Bluepine Bluepharma treatment for hypertension (6 blisters x 10 tablets)

Dosage form Box of 6 blisters x 10 tablets
Specifications Amlodipine
Ingredient Bluepharma Industria Farmaceutical, S.A.

Ingredient

Composition information	Content
Amlodipine	5mg

Uses

Indications

Bluepine is indicated for hypertension treatment (in patients with metabolic complications such as diabetes) and preventive treatment in stable angina patients.

Pharmacokological

amlodipine is a derivative of dihydropyridine that has a calcium blocker through cell membranes. Amlodipine prevents calculus channel L depending on the voltage, acting on blood vessels in the heart and muscle.

Amlodipine has anti -hypertension effects by directly relaxing smooth muscles around the peripheral artery and has less effect on myocardial calcium channel. Therefore, the drug does not conduct the atrial transmission in the heart worse and does not adversely affect the muscle force. Amlodipine also has a good effect of reducing kidney blood vessels, thus increasing blood flow in the kidneys and improving kidney function. So the drug can also be used to treat people with heart failure.

Amlodipine has no adverse effects on plasma lipid concentrations or metabolism.

glucose, so amlodipine can be used to treat hypertension in diabetes.

However, there are no long -term clinical trials to prove that Amlodipine has the effect of reducing death.

In many countries, the standard treatment to protect patients with hypertension from stroke and death is still beta and diuretics, these drugs are first selected for treatment. However, Amlodipine can be used in combination with beta blockers along with thiazid or diuretics and along with angiotensin conversion enzyme inhibitors.

Amlodipine has a good effect on standing, lying as well as sitting and while working. Because amlodipine is slowly acting, there is little risk of acute hypotension or reflective tachycardia.

Anti -angina effect: Amlodipine relaxes peripheral arteries, thus reducing the entire obstacle in the peripheral circuit (after the burden of the burden). Because the heart frequency is not affected, the post -burden of the heart reduces the heart, along with reducing the need for oxygen and energy to the heart muscle. This reduces the risk of angina.

In addition, amlodipine also causes coronary artery dilatation both in ischemic area and the area is provided with normal blood. This vasodilation increases the supply of oxygen for patients with cramped angina (Prinzmetal angina).

This reduces nitroglycerin demand and in this way, the risk of nitroglycerin resistance may decrease. The time for anti -angina effect is 24 hours. Agina patients can use Amlodipine in combination with beta blockers and always use with nitrate (basic treatment of angina).

pharmacokinetic

absorption:

After taking the treatment dose, Amlodipine is well absorbed with peak concentration in plasma reaching about 6 to 12 hours after drinking. Absolute bioavailability is estimated at 64% - 80%. The distribution volume is 21 l/kg.

Amlodipine's absorption is not affected by food.

Metabolism/excretion:

Amlodipine's plasma semi -discharged time is about 35 to 50 hours and is suitable for the dosage once a day. The concentration in the state of plasma is achieved after 7 to 8 days of continuous drug use.

amlodipine is metabolized largely in the liver into non -active metabolites.

10% of the initial substance and 60% of metabolic substances are eliminated in the urine.

Used in the elderly:

Time to reach the peak concentration of amlodidine plasma is the same between the elderly and young people. However, Amlodipine's clearance tends to decrease with an increase in the area under the curve (AUC) and the sale time in elderly patients.

The area under the curve and the sale time also increases in patients with congestion heart failure.

Use in children:

In a regular approach clinical study, 73 patients from 12 months to 17 years old have high blood pressure, with an average daily amlodipine dosage of 0.17 mg/kg. The clearance in these pediatric patients with an average weight of 45 kg is 23.7 l/hour and 17.6 l/hour respectively for men and women.

This clearance is also within the same limit as the assessment announced in the 70 kg adult adults is 24.8 l/hour. The average distribution voltage in patients with a weight of 45 kg is 1130 l (25.11 l/kg).

The effect of maintaining blood pressure for more than 24 hours with the observed dosage is very few differences in maximum and minimum fluctuations. When compared with pharmacokinetics in adults, the parameters in this study show that the one -time dose per day is appropriate.

Before taking Bluepine Bluepharma treatment for hypertension (6 blisters x 10 tablets)

How to use

oral drugs. Use as directed by the treating doctor.

Amlodipine can drink not to mention meals.

Dosage

The usual dose:

The starting dose is 5 mg, once a day. The dose may increase to 10 mg for 1 time in 1 day. If the effect does not work after 4 weeks of treatment can increase the dose.

There is no need to adjust the amlodipine dose in case of use in conjunction with thiazide diuretics, beta receptor inhibitors or angiotensin transfer enzymes inhibitors.

Used in the elderly:

Should be used in normal dose. Overall amlodipine is well tolerated, should be used at the same dose for both elderly and young patients.

