Side Effects of Pravachol (Pravastatin Sodium), Warnings, Uses

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Pravachol 10 mg

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Pravachol 20 mg

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Pravachol 40 mg

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Pravachol 80 mg

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Pravastatin 10 mg-TEV

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Pravastatin 20 mg-MYL

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Pravastatin 40 mg-MYL

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Pravastatin 40 mg-TEV

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Pravastatin 40 mg-TEV

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Pravastatin 80 mg-COB

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Pravachol (pravastatin) dosing, indications, interactions, adverse effects, and more

Teva-Pravastatin – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Pravastatin belongs to the family of medications known as HMG CoA reductase inhibitors (“statins”). It is used in addition to diet and exercise to lower high cholesterol levels. Pravastatin works by blocking an enzyme that is needed to make cholesterol in the liver. Therefore, less cholesterol is made and levels of cholesterol in the blood decrease. Lowering cholesterol levels in the blood has been shown to reduce the risks associated with heart disease, such as heart attack.

Pravastatin can be used to reduce the risk of death, heart attacks, stroke, angioplasty, and hospitalization for people with heart disease and normal to moderately high cholesterol. It is also used to reduce the risk of heart attacks, angioplasty, and death for people with high cholesterol who do not already have heart disease.

The medication usually takes about 4 weeks to have a significant effect on cholesterol levels in your blood. After this time, your doctor will likely send you for a lab test to check for changes in your cholesterol levels.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

10 mg
Each pink-to-peach, rounded, rectangular, biconvex, compressed tablet, engraved “N” on one side and “10” on the other side, contains 10 mg of pravastatin. Nonmedicinal ingredients: calcium phosphate dibasic anhydrous, croscarmellose sodium, crospovidone, ferric oxide red, lactose anhydrous, microcrystalline cellulose, povidone, and sodium stearyl fumarate.

20 mg
Each yellow, rounded, rectangular-shaped, biconvex, compressed tablet, engraved “N” on one side and “20” on the other side, contains 20 mg of pravastatin. Nonmedicinal ingredients: calcium phosphate dibasic anhydrous, croscarmellose sodium, crospovidone, ferric oxide yellow, lactose anhydrous, microcrystalline cellulose, povidone, and sodium stearyl fumarate.

40 mg
Each green, rounded, rectangular, biconvex, compressed tablet, engraved “N” on one side and “40” on the other side, contains 40 mg of pravastatin. Nonmedicinal ingredients: calcium phosphate dibasic anhydrous, D&C Yellow No. 10 Aluminum Lake 18%-24%, FD&C Blue No. 1 Aluminum Lake 11%-13%, croscarmellose sodium, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone, and sodium stearyl fumarate.

How should I use this medication?

Before starting pravastatin, you should be on a cholesterol-lowering diet. If appropriate, a program of weight control and physical exercise should be implemented.

The recommended starting dose of pravastatin is 20 mg daily, taken with or without food in a single dose at bedtime. Your doctor will do blood tests to tell how well this dose is working for you and may gradually increase the dose to get the desired response. The maximum recommended dose for adults is 80 mg taken once daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

For best results in lowering your cholesterol, it is very important that you closely follow the diet suggested by your doctor. It is also very important that you take pravastatin exactly as prescribed by your doctor.

If you miss a dose of this medication, take it as soon as you remember and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

• are allergic to pravastatin or any ingredients of this medication
• are breast-feeding
• are pregnant or plan to become pregnant
• have active liver disease or unexplained increases in liver function tests

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• constipation
• cough
• diarrhea
• dizziness
• headache
• heartburn
• nausea
• nightmares
• rash
• sexual problems
• trouble sleeping

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• anxiety or nervousness
• chest pain
• confusion
• cough or shortness of breath
• memory loss or forgetfulness
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of liver problems (e.g., yellow skin or eyes, abdominal pain, dark urine, clay-coloured stools, loss of appetite, nausea and vomiting, or itching)
• symptoms of muscle damage (unexplained muscle pain, tenderness or weakness, or brown or discoloured urine – especially if you also have a fever or a general feeling of being unwell)
• vision problems (i.e., blurred vision)

Stop taking the medication and seek medical attention immediately if any of the following occur:

• severe skin rash, including skin blistering and peeling (possibly with headache, fever, sore throat or mouth, coughing, or aching)
• symptoms of a serious allergic reaction (such as swelling of the face or throat, hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Alcohol: People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking this medication. Alcohol can increase the risk of developing liver problems with this medication. Tell your doctor if you drink more than 3 alcoholic drinks per day.

Diabetes: Pravastatin may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Diet: Pravastatin is not intended for use alone to reduce high cholesterol levels. It is important that a cholesterol-reducing diet along with appropriate exercise be attempted before taking any medication and continued while taking medication.

Grapefruit juice: Tell your pharmacist or doctor if you regularly drink grapefruit juice, because grapefruit juice may interact with pravastatin.

Kidney problems: If you have decreased kidney function or a history of kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Pravastatin may reduce liver function and can cause liver failure. Laboratory signs of harmful effects to the liver occur in about 0.5% of adults who take pravastatin for extended periods. When the medication is stopped, the laboratory tests usually slowly return to normal.

Your doctor may want to test your liver function regularly with blood tests while you are taking this medication. This medication should not be used by people with active liver disease or by people whose liver function tests are higher than normal. If you have a history of liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred rarely in some people taking this medication. This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking pravastatin, contact your doctor immediately.

Muscle effects: In rare cases, serious muscle damage has been associated with the use of statin medications (i.e., cholesterol-lowering medications whose names end in “-statin,” such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, or simvastatin), especially at higher doses. Before taking this medication, tell your doctor or pharmacist if you:

• are over the age of 65
• are taking other medications, including prescription, non-prescription and natural health products, as drug interactions are possible
• are taking other cholesterol-lowering medication such as fibrates (gemfibrozil, fenofibrate) or niacin
• are physically frail
• do excessive physical exercise
• have diabetes
• have a family history of muscular disorders
• have kidney or liver problems
• have uncontrolled thyroid problems
• have undergone surgery or other tissue injury
• have had any past problems with the muscles (pain, tenderness), after using a statin
• regularly drink three or more alcoholic drinks daily

Report any unexplained muscle pain, tenderness, weakness, cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Pregnancy: This medication should not be taken during pregnancy, as it may cause harm to the developing baby. If you become pregnant while taking this medication, stop taking it immediately and contact your doctor.

This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, stop taking it immediately and contact your doctor.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking pravastatin, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: There is limited experience with the use of this medication by children. The safety and effectiveness of using this medication have not been established for children under 16 years old.

Seniors: If you are over 65 years old, your doctor will likely monitor you closely for muscle-related side effects.

What other drugs could interact with this medication?

There may be an interaction between pravastatin and any of the following:

• “azole” antifungal medications (e.g., ketoconazole, itraconazole)
• carbamazepine
• certain HIV protease inhibitors (e.g., darunavir, letermovir, nelfinavir, saquinavir)
• cholestyramine
• colchicine
• colesevelam
• colestipol
• cyclosporine
• daptomycin
• efavirenz
• eltrombopag
• fibrates (e.g., bezafibrate, gemfibrozil, fenofibrate)
• hepatitis C antiviral medications (e.g., asunaprevir, daclatasvir, glecavir, ledipasvir, pibrentasvir, sofosbuvir, voxilaprevir)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• niacin (nicotinic acid)
• niacinamide
• paroxetine
• phenytoin
• raltegravir
• repaglinide
• rifabutin
• rifampin
• rupatadine
• teriflunomide
• tolvaptan
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Teva-Pravastatin

Pravastatin Sodium | Healthgrades | (tablet)

Brand Name: Pravastatin Sodium

Generic Name: PRAVASTATIN SODIUM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET

Data Current As Of: 2018-10-05

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.

prevention of cardiovascular disease

In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablets are indicated to:

• reduce the risk of myocardial infarction (MI).
• reduce the risk of undergoing myocardial revascularization procedures.
• reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes.

