December, 1998
`Editor: Or. C.M. Gulhati
`
`MIMS-an independent professionally edited index of ethical preparations
`
`available for prescription in India. It is for use only by registered medical practitioners
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`and pharmacists. As MIMS is amended each month, out of date copies
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`should not in any event be referred to. Although pharmaceutical manufacturers send
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`details on their products to MIMS, all the product entries and new drug
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`reviews are independently written and edited by MIMS' own staff.
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`Monographs are written on the basis of authentic information from diverse sources
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`such as text books, medical journals, clinical trials, MIMS editions from
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`other countries and information from drug regulatory authorities around the world.
`Th~ necessity ~o keep information concise and in a form· considered to be most
`useful to prescribers means that certain deta.ils such as additional ingredients
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`(e.g. gluten, colouring agents) cannot be included; when full product
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`information is required it may be obtained from the Editor of MIMS
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`or the appropriate manufacturer. While every effort is made to ensure that ·
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`the contents are accurate at the time of going to press, the publishers and printers
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`can accept no responsibility for errors or omissions caused either in the preparation
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`
`1 of 3
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1009
`
`

`

`December 31, 1998
`(Update:
`November 30, 1998)
`
`REVIEW:
`Tea: New Tonic for Heart
`
`Founded: 1959
`
`ISSN: 0970-1036
`
`CONTENTS
`
`6 JAJi-: 1~99
`
`r
`· -
`l 1: . • ' ·
`
`;
`
`... ~.
`
`Founder
`Late Alfred E. Morgan
`
`Editor
`Dr. Chandra M. Gulhatl
`
`Editorial Production Controller
`Poof a Sharma
`
`Subscriptions
`Neera Sharma
`
`Safes
`AnuSharma
`
`E.D.P.
`ShllplVerma
`
`2 From the Editor's Desk
`3 Readers' Forum
`5 Pharmacological Index
`6 Review: Tea - A Newly
`OiSCOvered Cardioprotectant .~
`11 New Entries
`"' •
`13 General Index of Products
`23 Eradication regimens for H. Pylori Chart
`52 Management of Hypertension Chart
`140 Summary of Antibacterial Therapy Chart
`159 Antibiotic Prophylaxis for Surgery Chart
`162 Antibacterial Classes & Formulations Chart
`211 Management of Asthma Chart
`257 Management of Lipid Levels Chart
`264 Generic-Brand Index
`286 Therapeutic Index
`288 Deleted Products
`290 Directory of Manufacturers
`293 Alphabetical Index
`
`Single Copy
`Rs.45
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`Annual Subscription
`Rs. 270
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`MIMS /NOIA is the registered trade mark.
`Copyright A E Morgan Publica/IOflS {India) Private Ltm1/ed
`All fights reserved. Worldwide copyflghts held by publishers in respect of style of presen·
`tat1on, Pharmacological and Therapeutic Indices No part of the publicstlOfl may be
`reproduced m any form whatsoever without the written permission of the publisher.
`Published. edited and pflflted by Or. CM. Gulhat1 from 90. Nehru Place. New Delhi
`110019 Pmted at lndrapraslha Press. Bahaclur Shah Zalar Marg. New Delli 110002.
`
`A. E. Morgan Publications (India) Private Limited
`503 Mansarovar, 90 Nehru Place, New Delhi 110019
`Tel: 6414693, 6433115, 6234875, 6463720
`Fax: 011 6424016. E-mail: mims@ndb.vsnl.net.in
`
`/
`
`I
`
`or
`
`orrow!
`
`s
`relapse
`
`ns
`IC)Uinolones
`
`)9.
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`8
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`0
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`2 of 3
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1009
`
`

`

`256 140 Poisoning & metabolic dysfunction
`doses attar food ad)uated to
`Paget's disease: Smg/l<g as
`a slngle dally dose for
`maintain urinary cystone below
`200mg/lltl'1!. See literature.
`up to 6 months; doses above
`10mgfkg for up to 3 months
`CIT: Lupus erythematosus.
`may be used with caution
`Agranulocytosls, lhrombocytopenia.
`Pregnancy, lactation.
`but doses above 20mg/kg
`SIFT: Penrcillin sensitivity.
`dally are not recommended.
`Children: safety & efficacy
`Monitor blood, liver & renal functions
`frequently dunng treatment.
`not established.
`CIT: Moderate to severe renal
`Renal insufficiency.
`DI/NT: Gold salts, antimalarial or
`impairment, pre!Jf)ancy. lactation.
`cytotoxic drugs, phenylbutazone,
`SIP: Reduce dose in mild renal
`antacids, zinc or iron salts.
`impairment. Adequate nutritional
`intake, notably calclum & vit. D.
