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Advicor
Overview
What is Advicor?
ADVICOR (niacin extended-release and lovastatin) is intended to facilitate the daily administration of its individual components, Niaspan and lovastatin, when used together for the intended patient population (see and ).
ADVICOR contains niacin extended-release and lovastatin in combination. Lovastatin, an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, and niacin are both lipid-altering agents.
Niacin is nicotinic acid, or 3-pyridinecarboxylic acid. Niacin is a white, nonhygroscopic crystalline powder that is very soluble in water, boiling ethanol and propylene glycol. It is insoluble in ethyl ether. The empirical formula of niacin is CHNO and its molecular weight is 123.11. Niacin has the following structural formula:
Lovastatin is [1S -[1(alpha)(R *), 3(alpha), 7(beta), 8(beta)(2S *, 4S *), 8a(beta)]]-1,2,3, 7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl) ethyl]-1-naphthalenyl 2-methylbutanoate. Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. The empirical formula of lovastatin is CHO and its molecular weight is 404.55. Lovastatin has the following structural formula:
ADVICOR tablets contain the labeled amount of niacin and lovastatin and have the following inactive ingredients: hypromellose, povidone, stearic acid, polyethylene glycol, titanium dioxide, polysorbate 80.
The individual tablet strengths (expressed in terms of mg niacin/mg lovastatin) contain the following coloring agents:
ADVICOR 500 mg/20 mg - Iron Oxide Yellow, Iron Oxide Red.ADVICOR 750 mg/20 mg - FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake.ADVICOR 1000 mg/20 mg - Iron Oxide Red, Iron Oxide Yellow, Iron Oxide Black.ADVICOR 1000 mg/40 mg - Iron Oxide Red.
What does Advicor look like?
What are the available doses of Advicor?
Sorry No records found.
What should I talk to my health care provider before I take Advicor?
Sorry No records found
How should I use Advicor?
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 indicated 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 (see also and the NCEP treatment guidelines).
The patient should be placed on a standard cholesterol-lowering diet before receiving ADVICOR or its individual active components and should continue on this diet during treatment with lipid-altering therapy (see ).
What interacts with Advicor?
ADVICOR is contraindicated in patients with a known hypersensitivity to niacin, lovastatin or any component of this medication, active liver disease or unexplained persistent elevations in serum transaminases (see ), active peptic ulcer disease, or arterial bleeding.
Concomitant administration with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone) (see ).
Pregnancy and lactation
ADVICOR should be administered to women of childbearing age only when such patients are highly unlikely to conceive.
What are the warnings of Advicor?
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Liver Dysfunction
Cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have substituted sustained-release (modified-release, timed-release) niacin products for immediate-release (crystalline) niacin at equivalent doses.
ADVICOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a past history of liver disease. Active liver disease or unexplained transaminase elevations are contraindications to the use of ADVICOR.
Niacin preparations and lovastatin preparations have been associated with abnormal liver tests. In studies using NIASPAN alone, 0.8% of patients were discontinued for transaminase elevations. In studies using lovastatin alone, 0.2% of patients were discontinued for transaminase elevations. In three safety and efficacy studies involving titration to final daily ADVICOR doses ranging from 500 mg/10 mg to 2500 mg/40 mg, ten of 1028 patients (1.0%) experienced reversible elevations in AST/ALT to more than 3 times the upper limit of normal (ULN). Three of ten elevations occurred at doses outside the recommended dosing limit of 2000 mg/40 mg; no patient receiving 1000 mg/20 mg had 3-fold elevations in AST/ALT.
In clinical studies with ADVICOR, elevations in transaminases did not appear to be related to treatment duration; elevations in AST and ALT levels did appear to be dose related. Transaminase elevations were reversible upon discontinuation of ADVICOR.
It is recommended that liver enzyme tests be obtained prior to initiating therapy with ADVICOR and repeated as clinically indicated.
There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including lovastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with ADVICOR, promptly interrupt therapy. If an alternate etiology is not found do not restart ADVICOR.
What are the precautions of Advicor?
General
Before instituting therapy with a lipid-altering medication, an attempt should be made to control dyslipidemia with appropriate diet, exercise, and weight reduction in obese patients, and to treat other underlying medical problems (see ).
