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.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting (especially when standing up quickly)
- New or worsening chest pain
- Significant swelling in your ankles, feet, or hands
- Unusual fatigue or weakness
- Difficulty breathing
- Yellowing of the skin or eyes (jaundice)
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. Be sure to describe the allergic reaction and its symptoms.
If you have been diagnosed with intolerance to certain sugars, such as lactose, glucose, or galactose, as some formulations of this medication may contain lactose.
If you have recently experienced a heart attack.
If you are taking any medications, including prescription and over-the-counter 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 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 your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have been diagnosed with intolerance to certain sugars, such as lactose, glucose, or galactose, as some formulations of this medication may contain lactose.
If you have recently experienced a heart attack.
If you are taking any medications, including prescription and over-the-counter 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 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.
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, it is possible to experience new or worsening chest pain after initiating this medication or increasing the dose, which may lead to 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 instructed by your healthcare provider. Additionally, undergo blood tests as recommended by your doctor and discuss the 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 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.
It is essential to inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. You and your doctor will need to discuss the potential benefits and risks of this medication to 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, it is possible to experience new or worsening chest pain after initiating this medication or increasing the dose, which may lead to 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 instructed by your healthcare provider. Additionally, undergo blood tests as recommended by your doctor and discuss the 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 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.
It is essential to inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding. You and your doctor will need to discuss the potential benefits and risks of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Profound hypotension (very low blood pressure)
- Bradycardia (slow heart rate)
- Tachycardia (fast heart rate)
- Dizziness
- Confusion
- Nausea
- Vomiting
- Metabolic acidosis
- Hyperglycemia
- Cardiogenic shock
- Pulmonary edema
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is supportive and may include IV fluids, vasopressors, calcium gluconate, and atropine.
Drug Interactions
Contraindicated Interactions
- Strong CYP3A4 inducers (e.g., Rifampin, Phenobarbital, Phenytoin, Carbamazepine) - may significantly reduce nifedipine levels and efficacy.
Major Interactions
- Strong CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin, Nefazodone) - may significantly increase nifedipine levels and risk of adverse effects.
- Grapefruit juice - significantly increases nifedipine levels and risk of hypotension.
- Beta-blockers - additive hypotensive and bradycardic effects; monitor closely.
- Digoxin - nifedipine may increase digoxin levels; monitor digoxin levels.
- Quinidine - nifedipine may decrease quinidine levels; quinidine may decrease nifedipine levels.
Moderate Interactions
- Cimetidine - may increase nifedipine levels.
- Theophylline - nifedipine may increase theophylline levels.
- Fentanyl - severe hypotension has been reported with concomitant use.
- Magnesium sulfate - enhanced hypotensive effect.
- Tacrolimus - nifedipine may increase tacrolimus levels; monitor tacrolimus 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 or bradycardia.
Timing: Prior to initiation of therapy.
Liver Function Tests (LFTs)
Rationale: Nifedipine is extensively metabolized by the liver; important for patients with pre-existing hepatic impairment.
Timing: Prior to initiation in patients with suspected hepatic impairment.
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 (general hypertension target, may vary based on patient comorbidities)
Action Threshold: If BP remains uncontrolled or drops excessively (e.g., symptomatic hypotension).
Heart Rate (HR)
Frequency: Regularly, especially during dose titration and then periodically.
Target: 60-100 bpm (unless otherwise indicated)
Action Threshold: Persistent bradycardia (<50 bpm) or significant reflex tachycardia.
Peripheral Edema
Frequency: Regularly, especially during dose titration and then periodically.
Target: Absence of significant edema
Action Threshold: Development of significant or bothersome ankle/leg edema.
Symptom Monitoring
- Dizziness
- Headache
- Flushing
- Peripheral edema (swelling of ankles/feet)
- Palpitations
- Fatigue
- Chest pain (worsening or new onset)
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 hypertension in pregnancy.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies at high doses. Human data are limited but generally do not show a consistent pattern of major malformations.
Second Trimester:
Generally considered safer than in the first trimester if needed for maternal conditions like hypertension.
Third Trimester:
May be associated with maternal hypotension, which can compromise placental perfusion. Used with caution for severe hypertension or preterm labor, but close monitoring is required.
Lactation
Nifedipine is excreted in breast milk in small amounts. The amount ingested by the infant is generally considered low and unlikely to cause adverse effects. It is generally considered compatible with breastfeeding, but monitor the infant for signs of hypotension or lethargy.
Infant Risk:
Low risk. Monitor for drowsiness, poor feeding, or hypotension.
Pediatric Use
Safety and effectiveness of Nifedipine ER 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. Start with the lowest effective dose and titrate slowly. Monitor blood pressure closely to avoid excessive drops and orthostatic hypotension.
Clinical Information
Clinical Pearls
- Nifedipine ER tablets are designed for once-daily dosing and should not be chewed, crushed, or divided, as this 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.
- Educate patients about orthostatic hypotension (dizziness upon standing) and advise them to rise slowly.
- Avoid concomitant use with grapefruit or grapefruit juice due to significant interaction risk.
- Nifedipine is a potent vasodilator; monitor for peripheral edema, a common side effect.
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)
- Beta-blockers (e.g., Metoprolol, Atenolol)
Cost & Coverage
Average Cost:
$30 - $150 per 30 tablets (60mg ER)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for 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 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 details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.