Rosuvastatin

What is Rosuvastatin?

Rosuvastatin (Crestor, Ezalor Sprinkle) is a prescription drug that is used to treat excessive cholesterol and to prevent coronary heart attacks as well as strokes.

Rosuvastatin is a member of a group of medications known as statins. It functions on two levels. Rosuvastatin is a drug that blocks an enzyme that is found in the liver called HMG-CoA reductase, which results in the liver producing less cholesterol. It also increases the liver's ability to absorb cholesterol in your blood, reducing its breakdown.

Rosuvastatin is available as tablets and capsules. The tablet formulation of rosuvastatin was approved by the US Food and Drug Administration (FDA) in 2003 under the brand name Crestor. Numerous generic rosuvastatin tablets are now accepted by the FDA.

Rosuvastatin can also be purchased as capsules, which were approved in the year 2018 under the name Ezalor Sprinkle. Adults who have difficulty swallowing tablets or capsules may open the capsules, sprinkle the granules on soft food, and consume it. A generic capsule isn't accepted.

Uses of Rosuvastatin

Rosuvastatin Tablets are taken alongside a diet for:

• Reduce the amount that you have of "bad" cholesterol (low-density lipoprotein LDL, also known as low-density lipoprotein).
• Boost the amount that you have of "good" cholesterol (high-density lipoprotein, HDL).
• Reduce the amount of cholesterol in the blood (triglycerides).
• Reduce the accumulation of fat deposits (plaque) within blood vessel walls.

Rosuvastatin tablets can be used for:

• For adults who are unable to reduce their cholesterol levels with diet and exercise on their own.
• For children aged 8 to 17 years old who suffer from heterozygous familial hypercholesterolemia (an inheritable condition that results in the body producing high concentrations of LDL). Rosuvastatin tablets cannot be permitted for use by children suffering from heterozygous familial hypercholesterolemia younger than 8 years old.
• For children aged 7 to 17 years old with homozygous familial hypercholesterolemia (a genetic condition that can cause excessive concentrations of LDL). Rosuvastatin tablets have not been recommended for use in children suffering from homozygous familial hypercholesterolemia younger than 7 years old.
• To lower the risk of heart attacks as well as strokes for people 50 years old or older and women who are 60 and over who do not suffer from heart disease but have additional risk factors.

It is the only way that Crestor tablets are authorized for use in children. Rosuvastatin tablets that are generic or capsules containing rosuvastatin are not recommended for use in youngsters due to the manufacturer of Crestor tablets currently possessing exclusive rights to market and sell rosuvastatin for this age range.

Rosuvastatin capsules are utilized by adults in conjunction with food to

• Lower the amount of "bad" cholesterol (LDL).
• Reduce the amount that your blood contains fat (triglycerides).

It isn't known whether rosuvastatin can be safe and efficient in patients with Fredrickson Type I and V dyslipidemias.

Who Should Not Be Taking Rosuvastatin?

You should not be taking rosuvastatin when you:

• You may be allergic to rosuvastatin or any of the other ingredients that are in your rosuvastatin tablets or capsules. Look below for a full listing of the ingredients.
• Have liver issues.

What Should I Ask My Doctor Before I Start Taking Rosuvastatin?

Before you take rosuvastatin, tell your physician about any or all medical conditions, such as the following:

• Are afflicted with unidentified muscle pains or an insufficiency
• Have had or are experiencing kidney issues.
• Have had or are experiencing liver issues.
• Consume more than two glasses of alcoholic drinks per day.
• Have thyroid problems

Inform your doctor that you are 65 years old or older, or of Asian descent.

How to Take Rosuvastatin?

• Follow the instructions exactly as your doctor has instructed you to.
• The tablets are taken by mouth at least once a day. Take the tablet in its entirety.
• Tablets can be consumed anytime during the day, with or without meals.
• Do not alter your dosage or stop taking this medication without consulting your physician, even if you're well and feeling well.
• Your doctor can conduct blood tests to assess your cholesterol levels prior to and during treatment with the drug rosuvastatin. Your doctor can alter the dosage of this medication as required.
• Your doctor might put you on a cholesterol-lowering diet prior to giving you rosuvastatin. Keep this diet in place when you are taking this medication.
• At least 2 hours after taking the tablets of rosuvastatin, take an antacid that is a mixture of magnesium hydroxide and aluminum.

What should I do to take my rosuvastatin capsules?

• Make sure you take the capsules exactly as the doctor instructs you to.
• Inhale the capsules at least once a day. Take the capsules whole.
• Avoid chewing or crushing the capsules.
• The capsules can be consumed anytime during the day, with or without meals.