Patients with a past history of jaundice, hepatobiliary disease, or peptic ulcer should be observed closely during ADVICOR therapy. Frequent monitoring of liver function tests and blood glucose should be performed to ascertain that the drug is producing no adverse effects on these organ systems.
Diabetic patients may experience a dose-related rise in fasting blood sugar (FBS). In three clinical studies, which included 1028 patients exposed to ADVICOR (6 to 22% of whom had diabetes type II at baseline), increases in FBS above normal occurred in 46 to 65% of patients at any time during study treatment with ADVICOR. Fourteen patients (1.4%) were discontinued from study treatment: 3 patients for worsening diabetes, 10 patients for hyperglycemia and 1 patient for a new diagnosis of diabetes. In the studies in which lovastatin and NIASPAN were used as active controls, 24 to 41% of patients receiving lovastatin and 43 to 58% of patients receiving NIASPAN also had increases in FBS above normal. One patient (1.1%) receiving lovastatin was discontinued for hyperglycemia. Diabetic or potentially diabetic patients should be observed closely during treatment with ADVICOR, and adjustment of diet and/or hypoglycemic therapy may be necessary.
In one long-term study of 106 patients treated with ADVICOR, elevations in prothrombin time (PT) >3 times ULN occurred in 2 patients (2%) during study drug treatment. In a long-term study of 814 patients treated with ADVICOR, 7 patients were noted to have platelet counts <100,000 during study drug treatment. Four of these patients were discontinued, and one patient with a platelet count <100,000 had prolonged bleeding after a tooth extraction. Prior studies have shown that NIASPAN can be associated with dose-related reductions in platelet count (mean of -11% with 2000 mg) and increases of PT (mean of approximately +4%). Accordingly, patients undergoing surgery should be carefully evaluated. In controlled studies, ADVICOR has been associated with small but statistically significant dose-related reductions in phosphorus levels (mean of -10% with 2000 mg/40 mg). Phosphorus levels should be monitored periodically in patients at risk for hypophosphatemia. In clinical studies with ADVICOR, hypophosphatemia was more common in males than in females. The clinical relevance of hypophosphatemia in this population is not known.
Niacin
Caution should also be used when ADVICOR is used in patients with unstable angina or in the acute phase of MI, particularly when such patients are also receiving vasoactive drugs such as nitrates, calcium channel blockers, or adrenergic blocking agents.
Elevated uric acid levels have occurred with niacin therapy; therefore, in patients predisposed to gout, niacin therapy should be used with caution. Niacin is rapidly metabolized by the liver, and excreted through the kidneys. ADVICOR is contraindicated in patients with significant or unexplained hepatic dysfunction (see and ) and should be used with caution in patients with renal dysfunction.
Lovastatin
Lovastatin may elevate creatine phosphokinase and transaminase levels (see and ). This should be considered in the differential diagnosis of chest pain in a patient on therapy with lovastatin.
Lovastatin may elevate creatine phosphokinase and transaminase levels (see and ). This should be considered in the differential diagnosis of chest pain in a patient on therapy with lovastatin.
Lovastatin may elevate creatine phosphokinase and transaminase levels (see and ). This should be considered in the differential diagnosis of chest pain in a patient on therapy with lovastatin.
Information for Patients
- to report promptly unexplained muscle pain, tenderness, or weakness (see );
- to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice (see );
- to take ADVICOR at bedtime, with a low-fat snack. Administration on an empty stomach is not recommended;
- to carefully follow the prescribed dosing regimen (see );
- that flushing is a common side effect of niacin therapy that usually subsides after several weeks of consistent niacin use. Flushing may last for several hours after dosing, may vary in severity, and will, by taking ADVICOR at bedtime, most likely occur during sleep. If awakened by flushing, especially if taking antihypertensives, rise slowly to minimize the potential for dizziness and/or syncope;
- that taking aspirin (up to approximately 30 minutes before taking ADVICOR) may minimize flushing;
- to avoid ingestion of alcohol, hot beverages and spicy foods around the time of ADVICOR administration, to minimize flushing;
- should not be administered with grapefruit juice;
- that if ADVICOR therapy is discontinued for an extended length of time, their physician should be contacted prior to re-starting therapy; re-titration is recommended (see );
- to notify their physician if they are taking vitamins or other nutritional supplements containing niacin or related compounds such as nicotinamide (see );
- to notify their physician if symptoms of dizziness occur;
- if diabetic, to notify their physician of changes in blood glucose;
- that ADVICOR tablets should not be broken, crushed, or chewed, but should be swallowed whole.
