Lipideks CP 14s 250 mg modified-release capsules
- $17.20
Trade name
of Lipideks® of SR
the International unlicensed
name Fenofibrat Lekarstvennaya
the Capsule form with the modified release, 250 mg
Structure
One capsule contains
active agent – the fenofibrat of micropellets of 334.20 mg (it is equivalent to a fenofibrat of 250 mg),
structure of the capsule: the body - yellow sunset of FCF (E110), gelatin
a lid - yellow sunset of FCF (E110), the titan dioxide (E171),
gelatin
structure of micropellets: microgranules neutral (size 30), a kopolimer of bottled methacrylate of the basic (Eudragit E 100), methacrylic acid - a kopolimer of methylmethacrylate (1:1) (Eudragit of L 100), talc
the Description
Solid gelatin capsules of No. in size 1 with the transparent body of orange color and an opaque lid of light orange color.
Contents of capsules – whitish and cream spherical micropellets, flavourless.
Pharmacotherapeutic group
Hypolipidemic drugs. Gipokholesterinemichesky and gipotriglitseredemichesky drugs. Fibrata. Fenofibrat.
The ATX C10AB05 code
the Pharmacological
Pharmacokinetics of Lipideks® of SR properties is well soaked up from digestive tract.
After oral administration of the drug Lipideks® SR of the slowed-down release the average concentration is reached in 6 hours and makes 13 mkg/ml. After absorption fenofibrat is exposed to hydrolysis with participation of esterases and forms an active metabolite – fenofibroyevy acid. Elimination half-life of fenofibroyevy acid makes about 20 hours.
At administration of drug with food the bioavailability of the fenofibrat increases.
Fenofibroyevy acid for 99% contacts proteins of plasma.
Fenofibroyevy acid conjugates with glucuronic acid and is removed with urine. In small amounts fenofibroyevy acid is exposed to benzgidrolny metabolism. Metabolites are also exposed to conjugation with glucuronic acid and are removed with urine. 60% of the accepted dose are removed with urine and about 25% with excrements.
A pharmacodynamics
of Lipideks® of SR hypolipidemic drug from group of derivatives of fibroyevy acid. Lowers the level of triglycerides and (to a lesser extent) cholesterol in blood. Promotes reduction of maintenance of LPONP, LPNP (to a lesser extent), to increase in maintenance of anti-atherogenous LPVP.
Activates lipoproteinlipase and by that influences exchange of triglycerides, breaks synthesis of fatty acids and cholesterol, promotes increase in number of LDL receptors in a liver.
Fenofibrat reduces aggregation of thrombocytes, reduces the increased fibrinogen level in plasma, can lower several glucose level in blood at patients with diabetes, reduces the level of uric acid in blood.
The type
the Main
raised lipid
the Raised
lipoproteins
the II a
Holesterin
Lipoproteins of the low density (LDL)
the II b
Cholesterol, triglycerides
Lipoproteins of the low density (LDL), lipoproteins of very low density (LPONP)
the III
Cholesterol, triglycerides
Lipoproteins of the intermediate density (LPPP),
chylomicrons IV
Triglycerides
Lipoproteins of very low density (LPONP)
the V
Triglycerides
Chylomicrons, lipoproteins of very low density (LPONP)
of Lipideks® of SR should be used at the lipidemia which is not giving in to correction by a diet and at patients at whom the risk of the remote adverse effects depends on treatment only after carrying out full inspection for establishment of the true cause of pathology. Risk factors, such as hypertensia and smoking also demand control.
Epidemiological researches showed direct dependence between the increased level of lipids and development of the coronary heart disease (CHD). But expected favorable effect of the fenofibrat at an ischemic heart disease and influence on mortality are not proved yet.
Studying influence of the fenofibrat for lipoprotein fractions showed reduction of level of LDL and LPONP. Lowering of lipoproteins of low and very low density in relation to lipoproteins of high density, in epidemiological researches correlated with lowering of atherogenous risk. Levels apolipoproteina-A and aplipoproteina-V changed in parallel with the LPVP, LPNP and LPONP levels respectively.
Fenofibrat reduces synthesis of the triglycerides which are a part of LPONP, increases activity of the lipoproteinlipase destroying LPONP, raises not receptor and, perhaps, receptor capture of LPONP and LDL.
Regress of xanthomas was observed during therapy fenofibraty. Plasma level of uric acid increased approximately at 20% of patients with a lipidemia, especially patients with the IV type have lipidemias. Липидекс® SR has uricosuric effect and therefore has additional benefit at such patients.
Indications
- the giperlipoproteinemiya resistant to correction by a diet, type II a, II b, III, IV and V (Frederikson's classification).
