FREE Shippingto US, AU, UK and EU on all orders over $149

Highlight

  • New Arrivals
  • Sale
  • Hot items
/

Lopirel 30s 75 mg coated tablets

$32.70

a93bb88f7398

Description

Trade name
Lopirel

Mezhdunarodnoye the unlicensed

name Klopidogrel Lekarstvennaya
the Tablet form, coated 75 mg

Structure
One tablet contains
active agent – klopidogrelya hydrosulphate 97, 87 mg,
(it is equivalent klopidogrelyu 75.00 mg),
excipients: lactose anhydrous, cellulose microcrystalline, krospovidon (Type A), glitserola dibekhenat, talc
structure of a cover of Opadry II 85G34669 Pink: polyvinyl alcohol, talc, the titan E 171 dioxide, a macrogoal 3350, lecithin (E322), gland (III) oxide red E172

the Description
Round, biconvex tablets, coated pink color, with a diameter of 9 mm and an engraving of the letter I on one party

Pharmacotherapeutic group
Anticoagulants. Inhibitors of aggregation of thrombocytes. Klopidogrel
the ATX B01AC04 Code

klopidogret the Pharmacological Pharmacokinetics Later properties of repeated intakes in a dose of 75 mg quickly is absorbed in digestive tract. However concentration of initial connection in blood plasma is insignificant and in 2 hours after reception does not reach a measurement limit (0.25 mkg/l). Absorption is 50%. The maximum concentration in blood plasma of the main circulating metabolite (carboxyl derivative) after repeated administrations of drug Lopirel in a dose of 75 mg makes 3mg/l and about 1 hour after reception is observed. The pharmacokinetics of the main metabolite showed linear dependence within doses klopidogrelya from 50 to 150 mg.
Klopidogrel and his main metabolite reversibly contact proteins of in vitro blood plasma (98% and 94%, respectively).
Klopidogrel biotransformirutsya quickly in a liver. Its main metabolite, derivative carboxyl acid, has no pharmacological activity and makes about 85% of the connection circulating in plasma. Klopidogrel is a predecessor of active ingredient. Its active metabolite, tiolny derivative, is formed by oxidation klopidogrelya in 2-oxo-klopidogrel and the subsequent hydrolysis. The oxidizing step is regulated by CYP2B6 and 3A4, to a lesser extent – CYP1A1, 1A2, 1C19. An active tiolny metabolite quickly it is also irreversible contacts platelet receptors, suppressing, thus, aggregation of thrombocytes. This metabolite in blood plasma is not found.
About 50% of the accepted dose klopidogrelya are allocated with urine and about 46% with a stake within 5 days after reception. Elimination half-life of a metabolite makes 8 hours after single and repeated reception.
A pharmacodynamics
Lopirel – inhibitor of aggregation of thrombocytes. Lopirel selectively inhibits linking of adenosinediphosphate (ADF) with his receptors located on surfaces of thrombocytes and the subsequent activation of a complex IIb/IIIa glycoprotein, inhibiting thus, aggregation of thrombocytes. Biotransformation klopidogrelya is necessary for inhibition of thrombocytes. Lopirel also interferes with the aggregation of thrombocytes caused by other agonists by blockade of increase in activity of thrombocytes to the released ADF. The effect klopidogrelya lasts during all life of a thrombocyte, platelet function is restored in 7-10 days after cancellation klopidogrelya. At long purpose of therapeutic doses klopidogrelya (75 mg a day) the noticeable inhibition of aggregation of thrombocytes is noted in the first day of treatment, then the antiagregantny effect gradually increases and reaches a maximum for 3-7 day of regular administration of drug. At long reception of therapeutic doses the average level of inhibition is between 40 and 60%. After the end of treatment the effect klopidogrelya on aggregation of thrombocytes and a bleeding time usually decreases within 5 days. Drug leads to statistically reliable decrease in frequency of new ischemic disturbances (a myocardial infarction, an ischemic stroke and sudden death) in comparison with acetylsalicylic acid.

