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LEVOFLOX: Armed with Excellence

Qui nolones are a very important family of antibacterial agents that are widely prescribed for the treatment of infections i n humans. Since their discovery in the early 1960s, the quinolone group of antibacteri al has generated considerable clinical and scientifi c i nterest.

Levofloxacin is a synthetic chemotherapeutic antibiotic of the quinolone drug class and is used to treat severe or life-threateni ng bacteri al infections or bacterial i nfections that have failed to respond to other antibiotic cl asses. It i s a trusted and accepted mol ecul e for treati ng various respiratory tract as well as urinary tract infections. Recently, a hi gh-dose, short-course regimen (750 mg once daily for 5 days) of levofloxaci n has been developed with the aim of enhancing concentration-dependent bactericidal activity and reducing the potenti al for the emergence of resistance. The c onvenient once-daily dosi ng is of particular benefit i n those patients who may not be compliant. Levofloxacin is rapi dly bacterici dal and has a broad spectrum of activity, with a better safety and tolerability profile compared to other quinolones. Excellent bioavailability wi th both orally and i ntravenously available forms advances i ts use for treati ng various difficult-to-treat i nfections.

Levofloxacin is one of the respiratory fluoroqui nolones that is recommended by international guidelines like IDSA, ATS and ERS for treating various respi ratory tract infections. The mol ecul e, due to i ts excellent tissue concentrations in the urinary tract, is also recommended by the European Association of Urology (EAU) for treating various complicated and uncomplicated urinary tract i nfections. Levofloxacin is approved for treati ng nosocomial and community-acquired pneumoni a, acute bacterial sinusitis, acute bacterial exacerbation of chroni c bronchi tis, complicated/uncomplicated skin and ski n structure infections, chronic bacteri al prostati tis, complicated/uncomplicated uri nary tract i nfections, acute pyelonephri tis, and inhal ational anthrax (postexposure).

LEVOFLOX (Levofloxacin) is currently available as 250 mg, 500 mg and 750 mg oral tablets, and a 500 mg intravenous (I.V.) i nfusion. The usual dose of l evofloxaci n tablets is one tablet every 24 hours, while the I.V. solution is to be administered by slow i nfusion over 60 minutes every 24 hours.

Cefoprox CV: The extra whenever you need

The most important concern i n the management of upper respi ratory tract i nfections (URTIs) is Antibiotic resistance.

Worldwide evidence suggests that inappropri ate antibiotic use for non-severe URTIs, most of which are viral, adds to the overall burden of antibiotic resistance, a phenomenon which is becoming more prevalent. This resistance to antibioti cs consti tutes a major threat to public health. Nowadays, the resistance pattern for Cefpodoxime in Indi a for various pathogens is on the i ncreasing trend such as for E.coli (85%), K. pneumoniae (65%), S. aureus (60%), P. aeruginosa (100%), A. baumanni i (67%) etc.

Therefore reintroduction of currentl y availabl e penicillins and cephalospori ns along wi th other agents such as lactamase inhibi tors is an attractive opportunity for many reasons: Well established safety and efficacy profile, Production of -l actamase is the most common mechanism of resi stance to -lactam antibiotics, especially in gram negati ve bacteria, Convenience of use, and more essenti ally an understandi ng that using such combination empi rically may help in not only overcome therapeutic failures due to resistant bacteria but will also delay resistance development in susceptibl e bacteri a.

Hence the combination of Cefpodoxime (3

rd

generation cephalospori n) and Cl avul anic acid (-lactamase inhibi tor)

provides a sol ution for treatment of bacterial i nfections caused by beta lactam resistant pathogens.

CEFOPROX CV is a combination of a thi rd generation -l actam antibiotic Cefpodoxime proxetil 200 mg along wi th a -lactamase inhibi tor Cl avul anic acid 125 mg.

