Side effects for pravachol. Pravastatin (Pravachol): Comprehensive Guide to Side Effects, Uses, and Dosage
What are the common side effects of Pravastatin. How does Pravastatin work to lower cholesterol. What precautions should be taken when using Pravachol. Who should avoid taking Pravastatin. How is Pravachol administered for optimal effectiveness. What interactions can occur with Pravastatin. When should you seek medical attention while taking Pravachol.
Understanding Pravastatin: A Powerful Cholesterol-Lowering Medication
Pravastatin, commonly known by its brand name Pravachol, is a widely prescribed medication belonging to the statin class of drugs. Its primary function is to lower cholesterol levels in the blood, thereby reducing the risk of cardiovascular diseases. But how exactly does this medication work, and what should patients know before starting treatment?
How Does Pravastatin Work?
Pravastatin operates by inhibiting an enzyme called HMG-CoA reductase, which plays a crucial role in cholesterol production in the liver. By blocking this enzyme, Pravastatin effectively reduces the amount of cholesterol manufactured by the body. This mechanism not only lowers LDL (bad) cholesterol but also helps increase HDL (good) cholesterol levels.
Key Uses of Pravastatin: Beyond Cholesterol Management
While Pravastatin is primarily known for its cholesterol-lowering properties, its applications extend beyond this primary use. Healthcare providers may prescribe Pravastatin for various conditions related to lipid abnormalities and cardiovascular health.
- 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
Can Pravastatin be used for other medical conditions? While the primary uses are listed above, ongoing research continues to explore potential applications of statins like Pravastatin in other areas of medicine, including certain types of cancer prevention and cognitive health. However, these uses are not yet FDA-approved and should only be considered under strict medical supervision.
Critical Warnings and Precautions for Pravastatin Users
Before initiating Pravastatin therapy, it’s crucial to be aware of certain warnings and precautions. These guidelines ensure the safe and effective use of the medication while minimizing potential risks.
Who Should Avoid Pravastatin?
Pravastatin is contraindicated in certain individuals. Do not use Pravastatin if you:
- Are allergic to pravastatin or any of its components
- Are pregnant or breastfeeding
- Have active liver disease
Is it safe to take Pravastatin if you have other medical conditions? Caution is advised if you have a history of:
- Kidney disease
- Abnormal liver function tests
- Muscle pain or weakness
- Thyroid disorders
- Alcohol consumption (more than 2 drinks daily)
Always inform your healthcare provider about your complete medical history and any medications you’re currently taking to ensure Pravastatin is safe for you.
Understanding the Side Effects of Pravastatin
Like all medications, Pravastatin can cause side effects. While not everyone experiences these, it’s important to be aware of potential adverse reactions.
Common Side Effects
The most frequently reported side effects of Pravastatin include:
- Muscle or joint pain
- Nausea, vomiting, diarrhea
- Headache
- Cold symptoms (stuffy nose, sneezing, sore throat)
Serious Side Effects
While rare, some side effects require immediate medical attention:
- Signs of an allergic reaction (hives, difficulty breathing, swelling of face, lips, tongue, or throat)
- Unexplained muscle pain, tenderness, or weakness (especially with fever, unusual tiredness, or dark urine)
- Liver problems (loss of appetite, upper right stomach pain, tiredness, dark urine, jaundice)
How often do serious side effects occur with Pravastatin? Serious side effects are rare, affecting less than 1 in 1,000 people. However, if you experience any of these symptoms, seek medical attention immediately.
Proper Dosage and Administration of Pravastatin
Correct dosage and administration are crucial for the effectiveness and safety of Pravastatin. Always follow your healthcare provider’s instructions or the guidelines on the prescription label.
Standard Dosage Guidelines
The typical starting dose for adults is 40 mg once daily. However, your doctor may adjust this based on your individual needs and response to the medication. Dosages can range from 10 mg to 80 mg daily.
Administration Tips
- Take Pravastatin at the same time each day, with or without food
- If you miss a dose, take it as soon as you remember, unless it’s almost time for your next dose
- Never take two doses at once to make up for a missed dose
Should Pravastatin be taken in the morning or at night? While it can be taken at any time, some studies suggest taking it in the evening may be more effective as cholesterol production in the liver is highest at night.
Potential Drug Interactions with Pravastatin
Pravastatin can interact with various medications and substances, potentially altering its effectiveness or increasing the risk of side effects.
Common Interactions
- Other cholesterol-lowering medications (e.g., fibrates, niacin)
- Certain antibiotics (e.g., erythromycin, clarithromycin)
- Antifungal medications (e.g., itraconazole, ketoconazole)
- HIV protease inhibitors
- Cyclosporine
- Warfarin
Dietary Considerations
Are there any foods to avoid while taking Pravastatin? Yes, certain dietary choices can impact the effectiveness of Pravastatin:
- Avoid grapefruit and grapefruit juice, as they can increase the concentration of the drug in your bloodstream
- Limit alcohol consumption, as it may increase the risk of liver damage
- Maintain a low-fat, low-cholesterol diet for optimal results
Pravastatin in Special Populations: Pregnancy, Breastfeeding, and Elderly
The use of Pravastatin requires special consideration in certain populations due to potential risks or altered effectiveness.
Pregnancy and Breastfeeding
Pravastatin is contraindicated during pregnancy and breastfeeding. The drug can potentially harm the developing fetus or nursing infant. Women of childbearing age should use effective contraception while taking Pravastatin and inform their healthcare provider immediately if they become pregnant.
