Rotorlip 20 DHG treatment for hypercholesterol blood, prevent cardiovascular events (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Rosuvastatin
Ingredient
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| Composition information | Content |
| Rosuvastatin | 20mg |
Uses
indications
Rotorlip 20 drugs are indicated in the following cases:
Supplements to eat and drink in the following cases: hypercholesterolemia (type IIA including hypercesting family blood heterozygous), mixed blood lipid disorders (type IIB), primary blood lipoprotein disorders, triglycerides, and to slow down the progression of coronary artery atherosclerosis.
Hypersensitivity to household blood type: Additional diet and other blood lipid reduction treatments or when these measures are not suitable.
Prevention of primary cardiovascular disease (reducing the risk of stroke, myocardial infarction, coronary regeneration procedure) in people with high risk of cardiovascular disease without clinical manifestations of coronary artery.
Pharmacokology
ATC code: C10AA07
Rotorlip 20 contains rosuvastatin, which is a competitive inhibitor with methylglutaryl Coenzym (HMG - CoA) Reductase, preventing HMG - CoA to Mevalonate, the precursor of cholesterol. The drug inhibits cholesterol biosynthesis, reduces cholesterol in liver cells, stimulates the synthesis of LDL receptors (low density lipoprotein), and thereby increasing LDL transport from blood. The final result is to reduce cholesterol levels in plasma.
Rosuvastatin reduces LDL very effectively. In addition, the drug also increases HDL cholesterol levels (high density lipoprotein) and thus lowering LDL/ HDL ratios and total/ HDL cholesterol. The drug also reduces plasma triglycerides by increasing VLDL (very low density lipoprotein) residues thanks to the LDL receptor.
In clinical studies, evidence suggests that statins significantly reduce coronary artery events, all cardiovascular events have existed and reduce the total number of deaths in people with coronary artery disease.
Pharmacokinetics
absorption
Rosuvastatin's peak plasma concentration is about 5 hours after drinking. Absolute bioavailability of about 20%.
Distribution
Rosuvastatin widely distributed in the liver is the main place for cholesterol and LDL clearance - C. Rosvastatin's distribution volume is about 134 L. About 90% of Rosuvastatin combined with plasma proteins, mainly with albumin.
Metabolism
Rosuvastatin is less metabolized (about 10%). In vitro studies on metabolism use liver cells of the person who determines that rosuvastatin is a weak substrate for metabolism through cytochrom P450. CYP2C9 is the main enzyme involved in the metabolism, 2C19, 3A4 and 2D6 participating at a lower level. The main metabolites are identified as N - Desmethyl and Lacton. N - Desmethyl metabolites have a weaker activity about 50% than rosuvastatin while lacton form is not clinically active. Rosuvastatin accounts for more than 90% of HMG inhibitors - CoA Reductase in circulation.
Elimination
About 90% of rosuvastatin dose is eliminated in a constant form (including the active ingredient that is absorbed and not absorbed) and the rest is excreted into urine. About 5% are excreted into unchanged urine. Selling time for plasma is about 19 hours. The sale time does not increase when using a higher dosage. The average plasma clearance is about 50 liters/ h (the variable coefficient is 21.7%). Like other HMG - CoA Reductase inhibitors, the transportation of rosuvastatin through the liver requires the transportation of Oatp - C. This transportation is important in the elimination of rosuvastatin through the liver.
linear
Rosuvastatin's exposure level is calculated by concentration and time increased proportional to the dose. There is no change in pharmacokinetic parameters after daily doses.
pharmacokinetics on special subjects:
Age and gender
The impact of age or gender on the pharmacokinetics of rosuvastatin is unrelated clinical in adults. The pharmacokinetics of rosuvastatin in children and teenagers with hyperlested hypertension heterozygous family are similar or lower on adults with blood lipid disorders.