Indications
For prevention of aterotrombotichesky disturbances:
– after recently postponed myocardial infarction (up to 35 days after a myocardial infarction), an ischemic stroke (from 7 days to 6 months) or the diagnosed disease of peripheric circulation with occlusion elements
– at a syndrome of acute coronary insufficiency:
1) a syndrome of acute coronary insufficiency without increase in a segment of ST (unstable stenocardia or a myocardial infarction without tooth Q), including patients with cherezkozhny coronary placement of a stent (in a combination with acetylsalicylic acid)
2) an acute myocardial infarction with increase in a segment of ST (in
a combination with acetylsalicylic acid the patient having indications to thrombolytic therapy)

need to accept the Route of administration and doses of the Tablet inside, washing down with enough water irrespective of meal.
After recently had myocardial infarction, an ischemic stroke or diseases of peripheral arteries
the Recommended daily dose Lopirel – 75 mg (one tablet) once a day.
A sharp coronary syndrome
the Initial dose of the drug Lopirel – 300 mg once. A maintenance dose – 75mg/days in combination with acetylsalicylic acid in a dose of 75-325 mg/days. As use of acetylsalicylic acid in higher doses is connected with increase in risk of bleedings, the dose of acetylsalicylic acid recommended at this indication should not exceed 100 mg.
According to data of clinical trials, the maximum therapeutic effect is observed in 3 months, a course of treatment up to 12 months.
At patients 75 years are more senior treatment should be begun without reception of an initial dose.
Patients with a renal failure
the Experience of use for patients with a renal failure is limited.
Patients with a liver failure
the Experience of use for patients with a liver failure is limited.

Side effects
Often
– pains in a stomach, dyspepsia, diarrhea, gastrointestinal
bleedings
– bruises, a hematoma, bleedings in the place of a puncture
– nasal bleedings
Infrequently
– thrombocytopenia, a leukopenia, an eosinophilia
– intracraneal hemorrhage
– a headache, dizziness, paresthesias
– hemorrhage conjunctival, in an eye retina
– gastritis, a peptic ulcer of a stomach and duodenum,
nausea, vomiting, a constipation, a meteorism
– skin rash, an itching, a purpura
– a hamaturia
– lengthening of a bleeding time, reduction of quantity of neutrophils,
reduction of quantity of thrombocytes in peripheral blood
Is rare
– a neutropenia, including a heavy neutropenia
– bleeding in retroperitoneal space
is Very rare
– the trombotichesky Werlhof’s disease (TWD)
– anemia, including. aplastic, a pancytopenia, an agranulocytosis,
thrombocytopenia heavy, a granulocytopenia
– a serum disease, anaphylactoid reactions
– hallucinations, confusion of consciousness
– disturbance of flavoring perception
– bleeding from an operational wound
– a vasculitis
– hypotension
– a pneumorrhagia, pulmonary bleeding
– a bronchospasm, an interstitial pneumonitis
– gastrointestinal bleeding
– pancreatitis, colitis, including ulcer and lymphocytic colitis,
stomatitis
– disturbance of functions of a liver, hepatitis, an acute liver failure
– bullous dermatitis (toxic epidermal necrolysis,
Stephens-Johnson’s syndrome, a multiformny erythema), a Quincke’s disease,
erythematic rash, a small tortoiseshell, eczema, red flat deprive
– a hemarthrosis, arthritis, arthralgias, myalgias
– a glomerulonephritis, increase in level of creatinine in blood

Contraindication fever
– hypersensitivity to drug components
– heavy abnormal liver functions
– acute bleeding (for example, in ulcer of stomach or
duodenum or intracraneal hemorrhage)
– pregnancy, the lactation period
– children’s and teenage age up to 18 years
– hereditary intolerance of fructose, deficiency of Lapp-enzyme
of lactase, a glucose galactose sprue