Patients should be advised of the following:
Drug Interactions
Niacin
Lovastatin
Drug/Laboratory Test Interactions
Niacin may produce false elevations in some fluorometric determinations of plasma or urinary catecholamines. Niacin may also give false-positive reactions with cupric sulfate solution (Benedict's reagent) in urine glucose tests.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been conducted with ADVICOR regarding carcinogenesis, mutagenesis, or impairment of fertility.
Niacin
Niacin, administered to mice for a lifetime as a 1% solution in drinking water, was not carcinogenic. The mice in this study received approximately 6 to 8 times a human dose of 3000 mg/day as determined on a mg/m basis. Niacin was negative for mutagenicity in the Ames test. No studies on impairment of fertility have been performed.
Lovastatin
No studies have been conducted with ADVICOR regarding carcinogenesis, mutagenesis, or impairment of fertility.
Pregnancy
— See .
ADVICOR should be administered to women of childbearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazard. Safety in pregnant women has not been established and there is no apparent benefit to therapy with ADVICOR during pregnancy (see ). Treatment should be immediately discontinued as soon as pregnancy is recognized.
Labor and Delivery
No studies have been conducted on the effect of ADVICOR, niacin or lovastatin on the mother or the fetus during labor or delivery, on the duration of labor or delivery, or on the growth, development, and functional maturation of the child.
Nursing Mothers
No studies have been conducted with ADVICOR in nursing mothers.
Because of the potential for serious adverse reactions in nursing infants from lipid-altering doses of niacin and lovastatin (see ), ADVICOR should not be taken while a woman is breastfeeding.
Niacin has been reported to be excreted in human milk. It is not known whether lovastatin is excreted in human milk. A small amount of another drug in this class is excreted in human breast milk.
Pediatric Use
No studies in patients under 18 years-of-age have been conducted with ADVICOR. Because pediatric patients are not likely to benefit from cholesterol lowering for at least a decade and because experience with this drug or its active ingredients is limited, treatment of pediatric patients with ADVICOR is not recommended at this time.
Geriatric Use
Of the 214 patients who received ADVICOR in double-blind clinical studies, 37.4% were 65 years-of-age and older, and of the 814 patients who received ADVICOR in open-label clinical studies, 36.2% were 65 years-of-age and older. Responses in LDL-C, HDL-C, and TG were similar in geriatric patients. No overall differences in the percentage of patients with adverse events were observed between older and younger patients. No overall differences were observed in selected chemistry values between the two groups except for amylase which was higher in older patients.
What are the side effects of Advicor?
Overview
In controlled clinical studies, 40/214 (19%) of patients randomized to ADVICOR discontinued therapy prior to study completion. Of the 214 patients enrolled 18 (8%) discontinued due to flushing. In the same controlled studies, 9/94 (10%) of patients randomized to lovastatin and 19/92 (21%) of patients randomized to NIASPAN also discontinued treatment prior to study completion secondary to adverse events. Flushing episodes (i.e., warmth, redness, itching and/or tingling) were the most common treatment-emergent adverse events, and occurred in 53% to 83% of patients treated with ADVICOR. Spontaneous reports with NIASPAN and clinical studies with ADVICOR suggest that flushing may also be accompanied by symptoms of dizziness or syncope, tachycardia, palpitations, shortness of breath, sweating, burning sensation/skin burning sensation, chills, and/or edema.
Adverse Reactions Information
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. The adverse reaction information from clinical studies does, however provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
The data described in this section reflect the exposure to ADVICOR in two double-blind, controlled clinical studies of 400 patients. The population was 28 to 86 years-of-age, 54% male, 85% Caucasian, 9% Black, and 7% Other, and had mixed dyslipidemia.
In addition to flushing, other adverse events occurring in 5% or greater of patients treated with ADVICOR are shown in below.
See also the full prescribing information for niacin extended release (Niaspan) and lovastatin products.
The following adverse events have also been reported with niacin, lovastatin, and/or other HMG-CoA reductase inhibitors, but not necessarily with ADVICOR, either during clinical studies or in routine patient management.
