Matzim LA 300mg Tablets

Manufacturer ACTAVIS PHARMA Active Ingredient Diltiazem Long-Acting Tablets(dil TYE a zem) Pronunciation dil TYE a zem
It is used to treat high blood pressure.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
Calcium Channel Blocker, Antihypertensive, Antianginal
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Pharmacologic Class
Non-dihydropyridine Calcium Channel Blocker
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Pregnancy Category
Category C
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FDA Approved
Mar 2007
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Diltiazem is a medication that helps relax blood vessels, which lowers blood pressure and can reduce chest pain (angina). It also helps to slow down your heart rate and can be used to control certain irregular heart rhythms. It works by blocking calcium from entering heart and blood vessel cells.
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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.

Take your medication as directed by your doctor, swallowing the tablets whole without chewing, breaking, or crushing them.
Establish a routine by taking your medication at the same time every day.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.

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 it in a bathroom.
Keep your medication in a secure location, out of the reach of children and pets.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. Check with your pharmacist for guidance on the best disposal methods, and consider participating in 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. Avoid taking two doses at the same time or taking extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take the medication exactly as prescribed, usually once daily. Do not crush, chew, or break extended-release tablets.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the levels of diltiazem in your body and lead to more side effects.
  • Maintain a healthy lifestyle, including a balanced diet (low in sodium and saturated fats), regular exercise, and stress management, to support blood pressure control.
  • Limit alcohol consumption, as it can also lower blood pressure and cause dizziness.
  • Inform your doctor or dentist that you are taking diltiazem before any surgery or dental procedures.

Dosing & Administration

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Adult Dosing

Standard Dose: 300 mg orally once daily
Dose Range: 120 - 540 mg

Condition-Specific Dosing:

hypertension: Initial: 180-240 mg once daily; Titrate to 240-360 mg once daily. Max: 540 mg once daily.
chronicstableangina: Initial: 120-180 mg once daily; Titrate to 240-360 mg once daily. Max: 480 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for hypertension or angina; limited data for other conditions, generally not recommended.
Adolescent: Not established for hypertension or angina; limited data for other conditions, generally not recommended.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required, but monitor for exaggerated effects.
Severe: Use with caution; monitor for exaggerated effects (e.g., hypotension, bradycardia). Consider lower initial doses.
Dialysis: Diltiazem is not significantly removed by hemodialysis. Use with caution and monitor for effects.

Hepatic Impairment:

Mild: Use with caution; monitor for exaggerated effects.
Moderate: Use with caution; consider lower initial doses and careful titration due to extensive hepatic metabolism.
Severe: Contraindicated in severe hepatic impairment due to risk of accumulation and exaggerated effects.

Pharmacology

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Mechanism of Action

Diltiazem is a non-dihydropyridine calcium channel blocker that inhibits the influx of extracellular calcium ions across the myocardial and vascular smooth muscle cell membranes. This leads to relaxation of vascular smooth muscle and coronary vasodilation, resulting in decreased peripheral vascular resistance and reduced afterload. In the heart, it decreases myocardial contractility, slows sinoatrial (SA) node firing, and prolongs atrioventricular (AV) node conduction, leading to a reduction in heart rate and myocardial oxygen demand.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40% (due to extensive first-pass metabolism)
Tmax: Approximately 10-14 hours (for extended-release formulations)
FoodEffect: Food may increase bioavailability slightly but is generally not clinically significant; can be taken with or without food.

Distribution:

Vd: Approximately 5.3 L/kg
ProteinBinding: 70-80%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 5-10 hours (parent drug, for extended-release formulations, effective half-life is longer due to sustained release)
Clearance: Approximately 6-13 mL/min/kg
ExcretionRoute: Urine (35-65%), Feces (35-65%)
Unchanged: Less than 4% (in urine)
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes (for initial effect, full effect for LA formulations takes longer)
PeakEffect: Approximately 10-14 hours (for LA formulations)
DurationOfAction: 24 hours (for once-daily LA formulations)

