Hypevas 10 Ha Tay treats hypercholesterol blood cholesterol (6 blisters x 10 tablets)

Dosage form Box of 6 blisters x 10 tablets
Specifications Pravastatin sodium

Ingredient

Composition information	Content
Pravastatin sodium	10mg

Uses

indications

Hypevas 10 indications for treatment in the following cases:

Hemorrhage hypercholesteroline treatment: Treatment of primary blood cholesterol or mixed blood lipid disorders, such as a diet support, when responding to diet and other non -drug treatments (such as exercise, weight loss) is not enough.

Initial prevention: Reducing cardiovascular mortality and incidence in patients with medium or severe hypercholesteroline hypercholesteroline and high risk of a first cardiovascular complication, as a diet support.

Secondary prevention: Reducing the death rate and the incidence of the disease in patients with a history of myocardial infarction or unstable angina and with one of the two normal or increased cholesterol levels, as a supportive drug to repair other risk factors.

After organ transplantation: Reducing hyperlipidemia in patients with post -organ transplant inhibitors.

Pharmacokology

Mechanism of action

Pravastatin is a competitive inhibitor with 3-hydroxy-3-methylglutaryl-coenzym (HMG -coA) reductase, preventing HMG-COA into Mevabonate, the precursor of cholesterol. Therefore, pravastatin inhibits cholesterol biosynthesis, reduces cholesterol in liver cells, increases the amount of LDL - cholesterol receptor and thereby increases the transport of LDL - cholesterol from circulation. In addition, Pravastatin also inhibits the synthesis of VLDL - cholesterol liver, VLDL - cholesterol will convert into LDL - cholesterol.

In normal doses, HMG - CoA Reductase is not completely inhibited, so there is still enough meevalonic acid for many other metabolic processes.

In both healthy people and patients with hypercholesterol, sodium pravastatin reduces total cholesterol, LDL-Cholesterol, Apolipoprotein B, VLDL-Cholesterol, Triglycerides and HDL-Cholesterol and Apoliprotein a.

Dynamic pharmacokinetics

Absorption: fast absorption drug and not affected by food. On average, 34% of oral doal dose is absorbed. Low bioavailability (17%) for first metabolism through strong liver (> 60%). Tmax from 1 to 1.5 hours, plasma concentrations are proportional to the dose,

Distribution: Pravastatin binds to plasma proteins about 55 - 60%. The distribution volume 0.5 l/kg. A small amount of pravastatin excreted into breast milk. The drug has a rainwater body does not pass through the bloody barrier.

Metabolism: Metabolizes mainly through the liver into active and non -active substances.

Elimination: After drinking, 20% of the initial dose is eliminated in the urine and 70% in the feces, the exhaust time is from 1.5 to 2 hours.

Children: After taking the dose of 20 mg, cmax and AUC of Pravastatin in children are similar in adults.

Patients with liver failure: exposure to pravastatin and metabolites increased by 50% in patients with alcoholic cirrhosis compared to patients with normal liver function.

Patients with renal failure: Pharmacokinetics have not changed significantly in patients with mild renal impairment. However, in patients with average and severe renal failure, exposure to pravastatin and metabolites twice.

Before taking Hypevas 10 Ha Tay treats hypercholesterol blood cholesterol (6 blisters x 10 tablets)

How to use

Need to follow a diet to reduce cholesterol before and during pravastatin treatment.

Can take medicine at meals or when hungry, drink once a day in the evening.

Dosage

adults

Hyper cholesterol:

Dosage recommended from 10 to 40 mg once a day at bedtime. Adjust the dose every 4 weeks, if needed and tolerated, the maximum dose is 40 mg/day.

Preventing cardiovascular diseases:

Starting dose and maintenance dose are 40 mg/day.

Dosage after organ transplantation:

After the starting organs, the starting dose is 20 mg/day for patients using immunosuppressive therapy. Depending on the lipid indicators, there is an appropriate dose adjustment, which can be increased to 40 mg/day with the close supervision of medical staff.

Children and teenagers (from 8 to 18 years old) increased blood heterozyges:

recommended dose for children from 8 to 13 years old is: 10 - 20 mg/day (no full study with a dose greater than 20 mg in this age group).

Dosage recommended for children from 14 - 18 years old is: 10 - 40 mg/day (no complete research with a dose greater than 40 mg in this age group).

No dose studies for children under 8 years old.

The elderly: No need to adjust the dose except for patients with risk factors or some drug interactions and some special patients.

Patients with body or liver disease: The recommended starting dose is 10 mg/day, monitoring and adjusting the dose if necessary.

Medicine coordination:

When using sodium pravastatin along with ciclosporin (combined or not combined with other immunosuppressive drugs), the initial treatment dose is 20mg/day and carefully adjusted to 40mg/day.

sodium pravastatin and bile acid -mounted plastic (cholestyramin, colestipol) have a supplementary mechanism for each other; Combining these groups of drugs has a plus effect on LDL cholesterol. When using sodium pravastatin along with bile acid -mounted resin, such as cholestyramin, sodium pravastatin must be taken before 1 hour or 4 hours after taking plastic to avoid clear interaction due to the drug attached to the plastic.

