Description overdue on 03/07/2014
- Latin name: Prestance
- ATC code: C09BB04
- Active substance: Perindopril (Perindopril), Amlodipine (Amlodipine)
- Manufacturer: Les Laboratoires Servier (France)
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications
- Contraindications
- Side effects
- Prestancia, instructions for use
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Cautions
- Analogs
- Babies
- During pregnancy (and lactation)
- Reviews
- Price, where to buy
Composition
Prestancia is available in 4 different variants of the ratio of active ingredients: perindopril arginine - 5 mg / 10 mg (equivalent to 3,395 mg / 6.79 mg perindopril ) amlodipine besylate - 6,935 mg / 13.87 mg (equivalent to 5 mg / 10 mg amlodipine ).
Excipients: lactose monohydrate, microcrystalline cellulose magnesium stearate colloidal silica .
Product form
The drug is a biconvex white tablets engraved on one edge and logo - on the other. 30 of such tablets in a polypropylene vial, a bottle in a paper stack with the control opening.
Pharmacological action
The drug has hypotensive action, but also inhibits angiotensin-converting enzyme and Calcium channels .
Pharmacodynamics and pharmacokinetics
Pharmacodynamics
Perindopril inhibits an enzyme that transforms angiotensin I at Angiotensin II . Kininaza II Or angiotensin-converting enzyme Performs as a transformation Angiotensin I in vazaokonstrikter Angiotensin II And inactivation bradykinin , Which exerts vasodilatory effect.
Perindopril It has a therapeutic effect due to its metabolite - perindoprilat . Other derivatives have no effect. Perindopril - a drug for the treatment of hypertension of any form and severity. It reduces the systolic and diastolic blood pressure in the vertical and horizontal position.
The medicine lowers the peripheral resistance vessels, that the leads to a decrease the enlarged of arterial pressure and on the Strengthening of peripheral of blood supply without increase of frequency of cardiac contractions.
Effect of the drug reaches a maximum 5-6 hours after administration and persists for days. Pressure reduction is achieved quickly. Therapeutic effect occurs within 1 month after initiation of therapy. After termination of the treatment does not develop the syndrome.
Perindopril also increases the elasticity of the large vessels, the restoration of the wall structure of smaller arteries and reduce LVH .
Amlodipine - Blocker calcium channel . It inhibits the transmembrane movement of calcium ions in the tissue infarction and vascular smooth muscle cells.
It is known that Amlodipine :
- expands the arterioles Reducing peripheral resistance, heart rate, however, remains the same, but a necessity infarction oxygen is reduced;
- expands cordial artery and arterioles . At persons with the Prinzmetal angina in this case, the coronary blood flow is enhanced.
Amlodipine It does not affect lipidnoy profile and hypolipidemic indicators of blood. The drug can be used in patients with diabetes . asthma and gout .
Pharmacokinetics
When taken orally perindopril quickly is adsorbed, maximum concentration in blood appears through 1 hour. The half-life from the blood is also 1 hour.
Perindopril pharmacologically inactive. 27% of the material falls into the bloodstream in the form of perindoprilat (active metabolite). Besides perindoprilat 5 already known metabolites are pharmacologically inactive. The maximum concentration perindoprilat It appears in the blood at 3 hours after administration. Receiving food slows conversion to perindoprilat Influencing the bioavailability. Consequently, the drug should be used one time per day, before breakfast.
Binding perindoprilat with proteins of the blood is about 20% and is dose dependent.
Perindoprilat It stands out from the of the organism through the kidneys. Terminal half-life is 17 hours, however, the equilibrium concentration is reached within four days.
Upon receiving Amlodipine absorbed from the digestive tract slowly perindaprila . Food intake does not alter the bioavailability of the substance. The maximum concentration of amlodipine in the blood there comes through a 7-11 hours. Bioavailability is in the range 64-80%.
Approximately 97% of circulating blood amlodipine blood is bound.
The final half-life amlodipine blood - 37-50 hours. This allows reception of the drug once a day. It is metabolized in the liver, with 10% of the dose is excreted in the original form and 60% is excreted in the urine as metabolites. Not output means dialysis .
Indications
- Stable angina stress in people who need treatment amlodipine and perindopril .
- Arterial hypertension .
Contraindications
Contraindications to reception of perindopril :
- angioedema ;
- allergy perindopril or other drugs from the group of ACE inhibitors;
- age less than 18 years.
Contraindications to receive of amlodipine :
- allergy to amlodipine ;
- shock , including cardiogenic ;
- expressed hypotension ;
- obstruction of outflow the path of the left ventricle;
- heart failure hemodynamically unstable after myocardial infarction ;
- age less than 18 years.
Contraindications to receive Prestancia:
- allergy to any component of the formulation;
- renal failure ;
- age less than 18 years;
- intolerance lactose , Failure Lactase and galactose malabsorption glucose .
Use with caution in: one kidney, renal artery stenosis . hepatic or renal failure Therapy allopurinol , Immunodepressantami, procainamide, systemic diseases connective tissue, cerebrovascular violations atherosclerosis . diabetes . renovascular hypertension . heart failure , Simultaneous estramustine , Potassium-sparing diuretics, dantrolene , Drugs, potassium, lithium preparations, hyperkalemia , Surgery, advanced age, desensitizing therapy, aortic or mitral stenosis .
Side effects
- On the side blood : leukopenia, agranulocytosis, pancytopenia, neutropenia, thrombocytopenia , Reduction hematocrit and Hemoglobin .
- On the side metabolism : hyperglycemia, hypoglycemia .
- On the side immunity : Allergic reaction .
- On the side Otolaryngology : Blurred vision, tinnitus.
