Novaduc-40 Windlas treatment for hypertension (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Telmisartan

Ingredient

Composition information	Content
Telmisartan	40mg

Uses

Indications

Novaduc 40 are indicated in the following cases:

Treatment of monochromatic hypertension or in combination with other anti -hypertension drugs. Reason

Angiotensin II receptor antagonistic drugs.

ATC code: C09CA07

Mechanism of impact

Telmisartan is an Angiotensin II receptor antagonist (AT1 type) and uses oral effectively. Telmisartan replaces Angiotensin II with a very strong affinity from the location attached to the position next to the AT1 receptor, responsible for the known activities of Angiotensin II.

Telmisartan does not show any partial transportation activity at the AT1 receptor. Telmisartan is selected with AT1 receptor. Sustainable links lasting. Telmisartan does not show affinity for other receptors, including AT2 and other less characteristic AT receptors. People do not know the function of these receptors as well as the effectiveness of excessive stimulation they may be by angiotensin II, when angiotensin II concentration increases due to telmisartan.

Telmisartan reduces the amount of aldosteron in the blood. Telmisartan does not inhibit human blood renin or does not choose ion channels. Telmisartan does not inhibit the enzyme in the form of angiotensin (Kinase II), which works to degenerate Bradykinin. Therefore, there are no side effects caused by intermediate Bradykinin.

In humans, Telmisartan 80 mg dose almost completely inhibited Angiotensin II causing hypertension. The inhibitory effect is maintained for 24 hours and is still up to 48 hours.

Effective and safe in the treatment of idiopathic hypertension

After the first Telmisartan dose, the hypotension effect will gradually be clearer within 3 hours. Hypotension effects most effectively after about 4-8 weeks of treatment and is maintained when long -term treatment. The effect of lowering the pressure stabilizes continuously for 24 hours after taking the drug, including the last 4 hours before taking the next dose. This is confirmed by the base/peak curve to always reach over 80% after taking the dose of 40 mg and 80 mg Telmisartan in clinical studies to control with placebo.

There is a clear tendency for the relationship between the dose and the time for the systolic blood pressure to return to the original level. In this respect, data related to diastolic blood pressure is inconsistent. In hypertension patients, Telmisartan has the effect of reducing both systolic and diastolic blood pressure without affecting the heart rate.

Telmisartan's lowering effects are equivalent to medications for hypertension in other groups (prove through clinical studies comparing telmisartan with amlodipine, atenolol, enalapril, hydrochlorothiazid and lisinopril). If stopped with Telmisartan, blood pressure will gradually return to the value before treatment after a few days without the phenomenon of hypertension.

The rate of dry cough in patients using Telmisartan is significantly lower than those who use Angiotensin -shifting enzyme inhibitors.

Pharmacokinetics

absorption

Telmisartan absorbs fast, although the absorption amount changes. Absolute bioavailability is about 50%on average. When taking Telmisartan along with food, the area under the plasma concentration curve over time (AUC) decreased from 6% (dose of 40 mg) to about 19% (at a dose of 160 mg). Telmisartan's plasma concentrations or food after 3 hours are similar. Non -linear linear levels: AUC reduces less, does not reduce the effectiveness of treatment.

Distribution

Telmisartan is mostly linked to plasma proteins (> 99.5%), mainly with albumin and alpha-1 acid Glycoprotein. The average indicator distribution is in the stable state of Telmisartan about 500 l.

Metabolism

Telmisatan metabolizes by the reaction with glucuronid of the original compound that creates a non -pharmacological activity.

Elimination

Telmisartan is eliminated by the second -level dynamic equation with the final selling time of more than 20 hours. The maximum plasma concentration (CMAX) and the decrease in AUC increases not commensurate with the dose. There is no clinically related evidence of Telmisartan's accumulation at the recommended dose.

Before taking Novaduc-40 Windlas treatment for hypertension (3 blisters x 10 tablets)

How to use

oral medication.

Dosage

recommended dose is 40 mg, once a day.

Some patients may work at a dose of 20 mg/day.

