Adalat CC 30mg 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
Calcium Channel Blocker, Dihydropyridine
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Pregnancy Category
Category C
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FDA Approved
Sep 1992
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nifedipine extended-release is a type of medicine called a calcium channel blocker. It works by relaxing blood vessels, which helps to lower high blood pressure and reduce chest pain (angina). The extended-release form means the medicine is released slowly over time, so you usually only need to take it once a day.
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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. 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 essential to take your medication for the full prescribed period. 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 reduce the dose.

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 specific 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. Keep all medications in a secure location, out of the reach of children and pets.

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 guidance on the best disposal method. You may also want to explore local drug take-back programs for safe and responsible disposal.

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.
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Lifestyle & Tips

  • Take the tablet whole; do not chew, crush, or divide it.
  • Take at the same time each day, preferably on an empty stomach or with a light meal.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the drug's effects.
  • Limit alcohol consumption, as it can worsen dizziness or low blood pressure.
  • Maintain a healthy diet, regular exercise, and manage stress to support blood pressure control.
  • Monitor your blood pressure at home as advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: 30 mg orally once daily
Dose Range: 30 - 90 mg

Condition-Specific Dosing:

hypertension: Initial: 30 mg orally once daily. Titrate over 7-14 days. Max: 90 mg once daily.
chronic stable angina: Initial: 30 mg orally once daily. Titrate over 7-14 days. Max: 90 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No specific adjustment recommended, but use with caution due to potential for exaggerated hypotensive response in volume-depleted patients.
Dialysis: Not dialyzable. No specific adjustment needed.

Hepatic Impairment:

Mild: Consider lower initial dose (e.g., 30 mg every other day or 20 mg once daily) and careful titration.
Moderate: Consider lower initial dose (e.g., 30 mg every other day or 20 mg once daily) and careful titration.
Severe: Consider lower initial dose (e.g., 30 mg every other day or 20 mg once daily) and careful titration. Monitor closely.

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 vascular smooth muscle cells. This inhibition leads to peripheral arterial vasodilation, reducing systemic vascular resistance and blood pressure. It also causes coronary vasodilation, increasing myocardial oxygen supply.
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Pharmacokinetics

Absorption:

Bioavailability: 45-68%
Tmax: 2.5-5 hours
FoodEffect: Food increases the rate and extent of absorption. Adalat CC should be taken on an empty stomach or with a light meal to ensure consistent absorption.

Distribution:

Vd: 0.77-1.7 L/kg
ProteinBinding: >90%
CnssPenetration: Limited

Elimination:

HalfLife: 6-11 hours (extended-release formulation)
Clearance: Not available
ExcretionRoute: Renal (60-80%), Fecal (15-20%)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within 6 hours (for blood pressure reduction)
PeakEffect: 6-12 hours
DurationOfAction: 24 hours

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
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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • New or worsening chest pain
  • Significant swelling in the ankles, feet, or hands
  • Unusual fatigue or weakness
  • Severe headache that is new or different
  • Yellowing of the skin or eyes (jaundice)
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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 drug, its components, or other medications, foods, or substances. Be sure to describe the allergic reaction you experienced.
If you have been diagnosed with intolerance to certain sugars, such as lactose, glucose, or galactose, as some products contain lactose.
If you have recently had a heart attack.
If you are taking any medications, including prescription and over-the-counter drugs, natural products, or vitamins, that should not be taken with this medication. This includes certain medications used to treat HIV, infections, seizures, and other conditions. Please note that this is not an exhaustive list of interacting medications.

To ensure your safety, it is crucial to discuss all of your medications (prescription and over-the-counter), natural products, vitamins, and health problems with your doctor and pharmacist. This will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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 driving or performing tasks that require alertness, as it may affect you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position and exercise care when navigating stairs.

Although rare, this medication may cause new or worsening chest pain, which can 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 this with your doctor.