Elderly Patients
Older adults may be more sensitive to the effects of Pravastatin, particularly the risk of muscle-related side effects. Dosage adjustments may be necessary, and closer monitoring is often required in this population.
Does age affect the effectiveness of Pravastatin? While age itself doesn’t significantly impact the drug’s effectiveness, older adults may have other health conditions or medications that could interact with Pravastatin, necessitating careful management.
Monitoring and Long-Term Use of Pravastatin
Long-term use of Pravastatin requires regular monitoring to ensure its continued effectiveness and safety.
Regular Check-ups
Your healthcare provider will likely schedule periodic blood tests to monitor:
- Cholesterol levels
- Liver function
- Muscle enzyme levels (if muscle symptoms occur)
Long-Term Considerations
While Pravastatin is generally safe for long-term use, ongoing monitoring is crucial. Some patients may need to continue the medication indefinitely to maintain cholesterol control.
Can Pravastatin be stopped abruptly? It’s not recommended to stop Pravastatin suddenly without consulting your healthcare provider. Abrupt discontinuation may lead to a rapid increase in cholesterol levels and potentially increase cardiovascular risk.
Comparing Pravastatin to Other Statins: Efficacy and Side Effect Profile
Pravastatin is one of several statins available for cholesterol management. Understanding how it compares to other statins can help patients and healthcare providers make informed decisions.
Efficacy Comparison
Pravastatin is generally considered a moderate-intensity statin. Compared to high-intensity statins like atorvastatin or rosuvastatin, it may have a slightly lower potency in reducing LDL cholesterol. However, it remains highly effective for many patients and may be preferred in certain situations due to its side effect profile.
Side Effect Profile
Pravastatin is often noted for having a favorable side effect profile compared to some other statins. It has a lower risk of drug interactions and may be less likely to cause muscle-related side effects. This makes it a good option for patients who have experienced side effects with other statins or who are taking multiple medications.
How does Pravastatin compare to natural cholesterol-lowering methods? While lifestyle changes like diet and exercise are crucial for heart health, Pravastatin offers a more potent and rapid reduction in cholesterol levels for many patients. However, it’s often used in conjunction with lifestyle modifications for optimal results.
Pravastatin and Cardiovascular Disease Prevention: Beyond Cholesterol Lowering
While Pravastatin’s primary action is lowering cholesterol, research suggests it may have additional benefits in preventing cardiovascular disease.
Pleiotropic Effects
Pravastatin, like other statins, exhibits pleiotropic effects – benefits beyond cholesterol reduction. These may include:
- Improved endothelial function
- Reduced inflammation
- Stabilization of atherosclerotic plaques
- Decreased risk of blood clots
Primary vs. Secondary Prevention
Pravastatin has shown efficacy in both primary prevention (preventing first occurrence of cardiovascular events in high-risk individuals) and secondary prevention (preventing recurrence in those with established cardiovascular disease).
Can Pravastatin reverse existing arterial plaque? While Pravastatin may not completely reverse existing plaque, studies suggest it can help stabilize plaques and slow their progression, potentially reducing the risk of heart attacks and strokes.
Managing Side Effects and Optimizing Pravastatin Therapy
While Pravastatin is generally well-tolerated, some patients may experience side effects. Understanding how to manage these and optimize therapy can improve outcomes and quality of life.
Strategies for Managing Side Effects
- Muscle pain: If mild, it may resolve on its own. Severe or persistent pain should be reported to your doctor.
- Gastrointestinal issues: Taking the medication with food may help alleviate nausea or stomach discomfort.
- Headaches: These often improve over time. Over-the-counter pain relievers may help if needed.
Optimizing Therapy
To get the most benefit from Pravastatin:
- Adhere to the prescribed dosage and schedule
- Maintain a heart-healthy lifestyle, including a balanced diet and regular exercise
- Attend all follow-up appointments and complete recommended blood tests
- Communicate any concerns or side effects to your healthcare provider promptly
Is it possible to reduce Pravastatin dosage over time? In some cases, if cholesterol levels are well-controlled and lifestyle changes are effective, your doctor may consider reducing the dosage. However, this should only be done under medical supervision.
Future Directions: Ongoing Research and Potential New Applications of Pravastatin
The field of statin research is continually evolving, with ongoing studies exploring new potential uses and refining our understanding of these medications.
Emerging Research Areas
- Cancer prevention: Some studies suggest statins like Pravastatin may have a role in preventing certain types of cancer, though more research is needed.
- Neurodegenerative diseases: Preliminary research is exploring the potential neuroprotective effects of statins in conditions like Alzheimer’s disease.
- Autoimmune disorders: The anti-inflammatory properties of statins are being investigated for potential benefits in autoimmune conditions.
Personalized Medicine Approaches
Future research may lead to more personalized approaches to statin therapy, considering individual genetic factors and biomarkers to optimize treatment and minimize side effects.
Could Pravastatin be used for purposes other than cholesterol management in the future? While current FDA approvals are limited to lipid management and cardiovascular disease prevention, ongoing research may uncover new applications. However, it’s crucial to use Pravastatin only as prescribed by your healthcare provider and for approved indications.
In conclusion, Pravastatin remains a cornerstone in the management of hyperlipidemia and prevention of cardiovascular disease. Its well-established efficacy, combined with a favorable side effect profile, makes it a valuable option for many patients. As with any medication, the key to success lies in proper use, regular monitoring, and open communication with healthcare providers. As research continues, our understanding of Pravastatin and its potential applications may expand, potentially offering new hope for patients beyond its current use in cholesterol management.
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 |