RiteMED Losartan

Concise Prescribing Info Manufacturer Info

Concise Prescribing Info
Manufacturer
RiteMED
Distributor
United Lab
Contents
Losartan K
Indications / Uses
Monotherapy or in combination w/ other antihypertensive agents for the treatment of HTN.
Dosage / Direction for Use
HTN Adult Initial & maintenance dose: 50 mg once daily, may be increased to 100 mg once
daily. Patients w/ intravascular vol-depletion eg, those treated w/ high-dose diuretics, history
of liver disease & moderate to severe renal disease 25 mg once daily. Total daily dose: 25-100
mg once or bid. Childn 6 yr Recommended starting dose: 0.7 mg/kg once daily up to a total of
50 mg, 50 kg 50 mg up to a max of 100 mg daily, 20-<50 kg 25 mg up to a max of 50 mg
daily. Hypertensive patients w/ left ventricular hypertrophy Initially 50 mg once daily, add
hydrochlorothiazide (HCTZ) 12.5 mg daily &/or increased losartan to 100 mg once daily
followed by an increase in HCTZ 25 mg once daily based on BP response.
Administration
May be taken with or without food.
Contraindications
Pregnancy.
Special Precautions
Correct intravascular vol-depletion eg, those treated w/ high-dose diuretics prior to therapy.
Monitor serum K levels in diabetic patients w/ nephropathy. Electrolyte/fluid imbalance.
Reversible changes in renal function, severe CHF, uni- or bilateral renal artery stenosis; history
of liver impairment. Concurrent use w/ K-sparing diuretics, K supplements or salt substitutes
containing K & drugs affecting renin-angiotensin-aldosterone system. Ischemic cardiopathy or
cerebrovascular disease. Lactation. Neonates, childn w/ GFR <30 mL/min/1.73 m2 & liver
impairment. Infants w/ history of in utero exposure to losartan.
Side Effects / Adverse Reactions
CV, endocrine, GI, hematologic, liver/biliary; metabolic, musculoskeletal, nervous
system/psychiatric, resp, skin, special senses & urogenital adverse effects. Asthenia, chest pain,
edema, facial edema, fatigue, fever, infection, flu-like disease, orthostatic effects, syncope,
trauma.
Interactions
Lithium; K-sparing diuretics (eg, spirinolactone, triamterene, amiloride), K supplements or K-
containing salt substitutes; NSAIDs including selective COX-2 inhibitors; rifampicin;
fluconazole.
Preg Safety (US)
Category D: There is positive evidence of human foetal risk, but the benefits from use in
pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-
threatening situation or for a serious disease for which safer drugs cannot be used or are
ineffective).
MIMS Class
Angiotensin II Antagonists
ATC Classification
C09CA01 - losartan ; Belongs to the class of angiotensin II antagonists. Used in the treatment of
cardiovascular disease.
Regulatory Classification
Rx

Concise Info

Losartan
> Indications
> Dosage Available Brands
> Dosage Details Actimed Lo...
> Hepatic Impairment Aesartan
> Administration Anzar
> Contraindications Arbloc
> Special Precaution Artal
> Adverse Drug Reactions Besartan
> Pregnancy Category (US FDA) Cardizar
> Monitoring Parameters Cozaar
> Overdosage Doxar
> Drug Interactions Dylaran/Dy...
> Mechanism of Action
> Storage
See more brands
> MIMS Class

Other Known Brands

A.R.A.
Actizar
Amozar
Angioten
Angisartan
Blozar
Boie Losar...
Cotenace
Eseflah
Ezartan 50
See more brands
 Listed in Dosage.
Indications
Adult : PO HTN 50 mg once daily, may increase to 100 mg/day as single dose or
Dosage in 2 divided doses if needed. Patients w/ intravascular volume depletion: Initial:
25 mg once daily. Heart failure Initial: 12.5 mg once daily, may be doubled at
wkly intervals. Maintenance: 50 mg once daily. Max: 150 mg once daily.
Diabetic nephropathy in Type 2 DM Initial: 50 mg once daily, may increase to
100 mg once daily depending on BP response.
Oral
Dosage Details Hypertension
Adult: 50 mg once daily, may increase to 100 mg/day as single dose or in 2
divided doses if needed. Patients w/ intravascular volume depletion: Initially,
25 mg once daily.
Child: 6 yr 20-50 kg: Initially, 0.7 mg/kg. Max: 50 mg/day; >50 kg: Initially, 1.4
mg/kg. Max: 100 mg/day.
Elderly: >75 yr Initially, 25 mg/day.

