Adalat CC 90mg Tablets

Manufacturer ALMATICA Active Ingredient Nifedipine Extended-Release Tablets(nye FED i peen) Pronunciation nye FED i peen
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.
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Drug Class
Antihypertensive, Antianginal
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Pharmacologic Class
Dihydropyridine Calcium Channel Blocker
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Pregnancy Category
Category C
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FDA Approved
Aug 1992
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DEA Schedule
Not Controlled

Overview

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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 your heart.
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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 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, 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. Stopping your medication abruptly without consulting your doctor can 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 to minimize potential side effects.

Some medications should be taken with food, while others should be taken on an empty stomach. If you're unsure about the best way to take your medication, consult with your pharmacist for guidance.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light and moisture. Avoid storing your medication in a bathroom, as the humidity and temperature fluctuations can affect its potency. Keep your medication in a secure location, out of the reach of children and pets.

When your medication is no longer needed or has expired, dispose of it properly. 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 guidance on 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 the missed one.
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Lifestyle & Tips

  • Take the medication exactly as prescribed, usually once daily.
  • Swallow the tablet whole; do not crush, chew, or divide it, as this will destroy the extended-release properties and could lead to a sudden release of the drug.
  • Avoid consuming grapefruit or grapefruit juice while taking this medication, as it can increase the levels of nifedipine in your body and lead to more side effects.
  • Limit alcohol consumption, as it can further lower blood pressure.
  • Maintain a healthy diet, regular exercise, and manage stress to support blood pressure control.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can lead to a rebound increase in blood pressure or angina.

Dosing & Administration

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Adult Dosing

Standard Dose: 30 mg to 60 mg orally once daily, titrated as needed
Dose Range: 30 - 120 mg

Condition-Specific Dosing:

hypertension: Initial 30-60 mg once daily; usual maintenance 30-90 mg once daily. Max 120 mg/day.
chronic stable angina: Initial 30-60 mg once daily; usual maintenance 30-90 mg once daily. Max 120 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and efficacy not established for hypertension or angina in pediatric patients)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment typically needed
Moderate: No adjustment typically needed
Severe: Use with caution; monitor closely. No specific dose adjustment guidelines, but individual response may vary.
Dialysis: Not dialyzable. No specific supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: Consider lower starting dose and careful titration.
Moderate: Consider lower starting dose (e.g., 30 mg once daily) and careful titration. Monitor closely for exaggerated effects.
Severe: Use with extreme caution. Significant dose reduction may be necessary (e.g., 30 mg once daily or less). Monitor closely for hypotension and other adverse effects.

Pharmacology

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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. In angina, it reduces myocardial oxygen demand by decreasing afterload and may increase myocardial oxygen supply by dilating coronary arteries.
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Pharmacokinetics

Absorption:

Bioavailability: 45-70% (extended-release formulations)
Tmax: 2.5-5 hours (Adalat CC)
FoodEffect: Absorption of Adalat CC is not significantly affected by food.

Distribution:

Vd: 0.77-1.1 L/kg
ProteinBinding: >90% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: 2-5 hours (terminal half-life for ER formulations can be longer due to sustained release properties)
Clearance: Approximately 0.5-1 L/kg/hr
ExcretionRoute: Mainly renal (60-80% as inactive metabolites), remainder in feces (15-20%).
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Within 6 hours (for blood pressure lowering with ER formulations)
PeakEffect: 6-12 hours (for blood pressure lowering with ER formulations)
DurationOfAction: 24 hours (due to extended-release formulation)

Safety & Warnings

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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 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

Note: For some brands, you may notice the tablet shell in your stool. This is a normal occurrence and not a cause for concern. If you have questions, consult your doctor.

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact 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 (signs of low blood pressure)
  • New or worsening chest pain
  • Severe or unusual swelling in your ankles, feet, or hands
  • Difficulty breathing
  • Rash or allergic reaction
  • Yellowing of skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems)
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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 been diagnosed with intolerance to certain sugars, including lactose, glucose, or galactose. 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 (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 interacting medications.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, including prescription and OTC drugs, natural products, and vitamins, as well as any health problems you are experiencing. This will enable them to verify that it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or modify the dosage of any medication without first consulting your doctor.
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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 increase the risk of a heart attack. This risk is particularly higher in individuals with severe heart blood vessel disease. It is crucial to discuss these potential risks with your doctor.