Pravastatin sodium tablets are indicated:

Pravastatin sodium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

For the concurrent therapy of either cyclosporine, fibrates, niacin (nicotinic acid), or erythromycin, the risk of myopathy increases [see Warnings and Precautions (5.1) and Clinical Pharmacology ( 12.3 )].

The risk of myopathy/rhabdomyolysis is increased with concomitant administration of cyclosporine. Limit pravastatin to 20 mg once daily for concomitant use with cyclosporine [see Dosage and Administration (2.5), Warnings and Precautions (5.1), and Clinical Pharmacology ( 12.3 )].

The risk of myopathy/rhabdomyolysis is increased with concomitant administration of clarithromycin. Limit pravastatin to 40 mg once daily for concomitant use with clarithromycin [see Dosage and Administration (2.6), Warnings and Precautions (5.1), and Clinical Pharmacology ( 12.3 )].

patient counseling information

Patients should be advised to report promptly unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever [see Warnings and Precautions (5.1)].

Manufactured In Czech Republic By:

TEVA Czech Industries, s.r.o.

Opava-Komarov, Czech Republic

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. O 5/2011

• PRAVACHOL (tablet)
• Pravastatin (tablet)

Pravastatin Sodium (Sandoz) | healthdirect

What it is used for

As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. Patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/L) serum cholesterol levels. Patients with unstable angina pectoris (see Clinical Trials). As an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see Clinical Trials).

How to take it

The way to take this medicine is: Oral.
This medicine is taken by mouth.

• Store below 25 degrees Celsius
• Protect from Moisture
• Protect from Light
• Shelf lifetime is 3 Years.

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.

Always read the label. If symptoms persist see your healthcare professional.

Visual appearance

light brown, mottled, oval tablet, scored on both sides and debossed with “P 40” on one side

Images are the copyright of the Pharmacy Guild of Australia

Do I need a prescription?

What is the medicines and poisons schedule?

All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.

You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.

close tooltip Ok

This medicine is available from a pharmacist and requires a prescription. It is
Schedule 4 : Prescription Only Medicine.

open tool tip to find out more

Is this medicine subsidised?

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on August 1, 2021. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy?

For the active ingredient pravastatin

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Download leaflet

For side effects, taking other medicines and more

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

What it is used for

As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. Patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/L) serum cholesterol levels. Patients with unstable angina pectoris (see Clinical Trials). As an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see Clinical Trials).

How to take it

The way to take this medicine is: Oral.
This medicine is taken by mouth.

• Store below 25 degrees Celsius
• Protect from Moisture
• Protect from Light
• Shelf lifetime is 3 Years.

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.

Always read the label. If symptoms persist see your healthcare professional.

Visual appearance

A light brown, mottled, oval tablet, debossed with “HLP 80” on one side.

Images are the copyright of the Pharmacy Guild of Australia

Do I need a prescription?

What is the medicines and poisons schedule?

All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.

You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.

close tooltip Ok

This medicine is available from a pharmacist and requires a prescription. It is
Schedule 4 : Prescription Only Medicine.

open tool tip to find out more

Is this medicine subsidised?

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on August 1, 2021. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy?

For the active ingredient pravastatin

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Download leaflet

For side effects, taking other medicines and more

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

What it is used for

As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. Patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/L) serum cholesterol levels. Patients with unstable angina pectoris (see Clinical Trials). As an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see Clinical Trials).

How to take it

The way to take this medicine is: Oral.
This medicine is taken by mouth.

• Store below 25 degrees Celsius
• Protect from Moisture
• Protect from Light
• Shelf lifetime is 3 Years.

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.

Always read the label. If symptoms persist see your healthcare professional.

Visual appearance

light brown, mottled, oval tablet, scored on both sides and debossed with “P 20” on one side

Images are the copyright of the Pharmacy Guild of Australia

Do I need a prescription?

What is the medicines and poisons schedule?

All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.

You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.

close tooltip Ok

This medicine is available from a pharmacist and requires a prescription. It is
Schedule 4 : Prescription Only Medicine.

open tool tip to find out more

Is this medicine subsidised?

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on August 1, 2021. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy?

For the active ingredient pravastatin

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Download leaflet

For side effects, taking other medicines and more

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

What it is used for

As an adjunct to diet for the treatment of hypercholesterolaemia. Prior to initiating therapy with pravastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. Patients with previous myocardial infarction including those who have normal (4.0 to 5.5 mmol/L) serum cholesterol levels. Patients with unstable angina pectoris (see Clinical Trials). As an adjunct to diet and lifestyle modification for the treatment of heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older (see Clinical Trials).

How to take it

The way to take this medicine is: Oral.
This medicine is taken by mouth.

• Store below 25 degrees Celsius
• Protect from Moisture
• Protect from Light
• Shelf lifetime is 3 Years.

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.

Always read the label. If symptoms persist see your healthcare professional.

Visual appearance

light brown, mottled, oval tablet, scored on both sides and debossed with “P 10” on one side

Images are the copyright of the Pharmacy Guild of Australia

Do I need a prescription?

What is the medicines and poisons schedule?

All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.

You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.

close tooltip Ok

This medicine is available from a pharmacist and requires a prescription. It is
Schedule 4 : Prescription Only Medicine.

open tool tip to find out more

Is this medicine subsidised?

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on August 1, 2021. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy?

For the active ingredient pravastatin

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Download leaflet

For side effects, taking other medicines and more

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

Pravastatin – an overview | ScienceDirect Topics

Chemistry and Pharmacokinetics

Chemical Properties

Pravastatin (C₂₃H₃₅NaO₇; FW = 446.52) is designated chemically as (1-naphthalene-heptanoic acid, 1,2,6,7,8,8ahexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, [1S[1α(βS*,δS*),2α,6α,8β(R*),8aα]]-) (Fig. 1) and is produced as an “odorless white to off-white fine or crystalline powder” (Center for Drug Evaluation and Research – FDA, 2011). It is produced by the hydroxylation of compactin (ML-236B) (Matsuoka et al., 1989; Haruyama et al., 1986) a naturally-occurring statin produced by Penicllium citrinium. Originally identified as a compactin metabolite in the urine of dogs Haruyama et al. (1986), it was later found that pravastatin could also be produced by hydroxylation of compactin following induction of cytochrome P450_sca in Steptomyces carbophilus (Matsuoka et al., 1989). Structurally, it is similar to lovastatin, another naturally occurring statin produced by Aspergillus terreus, and simvastatin, a semisynthetic derivative of lovastatin (Schachter, 2004). All three of these statins are referred to as type 1 statins based on the presence of a butyrate side chain (methylbutyrate for pravastatin and lovastatin and dimethylbutyrate for simvastatin) and a partially reduced naphthalene (hexahydronapthelene) ring. By contrast, the type 2 statins are entirely synthetic, contain a 4-fluorophenyl group in place of the butyrate side chain, and have a much larger hydrophobic region (Schachter, 2004; Hatanaka, 2000; Neuvonen et al., 2008; Fong, 2014; Mason et al., 2005).

Fig. 1. Chemical Structure of Pravastatin.