Race
Dynamic studies show that AUC and CMAX increased by 2 times in Asians living in Asia compared to white people living in the West. Asians - India also have AUC and CMAX about 1.3 times. A pharmacokinetics analysis by population shows that there is no clinical difference in pharmacokinetics in white and black groups.
kidney failure
In people's research on kidney failure at different degrees shows that the kidney disease from mild to medium does not affect the level of rosuvastatin or N - Desmethyl metabolites in plasma. Patients with severe renal impairment (plasma creatinine clearance Hepatic failure
In research on liver damage to many different levels, there is no evidence of rising rosder of rosuvastatin in patients with Child - PUGH ≤ 7. However, 2 patients with Child - Pugh score are 8 and 9 with the contact level of Rosuvastatin increasing at least 2 times compared to people with lower Child - PUGH scores. Inexperienced in patients with Child - Pugh> 9.
Genetic forms
The distribution of HMG - CoA Reductase inhibitors, including rosuvastatin, is related to OATP1B1 and BCRP transport proteins. In patients with SLCO1B1 genetic polymorphism (OATP1B1) and/ or ABCG2 (BCRP), there is a risk of increased contact with rosuvastatin. SLCO1B1 C.521cc and ABCG2 C.421AA is related to increasing the level of contact with Rosuvastatin (AUC) compared to the genotypes of SLCO1B1 C.521TT or ABCG2 C.421cc. This specific genotype has not been clinically set, but for patients carrying these forms of daily dose rosmastatin.
Children
Two studies on pharmacokinetics with rosuvastatin (tablets) in children with hyperlested blood cholesterol heterozygous families from 10 to 17 years old or 6 - 17 years old (total 214 patients) shows that the level of contact with rosuvastatin in children is equivalent or lower than an adult patient. Rosuvastatin exposure can be predicted in dosage and time in a period of 2 years.
Before taking Rotorlip 20 DHG treatment for hypercholesterol blood, prevent cardiovascular events (3 blisters x 10 tablets)
How to use
Before starting treatment, the patient must follow a standard diet of cholesterol reduction and continue to maintain this diet during treatment. Use current treatment instructions to adjust the dose of rosuvastatin for each patient according to the patient's treatment and response goals. You can take medicine anytime of the day, during or away from meals.
Dosage
adults:
Hyper cholesterol treatment
The recommended starting dose is 5 mg or 10 mg x 1 time/day for both patients who have never used Statin groups and patients to move from HMG - Coa Reductase inhibitors to use Rosuvastatin.
The starting dose should be paid to the level of cholesterol of each patient, later cardiovascular risk as well as the possibility of unwanted effects. Adjusting the dose to the next dose can be done after 4 weeks if necessary. Because the frequency of unwanted effects increases when using 40 mg dose compared to lower doses, the final dose standard up to 40 mg should only be considered for patients with severe hypercholesterolic cholesterol with high risk of cardiovascular disease (especially patients with hypercholesterol blood cholesterol), without achieving treatment goals at the dose of 20 mg and these patients need to be monitored regularly.
It is necessary to have a close monitoring of a specialist at the start of a 40 mg dose.
Provisions of cardiovascular events
In studies reducing the risk of cardiovascular events, the dose is 20 mg/day.
Children:
Only use when there is a specialist's instructions.
Hyperized hypertension in patients from 6 to 17 years old (tanner phase
Hypersensitivity to homozygous family type
Children from 6 - 17 years old: The starting dose of 5 - 10 mg x 1 time/day depending on age, weight, history of using statin. The maximum dose can be increased to 20 mg depending on the patient's response and tolerance and must be appointed by a pediatrician. Patients must follow a standard diet that reduces cholesterol before treatment with rosuvastatin and continues to maintain this regime during treatment.
Inexperienced in doses higher than 20 mg. Do not use 40 mg for this object.
Children
Special subjects:
Elderly:
Should start at a dose of 5 mg x 1 time/day in people over 70 years old. No need to adjust the dose due to age.
Patients with renal failure:
No dose adjustment in patients with mild to medium renal failure. The recommended starting dose is 5 mg in medium renal failure patients (CrCl
Patients with liver failure:
The level of exposure to rosuvastatin does not increase in patients with child-pugh scores ≤ 7. However, the level of exposure to the increase in drugs has been recorded in patients with Child-Pugh 8 and 9 scores. In these patients, they should consider evaluating kidney function. Inexperienced in patients with Child-Pugh> 9.
Race
In Asian patients, the starting dose is 5 mg/ time/ day due to increased plasma rosuvastatin levels. Contraindicated doses of 40 mg.
