What is Pravachol, and how does it work?
Pravachol is a prescription medicine used to treat the symptoms of high cholesterol, to lower blood levels of “bad” cholesterol (low-density lipoprotein or LDL), to increase levels of "good" cholesterol (high-density lipoprotein, or HDL) and to lower triglycerides. Pravachol may be used alone or with other medications.
Pravachol belongs to a class of drugs called Lipid-Lowering Agents, Statins, HMG-CoA Reductase Inhibitors.
It is not known if Pravachol is safe and effective in children younger than 8 years of age.
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),
Pravachol (pravastatin sodium) is
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.
In patients with clinically evident CHD, Pravachol is
indicated to:
- reduce the risk of total mortality by reducing coronary
death. - reduce the risk of MI.
- 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
Pravachol is indicated:
- as an adjunct to diet to reduce elevated total
cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C),
apolipoprotein B (ApoB), and triglyceride (TG) levels and to increase
high-density lipoprotein cholesterol (HDL-C) in patients with primary
hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and
IIb).1 - as an adjunct to diet for the treatment of patients with
elevated serum TG levels (Fredrickson Type IV).  - for the treatment of patients with primary
dysbetalipoproteinemia (Fredrickson Type III) who do not respond
adequately to diet. - as an adjunct to diet and lifestyle modification for
treatment of heterozygous familial hypercholesterolemia (HeFH) in children and
adolescent patients ages 8 years and older if after an adequate trial of diet
the following findings are present:- LDL-C remains ≥ 190 mg/dL or
- LDL-C remains ≥ 160 mg/dL and:
- there is a positive family history of premature
cardiovascular disease (CVD) or - two or more other CVD risk factors are present in the
patient.
Limitations Of Use
Pravachol has not been studied in conditions where the
major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types
I and V).
What are the side effects of Pravachol?
Pravachol may cause serious side effects including:
- unexplained muscle pain, tenderness or weakness,
- fever,
- unusual tiredness,
- dark colored urine,
- chest pain,
- upper stomach pain,
- loss of appetite, and
- yellowing of the skin or eyes (jaundice)
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Pravachol include:
- muscle or joint pain,
- nausea,
- vomiting,
- diarrhea,
- headache, and
- cold symptoms (stuffy nose, sneezing or sore throat)
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Pravachol. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Pravachol?
General Dosing Information
- The patient should be placed on a standard cholesterol-lowering diet before
receiving Pravachol and should continue on this diet during treatment with
Pravachol.
Adult Patients
- The recommended starting dose is 40 mg once daily. If a
daily dose of 40 mg does not achieve desired cholesterol levels, 80 mg once
daily is recommended. - Pravachol can be administered orally as a single dose at
any time of the day, with or without food. - Since the maximal effect of a given
dose is seen within 4 weeks, periodic lipid determinations should be performed
at this time and dosage adjusted according to the patient’s response to therapy
and established treatment guidelines.
Patients With Renal Impairment
- In patients with severe renal impairment, a starting dose
of 10 mg pravastatin daily is recommended. - Although the Pravachol 10 mg tablets
are no longer available, pravastatin 10 mg tablets are available.
Pediatric Patients
Children (Ages 8 to 13 Years, Inclusive)
- The recommended dose is 20 mg once daily in children 8 to
13 years of age. - Doses greater than 20 mg have not been studied in this patient
population.
Adolescents (Ages 14 to 18 Years)
- The recommended starting dose is 40 mg once daily in
adolescents 14 to 18 years of age. - Doses greater than 40 mg have not been
studied in this patient population. - Children and adolescents treated with pravastatin should be reevaluated
in adulthood and appropriate changes made to their cholesterol-lowering
regimen to achieve adult goals for LDL-C.
Concomitant Lipid-Altering Therapy
- Pravachol may be used with
bile acid resins. - When
administering a
bile-acid-binding
resin (e.g., cholestyramine, colestipol) and pravastatin, Pravachol should be
given either 1 hour or more before or at least 4 hours following the resin.
Dosage In Patients Taking Cyclosporine
- In patients taking
immunosuppressive
drugs such as cyclosporine concomitantly with pravastatin, therapy should begin
with 10 mg of pravastatin sodium once-a-day at bedtime and titration to 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
cyclosporine, therapy should be limited to 20 mg of pravastatin sodium once
daily. - Although the Pravachol 10 mg
tablets are no longer available, pravastatin 10 mg tablets are available.
Dosage In Patients Taking Clarithromycin
- In patients taking clarithromycin, therapy should be limited to 40 mg of
pravastatin sodium once daily.
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What drugs interact with Pravachol?
For the concurrent therapy of either cyclosporine, fibrates, niacin
(nicotinic acid), or erythromycin, the risk of myopathy increases.
Cyclosporine
- The risk of myopathy/rhabdomyolysis is increased with concomitant
administration of cyclosporine. Limit pravastatin to 20 mg once daily for
concomitant use with cyclosporine.
Clarithromycin And Other Macrolide Antibiotics
- The risk of myopathy/rhabdomyolysis is increased with concomitant
administration of clarithromycin. Limit pravastatin to 40 mg once daily for
concomitant use with clarithromycin. - Other macrolides (e.g.,
erythromycin and azithromycin)
have the potential to increase statin exposures while used in combination. - Pravastatin should be used cautiously with
macrolide antibiotics due to a
potential increased risk of myopathies.
Colchicine
- The risk of myopathy/rhabdomyolysis is increased with
concomitant administration of
colchicine.
Gemfibrozil
- Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase
inhibitors are coadministered with gemfibrozil, concomitant administration of
Pravachol with gemfibrozil should be avoided.
Other Fibrates
- Because it is known that the risk of myopathy during treatment with HMG-CoA
reductase inhibitors is increased with concurrent administration of other
fibrates, Pravachol should be administered with caution when used concomitantly
with other fibrates.
Niacin
- The risk of
skeletal muscle effects may be enhanced when
pravastatin is used in combination with
niacin;
a reduction in Pravachol dosage should be considered in this setting.
Is Pravachol safe to use while pregnant or breastfeeding?
- Pravachol is contraindicated for use in pregnant woman because of the potential for fetal harm. As safety in pregnant women has not been established and there is no apparent benefit to therapy with
Pravachol during pregnancy, Pravachol should be immediately discontinued as soon as pregnancy is recognized. - Limited published data on the use of Pravachol in pregnant women are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage.
- Pravastatin use is contraindicated during breastfeeding.
- Based on one lactation study in published literature, pravastatin is present in human milk. There is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production.
- Because of the potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with
Pravachol.