Fasthan 20 Savipharm medicine treats blood lipid disorders, prevention of cardiovascular events (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Pravastatin sodium

Ingredient

Composition information	Content
Pravastatin sodium	20mg

Uses

indications

Fasthan 20 drug is indicated in the following cases:

Treatment of blood lipid disorders.

Treatment of primary cholesterol hypertrophy and mixed blood lipid disorders, combined with diet adjustment, when patients do not respond to non -drug treatment (diet, exercise).

Preventive prophylaxis of Tien Phat cardiovascular events.

Reducing the death rate and the incidence of cardiovascular disease in patients with medium or severe hypercholesteroline hypercholesteroline and high risk of cardiovascular events for the first time, combined with diet adjustment.

Secondary cardiovascular events.

Reduce cardiovascular mortality and recurrence rate in patients with a history of myocardial infarction or unstable angina, accompanied by increased blood cholesterol.

Reducing blood lipids in people with organ transplants are taking anti -waste drugs.

Pharmacology

Pravastatin is a competitive inhibitor with enzyme 3 - hydroxy - 3 - methylglutaryl and Coen Zym A (HMG - CoA) Reductase, a catalyst to convert HMG - CoA into Mevalonic Acid, a precursor to synthesize cholesterol. HMG inhibitors - COA Reductase reduces cholesterol levels in cells. This stimulates increased LDL receptors (Low Density Lipoprotein (cholesterol) on the liver cell membrane, thus increasing LDL -cholesterol clearance from circulation. In addition, Pravastatin also prevents LDL - cholesterol synthesis by inhibiting the synthesis of VLDL - Cholesterol (Very Low Density Lipoprotein (Cholesterol) in the liver.

Pharmacokinetics

absorption

Pravastatin is fast orally absorbed, the peak of plasma is achieved after about 1 - 1.5 hours. About 34% of the dose is absorbed after oral, absolute bioavailability is 17%. Food reduces the bioavailability of pravastatin, but does not affect the effect of reducing cholesterol.

After absorption, 66% pravastatin was first metabolized in the liver.

Distribution

about 50% pravastatin during circulation is attached to plasma proteins. The distribution volume is about 0.5 l/kg. A small amount of pravastatin secreted into breast milk.

Metabolism

Pravastatin is not significantly metabolized through Cytochrom P450, nor is it a substance or a substance of polycoprotein; It is the substrate of another shipping protein. The main metabolite of pravastatin is the isomer Isomer of 3 - A - Hydroxy. This metabolic substance has about 1/10 - 1/40 active compared to pravastatin.

Elimination

After drinking, about 20% of the initial dose was found in the urine and 53% was found in feces. The half -life of pravastatin is 1.5 - 2 hours. The total clearance of pravastatin is 0.81 liters/hour/kg and the renal clearance is 0.38 liters/hour/kg.

pharmacokinetics of special cases

Children (8 - 18 years old)

CMAX and AUC (Area Under Curve: area under the curve) in children similar to adults after taking the dose of 20 mg.

kidney failure

There is no major difference in pravastatin pharmacokinetics in mild and normal renal failure people. However, in medium and severe kidney failure, pravastatin and metabolic substances can double.

Hepatic failure

Pravastatin and metabolic in patients with alcoholic cirrhosis increases by about 50% compared to people with normal liver function.

Before taking Fasthan 20 Savipharm medicine treats blood lipid disorders, prevention of cardiovascular events (3 blisters x 10 tablets)

How to use

Fasthan 20 uses oral. Can be taken with the same food.

The drug must be used in accordance with the instructions of the doctor.

Dosage

adults

Treatment of blood lipid disorders:

recommended dose is 10 - 40 mg, 1 time a day. The maximum dose is 40 mg, 1 time 1 day.

Preventive and secondary cardiovascular events:

The starting dose and the maintenance dose are 40 mg, 1 time a day.

Reducing blood lipids in people with organ transplants are taking anti -waste drugs:

The normal starting dose is 20 mg, 1 time a day. Depending on the response of each person, the doctor will adjust the dose accordingly, the maximum dose is 40 mg, 1 time 1 day.

Children

From 8 to 13 years old:

recommended dose is 10 - 20 mg, 1 time 1 day.

From 14 - 18 years old:

recommended dose is 10 - 40 mg, 1 time 1 day.

Elderly people

Take it according to the doctor's instructions.

People with liver or kidney failure

The recommended starting dose in people with medium and medium liver failure is 10 mg, 1 time 1 day.

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 do

do when overdose?

In case of an overdose, patients need to see a doctor or the nearest medical facility immediately.

What to do when you forget 1 dose? Absolutely do not drink double the dose.

Side Effects

When using Fasthan 20, you may experience unwanted effects (ADR).

Pravastatin can cause some unwanted effects of some people. If symptoms such as: unexplained muscle pain, persistent, muscle weakness or cramps should stop taking the drug and immediately report to the doctor, especially when the patient has a fever and feel tired. Some rare cases can occur in muscle pattern, leading to serious acute renal failure, to threaten life.

Serious allergic reactions including swelling of the face, lips, tongue or throat may cause shortness of breath. Need to report immediately to the doctor if these symptoms occur.

Uncommon, 1/1000

Central nerve: dizziness, fatigue, headache, sleep disorders, insomnia.