DOSAGE AND INDICATIONS

Adults and Adolescents (aged 12 years and older) Type of infections Pharyngi tis and/or tonsillitis Acute community-acquired pneumoni a Acute bacteri al exacerbations of chroni c bronchi tis Skin and skin structure 800 mg 400 mg q12 hours 7-14 days 400 mg 200 mg q12 hours 10 days Total daily dose 200 mg 400 mg Dose frequency 100 mg q12 hours 200 mg q12 hours Duration 5-10 days 14 days

Acute maxillary si nusi tis Uncomplicated uri nary tract infection

400 mg 200 mg

200 mg q12 hours 100 mg q12 hours

10 days 7 days

*Dose of CEFOPROX CV Tablets is based on the cefpodoxime component.

KEY HIGHLIGHTS

1.

More potent in vitro activi ty i n comparison to amoxicillin+ cl avulanic acid against -lactamase producing strai ns of Gram-positive and Gram-negative bacteri a.

2. 3. 4.

8-fold reduction in MIC against ESBL-positi ve organism has been observed. The combi nation extends the antibiotic spectrum and enhances the activity of cefpodoxime. Highl y effective combination i n Swi tch Therapy.

April 2011

Montair FX: For an Active, Non-Sedative Day in AR

Allergic Rhi nitis (AR) is a common disease worldwide, affecting about 1050% of the population. It exacts a toll on a patient's quality of life, cognitive and learni ng functions, decision-making and sel f-perception and, if left untreated, can contri bute to co-morbiditi es, including asthma, sinusitis and oti tis media wi th effusion or the development of nasal polyps.

MONTAIR FX is a combi nation of an antileukotri ene montelukast 10 mg wi th the second generation antihistamine fexofenadi ne 120 mg.

Montelukast is a sel ective and orally active leukotriene receptor-antagonist that i nhibits CysLT

wi th 24-hour

action. It has been shown to decrease the number of eosi nophi ls in the blood of patients with AR, suggesti ng a decrease in the i nflammation and improvement in daytime and night-ti me symptoms as well as to i mprove the disease-rel ated quality of life.

Fexofenadine hydrochloride, a second-generation anti histamine, is the pharmacological metabolite of terfenadine and a potent and selective antagonist of peripheral H 1 -receptors. It has an earl y onset of action as compared to levocetirizi ne, and causes a significantly higher reduction in the wheal si ze after 3 to 6 hours when compared to desloratadi ne. Fexofenadine is as effective as the popular antihistamine, ceti rizine, but it l acks the sedating effects associ ated with ceti rizine. Thi s is because of its inability to cross the bloodbrain barri er. Fexofenadi ne is also superior to loratadine in improving nasal congestion, ocular symptoms and the quality of life for patients with AR.

The combi nation of montelukast and fexofenadine has been shown to be superior to monotherapy in a randomi zed, double-blind, multicentred, prospective study wi th 275 adult patients in terms of reduction in nasal obstruction, nasal resistance as well as in daily symptoms and also offered higher pati ent satisfaction.

Thus with the i ntroduction of MONTAIR FX , there opens up another treatment option for pati ents with AR who want complete control along with no sedation.

March 2011

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ROKFOS: Infusing life into Bones

Osteoporosis is a progressive systemic disease resul ting in increased bone fragility and susceptibility to fractures at vertebral and nonvertebral si tes.

Therapeutic adherence is a key factor influencing the effectiveness of treatment i n chronic diseases where the effects of the therapy can only be seen after a long-term application of drugs or are subjectively not perceived at all.

The situation is even more complicated i n chronic asymptomati c diseases like hypertension or osteoporosis.

Once yearly dosi ng wi th Zoledronic acid is a new al ternative in the therapy of osteoporosis and represents an important step towards an improvement in the adherence to treatment.

Cipla introduces ROKFOS , once yearly Zoledroni c acid 5 mg for the management of osteoporosis.