Medicinal interactions
Warfarin: combined use Lopirel and warfarin because of the increased risk of bleeding is not recommended.
IIb/IIIa glycoprotein inhibitors: prescribing of inhibitors of a glycoprotein of IIb/IIIa together with the drug Lopirel demands care.
Acetylsalicylic acid: acetylsalicylic acid does not change the inhibiting Lopirel’s effect on ADF-indutsirovannuyu aggregation of thrombocytes, but Lopirel strengthens effect of acetylsalicylic acid on collagen – the induced aggregation of thrombocytes. Pharmakodinamichesky interaction between the drug Lopirel and acetylsalicylic acid is possible and it increases risk of developing bleeding. Therefore combined use of these drugs demands care. However there are data on safe use of this combination during 1 year.
Heparin: at simultaneous use with Lopirel heparin does not change either the general need for heparin, or effect of heparin to fibrillation. Simultaneous use of heparin did not change inhibiting effect Lopirel to aggregation of thrombocytes.
Trombolitiki: safety of combined use Lopirel, fibrin – specific or fibrin – nonspecific thrombolytic drugs and heparin was investigated at patients with an acute myocardial infarction. Frequency of clinically significant bleedings was similar to that that it was observed in case of combined use of thrombolytic means and heparin with acetylsalicylic acid. Safety of combined use of Lopirel with other trombolitika is not rather studied therefore it is necessary to apply with care.
Non-steroidal anti-inflammatory drugs (NPVS): according to clinical trial the concomitant use of the drug Lopirel and Naproxenum increases risk of emergence of the hidden blood losses in digestive tract. Now it is not clear whether the increased risk of gastrointestinal bleedings is characteristic of all NPVS. Thus, purpose of NPVS, including TsOG-2 inhibitors, and Lopirela demands care.
Other joint therapy: clinically significant pharmakodinamichesky interaction at use of the drug Lopirel together with atenolol, nifedipine or both drugs is noted. The effect Lopirel did not change at combined use with phenobarbital, Cimetidinum and estrogen. The pharmacokinetics of digoxin and theophylline did not change at combined use with the drug Lopirel. Antiacid means did not change extent of absorption of Lopirel.
Experimental data show that at high concentrations Lopirel inhibits activity of Р450(2С9) therefore the level of some medicines in blood plasma (Phenytoinum, tolbutamide, tamoxifen, warfarin, torsemid, fluvastatin, non-steroidal anti-inflammatory drugs) can increase. Therefore these drugs have to be used together with the drug Lopirel with care.

Special instructions
Due to the existing risk of developing bleeding and hematologic side effects in case of emergence during treatment of the clinical symptoms indicating it, it is necessary to carry out blood test. Patients have to be carefully checked for symptoms of bleeding, including the concealed hemorrhages, especially in the first weeks of treatment and/or after the invasive cardiological procedures or surgical intervention.
Lopirel prolongs the bleeding period and therefore it is necessary to appoint it with care at the patients subject to the increased risk of bleeding connected with an injury, surgical interventions or other morbid conditions (especially gastrointestinal and intraocular) and also in case of combination of drug with acetylsalicylic acid, non-steroidal anti-inflammatory drugs, heparin, inhibitors of a glycoprotein IIb/IIIa and trombolitikama. At the planned surgical interventions the course of treatment the drug Lopirel needs to be stopped in 5 days prior to operation.
Patsiyentov it is necessary to warn that bleeding stops longer, than usually at reception Lopirel (separately or together with acetylsalicylic acid) and that they have to report to the doctor about all unusual bleedings (localization or duration). Patients have to inform also the doctor and the stomatologist on administration of drug Lopirel if surgeries are coming them or if the doctor appoints new drug.
Very seldom after use of the drug Lopirel the Werlhof’s trombotichesky disease (WTD) developed, sometimes even at short-term reception. It was characterized by thrombocytopenia, mikroangiopatichesky hemolytic anemia, neurologic disturbances, dysfunction of kidneys, temperature increase. The TPP is the state demanding immediate intervention including a plasmapheresis. Because of insufficient experience of use, patients need to appoint the drug Lopirel with care with moderate abnormal liver functions in which developing of hemorrhagic diathesis is possible. In a renal failure it is necessary to appoint drug also with care.
As drug contains lactose, it is impossible to appoint it the patient with congenital intolerance of a galactose, a sprue of glucose and a galactose and deficiency of lactase.
Use in pediatrics
is not recommended to Children use of this medicine as safety and efficiency of drug for this age group is not proved.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous
Lopirel mechanisms should appoint with care at control of transport or potentially dangerous mechanisms.

Overdose
Symptoms: lengthening of a bleeding time and following from this complication.
Treatment: drug withdrawal. In need of fast correction of a bleeding time – transfusion of platelet concentrate, symptomatic treatment. There is no specific antidote.

A form of release and packing
On 7 or 10 tablets in blister strip packaging of Al/Al.
On 2 or 4 planimetric packs on 7 tablets together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
On 3 or 9 planimetric packs on 10 tablets together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.

To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!

3 years
not to apply a period of storage after an expiration date.

Prescription status
According to the prescription

of Proizvoditel Aktavis Ltd.
To develop

Additional information

Ingredient

Reviews

There are no reviews yet.

Be the first to review “Lopirel 30s 75 mg coated tablets”

Your email address will not be published. Required fields are marked *