Eyes: Points, blurred vision.

digestion: indigestion, nausea, vomiting, abdominal pain, discomfort, diarrhea or constipation.

Skin and hair: rashes, pimples, hives, hair loss.

Urinary urinary: urinating, urinating at night.

musculoskeletal: muscle pain, joint pain.

Very rare, ADR

Central nerve: Itching, heat, numbness due to nerve damage.

Skin: Serious disease on the skin (Lupus erythematosus system). liver: hepatitis or pancreatitis, jaundice, necrosis of liver cells. musculoskeletal joints: myocarditis leads to weakness and muscle pain, tendonitis can lead to tendon breaks.

Testing: increased transaminase (signs of liver disease).

In addition, the drug can cause memory loss, confusion.

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

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Fasthan 20 drug contraindicated in the following cases:

Patients with hypersensitivity to sodium pravastatin or any ingredients of the drug.

Patients with liver disease.

Patients with abnormal high liver enzyme test index.

Pregnant women and nursing women.

Be cautious when using

Need to notify the doctor or pharmacist if the patient suffers from the following conditions:

Kidney disease.

Severe respiratory failure.

Hypothyroidism.

liver disease.

muscle disease.

There are unwanted effects on the basis of other drugs in the statin group and fibrat groups.

For patients who are experiencing these conditions or patients over 70 years old, the doctor will perform some tests before appointing Fasthan 20 to assess the risk of side effects on the patient.

During treatment, it is necessary to notify your doctor when there are muscle manifestations such as muscle pain, muscle stiffness, muscle weakness.

Patients with diabetes or risk of diabetes (high blood and fat, obesity, high blood pressure) should be closely monitored during the medication period.

Patients with lactose intolerance should not use Fasthan 20, because may experience intolerant symptoms such as bloating, flatulence, nausea and sometimes vomiting, diarrhea.

Ponecau 4r lake component in preparations can cause allergic reactions in some people. The doctor will prescribe medication for a certain period of time.

Patients need to follow and use the drug regularly and as directed by the doctor even when they have to take it for a long time. Do not stop taking the drug on your own.

The ability to drive and operate machinery

Pravastatin does not affect the ability to drive and operate machinery. However, if the symptoms appear dizziness, blurred vision or double look, do not drive and operate machinery.

Pregnancy

Pregnant women must not use Fasthan 20. If you are detected pregnancy when using Fasthan 20, you need to notify your doctor immediately.

breastfeeding period

Women who are breastfeeding must not use Fasthan 20.

Drug interaction

Need to notify your doctor if you are in use or have recently used the following drugs:

Other drugs also have the effect of lowering blood cholesterol (such as gemfibrozil, fenofibrat).

Immune inhibitors (such as ciclosporin).

antibiotics (erythromycin, clarithromycin ...).

HIV and hepatitis c medicine such as Darunavir + Ritonavir, Lopinavir + Ritonavir.

If the patient is using blood lipid medications such as resin (Colestyramin or Colestipol), then take pravastatin at least 1 hour ago and 4 hours after taking resin. Because resin affects the absorption of pravastatin if taking these 2 drugs is too close to each other. Do not drink alcohol while using fasthan 20.

Drug interaction

fibrat:

Using statin and fibrat combination increases the risk of unwanted effects on muscles, including pattern. Therefore, this combination should therefore, unless it is necessary and must be clinically monitored, check CK in these cases.

Colestyramin/Colestipol:

Used in combination with pravastatin reduces about 40-50% of pravastatin bioavailability. Pravastatin's bioavailability is not much affected if drinking pravastatin 1 hour or after 4 hours of drinking Colestipol/Colestyramin.

ciclosporin:

Used in combination with pravastatin increases the bioavailability of pravastatin about 4 times. Need to closely monitor the patients using this combination.

substances metabolized by cytochrom P450:

Pravastatin is not metabolized mainly through the Cytochrom P450 system, so the metabolites through the P450 can be used in combination with pravastatin to a certain extent without greatly affecting the plasma concentration of pravastatin. Do not see drug interactions with induction substances or CYP3A4 inhibitors (such as Diltiazem, Verapamil, Itraconazole, Ketoconazole, Protease inhibitors, Grapefruit juice) and CYP2C9 inhibitors (such as fluconazol). Two interactive studies between pravastatin and erythromycin show that the AUC and CMAX of Pravastatin increases statistically significance. Although these changes are very small, it is necessary to be cautious when used in combination of pravastatin with erythromycin or clarithromycin.

warfarin and other oral anticoagulants:

Pravastatin's bioavailability is not changed when used with Warfarin. With the usual dose, Pravastatin does not change the anticoagulant effect of Warfarin.

Darunavir + Ritonavir, Lopinavir + Ritonavir:

Simultaneous use of statin lipid medications with HIV and hepatitis C (HCV) can increase the risk of muscle damage, the most serious muscle, kidney damage leading to kidney failure and may be fatal.

Other drugs:

There is no important change in bioavailability when used in combination of pravastatin with acetylsalicylic acid, antacid (if taken before pravastatin 1 hour) or Probucol.

Increase the risk of muscle damage when using statin simultaneously with the following drugs:

gemfibrozil

other fibrat blood cholesterol medications.

Storage

In a dry place, the temperature does not exceed 30⁰C, avoiding light.

Other drugs

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