There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
| Adverse Event | ADVICOR | NIASPAN | Lovastatin |
| Total Number of Patients | 214 | 92 | 94 |
| Cardiovascular | 163 (76%) | 66 (72%) | 24 (26%) |
| Flushing | 152 (71%) | 60 (65%) | 17 (18%) |
| Body as a Whole | 104 (49%) | 50 (54%) | 42 (45%) |
| Asthenia | 10 ( 5%) | 6 ( 7%) | 5 ( 5%) |
| Flu Syndrome | 12 ( 6%) | 7 ( 8%) | 4 ( 4%) |
| Headache | 20 ( 9%) | 12 (13%) | 5 ( 5%) |
| Infection | 43 (20%) | 14 (15%) | 19 (20%) |
| Pain | 18 ( 8%) | 3 ( 3%) | 9 (10%) |
| Pain, Abdominal | 9 ( 4%) | 1 ( 1%) | 6 ( 6%) |
| Pain, Back | 10 ( 5%) | 5 ( 5%) | 5 ( 5%) |
| Digestive System | 51 (24%) | 26 (28%) | 16 (17%) |
| Diarrhea | 13 ( 6%) | 8 ( 9%) | 2 ( 2%) |
| Dyspepsia | 6 ( 3%) | 5 ( 5%) | 4 ( 4%) |
| Nausea | 14 ( 7%) | 11 (12%) | 2 ( 2%) |
| Vomiting | 7 ( 3%) | 5 ( 5%) | 0 |
| Metabolic and Nutrit. System | 37 (17%) | 18 (20%) | 13 (14%) |
| Hyperglycemia | 8 ( 4%) | 6 ( 7%) | 6 ( 6%) |
| Musculoskeletal System | 19 ( 9%) | 9 (10%) | 17 (18%) |
| Myalgia | 6 ( 3%) | 5 ( 5%) | 8 ( 9%) |
| Skin and Appendages | 38 (18%) | 19 (21%) | 11 (12%) |
| Pruritus | 14 ( 7%) | 7 ( 8%) | 3 ( 3%) |
| Rash | 11 ( 5%) | 11 (12%) | 3 ( 3%) |
| Body as a Whole: | chest pain; abdominal pain; edema; chills; malaise | ||
| Cardiovascular: | atrial fibrillation; tachycardia; palpitations, and other cardiac arrhythmias; postural hypotension, orthostasis; hypotension; syncope | ||
| Eye: | toxic amblyopia; cystoid macular edema; ophthalmoplegia; eye irritation, blurred vision, progression of cataracts | ||
| Gastrointestinal: | activation of peptic ulcers and peptic ulceration; dyspepsia; vomiting; anorexia; constipation; flatulence, pancreatitis; hepatitis; fatty change in liver; jaundice; and rarely, cirrhosis, fulminant hepatic necrosis, and hepatoma, eructation, fatal and non-fatal hepatic failure | ||
| Metabolic: | gout, decreased glucose tolerance | ||
| Musculoskeletal: | muscle cramps; myopathy; rhabdomyolysis; arthralgia, myalgia | ||
| Nervous: | dizziness; insomnia; dry mouth; paresthesia; anxiety; tremor; vertigo; peripheral neuropathy; psychic disturbances; dysfunction of certain cranial nerves, nervousness, burning sensation/skin burning sensation, peripheral nerve palsy | ||
| Psychiatric | depression | ||
| Skin: | hyper-pigmentation; acanthosis nigricans; urticaria; alopecia; dry skin; sweating; and a variety of skin changes (e.g., nodules, discoloration, dryness of mucous membranes, changes to hair/nails), vesiculobullous rash, maculopapular rash | ||
| Respiratory: | dyspnea; rhinitis | ||
| Urogenital: | gynecomastia; loss of libido; erectile dysfunction | ||
| Hypersensitivity reactions: | An apparent hypersensitivity syndrome has been reported rarely, which has included one or more of the following features: anaphylaxis, angioedema, tongue edema, larynx edema, face edema, peripheral edema, laryngismus, lupus erythematous-like syndrome, polymyalgia rheumatica, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome, dermatomyositis | ||
| Other: | migraine |
Clinical Laboratory Abnormalities
Chemistry
Elevations in serum transaminases (see ), CPK and fasting glucose, and reductions in phosphorus. Niacin extended-release tablets have been associated with slight elevations in LDH, uric acid, total bilirubin, amylase and creatine kinase. Lovastatin and/or HMG-CoA reductase inhibitors have been associated with elevations in alkaline phosphatase, γ-glutamyl transpeptidase and bilirubin, and thyroid function abnormalities.
