Cardomin-sanovel (Tablets) Instructions for Use

Marketing Authorization Holder

Sanovel Pharmaceutical Products Ind., Inc. (Turkey)

ATC Code

C09CA01 (Losartan)

Active Substance

Losartan (Rec.INN registered by WHO)

Dosage Form

Cardomin-sanovel

Film-coated tablets, 50 mg: 28 or 56 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets green, oblong, biconvex; the tablet core is white or almost white on the break.

Excipients: lactose – 58 mg, microcrystalline cellulose – 19.25 mg, pregelatinized starch – 20.5 mg, magnesium stearate – 2.25 mg.

Shell composition opadry green [hypromellose 35%, hypromellose 34%, titanium dioxide 26.64%, indigo carmine 2.56%, quinoline yellow 1.79%, sunset yellow FCF 0.01%] – 4.55 mg.

14 pcs. – blisters (2) – cardboard packs.
14 pcs. – blisters (4) – cardboard packs.

Clinical-Pharmacological Group

Angiotensin II receptor antagonist

Pharmacotherapeutic Group

Angiotensin II receptor antagonist

Pharmacological Action

Antihypertensive agent. It is a non-peptide blocker of angiotensin II receptors. It has high selectivity and affinity for AT₁ receptors (through which the main effects of angiotensin II are mediated). 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 to form a carboxylic acid metabolite, which has more pronounced pharmacological activity than Losartan, and a number of inactive metabolites. C_max in 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 as 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.

Renal 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

Dosage Regimen

For arterial hypertension, the initial dose is 50 mg taken orally once daily.

Adjust the therapeutic dose based on individual blood pressure response. The maintenance dose range is 25 mg to 100 mg daily.

For a dose of 100 mg daily, administer as a single dose or divide into two 50 mg doses.

For chronic heart failure, initiate therapy at a starting dose of 12.5 mg once daily.

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

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

Increase the dose to 100 mg once daily based on individual tolerability to achieve further blood pressure reduction.

In patients with hepatic impairment or a history of liver disease, use a lower initial dose of 25 mg daily.

In patients with intravascular volume depletion, correct the imbalance prior to administration or initiate therapy with a 25 mg dose.

For elderly patients, no initial dose adjustment is typically required, but monitor blood potassium levels regularly.

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 imbalance, 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 imbalances should be carried out before starting treatment, or a lower initial dose should be used.

In patients with dehydration (for example, 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 30°C (86°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.