Usage
- Rosuvastatin + Vitamin D3 is prescribed to manage high cholesterol levels (hypercholesterolemia or dyslipidemia), specifically to lower LDL cholesterol and triglycerides. It also aids in the prevention of cardiovascular events such as heart attack and stroke. Additionally, the vitamin D3 component helps with calcium absorption, promoting bone health, and it’s also thought to lessen muscle pain sometimes caused by statins.
- Pharmacological Classification: Rosuvastatin is a HMG-CoA reductase inhibitor (statin). Cholecalciferol is a fat-soluble vitamin (Vitamin D3).
- Mechanism of Action: Rosuvastatin inhibits HMG-CoA reductase, an enzyme crucial for cholesterol synthesis in the liver, thus reducing LDL cholesterol production and increasing LDL receptor activity, which clears LDL from the blood. Vitamin D3 aids calcium absorption and potentially reduces statin-induced myalgia.
Alternate Names
- Rosuvastatin and Cholecalciferol.
- Brand Names: StayHappi Rosuvastatin + Vitamin D3, D Rozavel, Rosuvas D, and others. (Note: Brand names can vary regionally.)
How It Works
- Pharmacodynamics: Rosuvastatin lowers LDL cholesterol and triglycerides, and slightly increases HDL cholesterol. Vitamin D3 promotes calcium absorption and bone mineralization. It may also contribute to muscle health.
- Pharmacokinetics: Rosuvastatin is absorbed orally, reaching peak plasma concentration in about 5 hours. It’s extensively metabolized by the liver (mainly CYP2C9) and primarily excreted in bile and feces, with some renal excretion. Vitamin D3 is absorbed from the gut and hydroxylated in the liver and kidney to its active form, calcitriol. It’s stored in adipose tissue and eliminated slowly.
- Mode of Action: Rosuvastatin competitively inhibits HMG-CoA reductase. Vitamin D3 binds to vitamin D receptors, modulating gene expression related to calcium homeostasis and other functions.
- Elimination Pathways: Rosuvastatin mainly through hepatic metabolism and biliary excretion. Vitamin D3 via hepatic metabolism and slow excretion.
Dosage
Standard Dosage
Adults:
- Rosuvastatin: Starting dose is usually 5-10 mg orally once daily, adjustable up to 40 mg/day depending on individual response and LDL cholesterol goals.
- Vitamin D3: Dosage varies based on individual vitamin D levels; commonly 600-1000 IU daily, but higher doses may be used for deficiency.
Children:
- Rosuvastatin: For heterozygous familial hypercholesterolemia: 8 to <10 years: 5-10 mg/day; 10-17 years: 5-20 mg/day (not to exceed 20 mg/day). Homozygous familial hypercholesterolemia: 7-17 years: starting dose 20mg/day. Safety and efficacy not established for children under 8 years old with HeFH or under 7 with HoFH.
- Vitamin D3: Pediatric dosing varies depending on age, vitamin D levels, and specific needs; consult pediatric guidelines.
Special Cases:
- Elderly Patients: Initial lower doses of rosuvastatin may be considered due to potential for increased exposure.
- Patients with Renal Impairment: Dose adjustments for rosuvastatin may be necessary in moderate to severe renal impairment.
- Patients with Hepatic Dysfunction: Rosuvastatin is contraindicated in active liver disease or unexplained persistent elevations in liver enzymes.
- Patients with Comorbid Conditions: Careful monitoring is needed in patients with diabetes, hypothyroidism, or history of muscle disorders.
Clinical Use Cases
This combination is not typically used in acute clinical settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations. Its focus is on chronic cholesterol management and related cardiovascular risk reduction.
Dosage Adjustments:
Adjustments are based on LDL cholesterol response, tolerability, and the presence of renal/hepatic impairment, drug interactions, or other individual factors.
Side Effects
Common Side Effects:
Headache, myalgia, nausea, constipation, dizziness, abdominal pain.
Rare but Serious Side Effects:
Rhabdomyolysis (muscle breakdown), hepatotoxicity, allergic reactions.
Long-Term Effects:
Chronic complications are rare but might include persistent muscle pain or weakness, liver dysfunction, or increased blood glucose levels.
Adverse Drug Reactions (ADR):
Rhabdomyolysis, hepatotoxicity, severe allergic reactions require immediate attention.
Contraindications
Active liver disease, pregnancy, breastfeeding, hypersensitivity to rosuvastatin or vitamin D3.
Drug Interactions
- Cyclosporine, gemfibrozil, warfarin, some antacids, some antifungals, and drugs metabolized by CYP2C9 can interact with rosuvastatin.
- Bile acid sequestrants, certain medications, or foods containing excessive amounts of vitamin D and calcium may have additive effects and lead to hypervitaminosis D or hypercalcemia.
Pregnancy and Breastfeeding
Rosuvastatin is contraindicated in pregnancy and breastfeeding. Vitamin D3 should be used cautiously during pregnancy and breastfeeding, considering maternal and infant needs.
Drug Profile Summary
- Mechanism of Action: Rosuvastatin inhibits HMG-CoA reductase; vitamin D3 promotes calcium absorption and potentially reduces myalgia.
- Side Effects: Headache, myalgia, nausea, constipation, dizziness; rarely rhabdomyolysis, hepatotoxicity.
- Contraindications: Active liver disease, pregnancy, breastfeeding, hypersensitivity.
- Drug Interactions: Cyclosporine, gemfibrozil, warfarin, some antacids, some antifungals.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Rosuvastatin: 5-40 mg/day; Vitamin D3: individualized based on vitamin D levels.
- Monitoring Parameters: LDL cholesterol, liver function tests, blood glucose, creatine kinase (if myalgia occurs).
Popular Combinations
Often prescribed alone or with other cardiovascular medications like antihypertensives or aspirin, based on individual patient risk factors.
Precautions
Monitor liver function and creatine kinase, particularly at initiation or dose escalation. Patients with diabetes should have blood glucose monitored. Advise patients to report any unexplained muscle pain or weakness.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Rosuvastatin + Vitamin D3?
A: Rosuvastatin: 5-40 mg orally once daily, adjustable based on individual response and LDL goals. Vitamin D3 dosing is based on individual vitamin D levels and typically ranges from 600-1000 IU daily, but higher doses may be used for correcting deficiencies. Pediatric and special population dosing differs.
Q2: How should this combination be taken?
A: Orally, once daily, with or without food.
Q3: Can I take this while pregnant or breastfeeding?
A: No, it’s contraindicated in pregnancy and breastfeeding.
Q4: What are the major side effects to watch out for?
A: Muscle pain, tenderness, or weakness (signs of potential rhabdomyolysis), as well as any signs of liver dysfunction.
Q5: What should I do if I experience muscle pain while taking this medication?
A: Contact your doctor immediately as it could be a sign of a serious condition.
Q6: Does this combination interact with other medications?
A: Yes, interactions are possible with certain drugs like cyclosporine, gemfibrozil, and some antifungals. Always inform your doctor about all medications you are currently taking, including OTC drugs and supplements.
Q7: Are there specific dietary recommendations while on this medication?
A: A low-fat diet is often recommended in conjunction with this medication to maximize cholesterol-lowering effects.
Q8: Can I stop taking this medication once my cholesterol is under control?
A: No, discontinuation should only be done under the guidance of your physician.
Q9: How does vitamin D3 benefit this combination?
A: It aids in calcium absorption, promoting bone health, and is thought to potentially alleviate statin-induced muscle aches.