Hematology
Niacin extended-release tablets have been associated with slight reductions in platelet counts and prolongation in PT (see ).
What should I look out for while using Advicor?
ADVICOR is contraindicated in patients with a known hypersensitivity to niacin, lovastatin or any component of this medication, active liver disease or unexplained persistent elevations in serum transaminases (see ), active peptic ulcer disease, or arterial bleeding.
Concomitant administration with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone) (see ).
Pregnancy and lactation
ADVICOR should be administered to women of childbearing age only when such patients are highly unlikely to conceive.
ADVICOR should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to NIASPAN, therapy with NIASPAN should be initiated with low doses (i.e., 500 mg once daily at bedtime) and the NIASPAN dose should then be titrated to the desired therapeutic response (see ).
What might happen if I take too much Advicor?
Information on acute overdose with ADVICOR in humans is limited. Until further experience is obtained, no specific treatment of overdose with ADVICOR can be recommended. The patient should be carefully observed and given supportive treatment.
How should I store and handle Advicor?
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.ADVICOR is an unscored capsule-shaped tablet containing either 500, 750, or 1000 mg of extended-release niacin, and 20 mg of immediate-release lovastatin (ADVICOR 500 mg/20 mg, 750 mg/20 mg, 1000 mg/20 mg), or 1000 mg of extended-release niacin and 40 mg of immediate-release lovastatin (ADVICOR 1000 mg/40 mg). Tablets are color-coated and printed with the Abbott ‘A’ logo and a code number specific to the tablet strength on the same side. ADVICOR 500 mg/20 mg tablets are light yellow, code “502”. ADVICOR 750 mg/20 mg tablets are light orange, code “752”. ADVICOR 1000 mg/20 mg tablets are dark pink/light purple, code “1002”. ADVICOR 1000 mg/40 mg tablets are reddish brown, code “1004.” Tablets are supplied in bottles of 90 tablets as shown below. 500 mg/20 mg tablets:bottles of 30 - NDC 54868-4807-1 bottles of 60 - NDC 54868-4807-0 1000 mg/40 mg tablets:bottles of 30 - NDC 54868-5653-0 bottles of 90 - NDC 54868-5653-1 Store at room temperature (20° to 25°C or 68° to 77°F). NIASPAN is a registered trademark of Abbott Laboratories, and Mevacor is a registered trademark of Merck & Co., Inc. ADVICOR is an unscored capsule-shaped tablet containing either 500, 750, or 1000 mg of extended-release niacin, and 20 mg of immediate-release lovastatin (ADVICOR 500 mg/20 mg, 750 mg/20 mg, 1000 mg/20 mg), or 1000 mg of extended-release niacin and 40 mg of immediate-release lovastatin (ADVICOR 1000 mg/40 mg). Tablets are color-coated and printed with the Abbott ‘A’ logo and a code number specific to the tablet strength on the same side. ADVICOR 500 mg/20 mg tablets are light yellow, code “502”. ADVICOR 750 mg/20 mg tablets are light orange, code “752”. ADVICOR 1000 mg/20 mg tablets are dark pink/light purple, code “1002”. ADVICOR 1000 mg/40 mg tablets are reddish brown, code “1004.” Tablets are supplied in bottles of 90 tablets as shown below. 500 mg/20 mg tablets:bottles of 30 - NDC 54868-4807-1 bottles of 60 - NDC 54868-4807-0 1000 mg/40 mg tablets:bottles of 30 - NDC 54868-5653-0 bottles of 90 - NDC 54868-5653-1 Store at room temperature (20° to 25°C or 68° to 77°F). NIASPAN is a registered trademark of Abbott Laboratories, and Mevacor is a registered trademark of Merck & Co., Inc. ADVICOR is an unscored capsule-shaped tablet containing either 500, 750, or 1000 mg of extended-release niacin, and 20 mg of immediate-release lovastatin (ADVICOR 500 mg/20 mg, 750 mg/20 mg, 1000 mg/20 mg), or 1000 mg of extended-release niacin and 40 mg of immediate-release lovastatin (ADVICOR 1000 mg/40 mg). Tablets are color-coated and printed with the Abbott ‘A’ logo and a code number specific to the tablet strength on the same side. ADVICOR 500 mg/20 mg tablets are light yellow, code “502”. ADVICOR 750 mg/20 mg tablets are light orange, code “752”. ADVICOR 1000 mg/20 mg tablets are dark pink/light purple, code “1002”. ADVICOR 1000 mg/40 mg tablets are reddish brown, code “1004.” Tablets are supplied in bottles of 90 tablets as shown below. 