Safety & Warnings

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Side Effects

Urgent 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 or seek immediate 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe dizziness or fainting
Slow heartbeat
New or worsening abnormal heartbeat
Worsening heart failure (if you have a history of heart failure, consult your doctor). Seek immediate medical attention if you experience:
+ Shortness of breath
+ Significant weight gain
+ Swelling in the arms or legs
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions (sometimes life-threatening). Seek medical help right away if you notice:
+ Red, swollen, blistered, or peeling skin
+ Other skin irritation (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Headache
Dizziness
Fatigue
* Weakness

This is not an exhaustive list of possible 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 lightheadedness, especially when standing up
  • Fainting spells
  • Unusually slow heartbeat (less than 50 beats per minute)
  • Significant swelling in your ankles, feet, or hands
  • Shortness of breath or difficulty breathing, especially with exertion or lying down
  • Unusual fatigue or weakness
  • Yellowing of the 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 conditions to ensure safe use of this medication:

Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain types of abnormal heart rhythms, as this medication is not suitable for all types. If you are unsure, consult your doctor or pharmacist for guidance.
Specific health conditions, including:
+ Fluid accumulation in the lungs
+ Low blood pressure
+ Recent heart attack
Concurrent use of certain medications, such as:
+ Ivabradine
+ Rifampin

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to assess potential interactions and ensure safe use of this medication. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
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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, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and exercise caution when climbing stairs.

As directed by your doctor, regularly monitor your blood pressure and heart rate. You may need to undergo an electrocardiogram (ECG) before initiating treatment and periodically while taking this medication. Discuss any concerns or questions with your doctor.

If you have high blood pressure and are taking this medication, 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.

If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor. Additionally, talk to your doctor before consuming alcohol while taking this medication.

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, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (very low blood pressure)
  • Profound bradycardia (extremely slow heart rate)
  • High-degree AV block (heart block)
  • Cardiogenic shock
  • Asystole (cardiac arrest)
  • Metabolic acidosis
  • Hyperglycemia

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment may involve gastric lavage, activated charcoal, IV fluids, atropine, calcium gluconate, vasopressors, glucagon, or cardiac pacing depending on the severity and symptoms.

Drug Interactions

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Contraindicated Interactions

  • Dantrolene (IV) (risk of hyperkalemia and myocardial depression)
  • Ivabradine (additive heart rate lowering effects)
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Major Interactions

  • Beta-blockers (e.g., metoprolol, carvedilol) - increased risk of bradycardia, AV block, heart failure
  • Digoxin - increased digoxin levels, risk of bradycardia, AV block
  • Amiodarone - increased risk of bradycardia, AV block, hypotension
  • Statins (e.g., simvastatin, lovastatin, atorvastatin) - increased statin levels due to CYP3A4 inhibition, risk of myopathy/rhabdomyolysis
  • Cyclosporine, Tacrolimus, Sirolimus, Everolimus - increased immunosuppressant levels due to CYP3A4 inhibition, risk of toxicity
  • Fentanyl - increased fentanyl levels, risk of respiratory depression
  • Midazolam, Triazolam - increased benzodiazepine levels, prolonged sedation
  • Carbamazepine - increased carbamazepine levels, risk of toxicity
  • Rifampin - decreased diltiazem levels, reduced efficacy
  • Alpha-blockers (e.g., prazosin, doxazosin) - increased risk of orthostatic hypotension
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Moderate Interactions

  • Other antihypertensives (e.g., ACE inhibitors, ARBs, diuretics) - additive hypotensive effects
  • Cimetidine, Ranitidine - may increase diltiazem levels (less significant than CYP3A4 inhibitors)
  • Grapefruit juice - may increase diltiazem levels (CYP3A4 inhibition)
  • Clonidine - increased risk of bradycardia, AV block
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Minor Interactions

  • NSAIDs - may reduce antihypertensive effect (minor interaction)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess efficacy for hypertension/angina.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and monitor for bradycardia.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm and PR interval, especially in patients with pre-existing conduction abnormalities.

Timing: Prior to initiation, especially if cardiac history

Liver Function Tests (LFTs)

Rationale: Diltiazem is extensively metabolized by the liver; to assess baseline hepatic function.