Restricting pravastatin sodium combination with other lipid medications because of its ability to increase muscle disease.

Note:

Patients need to follow a standard diet, low cholesterol, before taking HMG - coa reductase inhibitors and continue to maintain this diet during treatment.

Adjust the dosage of sodium pravastatin according to the needs and response of each person by increasing the dose of each time apart for no less than 4 weeks, until the desired LDL cholesterol level, or when the maximum dose is reached.

Because the synthesis of cholesterol in the liver occurs mainly at night, taking drugs in the evening will increase the effect of drugs.

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?

How to handle: If an overdose occurs, immediately transfer to the medical facility, need symptom treatment and support when necessary. Due to the strong drug associated with plasma proteins, the hemorrhage does not expect significantly increasing sodium pravastatin clearance.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

The frequencies of unwanted effects are arranged as follows: Very common (≥1/100,

Nervous system disorders:

Less: dizziness, headache, disturbing sleep, insomnia.

Uncommon: vision disorders (including blurred vision and double view).

Digestive disorders:

Uncommon: digestive disorders, heartburn, abdominal pain, nausea, vomiting, constipation, diarrhea, flatulence.

Less: itching, rash, urticaria, scalp/abnormal hair (including hair loss).

Kidney and urinary disorders:

Uncommon: abnormal urination (including difficulty, frequency, night urine).

Breeding and breast disorders:

Uncommon: Sexual dysfunction.

General disorders:

Less: fatigue.

Immune system disorders:

Very rare: hypersensitivity reactions: anaphylactic shock, angioedema, erythema syndrome like lupus.

Very rare: jaundice, hepatitis, acute liver necrosis.

Very rare: pattern, may be related to acute renal failure, myoglobin urine, muscle disease; Muscle inflammation, special case of tendon disorders.

The following unwanted effects have been reported to some statins:

nightmares.

Memory loss, depression. History of hypertension).

Notify the doctor with unwanted effects when using the drug.

Warnings

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

Contraindicated

Hypevas 10 contraindications in the following cases:

Hypersensitivity to HMG - Coa Reductase inhibitors or any ingredients of the drug.

Be cautious when using

pravastatin has not been evaluated in patients with hypertonic hypercholesterol. This therapy is not suitable for hypercholesterolemia is caused by high HDL-cholesterol.

For other HMG-CAA Reductase reducing inhibitors, Pravastatin should not be combined with fibrat.

In children before puberty, the benefits/risks of treatment should be evaluated by the kidneys by doctors before starting treatment.

Be cautious when pravastatin is used for patients with a history of liver disease or severe alcoholism.

Mechanical disorders: As other HMG-CoA Reductase (statin) enzyme inhibitors (statin), pravastatin has been associated with the beginning of muscle pain, muscle disease and very rarely, muscle pattern. Mechanical diseases must be considered in any patient who uses statin with muscle symptoms of unknown causes such as pain or mild pain, muscle weakness, or cramps.

Before starting treatment: Precautions when used in patients with renal impairment, hypothyroidism, a history of muscle poisoning with statin or fibrat, personal history or family with genetic muscle disorders, or alcohol abuse.

Caution for patients with liver disorders: Moderate increases the level of liver transaminase. In most cases, the liver transaminase concentration has returned to their original value without having to stop treatment. Pay special attention if the patient has an increase in transaminase levels, increases the alanin aminotransferase (ALT) and Aspartat Aminotransferase (AST) that exceeds three upper limits of normal should be discontinued with pravastatin.

Diabetes: Some evidence suggests that statin increases blood sugar in some patients. The risk of diabetes when using statins often increases when the patient has some risks (blood sugar at 5.6 - 6.9 mmol/l, BMI> 30kg/m2, increased triglycerides, hypertension), should be monitored both clinically and biochemical as instructed.

Need to test the liver enzyme before starting treatment with pravastatin and in the case of clinical indications for testing later.

Consider monitoring Creatin Kinase (CK) in the case:

Before treatment, CK tests should be conducted in the conversions: impaired renal function, weakness, history of self or family history of genetic muscle disease, a history of muscle disease due to the use of statin or fibrat before, a history of liver disease and/or drinking lots of alcohol, elderly patients (> 70 years old) have risk factors for muscle pattern, special possibility of drug interactions. In these cases, the benefits/risks should be considered and monitor patients clinically when treated with pravastatin. If CK test results> 5 times the upper limit of normal levels, do not start treatment with pravastatin.

During Pravastatin treatment, patients need to notify when there are muscle manifestations such as muscle pain, stiffness, muscle weakness ... When these manifestations, patients need to test CK to take appropriate interventions.

Before the first treatment with sodium pravastatin, it is necessary to eliminate the causes of blood cholesterol (for example, under controlled diabetes, thyroid defect, nephrotic syndrome, then blood protein disorders, biliary liver disease, due to some other drugs, alcoholism) and quantification of total cholesterol, LDL cholesterol, HDL cholesterol and triglyceride. Periodic lipid quantification must be conducted, with a distance of less than 4 weeks, and adjust the dosage according to the patient's response to the drug. The goal of treatment is to reduce LDL cholesterol so it is necessary to use LDL cholesterol levels to start treatment and evaluate treatment. Only when the LDL cholestrol is not tested, will the total cholesterol use to monitor treatment.

