Matzim LA 420mg ER Tablets

Manufacturer ACTAVIS 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
Antihypertensive, Antianginal, Antiarrhythmic
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Pharmacologic Class
Calcium Channel Blocker (Non-dihydropyridine)
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Pregnancy Category
Category C
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FDA Approved
Aug 2007
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Matzim LA is a type of medicine called a calcium channel blocker. It works by relaxing blood vessels in your body and heart, which helps to lower blood pressure and reduce chest pain (angina). It also helps to slow down your heart rate, which can be useful for certain heart rhythm problems. This is an extended-release tablet, meaning it releases the medicine slowly over 24 hours.
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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.
Keep it in a dry place, avoiding storage in a bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.

What to Do If You Miss a Dose

If you miss a dose of your medication:

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 Matzim LA exactly as prescribed, usually once daily. Do not crush, chew, or divide the tablet.
  • Maintain a healthy diet, low in sodium and saturated fats.
  • Engage in regular physical activity as advised by your doctor.
  • Limit alcohol consumption.
  • Avoid smoking.
  • Monitor your blood pressure and heart rate regularly at home if advised by your doctor.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the levels of diltiazem in your body.

Dosing & Administration

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Adult Dosing

Standard Dose: 420 mg orally once daily
Dose Range: 120 - 540 mg

Condition-Specific Dosing:

hypertension: Initial dose typically 180-240 mg once daily, titrated up to 420 mg once daily based on response. Matzim LA 420mg is a specific strength for maintenance.
chronicstableangina: Initial dose typically 120-180 mg once daily, titrated up to 420 mg once daily based on response. Matzim LA 420mg is a specific strength for maintenance.
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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 specific adjustment, use with caution.
Moderate: No specific adjustment, use with caution.
Severe: Use with caution, monitor closely for exaggerated effects.
Dialysis: Diltiazem is not significantly removed by dialysis. Use with caution, monitor closely.

Hepatic Impairment:

Mild: Consider lower starting dose and careful titration.
Moderate: Consider lower starting dose and careful titration due to reduced clearance.
Severe: Contraindicated in severe hepatic impairment or use with extreme caution and significant dose reduction.

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 action leads to relaxation of vascular smooth muscle, resulting in coronary vasodilation and peripheral arterial vasodilation, which reduces systemic vascular resistance and blood pressure. It also decreases myocardial contractility and slows conduction through the sinoatrial (SA) and atrioventricular (AV) nodes, leading to a reduction in heart rate and a negative dromotropic effect.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-60% (due to extensive first-pass metabolism for ER formulations)
Tmax: 10-14 hours (for extended-release formulations)
FoodEffect: Food may increase the rate and extent of absorption.

Distribution:

Vd: Approximately 5.3 L/kg
ProteinBinding: 70-85%
CnssPenetration: Limited

Elimination:

HalfLife: 5-10 hours (terminal half-life for ER formulations can be up to 14 hours)
Clearance: Approximately 1.1 L/min
ExcretionRoute: Primarily renal (60-65%) and fecal (35%)
Unchanged: <4% (in urine)
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Pharmacodynamics

OnsetOfAction: Gradual (for ER formulations)
PeakEffect: Corresponds to Tmax (10-14 hours)
DurationOfAction: 24 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Immediately

While rare, some people may experience severe and potentially life-threatening side effects when 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
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ 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), characterized by:
+ 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, which may be life-threatening
+ Signs of severe skin reactions include:
- Red, swollen, blistered, or peeling skin
- Skin irritation (with or without fever)
- Red or irritated eyes
- Sores in the mouth, throat, nose, or eyes

Other Possible Side Effects

Most people experience either no side effects or only mild side effects when taking this medication. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Headache
* Feeling dizzy, tired, or weak

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
  • Unusual swelling in your ankles, feet, or legs.
  • Shortness of breath or difficulty breathing.
  • Very slow heart rate (e.g., less than 50 beats per minute) or irregular heartbeat.
  • Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, severe stomach pain).
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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 treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
Certain types of abnormal heart rhythms, as this medication is not suitable for use with these conditions. 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 existing health problems. Your doctor and pharmacist need this information to assess potential interactions and ensure safe treatment. Never start, stop, or adjust the dosage 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 down 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 this medication and during treatment. Discuss any concerns 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 supplements.

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, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Profound bradycardia (very slow heart rate)
  • Severe hypotension (very low blood pressure)
  • First-, second-, or third-degree atrioventricular (AV) block
  • Asystole (cardiac arrest)
  • Cardiogenic shock
  • Congestive heart failure

What to Do:

In case of suspected overdose, seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment may involve supportive care, IV fluids, atropine, calcium gluconate, vasopressors, or cardiac pacing.

