• Dosage of Statlip in details
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Dosage of Statlip in details

Statlip Dosage

Generic name: Statlip CALCIUM TRIHYDRATE 10mg

Dosage form: tablet, film coated

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)

The recommended starting dose of Statlip is 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of Statlip is 10 to 80 mg once daily. Statlip can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of Statlip should be individualized according to patient characteristics such as goal of therapy and response. After initiation and/or upon titration of Statlip, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10–17 years of age)

The recommended starting dose of Statlip is 10 mg/day; the maximum recommended 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. Adjustments should be made at intervals of 4 weeks or more.

Homozygous Familial Hypercholesterolemia

The dosage of Statlip in patients with homozygous FH is 10 to 80 mg daily. Statlip should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Concomitant Lipid-Lowering Therapy

Statlip may be used with bile acid resins. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution.

Dosage in Patients With Renal Impairment

Renal disease does not affect the plasma concentrations nor LDL-C reduction of Statlip; thus, dosage adjustment in patients with renal dysfunction is not necessary.

Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or Certain Protease Inhibitors

In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis C protease inhibitor (telaprevir), therapy with Statlip should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing Statlip 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 Statlip should be limited to 20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of Statlip is employed. In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, therapy with Statlip should be limited to 40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of Statlip is employed.

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What other drugs will affect Statlip?

Many drugs can interact with Statlip. Below is just a partial list. Tell your doctor if you are using:

• birth control pills;
• cimetidine (Tagamet);
• conivaptan (Vaprisol);
• imatinib (Gleevec);
• isoniazid (for treating tuberculosis);
• spironolactone (Aldactone, Aldactazide);
• an antibiotic such as dalfopristin/quinupristin (Synercid), rifampin (Rifater, Rifadin, Rifamate), telithromycin (Ketek), and others;
• an antidepressant such as nefazodone;
• heart or blood pressure medication such as digoxin (Lanoxin), diltiazem (Cartia, Cardizem), nicardipine (Cardene), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others;
• HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva, Atripla), indinavir (Crixivan), and others; or
• any other "statin" medication such as amlodipine and Statlip (Caduet), fluvastatin (Lescol), lovastatin (Altoprev, Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor, Simcor, Vytorin).

This list is not complete and there are many other drugs that can increase your risk of serious medical problems if you take them together with Statlip. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Statlip interactions

The risk of myopathy during treatment with statins is increased with concurrent administration of fibric acid derivatives, lipid-modifying doses of niacin, cyclosporine, or strong CYP 3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, and itraconazole).

Strong Inhibitors of CYP 3A4

Statlip is metabolized by cytochrome P450 3A4. Concomitant administration of Statlip with strong inhibitors of CYP 3A4 can lead to increases in plasma concentrations of Statlip. The extent of interaction and potentiation of effects depend on the variability of effect on CYP 3A4.

Clarithromycin

Statlip AUC was significantly increased with concomitant administration of Statlip 80 mg with clarithromycin (500 mg twice daily) compared to that of Statlip alone. Therefore, in patients taking clarithromycin, caution should be used when the Statlip dose exceeds 20 mg.

Combination of Protease Inhibitors

Statlip AUC was significantly increased with concomitant administration of Statlip 40 mg with ritonavir plus saquinavir (400 mg twice daily) or Statlip 20 mg with lopinavir plus ritonavir (400 mg + 100 mg twice daily) compared to that of Statlip alone. Therefore, in patients taking HIV protease inhibitors, caution should be used when the Statlip dose exceeds 20 mg.

Itraconazole

Statlip AUC was significantly increased with concomitant administration of Statlip 40 mg and itraconazole 200 mg. Therefore, in patients taking itraconazole, caution should be used when the Statlip dose exceeds 20 mg.

Grapefruit Juice

Contains one or more components that inhibit CYP 3A4 and can increase plasma concentrations of Statlip, especially with excessive grapefruit juice consumption ( > 1.2 liters per day).

Cyclosporine

Statlip and Statlip-metabolites are substrates of the OATP1B1 transporter. Inhibitors of the OATP1B1 (e.g., cyclosporine) can increase the bioavailability of Statlip. Statlip AUC was significantly increased with concomitant administration of Statlip 10 mg and cyclosporine 5.2 mg/kg/day compared to that of Statlip alone. In cases where co-administration of Statlip with cyclosporine is necessary, the dose of Statlip should not exceed 10 mg.

Rifampin or other Inducers of Cytochrome P450 3A4

Concomitant administration of Statlip with inducers of cytochrome P450 3A4 (e.g., efavirenz, rifampin) can lead to variable reductions in plasma concentrations of Statlip. Due to the dual interaction mechanism of rifampin, simultaneous co-administration of Statlip with rifampin is recommended, as delayed administration of Statlip after administration of rifampin has been associated with a significant reduction in Statlip plasma concentrations.

Digoxin

When multiple doses of Statlip and digoxin were coadministered, steady state plasma digoxin concentrations increased by approximately 20%. Patients taking digoxin should be monitored appropriately.

Oral Contraceptives

Co-administration of Statlip and an oral contraceptive increased AUC values for norethindrone and ethinyl estradiol. These increases should be considered when selecting an oral contraceptive for a woman taking Statlip.

Warfarin

Statlip had no clinically significant effect on prothrombin time when administered to patients receiving chronic warfarin treatment.

References

1. DailyMed. "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. FDA/SPL Indexing Data. "A0JWA85V8F: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
3. MeSH. "Hydroxymethylglutaryl-CoA Reductase Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Statlip are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Statlip. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology