Lercanidipine hcl is not official in any pharmacopeia, so no official dissolution method is available. Lercanidipine hcl, lercanidipine hydrochloride, belongs to a group of medicines called calcium channel. Lercanidipine hcl is completely absorbed after 1020 mg oral administration and peak plasma levels, 3. There are few references to the analysis of lercanidipine hydrochloride and its. Lercanidipine hydrochloride please note that only artwork studio is permitted to make changes to the above artwork. Development of fast dissolving oral films containing lercanidipine hcl nanoparticles in semicrystalline polymeric matrix for enhanced dissolution and ex vivo. Do not take lercanidipine an if you are breastfeeding or plan to breastfeed. Antiinflammatory activity of calcium channel blocker lercanidipine hydrochloride. In discussing the main pharmacological features of the drug combination,26 it should be worth mentioning that the presence of an obese state may affect the main pharmacological properties of a given drug, particularly the socalled volume of distribution of the compound, ie, the drug location into different interstitial and. Lercanidipine questions about lercanidipine answered. Enhancement of solubility and dissolution of lercanidipine by.
Polymorphic form of lercanidipine hydrochloride and process. Development and validation of a rphplc method for the simultaneous estimation of atenolol and lercanidipine hydrochloride in pharmaceutical dosage forms deepak kumar jain1, pratibha patel1, abu sahma khan2, nilesh jain 3 1truba institute of pharmacy, karond gandhi nagar bypass road, bhopal, m. Lercanidipine drug used to treat hypertension pharmacybook. Contents of the pack and other information other medicines and lercanidipine hydrochloride. It is a racemate due to the presence of a chiral carbon atom at position 4 of the 1,4dihydropyridine ring. Fixeddose combination lercanidipineenalapril springerlink. Cyclosporin and lercanidipine concentration can both increase when taken together, leading to toxicity and other side effects. On this page about lercanidipine hydrochloride sandoz you will find information relating to side effects, age restrictions, food interactions, whether the medicine is available at a government subsidised price on the pharmaceutical benefits scheme pbs as well as other useful information. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. A selective hplc method for determination of lercanidipine. Waters 600 controller, waters inline degasser af and manual injector with 20. Avoid breastfeeding while using this medicine, because this medicine passes into breast milk. Lercanidipine is a medication for high blood pressure or hypertension disorder.
Assay of lercanidipine hydrochloride in dosage forms using. A stabilityindicating hplc method for assay of lercanidipine. Antiinflammatoryactivity of calciumchannel blocker lercanidipine. Australian product information zanextra lercanidipine hydrochloride and enalapril maleate filmcoated tablets 1 name of the medicine lercanidipine hydrochloride and enalapril maleate 2 qualitative and quantitative composition zanextra filmcoated tablets are immediate release filmcoated tablets for oral use. Lercanidipineenalapril combination in the management of obesityrelated hypertension guido grassi1,2 1internal medicine, department of health science, universita. Enhancement of dissolution of lercanidipine hydrochloride. Unlike other dhpccbs, the high lipophilicity of lercanidipine hcl provides a slow onset of action, a longlasting smooth muscle relaxation, and a peripheral. Lercanidipine interactions bnf content published by nice. Except as otherwise noted, this work is licensed under a creative commons attributionnoncommercialshare alike 4. Patient information for lercanidipine hydrochloride 20mg tablets including dosage instructions and possible side effects. Enhancement of wettability and in vitro dissolution. When you take lercanidipine together with other drugs the way they work can interact, changing the effect they have on your body. By deforming the channel, inhibiting ioncontrol gating mechanisms, andor interfering with the release of calcium from the sarcoplasmic reticulum, lercanidipine inhibits the influx of extracellular calcium across the myocardial and vascular smooth muscle cell membranes the decrease in intracellular calcium.
It produced no significant heart rate changes, while most adverse events were the result of vasodilatation early in treatment. It belongs to the dihydropyridine class of calcium channel blockers, which work by relaxing and opening the blood vessels allowing the blood to circulate more freely around the body. Basic pharmacology profile of enalapril lercanidipine combination. Lercanidipine hydrochloride 10 mg filmcoated tablets. Please do not take lercanidipine hydrochloride tablets with grapefruit or grapefruit juice. The content of this database of side effects adverse drug reactions is intended for educational and scientific research purposes only. What you need to know before you take lercanidipine hydrochloride 3.
