Side effects for pravachol: Pravastatin (Pravachol) – Side Effects, Interactions, Uses, Dosage, Warnings
Pravastatin (Pravachol) – Side Effects, Interactions, Uses, Dosage, Warnings
uses
What is Pravastatin (Pravachol) used for?
- Hyperlipidemia
- Hyperlipoproteinemia Type IIa (Elevated LDL)
- Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL)
- Hyperlipoproteinemia Type III (Elevated beta-VLDL + IDL)
- Hyperlipoproteinemia Type IV (Elevated VLDL)
- Hypertriglyceridemia
- Prevention of Cardiovascular Disease
- Heterozygous Familial Hypercholesterolemia
warnings
What is the most important information I should know about Pravastatin (Pravachol)?
You should not use pravastatin if you are allergic to it, or if:
Do not use if you are pregnant. This medicine can harm an unborn baby. Use effective birth control to prevent pregnancy. Stop taking this medicine and tell your doctor at once if you become pregnant.
Do not breastfeed while using this medicine.
- you are pregnant or breastfeeding; or
- you have active liver disease.
- kidney disease;
- abnormal liver function tests;
- muscle pain or weakness;
- a thyroid disorder; or
- if you drink more than 2 alcoholic beverages daily.
Tell your doctor if you have ever had:
Pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).
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Side Effects
What are the side effects of Pravastatin (Pravachol)?
Get emergency medical help if you have hives; difficulty breathing; swelling of your face, lips, tongue, or throat. signs of an allergic reaction:
In rare cases, pravastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure.
Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.
Call your doctor right away if you have:
- muscle weakness in your hips, shoulders, neck, and back;
- trouble lifting your arms, trouble climbing or standing; or
- liver problems–loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes).
- muscle or joint pain;
- nausea, vomiting, diarrhea;
- headache; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Pravastatin (Pravachol) if I’m pregnant or breastfeeding?
Contraindicated in pregnancy
Based on FDA pregnancy categories
Do not use if you are pregnant.
This medicine can harm an unborn baby. Use effective birth control to prevent pregnancy. Stop taking this medicine and tell your doctor at once if you become pregnant.
Do not breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Pravastatin (Pravachol)?
Avoid eating foods high in fat or cholesterol, or pravastatin will not be as effective.
Grapefruit may interact with pravastatin and lead to unwanted side effects. Avoid the use of grapefruit products.
Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.
Dosage Guidelines & Tips
How to take Pravastatin (Pravachol)?
Use Pravastatin (Pravachol) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
What should I do if I missed a dose of Pravastatin (Pravachol)?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose.
take two doses at one time. Do not
Overdose Signs
What happens if I overdose on Pravastatin (Pravachol)?
If you think you or someone else may have overdosed on: Pravastatin (Pravachol), call your doctor or the Poison Control center
(800) 222-1222
If someone collapses or isn’t breathing after taking Pravastatin (Pravachol), call 911
911
Images
PRAVACHOL 20, LOGO P
Color: yellow
Shape: square
Form: film coated
Imprint: PRAVACHOL 20, LOGO P
PRAVACHOL 40, LOGO P
Color: green
Shape: square
Form: film coated
Imprint: PRAVACHOL 40, LOGO P
BMS, 80
Color: yellow
Shape: oval
Imprint: BMS, 80
Side effects of pravastatin – NHS
Like all medicines, pravastatin can cause side effects in some people, but not everybody gets them.
Talk to your doctor or pharmacist if you get any side effects at all, and if they bother you or do not go away. Your doctor may recommend trying a lower dose of pravastatin or a different statin.
Serious side effects
It happens rarely, but less than 1 in 1,000 people taking pravastatin may have a serious side effect.
Stop taking pravastatin and call a doctor or contact 111 if:
- you get unexplained muscle pain, tenderness, weakness or cramps. This is more likely if you’re taking a higher dose of pravastatin – and it can happen a few weeks or months after you first start taking this medicine. These can be a sign of muscle breakdown and kidney damage
- the whites of your eyes or skin turn yellow (this may be less noticeable on black or brown skin), or if you have pale poo and dark pee – these can be signs of liver problems
- you get a skin rash with pink-red blotches, especially on the palms of the hands or soles of the feet – this could be a sign of a skin reaction called erythema multiforme
- you have severe stomach pain – this can be a sign of inflammation of the pancreas (acute pancreatitis)
- you have a cough, shortness of breath and have lost weight – these can be signs of lung disease
Go to 111.
nhs.uk or call 111.
