Index
This medication belongs to a group of drugs called HMG CoA Reductase inhibitors, or “Statins.”
Pravastatin reduces the levels of “bad” cholesterol (low-density lipoprotein or LDL) and triglycerides in the blood while increasing the levels of “good” cholesterol (high-density lipoprotein or HDL).
Its most common use is to reduce cholesterol and triglycerides (types of fat) in the blood.
It is also used to decrease the risk of stroke, heart attack, and other cardiac complications in people with diabetes, coronary heart disease, or other risk factors.
It is used in adults and children at least eight years old.
What are the possible side effects of Pravastatin?
Seek emergency medical attention if you have any of these symptoms of an allergic reaction:
- Rochas
- Difficult breathing
- Swelling of your face, lips, tongue, or throat.
Stop taking Pravastatin and call your doctor immediately if you have any of these severe side effects:
- Unexplained muscle pain.
- Sensibility or weakness
- Confusion.
- Memory problems.
- Fever.
- Unusual tiredness and dark-colored urine.
- Chest pain.
- Increased thirst, increased urination, hunger.
- Dry mouth.
- The smell of fruity breath.
- Drowsiness.
- Dry Skin.
- Blurry vision.
- Weightloss.
- Swelling
- Weight gain
- Urinating less than usual or not urinating.
- Nausea, pain in the upper part of the stomach, itching, loss of appetite, dark urine, clay-colored stools, and jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- Mild muscular pain
- Diarrhea.
- Mild skin rash
- Dizziness
This is not a complete list of side effects, and others may occur. Call your doctor for medical information about side effects.
What is the most important information I should know?
You should not take Pravastatin if you are allergic to it, pregnant or breastfeeding, or if you have liver disease.
Stop taking this medication and tell your doctor right away if you become pregnant.
Before taking Pravastatin, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder or if you drink more than two alcoholic beverages per day.
In rare cases, Pravastatin can cause a condition that causes the breakdown of skeletal muscle tissue and causes kidney failure.
Call your doctor if you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever, unusual tiredness, and dark-colored urine.
Avoid eating foods high in fat or cholesterol. Pravastatin will not be as effective in reducing cholesterol if you do not follow a diet plan to lower cholesterol.
Avoid drinking alcohol. You can raise triglyceride levels and increase your risk of liver damage.
Many other drugs can increase your risk of serious medical problems if you take them with Pravastatin. Tell the doctor about all medicines you take. This includes prescriptions, over-the-counter vitamins, and herbs.
Do not start a new medication without telling your doctor. Keep a list of all your drugs and show it to any health care provider who treats you.
Pravastatin consumption is only part of a complete treatment program that includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines continuously.
What should I discuss with my healthcare provider before taking Pravastatin?
You should not take Pravastatin if you are allergic to it, pregnant or breastfeeding, or have liver disease.
To make sure you can take Pravastatin safely, tell your doctor if you have any of these other conditions:
- History of liver disease.
- History of kidney disease.
- Diabetes.
- A thyroid disorder.
- If you drink more than two alcoholic drinks daily.
In rare cases, Pravastatin can cause a condition that causes the breakdown of skeletal muscle tissue and causes kidney failure.
It is more likely that this condition occurs in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).
Tell your doctor about all other medications you use. Certain other drugs can increase your risk of severe muscle problems, and your doctor must know if you are using any of them:
- Gemfibrozil (Lopid), Fenofíbrico (Fibricor, Trilipix) or Fenofibrate (Antara, Fenoglide, Lipofen, Lofibra, Tricor, Triglide);
- Medications containing Niacin (Advisor, Niaspan, Niacor, Simcor, Slo-Niacin, and others).
- Drugs that weaken your immune systems, such as steroids, cancer medications, or medicines used to prevent rejection of organ transplants, such as Cyclosporin (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf).
Indications
Therapy with agents that alter lipids should be only one component of the intervention with multiple risk factors in individuals with a significantly higher risk of atherosclerotic vascular disease due to hypercholesterolemia.
Pharmacological therapy is indicated as a dietary supplement when the response to a diet restricted in saturated fats and cholesterol and other non-pharmacological measures alone have been inadequate.
Prevention of cardiovascular disease
In hypercholesterolemic patients without clinically evident coronary disease, Pravastatin is indicated for:
- Reduce the risk of myocardial infarction (MI).
- Reduce the risk of undergoing myocardial revascularization procedures.
- Reduce the risk of cardiovascular mortality without increasing deaths from non-cardiovascular causes.
- In patients with clinically evident congenital heart disease, Pravastatin is indicated for:
- Reduce the risk of total mortality by reducing coronary death.
- Reduce the risk of myocardial infarction
- Reduce the risk of undergoing myocardial revascularization procedures.
- Reduce the risk of Stroke and stroke / transient ischemic attack (TIA).
- Slow the progression of coronary atherosclerosis.
- Hyperlipidemia
Pravastatin is indicated:
- As an adjunct to the diet to reduce high levels of total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), Apolipoprotein B (ApoB), and triglycerides (TG) and to increase lipoprotein cholesterol high density (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Types IIa and IIb of Fredrickson) 1.
- As an adjunct to the diet for treating patients with elevated levels of serum TG (Fredrickson Type IV).
- For the treatment of patients with primary Disbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to the diet.
- As a complement to the modification of diet and lifestyle for the treatment of heterozygous familial hypercholesterolemia (HeFH) in children and adolescents older than eight years if, after a good diet test, the following findings are present:
- LDL-C permanece ≥ 190 mg / dL o
- LDL-C permanece ≥ 160 mg / dL y:
- If there is a positive family history of premature cardiovascular disease (CVD)
- If there are two or more CVD risk factors, they are present in the patient.
Dosage and Administration
General dosing information
Adult patients
The recommended initial dose is 40 mg once a day. If a daily dose of 40 mg does not reach the desired cholesterol levels, 80 mg once a day is recommended.
Pravastatin can be administered orally as a single dose on any day, with or without food.
Since the maximum effect of a given dose is observed within four weeks, periodic lipid determinations should be made. The amount is adjusted according to the patient’s response to the therapy and established treatment guidelines.
Patients with renal failure
An initial dose of 10 mg of Pravastatin per day is recommended in patients with severe renal impairment.
Pediatric patients
Children (ages 8 to 13, inclusive)
The recommended dose is 20 mg once a day in children 8 to 13 years of age. Doses above 20 mg have not been studied in this patient population.
Adolescents (ages 14 to 18)
The recommended initial dose is 40 mg once a day in adolescents 14 to 18 years of age. Doses above 40 mg have not been studied in this patient population.
Children and adolescents treated with Pravastatin should be reevaluated in adulthood, and appropriate changes in their cholesterol-lowering regimen should be made to achieve adult goals for LDL-C.
Concomitant therapy to alter lipids
Pravastatin can be used with bile acid resins. A bile acid-binding resin (e.g., cholestyramine, Colestipol) and Pravastatin should be administered 1 hour or more before or at least 4 hours after the wax.
Dosage in patients taking Ciclosporin
In patients taking immunosuppressant drugs such as Ciclosporin in conjunction with Pravastatin, treatment should start with 10 mg Pravastatin sodium once a day at bedtime. Assessment at higher doses should be done with caution.
Most patients treated with this combination received a maximum Pravastatin sodium dose of 20 mg/day. In patients taking Ciclosporin, treatment should be limited to 20 mg of Pravastatin sodium once a day.
