Adalat CC 60mg ER 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
C
FDA Approved
Aug 1989
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nifedipine extended-release 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 the heart.
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 prescription, and follow the instructions closely. When taking your medication, swallow the tablets or capsules whole - do not chew, break, or crush them.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. 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 reduce the dosage.
Some medications may need to be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on 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, and keep it out of reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for 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, 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 prescription, and follow the instructions closely. When taking your medication, swallow the tablets or capsules whole - do not chew, break, or crush them.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. 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 reduce the dosage.
Some medications may need to be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on 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, and keep it out of reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for 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, 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, as this will affect the extended-release properties.
- Take at the same time each day, preferably with food.
- Avoid grapefruit and grapefruit juice while taking this medication, as it can significantly increase the drug's effects and side effects.
- Limit alcohol consumption, as it can increase the risk of dizziness and low blood pressure.
- Maintain a healthy diet (e.g., low sodium, low fat), regular exercise, and manage stress to help control blood pressure.
- Inform your doctor or dentist that you are taking nifedipine before any surgery or dental procedures.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
30 mg or 60 mg extended-release tablet once daily
Dose Range:
30 - 90 mg
Condition-Specific Dosing:
hypertension:
Initial dose 30 mg or 60 mg once daily; titrate over 7 to 14 days. Max 90 mg once daily.
chronic stable angina:
Initial dose 30 mg or 60 mg once daily; titrate over 7 to 14 days. Max 90 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed.
Moderate:
No adjustment typically needed.
Severe:
No adjustment typically needed.
Dialysis:
Nifedipine is highly protein bound and 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 lower initial dose and careful titration. Monitor closely for exaggerated effects.
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 coronary and peripheral vasodilation, reducing peripheral vascular resistance and myocardial oxygen demand, thereby lowering blood pressure and relieving angina.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 86% (extended-release formulation)
Tmax:
Approximately 2.5-5 hours (extended-release)
FoodEffect:
Food does not significantly alter the absorption of Adalat CC, but grapefruit juice can increase bioavailability.
Distribution:
Vd:
0.77-1.1 L/kg
ProteinBinding:
92-98%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 7 hours (extended-release)
Clearance:
Approximately 0.5-1.0 L/kg/hr
ExcretionRoute:
Mainly renal (60-80% as inactive metabolites), fecal (15% as inactive metabolites).
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Within 6 hours (for blood pressure reduction with ER)
PeakEffect:
Approximately 6-12 hours (for blood pressure reduction with ER)
DurationOfAction:
24 hours (extended-release)
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 or any other 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. Remember, this is not an exhaustive list of possible side effects. If you have any questions, consult your doctor for medical advice.
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 or any other 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. Remember, this is not an exhaustive list of possible side effects. If you have any questions, consult your doctor for medical advice.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting
- Swelling in the ankles or feet that is new or worsening
- Persistent or worsening headache
- New or worsening chest pain
- Shortness of breath
- Unusual fatigue or weakness
- Yellowing of 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, 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, as 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. Therefore, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe use.
To guarantee your safety, always check with your doctor before:
- Starting any new medication
- Stopping any medication
- Changing the dosage of any medication
This will help prevent potential interactions and ensure that it is safe to take this medication with your other medications and health conditions.
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, as 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. Therefore, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe use.
To guarantee your safety, always check with your doctor before:
- Starting any new medication
- Stopping any medication
- Changing the dosage of any medication
This will help prevent potential interactions and ensure that it is safe to take this medication with your other medications and health conditions.
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, new or worsening chest pain can occur 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 vital to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks 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, new or worsening chest pain can occur 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 vital to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Profound hypotension (very low blood pressure)
- Bradycardia (slow heart rate)
- Tachycardia (fast heart rate)
- Palpitations
- Dizziness, lightheadedness, fainting
- Flushing
- Hyperglycemia (high blood sugar)
- Metabolic acidosis
- Cardiogenic shock with pulmonary edema
- Loss of consciousness
What to Do:
In case of suspected overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management typically involves supportive care, including intravenous fluids for hypotension, vasopressors, calcium gluconate, and potentially atropine or glucagon for bradycardia. Activated charcoal may be considered if ingested recently.
