Generic Micardis Telmisartan

1. MICARDIS HISTORY
(How was Micardis discovered?)

Micardis is a registered trademark of Boehringer Ingelheim. 

Boehringer Ingelheim was founded in Ingelheim am Rhein (Germany) in 1885, where the corporate headquarters are still located today.

Boehringer Ingelheim headquartered in Ingelheim, Germany, currently has nearly 36,000 employees and 144 affiliated companies spread around the globe.

The business of Boehringer Ingelheim consists Prescription Medicines, Consumer Health Care and Animal Health. Activities grouped under Industrial Customer, include Fine Chemicals and Biopharmaceuticals.

The focus is on the production of innovative drugs and treatments that represent major therapeutic advances. 

Note: World-drugs.net sells generic version of Micardis

2. MICARDIS FACTS

Micardis tablets contain the active ingredient telmisartan, which is a type of medicine called an angiotensin II receptor antagonist. It works by preventing the action of a hormone in the body called angiotensin II.

Angiotensin II normally acts on special receptors in the body, with two main results. Firstly, it causes the peripheral blood vessels to narrow, and secondly, it stimulates the production of another hormone called aldosterone. Aldosterone causes salt and water to be retained by the kidneys, which increases the volume of fluid in the blood vessels.

Micardis blocks the receptors that angiotensin II acts on, and so prevents its actions. The main result of this is that the peripheral blood vessels are allowed to widen, which means that there is more space and less resistance in these blood vessels. This is the main mechanism by which the pressure in the blood vessels is lowered.

Blocking the actions of angiotensin II also reduces the action of aldosterone on the kidneys. The result of this is an increase in the amount of fluid removed from the blood by the kidneys. This decreases the amount of fluid in the blood vessels, which also lessens the resistance and pressure in the blood vessels. 

3. ABOUT MICARDIS MEDICATION

What is High Blood Pressure (Hypertension)?

High blood pressure, also known as hypertension, is a serious disease affecting your heart and blood vessels. It occurs when the blood exerts too much pressure against the walls of the blood vessels. In fact, that is what the term hypertension means: "too much" (hyper) "pressure" (tension). It affects upwards of 58 million people nationwide.

 

High blood pressure is serious because it places you at risk for certain life threatening and disabling conditions. If left untreated, High blood pressure could lead to heart attack, kidney disease, and/or stroke.

This happens because as your blood continuously exerts too much pressure against the walls of the blood vessels, it places extra stress on the heart and blood vessels.

Blood pressure is measured in two numbers, systolic (top or higher number) and diastolic (lower number). The higher number is the maximum pressure, which occurs when the heart beats (systole), and the lower number is the lowest pressure measured when the heart relaxes between beats (diastole), just before the next contraction. A systolic reading of 140 or greater and a diastolic reading of 90 or greater is considered high.

The normal blood pressure is less than 120/80. In fact, for every 20/10 increase in blood pressure, your risk of cardiovascular events, such as heart attack or stroke, is DOUBLED.

Risk increases as blood pressure rises.

Symptoms of High Blood Pressure
High blood pressure is sometimes called the "silent killer" because the symptoms are rarely seen or felt. So, even though it might be upsetting to be told that you have High blood pressure, it's good that your doctor has discovered it. Treatment can help avoid the serious, long-term effects of High blood pressure.

What are antihypertensives?
Antihypertensives are medications used to treat High blood pressure (hypertension). Although some patients do not need to take medication to control their high blood pressure, anyone who is prescribed medication needs to take it exactly as prescribed to avoid the serious medical problems associated with the condition. People taking Antihypertensives are also encouraged to make healthy lifestyle changes, such as quitting smoking, losing weight and getting regular exercise. Furthermore, they are encouraged to speak with their physician before taking any prescription medications, such as narcotics, or over-the-counter medications, such as diet pills.
Finally, people with High blood pressure are urged to be patient as the type and level of their medication are adjusted for optimal results. This is especially important because the vast majority of patients have no symptoms, making hypertension the silent killer.

There are a wide variety of Antihypertensives and combinations of different medications that are available, and it may take some time before the ideal treatment has been found and finely tuned to the patients needs.

Antihypertensives include:

Diuretics ("water pills")
Diuretics are sometimes called "water pills" because they work in the kidney and flush excess water and sodium from the body.

Beta Blockers
Beta-blockers reduce nerve impulses to the heart and blood vessels. This makes the heart beat slower and with less force. Blood pressure drops and the heart works less hard.

Alpha Blockers
Alpha-blockers reduce nerve impulses to blood vessels, which allows blood to pass more easily, causing the blood pressure to go down.

Alpha-Beta Blockers
Alpha-beta-blockers work the same way as alpha-blockers but also slow the heartbeat, as beta-blockers do. As a result, less blood is pumped through the vessels and the blood pressure goes down.

Nervous System Inhibitors
Nervous system inhibitors relax blood vessels by controlling nerve impulses. This causes the blood vessels to become wider and the blood pressure to go down.