- On the side Nervous System : Headache, dizziness, mood lability, drowsiness, insomnia, tremor . depression . peripheral neuropathy .
- On the side Cardiovascular : Strong pressure reduction, heart attack . angina . stroke . vasculitis .
- On the side Respiratory system : Cough, eosinophilic pneumonia . bronchospasm .
- On the side digestive system : Abdominal pain, nausea, diarrhea . dyspepsia . constipation , Dry mucous membranes of the mouth.
On the side hepatobiliary system : jaundice, hepatitis, increased concentration of liver enzymes. - On the side skin : Itching, rash, angioedema , Purpura, alopecia, skin discoloration, sweating, hives . Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis .
- On the side musculoskeletal system : Swelling of lower legs, muscle spasms, myalgia, arthralgia .
- On the side of the genitourinary system : nocturia, impaired renal function, impaired urination, impotence . gynecomastia .
- Disorders of a general nature: asthenia , Swelling, fatigue, chest pain, changes in body weight.
Also registered sporadic cases of extrapyramidal syndrome .
Prestancia, instructions for use
Instructions for use Prestancia recommends taking pills inside, one time a day before breakfast. The dose of medication is chosen individually on the basis of four possible ratios of doses perindopril and amlodipine in the preparation: Prestancia 5 mg + 5 mg + 5 mg Prestancia 10mg Prestancia 10 mg + 5 mg + 10 mg Prestancia 10 mg.
In elderly patients and patients with renal impairment should be continuous monitoring creatinine and potassium in blood so how this group of persons deducing perindoprilat delayed.
In individuals with hepatic insufficiency need to with caution to carry out, dose selection. It is best to start with the drug use small doses.
Overdose
Data on overdose Prestancia absent.
Overdose amlodipine It causes: severe reduction in blood pressure with possible development tachycardia and peripheral vasodilatation .
Treatment: gastric lavage is necessary to make, to carry out reception Activated Carbon Maintaining indicators of heart and respiratory system, control blood volume and diuresis, symptomatic therapy , Intravenous calcium gluconate and dopamine .
Symptoms of overdose perindopril : Marked reduction of of arterial pressure, electrolyte disturbances, shock, kidney failure, tachycardia . dizziness . anxiety .
Treatment: gastric lavage, and receive Activated Carbon Correction hypovolemia , Intravenous catecholamines . hemodialysis .
Cooperation
Interaction with Perindopril
When co-administered with preparations Potassium and lithium . potassium-sparing diuretics some individuals may develop hyperkalemia and increase in lithium in blood.
Simultaneous reception ACE inhibitors from NSAIDs weakens antihypertensive action And can also lead to renal dysfunction, increased concentrations Potassium in blood.
Hypoglycemics interacting with ACE inhibitors increase the hypoglycemic effect insulin and metabolites sulfonylureas at persons with diabetes .
Patients using diuretics at the beginning of therapy ACE inhibitors probably a strong drop in blood pressure.
Sympathomimetics weaken hypotensive effect ACE inhibitors .
Joint use ACE inhibitors and preparations for general anesthesia leads to activation of the antihypertensive effect.
Interaction with Amlodhi ping .
Simultaneous use of inductors of CYP3A4 ( rifampicin . St. John's wort preparations ) Reduces the concentration amlodipine in blood.
Amlodipine activates hypotensive effect other tablets pressure.
Studies Prestancia pills had no effect on the pharmacokinetics digoxin, atorvastatin, warfarin and cyclosporine .
Addicting of grapefruit juice or grapefruits increases the bioavailability of amlodipine in some patients, which may lead to a strong reduction in blood pressure.
Tricyclic antidepressants, antipsychotics . Amifostine, baclofen, antihypertensives vasodilators enhance the antihypertensive effect perindopril and amlodipine .
Terms of sale
It sold strictly on prescription.
Storage conditions
The drug not requires special storage conditions. The vial is necessary to store closed in a original packaging. Keep away from children.
Shelf life
Two years.
Cautions
Withdrawal perindopril It slowed down in the elderly and in patients with kidney and Heart Failure , So they should be checked regularly concentration Potassium and creatinine in blood plasma.
Because of the possible severe reduction in blood pressure of drowsiness, dizziness and other side effects, you should be careful when driving, especially at the start of therapy and at higher dose consumed.
Analogs Prestancia
Analogs Prestancia 5/5 mg ( 5/10 mg , 10/5 mg, 10/10 mg): BBC Prestarium 5/5 mg (5/10 mg, 10/5 mg, 10/10 mg) Amlessa 4/5 mg (4/10 mg 8/5 mg, 8/10 mg).
Babies
Banned for use to persons under 18 years of age.
During pregnancy and lactation
It is forbidden to take Prestancia during pregnancy and breastfeeding due to lack of clinical experience with amlodipine and perindopril .
Reviews Prestancia
Reviews Prestancia 5.5 mg, 5.10 mg, 5.10 mg and reviews of Prestancia 10/10 mg are not fundamentally different, and are characterized by frequent reports of the occurrence of edema shins. Reviews of physicians in general well-evaluate the drug, but indicate the need for an individual approach to the treatment of drug and dose selection. Forums also report concerning the frequent occurrence of headaches and of edemas on the background of effectively reduce of arterial pressure after use of Prestancia.
Price Prestancia
Cost Prestancia 5/5 mg in Russia is 517-603 rubles, Ukraine is in the range 390-437 hryvnia; price Of Prestancia 5/10 mg of in Russia and Ukraine - 663-747 and 580-591 rubles hryvnia, respectively; price Prestancia 10/10 mg - 747-839 and 605-645 rubles hryvnia and buy Of Prestancia 5/10 mg of It will cost 685-793 rubles or 590-612 hryvnia depending on the location.
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