Can increase the dose of Telmisartan to a maximum dose of 80 mg, once a day to achieve target blood pressure.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

Symptoms

The most prominent expression of Telmisartan is hypotension and tachycardia. There are also reports on slow heart rate, dizziness, vomiting, increased serum creatinine and acute renal failure.

Treatment

Telmisartan is not excluded by dialysis. Patients should be closely monitored, symptomatic treatment and support treatment when needed. The processing depends on the time from the absorption of drugs and the severity of symptoms.

Suggested measures include vomiting and/or gastric wash. Activated carbon can work in the treatment of overdose. The electrolytes and serum creatinine should be monitored regularly. If hypotension occurs, patients should be placed in a lying position, quickly for compensation and salt.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Novaduc 40 often has unwanted effects (ADR).

Common, ADR> 1/100

Respiratory: Upper respiratory infection, sinusitis.

Body: back pain.

Uncommon, 1/1000

Neurological: helpless, migraine.

Metabolism: Gout.

Unknown frequency

Allergy: rash.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Contraindicated

Novaduc 40 Contraindicated for use in the following cases:

Hypersensitivity to active ingredients or any excipients of the drug.

Women who are 3 months pregnant between and the last 3 months of pregnancy.

Lactating women.

Pathological stasis and bile congestion.

severe liver failure.

Severe kidney failure.

Caution when using

pregnancy

Do not start treatment with angiotensin II receptor receptors during pregnancy. Unless the continued treatment with the necessary Angiotensin II receptor drugs, female patients if there is a plan to become pregnant, they should switch to alternative hypertension therapy that has drug safety data proved to be used during pregnancy. If pregnant is detected, Angiotensin II receptor is detected immediately and if necessary, should start with replacement therapy.

Hepatic failure

Do not use Telmisartan for patients with bile stasis, bile congestion disorders or severe liver failure, because Telmisartan is excreted mainly through bile. Telmisartan clearance is impaired in these patients. Telmisartan should be used carefully in patients with mild and medium liver function impairment.

Hypertension caused by kidney disease

Increased the risk of strong hypotension and renal failure when the patient has narrowing of the kidney artery on both sides, or the artery stenosis of a kidney is still active to be treated with drugs that affect the Renin-Anotensin-Aldosteron system.

kidney failure and kidney transplant

When Telmisartan is used in patients with renal function, periodic monitoring of potassium and serum creatinine should be monitored. There is no experience using Telmisartan in new kidney transplant patients.

The ability to drive and operate machinery

There is no research on the effects of the drug on the ability to drive and control machinery. However, when driving or operating machinery, it is important to pay attention to the feeling of dizziness or drowsiness can sometimes occur during the treatment of hypertension.

Pregnancy

It is not recommended to use Angiotensin II receptor anti -receptor drugs in the first 3 months of pregnancy. Contraindicated using Angiotensin II receptor drugs in 3 months between and at the end of pregnancy.

The breastfeeding period

Because there is no information on the use of Telmisartan during breastfeeding, it is not recommended to use Telmisartan and priority for alternatives with safe data has been determined during this period, especially for infants and children who are born monthly.

Interactive drug

like drugs that affect the renin-angiotensin-aldosteron system, Telmisartan may cause hyperkalemia. The coordination of treatment with other drugs may also increase the risk of hyperkalemia (salt-alternative drugs containing potassium, potassium-keeping diuretics, angiotensin-shaped enzyme inhibitors, angiotensin II receptor anti-receptor, non-steroid an anti-inflammatory anti-inflammatory anti-inflammatory (NSAIDs, including COX-2 inhibitors), Heparin, immunosuppressants (cyclosporin or tacrolimus), and, and tacrolimus) trimethoprim).

Hemolytic hyperpass depends on related risk factors. The risk will increase when combining the above treatment. Especially high risk when combined with potassium diuretics and salt replacement drugs containing potassium. The combination with the enzyme inhibitor in the form of angiotensin or nsaids should be cautious when used.

Storage

Store in a cool dry place, below 30 ° C, avoid moisture.

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