A route of administration and doses
the Recommended initial dose for adults - 250 mg once a day inside, at meal time. The recommended dose can be used also for elderly patients. Drug is badly absorbed at reception on an empty stomach therefore Lipideks® of SR should be accepted with food. During therapy of Lipideks® of SR
it is necessary to adhere to the recommended diet.
Response to treatment should be controlled on change of indicators of lipidic exchange. As necessary it is possible to increase a dose to 500 mg a day (2 times a day). The SR Lipideks® drug treatment is followed by fast decrease in serumal lipidic level.
If within 3 months positive dynamics is not reached, it is necessary to stop treatment by this drug.
Patients of advanced age are recommended to appoint a standard dose for adults.
Side effects
the Side effects observed during drug treatment are not frequent, as a rule, they are insignificant, passing and do not interfere with treatment.
Often
- an abdominal pain, nausea, vomiting, diarrhea and a meteorism of moderate weight
- moderate increase in activity of hepatic transaminases
Infrequently
- a headache
- pancreatitis, formation of gallstones
- rash, an itching, urticaria, reactions of photosensitivity
- a deep vein thrombosis, a pulmonary embolism
- increase in level of creatinine and urea in blood serum
is rare
- an alopecia
- diffusion myalgia, a miositis, muscular spasms and muscle weakness
- decrease in level of hemoglobin and the maintenance of leukocytes
- disturbance of erectile function
is Very rare
- hepatitis. At emergence of symptoms of hepatitis (jaundice, an itching) it is necessary to conduct laboratory researches and, in case of confirmation of the diagnosis, to cancel drug
- a rhabdomyolysis
- the photosensitization which is followed by an erythema, formation of blisters or small knots on the sites of skin subjected to impact of sunlight or artificial UF-illumination, for example, of a quartz lamp (these effects can arise even after months-long use without any complications)
- interstitial pneumopathies
of the Contraindication
- hypersensitivity to a fenofibrat or excipients of drug
- existence in the anamnesis of a photosensitization or phototoxicity at treatment of a fibratama or ketoprofen
- chronic or acute pancreatitis except for acute pancreatitis owing to a heavy gipertriglitseridemiya
- a liver failure (including cirrhosis)
- a renal failure
- diseases of a gall bladder
- children's and teenage age up to 18 years
- pregnancy and the period of a lactation
Medicinal interactions
At simultaneous use of Lipideks® of SR:
- with anticoagulants, the dose of anticoagulants needs to be lowered on 1/3 in an initiation of treatment, then to regulate gradually as necessary as the risk of bleedings increases
- with other fibrata, induces the microsomal oxidases with the mixed function involved in metabolism of fatty acids and can interact with drugs which metabolism proceeds by means of these enzymes
- with other anti-atherosclerotic means, their action is exponentiated
- with coumarins, insulin and oral anti-diabetic means, amplify their action
- non-steroidal anti-inflammatory drugs, amplify action of the fenofibrat
- with antacids and oral contraceptives (estrogensoderzhashchy), the efficiency of the fenofibrat decreases
- with other hypolipidemic drugs (at prolonged use), there can be a hepatotoxic effect.
The special
instructions Efficiency of Therapy should be estimated on the maintenance of lipids (Hs, LDL, triglycerides) in blood serum. In the absence of therapeutic effect after several months of therapy (as a rule, after 3 months) it is necessary to consider expediency of purpose of the accompanying or alternative therapy.
Before therapy by the drug LIPIDEKS® SR, it is necessary to carry out the corresponding treatment for elimination of the reason of a secondary lipidemia (for example, such as uncontrollable diabetes 2 types, a hypothyroidism, a nephrotic syndrome, a disproteinemia, obstructive diseases of a liver, a consequence of medicamentous therapy, alcoholism). It is necessary to find out from the patients with a lipidemia accepting estrogen or hormonal contraceptives, containing estrogen whether the lipidemia has primary or secondary nature. In such cases the increase in level of lipids can be caused by intake of estrogen.
In dysfunction of kidneys the dose of the drug Lipideks® SR can be reduced depending on clearance of creatinine (for example, up to 200 mg daily at clearance of creatinine of 60 ml/min. and up to 100 mg daily at clearance of creatinine of 20 ml/min.).