Genetic polymorphism
Some genetic forms will increase the concentration of rosuvastatin in the blood. In this case, the dosage should be reduced for patients.
Patients with factors affecting muscle diseases: The starting dose is 5 mg, contraindicated use of 40 mg.
Used in drug combination treatment
Rosuvastatin is the substrate of various shipping proteins (OATP1B1 and BCRP). The risk of muscle disease (including muscle pilot) increases when using simultaneously rosuvastatin with some drug products that may increase the plasma concentration of rosuvastatin due to interaction with these shipping proteins (cyclosporin and some protease inhibitors include ritonavir combination with acazanavir, classinavir, and/ or tipranavir).
If possible, consider alternative drugs, and if necessary, temporarily stop treatment with rosuvastatin. In case of simultaneous use, it is necessary to consider the benefits and risks and must carefully adjust the dose of Rosuvastatin.
Note:
with a dose of 10 mg: Request using Rotorlip 10.
with a dose of 5 mg: suggest to switch to using other products.
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?
There is no specific treatment for overdose. When an overdose, patients should be treated with symptoms and applied supportive measures when necessary. Should monitor liver function and ck concentration. Blood decomposition may not benefit.
In an 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 dose to compensate for missed dose.
Side Effects
Based on the frequency of encounter, we classify unwanted effects (ADR) as follows: Common (1/100 ≤ ADR Blood disorders and lymphatic system pattern The impact on the kidneys: proteinuria, detected by the test strip and has the main origin from the renal tubules, which has been recorded in patients treated with rosuvastatin. The change in the amount of proteinuria from no or only traces to positive ++ or higher has been noticed in Acting on the skeletal muscle system: The impact on the musculoskeletal system such as muscle pain, muscle disease and some rare cases of muscle pattern have or without renal failure have been recorded in patients treated with rosuvastatin at all doses and especially at the doses> 20 mg. Increased CK concentration at the dose is observed in patients using rosuvastatin, most of the mild, asymptomatic and transient cases. If the concentration of CK increases (> 5 times ULN), the treatment should be temporarily suspended Acting on the liver: Like other HMG - Coa Reductase inhibitors, increasing transaminase at the dose recorded in a few patients using rosuvastatin, most cases are mild, asymptomatic and transient. Unwanted effects have been recorded when using statins include: sexual dysfunction, interstitial lung disease (especially when long -term treatment), pattern. The rate of serious side effects on the liver (increased transaminase), the kidneys increases when taking the dose above 40 mg. For children: In a 52 -week clinical study, there are often cases where Creatin Kinase increases> 10 times ULN and increases muscle pain symptoms after exercise or physical activity in young children and adolescents than adults. In some other studies, the safety of rosuvastatin in children and adolescents is equivalent to adults.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Rotorlip 20 contraindicated drug in the following cases:
Contraindicated to use 40 mg in patients with risk factors for muscle disease/muscle pilot. These risk factors include:
Caution when using
influence on the kidneys
proteinuria, detected by the test strip and is the main origin from the renal tubules, which has been recorded in patients treated with high -dose rosuvastatin, especially at 40 mg dose, most of this condition is transient or occasionally occurs. Proteinuria is not a warning sign of acute or progressive kidney disease. It is necessary to assess the kidney function during monitoring of patients who have been treated at a dose of 40 mg.
Muscle effects
Musculosa effects such as causing muscle pain and muscle disease and some rare cases of muscle pattern have been recorded in patients treated with rosuvastatin at all doses and especially at> 20 mg. It is very rare for the pattern that has been reported when using Ezetimib in combination with HMG - CoA Reductase inhibitors. It is not possible to eliminate pharmacokinetic interaction and need to be cautious when using the combination of these two drugs. Like other HMG - Coa Reductase inhibitors, the rate of encountering the pattern is related to Rosuvastain (post -marketing period) is higher when used at the dose of 40 mg.
measure the concentration of creatin kinase (ck)
Do not measure the level of creatin kinase (ck) after exertion or when there is a certain cause that can increase CK because this may falsify the results. If CK concentration increases significantly before treatment (> 5 times ULN), a test should be done to redefine within 5-7 days. If the test is repeated, determine the concentration of CK before treatment is still greater than 5 times, ULN should not start treatment.