Regularly monitor your blood pressure as directed by your healthcare provider. Additionally, adhere to the scheduled blood work and follow-up appointments as recommended by your doctor to ensure close monitoring of your condition.

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 these potential risks with your doctor.

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

It is vital to inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding, as you will need to discuss the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Profound hypotension (very low blood pressure)
  • Bradycardia (slow heart rate)
  • Tachycardia (fast heart rate, reflex)
  • Dizziness
  • Fainting
  • Flushing
  • Hyperglycemia
  • Metabolic acidosis
  • Cardiogenic shock with pulmonary edema

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. May involve gastric lavage, activated charcoal, IV fluids, vasopressors, calcium gluconate, glucagon, or atropine depending on severity and symptoms.

Drug Interactions

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Contraindicated Interactions

  • Strong CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Phenobarbital, St. John's Wort) - may significantly reduce nifedipine plasma concentrations and efficacy.
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Major Interactions

  • Strong CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin, Nefazodone, Grapefruit juice) - may significantly increase nifedipine plasma concentrations, leading to increased hypotensive effects and adverse reactions.
  • Beta-blockers - may cause excessive hypotension or exacerbate angina in rare cases (though often used together cautiously).
  • Digoxin - may increase digoxin levels.
  • Quinidine - may decrease quinidine levels or, rarely, increase nifedipine levels.
  • Cimetidine - may increase nifedipine levels.
  • Fentanyl - severe hypotension has been reported with concomitant use.
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Moderate Interactions

  • Moderate CYP3A4 inhibitors (e.g., Erythromycin, Fluconazole, Diltiazem, Verapamil) - may increase nifedipine levels.
  • Alpha-blockers (e.g., Prazosin) - additive hypotensive effects.
  • Magnesium sulfate (parenteral) - increased risk of hypotension and neuromuscular blockade.
  • Tacrolimus - may increase tacrolimus levels.
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Minor Interactions

  • Theophylline - may alter theophylline levels (variable effect).
  • Warfarin - no significant interaction reported, but monitor INR.

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 important, especially in patients with suspected hepatic impairment.

Timing: Prior to initiation, particularly if hepatic impairment is suspected or known.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then monthly to quarterly for maintenance).

Target: Individualized based on treatment goals (e.g., <130/80 mmHg for most adults with 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; monitor for reflex tachycardia.

Action Threshold: Persistent tachycardia or bradycardia outside normal limits, or if symptomatic.

Peripheral Edema

Frequency: Regularly, especially during initial therapy.

Target: Absence of significant edema.

Action Threshold: Development of new or worsening peripheral edema.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Headache
  • Flushing
  • Peripheral edema (swelling of ankles/feet)
  • Palpitations
  • Chest pain (worsening or new onset)
  • Shortness of breath

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 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 generally avoided unless clearly needed.
Second Trimester: May be used for severe hypertension or preterm labor under close medical supervision.
Third Trimester: May be used for severe hypertension or preterm labor under close medical supervision. Potential for maternal hypotension and reduced placental perfusion.
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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 potential adverse effects such as lethargy or poor feeding.

Infant Risk: Low risk. Monitor for signs of hypotension or sedation in the infant.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients for hypertension or angina. Use is generally not recommended.

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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, falls, and peripheral edema.

Clinical Information

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Clinical Pearls

  • Adalat CC is an extended-release formulation and must be swallowed whole. Crushing or chewing can lead to rapid drug release and potentially dangerous hypotension.
  • Patients may notice a 'ghost tablet' in their stool, which is the inert shell of the extended-release tablet. This is normal and does not mean the medication was not absorbed.
  • Peripheral edema (swelling of ankles/feet) is a common side effect of dihydropyridine calcium channel blockers like nifedipine. It is dose-dependent and often managed by dose reduction or adding a diuretic.
  • Avoid abrupt discontinuation, especially in patients with angina, as it may lead to a rebound increase in symptoms.
  • Educate patients about the importance of avoiding grapefruit and grapefruit juice due to significant drug interaction.
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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)
  • Beta-blockers (e.g., Metoprolol, Atenolol)
  • Diuretics (e.g., Hydrochlorothiazide, Furosemide)
  • Other antianginal agents (e.g., Nitrates, Ranolazine)
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Cost & Coverage

Average Cost: $10 - $50 (generic); $100 - $300+ (brand) per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 (generic) or Tier 2/3 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.