There are data on influence of fibrat on muscle tissue, including a rhabdomyolysis. These processes are more often observed at the reduced level of seralbumin and the previous renal failure. If the patient has diffusion myalgia, increase in a kreatinfosfokinaza (more than by 5 times) it is necessary to stop reception of the fenofibrat. Risk of developing a rhabdomyolysis increases at predisposition to a myopathy and/or a rhabdomyolysis, including age 70 years, the burdened anamnesis on hereditary muscular diseases, a renal failure, a hypothyroidism, an alcohol abuse are more senior and also at a concomitant use of inhibitors of HMG-CoA reductase. In this regard, purpose of Lipideks® of SR in a combination with statine is admissible only in the presence at the patient of the heavy mixed dislipidemiya and high is warm - vascular risk, in the absence of a disease of muscles in the anamnesis and in the conditions of the fixed control directed to identification of signs of development of muscular toxicity.
Cases of development of pancreatitis during treatment fenofibraty were described. The possible causes of pancreatitis in these cases were: insufficient efficiency of drug at patients with a heavy gipertriglitseridemiya, direct influence of drug and also the secondary phenomena connected with existence of the stones or formation of a deposit in a gall bladder which are followed by impassability of the general bile duct.
At long-term treatment periodically (it is desirable every 3 month) it is necessary to control activity of hepatic transaminases (at increase more than by 3 times – to stop reception) and the KFK level.
It is not necessary to appoint drug along with perhexiliny a maleate and
MAO inhibitors.
To take at advanced age with caution.
Pregnancy and a lactation
Data on use of the fenofibrat at pregnancy are not numerous. The potential risk for the person is unknown, in this regard drug is not appointed to pregnant women. Due to the lack of data on safety, use of Lipideks® of SR in the period of a lactation (breastfeeding) is contraindicated.
Influence of drug on ability to run the vehicle or potentially dangerous mechanisms is not established to feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms.
Overdose
Symptoms: specific symptoms and dangerous consequences of overdose are not revealed. Headache, vomiting, abdominal pain.
Treatment: there are no specific antidotes. Treatment of acute overdose has to be symptomatic. As necessary it is possible to make
gastric lavage and maintenance therapy.
A form of release and packing
of the Capsule with the modified release, 250 mg.
On 7, 10 or 15 capsules in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 2 planimetric packs (on 7 capsules and 15 capsules) or 3 planimetric packs (on 10 capsules) together with the instruction for use in the state and Russian languages in a pack cardboard with the hologram of manufacturing firm.
To Store storage conditions at a temperature not above 25 °C in the dry, protected from light place.
To store out of children's reach!
3 years
not to apply a period of storage after a period of storage.
Prescription status
According to the prescription
JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Razvernut Producer
of Lipideks® of SR
the International unlicensed
name Fenofibrat Lekarstvennaya
the Capsule form with the modified release, 250 mg
Structure
One capsule contains
active agent – the fenofibrat of micropellets of 334.20 mg (it is equivalent to a fenofibrat of 250 mg),
structure of the capsule: the body - yellow sunset of FCF (E110), gelatin
a lid - yellow sunset of FCF (E110), the titan dioxide (E171),
gelatin
structure of micropellets: microgranules neutral (size 30), a kopolimer of bottled methacrylate of the basic (Eudragit E 100), methacrylic acid - a kopolimer of methylmethacrylate (1:1) (Eudragit of L 100), talc
the Description
Solid gelatin capsules of No. in size 1 with the transparent body of orange color and an opaque lid of light orange color.
Contents of capsules – whitish and cream spherical micropellets, flavourless.
Pharmacotherapeutic group
Hypolipidemic drugs. Gipokholesterinemichesky and gipotriglitseredemichesky drugs. Fibrata. Fenofibrat.
The ATX C10AB05 code
the Pharmacological
Pharmacokinetics of Lipideks® of SR properties is well soaked up from digestive tract.
After oral administration of the drug Lipideks® SR of the slowed-down release the average concentration is reached in 6 hours and makes 13 mkg/ml. After absorption fenofibrat is exposed to hydrolysis with participation of esterases and forms an active metabolite – fenofibroyevy acid. Elimination half-life of fenofibroyevy acid makes about 20 hours.
At administration of drug with food the bioavailability of the fenofibrat increases.
Fenofibroyevy acid for 99% contacts proteins of plasma.
Fenofibroyevy acid conjugates with glucuronic acid and is removed with urine. In small amounts fenofibroyevy acid is exposed to benzgidrolny metabolism. Metabolites are also exposed to conjugation with glucuronic acid and are removed with urine. 60% of the accepted dose are removed with urine and about 25% with excrements.
A pharmacodynamics
of Lipideks® of SR hypolipidemic drug from group of derivatives of fibroyevy acid. Lowers the level of triglycerides and (to a lesser extent) cholesterol in blood. Promotes reduction of maintenance of LPONP, LPNP (to a lesser extent), to increase in maintenance of anti-atherogenous LPVP.