Before treatment
Like HMG - Coa Reductase inhibitors, Rosuvastatin should be used with caution in patients with risk factors that can lead to muscle damage, muscle/muscle pilot disease. These factors include:
In these cases, the benefits, risks and monitor patients should be clinically monitored when treated with statin. If the results of CK test> 5 times the upper limit of normal levels, do not start treatment with statin.
during treatment
Patients should be reported on muscle pain, physical weakness or cramps, especially if there are uncomfortable symptoms or fever. CK levels should be measured in these patients. It is necessary to stop taking the drug if the concentration of CK increases significantly (> 5 times ULN) or if the muscle symptoms are serious and cause daily discomfort (even if the concentration CK ≤ 5 times ULN).
If the symptoms are relieved and the CK level returns to normal, it is advisable to reconsider to specify rosuvastatin or another HMG - CoA Reductase inhibitor at the lowest dose with close monitoring. Regularly monitor the concentration of CK in disadvantaged patients.
There have been very rare reports on muscle necrosis through immunity (IMNM) during or after statin treatment, including rosuvastatin. IMNM is clinically characterized by muscle weakness and increased creatin kinase, these symptoms still exist despite stopping statin treatment.
In clinical trials, there is no evidence of an increase in the effects on the musculoskeletal system in a small number of patients used to treat simultaneously with rosuvastatin.
However, the increase in the rate of muscle and muscle disease of the patient has been noticed in patients using other HMG - Coa Reductase inhibitors along with the derivatives of fibric acid such as gemfibrozil, cyclosporin, nicotine acid, Azol antifungal drugs, protease inhibitors and macrolid antibiotics. Gemfibrozil increases the risk of muscle diseases when used simultaneously with some HMG - coa reductase inhibitors. Therefore, it should not be used simultaneously rosuvastatin and gemfibrozil. It is necessary to reconsider the benefits and risks when using combination of rosuvastatin and fibrat or niacin. Contraindicated use of 40 mg rosvastatin with fibrat.Do not use rosuvastatin simultaneously and fusidic acid system for systemic sugar or within 7 days of stopping fusidic acid treatment. In case the patient needs to use the whole body fusidic acid, it is recommended to stop using statin during the treatment of fusidic acid. There has been a report on the condition of the pattern (including some deaths) in patients with fusidic acid and a combination statin.
Patients need advice to find medical advice if they have any muscle weakness, pain or physical pain. Statin therapy can be reused for 7 days after the last dose of fusidic acid. In special cases, if using prolonged fusidic acid (such as treatment of severe infections) should be considered on the basis of each specific case and under strict medical monitoring.
Do not use rosuvastatin for patients with acute serious condition, suspicion of muscle disease or may lead to secondary renal failure due to muscle pilot (such as blood infection, hypotension, great surgery, injury, electrolyte disorders, endocrine and serious metabolism; or uncontrolled convulsions).
influence on the liver
Like other HMG-Coa Reductase inhibitors, caution should be cautious when using rosuvastatin in patients with severe alcoholism and/ or a history of liver disease.
Liver function tests are recommended before treatment and 3 months after starting treatment with rosuvastatin. Rosuvastatin should be discontinued if the serum transaminase concentration is 3 times the upper limit of normal levels. The post -marketing data shows that at a dose of 40 mg increases the risk of harmful effects on the liver (including transaminase increase). In patients with secondary cholesterol growth due to thyroid discharge or nephrotic syndrome, these diseases must be treated before starting rosuvastatin.
Race
Dynamic studies show that there is an increase in the level of exposure to drugs calculated by concentration and time in Asian patients compared to white people.
Protease inhibitors: Observed the increase in contact levels in patients using rosuvastatin along with different protease inhibitors in combination with ritonavir. It is necessary to consider the benefits of lipid lowering by using rosuvastatin in HIV patients using protease inhibitors and the risk of increased rosvastatin concentration in plasma when starting and adjusting the dose of rosuvastatin. It is not recommended to use simultaneously with protease inhibitors unless the dose is rosder.