Timing: Prior to initiation, especially in patients with suspected hepatic impairment

Renal Function Tests (RFTs)

Rationale: To assess baseline renal function, though dose adjustment is less critical than for hepatic impairment.

Timing: Prior to initiation

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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/quarterly)

Target: <130/80 mmHg (general hypertension target, individualized)

Action Threshold: Persistent hypotension (<90/60 mmHg) or inadequate BP control

Heart Rate (HR)

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

Target: 50-90 bpm (individualized)

Action Threshold: Persistent bradycardia (<50 bpm) or symptomatic bradycardia

Signs/Symptoms of Peripheral Edema

Frequency: Periodically, at each visit

Target: Absence of significant edema

Action Threshold: Development of significant or bothersome edema

Liver Function Tests (LFTs)

Frequency: Periodically, if clinically indicated or if signs of hepatic dysfunction develop

Target: Within normal limits

Action Threshold: Significant elevation of liver enzymes (e.g., >3x ULN)

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting (syncope)
  • Swelling of ankles/feet (peripheral edema)
  • Shortness of breath
  • Unusual fatigue or weakness
  • Slow or irregular heartbeat
  • Chest pain (angina, monitor for improvement or worsening)
  • Headache
  • Nausea

Special Patient Groups

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Pregnancy

Diltiazem is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for developmental abnormalities observed in animal studies at high doses. Human data are limited.
Second Trimester: Limited human data. Use only if clearly needed.
Third Trimester: Limited human data. Use only if clearly needed. Potential for effects on fetal heart rate or blood pressure.
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Lactation

Diltiazem is excreted in human breast milk. The American Academy of Pediatrics considers diltiazem to be compatible with breastfeeding, but caution is advised. Monitor the infant for potential adverse effects such as bradycardia, hypotension, or sedation.

Infant Risk: L3 (Moderate risk). Potential for infant bradycardia, hypotension, or drowsiness. Monitor infant closely.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established for hypertension or angina. Use is generally not recommended in children for these indications. Limited data exist for other specific conditions, but generally, it is not a first-line agent.

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Geriatric Use

Geriatric patients may be more sensitive to the hypotensive and bradycardic effects of diltiazem. Start with lower doses and titrate slowly, monitoring blood pressure and heart rate closely. Increased risk of peripheral edema.

Clinical Information

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Clinical Pearls

  • Matzim LA is an extended-release formulation designed for once-daily dosing. Emphasize to patients not to crush, chew, or divide the tablets.
  • Advise patients to take the medication at approximately the same time each day to maintain consistent drug levels.
  • Monitor heart rate and blood pressure regularly, especially during initiation and dose adjustments, to avoid excessive bradycardia or hypotension.
  • Educate patients about common side effects like peripheral edema (swelling of ankles/feet) and dizziness, and when to report them.
  • Caution patients about potential drug interactions, particularly with beta-blockers, digoxin, and CYP3A4 substrates (e.g., certain statins, immunosuppressants).
  • Remind patients to avoid grapefruit and grapefruit juice due to the risk of increased diltiazem levels and side effects.
  • Diltiazem is a non-dihydropyridine CCB, meaning it has significant effects on cardiac conduction and contractility, unlike dihydropyridines (e.g., amlodipine) which primarily affect vascular smooth muscle.
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Alternative Therapies

  • Other Calcium Channel Blockers (e.g., Amlodipine, Felodipine, Nifedipine for dihydropyridines; Verapamil for other non-dihydropyridine)
  • Beta-blockers (e.g., Metoprolol, Atenolol, Carvedilol)
  • ACE Inhibitors (e.g., Lisinopril, Ramipril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
  • Diuretics (e.g., Hydrochlorothiazide, Furosemide)
  • Nitrates (for angina, e.g., Isosorbide mononitrate, Nitroglycerin)
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Cost & Coverage

Average Cost: $20 - $150+ per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Generics are typically Tier 1 or 2; Brand names are typically Tier 2 or 3.
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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 for more information. If you have any questions or concerns about this 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.