The lercanidipine hydrochloride substantially in polymorph form v of claim 1, further characterized by exhibiting characteristic peaks expressed in degrees 2. The solubility values of lercanidipine hcl in phosphate buffer ph 6. The best time to take lercanidipine is 15 minutes before your meal. Lercanidipine hydrochloride hcl is ltype calcium channel blocker widely used in the management of hypertension. Each filmcoated tablet contains 20 mg of lercanidipine as the hydrochloride, which is equivalent to 18. Lercanidipine hydrochloride hazardous combustion products thermal decomposition or combustion products may include the following substances.
This assessment report concerns a generic version of lercanidipine hydrochloride 10 and 20 mg film coated tablets approved via the decentralised procedure. The present work is mainly focussed on development and validation of a dissolution test that can be used as a quality control test for lercanidipine hcl tablets and formulations. Lercanidipine hcl is available in blister packs of 7, 14, 28, 35, 42, 50, 56, 98, 100 tablets. The lercanidipine hydrochloride solubility in water 37 1 c is 0. Lercanidipine hydrochloride 20mg tablets are pink, round, biconvex 8. Lercanidipine hcl oel fastrac with ade affygility solutions. Product identifier product name lercanidipine hydrochloride product number fl24869. Oct 23, 2019 lercanidipine hcl 20 mg filmcoated tablets patient information leaflet pil by recordati pharmaceuticals limited. The lercanidipine hydrochloride substantially in polymorph form v of claim 1, having a purity of equal to or greater than about 98.
A search of the literature was performed using medline 1966september. Assay of lercanidipine hydrochloride in dosage forms using nucleophilic substitution reaction. If you have any further questions, ask your doctor or pharmacist. Lercanidipineenalapril combination in the management of. Lercanidipine was well tolerated in all of the uncontrolled studies and in the controlled studies reported in table 1. Lercanidipine hydrochloride 20mg filmcoated tablets patient information leaflet continued if you take more lercanidipine hydrochloride than you should do not exceed the prescribed dose. Journal of pharmacology and pharmacotherapeutics anti. Lercanidipine hcl 20 mg filmcoated tablets lercanidipine hydrochloride.
Lercanidipine hydrochloride is a calcium channel protein inhibitor. Polymorphic form of lercanidipine hydrochloride and. A fixeddose tablet formulation of lercanidipine enalapril is approved in germany for the treatment of hypertension in patients not responding to monotherapy. Lercanidipine hydrochloride c36h42cln3o6 chemspider. Lercanidipine sandoz helps most people with high blood pressure, but it may have unwanted side effects in a few people. A simple and sensitive spectrophotometric method has been developed for the assay of lercanidipine hydrochloride ler in bulk and in formulations. Lercanidipine hydrochloride 10mg and 20mg filmcoated tablets. Lercanidipine hydrochloride is a calcium channel blocker of the dihydropyridine classtarget. If you take more than the prescribed dose or in the event of overdose, seek medical advice immediately and, if possible, take your tablets andor the. Sds of lercanidipine hydrochloride, safety data sheets.
Lercanidipine an lercanidipine hydrochloride consumer medicine information lercanidipine an published by mims november 2014 1 what is in this leaflet this leaflet answers some of the common questions about lercanidipine an. Lercanidipine is a third generation dihydropyridine calcium antagonist with a bulky bisphenylalkylamine side chain. Lercanidipine enalapril 10mg10mg once daily significantly reduced sitting diastolic blood pressure and. Lercanidipine may often help to lower blood pressure and therefore may allow the heart to work more efficiently. Lercanidipine an is not recommended for use during pregnancy. Lercanidipine hydrochloride 10 mgd and felodipine sustainedrelease tablets 5 mgd were given to their respective groups.