Activates lipoproteinlipase and by that influences exchange of triglycerides, breaks synthesis of fatty acids and cholesterol, promotes increase in number of LDL receptors in a liver.
Fenofibrat reduces aggregation of thrombocytes, reduces the increased fibrinogen level in plasma, can lower several glucose level in blood at patients with diabetes, reduces the level of uric acid in blood.
The type
the Main
raised lipid
the Raised
lipoproteins
the II a
Holesterin
Lipoproteins of the low density (LDL)
the II b
Cholesterol, triglycerides
Lipoproteins of the low density (LDL), lipoproteins of very low density (LPONP)
the III
Cholesterol, triglycerides
Lipoproteins of the intermediate density (LPPP),
chylomicrons IV
Triglycerides
Lipoproteins of very low density (LPONP)
the V
Triglycerides
Chylomicrons, lipoproteins of very low density (LPONP)
of Lipideks® of SR should be used at the lipidemia which is not giving in to correction by a diet and at patients at whom the risk of the remote adverse effects depends on treatment only after carrying out full inspection for establishment of the true cause of pathology. Risk factors, such as hypertensia and smoking also demand control.
Epidemiological researches showed direct dependence between the increased level of lipids and development of the coronary heart disease (CHD). But expected favorable effect of the fenofibrat at an ischemic heart disease and influence on mortality are not proved yet.
Studying influence of the fenofibrat for lipoprotein fractions showed reduction of level of LDL and LPONP. Lowering of lipoproteins of low and very low density in relation to lipoproteins of high density, in epidemiological researches correlated with lowering of atherogenous risk. Levels apolipoproteina-A and aplipoproteina-V changed in parallel with the LPVP, LPNP and LPONP levels respectively.
Fenofibrat reduces synthesis of the triglycerides which are a part of LPONP, increases activity of the lipoproteinlipase destroying LPONP, raises not receptor and, perhaps, receptor capture of LPONP and LDL.
Regress of xanthomas was observed during therapy fenofibraty. Plasma level of uric acid increased approximately at 20% of patients with a lipidemia, especially patients with the IV type have lipidemias. Липидекс® SR has uricosuric effect and therefore has additional benefit at such patients.
Indications
- the giperlipoproteinemiya resistant to correction by a diet, type II a, II b, III, IV and V (Frederikson's classification).
A route of administration and doses
the Recommended initial dose for adults - 250 mg once a day inside, at meal time. The recommended dose can be used also for elderly patients. Drug is badly absorbed at reception on an empty stomach therefore Lipideks® of SR should be accepted with food. During therapy of Lipideks® of SR
it is necessary to adhere to the recommended diet.
Response to treatment should be controlled on change of indicators of lipidic exchange. As necessary it is possible to increase a dose to 500 mg a day (2 times a day). The SR Lipideks® drug treatment is followed by fast decrease in serumal lipidic level.
If within 3 months positive dynamics is not reached, it is necessary to stop treatment by this drug.
Patients of advanced age are recommended to appoint a standard dose for adults.
Side effects
the Side effects observed during drug treatment are not frequent, as a rule, they are insignificant, passing and do not interfere with treatment.
Often
- an abdominal pain, nausea, vomiting, diarrhea and a meteorism of moderate weight
- moderate increase in activity of hepatic transaminases
Infrequently
- a headache
- pancreatitis, formation of gallstones
- rash, an itching, urticaria, reactions of photosensitivity
- a deep vein thrombosis, a pulmonary embolism
- increase in level of creatinine and urea in blood serum
is rare
- an alopecia
- diffusion myalgia, a miositis, muscular spasms and muscle weakness
- decrease in level of hemoglobin and the maintenance of leukocytes
- disturbance of erectile function
is Very rare
- hepatitis. At emergence of symptoms of hepatitis (jaundice, an itching) it is necessary to conduct laboratory researches and, in case of confirmation of the diagnosis, to cancel drug
- a rhabdomyolysis
- the photosensitization which is followed by an erythema, formation of blisters or small knots on the sites of skin subjected to impact of sunlight or artificial UF-illumination, for example, of a quartz lamp (these effects can arise even after months-long use without any complications)
- interstitial pneumopathies
of the Contraindication
- hypersensitivity to a fenofibrat or excipients of drug
- existence in the anamnesis of a photosensitization or phototoxicity at treatment of a fibratama or ketoprofen
- chronic or acute pancreatitis except for acute pancreatitis owing to a heavy gipertriglitseridemiya
- a liver failure (including cirrhosis)
- a renal failure
- diseases of a gall bladder
- children's and teenage age up to 18 years
- pregnancy and the period of a lactation
Medicinal interactions
At simultaneous use of Lipideks® of SR:
- with anticoagulants, the dose of anticoagulants needs to be lowered on 1/3 in an initiation of treatment, then to regulate gradually as necessary as the risk of bleedings increases
- with other fibrata, induces the microsomal oxidases with the mixed function involved in metabolism of fatty acids and can interact with drugs which metabolism proceeds by means of these enzymes
- with other anti-atherosclerotic means, their action is exponentiated
- with coumarins, insulin and oral anti-diabetic means, amplify their action
- non-steroidal anti-inflammatory drugs, amplify action of the fenofibrat
- with antacids and oral contraceptives (estrogensoderzhashchy), the efficiency of the fenofibrat decreases
- with other hypolipidemic drugs (at prolonged use), there can be a hepatotoxic effect.
