Geriatric Use The beneficial effect of pravastatin in elderly subjects in reducing cardiovascular events and in modifying lipid profiles was similar to that seen in younger subjects. The adverse event profile in the elderly was similar to that in the overall population. Other reported clinical experience has not identified differences in responses to pravastatin between elderly and younger patients. Homozygous Familial Hypercholesterolemia Pravastatin has not been evaluated in patients with rare homozygous familial hypercholesterolemia.
In this group of patients, it has been reported that statins are less effective because the patients lack functional LDL receptors. Overdosage To date, there has been limited experience with overdosage of pravastatin. If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted as required. Description Pravastatin sodium is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis.
Pravastatin sodium, USP is white to yellowish white powder or crystalline powder, hygroscopic in nature. It is freely soluble in water and in methanol. Each pravastatin sodium tablet intended for oral administration contains 10 mg or 20 mg or 40 mg or 80 mg of pravastatin sodium.
In addition, each tablet contains the following inactive ingredients: Clinical Pharmacology Mechanism of Action Pravastatin is a reversible inhibitor of 3-hydroxymethylglutaryl-coenzyme A HMG-CoA reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevalonate, an early and rate limiting step in the biosynthetic pathway for cholesterol.
Pharmacokinetics General Absorption Pravastatin sodium is administered orally in the active form. In studies in man, peak plasma pravastatin concentrations occurred 1 to 1. While the presence of food in the gastrointestinal tract reduces systemic bioavailability, the lipid-lowering effects of the drug are similar whether taken with or 1 hour prior to meals. Pravastatin plasma concentrations, including area under the concentration-time curve AUC , Cmax, and steady-state minimum Cmin , are directly proportional to administered dose.
Despite this decrease in systemic bioavailability, the efficacy of pravastatin administered once daily in the evening, although not statistically significant, was marginally more effective than that after a morning dose. The geometric means of pravastatin Cmax and AUC following a 20 mg dose in the fasted state were Steady-state AUCs, Cmax, and Cmin plasma concentrations showed no evidence of pravastatin accumulation following once or twice daily administration of pravastatin sodium tablets.
Metabolism The major biotransformation pathways for pravastatin are: Pravastatin undergoes extensive first-pass extraction in the liver extraction ratio 0. Specific Populations Renal Impairment A single 20 mg oral dose of pravastatin was administered to 24 patients with varying degrees of renal impairment as determined by creatinine clearance.
Similarly, the peak pravastatin values varied fold for cirrhotic patients compared to 6-fold for healthy subjects. The corresponding values for Cmax were No conclusion can be made based on these findings due to the small number of samples and large variability. 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.
Patients treated with pravastatin had an adverse experience profile generally similar to that of patients treated with placebo with influenza and headache commonly reported in both treatment groups.
Double-blind, placebo-controlled pravastatin studies in children less than 8 years of age have not been conducted. Across these 2 studies, The beneficial effect of pravastatin in elderly subjects in reducing cardiovascular events and in modifying lipid profiles was similar to that seen in younger subjects.
The adverse event profile in the elderly was similar to that in the overall population. Other reported clinical experience has not identified differences in responses to pravastatin between elderly and younger patients. Homozygous Familial Hypercholesterolemia Pravastatin has not been evaluated in patients with rare homozygous familial hypercholesterolemia.
In this group of patients, it has been reported that statins are less effective because the patients lack functional LDL receptors. Postmarketing surveillance of lovastatin and simvastatin exposure during pregnancy.
If an overdose occurs, it should be treated symptomatically with laboratory monitoring and supportive measures should be instituted as required. Pregnancy Atherosclerosis is a chronic process and discontinuation of lipid -lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Cholesterol and other products of cholesterol biosynthesis are essential components for fetal development including synthesis of steroids and cell membranes.
Since statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they are contraindicated during pregnancy and in nursing mothers. If the patient becomes pregnant while taking this class of drug, therapy should be discontinued immediately and the patient apprised of the potential hazard to the fetus [see Use in Specific Populations ].
Lactation Pravastatin is present in human milk. In studies in man, peak plasma pravastatin concentrations occurred 1 to 1. He takes it at night, wakes up every morning sick to his stomach, cannot eat, and has a loss of appetite. Also had symtoms of a heart attack. He had his heart checked and is okay. Can pravastatin being causing these symptoms? Pravastatin works in the body by blocking the production of some cholesterol. The medication lowers LDL low density lipoprotein and total cholesterol.