Lercanidipine 10 mg filmcoated tablets lercanidipine 20 mg filmcoated tablets lercanidipine hydrochloride read all of this leaflet carefully before you start using this medicine. Lercanidipine is given by mouth as the hydrochloride in a usual initial dose of 10 mg once daily before food, increased if necessary, after at least 2 weeks, to 20 mg daily. The mechanism of its antihypertensive blood pressuring lowering action is due to a direct relaxant effect on vascular smooth muscles of blood vessels thus lowering blood pressure. A simple, rapid, precise and accurate spectrophotometric method has been developed and validated for determination of lercanidipine in tablet formulation. Lercanidipine is a type of medicine called a calcium channel blocker. Lercanidipine inhibits the influx of extra cellular calcium across the myocardial and vascular smooth muscle cell membranes possibly by deforming the channel, inhibiting ioncontrol gating mechanisms, andor interfering with the release of calcium from the.
Rvg 107822 lercanidipine hcl 10 mg teva, filmomhulde tabletten rvg 107825 lercanidipine hcl 20 mg teva, filmomhulde tabletten this medicinal product is authorised in the member states of the eea under the following names. What lercanidipine hydrochloride tablets looks like and contents of the pack lercanidipine hydrochloride 10mg tablets are yellow, round, biconvex 6. For commercial use or customized versions, please contact biobyte solutions gmbh. Like other dihydropyridines, lercanidipine relaxes vascular smooth muscle to lower peripheral resistance. Lercanidipine hydrochloride according to regulation ec no 19072006, annex ii, as amended. Tell your doctor immediately if you become pregnant while you are taking lercanidipine an. Lercanidipine may also be sold in pharmacies under the name zanidip. F, shree ganesh industrial estate, 423248, mahagujarat industrial estate, sarkhejbavla road, moraiya, ahmedabad 382 2,gujarat, india. If you use other drugs or over the counter products at the same time, the effects of lercanidipine hcl tablet may change. If you suffer from high blood pressure, taking a calcium channel blocker like lercanidipine can reduce your risk of dangerous side effects like strokes, heart attacks, and even heart disease. Lercanidipine hydrochloride cas 2866116 scbt santa. Spectrophotometric method for determination of lercanidipine.
Lercanidipine sandoz lercanidipine hydrochloride consumer medicine information lercanidipine sandoz published by mimsmydr november 2012 1 what is in this leaflet this leaflet answers some of the common questions about lercanidipine sandoz. Improved dissolution properties were observed for lercanidipine hpmc nanoparticles and the extent of dissolution increased. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Lercanidipine hcl 20 mg filmcoated tablets patient. Lercanidipine is a dihydropyridine calcium channel antagonist. It does not replace seeking advice from your doctor or. Obesityrelated hypertension represents a condition frequently observed in current. Lercanidipine high blood pressure calcium channel blocker. The study involved fourier analysis of 24hour blood pressure profiles, but mean reductions in blood pressure taken between 2 to 6 hours after the dose were also presented. Like most calcium channel blockers lercanidipine an is not recommended while you are breastfeeding. Identification of the substancemixture and of the companyundertaking 1. This is a temporary file and hence do not link it from a website, instead link the url of this page if you wish to link the pdf file.
Lercanidipine is a lipophilic, dihydropyridine calcium antagonist with a long receptor halflife. Advice for firefighters special protective equipment for firefighters. Lercanidipine hcl aurobindo 20 mg the active substance is lercanidipine hydrochloride. Lercanidipine trade name zanidip, among others is an antihypertensive blood pressure lowering drug. For commercial use or customized versions, please contact biobyte solutions gmbh disclaimer. What lercanidipine hydrochloride is and what it is used for 2. Commission regulation eu no 2015830 of 28 may 2015. Dissolution of all prepared lercanidipine hpmc nanoparticles withwithout surfactants was determined and in vitro dissolution profiles are shown in fig. Lercanidipine is similar to other peripheral vasodilators. Pdf spectrophotometric determination of lercanidipine. One 20 mg filmcoated tablet contains 20 mg lercanidipine hydrochloride, equivalent to 18.
Development of fast dissolving oral films containing lercanidipine. Read all of this leaflet carefully before you start taking this medicine because it contains. Lercanidipine may often cause many questions regarding the side effects, complications and even uses. Pdf lercanidipine hydrochloride hcl is ltype calcium channel blocker widely used in the management of hypertension. Analytical methodologies for determination of lercanidipine and. One of the challenging requests of drug development is to enhance the dissolution behavior of drugs that are sparingly soluble in water 3. The method is based on diazotization of reduced lercanidipine with nitrous acid followed by its coupling. Theaimofthe present studywas to improve lercanidipine hcl solubility and in vitro dissolution rate by preparing solid dispersion with polyethylene glycol peg 6000 using the solvent evaporation technique.
