The usual starting dose of Lozaris is 50 mg once daily. The dosage can be increased to a maximum dose of 100 mg once daily as needed to control blood pressure. A starting dose of 25 mg is recommended for patients with possible intravascular depletion (e.g., on diuretic therapy).

Pediatric Hypertension

The usual recommended starting dose is 0.7 mg per kg once daily (up to 50 mg total) administered as a tablet or a suspension. Dosage should be adjusted according to blood pressure response. Doses above 1.4 mg per kg (or in excess of 100 mg) daily have not been studied in pediatric patients.

Lozaris is not recommended in pediatric patients less than 6 years of age or in pediatric patients with estimated glomerular filtration rate less than 30 mL/min/1.73 m2.

Hypertensive Patients with Left Ventricular Hypertrophy

The usual starting dose is 50 mg of Lozaris once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of Lozaris should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response.

Nephropathy in Type 2 Diabetic Patients

The usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response.

Dosage Modifications in Patients with Hepatic Impairment

In patients with mild-to-moderate hepatic impairment the recommended starting dose of Lozaris is 25 mg once daily. Lozaris has not been studied in patients with severe hepatic impairment.

Preparation of Suspension (for 200 mL of a 2.5 mg/mL suspension)

Add 10 mL of Purified Water USP to an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle containing ten 50 mg Lozaris tablets. Immediately shake for at least 2 minutes. Let the concentrate stand for 1 hour and then shake for 1 minute to disperse the tablet contents. Separately prepare a 50/50 volumetric mixture of Ora-Plus™ and Ora-Sweet SF™. Add 190 mL of the 50/50 Ora-Plus™/Ora-Sweet SF™ mixture to the tablet and water slurry in the PET bottle and shake for 1 minute to disperse the ingredients. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 4 weeks. Shake the suspension prior to each use and return promptly to the refrigerator.

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What other drugs will affect Lozaris?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Lozaris, especially:

a diuretic or "water pill";
other blood pressure medications;
lithium;
celecoxib; or
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with Lozaris, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Lozaris interactions

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No significant drug-drug pharmacokinetic interactions have been found in interaction studies with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital. Rifampin, an inducer of drug metabolism, decreased the concentrations of Lozaris and its active metabolite. In humans, 2 inhibitors of CYP450 3A4 have been studied. Ketoconazole did not affect the conversion of Lozaris to the active metabolite after IV administration of Lozaris, and erythromycin had no clinically significant effect after oral administration. Fluconazole, an inhibitor of CYP450 2C9, decreased active metabolite concentration and increased Lozaris concentration. The pharmacodynamic consequences of concomitant use of Lozaris and inhibitors of CYP450 2C9 have not been examined. Subjects who do not metaolize Lozaris to active metabolite have been shown to have a specific, rare defect in CYP450 2C9. These data suggest that the conversion of Lozaris to its active metabolite is mediated primarily by CYP450 2C9 and not CYP450 3A4.

No difference in exposure was found with concomitant treatment with fluvastatin (weak inhibitor of CYP2C9).

As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), drugs which may increase potassium levels (heparin), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. Co-medication is not advisable.

Lithium: As with other drugs which affect the excretion of sodium, lithium excretion may be reduced. Therefore, serum lithium levels should be monitored carefully if lithium salts are to be co-administered with angiotensin II receptor antagonists.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 (COX-2) Inhibitors: In some patients with compromised renal function who are being treated with NSAIDs including those that selectively inhibit COX-2 inhibitors, the co-administration of angiotensin II receptor antagonists including Lozaris may result to a further deterioration of renal function. These effects are usually reversible.

Reports suggest that NSAIDs including COX-2 inhibitors may diminish the antihypertensive effect of angiotensin II receptor antagonists, including Lozaris. This interaction should be given consideration in patients taking NSAIDs including selective COX-2 inhibitors concomitantly with angiotensin II receptor antagonists.

The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy and periodically thereafter.

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References

DailyMed. "LOSARTAN POTASSIUM: 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).
FDA/SPL Indexing Data. "JMS50MPO89: 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).
MeSH. "Antihypertensive Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Lozaris Dosage

Dosage of Lozaris in details