Synthesis of pravastatin involves fermentation of P. citrinium to produce compactin which, is followed by a two-step process in which the lactone ring of compactin is opened and the purified product is hydroxylated by S. carbophilus (Matsuoka et al., 1989). However, the use of a genetically engineered organism (Penicillium chrysgenum) capable of producing pravastatin through a single-step fermentative process may emerge as an alternative production method (McLean et al., 2015).

The open lactone ring attached to the naphthalene nucleus serves as the pharmacophore of pravastatin (Schachter, 2004; Fong, 2014). By contrast, the other type 1 statins (lovastatin and simvastatin) contain a lactone ring that must be converted to the active β-hydroxy form by carboxylesterase in the liver (Laizure et al., 2013). Thus, these statins may inhibit the carboxylesterase (CSE1) required for conversion of other drugs (e.g., ACE inhibitors) into their active form (Fukami et al., 2010). Pravastatin, on the other hand, does not compete for carboxylesterase activity (Fukami et al., 2010) and, therefore may not impair the activity of other drugs that require activation by this transformation process.

Pravastatin also differs from other type 1 statins by the presence of a hydroxyl group at C6 which makes it relatively hydrophilic. In fact, it has the lowest log partition coefficient (octanol:water) of all statins (Ahern et al., 2011; Joshi et al., 1999). Its hydrophilic nature is reflected by the fact that pravastatin only binds to polar head groups of dodecylphosphocholine (DPC) micelles, does not penetrate into the core of micelles (Galiullina et al., 2017), and only associates with the hydrated surface of membranes (Mason et al., 2005).

Hepatic Uptake

The hydrophilic properties of pravastatin necessitate the use of active transport mechanisms for uptake at the plasma membrane. The liver-specific organic anion transporter, originally identified as OATP2 (Hsiang et al., 1999; Nakai et al., 2001) and now designated as OATP1B1 (Kalliokoski and Niemi, 2009), is responsible for pravastatin uptake from the portal blood at the basolateral membrane of hepatocytes (Kalliokoski and Niemi, 2009; Niemi et al., 2011). The significance of this transporter is illustrated by the finding that targeted disruption of the transporter gene (Slco1b2) significantly increased the steady-state plasma concentration of pravastatin and decreased the steady-state hepatic concentration following drug infusion in mice (Zaher et al., 2008).

The disposition of pravastatin is similarly affected in humans with genetic variation in SLCO1B1. Specifically, compared with the reference haplotype (*1a), at least three other haplotypes (*1b, *5, and *15) containing a single nucleotide polymorphism c.388A˃G, c.521T > C, or combination of these alleles, demonstrated increased area under the curve (AUC) in human subjects and decreased maximal transport in cultured human cell lines (reviewed in Niemi et al., 2011; Romaine et al., 2010).

Effective uptake by the liver and intestine (Hatanaka, 2000) accounts for the relatively low systemic bioavailability of pravastatin (Singhvi et al., 1990). This does not adversely affect its efficacy, however, because the major beneficial effect is derived from upregulation of hepatic LDL receptors (i.e., the liver is the major target organ) (Pedersen, 2016; Everett et al., 2015). However, both beneficial and potential adverse effects, including direct effects that occur at the level of the artery wall, may be reduced by limited availability to peripheral tissues.

Target Binding and Metabolism

The unique properties of the naphthalene ring affect the interaction of pravastatin with HMGCoA reductase. Generally speaking, enthalpic contributions to binding thermodynamics reflect the strength of interaction between the drug and the target protein (Carbonell and Freire, 2005; Ladbury et al., 2010). However, when binding is driven by entropic contributions, more non-selective interactions may occur (Tarcsay and Keseru, 2015). In the case of pravastatin, the interaction with HMGCoA reductase is driven by both enthalpic and entropic processes (Carbonell and Freire, 2005; Ladbury et al., 2010; Tarcsay and Keseru, 2015). The enthalpic contributions may account for some of its hepato-selectivity (Ladbury et al., 2010; Tarcsay and Keseru, 2015) while entropic contributions may account for interaction at off-target sites (Tarcsay and Keseru, 2015). In addition, pravastatin has a relatively high inhibition constant (K_i) (i.e., low inhibition potency) (Carbonell and Freire, 2005). Based on this type of thermodynamic analysis, it appears that the strength and complementarity of its interaction with HMGCoA reductase is intermediate between that of fluvastatin (high entropic contributions) on the one hand and rosuvastatin (high enthalpic contributions) on the other hand (Carbonell and Freire, 2005; Ladbury et al., 2010).

Pravastatin is also unique with regard to its metabolism by CYP3A4, a major member of the cytochrome P450 superfamily of enzymes (Mason et al., 2005). This enzyme plays a major role in the metabolism of most statins, but only a minor role in pravastatin metabolism (Neuvonen et al., 2008; Jacobsen et al., 1998). Pravastatin is also the least effective inhibitor of CYP2C8 another major drug metabolizing enzyme (Tornio et al., 2005). Its lack of metabolism by these two P450 enzymes (Bottorff and Hansten, 2000), accounts for the fact that it is relatively free of clinically significant drug interactions (Neuvonen et al., 2008).

There are three other unique characteristics of pravastatin metabolism that could affect its safety and efficacy (Schachter, 2004; Hatanaka, 2000; Neuvonen et al., 2008). First, it is eliminated by both hepatic and renal routes. Elimination in the urine could be especially important for individuals that possess a variant form of SLCO1B1 (see previous section) as it would mitigate the potentially toxic effects of prolonged exposure resulting from impaired hepatic clearance. Second, there are relatively few active metabolites (i.e., it is eliminated intact) thus reducing concern over potentially toxic metabolic-induced side effects. Third, its relatively high degree of hydrophilicity accounts for the fact that greater than 50% of circulating pravastatin is not bound to protein; by contrast, greater than 90% of all other statins are protein-bound. Although this could increase exposure of non-hepatic tissues to active pravastatin, the relatively rapid clearance and hepato-selectivity reduce this possibility.

Pravastatin Sandoz Tablets – MyDr.com.au

pravastatin sodium tablets

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Pravastatin Sandoz.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

WHAT PRAVASTATIN SANDOZ IS USED FOR

This medicine is used to lower high blood cholesterol levels (doctors call this hypercholesterolaemia).

It is also used in people who have had a heart attack or an episode of unstable angina, even when their cholesterol levels are normal.

It is also used to treat heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older as an adjunct to diet and lifestyle changes.

It contains the active ingredient pravastatin sodium. Pravastatin sodium belongs to a group of medicines called HMG-CoA reductase inhibitors.

It works by reducing the level of cholesterol in your blood and helps to protect you in other ways from heart attack or stroke.

It is more effective if it is taken with a diet low in fat.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is not addictive.

This medicine is available only with a doctor’s prescription.

BEFORE YOU TAKE PRAVASTATIN SANDOZ

When you must not take it

Do not take this medicine if you have an allergy to:

• pravastatin sodium, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description.
• any other similar medicines, especially if they are in the same drug class as Pravastatin Sandoz (HMG-CoA reductase inhibitor).
  Some of the symptoms of an allergic reaction may include:
  – shortness of breath
  – wheezing or difficulty breathing
  – swelling of the face, lips, tongue or other parts of the body
  – rash, itching or hives on the skin.

Do not take this medicine if you have or have had problems with your liver.

Do not take this medicine if you are pregnant. It may affect your developing baby if you take it during pregnancy.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• kidney problems
• liver problems. Your doctor will do a blood test to make sure you have no problems with your liver.
• muscle pain from other medicines used to treat high cholesterol
• breathing discomfort, persistent cough, fatigue, weight loss and fever
• suffer from hormonal disorders
• suffer from central nervous system vascular lesions
• suffer from allergies
• suffer from homozygous familial hypercholesterolaemia (a doctor will have told you this)
• have increased triglycerides in your blood (a doctor will have told you this also)
• suffer from muscle disease (including pain, tenderness or weakness).

Tell your doctor if you plan on becoming pregnant or will be breastfeeding while you are using Pravastatin Sandoz. You doctor can discuss with you the risks and benefits involved.

Tell your doctor if you drink alcohol regularly.

If you have not told your doctor about any of the above, tell him/her before you start taking Pravastatin Sandoz.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Pravastatin Sandoz may interfere with each other. These include:

• any other medicine to lower cholesterol, such as gemfibrozil, cholestyramine or colestipol
• ciclosporin, a medicine used to suppress the immune system
• ketoconazole, a medicine used to treat fungal infections
• spironolactone, a medicine used to treat high blood pressure
• cimetidine, a medicine used to treat ulcers
• gemfibrozil
• cholestyramine and colestipol
• antacids.

These medicines may be affected by Pravastatin Sandoz or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

It generally does not interfere with your ability to drive or operate machinery. However some people may experience dizziness, so you should be sure how you react to Pravastatin Sandoz before you drive a car, or operate machinery.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

HOW TO TAKE PRAVASTATIN SANDOZ

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions, ask your doctor or pharmacist for help.

How much to take

Adults – The usual dose is 10 to 80 mg per day for lowering cholesterol and 40mg for reducing the risk of a stroke or heart attack.

If you have kidney or liver problems, or if you are over 65 years old, the starting dose is 10mg.

Children (8 to 13 years old) with heterozygous familial hypercholesterolaemia – The usual dose is 20mg once daily.

Adolescents (14 to 18 years old) with heterozygous familial hypercholesterolaemia – The usual dose is 40mg once daily.

Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.

Follow the instructions they give you.

If you take the wrong dose, Pravastatin Sandoz may not work as well and your problem may not improve.

How to take it

Swallow the tablets with a glass of water or another liquid. The tablets can be broken in half. If you need to break Pravastatin Sandoz, hold the tablet with both hands and snap along the break line.

Pravastatin Sandoz can be taken with or without food.

When to take Pravastatin Sandoz

Take your medicine once a day in the evening before bedtime.

Taking it at the same time each day will have the best effect. It will also help you to remember when to take it.

How long to take Pravastatin Sandoz

Continue taking your medicine for as long as your doctor tells you.

This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.

If you forget to take it

Take your dose as soon as you remember, and continue to take it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doc
tor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Pravastatin Sandoz. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

WHILE YOU ARE TAKING PRAVASTATIN SANDOZ

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Pravastatin Sandoz.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests (such as checking your cholesterol levels) from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do

Do not take Pravastatin Sandoz to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how Pravastatin Sandoz affects you. This medicine generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, Pravastatin Sandoz may cause dizziness in some people. If you have any of those symptoms, do not drive, operate machinery or do anything else that could be dangerous.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Pravastatin Sandoz.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

• upset stomach, nausea, diarrhoea, wind
• constipation
• headache
• dizziness
• blurred vision
• fatigue
• sleep disturbance
• sexual dysfunction
• depression.

Tell your doctor as soon as possible if you notice any of the following:

• unexplained muscle pain, muscle tenderness or weakness, muscle cramps
• chest pain, feeling of tightness, pressure or heaviness in the chest.

The above lists include the most common side effects of the medicine.

Tell your doctor immediately if you notice any of the following:

• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
• joint pain
• skin rash or itchiness
• sensitivity to light
• fever, generally feeling unwell.

These are the symptoms of an hypersensitivity reaction.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

AFTER TAKING PRAVASTATIN SANDOZ

Storage

Keep your medicine in the original container.

If you take it out of its original container it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store Pravastatin Sandoz or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

PRODUCT DESCRIPTION

What it looks like

Pravastatin Sandoz comes in four types of tablets:

Pravastatin Sandoz 10 mg – light brown, oval tablet, scored on both sides and marked with “P10”.

Pravastatin Sandoz 20 mg – light brown, oval tablet, scored on both sides and marked with “P20”.

Pravastatin Sandoz 40 mg – light brown, oval tablet, scored on both sides and marked with “P40”.

Pravastatin Sandoz 80 mg – light brown, oval tablet, marked with “HLP80”.

Available in blister packs of 30 tablets.

Not all strengths may be marketed.

Ingredients

Active ingredient:

• Pravastatin Sandoz 10 mg – 10 mg pravastatin sodium
• Pravastatin Sandoz 20 mg – 20 mg pravastatin sodium
• Pravastatin Sandoz 40 mg – 40 mg pravastatin sodium
• Pravastatin Sandoz 80 mg – 80 mg pravastatin sodium

Inactive ingredients:

• microcrystalline cellulose
• lactose monohydrate
• dibasic sodium phosphate
• croscarmellose sodium
• sodium lauryl sulphate
• povidone
• iron oxide red CI77491
• colloidal anhydrous silica
• magnesium stearate.

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 726 369

This leaflet was revised in September 2018.

Australian Register Numbers

Pravastatin Sandoz 10 mg tablets: AUST R 152451

Pravastatin Sandoz 20 mg tablets: AUST R 152458

Pravastatin Sandoz 40 mg tablets: AUST R 152450

Pravastatin Sandoz 80 mg tablets: AUST R 152452

Published by MIMS December 2018

instructions for use, classification, articles »Drug Handbook

As for other lipid-lowering agents, a moderate increase in the level of hepatic transaminases was observed. In most cases, hepatic transaminase levels return to normal without interrupting treatment. Particular attention should be paid to patients in whom the level of transaminases is elevated. Therapy should be discontinued if ALT and AST levels are three times the upper limit of normal and continue to rise.

Care should be taken to prescribe the drug to patients with a history of liver disease or alcohol abuse.

application features

With the use of pravastatin, as with the use of other inhibitors of HMG-CoA reductase (statins), the appearance of myalgia, myopathy, and very rarely rhabdomyolysis was noted. The possibility of myopathy should be considered for each patient taking statins. In the case of muscle symptoms of unexplained etiology (pain in the limbs, muscle weakness or muscle cramps), the CPK level should be determined in the patient. Therapy should be discontinued if its level is 5 times the upper limit of the norm or if the increase has serious clinical consequences.Very rarely (1 in 100,000 patients), rhabdomyolysis occurs with or without secondary renal failure. Rhabdomyolysis is an acute, potentially fatal skeletal muscle condition that can develop at any time during treatment. It is characterized by massive destruction of muscles, which is associated with a significant increase in the level of CPK (more than 30-40 times higher than the upper limit of the norm) and leads to myoglobinuria.

The risk and severity of muscle disorders during therapy with pravastatin increases with its simultaneous use with fibrates.Caution should be given to the combination of pravastatin with nicotinic acid. An increase in the incidence of myopathy was also observed in patients treated with other statins in combination with inhibitors of cytochrome metabolism ₄₅₀ . This may be due to pharmacokinetic interactions not reported for pravastatin. Muscle symptoms may disappear after stopping statin therapy.

Pravastatin is prescribed with caution to patients with factors contributing to the development of myopathy, such as renal impairment, hypothyroidism, a history of muscle disorders with the use of statins or fibrates, individual or hereditary muscle disorders, alcohol abuse.In such cases, the CPK level should be determined before starting therapy. Determination of the CPK level before starting treatment should also be provided for the elderly (over 70 years old), especially if there are other favorable factors in this category of patients. If the CPK level is more than 5 times the upper limit of the norm, treatment is not started, and the results are checked after 5-7 days.

The patient should be warned about the need to report muscle pain of unclear etiology, weakness and convulsions.In this case, the CPK level should be measured. If it is more than 5 times the upper limit of the norm, statin therapy should be discontinued. Discontinuation of treatment should also be considered in the case of severe muscle symptoms and discomfort, even if the CPK level exceeds the upper limit of the norm by less than 5 times. If symptoms disappear and CPK levels normalize, statin therapy can be continued, but in low doses and under medical supervision. If the patient has hereditary muscle disease, statin therapy should not be given.

The drug contains lactose, therefore patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use this drug.

The ability to influence the reaction rate when driving or driving other mechanisms

Reception of pravastatin is characterized by an absent or insignificant effect on the ability to drive vehicles or other mechanisms that require increased concentration of attention and speed of psychomotor reactions.

Statins and carbohydrate metabolism uMEDp

The article examines the consequences of taking statins in terms of the effect on carbohydrate metabolism, compares the effects of various statins on the indicators of carbohydrate metabolism, and provides a possible explanation of these effects.

Epidemiology of cardiovascular disease and type 2 diabetes mellitus

Pathology of the cardiovascular system is the cause of about 30% of deaths worldwide [1].

After the peak of deaths from cardiovascular diseases, reached in 1968, their number has significantly decreased by now [2]. Based on statistical data [3-6], E.S. Ford et al. found that a 47% decrease in deaths from coronary heart disease (CHD) in the United States from 1980 to 2000 was associated with advances in therapies, including the treatment of acute coronary syndrome and heart failure, by approximately 44% – with a decrease in such factors risk, such as hypercholesterolemia, arterial hypertension, smoking.However, the positive results were counterbalanced by the increased incidence of type 2 diabetes mellitus (DM) and exogenous constitutional obesity [7].

In contrast to the United States, the epidemic of cardiovascular diseases in the world continues to spread rapidly. The mortality rate from them in developing countries is twice as high as in developed countries [1]. At the same time, in countries with low and middle income per capita, the prevalence of cardiovascular risk factors, especially smoking and obesity, is increasing [8].

The effect of diabetes on the risk of developing cardiovascular disease is well understood. Even in the Framingham Heart Study, it was proved that the incidence of cardiovascular pathology among men with diabetes is twice as high as in men without diabetes. Among women, this ratio increases – 3: 1 [9]. According to the Copenhagen City Heart Study, the risk of myocardial infarction among patients with diabetes is two to three times higher than in patients without diabetes, regardless of the presence of other cardiovascular risk factors (eg, arterial hypertension) [10].

It should be noted that modern data on the epidemiology of diabetes and its relationship with the development of cardiovascular diseases were obtained in the course of studies conducted in countries with a predominantly Caucasian population. Recently, however, works have appeared covering different ethnic and racial groups.

H. King et al. based on the database of the World Health Organization, as well as demographic projections of the United Nations, the prevalence of diabetes in the world was analyzed.It has been established that the prevalence of diabetes per capita is lower in developing countries than in developed countries, and this situation will persist until at least 2025. At the same time, if in 1995 the number of patients with diabetes in developing countries was 62%, then in 2025 year it will increase to 75% [11].

The INTERHEART study, which included patients from 52 countries, assessed the relationship between myocardial infarction and a variety of risk factors, including diabetes, geographic region, ethnicity, gender, age, etc.e. Diabetes was one of nine factors that significantly influenced the incidence of myocardial infarction in all age, sex, and racial groups [12].

Diabetes mellitus is directly associated with an increased risk of cardiovascular death and the development of cardiovascular pathologies such as ischemic heart disease, congestive heart failure [13] and atrial fibrillation [14].

The relationship between the level of glycemia and diastolic dysfunction of the myocardium, atrial fibrillation, is still a subject of debate.The relationship between hyperglycemia and atherosclerotic vascular lesions, on the contrary, is the central object of fundamental science, epidemiological and clinical research [15].

Pathogenesis of cardiovascular diseases in type 2 diabetes mellitus

One of the main causes of macrovascular complications in diabetic patients is atherosclerosis, which leads to narrowing of the lumen of the coronary and peripheral arteries [16].

Metabolic changes (chronic hyperglycemia, dyslipidemia, and insulin resistance) accompanying diabetes contribute to the damage to the arterial wall.The functions of several types of cells are impaired, including endothelial cells, smooth muscle cells, and platelets. As a consequence, atherosclerotic plaques are formed [17].

Endothelial cells of blood vessels synthesize a number of important bioactive substances such as nitric oxide (NO) and reactive oxygen species, prostaglandins, endothelin and angiotensin II. The latter regulate the function and structure of blood vessels.

Nitric oxide has a powerful vasodilator effect and is a key link in the vasoconstrictor function of the endothelium.In addition, it suppresses platelet activation, limits inflammation by reducing the adhesion of leukocytes to the endothelium and their migration into the vascular wall, and reduces the proliferation and migration of vascular smooth muscle cells [18–20]. Thus, nitric oxide prevents atherogenesis.

Endothelium-dependent (NO-mediated) vasodilation worsens in diabetes mellitus [21, 22]. Several mechanisms are known to reduce the production of nitric oxide by the endothelium of blood vessels.

As a result of hyperglycemia, activation of endothelial NO-synthase (eNOS) is blocked and the production of reactive oxygen species (especially superoxide anion (O _2- )) in smooth muscle cells and endothelial cells is increased, which in turn reduces the production of nitric oxide and its activity [23 ].The superoxide anion combines with nitric oxide. As a result, a toxic ion of peroxynitrite (ONOO-) is formed, which breaks eNOS, oxidizing its cofactor, tetrahydrobiopterin [24].

Insulin resistance also contributes to a decrease in nitric oxide production. It leads to excessive release of free fatty acids from adipose tissue [25]. Free fatty acids activate a signaling enzyme – protein kinase C, inhibit phosphatidylinositol-3-kinase, and also stimulate the production of reactive oxygen species, which together disrupt the production of nitric oxide or reduce its activity.

In addition to enhancing atherogenesis in diabetes, plaque instability increases. On the one hand, the production of cytokines by endothelial cells increases, which in turn reduce the synthesis of collagen de novo by smooth muscle cells [26]. On the other hand, the production of matrix metalloproteinase, which destroys collagen, increases. As a result of a decrease in collagen synthesis and an increase in collagen breakdown, the risk of plaque rupture and, as a result, thrombus formation increases.

With diabetes, the synthesis of vasoconstrictors, primarily endothelin 1, increases. Endothelin 1 activates endothelin A receptors, which cause vasodilation. Endothelin 1 also increases the reabsorption of sodium and water in the renal tubules, stimulates the renin-angiotensin system, and affects hypertrophy of smooth muscle cells of blood vessels [27].

The role of other vasoactive substances, such as prostanoids and angiotensin II, in the development of pathological processes occurring in diabetes, continues to be studied [28, 29].

Mechanism of action of statins

The above suggests that statin therapy for diabetes is a necessity. Failure to do so can significantly worsen the overall prognosis.

Statins act by competitively inhibiting 3-hydroxy-3-methyl-glutaryl coenzyme A reductase (HMG-CoA reductase). Because statins are molecularly similar to HMG-CoA, they take its place in the enzyme, inhibiting the ability to produce mevalonate.Mevalonate is the next participant in the chain of reactions leading to the synthesis of cholesterol, as well as a number of other compounds [30]. The decrease in the production of mevalonate becomes one of the reasons for the decrease in blood cholesterol levels.