Oral
Diabetic nephropathy in Type 2 diabetes mellitus
Adult: Initially, 50 mg once daily, may increase to 100 mg once daily depending
on BP response.
Elderly: >75 yr Initially, 25 mg/day.

Oral
Heart failure
Adult: Initially, 12.5 mg once daily, may be doubled at wkly intervals.
Maintenance: 50 mg once daily. Max: 150 mg once daily if tolerated.

Hepatic Hypertension; Diabetic nephropathy in Type 2 diabetes mellitus: Mild or

moderate: Initially, 25 mg once daily. Severe: Contraindicated.
Impairment
May be taken with or without food.
Administration
Concomitant use w/ aliskiren in patients w/ diabetes and renal impairment
Contraindications (GFR <60 mL/min). Severe hepatic impairment. Pregnancy.
Volume-depleted patients including patients on high-dose diuretics. Patients
Special w/ bilateral renal artery stenosis, aortic or mitral stenosis. Renal and mild to
Precautions moderate hepatic impairment. Lactation.
Upper resp infection, nasal congestion, sinusitis, headache, dizziness, back
Adverse Drug pain, leg pain, muscle cramps, asthenia or fatigue, neutropenia, chest pain,
Reactions cough, bronchitis, UTI, diarrhoea, gastritis, anaemia, hypoglycaemia, diabetic
vascular disease, cataracts, cellulitis, hyperkalaemia, myalgia, arthralgia,
hypotension, muscular weakness, hypoaesthesia, infection, knee pain. Rarely,
pruritus, rash, urticaria, angioedema, elevated liver enzyme values,
rhabdomyolysis.
 ROUTE(S) : PO
Pregnancy
Category (US
FDA) Category D: There is positive evidence of human foetal risk, but the benefits
from use in pregnant women may be acceptable despite the risk (e.g., if the
drug is needed in a life-threatening situation or for a serious disease for which
safer drugs cannot be used or are ineffective).

Monitoring Monitor BP, electrolytes and renal function.

Parameters
Symptoms: Hypotension, tachycardia, bradycardia (could occur from
Overdosage parasympathetic stimulation). Management: Supportive and symptomatic
treatment. May include immediate admin of activated charcoal after oral
intake.
May decrease plasma levels w/ fluconazole and rifampicin. May increase serum
Drug Interactions lithium levels and toxicity. May antagonise hypotensive effect and increase risk
of renal impairment w/ NSAIDs. Increased risk of hyperkalaemia w/ K-sparing
diuretics (e.g. amiloride, triamterene, spironolactone), K supplements or K-
containing salt substitutes.
Potentially Fatal: May increase nephrotoxic, hyperkalaemic and hypotensive
effect w/ aliskiren in patients w/ diabetes and renal impairment (GFR <60
mL/min).
Description: Losartan is an angiotensin II receptor antagonist. It selectively and
Mechanism of competitively blocks the vasoconstricting and aldosterone-secreting effects of
Action angiotensin II by selectively antagonising its binding to AT1 receptors.
Onset: 6 hr.
Pharmacokinetics:
Absorption: Readily absorbed from the GI tract. Bioavailability: 25-33%. Time
to peak plasma concentration: Approx 1 hr (losartan); approx 3-4 hr (active
metabolite).
Distribution: Volume of distribution: 34 L (losartan); 12 L (active metabolite).
Plasma protein binding: >98%.
Metabolism: Metabolised primarily by CYP3A4 and CYP2C9 isoenzymes to
active carboxylic acid metabolite (E-3174).
Excretion: Via urine (approx 4% as unchanged drug; approx 6% as active
metabolite); faeces (as unchanged drug and metabolites). Terminal elimination
half-life: Approx 1.5-2.5 hr (losartan); approx 3-9 hr (E-3174).

Store between 15-30C. Protect from light.

Storage
Angiotensin II Antagonists
MIMS Class