The package insert of the medicine Citalor

the package insert of the medicine Citalor. Active principles Atorvastatina Calcica.

what For?

Citalor (atorvastatin cálcica) is indicated as an adjunct to diet for reduction of elevated levels of total cholesterol, LDL-cholesterol, apolipoprotein B and triglycerides in patients with hypercholesterolemia primary hyperlipidemia combined (mixed); and familial hypercholesterolaemia heterozygous and homozygous, when the response to diet and other measures, non-pharmacological are inadequate.

Contraindications

When should I not use?

Citalor (atorvastatin cálcica) is contraindicated in patients who have hypersensitivity to any of the components of its formula; liver disease active or persistent elevations unexpected of serum transaminases exceeding 3 times the upper limit of normal; during pregnancy or lactation or in women of childbearing age who are not using contraceptive measures effective. Citalor (atorvastatin cálcica) should be administered to women of childbearing age only when you check-if highly unlikely the pregnancy, and when these patients have been informed of the potential risks to the fetus.

Dosage

How to use?

The patient should be placed on a standard diet for lowering cholesterol before starting treatment with Citalor (atorvastatin cálcica) and should continue this diet during treatment with Citalor (atorvastatin cálcica). The initial dose usual is 10 mg in a single dose daily. The dose may vary from 10 to 80 mg, in a single dose daily. The doses may be administered at any time of day, with or without food.

doses should be individualized according to baseline levels of LDL-C, the goal of treatment and the response of the patient. After the beginning and/or during the titration of dose of atorvastatin, lipid levels should be analyzed within 2 to 4 weeks, and the dose should be adjusted accordingly.

Hypercholesterolaemia and primary Hyperlipidemia Combined (mixed):
The majority of patients are controlled with 10 mg atorvastatin as a single dose daily. The therapeutic response is evident within 2 weeks, and maximum response is usually achieved within 4 weeks. The response is maintained during chronic treatment.

The following script treatment can be used to establish goals of treatment:
A. Goals of treatment according to the National Program of Cholesterol from the USA (NCEP)to control lipid
Atherosclerotic disease definidab
Two or more factors riscoc (excluding LDL-C)
LDL-C
mg/dL (mmol/L)
LDL-C
mg/dL (mmol/L)
Level Initial Minimum Targets
No no 3190 (34,9) < 160 (

Side Effects

What are the evils that can cause me?

Citalor (atorvastatin cálcica) is generally well tolerated. Adverse reactions have usually been mild in nature and transient. Less than 2% of patients were discontinued from clinical studies due to adverse effects attributed to the Citalor (atorvastatin cálcica).

The most frequent adverse events (1% or more) associated with treatment with atorvastatin, in patients participating in controlled clinical studies were constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, asthenia, diarrhea and insomnia.

The following adverse effects additional have been reported in clinical studies with atorvastatin: edema angioneurótico, cramping in muscle, myositis, myopathy, paresthesia, peripheral neuropathy, pancreatitis, hepatitis, cholestatic jaundice, anorexia, vomiting, alopecia, pruritus, rash (rash), impotence, hyperglycemia and hypoglycemia. Not all the effects listed above, had a relationship of causality associated with the treatment with atorvastatin.

Post-Marketing Experience
The adverse events that were reported after the marketing of Citalor (atorvastatin cálcica), that are not listed above and that may have no causal relationship with the atorvastatin, includes the rhabdomyolysis.

Warnings and Precautions

what should I know before using?

General:
Before being instituted therapy with Citalor (atorvastatin cálcica), should be performed an attempt to control hypercholesterolemia with appropriate diet, exercise, and weight reduction in obese patients, and treat other medical problems underlying (see “Information”).

The atorvastatin can cause elevation of the levels of creatine fosfoquinase and transaminase (see “Warnings” and “backlash”).

patients should be advised to promptly report the unexpected occurrence of pain, changes in sensitivity or muscle weakness, particularly if accompanied by malaise or fever.

Overdose

what to do if someone use a larger amount than is recommended?

there is No specific treatment for the treatment of overdosage with atorvastatin. In the case of an overdose, the patient should receive symptomatic treatment and should be instituted support measures, as needed. Due to the high binding to plasma proteins, hemodialysis should not increase the clearance of atorvastatin significantly.