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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Trandolapril And Verapamil Hydrochloride
Brand Name
Trandolapril And Verapamil Hydrochloride
Generic Name
Trandolapril And Verapamil Hydrochloride
Active Ingredient
TrandolaprilCategory
Angiotensin Converting Enzyme Inhibitor [EPC]
Variants
4
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Trandolapril And Verapamil Hydrochloride, you must consult a qualified healthcare professional.
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| 2 mg/1 | TABLET, FILM COATED, EXTENDED RELEASE | ORAL | 68462-295 |
Detailed information about Trandolapril And Verapamil Hydrochloride
Trandolapril is a potent, long-acting Angiotensin-Converting Enzyme (ACE) inhibitor used primarily to treat hypertension and improve survival in patients following a myocardial infarction (heart attack). It works by relaxing blood vessels to lower blood pressure and reduce the workload on the heart.
Dosage for Trandolapril is highly individualized based on the patient's clinical response and the condition being treated. Healthcare providers typically start with a low dose and 'titrate' (gradually increase) the dose to reach the desired therapeutic effect.
The safety and effectiveness of Trandolapril in pediatric patients (children under 18 years of age) have not been established. Consequently, healthcare providers generally do not prescribe this medication for children. Alternative antihypertensive agents with more robust pediatric data are typically preferred in this population.
Since Trandolaprilat is partially eliminated by the kidneys, dose adjustments are necessary for patients with significant renal dysfunction. For patients with a creatinine clearance (a measure of kidney function) of less than 30 mL/min, the starting dose is typically reduced to 0.5 mg once daily, with careful monitoring of kidney function and potassium levels.
In patients with severe hepatic (liver) impairment, such as cirrhosis, the conversion of the prodrug to its active form may be reduced. While specific guidelines vary, healthcare providers usually start these patients at 0.5 mg and monitor their clinical response closely.
Pharmacokinetic studies suggest that older adults may have higher plasma concentrations of the active metabolite. However, clinical trials have shown that the drug is generally well-tolerated in the elderly. Starting at the lower end of the dosing range (0.5 mg to 1 mg) is a common precautionary measure to avoid excessive hypotension (low blood pressure).
To ensure the best results and minimize side effects, follow these guidelines:
If you miss a dose of Trandolapril, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not take two doses at once to make up for a missed one, as this significantly increases the risk of severe low blood pressure.
An overdose of Trandolapril can lead to severe hypotension (extremely low blood pressure), shock, electrolyte imbalances (such as high potassium), and kidney failure. Symptoms may include extreme dizziness, lightheadedness, fainting, or a rapid or unusually slow heartbeat.
Emergency Measures: If an overdose is suspected, contact your local poison control center or seek emergency medical attention immediately. Treatment usually involves supportive care, such as intravenous fluids to raise blood pressure.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without medical guidance, as stopping suddenly can cause your blood pressure to spike.
While many patients tolerate Trandolapril well, some side effects are relatively frequent. The most characteristic side effect of the ACE inhibitor class is a persistent, dry, non-productive cough.
Trandolapril is a powerful cardiovascular medication that requires careful medical supervision. It is not suitable for everyone, and certain precautions must be taken to ensure patient safety. Patients must be aware that the first few doses may cause a significant drop in blood pressure, especially if they are also taking diuretics or are dehydrated. It is recommended to take the first dose at bedtime or under close observation.
There are several scenarios where Trandolapril must NEVER be used because the risks far outweigh any potential benefits:
Trandolapril is classified as pregnancy category D (in older systems) and carries a strong warning against use during the second and third trimesters. The use of drugs that act on the renin-angiotensin system during the first trimester has also been linked to an increased risk of cardiovascular and neurological malformations in the fetus.
Limited data suggest that Trandolapril may be excreted in human breast milk in very small amounts. Because of the potential for serious adverse reactions in nursing infants (including kidney issues and low blood pressure), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. In many cases, healthcare providers prefer using ACE inhibitors with more established safety data in breastfeeding, such as Enalapril or Captopril.
Trandolapril is a prodrug that is hydrolyzed in the liver to its active diacid form, Trandolaprilat. Trandolaprilat is a potent, competitive inhibitor of Angiotensin-Converting Enzyme (ACE). ACE is a peptidyl dipeptidase that catalyzes the conversion of Angiotensin I to the potent vasoconstrictor Angiotensin II.
By inhibiting ACE, Trandolaprilat reduces the levels of Angiotensin II, which leads to:
Common questions about Trandolapril And Verapamil Hydrochloride
Trandolapril is primarily prescribed to treat hypertension, also known as high blood pressure. By lowering blood pressure, it helps prevent serious complications such as strokes, heart attacks, and kidney problems. Additionally, healthcare providers use Trandolapril to improve survival in patients who have suffered a heart attack and have a weakened heart (left ventricular dysfunction). It works by relaxing the blood vessels so blood can flow more easily. Some doctors may also use it off-label to protect the kidneys in patients with diabetes. Always use this medication exactly as prescribed by your healthcare professional.
