Losartan-Hydrochlorothiazide (losartan potassium/hydrochlorothiazide)

Dosage of hydrochlorothiazide should be individualized according to the patient's requirements and response. The lowest dosage necessary to produce the desired clinical effect should be used. If hydrochlorothiazide is added to the regimen of a patient stabilized on a potent hypotensive agent, dosage of the hypotensive agent should initially be reduced to avoid the possibility of severe hypotension.

Available as losartan potassium; dosage is expressed in terms of the salt.

Hydrochlorothiazide is administered orally.

Losartan potassium is administered orally without regard to meals. It is available as oral tablets. It is also commercially available in fixed-combination tablets containing losartan potassium and hydrochlorothiazide; see the full prescribing information for administration of this combination product.

Losartan potassium tablets should be stored at 25degreesC (excursions permitted between 15-30degreesC) and protected from light.

For pediatric patients or patients unable to swallow tablets, losartan may be administered orally as an extemporaneously prepared suspension. An extemporaneous suspension containing losartan potassium 2.5 mg/mL can be prepared in the following manner. First, add 10 mL of purified water to a 240 mL amber polyethylene terephthalate (PET) bottle containing ten 50-mg tablets of losartan potassium. Shake the contents for at least 2 minutes. Allow the concentrated suspension to stand for 1 hour and then shake for 1 minute to disperse the contents. Separately, prepare a mixture containing equal parts (by volume) of syrup (Ora-Sweet SF(R)) and suspending vehicle (Ora-Plus(R)). To the concentrated suspension of losartan, add 190 mL of the Ora-Sweet SF(R) and Ora-Plus(R)mixture, and shake for 1 minute to disperse the ingredients. Refrigerate the suspension at 2-8degreesC. Shake the suspension before dispensing each dose and return promptly to refrigeration. The extemporaneous suspension is stable for up to 4 weeks when stored at 2-8degreesC.

No dosing information is available for this tab.

No dosing information is available for this tab.

In vitro studies indicate that cytochrome P-450 (CYP) 2C9 and 3A4 are involved in the biotransformation of losartan to active and inactive metabolites.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to losartan or any ingredient in the formulation.

*Concomitant therapy with aliskiren in patients with diabetes mellitus.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects occurring in at least 2% of patients with hypertension receiving losartan, and at a higher incidence than with placebo, include dizziness, upper respiratory infection, nasal congestion, and back pain.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Antihypertensive effects of losartan have been established in hypertensive pediatric patients 6-16 years of age.

Safety and efficacy of losartan in pediatric patients <6 years of age and pediatric patients with glomerular filtration rate <30 mL/minute per 1.73 m2 have not been established.

Losartan can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the RAS during the second or third trimester of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Oligohydramnios in pregnant women who use drugs affecting the RAS in the second or third trimester of pregnancy can result in reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations (including skull hypoplasia), hypotension, and death.

Discontinue losartan immediately when pregnancy is detected. In the rare case that there is no appropriate alternative therapy, apprise the mother of the potential risk to the fetus. If losartan is taken during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment; if oligohydramnios is observed, discontinue losartan, unless it is considered life-saving for the mother. Oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe neonates who have been exposed to losartan in utero for signs of hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required.

Losartan is distributed into milk in rats; it is not known whether the drug is distributed into human breast milk. A decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the potential risk in breastfeeding infants and the importance of the drug to the mother.

The manufacturer makes no specific dosage recommendations for geriatric patients.

In controlled clinical trials evaluating losartan for hypertension, 19% of patients were >=65 years of age and 2% were >=75 years of age. In controlled clinical trials evaluating losartan for renal protection in type 2 diabetes, 33% of patients were >=65 years of age. In controlled clinical trials evaluating losartan for the reduction of cardiovascular death, stroke, and myocardial infarction in hypertensive patients with left ventricular hypertrophy, 62% of patients were >=65 years of age and 18% were >=75 years of age. No overall differences in pharmacokinetics, safety, or efficacy of losartan have been observed between geriatric patients and younger adults, but increased sensitivity in some older individuals cannot be ruled out.