Sodium pravastatin therapy must be suspended or stop in any patient manifesting acute and severe muscle disease or with risk factors prone to acute renal failure due to muscle panodauma, such as severe acute bacterial infections, hypotension, surgery and large trauma, unusual metabolism, endocrine, electrolytes or uncontrolled convulsions.

Only use sodium pravastatin for women of reproductive age when they are certainly not pregnant and only in the case of hypercesting blood cholesterol is very high without responding to other drugs.

Because the composition of the drug has lactose, it is not used for people with congenital galactose, glucose and/or glactose or lactase absorption syndrome (rare metabolic diseases).

As most of other lipid lowering drugs, pravastatin also increases transaminase and in most cases of liver transaminase has returned to its original value without stopping the drug. However, for patients with liver transaminase increased simultaneously with Asat and alat concentration 3 times higher than normal and prolonged limits should stop using pravastatin. Be careful when using pravastatin for people with a history of liver disease or severe alcoholic.

Interstitial lung disease: The special case of interstitial lung disease has been reported to some statins, especially with long -term treatment. The manifestations may include shortness of breath, dry cough and health (fatigue, weight loss and fever). If there is suspect that the patient has developed into interstitial lung disease, it should stop statin.

The effect of the drug on driving and operating machinery

Pravastatin does not have or negatively affect the ability to drive and use machinery. However, do not drive or operate machinery if dizziness and visual disorders during treatment.

Using drugs for women during pregnancy and lactation

Pregnancy:

Contraindicated use of pravastatin during pregnancy and should only be used for patients without intentions to conceive. If the patient is planning to become pregnant or pregnant, immediately notify the doctor and should stop the drug because of the potential risk for the fetus

Breastfeeding period:

Small amount of pravastatin is excreted in breast milk so pravastatin is contraindicated during breastfeeding.

Drug interaction

Fibrat: Increased risk of muscle lesions when used simultaneously with stanin. Pravastatin should be avoided with Fibrat (Gemfibrozil, Fenofibrat), if needed together, the patient's subclinical and ck must be monitored.

Cholestyramin/Colestipol: Simultaneously led to a reduction of about 40-50% of pravastatin's bioavailability, this is not clinically significant when Pravastatin Duge takes 1 hour ago or 4 hours after taking cholestyramin or 1 hour before taking Colestipol. Bile acid -mounted resins can significantly reduce the bioavailability of sodium pravastatin when taken. So the time to use these 2 drugs must be apart.

ciclosporin: Concomitance Pravastatin and ciclosporin leads to a four -fold increase in pravastatin exposure and may be larger in some patients. Clinical and biochemical monitoring should be monitored.

If you are taking Fusidic acid to treat, patients need to temporarily stop using this drug, because when taken with sodium pravastatin with fusidic acid can lead to muscle weakness, pain or mild pain (muscle pattern).

Warfarin and other oral anticoagulants: Sodium pravastatin may increase the effect of warfarin. Prothrombin must be determined before starting to use sodium pravastatin and regular monitoring in the early stages of treatment to ensure no change in prothrombin time.

The drug is metabolized by Cytochrome P450: Pravastatin is not metabolized to a significant level of clinical by the cytochrome P450 enzyme. This is why drugs are metabolized by Cytochrome P450 enzyme system, or cytochrome P450 enzyme inhibitors can be used simultaneously with pravastatin without significantly changing the plasma pravastatin levels like other statins. This has been specially proven for some drugs such as CYP3A4 inhibitors (Diltiazem, Verapamil, Itraconazole, Ketoconazole, Protease inhibitors, Grapefruit juice) and CYP2C9 inhibitors (eg fluconazol).

Antyrin: simultaneously using pravastatin does not affect the clearance of antipipin.

erythromycin: Increasing the concentration of pravastatin auc (70%) and cmax (121%).

Clarithromycin: Increased concentration of pravastatin auc (110%) and cmax (127%). Although it is a small change, it is necessary to be careful when combining pravastatin with erythromycin or clarithromycin.

Other products: In interactive studies, the difference has no statistical significance in biologically reported when pravastatin is used with acetylsalicylic acid (aspirin), antacids (oral prased pravastatin per hour), acid or probucol.

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

high doses (1 day).

Colchicin.

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.

Pravastatin Sodium in combination with Darunavir + Ritonavir: Unlimited dosage.

Pravastatin Sodium in combination with Lopinavir + Ritonavir: No restrictions on dosage.

Although there is no clinical interactive studies in clinical interaction, there is no clinical interactive manifestation of clinical significance when using sodium pravastatin along with angiotensin transfer enzyme inhibitors, beta blockers, calcium channel blockers, diuretics and non -steroid anti -inflammatory drugs.

Storage

Leave a cool place, avoid light, temperatures below 30⁰C.

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