Regularly monitor your blood pressure as directed by your healthcare provider. Additionally, adhere to the scheduled blood tests 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 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 to 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, lightheadedness, fainting
  • Flushing
  • Hyperglycemia (high blood sugar)
  • Metabolic acidosis
  • Cardiogenic shock with pulmonary edema
  • Loss of consciousness

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management includes supportive care, IV fluids, vasopressors (e.g., norepinephrine), calcium gluconate, glucagon, and potentially insulin/dextrose for severe cases.

Drug Interactions

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Contraindicated Interactions

  • Rifampin (strong CYP3A4 inducer)
  • St. John's Wort (strong CYP3A4 inducer)
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Major Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nefazodone, grapefruit juice) - may increase nifedipine levels and effects.
  • Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, phenobarbital) - may decrease nifedipine levels and efficacy.
  • Beta-blockers - may cause excessive hypotension or exacerbate angina (rarely, due to reflex tachycardia suppression).
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Moderate Interactions

  • Digoxin - nifedipine may increase digoxin levels.
  • Quinidine - nifedipine may decrease quinidine levels.
  • Cimetidine - may increase nifedipine levels.
  • Fentanyl - severe hypotension has been reported with concomitant use.
  • Magnesium sulfate (parenteral) - increased risk of hypotension and neuromuscular blockade.
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Minor Interactions

  • Theophylline - nifedipine may increase theophylline levels.
  • Tacrolimus - nifedipine may increase tacrolimus levels.

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 (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 above target, or symptomatic hypotension.

Heart Rate (HR)

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

Target: 60-100 bpm (unless otherwise indicated by co-morbidities).

Action Threshold: Persistent symptomatic bradycardia or significant reflex tachycardia.

Peripheral Edema

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

Target: Absence of significant edema.

Action Threshold: Development of new or worsening peripheral edema.

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Symptom Monitoring

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

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Nifedipine has been shown to be teratogenic in animals at doses higher than human therapeutic doses. It is 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: Potential for teratogenicity observed in animal studies at high doses; human data are limited but do not consistently show increased risk of major birth defects.
Second Trimester: Generally considered safer than in the first trimester if clinically indicated for severe hypertension.
Third Trimester: May be used for severe hypertension or preterm labor; potential for maternal hypotension and reduced placental perfusion. Neonatal adverse effects (e.g., hypotension, bradycardia) have been reported with maternal use near term.
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Lactation

Nifedipine is excreted into breast milk. While the amount is small and generally considered compatible with breastfeeding, caution is advised. Monitor the infant for potential adverse effects such as lethargy, poor feeding, or bradycardia.

Infant Risk: Low risk, but monitor for signs of hypotension or sedation.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.

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Geriatric Use

Start with the lowest effective dose and titrate slowly. Elderly patients may be more sensitive to the hypotensive effects and may have reduced hepatic clearance, leading to higher plasma concentrations. Monitor closely for adverse effects like dizziness and peripheral edema.

Clinical Information

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Clinical Pearls

  • Adalat CC tablets must be swallowed whole; do not chew, crush, or divide, as this will disrupt the extended-release mechanism and could lead to rapid absorption and severe hypotension.
  • Patients should be advised to avoid grapefruit and grapefruit juice due to significant drug interaction.
  • Peripheral edema is a common side effect, often dose-dependent. It is due to arterial vasodilation and not fluid retention, so diuretics are generally not effective.
  • Nifedipine is a potent vasodilator; rapid dose escalation or use of immediate-release formulations in hypertensive emergencies can lead to precipitous drops in blood pressure and reflex tachycardia, potentially worsening angina or causing myocardial ischemia.
  • Monitor for signs of excessive hypotension, especially when initiating therapy or increasing dose.
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Alternative Therapies

  • Other dihydropyridine calcium channel blockers (e.g., amlodipine, felodipine, isradipine, nicardipine)
  • Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
  • Beta-blockers (e.g., metoprolol, carvedilol)
  • Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone)
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Cost & Coverage

Average Cost: $30 - $150 per 30 tablets (30mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 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 promptly. 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.