Nifedipine 10mg Capsules

Manufacturer LEADING PHARMA Active Ingredient Nifedipine Capsules(nye FED i peen) Pronunciation nye FED i peen
It is used to treat some types of chest pain (angina).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihypertensive, Antianginal
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Pharmacologic Class
Calcium Channel Blocker (Dihydropyridine)
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Pregnancy Category
Category C
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FDA Approved
Dec 1981
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nifedipine is a medication that helps relax blood vessels, which lowers blood pressure and can reduce chest pain (angina). It works by blocking calcium from entering certain cells in your heart and blood vessels.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions precisely.

When taking your medication, swallow the tablet whole - do not chew, break, or crush it. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's crucial not to stop taking your medication abruptly 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.

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 medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore 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.
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Lifestyle & Tips

  • Take exactly as prescribed, usually three times a day. Do not crush, chew, or break the capsules.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the drug's effects and side effects.
  • Monitor your blood pressure regularly as advised by your doctor.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or lightheadedness.
  • Limit alcohol consumption, as it can increase the blood pressure-lowering effect.
  • Report any new or worsening symptoms to your healthcare provider.

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mg orally three times daily
Dose Range: 10 - 30 mg

Condition-Specific Dosing:

anginaPectoris: Initial: 10 mg orally three times daily. Titrate over 7-14 days. Usual effective dose: 10-20 mg three times daily. Max: 30 mg three times daily.
hypertension: Initial: 10 mg orally three times daily. Titrate over 7-14 days. Usual effective dose: 10-20 mg three times daily. Max: 30 mg three times daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not generally recommended for immediate-release capsules due to risk of precipitous hypotension and reflex tachycardia. Use of extended-release formulations or other agents is preferred if a CCB is needed.
Adolescent: Not generally recommended for immediate-release capsules due to risk of precipitous hypotension and reflex tachycardia. Use of extended-release formulations or other agents is preferred if a CCB is needed.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment typically needed.
Moderate: No adjustment typically needed.
Severe: No adjustment typically needed, but monitor for exaggerated effects.
Dialysis: Not significantly dialyzable. No specific adjustment needed, but monitor response.

Hepatic Impairment:

Mild: No adjustment typically needed.
Moderate: Consider lower initial doses and slower titration. Monitor closely for adverse effects.
Severe: Reduce initial dose (e.g., 5 mg three times daily) and titrate slowly. Monitor closely for adverse effects and exaggerated hypotensive response.

Pharmacology

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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 of the peripheral vasculature and coronary arteries. This inhibition leads to relaxation of vascular smooth muscle, resulting in peripheral arterial vasodilation and coronary vasodilation. The peripheral vasodilation reduces systemic vascular resistance and blood pressure, while coronary vasodilation increases myocardial oxygen supply.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 45-70% (due to significant first-pass metabolism)
Tmax: Approximately 30 minutes (capsules)
FoodEffect: Food can delay the rate of absorption but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: 0.77-1.1 L/kg
ProteinBinding: Approximately 92-98%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 2-5 hours (capsules)
Clearance: Approximately 0.5-1.0 L/kg/hr
ExcretionRoute: Approximately 60-80% via urine (as inactive metabolites), 15% via feces
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Approximately 20 minutes (capsules)
PeakEffect: Approximately 30-60 minutes (capsules)
DurationOfAction: Approximately 4-8 hours (capsules)

Safety & Warnings

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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 immediately or seek emergency medical attention:

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 indicate a serious 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

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • Persistent or worsening swelling in your ankles or feet
  • Severe or persistent headache
  • Chest pain that worsens or does not go away
  • Unusual fatigue or shortness of breath
  • Rash or itching
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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, including any symptoms that occurred.
If you have recently had a heart attack.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat HIV, infections, seizures, and other conditions, should not be taken with this medication. There are numerous drugs that interact with this medication, and this list is not exhaustive.

To ensure your safety, it is vital 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

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure that you can take this medication safely with your other medications and health conditions.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.

Cardiovascular Risks
Although rare, new or worsening chest pain can occur after starting this medication or increasing the dose. In some cases, this can lead to a heart attack. People with severe heart blood vessel disease may be at higher risk. Discuss these risks with your doctor.

Monitoring and Follow-up
Regularly check your blood pressure as instructed by your doctor. Additionally, have your blood work checked as directed by your doctor and discuss the results with them.

Interactions with Other Substances
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
* Certain natural products or aids

Gastrointestinal Risks
Long-acting forms of this medication have been associated with severe stomach and bowel problems, including blockage and ulcers, which may require hospitalization. Discuss these risks with your doctor.

Use in Treating High Blood Pressure
This form of the medication is not approved for treating high blood pressure. Using it to rapidly lower high blood pressure can lead to severe hypotension, heart attack, and death. However, your doctor may determine that the benefits of taking this medication outweigh the risks. If you are taking this medication for high blood pressure, discuss the benefits and risks with your doctor.

Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to discuss the benefits and risks of taking this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (very low blood pressure)
  • Bradycardia (slow heart rate)
  • Tachycardia (fast heart rate, reflex)
  • Dizziness, lightheadedness, fainting
  • Nausea, vomiting
  • Confusion
  • Shock
  • Metabolic acidosis
  • Hyperglycemia

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. In the US, you can also call Poison Control at 1-800-222-1222. Management may include supportive care, IV fluids, vasopressors, calcium gluconate, or glucagon.

Drug Interactions

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Contraindicated Interactions

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

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, saquinavir, nefazodone): May significantly increase nifedipine plasma concentrations, leading to increased hypotensive effects and adverse reactions.
  • Grapefruit juice (large quantities): Inhibits CYP3A4, increasing nifedipine levels and hypotensive effects.
  • Beta-blockers: May cause excessive hypotension, bradycardia, or heart failure (additive negative inotropic/chronotropic effects, though less pronounced with dihydropyridines like nifedipine).
  • Magnesium sulfate: Increased risk of severe hypotension and neuromuscular blockade, especially in obstetric use.
  • Quinidine: Nifedipine may decrease quinidine levels; quinidine may increase nifedipine levels (variable interaction).
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Moderate Interactions

  • Cimetidine: May increase nifedipine levels.
  • Digoxin: Nifedipine may increase digoxin plasma concentrations.
  • Fentanyl: Severe hypotension has been reported when nifedipine is co-administered with high-dose fentanyl during surgery.
  • Phenytoin, Carbamazepine, Phenobarbital (CYP3A4 inducers): May decrease nifedipine levels.
  • Theophylline: Nifedipine may increase theophylline levels.
  • Tacrolimus: Nifedipine may increase tacrolimus levels (CYP3A4 inhibition).
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Minor Interactions

  • Not typically listed for minor interactions with significant clinical impact.

Monitoring

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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.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter.

Target: Individualized based on treatment goals (e.g., <130/80 mmHg for hypertension).

Action Threshold: If BP remains uncontrolled or if symptomatic hypotension occurs.

Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter.

Target: Typically 60-100 bpm, but monitor for reflex tachycardia.

Action Threshold: If persistent tachycardia (>100 bpm) or symptomatic bradycardia occurs.

Peripheral Edema

Frequency: Periodically

Target: Absence of significant edema.

Action Threshold: If significant or bothersome edema develops.

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Symptom Monitoring

  • Dizziness
  • Headache
  • Flushing
  • Peripheral edema (swelling of ankles/feet)
  • Palpitations/Tachycardia
  • Fatigue
  • Nausea
  • Chest pain (monitor for worsening or new onset)

Special Patient Groups

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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 off-label for preterm labor and severe preeclampsia, but caution is advised.

Trimester-Specific Risks:

First Trimester: Limited data, but animal studies show teratogenicity at high doses. Use with caution.
Second Trimester: May be used for hypertension or preterm labor if benefits outweigh risks.
Third Trimester: May be used for hypertension or preterm labor. Monitor for maternal hypotension and fetal effects.
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Lactation

Nifedipine is excreted into breast milk in small amounts. The American Academy of Pediatrics considers it compatible with breastfeeding. Monitor the infant for adverse effects such as lethargy or poor feeding.

Infant Risk: Low risk. Monitor for drowsiness, poor feeding, or other signs of adverse effects.
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Pediatric Use

Immediate-release nifedipine capsules are generally not recommended for pediatric patients due to the risk of precipitous hypotension and reflex tachycardia. Safety and efficacy have not been established in pediatric populations for approved indications. If a calcium channel blocker is required, extended-release formulations or other agents are often preferred.

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Geriatric Use

Elderly patients may be more sensitive to the hypotensive effects of nifedipine. Start with lower doses and titrate slowly. Monitor closely for dizziness, orthostatic hypotension, and peripheral edema.

Clinical Information

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Clinical Pearls

  • Immediate-release nifedipine capsules have a rapid onset and short duration of action, making them prone to causing reflex tachycardia and precipitous drops in blood pressure. They are generally not preferred for chronic hypertension management or acute hypertensive emergencies.
  • Avoid crushing, chewing, or breaking the capsules; they are designed for immediate release.
  • Peripheral edema (especially ankle edema) is a common side effect, often dose-dependent. It is due to precapillary vasodilation.
  • Patients should be advised to avoid grapefruit and grapefruit juice due to the potential for increased nifedipine levels and adverse effects.
  • Can cause gingival hyperplasia with long-term use.
  • Not recommended for use in acute myocardial infarction or unstable angina due to concerns about increased mortality in some studies with immediate-release formulations.
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Alternative Therapies

  • Other Dihydropyridine Calcium Channel Blockers (e.g., Amlodipine, Felodipine, Nicardipine, Isradipine - often preferred for longer duration and smoother BP control)
  • Non-Dihydropyridine Calcium Channel Blockers (e.g., Verapamil, Diltiazem)
  • ACE Inhibitors (e.g., Lisinopril, Enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
  • Beta-blockers (e.g., Metoprolol, Atenolol)
  • Thiazide Diuretics (e.g., Hydrochlorothiazide)
  • Alpha-1 Blockers (e.g., Prazosin, Terazosin)
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Cost & Coverage

Average Cost: $10 - $50 per 30 capsules (10mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.