Angiotensin Converting Enzyme (ACE) Inhibitors
Angiotensin converting enzyme (ACE) inhibitors prevent the formation of a hormone called angiotensin II, which normally causes blood vessels to narrow. The ACE inhibitors cause the vessels to relax and blood pressure goes down

Calcium Channel Blockers
CCBs keep calcium from entering the muscle cells of the heart and blood vessels. This causes the blood vessels to relax and pressure goes down.

Angiotensin Receptor Blockers (formal medical name angiotensin-2-receptor antagonists, known as "sartans" for short). These agents are sometimes prescribed together, for instance an ACE inhibitor along with a calcium channel blocker.

Angiotensin antagonists shield blood vessels from angiotensin II. As a result, the vessels become wider and blood pressure goes down.

Common Angiotensin Receptor blockers include:

  • Candesartan
  • Valsartan
  • Eprosartan
  • Irbesartan
  • Losartan
  • Telmisartan  

4. MICARDIS EFFECTIVENESS
(When is Micardis best taken?)

Following oral administration, peak concentrations (Cmax) of Micardis are reached in 0.5-1 hour after dosing. Food slightly reduces the bioavailability of Micardis, with a reduction in the area under the plasma concentration-time curve (AUC) of about 6% with the 40 mg tablet and about 20% after a 160 mg dose. The absolute bioavailability of Micardis is dose dependent. At 40 and 160 mg the bioavailability was 42% and 58%, respectively. The pharmacokinetics of orally administered Micardis are nonlinear over the dose range 20-160 mg, with greater than proportional increases of plasma concentrations (Cmax and AUC) with increasing doses. Micardis shows bi-exponential decay kinetics with a terminal elimination half-life of approximately 24 hours. Trough plasma concentrations of Micardis with once daily dosing are about 10-25% of peak plasma concentrations. Micardis has an accumulation index in plasma of 1.5 to 2.0 upon repeated once daily dosing.  

5. MICARDIS EFFECTS ON SPECIAL POPULATION
(How do different people react to Micardis?)

Pregnancy
When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Micardis should be discontinued as soon as possible.

Pediatric:
Micardis pharmacokinetics have not been investigated in patients <18 years of age.

Geriatric:
The pharmacokinetics of Micardis do not differ between the elderly and those younger than 65 years.

Gender:
Plasma concentrations of Micardis are generally 2-3 times higher in females than in males. In clinical trials, however, no significant increases in blood pressure response or in the incidence of orthostatic hypotension were found in women. No dosage adjustment is necessary.

6.MICARDIS EFFECTS ON MEDICAL CONDITIONS
(How does Micardis affect your existing condition/ailment?)

Renal Insufficiency:
Renal excretion does not contribute to the clearance of Micardis modest experience in patients with mild -to-moderate renal impairment (creatinine clearance of 30-80 mL/min, mean clearance approximately 50 mL/min), no dosage adjustment is necessary in patients with decreased renal function. Micardis is not removed from blood by hemofiltration.

Hepatic Insufficiency:
In patients with hepatic insufficiency, plasma concentrations of Micardis are increased, and absolute bioavailability approaches 100%. 

7. OTHER/ALTERNATE USES OF MICARDIS
(What else does Micardis treat?)

Micardis may be used for other purposes if prescribed by your physician.

8. ADVERSE/SIDE EFFECTS of MICARDIS
(What are the side effects of Micardis?)

Micardis has been evaluated for safety in over 1700 patients, including 716 treated for over six months and 420 for over one year. In clinical trials with Micardis, no unexpected adverse events have been observed. Adverse experiences have been limited to those that have been previously reported with Micardis. The overall incidence of adverse experiences reported with the combination was comparable to placebo. Most adverse experiences were mild in intensity and transient in nature and did not require discontinuation of therapy.

Adverse events occurring at an incidence of 2% or more in patients treated with Micardis and at a greater rate than in patients treated with placebo, irrespective of their causal association, are presented in Table below.

 

Placebo

(N=74) (%)

Micardis

(N=209) (%)

Body as a whole

 

 

Fatigue

1

3

Influenza -like symptoms

1

2

Central/peripheral nervous system

 

 

Dizziness

1

4

Gastrointestinal system

 

 

Diarrhea

0

5

Nausea

0

1

Respiratory system disorder

 

 

Sinusitis

3

3

Upper respiratory tract infection

7

7

The following adverse events were reported at a rate less than 2% in patients treated with Micardis and at a greater rate than in patients treated with placebo: back pain, dyspepsia, vomiting, tachycardia, hypokalemia, bronchitis, pharyngitis, rash, hypotension postural, abdominal pain.

Finally, the following adverse events were reported at a rate of 2% or greater in patients treated with Micardis, but were as, or more common in the placebo group: pain, headache, cough, urinary tract infection.

Adverse events occurred at approximately the same rates in men and women, older and younger patients, and black and non-black patients.

In controlled trials (n=1017), 0.3% of patients treated with Micardis, 80/12.5 mg or 80/25 mg discontinued due to orthostatic hypotension, and the incidence of dizziness was 4%, 7%, and 1% respectively.