Proprietary preparations lercanidipine hydrochloride multi. Lercanidipine hydrochloride 399 levetiracetam 400 levocetirizine hydrochloride 402 levodopa 403 levofloxacin 406 levomepromazine methotrimeprazine 408 levothyroxine sodium 410 linezolid 412 lisinopril 4 lithium 416 lofepramine 417 loperamide hydrochloride 419 lopinavir with ritonavir 420 loratadine 421 lorazepam 423 losartan potassium 424. Lercanidipine, a new third generation caantagonist in the. Use of the information, documents and data from the echa website is subject to the terms and conditions of this legal notice, and subject to other binding limitations provided for under applicable law, the information, documents and data made available on the echa website may be reproduced, distributed andor used, totally or in part, for noncommercial purposes provided that echa is.
Lercanidipine should not be used during pregnancy unless the benefit to the mother outweighs the risks to the child. Lercanidipine is a calcium antagonist of the dihydropyridine group and inhibits the transmembrane influx of calcium into cardiac and smooth muscle. Disclaimer the sds samples above are collected from the internet by chemblink and displayed here for the tutorial purpose only. Calcium channellercanidipine is a calcium channel blocker of the dihydropyridine class, which works by relaxing and opening the blood vessels allowing the blood to circulate more freely around the body. A selective hplc method for determination of lercanidipine in tablets article pdf available in journal of pharmaceutical and biomedical analysis 311. The amorphous lercanidipine hydrochloride of the present invention can also be prepared by a method comprising the steps of dissolving crystalline lercanidipine hydrochloride in an organic solvent, rapidly evaporating the organic solvent, and recovering the amorphous lercanidipine hydrochloride. Sep 12, 2012 lercanidipine, a dihydropyridine calcium channel blocker, and enalapril, an ace inhibitor, are established antihypertensive agents.
Like other calcium channel blockers, lercanidipine works by blocking calcium going into muscles in the heart and blood vessels. Lercanidipine hcl 10 mg filmcoated tablets summary of. Its slow onset of action helps to avoid reflex tachycardia associated with other dihydropyridines. Intravenous magnesium potentially increases the risk of hypotension when given with lercanidipine in pregnant women.
Muscles need calcium to contract, so when you block the calcium, it makes the muscle cells relax. This may increase your risk for sideeffects or cause your drug not to work properly. Pdf dissolution method development and validation for. Oct 25, 2019 lercanidipine hcl is contraindicated in patients with severe hepatic impairment or in patients with severe renal impairment gfr lercanidipine hcl in children aged up to 18 years have not been established. Lercanidipine hcl is available in blister packs of 7. Lercanidipine hydrochloride with food, drink and alcohol please do not consume alcohol during treatment with lercanidipine hydrochloride tablets since it may increase the effect of lercanidipine hydrochloride tablets. A wide variety of lercanidipine hcl options are available to you, such as medicine grade, food grade. Sironi et al 1996 antihypertensive effects of lercanidipine in experimental hypertensive rats and dogs. Lercanidipine produced a mean peak reduction in blood pressure of 16mm hg systolic and 18mmhg in diastolic. The two enantiomers of lercanidipine show a similar plasma level profile.
Pdf lercanidipine in the treatment of hypertension. Lercanidipine sandoz lercanidipine hydrochloride drug. Lercanidipine hcl 10 mg teva, filmomhulde tabletten brochure. Mast cell degranulation effect of lercanidipine was also carried out. Lercanidipine hcl uses, dmf, dossier, manufacturer. Lercanidipine belongs to a group of medicines called calcium channel blockers that block the entry of calcium into the muscle cells of the heart and the blood.
Public assessment report scientific discussion lercinigen dkh. It is readily soluble in chloroform and methanol, but practically insoluble in water. One 10 mg filmcoated tablet contains 10 mg lercanidipine hydrochloride, equivalent to 9. Lercanidipine also compared well against amlodipine, felodipine, and nifedipine gits table 1. Lercanidipine is calcium channel antagonist, used as an antihypertensive agent.