ROKFOS is indicated for:

y y y y

Treatment and Prevention of post-menopausal osteoporosis. of post-menopausal osteoporosis Treatment to i ncrease bone mass in men with osteoporosis. Treatment of Paget's disease of the bone. Prevention & treatment of glucocorticoid induced osteoporosis.

The recommended dose is a single intravenous infusion of 5 mg Zoledronic acid admi nistered once a year given over no less than 15 mi nutes. However, for prevention of postmenopausal osteoporosis, the recommended dose is a 5 mg infusion given once every 2 years i ntravenously over no less than 15 mi nutes.

March 2011

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VANLID 250: Hands down Victory against MRSA

Staphylococcus aureus ( S. aureus) is an important pathogen that frequently causes clinical disease in children. A wide array of illnesses can be caused by this common pathogen ranging from non-invasi ve skin infections to severe, life-threatening sepsi s. Additionally, as anti bacterials have been used to eradicate S. aureus , i t has developed resistance to these important therapeutic agents. Growing bacteri al resistance means that what were once effective and inexpensive treatments for infections caused by these bacteri a are now bei ng seriously questioned.

Methicillin-resistant S. aureus (MRSA) has become an increasing problem i n pediatric pati ents over the past decade. A new type of staphylococcus, usually termed community-acquired MRSA (CA-MRSA), which i s resistant to fewer antibiotics compared to the HA-MRSA, has also emerged i n the paediatric age group.

Vancomyci n was introduced in 1958 and has been a useful antibiotic for about 50 years. The recent advent of MRSA has provided a renai ssance for this glycopeptide. Over the years, vancomycin has become the mainstay of MRSA i nfection therapy and thus, is the primary therapeutic option i n severe, life-threateni ng invasive MRSA infections.

Several literatures have shown vancomycin to be clinically and microbiologically (i ncl udi ng the resistant Gramposi tive organisms) consistently very effective across all infections caused by presumed or documented resi stant Gram-positive pathogens across all paediatric age groups, including neonates. Vancomycin is well-tol erated and safe in paediatric patients i ncl udi ng in the criti cally ill neonates.

VANLID 250 i s India's First vancomycin I.V. wi th the right strength of 250 mg for paediatric pati ents. VANLID 250 is a chromatographically purified and lyophilized product.

VANLID 250 i s i ndicated for the treatment of staphylococcal infections like lower respiratory tract i nfections (like pneumoni a), septicaemia, ski n and soft tissue i nfections and osteomyelitis. It is also indicated for treatment of endocarditis caused by Staphylococci, Streptococcus viridans* or Streptococcus bovis* and Enterococci (e.g. E.faecalis ),** and Diphtheroids , for the treatment of early-onset prosthetic val ve endocarditis caused by Staphylococcus epidermidis or diphtheroids $ and as prophylaxisagainst endocardi tis i n patients at risk from dental or surgical procedures.

In paedi atric patients, the usual I.V. dosage of 10 mg/kg per dose is recommended every 6 hours (total daily

dosage 40 mg/kg of body weight). In neonates and young infants, an ini tial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours in the fi rst week of life and every 8 hours thereafter until 1 month of age. Longer dosi ng intervals may be necessary in premature i nfants. Each dose should be administered over a period of at l east 60 mi nutes.

Parenteral form of vancomci n can be admi nistered orally for treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile and Staphyl ococcal enterocolitis.

Orally, VANLID 250 I.V. can be administered usi ng 40 mg/kg body weight in three or four divided doses for 7 10 days. The total daily dose should not exceed 2 g.

Dosage adjustment must be made in patients wi th i mpai red renal function.