Use in children:

Dosage indications for high blood treatment for oral intake of pediatric patients from 6 to 17 years old is 2.5 mg to 5 mg once a day. The dose exceeds 5 mg daily has not been studied in pediatric patients.

Not known the effectiveness of amlodipine on blood pressure in patients under 6 years old.

Used in patients with liver function:

Like all other calcium channel blockers, Amlodipine's waste time is prolonged in patients with impaired liver function, so it is necessary to be used cautiously in these patients.

Used in patients with renal failure:

Can use amlodipine at normal doses for these patients. The change of amlodipine concentration in plasma is not related to the level of renal failure. Amlodipine is not separated.

What to do when overdose? The lag of prolonged blood pressure may be prolonged and including death shock.

Amlodipine absorption is significantly reduced when using activated carbon immediately or until 2 hours after taking Amlodipine 10 mg in healthy volunteers. In some cases, the stomach may need. In cases of heavy blood pressure drop due to amlodipine, positive cardiovascular support measures are required, including regular monitoring of cardiovascular and respiratory functions, high shelves and paying attention to the volume of circulation and urine.

can use vasoconstrictor drugs to restore vascular tone and blood pressure, as long as the patient does not have the contraindication to use the drug. Calcium gluconate intravenous injection can be taken to reduce the effect of calcium channel blockers.

Amlodipine is very much connected to plasma proteins, so the jurors do not bring results in this case.

What to do when you forget the dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

The most common side effect of Amlodipine is ankle edema, from light to medium, related to the dose. In clinical trials, there is a control of Placebo, this effect is about 3% of the patients treated at a dose of 5 mg/day and about 11% when taking 10 mg/day.

Common, ADR> 1/100

Systemic body: Ankle edema, headache, dizziness, blushing and feeling hot, fatigue, weakness.

circulating: excessive hypotension, tachycardia, chest pain.

circulatory: extra mind Translation: Diverse roses.

Warnings

Contraindicated

Amlodipine contraindicated in patients:

There is a history of hypersensitivity to dihydropyridines, amlodipine, or any ingredients of this drug.

Precautions when taking drugs

Use in heart failure patients:

In a long -term study of placebo -verified (praise - 2) using amlodipine in patients with heart failure due to anemia, III and micro -classification of NYHA (New York Association), Amlodipine is reported to be related to the increase in pulmonary edema ratio.

Use in patients with impaired liver function:

Like all other calcium channel blockers, Amlodipine's waste time is prolonged in patients with impaired liver function, so it is necessary to be used cautiously in these patients.

Used for patients with renal failure:

Amlodipine is widely converted into substances that are not active in 10% eliminated in a constant form in urine. Amlodipine plasma changes are not related to the level of renal failure. Amlodipine can be used for these patients with normal doses.amlodipine cannot be fecal.

The ability to drive and operate machinery

No report.

Pregnancy and lactation

Pregnancy:

The safety of amlodipine in pregnant women has not been established. Amlodipine is not toxic in animal reproductive studies, except for slowing labor and prolonging the time to stay in mice at a dose of 50 times higher than the recommended dose for humans. Therefore, Amlodipine should only be used during pregnancy when there is no safer replacement measure and when the disease itself contains greater risks for mothers and embryos.

Breastfeeding period:

The safety of amlodipine in breastfeeding people has not been set. Do not use for breastfeeding women.

Other special subjects

used for the elderly:

Time reaches the maximum concentration in amlodipine's plasma in the elderly is the same as young people.

Amlodipine clearance tends to decrease, thus resulting in an increase in AUC and the sale time in the elderly. The increase in AUC and the sale time in patients with congestive heart failure is also suitable for forecasts in patients in the research age group. Amlodipine used in the same dose for the elderly and young people are also well tolerated.

Therefore, the usual dosage can also be used for the elderly.

Use for children:

Not known the effectiveness of amlodipine on blood pressure in patients under 6 years old.

Medicinal interaction

Anesthesia increases the anti -hypertension effect of amlodipine and can make blood pressure more sharply.

Lithi when used with amlodipine, can cause nerves, nausea, vomiting, diarrhea.

Non -steroid anti -inflammatory drugs, especially indomethacin, can reduce the anti -hypertension effect of amlodipine due to prostaglandin synthesis inhibitors and/or keep sodium and fluid.

High -linked drugs with protein (such as Coumarin, Hytantoin ...) must be used to be used with amlodipine, because amlodipine is also highly linked to protein, so the concentration of the above drugs is free (not linked), can change in serum.

Storage

You should store at room temperature, avoid moisture and avoid light.

No storage in the bathroom or in the freezer.

You should remember that each drug may have different storage methods. Therefore, you should read carefully storage instructions on the packaging or ask the pharmacist.

Keep pills out of reach of children and pets.

Expiry date: 36 months from the date of manufacture.

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