Serious allergic reaction
In rare cases, it’s possible to have a serious allergic reaction (anaphylaxis) to pravastatin.
Immediate action required: Call 999 or go to A&E now if:
- you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
- you’re wheezing
- you get tightness in the chest or throat
- you have trouble breathing or talking
- your mouth, face, lips, tongue or throat start swelling
You could be having a serious allergic reaction and may need immediate treatment in hospital.
Other side effects
These are not all the side effects of pravastatin.
For a full list see the leaflet inside your medicines packet.
Information:
You can report any suspected side effect using the Yellow Card safety scheme.
Visit Yellow Card for further information.
Page last reviewed: 4 February 2022
Next review due: 4 February 2025
PRAVACHOLE: instructions, reviews, analogues, price in pharmacies Pregnancy
Pravahol is a lipid-lowering agent that belongs to the chemical derivatives of lovastatin. The basis of its chemical structure, like that of other statins, is a hydronaphthal ring, which interacts with the substrate for HMG-CoA reductase at the site of its binding to the enzyme (CoA site). One of the chemical properties of Pravachol is the presence of a hydroxy acid in its side chain, which makes the drug an initially active substance, unlike lovastatin and simvastatin, which are actually prodrugs.
The mechanism of action of Pravachol is the reversible inhibition of 3-hydroxy-3-methylglutaryl-CoA reductase (HMG CoA reductase), which catalyzes the conversion of HMC-CoA to mevalonate. As a result of the inhibition of this link in the biosynthesis of cholesterol in the cells of the liver and intestines, the intracellular pool of cholesterol (Xc) decreases. It has been shown that an effective decrease in LDL cholesterol when taking Pravachol is from 20 to 40%. To a lesser extent, Pravachol reduces the level of triglycerides (according to various sources, from 24% to 30%).
Pravahol intensively lowers the concentration of LDL-C particles, determined by spectroscopy using NMR (nuclear magnetic resonance) in patients with dyslipidemia. At the same time, data on the effect of Pravachol on this factor in individuals without hyperlipidemia or with confirmed CAD are very contradictory.
Along with the lipid-lowering effect, Pravachol causes an improvement in endothelial function, weakens the thrombophilic properties of blood in men and women, reduces the frequency of transient myocardial ischemia and has an anti-inflammatory effect.
There is evidence (CARE study) that Pravachol, when taken orally at a dose of 40 mg / day for 5 years, after myocardial infarction, reduced elevated CRP concentration in patients, the level of increase of which correlated with an increase in the risk of developing MI and NMC in healthy people.
Pravachol has a direct antiproliferative effect on the vascular wall, which may be of preventive value in the treatment of cardiovascular diseases (Corsini A. et al. 1998)
Pravachol, like other statins, has no therapeutic effect in patients with initially low LDL levels 3.49mmol/l).
It has an antiplatelet effect in patients with hypercholesterolemia, associated with the normalization of platelet activity and a decrease in the excretion of thromboxane A2, a vasoactive substance synthesized in platelets and which is their activator.
Pravachol is able to improve endothelial function and stabilize the growth of atherosclerotic plaques. This effect is realized due to a decrease in both lipids themselves and macrophages loaded with lipids, as well as an increase in the volume of collagen and smooth muscle cells inside the plaque, which leads to increased fibrosis of the plaque and a decrease in the risk of its rupture leading to thrombosis and the development of acute coronary complications.
Pharmacokinetics
When taken orally, Pravachol is absorbed by 54% (taking the drug 1 hour before a meal or with food reduces the systemic bioavailability and specific activity of Pravachol). Does not have lipophilic properties. It is subjected to significant binding by hepatocytes after the “first pass” through the liver. Cmax is reached in 1–1.5 hours. It binds to proteins by 43–48%.