The incidence was reported at 7 percent. Diarrhea is a reported side effect in 6 percent of patients. Heartburn has also been reported in 3 percent of patients during clinical trials of the medication.
Fatigue was reported in 4 percent of patients and dizziness has an incidence of reporting at 1 percent to 3 percent.
Chest pain is another possible side effect and was reported in 4 percent of patients. Muscle weakness was reported in less than 1 percent of patients. This is not a complete list of all the possible side effects associated with the use of pravastatin. Myopathy or muscle weakness could be a serious side effect of pravastatin. The fear is that it could be related to rhabdomyolysis, which is the breakdown of muscles.
Rhabdomyolysis is a serious medical condition that has been seen with the use of the class of medications that pravastatin belongs to. Medical references recommend that patients taking pravastatin should report to their physician any unexplained muscle pain, weakness, tenderness or brown colored urine. The recommendation is made to talk to your husband's physician regarding the symptoms that he is experiencing.
His physician will be able to determine the best course of action and diagnose his symptoms. Treatment options, which may include a change in medication, will need to be determined by his physician. He should not stop taking or change the dosage of his medication without first talking to his physician.
For more specific information, consult with your husband's doctor or pharmacist for guidance based on his health status and current medications, particularly before taking any action. Jen Marsico, RPh Q: Does Pravastatin have the following side effects: Pravastatin may be linked to reduced libido and impotence, however it has been found to be reversible in a study performed in The study found that the impotence and decreased sex drive returned to normal about 2 weeks after stopping the pravastatin.
Regarding the weight gain, pravastatin is not known to cause weight gain. If you are experiencing weight gain, I am not sure what is causing it. Possibly another medication that you are taking? Or less physical activity? If the side effects of the pravastatin are too bothersome for you, try speaking with your doctor to see if they want to try you on a different medication.
The doctor wants to put me on pravastatin. The literature states,"avoid alcohol" and a list of side effects. The proposed dose is 40 mg. I think I should follow the doctor's advice but I am unwilling to give up my 3 to 5 drinks per week. Also, the list of side effects are alarming given that I travel a lot and I'm concerned about getting in trouble far from home. I am unsettled about taking the drug, or any statin medication.
Do you have any comments? It is always good to check into a medication prior to starting to see how it will fit in with your lifestyle. It is not recommended to drink alcohol while on pravastatin or any statin for that matter because alcohol can increase triglyceride levels and can cause damage to the liver.
Pravastatin is metabolized by the liver and if there is damage done to the liver by the alcohol, the pravastatin may cause more damage and be harmful. Most times, the doctor will perform liver function tests to be sure that the liver is not getting damaged. If you are consuming all drinks at once, then it would probably be best for you to avoid pravastatin. However, if you drink one drink for nights out of the week, then I don't see it being of great concern.
Of course, this is something that you should bring up with your doctor. Side effects always seem alarming, but the majority of people they will not be too affected by them.
Perhaps you would be able to start pravastatin during a period while you are not traveling so that you can see how it affects you while you are still in a familiar surrounding. Pravastatin can be very beneficial because high cholesterol can cause very serious problems like stroke, heart attack, and coronary artery disease. It would be good for you to talk to your doctor to weigh the risks and benefits of this medication. Is dizziness a side effect of pravastatin? If you are experiencing this, and it is not going away or is intolerable, contact your doctor about an alternative.
It should not be used in children in this age range. Senior dosage ages 65 years and older The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly.
As a result, a higher amount of a drug stays in your body for a longer time. This increases your risk of side effects. Your doctor may start you on a lowered dosage or a different medication schedule. This can help keep levels of this drug from building up too much in your body. Dosage for heart disease prevention Adult dosage ages 18—64 years Typical starting dosage: Child dosage ages 0—17 years This medication has not been studied in children younger than 18 years.
Special dosage considerations For people with kidney disease: A starting dosage of 10 mg once per day is recommended in people with severe kidney disease.
Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.
Take as directed Pravastatin oral tablet is used for long-term treatment. Your cholesterol levels may not be controlled. This puts you at higher risk of heart disease, heart attack, or stroke.
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