Project Description
Mildrocard
international nonproprietary name
Mildrocard
Ref
BP-0083
Pharmacotherapeutic group
Not established
Composition of the preparation
The active substance is 3-(2,2,2-trimethylhydrazinium)propionate dihydrate. Antiischaemic agent of a metabolic action 5 ml (1 ampoule) of solution for injection contains 500 mg of 3-(2,2,2-trimethylhidrasinium) propionate dihydrate. Inactive ingredient: water for injection.
Pharmacological action
3-(2,2,2-trimethylhydrazinium)propionate dihydrate (Mildrocard) is astructural analogue of a precursor of carnitine — gamma-butyrobetaine(GBB). Mildrocard inhibits the activity ofgamma-butyrobetain-hydroxylase, causing a decrease of carnitinebiosynthesis and long-chain fatty acids transport through cellmembranes. It prevents the accumulation of Acyl-CoA and Acyl-carnitine,the metabolites of long-chain fatty acids in cells, thus diminishingtheir adverse effects. Under the conditions of ischemia,Mildrocard activates the anaerobic glycolysis and stimulates the ATPproduction, and transport, restores the balance between oxygen deliveryand consumption.Decrease of carnitine concentration results inactivation of synthesis of gamma-butyrobetaine, which possessvasodilatating activity. Mildrocard exerts cardio protectiveeffect. In the case of chronic congestive heart failure it augmentsmyocardial contractility, increases the tolerance of the organism tophysical overload. In patients with II—III stage stable angina pectorisMildrocard increases the physical capacity and decreases the number ofangina pectoris attacks. In the cases of acute and chronicischemic cerebrovascular disturbances Mildrocard ameliorates cerebralblood flow in the ischemic region, promoting redistribution of bloodflow in favour of ischemic zone. Mildrocard is alsocharacterised by a tonic effect. It prevents functional disturbances ofsomatic and vegetative nervous system. Cardiovascular diseases: chronic coronary heart disease, stable anginapectoris, chronic heart failure, functional cardiovasculardisturbances, cardiomyopathy. Acute and chronic ischemiccerebrovascular disturbances. Mildrocard is used also in thecases of decreased performance, physical and psycho emotional overload,and during recovery process.
Indications
Usual adult daily dose – 500 to 1000 mg intravenously. It is given as a single dose in the morning or in two divided doses. In view of a possible development of active substance exciting effect it is recommended to take in the first half of the day.
Special indication
Do not use Mildrocard: – if you are hypersensitive to Mildrocard or any of the other ingredients of the medicine. You must tell your doctor before using your medicine,if: · you are pregnant or intend to become pregnant; · are breast feeding. Special care with Mildrocard: Mildrocard should be used with caution in patients with chronic liveror kidney diseases during long term therapy. Safety of Mildrocard application in children less than 12 years age was not studied. Pregnancy: No clinical data are available on the drug safety during pregnancy. Toavoid a possible undesirable action on the organism of mother andfetus, Mildrocard is not given during pregnancy. Breast-feeding:It is not known whether active substance is excreted in human milk. Ifmother needs to be treated with the drug, she has to stop breast-feeding. Driving and using machines: The cases of Mildrocard unfavorable effect on ability to drive or use machines are unknown. Using other medicines:Please inform your doctor or pharmacist if you are taking or haverecently taken any other medicines, even those not prescribed.Mildrocard could be combined with antianginal drugs, anticoagulants,antiagregants, antarrhythmic drugs, cardiac glycosides, diuretics etc.Mildrocard may intensify the actions of several cardiovascular agentssuch as nitroglycerine, nifedipine, beta-adrenoblockers, hypotensiveagents and peripheral vasodilators.
Special warning
Do not use Mildrocard: – if you are hypersensitive to Mildrocard or any of the other ingredients of the medicine. You must tell your doctor before using your medicine,if: · you are pregnant or intend to become pregnant; · are breast feeding. Special care with Mildrocard: Mildrocard should be used with caution in patients with chronic liveror kidney diseases during long term therapy. Safety of Mildrocard application in children less than 12 years age was not studied. Pregnancy: No clinical data are available on the drug safety during pregnancy. Toavoid a possible undesirable action on the organism of mother andfetus, Mildrocard is not given during pregnancy. Breast-feeding:It is not known whether active substance is excreted in human milk. Ifmother needs to be treated with the drug, she has to stop breast-feeding. Driving and using machines: The cases of Mildrocard unfavorable effect on ability to drive or use machines are unknown.
Dosage and method of administration
Usual adult daily dose – 500 to 1000 mg intravenously. It is given as a single dose in the morning or in two divided doses. In view of a possible development of active substance exciting effect it is recommended to take in the first half of the day.
Overdosage
If you use more Mildrocard than you should:No data on Mildrocard overdose are known. It is low toxic and does notcause severe side effects. If sharp changes of arterial blood pressureare observed, symptomatic therapy should be given as appropriate. If you forget to use Mildrocard: Do not use a double dose to make up for forgotten individual doses.
Safety measures
Not established
Side effects
In separate cases, allergic reactions, dyspeptic disturbances,tachycardia, changes in arterial pressure, headache, agitation,weakness may occur; eosinophylia has been reported (one case reported). Patients should discontinue usage of medicine and consult their doctor, if allergic reactions are developed. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Contraindications
Do not use Mildrocard: – if you are hypersensitive to Mildrocard or any of the other ingredients of the medicine. You must tell your doctor before using your medicine,if: · you are pregnant or intend to become pregnant; · are breast feeding. Special care with Mildrocard: Mildrocard should be used with caution in patients with chronic liveror kidney diseases during long term therapy. Safety of Mildrocard application in children less than 12 years age was not studied. Pregnancy: No clinical data are available on the drug safety during pregnancy. Toavoid a possible undesirable action on the organism of mother andfetus, Mildrocard is not given during pregnancy. Breast-feeding:It is not known whether active substance is excreted in human milk. Ifmother needs to be treated with the drug, she has to stop breast-feeding. Driving and using machines: The cases of Mildrocard unfavorable effect on ability to drive or use machines are unknown.
Interactions with other medicinal preparations
Please inform your doctor or pharmacist if you are taking or haverecently taken any other medicines, even those not prescribed.Mildrocard could be combined with antianginal drugs, anticoagulants,antiagregants, antarrhythmic drugs, cardiac glycosides, diuretics etc.Mildrocard may intensify the actions of several cardiovascular agentssuch as nitroglycerine, nifedipine, beta-adrenoblockers, hypotensiveagents and peripheral vasodilators.
The form of release
The form of release Do not store above 25˚С. Keep out of the reach and sight of children. Do not use after expiratory date printed on package! Prescription drug.