Biotransformation is carried out in several ways: isomerization to 6-epipravastatin and 3-hydroxyisomer, enzymatic hydroxylation of the ring, followed by oxidation to ketone, oxidation of the ether or carboxyl ends of the chain, conjugation; the main metabolic products – 3-hydroxyisomers – have a specific activity ranging from 1/14 to 1/10 of the original. The elimination half-life (T½) of pravastatin and its metabolites is about 77 hours. Approximately 20% of an orally administered dose is excreted in the urine, 70% in the faeces. Pravachol is eliminated unchanged by the kidneys (Horsmans Y.
, 1999).
Due to the presence of a renal elimination pathway, a significant increase in plasma clearance of Pravachol can be expected in the presence of impaired renal function and the occurrence of renal failure.
Indications for use
Indications for the use of the drug Pravachol are: hyperlipidemia without coronary heart disease (reducing the risk of myocardial infarction), atherosclerosis and coronary artery disease, including myocardial infarction (to slow the progression of atherosclerosis and reduce the likelihood of re-infarction), type II hyperlipidemia (increase content of LDL, VLDL, total cholesterol), familial hypercholesterolemia (in patients with a transplanted heart to reduce the likelihood of developing coronary angiopathy).
How to use
Preparation Pravachol is used orally, 1 time per day, at bedtime. The initial dose is 10-20 mg (patients with a history of liver and / or kidney pathology are recommended to start treatment with 10 mg).
If there is no result within 4 weeks, the dose is gradually increased to 40 mg. In most cases, the effective daily dose is 20 mg. For people receiving immunosuppressive drugs (cyclosporine), monitoring of CPK levels is mandatory for the timely diagnosis of rhabdomyolysis.
Treatment of elderly patients: the use of Pravachol in elderly patients is associated with a number of difficulties in the dosing regimen of the drug. This is due to the presence of organ changes in patients of this category, as well as the presence of a variety of comorbidities. In this regard, we recommend starting the use of the drug with low initial doses while maintaining the frequency of administration. In addition, it is necessary to take into account the greater susceptibility of elderly patients to the development of side effects.
Treatment of patients with renal or hepatic insufficiency: in this category of patients there is a higher susceptibility to the development of side effects, in connection with this, treatment with Pravachol should also be started with low initial doses while maintaining the frequency of administration.
These patients should be treated under close medical supervision due to the high risk of complications.
Side effects
Usually Pravachol is well tolerated, but some patients may experience the following adverse events:
Hepatolenal system: dose-dependent hepatotoxic effect – the most common of all side effects developing in approximately 1% of cases with Pravachol.
It is mostly asymptomatic and is characterized by elevated levels of hepatic transaminases.
Musculoskeletal system: myopathy. A rare and most unpleasant side effect of Pravachol. The effect is dose-dependent. It manifests itself in the form of severe weakness, myalgia, and sometimes an increase in the level of CPK. As symptoms progress, rhabdomyolysis and kidney failure may develop.
Hematopoietic system: in rare cases, thrombocytopenia, leukopenia, hemolytic anemia, a positive test for antinuclear antibodies.
Nervous system: Pravachol may cause drowsiness, fatigue (especially at high doses), slow reaction times, headache, dizziness, muscle weakness, loss of sexual desire up to and including impotence.
These reactions usually occur as a result of the use of high doses of the drug or with long-term treatment with Pravachol, and are reversible.
Ophthalmology. When using Pravahol, there may be an increase in the incidence of cataracts or the progression of its development.
Most often this symptom is observed in the age group of patients.
Respiratory: Pravachol may cause slight respiratory depression, dyspnea, especially when using high doses of the drug.
Gastrointestinal tract: dry mouth, constipation, or diarrhea, loss of appetite, nausea, sometimes vomiting, heartburn, pain in the stomach, flatulence.
Skin and its appendages: there have been isolated cases of skin reactions, such as rash, urticaria; vasculitis, erythema multiforme, photosensitivity, Steven-Johnson syndrome, toxic epidermal necrolysis, including fatal, alopecia.
General disorders: asthenia, gait instability, lethargy, sometimes weakness, drowsiness, apathy, thyroid dysfunction.