The most frequently reported side effect of Trandolapril is a persistent, dry cough, which affects up to 15% of users. This cough is a class-wide effect of ACE inhibitors and is caused by the buildup of certain chemicals in the lungs. Other common side effects include dizziness, lightheadedness, and headache, particularly when you first start the medication. Some patients may also experience fatigue or a mild skin rash. Most of these effects are mild, but if the cough becomes bothersome, your doctor may switch you to a different class of medication. If you experience swelling of the face or difficulty breathing, seek emergency help immediately.
It is generally recommended to limit or avoid alcohol while taking Trandolapril. Alcohol can have an additive effect with the medication, causing your blood pressure to drop lower than intended. This can lead to increased dizziness, lightheadedness, and a higher risk of fainting or falling, especially when standing up quickly. Furthermore, chronic heavy alcohol use can interfere with blood pressure management in general. If you choose to drink, do so in moderation and monitor how it affects your balance and alertness. Discuss your alcohol consumption habits with your doctor to ensure your safety.
No, Trandolapril is not safe during pregnancy and carries a strict FDA Black Box Warning. Taking this medication during the second and third trimesters can cause severe injury or even death to the developing fetus by damaging its kidneys and skull. There is also evidence suggesting that use in the first trimester may increase the risk of birth defects. If you are planning to become pregnant or find out that you are pregnant while taking Trandolapril, you must contact your healthcare provider immediately. They will transition you to a safer blood pressure medication that does not affect the renin-angiotensin system.
Trandolapril begins to lower blood pressure within about 1 to 2 hours after the first dose is taken. However, the full therapeutic effect on your blood pressure may not be realized for several weeks. Most healthcare providers will wait 2 to 4 weeks before deciding if your dose needs to be adjusted. For patients taking it after a heart attack, the benefits in terms of heart protection are long-term and may not be 'felt' immediately. It is important to continue taking the medication even if you feel well, as hypertension often has no symptoms.
You should never stop taking Trandolapril suddenly without consulting your doctor. Discontinuing the medication abruptly can cause your blood pressure to rise quickly, a condition known as rebound hypertension. This sudden spike increases your risk of experiencing a heart attack or stroke. If you need to stop the medication due to side effects or a change in treatment, your doctor will provide a schedule to gradually reduce your dose. Always ensure you have a sufficient supply of the medication so you do not miss doses unexpectedly.
If you miss a dose of Trandolapril, take it as soon as you remember that same day. However, if it is already close to the time for your next scheduled dose, you should skip the missed dose and simply take the next one at your regular time. Never take two doses at once to make up for a missed one, as this can cause your blood pressure to drop to dangerously low levels. To help you remember your medication, try taking it at the same time every day, such as right after brushing your teeth in the morning.
Weight gain is not a typical side effect of Trandolapril. If you notice a sudden or significant increase in weight while taking this medication, it may be a sign of fluid retention, which could indicate that your heart or kidneys are not functioning properly. Swelling in the ankles, feet, or hands (edema) should be reported to your doctor immediately. While the drug itself doesn't cause fat accumulation, any rapid weight change in a cardiovascular patient requires medical evaluation. Always monitor your weight regularly if you have a history of heart failure.
Trandolapril can interact with several other medications, so it is vital to keep your doctor informed of everything you take. It is often safely combined with other blood pressure drugs like calcium channel blockers or diuretics, but combining it with potassium supplements or potassium-sparing diuretics can lead to dangerously high potassium levels. It should never be taken with Entresto (sacubitril/valsartan) due to the risk of severe swelling. NSAIDs like ibuprofen can also reduce its effectiveness and harm the kidneys. Always check with a pharmacist before starting any new over-the-counter drugs or supplements.
Yes, Trandolapril is available as a generic medication, which is typically much more affordable than the original brand-name version, Mavik. Generic versions are required by the FDA to have the same active ingredient, strength, dosage form, and route of administration as the brand-name drug. They must also prove bioequivalence, meaning they work in the body the same way. Most insurance plans cover generic Trandolapril. If you have questions about the cost or availability of the generic version, consult your pharmacist or insurance provider.
Other drugs with the same active ingredient (Trandolapril)
> Warning: Stop taking Trandolapril and call your doctor immediately if you experience any of these serious symptoms.
With prolonged use, the primary concern is the impact on renal (kidney) function. While ACE inhibitors generally protect the kidneys in diabetic patients, they can cause a decline in function in patients with bilateral renal artery stenosis (narrowing of the arteries to both kidneys). Regular monitoring of serum creatinine and potassium is essential for long-term safety. Some patients may also experience a gradual decrease in hemoglobin levels, though this is rarely clinically significant.