500 mg/20 mg tablets:bottles of 30 - NDC 54868-4807-1 bottles of 60 - NDC 54868-4807-0 1000 mg/40 mg tablets:bottles of 30 - NDC 54868-5653-0 bottles of 90 - NDC 54868-5653-1 Store at room temperature (20° to 25°C or 68° to 77°F). NIASPAN is a registered trademark of Abbott Laboratories, and Mevacor is a registered trademark of Merck & Co., Inc. ADVICOR is an unscored capsule-shaped tablet containing either 500, 750, or 1000 mg of extended-release niacin, and 20 mg of immediate-release lovastatin (ADVICOR 500 mg/20 mg, 750 mg/20 mg, 1000 mg/20 mg), or 1000 mg of extended-release niacin and 40 mg of immediate-release lovastatin (ADVICOR 1000 mg/40 mg). Tablets are color-coated and printed with the Abbott ‘A’ logo and a code number specific to the tablet strength on the same side. ADVICOR 500 mg/20 mg tablets are light yellow, code “502”. ADVICOR 750 mg/20 mg tablets are light orange, code “752”. ADVICOR 1000 mg/20 mg tablets are dark pink/light purple, code “1002”. ADVICOR 1000 mg/40 mg tablets are reddish brown, code “1004.” Tablets are supplied in bottles of 90 tablets as shown below. 500 mg/20 mg tablets:bottles of 30 - NDC 54868-4807-1 bottles of 60 - NDC 54868-4807-0 1000 mg/40 mg tablets:bottles of 30 - NDC 54868-5653-0 bottles of 90 - NDC 54868-5653-1 Store at room temperature (20° to 25°C or 68° to 77°F). NIASPAN is a registered trademark of Abbott Laboratories, and Mevacor is a registered trademark of Merck & Co., Inc. ADVICOR is an unscored capsule-shaped tablet containing either 500, 750, or 1000 mg of extended-release niacin, and 20 mg of immediate-release lovastatin (ADVICOR 500 mg/20 mg, 750 mg/20 mg, 1000 mg/20 mg), or 1000 mg of extended-release niacin and 40 mg of immediate-release lovastatin (ADVICOR 1000 mg/40 mg). Tablets are color-coated and printed with the Abbott ‘A’ logo and a code number specific to the tablet strength on the same side. ADVICOR 500 mg/20 mg tablets are light yellow, code “502”. ADVICOR 750 mg/20 mg tablets are light orange, code “752”. ADVICOR 1000 mg/20 mg tablets are dark pink/light purple, code “1002”. ADVICOR 1000 mg/40 mg tablets are reddish brown, code “1004.” Tablets are supplied in bottles of 90 tablets as shown below. 500 mg/20 mg tablets:bottles of 30 - NDC 54868-4807-1 bottles of 60 - NDC 54868-4807-0 1000 mg/40 mg tablets:bottles of 30 - NDC 54868-5653-0 bottles of 90 - NDC 54868-5653-1 Store at room temperature (20° to 25°C or 68° to 77°F). NIASPAN is a registered trademark of Abbott Laboratories, and Mevacor is a registered trademark of Merck & Co., Inc. ADVICOR is an unscored capsule-shaped tablet containing either 500, 750, or 1000 mg of extended-release niacin, and 20 mg of immediate-release lovastatin (ADVICOR 500 mg/20 mg, 750 mg/20 mg, 1000 mg/20 mg), or 1000 mg of extended-release niacin and 40 mg of immediate-release lovastatin (ADVICOR 1000 mg/40 mg). Tablets are color-coated and printed with the Abbott ‘A’ logo and a code number specific to the tablet strength on the same side. ADVICOR 500 mg/20 mg tablets are light yellow, code “502”. ADVICOR 750 mg/20 mg tablets are light orange, code “752”. ADVICOR 1000 mg/20 mg tablets are dark pink/light purple, code “1002”. ADVICOR 1000 mg/40 mg tablets are reddish brown, code “1004.” Tablets are supplied in bottles of 90 tablets as shown below. 