Several so-called natural statins (simvastatin, pravastatin and lovastatin) are synthesized by molds Penecillium and Aspergillus as secondary metabolites. Most likely, under natural conditions, synthesized statins help the aforementioned organisms in the competition with bacteria and other fungi: by inhibiting HMG-CoA reductase, they interfere with their normal life [31].

In the body, statins block the cholesterol biosynthesis cascade in the liver [32]. This is of great importance, since most of the cholesterol circulating in the body is of endogenous origin and only a small part comes from food. When the amount of cholesterol synthesized in the liver decreases, its total level in the blood also decreases.

It is believed that cholesterol biosynthesis occurs mainly at night [33]. This is why statins with a short half-life are usually taken at night.The effectiveness of such a regimen is also confirmed by the data of a number of studies: a decrease in low-density lipoprotein (LDL) and total cholesterol was more pronounced in the case of taking simvastatin at night compared to taking it in the morning [34, 35]. A similar effect was not observed when taking a long-acting statin, atorvastatin [36].

At the same time, in studies with the participation of animals, with a decrease in blood cholesterol levels, a compensatory increase in LDL receptors in liver cells is observed [37].This is achieved using proteases that break down membrane-bound SREBP (Sterol Regulatory Element-Binding Protein). The latter migrates to the nucleus and stimulates the production of a number of proteins, including LDL receptors. The synthesized LDL receptors migrate to the hepatocyte membrane, where they are responsible for the binding of LDL and very low density lipoproteins. In the liver, they are transformed into bile salts, which are subsequently excreted from the body.

Statins interfere with the production of not only cholesterol, but also specific prenylated proteins.

S.R. Spindler et al. showed that statin therapy prolongs survival and improves cardiac function in Drosophila by suppressing specific protein prenylation. It was concluded that a decrease in prenylation may improve cardiac function and life expectancy in higher multicellular organisms. This explains the pleiotropic (not associated with cholesterol metabolism) effect of statins on the cardiovascular system [38], in particular, the improvement of endothelial function [39].

Influence of various statins on the parameters of carbohydrate metabolism

HMG-CoA reductase inhibitors are the most widely prescribed drugs for patients with cardiovascular pathology [40]. Despite the fact that most patients tolerate statins well enough, data have been obtained on unexpected side effects of this group of drugs [41], in particular, an increase in the incidence of newly diagnosed type 2 diabetes mellitus [42].

Clinical studies show conflicting results regarding the level of glycemia and the incidence of diabetes in patients receiving statins [43].In this regard, one should be careful in the interpretation of these data [44].

Most of the studies analyzed did not initially set the goal of identifying type 2 diabetes, therefore, there was not enough statistical power to evaluate the result. In addition, the sample of patients in the studies varied, and hence the risk factors for the development of the disease.

Nevertheless, the data obtained are sufficient to suggest that different statins have different effects on carbohydrate metabolism, and this effect is not always negative [45].

Atorvastatin

A number of studies have recorded a reliable direct relationship between the dose of atorvastatin (10, 20, 40 and 80 mg) and the level of glycated hemoglobin (HbA1c), as well as an inverse relationship with tissue sensitivity to insulin [46, 47]. In the IDEAL and ASCOT-LLA studies, a slight increase in the relative odds (OR) of developing diabetes mellitus in patients treated with atorvastatin was recorded [48–50]. Analysis of statistical data from SPARCL clinical trials confirmed that the frequency of diagnosing type 2 diabetes is higher in patients who received 80 mg / day of atorvastatin compared with patients who received placebo (OR 1.37 with a 95% confidence interval (CI) 1.08 –1.75) [51].In the TNT study, the dependence of the frequency of newly diagnosed type 2 diabetes on the dose of the drug received was noted. So, in patients taking 80 mg / day of atorvastatin, this indicator is insignificant, but still higher than in patients taking 10 mg / day [51].

Rosuvastatin

In the JUPITER study, when comparing two groups of patients who received 20 mg of rosuvastatin and placebo, the first group recorded a statistically significant increase in the number of reports of newly diagnosed type 2 diabetes (p = 0.01) [52].The results of the CORONA study indicate that the risk of developing diabetes when taking rosuvastatin is unreliable (OR 1.15 (95% CI 0.91–1.44)) [53].

Simvastatin

In the HPS study, the use of simvastatin at a dose of 40 mg / day was associated with a slight trend towards an increase in the incidence of diabetes (OR 1.14 (95% CI 0.98–1.33)) [54]. According to the SEARCH study, the risk of developing the disease when taking simvastatin at a dose of 80 mg / day slightly exceeded the same risk when taking the drug at a dose of 20 mg / day (OR 1.07 (95% CI 0.95–1.19)) [55 ].The effect of simvastatin on tissue insulin sensitivity was also studied. The latter decreased with increasing doses of the drug (10, 20, 40 and 80 mg) compared with placebo [56].

Pravastatin

An unexpected effect of pravastatin was found in the WOSCOPS study: unlike the statins listed above, it reduced the risk of developing type 2 diabetes by 30% (OR 0.70 (95% CI 0.50–0.99)) [57]. The disadvantage of this work was non-standard diagnostic criteria for diabetes mellitus – fasting glycemia> 126 mg / dL (7 mmol / L).When using more stringent criteria, it turned out that the positive effect of pravastatin is exaggerated [58]. The difference between this study and other similar studies was that the data of the patients were not taken into account, as well as the low body mass index of the participants – on average 25.9 kg / m2 ² (versus 27 kg / m2 ² ) [52, 53] …

No significant effect (neither negative nor positive) of pravastatin on the risk of developing diabetes was found in the LIPID study (OR 0.95 (95% CI 0.77–1.16)) [59].

However, opposite results were obtained in the PROSPER study: in elderly patients treated with pravastatin, the incidence of diabetes increased by 32% (OR 1.32 (95% CI 1.03–1.69)), especially among those with metabolic syndrome [60] … To date, this is the only large study showing a significant negative effect of pravastatin.

Other studies did not record the negative effect of pravastatin on the risk of developing diabetes and / or deterioration in carbohydrate metabolism.Based on the findings, the US Food and Drug Administration in February 2012 ordered to add information on the risk of developing type 2 diabetes in the annotations to all HMG-CoA reductase inhibitors on the US market, with the exception of pravastatin [ 61, 62].

Pitavastatin

Pitavastatin is a relatively new and insufficiently studied drug (discovered and registered in Japan in 2003., admitted to circulation in the USA in 2009, in the UK in 2010). Nevertheless, numerous studies indicate a neutral, in some cases even a positive effect of the drug on carbohydrate metabolism. A study of the long-term efficacy and tolerability of pitavastatin compared with atorvastatin in patients with type 2 diabetes did not reveal significant differences in their effect on LDL levels, however, unlike atorvastatin, pitavastatin did not have a significant effect on fasting glycemia [63].

In a retrospective analysis, when comparing the effect of a three-month course of atorvastatin 10 mg / day, pravastatin 10 mg / day and pitavastatin 2 mg / day on carbohydrate metabolism in diabetic patients, it was shown that only atorvastatin significantly worsens the level of fasting glucose and HbA1c. No similar effects were observed for the other two statins [64].

When studying the efficacy and safety of Livalo (LIVES study), patients with hypercholesterolemia received pitavastatin at a dose of 1, 2 or 4 mg / day for five years.It was found that pitavastatin contributed to a significant decrease in the level of HbA1c in patients with diabetes [65].