Changes in laboratory parameters: increased activity of hepatic transaminases, alkaline phosphatase and bilirubin levels.
Contraindications
Pravachol is contraindicated for use:
– in patients with hypersensitivity to statins and / or any excipients included in Pravachol®,
– in patients taking immunosuppressive therapy,
– in patients with renal insufficiency,
– in patients with severe liver failure,
– during pregnancy,
– during lactation,
– in childhood.
Carefully Pravahol should be administered with caution to persons who abuse alcohol, have a history of symptoms of hypotension, with severe infections, epilepsy, trauma, intoxication, if there are indications of the possibility of major operations.
Pregnancy
:
Pravachol is contraindicated during pregnancy.
In this regard, if Pravachol is prescribed to a woman of childbearing age, she should be warned that in case of pregnancy or planned pregnancy, she needs to contact her doctor in order to stop the drug in time.
Since pravastatin has been found to pass into breast milk, Pravachol should not be given before and during breastfeeding, otherwise the physician should decide not to breastfeed the infant.
Interaction with other drugs
– when used together with cyclosporinorm, gemfibrozil, nicotinic acid, erythromycin – increased risk of myopathy.
– when used together with bile acid sequestrants – a decrease in the adsorption of Pravachol.
– with the combined use of propranolol – a decrease in the bioavailability of Pravachol.
– when used together with cimentidine, ranitidine and proton pump inhibitors (omeprozole), rifampicin, there is no change in the bioavailability of Pravachol.
– when used together with warfarin and other anticoagulants, an increase in prothrombin time is observed.
– when used together with digoxin and other cardiac glycosides – an increase in the concentration of digoxin in the blood.
– the simultaneous use of alcohol and Pravachol changes its bioavailability, which may affect the ability to drive a car or use other mechanisms.
Overdose
Currently, there are no data on overdose of Pravahol . There are only two reports of overdose of the drug, which were clinically asymptomatic, and were manifested only by changes in the biochemical blood test.
Treatment: symptomatic.
Storage conditions
Store in a dry place below 30°C.
Keep out of reach of children.
Form
Tablets, white, round, biconvex, do not have risks, on the one hand they have the inscription DEVA
and p10 (p20), 0.01 and 0.02 g each (10 and 20 mg), 20 tab. packaged.
Packing: tablets of 0.01 and 0.02 g (10 and 20 mg) of 20 tab. packaged.
Composition
Pravachol tablets 10, 20 mg -methyl-8-{[(2S)-2-methylbutanoyl]oxy}-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)-heptanoic acid,
Excipients: original composition.
Additionally
Pravachol may cause myopathy, manifested by muscle weakness. In patients with similar manifestations, it is necessary to reduce the therapeutic doses of Pravachol.
Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with Pravachol in adults in post-marketing trials. Most of the reported cases were observed with the combined use of Pravachol, with other lipid-lowering drugs. Therefore, when prescribing the drug, patients should be carefully examined for any symptoms of SJS, especially during the first 8 weeks of treatment. If such symptoms are detected, the use of Pravachol should be immediately discontinued and the possibility of using alternative therapy should be considered.
Respiratory depression. When Pravachol is prescribed, the respiratory function does not suffer. Isolated cases of minor dyspnea, which may have been associated with an existing comorbidity, have been described.
The use of Pravachol in renal and hepatic insufficiency
In patients with renal and hepatic insufficiency, the appointment of Pravachol may cause an increase in the incidence of side effects, as a result of which correction of single and daily doses of Pravachol may be required.
If long-term treatment of such patients is necessary, the functional capacity of these organs should be regularly monitored.
Elderly patients
In the elderly, there may be an increased tendency to a variety of negative reactions that develop due to possible multiple organ and vascular insufficiency, which may lead to the need to adjust the doses of Pravachol.
Carcinogenicity studies of Pravachol were carried out on small laboratory animals (rodents). A carcinogenic effect was recorded when using pravastatin at doses significantly higher than therapeutic ones.
Basic parameters
| Name: | PRAVAHOL |
| ATC code: | C10AA03 – Pravastatin |
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