500 mg/20 mg tablets:bottles of 30 - NDC 54868-4807-1 bottles of 60 - NDC 54868-4807-0 1000 mg/40 mg tablets:bottles of 30 - NDC 54868-5653-0 bottles of 90 - NDC 54868-5653-1 Store at room temperature (20° to 25°C or 68° to 77°F). NIASPAN is a registered trademark of Abbott Laboratories, and Mevacor is a registered trademark of Merck & Co., Inc. ADVICOR is an unscored capsule-shaped tablet containing either 500, 750, or 1000 mg of extended-release niacin, and 20 mg of immediate-release lovastatin (ADVICOR 500 mg/20 mg, 750 mg/20 mg, 1000 mg/20 mg), or 1000 mg of extended-release niacin and 40 mg of immediate-release lovastatin (ADVICOR 1000 mg/40 mg). Tablets are color-coated and printed with the Abbott ‘A’ logo and a code number specific to the tablet strength on the same side. ADVICOR 500 mg/20 mg tablets are light yellow, code “502”. ADVICOR 750 mg/20 mg tablets are light orange, code “752”. ADVICOR 1000 mg/20 mg tablets are dark pink/light purple, code “1002”. ADVICOR 1000 mg/40 mg tablets are reddish brown, code “1004.” Tablets are supplied in bottles of 90 tablets as shown below. 500 mg/20 mg tablets:bottles of 30 - NDC 54868-4807-1 bottles of 60 - NDC 54868-4807-0 1000 mg/40 mg tablets:bottles of 30 - NDC 54868-5653-0 bottles of 90 - NDC 54868-5653-1 Store at room temperature (20° to 25°C or 68° to 77°F). NIASPAN is a registered trademark of Abbott Laboratories, and Mevacor is a registered trademark of Merck & Co., Inc. ADVICOR is an unscored capsule-shaped tablet containing either 500, 750, or 1000 mg of extended-release niacin, and 20 mg of immediate-release lovastatin (ADVICOR 500 mg/20 mg, 750 mg/20 mg, 1000 mg/20 mg), or 1000 mg of extended-release niacin and 40 mg of immediate-release lovastatin (ADVICOR 1000 mg/40 mg). Tablets are color-coated and printed with the Abbott ‘A’ logo and a code number specific to the tablet strength on the same side. ADVICOR 500 mg/20 mg tablets are light yellow, code “502”. ADVICOR 750 mg/20 mg tablets are light orange, code “752”. ADVICOR 1000 mg/20 mg tablets are dark pink/light purple, code “1002”. ADVICOR 1000 mg/40 mg tablets are reddish brown, code “1004.” Tablets are supplied in bottles of 90 tablets as shown below. 500 mg/20 mg tablets:bottles of 30 - NDC 54868-4807-1 bottles of 60 - NDC 54868-4807-0 1000 mg/40 mg tablets:bottles of 30 - NDC 54868-5653-0 bottles of 90 - NDC 54868-5653-1 Store at room temperature (20° to 25°C or 68° to 77°F). NIASPAN is a registered trademark of Abbott Laboratories, and Mevacor is a registered trademark of Merck & Co., Inc. ADVICOR is an unscored capsule-shaped tablet containing either 500, 750, or 1000 mg of extended-release niacin, and 20 mg of immediate-release lovastatin (ADVICOR 500 mg/20 mg, 750 mg/20 mg, 1000 mg/20 mg), or 1000 mg of extended-release niacin and 40 mg of immediate-release lovastatin (ADVICOR 1000 mg/40 mg). Tablets are color-coated and printed with the Abbott ‘A’ logo and a code number specific to the tablet strength on the same side. ADVICOR 500 mg/20 mg tablets are light yellow, code “502”. ADVICOR 750 mg/20 mg tablets are light orange, code “752”. ADVICOR 1000 mg/20 mg tablets are dark pink/light purple, code “1002”. ADVICOR 1000 mg/40 mg tablets are reddish brown, code “1004.” Tablets are supplied in bottles of 90 tablets as shown below. 500 mg/20 mg tablets:bottles of 30 - NDC 54868-4807-1 bottles of 60 - NDC 54868-4807-0 1000 mg/40 mg tablets:bottles of 30 - NDC 54868-5653-0 bottles of 90 - NDC 54868-5653-1 Store at room temperature (20° to 25°C or 68° to 77°F). NIASPAN is a registered trademark of Abbott Laboratories, and Mevacor is a registered trademark of Merck & Co., Inc.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
A variety of clinical studies have demonstrated that elevated levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B-100 (Apo B) promote human atherosclerosis. Similarly, decreased levels of high-density lipoprotein cholesterol (HDL-C) are associated with the development of atherosclerosis. Epidemiological investigations have established that cardiovascular morbidity and mortality vary directly with the level of TC and LDL-C, and inversely with the level of HDL-C.