Lactose intolerance
Patients with rare genetic problems are galactose intolerance, Lapp Lactase deficiency or Glucose - Galactose should not be used.
Interstitial lung disease
Special cases of interstitial lung disease have been recorded when treated with some statins, especially when long -term treatment. Symptoms may include shortness of breath, dry cough and health impairment (fatigue, weight loss and fever). If the patient is suspected of developing interstitial lung disease, statin should be discontinued.
diabetes
Some evidence suggests that statins can cause hyperglycemia and in some patients, at high risk of future diabetes, can cause hyperglycemia and should be carefully cared for. However, this risk is not significantly compared to the effect of reducing the risk of circuit of statin and therefore should not stop treating statin. Patients with high risk (thrilling blood sugar from 5.6 to 6.9 mmol/ l, BMI> 30 kg/ m2, increased triglycerides, hypertension) should be monitored both clinically and biochemical according to the country's instructions.
In Jupiter study, the frequency of diabetes was reported by 2.8% in rosuvastatin and 2.3% in the placebo group, mainly in patients with blood sugar at 5.6 to 6.9 mmol/ l.
Use in children
The height, weight, BMI and secondary characteristics of tanner's gender maturity in patients from 6 to 17 years old when using Rosuvastatin are limited to two years. After two years of research, no effects on growth, weight, BMI or maturity of gender.
In a clinical trial of children and young people using rosuvastatin for 52 weeks, it is often seen increased CK> 10 times ULN and muscle symptoms after exercise or increased physical activity than in adults.
Related to excipients
Due to lactose excipients in the ingredients, Rotorlip 20 should not be used for patients with lactose tolerance, lactase deficiency or glucose - galactose absorption disorders.
The effect of the drug on driving and operating machinery
studies to determine the effects of rosuvastatin on driving capacity and operating the machine have not been performed. However, based on the pharmaceutical properties, Rosuvastatin does not seem to affect these possibilities. When driving or operating the machine should note that dizziness may occur during treatment.
Use drugs for women during pregnancy and nursing mothers
Contraindications for pregnant and lactating women.
Women who are likely to be pregnant need to use appropriate contraception.
Because cholesterol and cholesterol biosynthesis products are important for fetal development, the potential risk of HMG - CoA Reductase inhibitors is higher than the benefits of pregnancy. Animal studies provide evidence of reproductive toxicity limit. If a patient is pregnant during the use of this product, it is necessary to stop treating immediately. Rosuvastatin is excreted in mouse milk. There is no data on the excretion in human milk.
Drug interaction
The effect of shared drugs on rosuvastatin
Transport protein inhibitors
Rosuvastatin is the substrate of protein transportation including the gathering agents in OATP1B1 liver and the protein transported to BCRP. Simultaneous use of rosuvastatin and inhibitors of the aforementioned shipping proteins will increase rosuvastatin levels and increase the risk of muscle diseases.
cyclosporin
During the simultaneous treatment of rosuvastatin with cyclosporin, the AUC value of rosuvastatin average is 7 times higher than in healthy volunteers. Rosuvastatin is contraindicated in patients taking cyclosporin. Simultaneous use does not affect the plasma concentration of cyclosporin.
Protease inhibitors
Although it is unknown to interactive mechanism, simultaneous use of rosuvastatin with some protease inhibitors will increase the level of contact with rosuvastatin. For example, in a pharmacokinetic study, simultaneously used 10 mg of rosuvastatin and a combination of 2 protease inhibitors (300 mg of Atazanavir / 100 mg Ritonavir) in healthy people increasing the AUC and CMAX of Rosuvastatin, respectively 3 and 7 times respectively. The common use of rosuvastatin and protease inhibitors can be considered after adjusting the appropriate rosuvastatin dose.
gemfibrozil and other strange lipid drugs
Concentrated use of these drugs with rosuvastatin will double CMAX and AUC of rosuvastatin.