In a recent study, patients over 65 years of age with primary hyperlipidemia and mixed dyslipidemia received pitavastatin (1, 2, or 4 mg) or pravastatin (10, 20, or 40 mg). There were no significant differences in the dynamics of fasting glucose levels after 12 weeks of therapy between the groups [66].

The effect on fasting glucose levels in patients with metabolic syndrome and multiple risk factors for developing type 2 diabetes was not recorded when taking pitavastatin and pravastatin for six months [67].

In a 12-week, double-blind, randomized study INTREPID, 252 HIV-infected patients received 4 mg pitavastatin or 40 mg pravastatin. In both groups, there was no significant effect of therapy on the level of fasting glucose and / or HbA1c. However, in the group receiving pitavastatin, the decrease in LDL cholesterol was more pronounced [68].

Similar results were obtained in the PREVAIL US study, which compared the efficacy of 4 mg pitavastatin and 40 mg pravastatin in patients with primary hyperlipidemia and mixed dyslipidemia [69].

Therefore, there is no significant difference between pravastatin and pitavastatin in terms of the effect on carbohydrate metabolism indicators.

When comparing other statins with pitavastatin, the advantage of the latter was clear. Thus, in the course of a 12-week multicenter, double-blind, randomized study, which included patients with type 2 diabetes and dyslipidemia, in the group receiving 4 mg of pitavastatin, no changes in carbohydrate metabolism were recorded.At the same time, in the group receiving 20 mg of atorvastatin, a significant deterioration in fasting glycemia was revealed [70].

In another similar study, which compared the effects of pitavastatin at a dose of 4 mg and simvastatin at a dose of 40 mg in patients with hyperlipidemia and two or more risk factors for coronary insufficiency, taking pitavastatin was not associated with a deterioration in carbohydrate metabolism by the 12th week. therapy (-0.03 mg / dL (0.0016 mmol / L), p = 0.963), nor to the 56th (2.2 mg / dL (0.12 mmol / L), p = 0.060).While taking simvastatin, fasting glycemia did not increase by the 12th week of therapy (-1.40 mg / dL (0.78 mmol / L), p = 0.209), however, by the 56th week, a significant increase in this indicator was recorded – 7, 5 mg / dL (0.42 mmol / L), p = 0.0001 [71].

Most of the data on the positive effect of pitavastatin on glycemic parameters has been obtained from relatively small retrospective and / or single-center studies. Therefore, to confirm them, an open, prospective randomized controlled trial J-PREDICT was conducted, which examined the relationship between taking pitavastatin and the development of type 2 diabetes.Patients with impaired glucose tolerance (n = 1269) were randomized into two groups. Patients of the first group were recommended to change their lifestyle (elimination of risk factors for the development of type 2 diabetes) and take 1-2 mg of pitavastatin, the second group – only the first. Preliminary results from the study indicate that taking pitavastatin in combination with lifestyle changes is associated with a lower risk of developing type 2 diabetes [72].

Possible reasons for the effect of statins on carbohydrate metabolism indicators

Most lipophilic drugs are metabolized in the liver by the Cytochrome (CYP) P450 family.Statins are no exception. Simvastatin and atorvastatin are utilized by CYP3A4, fluvastatin by CYP2C9. Although pitavastatin is a lipophilic drug, only a small fraction of it is metabolized by CYP. Pitavastatin undergoes rapid glucuronidation by enzymes, after which it acquires an inactive lactone form as a result of the cleavage of glucuronic acid [73–75]. The metabolism of pitavastatin by CYP2C9 is so negligible that it can be neglected [75]. The consumption of grapefruit juice (a CYP3A4 inhibitor) while taking 4 mg of pitavastatin and 20 mg of atorvastatin (a lipophilic statin) leads to an increase in the concentration-time indicator: for atorvastatin – by 83%, for pitavastatin – by 13% [76].

It has also been shown that, unlike other lipophilic statins, pitavastatin does not inhibit the metabolism of other substances by CYP [77].

Thus, the metabolic effects of pitavastatin are similar to those of hydrophilic statins (pravastatin and rosuvastatin) [78].

It is widely believed that the differences in the effects of HMG-CoA reductase inhibitors on the parameters of carbohydrate metabolism are due precisely to the differences in the metabolism of hydro- and lipophilic statins.Therefore, hydrophilic statins are preferred over lipophilic ones. This is confirmed by the lack of convincing data on the disturbance of carbohydrate metabolism while taking hydrophilic pravastatin and hydrophilic pitavastatin. However, this result is not observed with the use of rosuvastatin, which is a hydrophilic drug [79]. This issue requires further study.

Conclusion

The significant advantages of using statins in patients with cardiovascular risk make them the number one drug in the complex treatment of patients with diabetes.Research results show that pravastatin and pitavastatin should be preferred when choosing lipid-lowering therapy. Both drugs are guaranteed not to worsen blood glucose and / or HbA1c values. However, pravastatin is not widely used in Russia, and pitavastatin is not registered.

Considering that the benefits of taking statins outweigh the potential risk of deteriorating carbohydrate metabolism parameters, the use of statins available in our country is mandatory in patients with diabetes.

Pravastatin :: Instruction :: Price :: Description of the drug

Pravastatin
Provides lipid-lowering (lipid / fat / blood reduction) action through two mechanisms. First, it causes a moderate decrease in intracellular cholesterol pools due to reversible suppression of HMG-CoA reductase activity. This leads to an increase in the number of receptors for LDL (low density lipoprotein) on the cell surface and to an increase in the level of catabolism (decomposition) carried out through the receptors, and the elimination of LDL from the body in the bloodstream.
Secondly, pravastatin suppresses the formation of LDL by suppressing the synthesis (formation) in the liver of VLDL (very low density lipoproteins), the precursors of LDL. In vitro studies have shown that pravastatin, which is a hydrophilic inhibitor of HMG-CoA reductase (a substance that suppresses enzyme activity), has tissue selectivity (selectivity), so that its suppressive effect is most pronounced in those tissues where cholesterol synthesis is carried out at a maximum rate, in particular in the liver, as well as in the ileum.Unlike other HMG-CoA reductase inhibitors, pravastatin has less effect on cholesterol synthesis in other tissues.
Used to reduce elevated concentrations of total cholesterol and LDL cholesterol in patients with primary hypercholesterolemia (high blood cholesterol) with ineffective diet therapy and other non-pharmacological treatments. It is also indicated for lowering cholesterol in patients with a combination of hypercholesterolemia and hypertriglyceridemia (elevated blood triglycerides), if elevated cholesterol is the leading disease.
Before starting treatment with pravastatin, the patient should be prescribed a standard cholesterol-lowering diet. During treatment with pravastatin, the patient should continue to follow this diet. The drug is taken 1 time a day before bedtime, regardless of food intake, at a dose of 10 to 40 mg. Typically, the starting dose is 10 to 20 mg. If the serum cholesterol concentration is significantly elevated (for example, total cholesterol over 300 mg / dL), the starting dose can be increased to 40 mg per day. It is possible to divide the prescribed dose of pravastatin into several doses.
Since the maximum effect of the dose of the drug appears within 4 weeks, at this time, periodic determinations of the concentration of lipids should be carried out, and the dosage of the drug should be adjusted accordingly, depending on the patient’s response to treatment.
Pravastatin is generally well tolerated. Skin rashes are possible.
Hypersensitivity to the drug, acute liver disease; pregnancy, lactation (breastfeeding).
If pregnancy occurs while taking the drug, treatment should be discontinued and the patient should be examined in order to identify the possible damaging effect of the drug on the fetus.
Tablets containing 10 or 20 mg, in a package of 10 pieces.
List B. In a dry place.