Cholesterol-enriched triglyceride-rich lipoproteins, including very low-density lipoproteins (VLDL), intermediate-density lipoproteins (IDL), and their remnants, can also promote atherosclerosis. Elevated plasma triglycerides (TG) are frequently found in a triad with low HDL-C levels and small LDL particles, as well as in association with non-lipid metabolic risk factors for coronary heart disease (CHD). As such, total plasma TG have not consistently been shown to be an independent risk factor for CHD.
As an adjunct to diet, the efficacy of niacin and lovastatin in improving lipid profiles (either individually, or in combination with each other, or niacin in combination with other statins) for the treatment of dyslipidemia has been well documented. The effect of combined therapy with niacin and lovastatin on cardiovascular morbidity and mortality has not been determined.
Non-Clinical Toxicology
ADVICOR is contraindicated in patients with a known hypersensitivity to niacin, lovastatin or any component of this medication, active liver disease or unexplained persistent elevations in serum transaminases (see ), active peptic ulcer disease, or arterial bleeding.Concomitant administration with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone) (see ).
Pregnancy and lactation
ADVICOR should be administered to women of childbearing age only when such patients are highly unlikely to conceive.
ADVICOR should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to NIASPAN, therapy with NIASPAN should be initiated with low doses (i.e., 500 mg once daily at bedtime) and the NIASPAN dose should then be titrated to the desired therapeutic response (see ).
Before instituting therapy with a lipid-altering medication, an attempt should be made to control dyslipidemia with appropriate diet, exercise, and weight reduction in obese patients, and to treat other underlying medical problems (see ).
Patients with a past history of jaundice, hepatobiliary disease, or peptic ulcer should be observed closely during ADVICOR therapy. Frequent monitoring of liver function tests and blood glucose should be performed to ascertain that the drug is producing no adverse effects on these organ systems.
Diabetic patients may experience a dose-related rise in fasting blood sugar (FBS). In three clinical studies, which included 1028 patients exposed to ADVICOR (6 to 22% of whom had diabetes type II at baseline), increases in FBS above normal occurred in 46 to 65% of patients at any time during study treatment with ADVICOR. Fourteen patients (1.4%) were discontinued from study treatment: 3 patients for worsening diabetes, 10 patients for hyperglycemia and 1 patient for a new diagnosis of diabetes. In the studies in which lovastatin and NIASPAN were used as active controls, 24 to 41% of patients receiving lovastatin and 43 to 58% of patients receiving NIASPAN also had increases in FBS above normal. One patient (1.1%) receiving lovastatin was discontinued for hyperglycemia. Diabetic or potentially diabetic patients should be observed closely during treatment with ADVICOR, and adjustment of diet and/or hypoglycemic therapy may be necessary.
In one long-term study of 106 patients treated with ADVICOR, elevations in prothrombin time (PT) >3 times ULN occurred in 2 patients (2%) during study drug treatment. In a long-term study of 814 patients treated with ADVICOR, 7 patients were noted to have platelet counts <100,000 during study drug treatment. Four of these patients were discontinued, and one patient with a platelet count <100,000 had prolonged bleeding after a tooth extraction. Prior studies have shown that NIASPAN can be associated with dose-related reductions in platelet count (mean of -11% with 2000 mg) and increases of PT (mean of approximately +4%). Accordingly, patients undergoing surgery should be carefully evaluated. In controlled studies, ADVICOR has been associated with small but statistically significant dose-related reductions in phosphorus levels (mean of -10% with 2000 mg/40 mg). Phosphorus levels should be monitored periodically in patients at risk for hypophosphatemia. In clinical studies with ADVICOR, hypophosphatemia was more common in males than in females. The clinical relevance of hypophosphatemia in this population is not known.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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