Consuming rosuvastatin capsules in soft food
If you're having trouble swallowing the whole capsule, it is possible to break the capsule open and consume the contents along with soft food (applesauce, chocolate, or vanilla-flavored pudding). Read the "Instructions for Use" that accompany your medication for instructions on how to take capsules with soft foods (applesauce, chocolate, or vanilla-flavored dessert).

Make sure to carefully remove the capsules.

Sprinkle the granules in the capsules over 1 teaspoon of soft food (such as applesauce, vanilla, or chocolate pudding).

Take a sip of the soft food granules in the first 60 minutes. Don't chew the granules.

Don't save the granule-soft food mixture for later use. Discard any granules or soft food mix.

• Injecting rosuvastatin capsules via a Nasogastric tube
  Check your "Instructions for Use" that are included with your prescription for the instructions for mixing and administering the capsules using the nasogastric tube (16 French or greater).
• Take the plunger out of the 60-mL syringe with the catheter tip.
• Make sure to open the capsules properly and empty the granules into the syringe barrel with a catheter tip.
• Add 40 mL of water to the granules, which are in the syringe barrel that has a catheter tip. Do not mix with other liquids.
• Replace the plunger, then shake the syringe with a catheter tip for 15 seconds.
• Attach the syringe tip of the catheter to a Nasogastric tube (>=16-French).
• Take the mixture immediately via the nasogastric tube directly to the stomach. Don't save the mixture to use later. Get rid of any remaining mix.
• After introducing the mixture, the nasogastric tubes should be flushed with 20 mL of water.
• Do not alter the dosage or stop taking this medication without consulting your physician.
• The doctor could conduct blood tests to determine your cholesterol levels prior to and during treatment with the drug rosuvastatin. Your doctor could alter your dosage of the drug as necessary.
• Your doctor might put you on a cholesterol-lowering diet before introducing rosuvastatin. Follow this diet while you take this drug.
• Take at least two hours after taking the tablets of rosuvastatin to consume an antacid containing an amalgamation of magnesium hydroxide and aluminum.

What Happens If I Miss a Dose?

If you are missing a dose of rosuvastatin, take it as soon as you remember. But don't take two doses within 12 hours of each other.

What Happens If I Overdose?

If you've taken too much rosuvastatin or have had an overdose, contact your physician or go to the closest emergency room in a hospital immediately.

Details on Dosage

Rosuvastatin Tablets:

• Dose range: 5–40 mg once daily. Take a dose of 40 mg only for patients who are not meeting the LDL cholesterol goals with 20 mg.
• Adults with homozygous familial hypercholesterolemia: Starting dose: 20 mg/day
• Paediatric patients with homozygous familial hypercholesterolemia: 20 mg/day for patients 7 to 17 years of age.
• Paediatric patients with heterozygous familial hypercholesterolemia: 5 to 10 mg/day for patients 8 to less than 10 years of age, and 5 to 20 mg/day for patients 10 to 17 years of age.

Rosuvastatin Capsules:

• The dosage range is 5–40 mg once a day. Only use a 40 mg dose for patients who are not reaching their LDL cholesterol goals with 20 mg.
• Adults with homozygous familial hypercholesterolemia: Starting dose: 20 mg/day

Side Effects of Rosuvastatin

• The pain, tenderness, and muscle weakness (myopathy).uscle issues, such as the breakdown of muscles, can be grave in some individuals and are not often a cause of kidney damage that could cause death. Tell your doctor right away if:
• You experience unanswered muscular pain, tenderness, or weakness. This is especially true in the case of an increase in temperature or feeling fatigued more than usual when you take this medicine.
• You have muscle issues that persist even after your doctor has instructed you to quit taking the medication. Your doctor might conduct additional tests to determine the source of your problems with muscles.
• Your chance of having issues with your muscles is higher when you:
• You are taking other medications when you are taking the drug rosuvastatin.
• Suffer from thyroid issues (hypothyroidism) that aren't managed.
• Suffer from kidney issues.
• Take greater doses of this drug.
• Liver issues. The doctor will conduct blood tests to examine your liver prior to beginning to use this medication and should you experience signs of liver problems during your treatment. Contact your physician immediately if you exhibit any of these symptoms of liver issues:
• Feel tired, weak, or uncharacteristically weak.
• Appetite loss
• Upper belly and abdominal pain
• Dark urine that is dark
• The skin's complexion is becoming yellow, as are the whites of your eyes.