Based on data from some studies showing no pharmacokinetic interaction with fenofibrat, however, the pharmacokinetic interaction may occur. Gemfibrozil, Fenofibrat, other fibrats and doses that help lower blood lipids (≥1 g/ day) of niacin (nicotinic acid) increase the risk of muscle disease when used simultaneously with HMG - Coa Reductase inhibitors because these drugs can also cause muscle disease when used for solitude. Contraindicated 40 mg when used simultaneously with fibrat and these patients should also start at a dose of 5 mg.
ezetimib
Simultaneous use of 10 mg of Rosuvastatin and 10 mg Ezetimib leads to 1.2 times the AUC value of Rosuvastatin in patients with hypercholesterol blood. Can not exclude pharmacological interaction, unwanted effects between rosuvastatin and ezetimib.
antacids
Simultaneous use of rosuvastatin with aluminum -containing antacids and Magnesi Hydroxyd leads to a reduction in plasma rosuvastatin levels by about 50%. This effect has been slightly reduced when antacids are used after taking rosuvastatin about 2 hours. The clinical involvement of this interaction has not been studied.
erythromycin
Simultaneous use of rosuvastatin and erythromycin leads to 20% reduction of AUC value and 30% reduction of rosvastatin CMAX value. The cause of this interaction may be caused by an increase in intestinal motility caused by erythromycin.
Metabolic drugs through cytochrom P450 enzyme
Results from In vitro and in vivo studies show that RosuVastatin is not a inhibitor or an enzyme induction Cytochrom P450. In addition, Rosuvastatin is a weak substrate for these isenzymes. Therefore, there is no drug interaction due to intermediate metabolism through Cytochrom P450. There is no clinical related interaction between rosuvastatin and fluconazole (CYP2C9 and CYP3A4 inhibitors) or with ketoconazole (CYP2A6 and CYP3A4 inhibitors).
Interactions need to adjust the dose of rosuvastatin
In cases where rosuvastatin is required and drugs that increase the level of contact with rosuvastatin, rosvastatin dose adjustments need to be adjusted. Start at a dose of 5 mg/ day if the ability to increase AUC doubled (or more). The maximum dose needs to be adjusted so that the level of contact with rosuvastatin is not higher than the dose of 40 mg/ day (or no) with other drugs. For example, 20 mg of Rosuvastatin with gemfibrozil (up 1.9 times) or 10 mg of rosuvastatin with Ritonavir/ Atazanavir (up 3.1 times).
ciclosporin 75-200 mg x 2 times/day for 6 months
tipranavir 500 mg/ritonavir 200 mg x 2 times/day for 11 days
iTraconazole 200 mg x 1 time/day for 5 days
fosamprenavir 700 mg/ritonavir 100 mg x 2 times/day for 8 days
silymarin 140 mg x 3 times/day for 5 days
rifampin 450 mg x 1 time/day for 7 days
baicalin 50 mg x 3 times/day for 14 days
Vitamin K resistance
Similar to other HMG - Coa Reductase inhibitors, the beginning of treatment or rising/ decreasing the dose of rosuvastatin when taken simultaneously with vitamin K anti -vitamin (such as warfarin or other coagulants) can increase the INR. Need to stop or adjust the dose to reduce the INR and in these cases, this index should be carefully monitored.
Hormone replacement therapy/oral contraceptive (HRT): simultaneous use of rosuvastatin and oral contraceptives lead to an increase in ethinyl estradiol and Norgestrel AUC, both 26% and 34%. Increased plasma drug concentration should be considered when choosing oral contraceptives. There is no pharmacokinetic data in subjects using rosuvastatin and HRT simultaneously and therefore cannot be excluded the same effect. However, the combination has been widely used in women in clinical trials and well tolerated.
Other drugs
Digoxin: No interaction between Digoxin and Rosuvastatin.
Fusidic Acid: Research on interaction between rosuvastatin and fusidic acid has not been conducted. The risk of muscle diseases including muscle pattern may increase when using fusidic acid simultaneously. Interactive mechanism (pharmacokinetics, pharmacological or both) is still unknown. There have been reports on cases of muscle pattern (including some deaths) in patients using these two drugs.
If needed to be treated with fusidic acid, it is necessary to stop using rosuvastatin during fusidic acid treatment.
Children: The interactions are only studied on adults. The level of interaction in the child population is not well known.
Storage
In a dry place, the temperature does not exceed 30 ° C, avoiding light.
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