Prezartan - instructions for use, dose, side effects, contraindications

Excipients: dried starch 12/24 mg, microcrystalline cellulose -124.50 / 249.00 mg, talc purified -2.00 / 4.00 mg, colloidal silica (aerosil-200) - 2.00 / 4.00 mg , sodium starch glycolate (primogel) - 5,00 / 10,00 mg, magnesium stearate - 3,00 / 6,00 mg, isopropyl alcohol, methylene chloride, Opadri Opadry OY-55030 - 3.85 / 7.70 mg, crimson red 4R Lake of Ponceau - 1.00 / 2.00 mg.

Description:

Prezartan 25 mg: Tablets of pink color, round biconcave, Film coated with a separation risk on one side.

Prezartan 50 mg: Tablets of pink color, round, biconcave, covered film shell without separation risks.

Pharmacotherapeutic group:Angiotensin II receptor antagonist

ATX: & nbsp

C.09.C.A.01 Losartan

C.09.C.A Angiotensin II antagonists

Pharmacodynamics:Losartan is a specific angiotensin II receptor antagonist (AT1). Do not inhibit kinase II - an enzyme that destroys bradykinin. Reduces the overall peripheral vascular resistance, reduces afterload, reduces systemic blood pressure. Reduces pressure in a small circle of blood circulation.

Pharmacokinetics:

Losartan is well absorbed in the gastrointestinal tract after taking the drug inside and is subjected to initial metabolism during primary passage through the liver. The bioavailability of losartan is about 33%. The drug is not cumulated in the body. The half-life of losartan is 2 hours. how losartan, and its metabolite binds to a high degree with plasma proteins of 92-99%. Losartan is excreted in the urine and bile.

Indications:

Arterial hypertension; chronic ischemic heart disease, accompanied by symptoms of heart failure (as part of a combination therapy with diuretics and cardiac glycosides).

Contraindications:

Hypersensitivity to the components of the drug; children's age till 18 years; pregnancy.

Pregnancy and lactation:

It is not known whether the blood is excreted losartan in breast milk.When prescribing Prezartan during lactation, a decision should be made either to stop breastfeeding, or to stop treatment with drugs.

Dosing and Administration:

With arterial hypertension, the initial daily dose is 25 mg, the average daily dose is 50 mg, the frequency of administration is 1 time / day.

The maximum hypotensive effect develops 3-6 weeks after the start of the drug. If necessary, the dose of the drug can be increased to 100 mg per day. In this case, the drug can be taken 2 times a day.

The initial dose for patients with heart failure is 12.5 mg 1 time / day. Typically, the dose is titrated at a weekly interval (ie 12.5 mg / day, 25 mg / day, 50 mg / day) to an average maintenance dose of 50 mg 1 time / day, depending on the patient's tolerance.

When appointing the drug to patients receiving high doses of diuretics, the initial dose should be reduced to 25 mg 1 time / day.

Patients with impaired liver function should be prescribed lower doses of losartan.

In elderly patients, as well as patients with impaired renal function, including patients on hemodialysis, there is no need to adjust the initial dose of the drug.

Prezartan can be administered together with other antihypertensive drugs. Losartan can be used regardless of the meal.

Side effects:

Prezartan is usually well tolerated. Can be observed: diarrhea, dyspepsia, muscle pain, swelling, dizziness, sleep disturbance, headache, hyperkalemia (potassium in the blood more than 5.5 meq / l). In rare cases, there may be coughing, breathing disorder, tachycardia, angioedema (including swelling of the face, lips, pharynx and / or tongue), urticaria, increased activity of "liver" transaminases, bilirubin in the blood.

Overdose:

Symptoms: arterial hypotension, tachycardia.

Treatment: symptomatic. Hemodialysis is ineffective.

Interaction:

Simultaneous administration with potassium-sparing diuretics, potassium preparations or substitutes for salt containing potassium, can lead to hyperkalemia.

With the simultaneous use of losartan with other antihypertensive drugs, there is a mutual increase in hypotensive effect. Simultaneous use with non-steroidal anti-inflammatory drugs (especially indomethacin) may cause a weakening of hypotensive action of losartan. The combination of losartan with diuretics can cause a drop in blood pressure.

Special instructions:

In patients with dehydration (eg, receiving treatment with high doses of diuretics), at the beginning of treatment with Prezartan, symptomatic hypotension may occur. It is necessary to correct the dehydration before prescribing Prasartan or start treatment with a low dose.

Pharmacological data indicate that the concentration of losartan in the blood plasma of patients with cirrhosis of the liver is significantly increased, so patients with a history of liver disease should be prescribed low doses of the drug.

Some drugs that affect the kinin-angiotensin system may increase urea levels in the blood and serum creatinine in patients with impaired renal function.

Form release / dosage:

Tablets, film-coated 25 mg, 50 mg.

Packaging:

For 10 or 14 tablets in a planar cell packaging (blister) made of aluminum or PVC / aluminum foil; 2 blisters for 14 tablets or 3 blisters for 10 tablets - in a pack of cardboard, complete with instructions for use.

Storage conditions:

Store in a dry, dark place at a temperature below 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014708 / 01

Date of registration:25.05.2009 / 22.07.2014

Expiration Date:Unlimited

The owner of the registration certificate:Ipka Laboratories Ltd.Ipka Laboratories Ltd. India

Manufacturer: & nbsp

IPCA LABORATORIES, Ltd. India

Representation: & nbspIPKA LABORATORIES LTD. IPKA LABORATORIES LTD. India

Information update date: & nbsp31.08.2016

Illustrated instructions

Instructions

Prezartan® (Presartan®)