`ADR: Nausea, anorexia, fever, rash,
`loss of taste, proteinuria, haematuria,
`Enterocolitis. High-calcium
`food, milk, milk products, vitamins
`blood dyscrasias, nephrotic syndrome,
`with mineral supplements or
`SLE, myasthenia gravis.
`antacids should not be taken
`within 2 hours of administration
`DI/NT: Antacids, sminoglycosides,
`iron, calcium salts.
`ADR- Nausea. diarrhoea.
`asymptomatichypocalcaem1a,
`increased bone painin Paget's
`disease, increased risk o1 fractures
`with high doses in Paget's disease
`(discontinue if fracture occurs),
`rarely skin reactions, angio-oedema.
`abdominal pain, constipation.
`transient taste loss.
`
`RHONE-POULENC
`CALSYNAR
`Synthetic salmon calcitonin
`100i.u., per ml; amps.
`Paget's disease. Postmenopausal
`osteoporosis. Osteolytlc
`hypercalcaemla of mallgna.,cy.
`Metastatic bone pain.
`5 amps .• Rs. 850
`Paget's disease: 501.u. 3 times
`weekly to 1001.u. dally In sl~gle
`or divided doses by s.c. or
`l.m. ln)ectlon. Postmenopausal
`osteoporosis: 1001.u. dally by
`s.c. or l.m. In). Patients should
`also receive 600mg elemental
`calcium& 400 units vlt. D dally.
`Hypercatcaemla: 4001.u. 6-8 hourly
`by s.c. or l.m. In).; max. 81.uJkg
`every 6 hours. Metastatic bone pain:
`2001.u. 6 hourly or4001.u.12 hourly
`by s.c. or l.m. In). for two days.
`Children: Not recommended for
`periods of more than a few weeks.
`Cl/: Hypersensitivity.
`SIP: History of allergy-perform
`scratch test. Pregnancy. lactation.
`Cardiac. renal failure.
`DI/NT: Cardiac glycosides.
`ADR: Nausea, vomiting, flushing,
`tingling hands, unpleasant taste.
`Alferg_ic reactions.
`
`OESFERAL Novartis
`Desferrioxsmine 500mg; vials.
`Acute iron poisoning,
`haemochromatoses. Aluminium
`ovenoad In dialysis patients.
`Price.NIA
`Iron overload: 20-40mg/l<g
`subcutaneous Infusion OVf"
`8-12 hours administered 3-7 nights
`each -k . May also be given by
`Infusion llne when tr11nsfuslng
`blood up to 2g per unit of blood.
`see l iterature.
`CIT: Absence of excess Iron stores
`SIP: Impaired renal function.
`Pregnancy. lactation. Perform
`eye and hearing tests on long(cid:173)
`term therapy. May produce
`seizures in patients with
`aluminium-related encephalopathy.
`pretreat with clonazepam.
`DI/NT: Prochlorperazine, methyl dopa,
`erythropoietin. PhenothiBZl.·nes.
`ADR: Shock with rapid in}
`Rarely allergic reactions.
`cardiovascular, neurological &
`g·i disturbances. Red colouration
`of urine. Retinal & lens changes
`Leg cramps. Hepatic & renal
`dysfunction. Blood dyscrasias.
`
`ORONATE·OS BDH
`Etidronate disodium 200mg; tabs
`Neoplastic hypercalcaemia.
`Pagers disease of bone.
`10, Rs. 217.39
`Neopl astic hypercalcaemta:
`20mg/l<g as a sing le dally dose for
`30 days. Maximum recommended
`treatment period: 90 days.
`
`METABOLISM
`divided doses. Dosage ad)ustrnent
`at 4 weeks or more intervals.
`Not recommended tor chlldren
`below 18 years.
`Cll: Active liver disease.
`Pregnancy; adequate contraception
`must be used. Lactation.
`SIP: History of liver disease; test
`eye & perform liver function
`tests during treatment Withdraw
`if creatine phosphokinase levels
`markedly raised.
`DI/NT: Take 1 hour before or 4 hour
`after cholestyramine or colestipo/.
`lmmunosuppressive drugs, nicotinic
`acid, erythromycin, rifampicin,
`gemfibrozil & other fibrates.
`ADR: Rash, muscle toxicity,
`headache, no'?-cardiac chest pain,
`nausea. vomiting. diarrhoea, fatigue.
`
`LIPIGEM TORRENT
`Gemfibrozll 300mg; caps.
`Primary prevention ol coronary
`heart disease In men between
`40-55 years of age with
`hyperllpldaemla unresponsive
`to diet & other appropriate
`measures. Type Ila, llb, 111, IV & V
`dysllpldaemias resistant to diet.
`10, Rs. 69.90
`600mg twice dally 30 minutes before
`meals. Range: 900-tSOOmg dally.