Trandolapril carries a FDA Black Box Warning regarding fetal toxicity.
Report any unusual symptoms to your healthcare provider immediately. Early detection of side effects is key to managing your cardiovascular health safely.
There is a risk of angioedema (rapid swelling under the skin) involving the extremities, face, lips, mucous membranes, tongue, glottis, or larynx. If the swelling involves the tongue or upper airway, it can cause fatal airway obstruction. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk. Black patients have been reported to have a higher incidence of angioedema compared to non-Black patients.
Excessive hypotension is rare in patients with uncomplicated hypertension but may occur in patients who are volume-depleted (e.g., those on high-dose diuretics, undergoing dialysis, or suffering from severe vomiting/diarrhea). In patients with heart failure, Trandolapril may cause excessive hypotension, which may be associated with oliguria (low urine output) or progressive azotemia (buildup of nitrogen waste).
In patients with severe heart failure or renal artery stenosis, ACE inhibitors can lead to acute renal failure. Healthcare providers will monitor kidney function closely, especially during the first few weeks of therapy.
Elevated serum potassium can occur, particularly in patients with renal impairment, diabetes mellitus, or those using potassium-sparing diuretics or potassium supplements. Potassium levels must be monitored periodically.
To ensure the medication is working safely and effectively, your doctor will likely order the following tests:
Trandolapril can cause dizziness, lightheadedness, or fatigue, particularly when starting the medication or after a dose increase. Patients should be cautious when driving or operating heavy machinery until they know how the medication affects them.
Alcohol can enhance the blood-pressure-lowering effect of Trandolapril, leading to an increased risk of dizziness, fainting, and falls. It is generally advised to limit or avoid alcohol consumption while taking this medication.
Do not stop taking Trandolapril abruptly. Stopping the medication suddenly can cause a rapid increase in blood pressure (rebound hypertension), which increases the risk of heart attack or stroke. If the medication needs to be stopped, your doctor will provide a tapering schedule.
> Important: Discuss all your medical conditions, including any history of kidney disease, liver disease, or heart problems, with your healthcare provider before starting Trandolapril.
For each major interaction, the management strategy usually involves dose adjustment, increased frequency of laboratory monitoring, or selecting an alternative medication.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. A complete list helps prevent dangerous drug-drug interactions.
In these conditions, healthcare providers will perform a careful risk-benefit analysis before prescribing Trandolapril:
Patients who are allergic to one ACE inhibitor are highly likely to be allergic to others in the same class. There is also a theoretical risk of cross-sensitivity in patients who have had severe allergic reactions to other drugs that affect the RAAS system, though this is less common. Always inform your provider of any past drug allergies.
> Important: Your healthcare provider will evaluate your complete medical history, including any rare genetic conditions or previous drug reactions, before prescribing Trandolapril.
Trandolapril is not approved for use in children. The pharmacokinetics and safety profile in pediatric patients have not been studied. Conditions requiring blood pressure management in children are usually treated with medications that have specific pediatric labeling and dosing guidelines.
Clinical studies did not identify overall differences in safety or effectiveness between patients over 65 and younger patients. However, older adults are more likely to have decreased renal function and may be taking multiple other medications (polypharmacy).
In patients with impaired renal function, the half-life of Trandolaprilat is prolonged. Dose adjustments are mandatory for those with a GFR (Glomerular Filtration Rate) below 30 mL/min. These patients are at a much higher risk for developing hyperkalemia and should have their electrolytes checked frequently.
In patients with hepatic cirrhosis, plasma concentrations of Trandolapril were higher, but concentrations of the active metabolite (Trandolaprilat) were not significantly affected. Nevertheless, since the liver is responsible for the activation of the drug, patients with severe liver disease should be started on the lowest possible dose (0.5 mg) and monitored closely for therapeutic response.
> Important: Special populations require individualized medical assessment and more frequent monitoring to ensure the safe use of Trandolapril.
| Parameter | Value |
|---|---|
| Bioavailability | ~10% (Trandolapril), ~70% (Trandolaprilat) |
| Protein Binding | ~80% (Trandolaprilat) |
| Half-life | 10-24 hours (Trandolaprilat terminal half-life) |
| Tmax | 1 hour (Trandolapril), 4-10 hours (Trandolaprilat) |
| Metabolism | Hepatic hydrolysis to Trandolaprilat |
| Excretion | Renal 33%, Fecal 66% |
Trandolapril belongs to the Angiotensin-Converting Enzyme (ACE) Inhibitor class. Related medications include Lisinopril, Enalapril, Ramipril, and Benazepril. Among these, Trandolapril is noted for its high lipophilicity and long duration of action, allowing for consistent 24-hour coverage.