pravastatin sodium
Onset
Unknown
Peak
Duration
Unknown Unknown
Adverse reactions
Pravachol
Pharmacologic class: HMG-CoA
reductase inhibitor
Therapeutic class: Antilipemic
Pregnancy risk category X
Action
Inhibits HMG-CoA reductase, an enzyme that catalyzes cholesterol synthesis pathway; this action decreases cholesterol, triglyceride, apolipoprotein B,
and low-density lipoprotein (LDL)
levels and increases high-density
lipoprotein levels
Availability
Tablets: 10 mg, 20 mg, 40 mg, 80 mg
1Indications and dosages
➣ Adjunct to diet to control levels of
LDL, total cholesterol, apolipoprotein
B, and triglycerides in patients with
primary hypercholesterolemia, mixed
dyslipidemia (including Fredrickson
types IIa and IIb), primary dysbetalipoproteinemia (Fredrickson type III),
hypertriglyceridemia (including Fredrickson type IV), and primary and secondary prevention of cardiovascular
events
Adults: 10 to 80 mg P.O. once daily
Contraindications
● Hypersensitivity to drug or other
HMG-CoA reductase inhibitors
● Active hepatic disease or unexplained,
persistent transaminase elevations
● Pregnancy, breastfeeding, females of
childbearing age
Administration
● If patient is also receiving a bile-acid
resin, give pravastatin at bedtime, at
least 4 hours after resin.
Canada
Route
P.O.
2Clinical alert
CNS: amnesia, abnormal dreams, emotional lability, facial paresis, headache,
hyperkinesia, poor coordination, malaise, paresthesia, peripheral neuropathy, drowsiness, syncope, asthenia
CV: orthostatic hypotension, palpitations, phlebitis, vasodilation, arrhythmias
EENT: amblyopia, glaucoma, eye hemorrhage, altered refraction, dry eyes,
hearing loss, tinnitus, epistaxis, gingival hemorrhage, glossitis, sinusitis,
pharyngitis
GI: nausea, vomiting, diarrhea, constipation, abdominal or biliary pain, colitis, gastric ulcer, dysphagia, esophagitis,
flatulence, dyspepsia, heartburn, gastroenteritis, melena, tenesmus, abdominal cramps, stomatitis, dry mouth,
taste loss, pancreatitis, rectal hemorrhage
GU: dysuria, hematuria, nocturia, urinary frequency or urgency, urinary retention, renal calculi, nephritis, abnormal ejaculation, cystitis, epididymitis,
decreased libido, impotence
Hematologic: anemia, thrombocytopenia
Hepatic: jaundice, hepatic failure,
hepatitis
Metabolic: hyperglycemia, hypoglycemia
Musculoskeletal: joint pain, bursitis,
back pain, gout, leg cramps, myalgia,
myositis, neck rigidity, torticollis, myasthenia gravis, rhabdomyolysis, increased creatine kinase level
Respiratory: dyspnea, pneumonia,
bronchitis
Skin: diaphoresis, acne, alopecia, contact dermatitis, eczema, dry skin, pruritus, rash, urticaria, skin ulcers, seborrhea, photosensitivity
Other: increased or decreased appetite,
weight gain, facial or generalized edeReactions in bold are life-threatening
ma, fever, flulike symptoms, infection,
allergic reaction
Interactions
Drug-drug. Antacids, colestipol: decreased pravastatin blood level
Azole antifungals, cyclosporine, erythromycin, niacin, gemfibrozil, other HMGCoA reductase inhibitors: increased risk
of myopathy
Digoxin: increased pravastatin blood
level and risk of toxicity
Hormonal contraceptives: increased
hormone levels
Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase:
increased levels
Drug-food. Grapefruit juice: increased
drug blood level
Drug-herb. Chaparral, comfrey, eucalyptus, germander, jin bu huan, kava,
pennyroyal, skullcap, valerian: increased
risk of hepatotoxicity
Red yeast rice: increased risk of adverse
drug reactions
Precautions
Use cautiously in:
● renal impairment; severe hypotension or hypertension; severe acute infection; severe metabolic, endocrine, or
electrolyte disorders; uncontrolled
seizures; visual disturbances; myopathy; major surgery; trauma; alcoholism
● history of hepatic disease
● concurrent use of gemfibrozil or
azole antifungals
● children under age 18 (safety not
established).
● Assess creatine kinase levels of patients experiencing muscle pain or receiving other drugs associated with
myopathy.
Patient teaching
● Caution patient not to take drug
with grapefruit juice or antacids.
● Teach patient to recognize and immediately report signs and symptoms
of allergic response and other adverse
reactions, especially myositis.
● Inform patient that drug may cause
headache, musculoskeletal pain, and
leg cramps. Encourage him to discuss
activity recommendations and pain
management with prescriber.
● Advise females of childbearing age to
notify prescriber of possible pregnancy.
● Tell male patient that drug may cause
erectile dysfunction (impotence) and
abnormal ejaculation. Recommend
that he discuss these issues with prescriber.
● Instruct patient to avoid driving and
other hazardous activities until he
knows how drug affects concentration,
alertness, and vision.
● Instruct patient not to take herbs unless prescriber approves.
● As appropriate, review all other significant and life-threatening adverse
reactions and interactions, especially
those related to the drugs, tests, foods,
and herbs mentioned above.
Patient monitoring
● Monitor for signs and symptoms of
allergic reaction.
● Monitor vital signs and cardiovascular status.
● Evaluate liver function test results before starting therapy, 6 to 12 weeks later, and at least semiannually thereafter;
also monitor lipid levels.
Canada
2Clinical alert
Reactions in bold are life-threatening