`Not recommended for children.
`CIT: Hepatic dysfunction, gallbladder
`disease. Alcoholism. Pregnancy.
`lactation.
`SIP: Perform lipid profile, blood
`count & liver function tests before
`therapy Check blood count every
`2 mths. during 1st 12 mlhs. of
`therapy Monitor serum lipids
`periodically. Check eyes annually.
`Discontinue if abnormal liver
`function tests persist.
`DllNT: Anticoagulants. Statins,
`cotes ti pol.
`ADR: GI upset, skin rashes, mya/gla,
`impotence, headache, dizziness,
`painful ex1remities. blurred vision.
`Cholestatlc jaundice, angio-oedema,
`atrial fibrillation. pancrealitis.
`
`UPIZYL Nicholas Piramal
`Gemfibrozil 300mg; caps.
`l,!pid or lipoprotein abnormalities.
`(Type Ila, lib, Ill. IV & V dyslipidemlas)
`resistant to diet.
`20,Rs. 70
`600mg twice dally 30 minutes
`before meats. Max: 1500mg dally.
`Not recommended for children.
`Cl/: Severe hepatic or renal
`dysfunction, gallbladder diS88se.
`Hypersens. Alcoholism.
`Pregnancy, lactation.
`SIP: Perform lipid profile, blood
`count & liver func. tests before
`therapy. Check blood count BY&ry
`2monthsdurlng 1st 12monthsof
`therapy. Monitor serum lipids
`periodically Check eyes annually.
`Discont 1(abnormafliver
`function persists
`DI/NT· Anticoagulants
`ADR· GI upset, skin rashes. myalgia,
`impotence, headache, dizziness,
`painful extremities. blurred vision
`
`LOPIO Parke-Davis
`Gemftbroz11300mg; caps
`Pnmary prevention ol coronary
`heart disease In men between
`40-55 years of age with
`hyperttpldaemla unresponsive
`to diet & other appropriate
`measures.Type Ila, llb. 111, IV &V
`dyslipidaem1as resistant to diet.
`10. Rs. 99.a6
`600mg twice dally 30 minutes before
`
`MIMS INOIA DECEMBER 1998
`
`Desirable
`<52
`
`Abnorm
`6.5-7.8
`
`Hioh
`>7.8
`
`Desiri
`<2.3
`
`Borde
`2.3-4J
`"W)4a
`
`POI'
`
`j
`
`GLUTANEUROL Franco-Indian
`l·glutamic acid 500mg; tabs.
`Cerebral deficiencies. Psychosis.
`Epilepsy. Mongolism. Myxoedema
`Nocturnal enuresis.
`50, Rs. 39.20
`5-20 tabs. dally. See literature.
`
`GUGLIP Cipla
`Gugulip1d (equiv. to guggul(cid:173)
`sterones) 25mg; tabs.
`Hyperlipedaemia. Hypercholes·
`teraem1a. Hypertriglyceridaemia.
`15,Rs.25
`1 tab. thrice dally.
`SIP: Hepatic disease
`Diarrhoea, dysentery.
`
`KELFER Clpla
`Deferiprone 250mg, 500rng; caps
`Transfusion haemoslderosts,
`acute iron poisoning. iron overload
`in liver cirrhosis, diagnosis of
`iron-storage disease.
`250mg: 50, Rs 475; SOOmg· 50, Rs. 800
`S0-100mglkg body wt. dally In 2-4
`divi ded dOses. Children below
`2 years: not recommended.
`CIT: Pregnancy.
`SIP: Renal or hepatic impairment.
`ADR: Anol&xia, nau56a. vomiting.
`gastric discomfort, altered taste,
`musculo-sketetal & joint pain.
`agranulocytosis, zinc depletion,
`reversible neutropenla.
`
`LEUCOVORIN CALCIUM Biochem
`Leucovorin cal. 3mg, per ml; inj.
`Antidote for melhotrexate
`& folic acid antagonists.
`6 amps .• Rs. 93.50
`See literature.
`
`KEE PHARMA
`LIPOIP
`Lovastatm 20mg; tabs.
`Primary hyperchlolesterolaemla.
`Combined hypercholesterolaemla
`& hypertrlgtycerldaemla. Type ll·A
`& 11-B tamlllal hypercholesterolaemla.
`Ad)unct to diet to slow progression
`ot coronary atherosclerosis & reduce
`Incidence of cardiac events In
`patients with hyperchoteaterolaemla
`& coronary heart disease.
`10, Rs. 85
`Usually 10-40mg (average: 20mg)
`dally as single doae with
`evening meal. Max. starting
`dose: 80mg In single or
`
`
`3 of 3
`
`Taro Pharmaceuticals, Ltd.
`Exhibit 1009
`
`