Lozartan Reneval (Tablets) Instructions for Use

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

ATC Code

C09CA01 (Losartan)

Active Substance

Losartan (Rec.INN WHO registered)

Dosage Forms

	Losartan Reneval	Film-coated tablets 12.5 mg: 28, 30, 42, 56, 60 or 90 pcs.
		Film-coated tablets 25 mg: 28, 30, 42, 56, 60 or 90 pcs.
		Film-coated tablets 50 mg: 28, 30, 42, 56, 60 or 90 pcs.
		Film-coated tablets 100 mg: 28, 30, 42, 56, 60 or 90 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from white or almost white in color; round, biconvex; surface roughness is allowed; the core on the cross-section is white or almost white.

	1 tab.
Losartan	12.5 mg

Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K30, magnesium stearate.

Shell composition polyvinyl alcohol (E1203), macrogol 4000 (polyethylene glycol), titanium dioxide (E171) or dry mix for film coating, consisting of: polyvinyl alcohol (E1203), macrogol 4000 (polyethylene glycol), titanium dioxide (E171).

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (9) – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (3) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
15 pcs. – contour cell packaging (2) – cardboard packs.
15 pcs. – contour cell packaging (4) – cardboard packs.
15 pcs. – contour cell packaging (6) – cardboard packs.

Film-coated tablets from white or almost white in color, with a score; round, biconvex; surface roughness is allowed; the core on the cross-section is white or almost white.

	1 tab.
Losartan	25 mg

Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K30, magnesium stearate.

Film-coated tablets from white or almost white in color; round, biconvex; surface roughness is allowed; the core on the cross-section is white or almost white.

	1 tab.
Losartan	50 mg

Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K30, magnesium stearate.

Film-coated tablets from white or almost white in color; round, biconvex; surface roughness is allowed; the core on the cross-section is white or almost white.

	1 tab.
Losartan	100 mg

Excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K30, magnesium stearate.

Clinical-Pharmacological Group

Angiotensin II receptor antagonist

Pharmacotherapeutic Group

Agents acting on the renin-angiotensin system, angiotensin II receptor antagonists (ARBs)

Pharmacological Action

Antihypertensive agent. It is a non-peptide blocker of angiotensin II receptors. It has high selectivity and affinity for AT₁ type receptors (through which the main effects of angiotensin II are realized). By blocking these receptors, Losartan prevents and eliminates the vasoconstrictive action of angiotensin II, its stimulating effect on the secretion of aldosterone by the adrenal glands, and some other effects of angiotensin II. It is characterized by a long duration of action (24 hours or more), which is due to the formation of its active metabolite.

Pharmacokinetics

After oral administration, Losartan is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 33%. It is metabolized during the first pass through the liver with the formation of a carboxyl metabolite, which has more pronounced pharmacological activity than Losartan, and a number of inactive metabolites. C_max in blood plasma for losartan and the active metabolite is reached after 1 hour and 3-4 hours, respectively. Plasma protein binding of losartan and the active metabolite is high – more than 98%.

T_1/2 of losartan and the active metabolite in the terminal phase is about 1.5-2.5 hours and 3-9 hours, respectively. Losartan is excreted in the urine and feces (via bile) unchanged and in the form of metabolites. About 35% is excreted in the urine and about 60% in the feces.

Indications

Arterial hypertension.

Reduction of the risk of associated cardiovascular morbidity and mortality in patients with arterial hypertension and left ventricular hypertrophy, manifested by a reduction in the combined frequency of cardiovascular mortality, stroke, and myocardial infarction.

Kidney protection in patients with type 2 diabetes mellitus with proteinuria – slowing the progression of renal failure, manifested by a reduction in the frequency of hypercreatininemia, the frequency of end-stage chronic renal failure requiring hemodialysis or kidney transplantation, mortality rates, as well as a reduction in proteinuria.

Chronic heart failure (as part of combination therapy, in case of intolerance or ineffectiveness of ACE inhibitor therapy).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
I10	Essential [primary] hypertension
I50.0	Congestive heart failure
N08.3	Glomerular disorders in diabetes mellitus

ICD-11 code	Indication
BA00.Z	Essential hypertension, unspecified
BD10	Congestive heart failure
MF83	Diabetic glomerular changes

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For arterial hypertension, initiate therapy with 50 mg orally once daily.

The maintenance dose is 25 mg to 100 mg daily, administered in one or two divided doses.

For a daily dose of 100 mg, administer as 50 mg twice daily to improve efficacy.

In patients with intravascular volume depletion or hepatic impairment, use a lower initial dose of 25 mg once daily.

For chronic heart failure, start with 12.5 mg once daily.

Titrate the dose upward to 50 mg once daily, as tolerated by the patient.

For renal protection in type 2 diabetes with proteinuria, the usual dose is 50 mg once daily.

If further blood pressure reduction is required, increase the dose to 100 mg once daily.

In patients with impaired renal function, including those on hemodialysis, a dose adjustment may be necessary.

For patients with a history of hepatic cirrhosis, initiate therapy with 25 mg once daily due to significantly increased plasma concentrations.

Administer tablets with or without food. Adhere to a consistent daily intake schedule.

Regularly monitor blood pressure, renal function, and serum potassium levels during therapy.

Adverse Reactions

From the cardiovascular system dizziness, orthostatic hypotension.

From the metabolism hyperkalemia.

Allergic reactions angioedema (including swelling of the face, lips, pharynx and/or tongue), urticaria.

From the digestive system diarrhea, increased ALT activity.

From the CNS headache.

Dermatological reactions itching.

Other impaired renal function, myalgia.

Contraindications

Pregnancy, lactation, children and adolescents under 18 years of age, hypersensitivity to losartan.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation.

Use in Hepatic Impairment

In patients with a history of liver disease, Losartan should be used in low doses. In liver cirrhosis, the plasma concentration of losartan increases significantly.

Use in Renal Impairment

In case of impaired renal function, a dose reduction of losartan may be required.

Pediatric Use

The safety and efficacy of losartan in children have not been established.

Geriatric Use

In elderly patients, blood potassium levels should be regularly monitored during treatment.

Special Precautions

Use with caution in arterial hypotension, reduced circulating blood volume, water and electrolyte balance disorders, bilateral renal artery stenosis or stenosis of the artery of a single kidney, in renal/hepatic insufficiency.

In patients with fluid and/or sodium deficiency, correction of water and electrolyte disturbances should be carried out before starting treatment or a lower initial dose should be used.

In patients with dehydration (e.g., those receiving high-dose diuretic therapy), symptomatic arterial hypotension may occur at the beginning of treatment with losartan.

In case of impaired renal function, a dose reduction of losartan may be required.

In patients with a history of liver disease, Losartan should be used in low doses. In liver cirrhosis, the plasma concentration of losartan increases significantly.

Blood potassium levels should be regularly monitored during treatment, especially in elderly patients and in patients with impaired renal function.

Concomitant use of losartan with potassium-sparing diuretics should be avoided.

The safety and efficacy of losartan in children have not been established.

Drug Interactions

With simultaneous use with diuretics in high doses, arterial hypotension is possible.

With simultaneous use with potassium preparations, potassium-sparing diuretics, the risk of hyperkalemia increases.

With simultaneous use with indomethacin, a decrease in the effectiveness of losartan is possible.

There is a report of lithium intoxication with simultaneous use with lithium carbonate.

With simultaneous use with orlistat, the antihypertensive effect of losartan decreases, which can lead to a significant increase in blood pressure and the development of a hypertensive crisis.

With simultaneous use with rifampicin, the clearance of losartan increases and its effectiveness decreases.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Medixlife (Author)

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