Adverse Effects

• Headache
• Aches and pains in the muscles
• Abdominal discomfort
• Weak spots
• Nausea

Other adverse effects mentioned with rosuvastatin include confusion and memory loss. Talk to your doctor if you are experiencing any adverse reaction that is bothersome or doesn't go away. This is not the only list of possible adverse effects. For more details, consult your physician or pharmacist. Contact your physician for advice from a medical professional regarding possible side effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.

Interactions with Other Drugs

Discuss with your doctor every medication you are taking, including prescription and non-prescription supplements as well as vitamins and herbal supplements. Discuss with your doctor when you begin to take any new medications. Rosuvastatin and certain other medicines can interact with each other, causing adverse consequences.

Tell your doctor if you take any of the following medications:

• Cyclosporine (a medicine to boost the immune system)
• Gemfibrozil (a fibric acid medication for lowering cholesterol)
• Darolutamide (a medication for the treatment of prostate cancer)
• Regorafenib (a medication used to treat colon cancer and the rectum)
• Antiviral medications, including specific HIV as well as hepatitis C virus medications, For example lopinavir, ritonavir, fosamprenavir, tipranavir, atazanavir, and simeprevir
• Combination of:
  • Sofosbuvir/velpatasvir/voxilaprevir
  • Dasabuvir/ombitasvir/paritaprevir/ritonavir
  • Elbasvir/grazoprevir
  • Sofosbuvir/velpatasvir
  • Glecaprevir/pibrentasvir and
  • All other combinations with ledipasvir, including ledipasvir/sofosbuvir
• Certain anti-fungal medications (such as ketoconazole, itraconazole, and fluconazole)
• Coumarin anticoagulants (medicines to help prevent blood clots, like warfarin)
• Niacin or nicotinic acid
• Fibric acid derivatives (such as Fenofibrate)
• Colchicine (a medicine that is used for treating gout)

Consult your physician or pharmacist for a list of these medications if you're not sure.  Be aware of all the medications you are taking. Make a list and show it to your doctor or pharmacist each time you are given a new medicine.

Breastfeeding and Pregnancy

Inform your doctor if you are pregnant, suspect you might be pregnant, or plan to be pregnant. Rosuvastatin may harm your unborn baby. If you find yourself pregnant, stop taking rosuvastatin immediately and contact your doctor now. If you do not plan to have children, take advantage of effective birth control (contraception) during the time you're taking this medication.

Inform your doctor if you are currently breastfeeding or plan to breastfeed. Certain medicines, like rosuvastatin, could be absorbed into milk and cause harm to the baby. Discuss with your doctor the best method to feed your child in the event that you are taking this medication.

Storage

• Keep rosuvastatin in a cool, dry place between 68 °F and 77 °F (20 °C between 25 and 30 °C).
• Place it in a dry area.
• Dispose of any medicines that are not current or are not needed anymore.

Make sure that this and all other medicines are out of the reach of children.

What are the Components in Rosuvastatin?

Active ingredient: rosuvastatin calcium

Inactive ingredients:

Tablets of Crestor: microcrystalline cellulose NF lactose monohydrate NF tribasic calciumphosphate NF Crospovidone NF, hypromellose NF, triacetin NF USP, yellow ferric oxide, and ferric oxide red NF

The generic versions of Rosuvastatin tablets could contain other inactive ingredients than those that are listed above. Look up the label on the specific formulation to get a full listing of the ingredients.

Ezallor Sprinkle capsules contain microcrystalline cellulose, manitol, crospovidone oxide, ferric oxide, sodium citrate, hypromellose, polyethylene glycol 4000, and silicon dioxide.

Capsule shell: gelatin, titanium dioxide, sodium lauryl, sodium sulfate, and colors: FD & C Red 40 (5 mg), FD & C Blue 1 (5 mg, 10 mg, 20 mg), D & C Red 28 (5 mg, 10 mg), FD & C Red 3 (20 mg), as well as FD & C Green 3 (40 mg). The imprinting ink is made up of dehydrated alcohol, shellac, isopropyl alcohol, butyl ethanol, propylene glycol, a strong ammonia solution, black iron oxide, purified water, and potassium hydroxide.

Crestor, the Crestor tablet of the rosuvastatin brand, is sold via AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, under license from Shionogi & Co., LTD., Oska, Japan. The generic versions of the tablets are made by several other companies.

Ezallor Sprinkle, which is the only available form of rosuvastatin capsules, is manufactured through Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway. Halol-389 350 is manufactured in Gujarat, India, and distributed through Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512.