The special
instructions Efficiency of Therapy should be estimated on the maintenance of lipids (Hs, LDL, triglycerides) in blood serum. In the absence of therapeutic effect after several months of therapy (as a rule, after 3 months) it is necessary to consider expediency of purpose of the accompanying or alternative therapy.
Before therapy by the drug LIPIDEKS® SR, it is necessary to carry out the corresponding treatment for elimination of the reason of a secondary lipidemia (for example, such as uncontrollable diabetes 2 types, a hypothyroidism, a nephrotic syndrome, a disproteinemia, obstructive diseases of a liver, a consequence of medicamentous therapy, alcoholism). It is necessary to find out from the patients with a lipidemia accepting estrogen or hormonal contraceptives, containing estrogen whether the lipidemia has primary or secondary nature. In such cases the increase in level of lipids can be caused by intake of estrogen.
In dysfunction of kidneys the dose of the drug Lipideks® SR can be reduced depending on clearance of creatinine (for example, up to 200 mg daily at clearance of creatinine of 60 ml/min. and up to 100 mg daily at clearance of creatinine of 20 ml/min.).
There are data on influence of fibrat on muscle tissue, including a rhabdomyolysis. These processes are more often observed at the reduced level of seralbumin and the previous renal failure. If the patient has diffusion myalgia, increase in a kreatinfosfokinaza (more than by 5 times) it is necessary to stop reception of the fenofibrat. Risk of developing a rhabdomyolysis increases at predisposition to a myopathy and/or a rhabdomyolysis, including age 70 years, the burdened anamnesis on hereditary muscular diseases, a renal failure, a hypothyroidism, an alcohol abuse are more senior and also at a concomitant use of inhibitors of HMG-CoA reductase. In this regard, purpose of Lipideks® of SR in a combination with statine is admissible only in the presence at the patient of the heavy mixed dislipidemiya and high is warm - vascular risk, in the absence of a disease of muscles in the anamnesis and in the conditions of the fixed control directed to identification of signs of development of muscular toxicity.
Cases of development of pancreatitis during treatment fenofibraty were described. The possible causes of pancreatitis in these cases were: insufficient efficiency of drug at patients with a heavy gipertriglitseridemiya, direct influence of drug and also the secondary phenomena connected with existence of the stones or formation of a deposit in a gall bladder which are followed by impassability of the general bile duct.
At long-term treatment periodically (it is desirable every 3 month) it is necessary to control activity of hepatic transaminases (at increase more than by 3 times – to stop reception) and the KFK level.
It is not necessary to appoint drug along with perhexiliny a maleate and
MAO inhibitors.
To take at advanced age with caution.
Pregnancy and a lactation
Data on use of the fenofibrat at pregnancy are not numerous. The potential risk for the person is unknown, in this regard drug is not appointed to pregnant women. Due to the lack of data on safety, use of Lipideks® of SR in the period of a lactation (breastfeeding) is contraindicated.
Influence of drug on ability to run the vehicle or potentially dangerous mechanisms is not established to feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms.
Overdose
Symptoms: specific symptoms and dangerous consequences of overdose are not revealed. Headache, vomiting, abdominal pain.
Treatment: there are no specific antidotes. Treatment of acute overdose has to be symptomatic. As necessary it is possible to make
gastric lavage and maintenance therapy.
A form of release and packing
of the Capsule with the modified release, 250 mg.
On 7, 10 or 15 capsules in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 2 planimetric packs (on 7 capsules and 15 capsules) or 3 planimetric packs (on 10 capsules) together with the instruction for use in the state and Russian languages in a pack cardboard with the hologram of manufacturing firm.
To Store storage conditions at a temperature not above 25 °C in the dry, protected from light place.
To store out of children's reach!
3 years
not to apply a period of storage after a period of storage.
Prescription status
According to the prescription
JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Razvernut Producer
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