Pleasure Balm Kama Sutra
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Uses
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet.
In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to:
- Reduce the risk of myocardial infarction
- Reduce the risk of stroke
- Reduce the risk for revascularization procedures and angina
In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, atorvastatin calcium tablets are indicated to:
- Reduce the risk of myocardial infarction
- Reduce the risk of stroke
In patients with clinically evident coronary heart disease, atorvastatin calcium tablets are indicated to:
- Reduce the risk of non-fatal myocardial infarction
- Reduce the risk of fatal and non-fatal stroke
- Reduce the risk for revascularization procedures
- Reduce the risk of hospitalization for CHF
- Reduce the risk of angina
Atorvastatin calcium tablets are indicated:
- As an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb);
- As an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV);
- For the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet;
- To reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable;
- As an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:
- LDL-C remains ≥ 190 mg/dL or
- LDL-C remains ≥ 160 mg/dL and:
- there is a positive family history of premature cardiovascular disease or
- two or more other CVD risk factors are present in the pediatric patient
Atorvastatin calcium tablets have not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).
History
There is currently no drug history available for this drug.
Other Information
Atorvastatin calcium is a synthetic lipid-lowering agent. Atorvastatin is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.
The drug substance used in atorvastatin calcium tablets is atorvastatin calcium in the form of propylene glycol solvate. The chemical name for atorvastatin calcium propylene glycol solvate is calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. The empirical formula of atorvastatin calcium propylene glycol solvate is C66H68CaF2N4O10 * C3H8O2 and its molecular weight is 1231.46. Its structural formula is:
Atorvastatin calcium is a white to off-white solid that is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol.
Atorvastatin calcium tablets for oral administration contain 10, 20, 40, or 80 mg atorvastatin and the following inactive ingredients: calcium acetate, croscarmellose sodium, sodium carbonate, microcrystalline cellulose, magnesium stearate (vegetable source), colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, polyethylene glycol and titanium dioxide.
Sources
Pleasure Balm Kama Sutra Manufacturers
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Kama Sutra
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Pleasure Balm Kama Sutra | International Laboratories, Inc.
2.1 Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)The recommended starting dose of atorvastatin calcium tablets are 10 or 20 mg once daily. Patients who
2.2 Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)
require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage
range of atorvastatin calcium tablets are 10 to 80 mg once daily. Atorvastatin calcium tablets can be
administered as a single dose at any time of the day, with or without food. The starting dose and
maintenance doses of atorvastatin calcium tablets should be individualized according to patient
characteristics such as goal of therapy and response (see current NCEP Guidelines). After initiation
and/or upon titration of atorvastatin calcium tablets, lipid levels should be analyzed within 2 to 4 weeks
and dosage adjusted accordingly.The recommended starting dose of atorvastatin calcium tablets is 10 mg/day; the maximum recommended
2.3 Homozygous Familial Hypercholesterolemia
dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses
should be individualized according to the recommended goal of therapy [see current NCEP Pediatric
Panel Guidelines, Clinical Pharmacology (12), and Indications and Usage (1.2)]. Adjustments should be
made at intervals of 4 weeks or more.The dosage of atorvastatin calcium tablets in patients with homozygous FH is 10 to 80 mg daily.
2.4 Concomitant Lipid-Lowering Therapy
Atorvastatin calcium tablets should be used as an adjunct to other lipid-lowering treatments (e.g., LDL
apheresis) in these patients or if such treatments are unavailable.Atorvastatin calcium tablets may be used with bile acid resins. The combination of HMG-CoA
2.5 Dosage in Patients With Renal Impairment
reductase inhibitors (statins) and fibrates should generally be used with caution [see Warnings and
Precautions, Skeletal Muscle (5.1), Drug Interactions (7)].Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin; thus,
2.6 Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or Certain Protease Inhibitors
dosage adjustment in patients with renal dysfunction is not necessary [see Warnings and Precautions,
Skeletal Muscle (5.1), Clinical Pharmacology, Pharmacokinetics (12.3)].In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis
C protease inhibitor (telaprevir), therapy with atorvastatin should be avoided. In patients with HIV taking
lopinavir plus ritonavir, caution should be used when prescribing atorvastatin and the lowest dose
necessary employed. In patients taking clarithromycin, itraconazole, or in patients with HIV taking a
combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus
ritonavir, therapy with atorvastatin should be limited to 20 mg, and appropriate clinical assessment is
recommended to ensure that the lowest dose necessary of atorvastatin is employed. In patients taking the
HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, therapy with
atorvastatin should be limited to 40 mg, and appropriate clinical assessment is recommended to ensure
that the lowest dose necessary of atorvastatin is employed [see Warnings and Precautions, Skeletal
Muscle (5.1), Drug Interactions (7)].
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