The manual was compiled by a team of authors and editors of the Piluli website. The list of authors of the reference book of medicines is presented on the page of the site editorial office: Site editorial board.

References to used sources of information.

Description of the drug “ Pravastatin ” on this page is a simplified and supplemented version of the official instructions for use. Before purchasing or using the drug, you should consult with your doctor and familiarize yourself with the annotation approved by the manufacturer.
Information on the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide on the appointment of the drug, as well as determine the doses and methods of its use.

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Pravastatin | Health News | Search and ordering of medicines in pharmacies in St. Petersburg and the Leningrad region.

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21.01.2020

Find a drug in pharmacies

Trade name of the drug: Pravastatin

International non-proprietary name: Pravastatin

Dosage form: tablets

Active ingredient: Pravastatin

Pharmacotherapeutic group: hypolipidemic agent – HMG-CoA reductase inhibitor

Pharmacological action:

Lipid-lowering agent from the group of statins, inhibitor of HMG-CoA reductase.According to the principle of competitive antagonism, the statin molecule binds to the part of the coenzyme A receptor where this enzyme attaches. Another part of the statin molecule inhibits the conversion of hydroxymethylglutarate to mevalonate, an intermediate in the synthesis of the cholesterol molecule. Inhibition of the activity of HMG-CoA reductase leads to a series of sequential reactions resulting in a decrease in the intracellular cholesterol content and a compensatory increase in the activity of LDL receptors and, accordingly, an acceleration of the catabolism of LDL cholesterol (Xc).

The lipid-lowering effect of statins is associated with a decrease in the level of total cholesterol due to

Xs-LDL. The decrease in LDL cholesterol is dose-dependent and not linear, but exponential.

According to controlled studies, pravastatin increases the level of HDL-C up to 10%.

Statins do not affect the activity of lipoprotein and hepatic lipases, do not have a significant effect on the synthesis and catabolism of free fatty acids, therefore their effect on the level of triglycerides is secondary and is mediated through their main effects on lowering the level of LDL-C.

In addition to the hypolipidemic effect, statins have a positive effect on endothelial dysfunction (a preclinical sign of early atherosclerosis), on the vascular wall, the state of atheroma, improve the rheological properties of blood, have antioxidant, antiproliferative properties.

Pharmacokinetics

After oral administration, 30-54% of the administered dose of pravastatin is rapidly absorbed, bioavailability is 15-20%. Pravastatin undergoes a “first pass” effect through the liver.Reception 1 hour before or with food reduces systemic bioavailability and specific activity. Plasma concentration is directly proportional to the administered dose. Cmax in blood plasma is reached after 1-1.5 hours. Plasma protein binding is 50%. Excreted in breast milk. Metabolized in several ways: isomerization to 6-epipravastatin and

3-hydroxy isomers, enzymatic hydroxylation of the ring and subsequent oxidation to ketone, oxidation of the ether or carboxyl ends of the chain, conjugation.The main metabolic products (3-hydroxy isomers) have a specific activity that ranges from 1/14 to 1/10 of the initial activity.

T1 / 2 – 1.3-2.7 hours. The kidneys are excreted 20%, through the intestines – 70%. 47% of the total clearance is accounted for by the kidneys and 53% by the extrarenal pathways. Due to the presence of two routes of excretion, a compensatory increase in excretion along one of them in case of violation of the other is possible, as well as the development of cumulation of pravastatin and its metabolites in renal and / or hepatic insufficiency.

Indications for use:

Primary hypercholesterolemia (with the exception of familial homozygous), predominantly IIa and IIb types (with ineffectiveness of diet therapy in patients at increased risk of coronary atherosclerosis), hypercholesterolemia in combination with hypertriglyceridemia; prevention of coronary artery disease (reducing the risk of myocardial infarction, the need for myocardial revascularization operations, mortality from CVD diseases).

Contraindications:

Hypersensitivity, acute diseases or exacerbations of chronic liver diseases, liver failure; persistent changes in liver function tests of unknown etiology; pregnancy, lactation, age up to 18 years (safety and efficacy have not been established).With care. Alcoholism, organ transplantation, immunosuppressive therapy, renal failure.

Method of administration and dosage:

Before starting therapy with Pravastatin, the patient should be prescribed a standard diet to lower cholesterol levels. During treatment with the drug, this diet must be followed.

The drug is taken orally, regardless of food intake, at an initial dose of 10-20 mg once, before bedtime. With a significant increase in plasma cholesterol concentration (more than 300 mg / dL), the initial dose is increased to 40 mg 1 time per day before bedtime.The maximum therapeutic effect develops within 4 weeks from the start of treatment. During this period, dose adjustment is possible depending on the dynamics of the concentration of lipids in the blood plasma.

Patients taking cyclosporine in combination with other immunosuppressants at the same time, treatment begins with a dose of 10 mg with a gradual increase. The maximum dose is 20 mg.

In hepatic or renal failure, the initial dose should not exceed

10 mg.

For elderly patients, a dose of 20 mg / day is usually effective.

Side effects:

From the nervous system: dizziness, headache, dysfunction of the cranial nerves (taste disturbance, involuntary eye movements, paresis of the facial nerve), peripheral polyneuropathy, tremor, anxiety, insomnia, depression, amnesia, paresthesia.

From the senses: cataract progression, ophthalmoplegia.

From the digestive system: nausea, decreased appetite, gastralgia, diarrhea or constipation, flatulence, hepatitis (incl.including chronic active and cholestatic), fatty liver, cirrhosis or necrosis of the liver, hepatoma, increased activity of “hepatic” transaminases (2-3 times compared with the norm) and alkaline phosphatase, hyperbilirubinemia, hypercreatininemia (3 times with respect to the upper border of the norm), theoretically possible acute pancreatitis.

From the side of hematopoiesis: thrombocytopenia, leukopenia, hemolytic anemia, eosinophilia.

From the musculoskeletal system: myalgia, myopathy, myositis, rhabdomyolysis.

From the genitourinary system: decreased libido and potency.

Allergic reactions: skin rash, itching, lupus-like syndrome, anaphylactic shock, angioedema, dermatomyositis, vasculitis, purpura, toxic epidermal necrolysis (Lyell’s syndrome), malignant exudative erythema (Stevens-Johnson syndrome).

On the part of the skin: alopecia, skin depigmentation, photosensitivity, dry skin and mucous membranes.

Laboratory indicators: increased activity of CPK, myoglobinuria.

Others: gynecomastia, palpitations, respiratory failure, gynecomastia, renal failure (due to rhabdomyolysis).

Interaction with other medicinal products:

Increases the effect of indirect anticoagulants and the risk of bleeding.

When administered simultaneously with ASA, antacids, cimetidine, gemfibrozil, nicotinic acid and probucol, the bioavailability of these drugs does not change.

Compatible with diuretics, antihypertensive drugs, digitalis drugs, ACE inhibitors, BMCC, beta-blockers, nitrates.

Fibrates, cycloslorin, erythromycin, nicotinic acid increase the risk of myopathy; gemfibrozil increases the concentration of CPK in plasma and the risk of side effects from the musculoskeletal system.

Anion exchange resins (colestyramine, colestipol) reduce AUC by 40-50% (pravastatin should be administered 1 hour before or 4 hours after taking these drugs).

Storage conditions:

In a dry, dark place at a temperature not exceeding 25 ° C.

Keep out of reach of children.

Expiry date: 2 years

Do not use later than the date printed on the package.

Pharmacy dispensing conditions: Prescription

Manufacturer: VALENTA PHARMACEUTICS, Russia

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