Drug Interactions

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Contraindicated Interactions

  • Ivabradine (increased risk of bradycardia)
  • Patients with sick sinus syndrome or second- or third-degree AV block (unless a functional ventricular pacemaker is present)
  • Patients with severe hypotension (systolic blood pressure <90 mmHg)
  • Patients with acute myocardial infarction and pulmonary congestion
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Major Interactions

  • Beta-blockers (e.g., metoprolol, carvedilol): Increased risk of bradycardia, AV block, and myocardial depression.
  • Amiodarone: Increased risk of severe bradycardia, sinus arrest, and AV block.
  • Digoxin: Increased digoxin serum concentrations (monitor digoxin levels).
  • Statins (e.g., simvastatin, lovastatin, atorvastatin): Increased statin concentrations due to CYP3A4 inhibition, leading to increased risk of myopathy/rhabdomyolysis.
  • Fentanyl: Increased fentanyl exposure, potentially leading to respiratory depression.
  • Dantrolene (IV): Risk of cardiovascular collapse.
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Moderate Interactions

  • Alpha-blockers (e.g., prazosin, doxazosin): Additive hypotensive effects.
  • Other antihypertensives: Additive hypotensive effects.
  • CYP3A4 substrates (e.g., cyclosporine, tacrolimus, carbamazepine, midazolam, quinidine, sildenafil): Increased concentrations of these drugs.
  • Grapefruit juice: May increase diltiazem plasma concentrations.
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Minor Interactions

  • Cimetidine: May increase diltiazem levels.
  • Rifampin: May decrease diltiazem levels.

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 conduction, especially for pre-existing AV block or sick sinus syndrome.

Timing: Prior to initiation

Liver Function Tests (LFTs)

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

Timing: Prior to initiation

Renal Function (BUN, Creatinine)

Rationale: To assess baseline renal function, as metabolites are renally excreted.

Timing: Prior to initiation

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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: Hypotension (e.g., SBP <90 mmHg or symptomatic hypotension); inadequate BP control.

Heart Rate (HR)

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

Target: Typically >50-60 bpm, individualized.

Action Threshold: Bradycardia (<50 bpm or symptomatic bradycardia).

Electrocardiogram (ECG)

Frequency: Periodically, especially with dose changes or if symptoms of conduction abnormalities occur.

Target: Normal sinus rhythm, PR interval <0.20 seconds.

Action Threshold: Prolonged PR interval, new onset AV block, or other arrhythmias.

Signs of Peripheral Edema

Frequency: Regularly, at each visit.

Target: Absence of significant edema.

Action Threshold: Development of new or worsening peripheral edema.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting (syncope)
  • Shortness of breath
  • Swelling in ankles, feet, or legs
  • Unusual fatigue or weakness
  • Chest pain (angina) frequency/severity
  • Palpitations or irregular heartbeat

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies at high doses.
Second Trimester: Limited human data; potential for fetal bradycardia or other cardiovascular effects.
Third Trimester: Potential for fetal bradycardia or other cardiovascular effects; may inhibit labor.
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Lactation

Diltiazem is excreted into breast milk. While the amount is generally considered low, monitor breastfed infants for signs of adverse effects, particularly bradycardia, hypotension, or sedation. The American Academy of Pediatrics considers diltiazem compatible with breastfeeding.

Infant Risk: Low to moderate risk. Monitor for bradycardia, hypotension, and 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

Geriatric patients may be more sensitive to the effects of diltiazem, particularly regarding hypotension and bradycardia. Lower starting doses and careful titration are recommended. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Matzim LA is an extended-release formulation and must be swallowed whole; do not crush, chew, or divide the tablet.
  • Take consistently once daily, preferably at the same time each day.
  • Patients should be advised to avoid grapefruit and grapefruit juice due to potential for increased diltiazem levels.
  • Monitor heart rate and blood pressure regularly, especially during initiation and dose adjustments.
  • Peripheral edema is a common side effect; differentiate from heart failure.
  • Caution is advised when co-administering with beta-blockers or other drugs that slow AV nodal conduction due to increased risk of bradycardia and AV block.
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Alternative Therapies

  • Other calcium channel blockers (e.g., amlodipine, felodipine, verapamil)
  • Angiotensin-converting enzyme (ACE) inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin receptor blockers (ARBs) (e.g., losartan, valsartan)
  • Thiazide diuretics (e.g., hydrochlorothiazide)
  • Beta-blockers (e.g., metoprolol, atenolol)
  • Other antianginal agents (e.g., nitrates, ranolazine)
  • Other antiarrhythmic agents (e.g., beta-blockers, amiodarone, digoxin)
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Cost & Coverage

Average Cost: $100 - $300+ per 30 tablets (Matzim LA 420mg)
Generic Available: Yes
Insurance Coverage: Tier 2-3 (for brand Matzim LA); Tier 1-2 (for generic diltiazem ER)
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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 taken, the amount, and the time it happened.