Zyrova 10 Zydus medicine treats high cholesterol in the blood (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Rosuvastatin

Ingredient

Composition information	Content
Rosuvastatin	10mg

Uses

indications

Zyrova 10 drugs are indicated in the following cases:

Treatment for patients with high cholesterol in the blood (heterosegous type IIA), and blood lipid disorders (Type IIB), or high cholesterol in the blood of the Homozygous group, have used diets and other treatment supports such as exercise, weight loss but not responding.

Pharmacokology

Rosuvastatin is a highly competitive inhibitor and selective HMG-COA reducing enzymes, inhibiting the 3-hydroxy-3-methylutaryl coenzyme A into Mevalonate, a precursor of sterol, including cholesterol.

Rosuvastatin increases the number of LDL receptors in the liver to the cell surface, increases the absorption and catabolism of LDL, inhibits the synthesis of VLDL liver. Therefore reducing the total of VLDL and LDL elements.

Rosuvastatin reduces cholesterol, LDL-C, APOB, and Non-HDL-C in patients with high cholesterol in the blood of Homozygous and Heterosegous (FH) and patients with lipid disorders. Rosuvastatin reduces triglycerides and increases HDL-C, reduces the total cholesterol, LDL-C, VLDL-C, APOB, Non-HDL-C and Triglycerides but increases HDL-C in patients with separate hyperglycerides.

Dynamic pharmacokinetics

absorption: In clinical pharmaceutical research, the peak concentration of plasma of rosuvastatin achieved within 3-5 hours after drinking. Rosuvastatin's plasma plasma concentrations do not change when taking the drug in the morning or evening. Both peak concentrations and AUC increases close to the dose. Rosuvastatin's bioavailability is nearly 20% but does not affect the scope of absorption.

Food reduces the absorption rate of the drug by about 20%. However, LDL-C is still significantly reduced whether or not they take it with food and it does not depend on the time of taking the drug during the day.

Distribution: The average distribution integral of rosuvastatin is approximately 134 liters. The cohesion with protein is about 88% mainly albumin and does not depend on plasma concentrations.

metabolism: Only about 10% of the dose rosuvastatin is found in the form of metabolism. The main metabolite is N-Desmethyl Rosuvastatin formed mainly by Cytochrom P450 2C9. In-Vitro research shows that N-Desmethyl Rosuvastatin accounts for about 1/6 to 2 Rosvastatin's HMG-CoA reducing enzyme inhibitors.

Race: According to the pharmacokinetic research in the US in Asians, the ability to absorb Rosuvastatin in Asians is twice as increased compared to white people, so it should be considered starting the starting dose of 5 mg for Asians.

Before taking Zyrova 10 Zydus medicine treats high cholesterol in the blood (10 blisters x 10 tablets)

How to use

oral tablets. Use as directed by the doctor.

Patients must have a standard low cholesterol level before Rosuvastatin treatment and must continue to diet during treatment. Rosuvastatin can use a single dose at any time of the day, with or without food. Dosage depending on the individual is mainly based on LDL-C concentrations, treatment goals and response of the patient.

Dosage

Initial dose for adults: 5 mg/time/day (Start treatment with the lowest dose that the drug works).

Adjust the dosage according to the needs and response of each person by increasing the dose of each time no less than 04 weeks apart and closely monitoring the harmful reactions of the drug, especially the harmful reactions to the muscle system.

Maintenance dose can be from 5 - 40 mg/day. Lipid index should be checked for 4 weeks, and adjust the dose according to the test results. Adjust the dose until you reach the desired LDL cholesterol level, or when the maximum dose is reached. Need closely monitoring for cases of 40 mg/day.

No dose adjustment for patients with mild and medium renal failure. Patients with severe renal failure (Creatinine clearance

In patients with cyclosporin, the treatment is limited to 5 mg/day/time.

Children: There are no studies that control the use of drugs for children. Therefore, it is not recommended for children.

Note: With the doses lower than the dose of Zyrova-10 tablets (Rosuvastatin 10 mg), refer to other forms of preparation: 5 mg tablets of the same active ingredient Rosuvastatin.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? If overdose, symptomatic treatment and necessary support measures. Because the drug is strongly connected to plasma proteins, hemorrhage does not have a significant effect in increasing rosuvastatin clearance.

In case of emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.

Side Effects

When using Zyrova 10 you can experience unwanted effects (ADR):

Common: headache, dizziness, digestive disorders, constipation, vomiting, abdominal pain, subcutaneous and skin tissue disorders. How to handle ADR:

Notify the physician the unwanted effects when using the drug.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Zyrova 10 contraindications in the following cases:

Patients with hypersensitivity to rosuvastatin or any ingredients of the drug. Breastfeeding women. Children.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Affects the liver: Like the medications that lower blood lipids in the same group, the increase in serum transaminase has been recorded after treatment with rosuvastatin. Liver function tests should be performed before treatment and later. Patients with any functional symptoms or entities that suggest liver damage should be tested for liver function. It is necessary to monitor in patients with increased transaminase levels until the abnormalities are resolved. If ALT or AST increases on normal, the dose should be reduced or stop using rosuvastatin. Caution should be used in patients with alcohol and/or a history of liver pathology.

Affects on skeletal muscles: It is necessary to consider when used for patients with risk factors leading to muscle damage. Rosuvastatin is at risk of causing harmful reactions to muscle systems such as muscle atrophy, muscleitis, especially for patients with risk factors such as patients over 65 years old, patients with untreated thyroid diseases, patients with kidney disease. Need to closely monitor the harmful reactions during drug use.

Patients should immediately notify the doctor to treat signs or symptoms of muscle pain, fatigue, fever, dark urine, nausea or vomiting during the use of the drug.

The risk of muscle disease during treatment with rosuvastatin will increase when used simultaneously with cyclosporine.

The effect of the drug on the ability to drive and operate machinery

There are no relevant reports. However, based on reports of adverse effects, headaches, dizziness can occur during treatment. Therefore, it is not advisable to drive and operate machines when using rosuvastatin.

Using drugs for women during pregnancy and lactation

Rosuvastatin is harmful to the fetus when used for pregnant women. So do not use rosuvastatin for women to prepare for pregnancy and pregnancy.

Due to the ability to cause adverse feedback to breastfeeding, do not use the drug while breastfeeding or stopping breastfeeding when needed to use the drug.

Drug interaction

cyclosporin: The average AUC value of rosuvastatin increased by 7 times when combining rosuvastatin and cyclosporin in healthy volunteers. This combination does not affect the concentration of cyclosporin in plasma.

Gemfibrozil and lipid -reduced drugs: CMAX and AUC of rosuvastatin increased twice as when combining rosuvastatin with gemfibrozil and lipid reduced drugs.

Antacid: Antacid contains aluminum and hydroxide magnesium reduces the blood concentration of rosuvastatin to nearly 50% when used in combination.

erythromycin: erythromycin reduces 20% AUC and 30% cmax of rosuvastatin when used combined.

Storage

Leave a cool place, avoid light, temperatures below 30⁰C.

To be out of reach of children, read the instructions carefully before use.

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