Drug Interactions
Contraindicated Interactions
- Grapefruit juice (concurrent use is contraindicated due to increased nifedipine plasma concentrations)
- Rifampin (concurrent use is contraindicated due to significant reduction in nifedipine efficacy)
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nefazodone) - may significantly increase nifedipine levels, leading to hypotension and edema.
- Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, phenobarbital, St. John's Wort) - may significantly decrease nifedipine levels, leading to loss of efficacy.
- Beta-blockers (e.g., metoprolol, propranolol) - may cause additive hypotensive effects; rarely, severe hypotension or heart failure.
- Quinidine - may decrease quinidine levels or increase nifedipine levels.
Moderate Interactions
- Digoxin - may increase digoxin plasma concentrations.
- Cimetidine - may increase nifedipine plasma concentrations.
- Magnesium sulfate (parenteral) - may cause excessive hypotension and neuromuscular blockade.
- Theophylline - may alter theophylline levels.
- Fentanyl - severe hypotension has been reported with concurrent use.
Minor Interactions
- Not many clinically significant minor interactions reported for nifedipine ER beyond those affecting CYP3A4 or 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: To assess hepatic function, especially in patients with suspected impairment, as nifedipine is extensively metabolized by the liver.
Timing: Prior to initiation, if clinically indicated.
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: Individualized, typically <130/80 mmHg for most adults with hypertension.
Action Threshold: Persistent BP outside target range, symptomatic hypotension, or uncontrolled hypertension.
Heart Rate (HR)
Frequency: Regularly, especially during dose titration and then periodically.
Target: Typically 60-100 bpm, unless otherwise indicated.
Action Threshold: Persistent bradycardia (<50 bpm) or significant reflex tachycardia (>100 bpm) with symptoms.
Peripheral Edema
Frequency: Regularly, especially during dose titration and then periodically.
Target: Absence of significant edema.
Action Threshold: Development or worsening of significant lower extremity edema.
Symptom Monitoring
- Dizziness or lightheadedness (especially upon standing)
- Headache
- Flushing
- Peripheral edema (swelling of ankles/feet)
- Palpitations
- Fatigue
- Chest pain (worsening or new onset)
- Shortness of breath
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. Studies in animals have shown adverse effects on the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data, but animal studies show teratogenic effects (skeletal abnormalities, digital anomalies). Use with caution.
Second Trimester:
May be used for severe hypertension or preeclampsia, but close monitoring of maternal and fetal well-being is essential.
Third Trimester:
Can be used for hypertension or tocolysis (off-label). Risk of maternal hypotension and potential for reduced uteroplacental perfusion. Neonatal adverse effects (e.g., hypotension, bradycardia) have been reported.
Lactation
Nifedipine is excreted into breast milk. The amount is small, and adverse effects on the infant are unlikely with typical doses. However, monitor the infant for signs of hypotension, lethargy, or poor feeding.
Infant Risk:
Low risk. L3 (Moderately safe).
Pediatric Use
Safety and effectiveness 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. A lower initial dose and slower titration may be appropriate. Monitor closely for dizziness, falls, and peripheral edema.
Clinical Information
Clinical Pearls
- Adalat CC is an extended-release formulation; instruct patients not to crush, chew, or divide the tablets. The tablet shell may be excreted in the stool, which is normal and does not mean the medication was not absorbed.
- Counsel patients to avoid grapefruit and grapefruit juice entirely while on nifedipine due to the risk of increased drug levels and adverse effects.
- Peripheral edema (swelling of ankles/feet) is a common side effect of dihydropyridine calcium channel blockers like nifedipine, due to precapillary vasodilation. It is dose-dependent and often manageable.
- Nifedipine ER is generally well-tolerated but can cause headache, flushing, and dizziness, especially at the start of therapy or with dose increases.
- Monitor blood pressure regularly, especially during the first few weeks of therapy and after any dose adjustments.
Alternative Therapies
- ACE inhibitors (e.g., lisinopril, enalapril)
- Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
- Thiazide diuretics (e.g., hydrochlorothiazide)
- Beta-blockers (e.g., metoprolol, carvedilol)
- Other classes of antihypertensives or antianginals depending on the specific indication and patient profile.
Cost & Coverage
Average Cost:
Varies, typically $20-$100+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
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.