*Vancomycin alone or in combination with an aminoglycoside **Vancomycin only in combination with an aminoglycoside $ Vancomycin in combination with either rifampin or an aminoglycoside or both

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VC 15: Healthy Skin Expert

Vitamins such as A, C and E are naturally present in human skin. These vitamins are part of a complex system of enzymatic and non-enzymatic antioxidants that protect the skin from harmful reactive oxygen species. However, the skin is subjected to substanti al envi ronmental free radical stress from sunlight, pollution and smoking, all of which deplete the dermal stores of naturally occurri ng antioxidants. To replenish these losses, vitamins should be applied topically on the skin.

Vitamin C (L-ascorbic acid) is the body's major aqueous phase antioxidant and is vital for life. Oral supplementation wi th Vitamin C does little to increase ski n concentration because active transport of vitami n C from the gastrointestinal tract is limited. Therefore, topical application of vitamin C i s the preferred method to increase its presence in the skin.

Vitamin C is an excellent antioxidant that sequentially donates electrons, thereby neutralizing free radicals present i n the aqueous compartment of the cell. Along with its antioxidant property i t has also got photoprotective, depigmenti ng and anti-i nfl ammatory properties. Vitamin C also provides the additional advantages of replenishing vitamin E and sti mul ating dermal collagen synthesis, a major target i n chronic photoagi ng.

VC 15 contai ns L-ascorbic acid at a concentration of 15%. It is a stable formul ation with a pH of 2.7. VC 15 promises to be non-i rritating and non-comedogenic. It i s availabl e i n a bottle of 15 ml along wi th a dropper.

VC 15 is i ndicated for photodamaged/ agi ng ski n, mel asma/ hyperpigmentation, acne and acne scars and post procedure i nfl ammation.

Properties supporting clinical uses of topical vitamin C (VC 15)

Clinical Uses Photodamaged/Aging skin Dry ski n Moisturization

Properties

Dull complexion, rough texture

Photoprotection and antioxidant

Fine lines and deep wrinkles

Collagen synthesis and antioxidant

Age spots Melasma/hyperpigmentation Acne and acne scars

Depigmentation and photoprotection Depigmentation and photoprotection Antioxidant, anti-i nfl ammatory and collagen synthesi s

Post-procedure inflammation

Antioxidant and anti-i nflammatory

VC 15 should be used once daily in the morni ng. Wi th the help of the dropper, take 7 to 10 drops of VC 15 onto your fingertips. Then, dab the serum onto your face and neck and gently massage until it is compl etel y absorbed.

VC 15 should be used wi thin one month after openi ng the bottl e.

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ENTAVIR: Persistent Efficacy in Treating Chronic Hepatitis B

Chronic hepatitis B is a worldwide public heal th challenge, approximately 2 billion people worldwide have been infected by hepatiti s B vi rus, and more than 350 million are chronic carri ers.

The pri mary goal in chronic hepatitis B treatment is to reduce serum HBV DNA level to the lowest possible level (undetectable) and thereby decrease the risk of developing liver cirrhosis and liver cancer.

Entecavir (ETV), a guanosine nucl eoside analogue, is a potent and selective i nhibitor of hepatitis B virus replication wi th around 94% patients continui ng to remai n HBV DNA undetectabl e and 80% patients wi th normalization of liver enzymes at the end of 5 years of continuous entecavi r therapy. Entecavir resi stance is rare in nucleoside-nave pati ents, around 1.2% after 6 years of treatment. It is recommended as a first line treatment in l ami vudine-nave chronic hepati tis B patients.

Long-term entecavi r therapy leads to potent suppression of HBV DNA, normalization of ALT and improvement in liver histology wi th accompanying regression of fibrosis, including those wi th advanced fibrosis or cirrhosis at baseline. Recent studi es have shown that entecavir has al so been successful i n preventing acute liver failure in patients of acute hepatitis B and progression to chronic hepatitis B. It can also be safely and effectively used i n HBV infected patients pre or post renal transpl ant without any renal compromise.

ENTAVIR (entecavi r) is a film coated tabl et for oral use and is available in two dose strengths of 0.5 mg and 1.0 mg whi ch have specific indications in patients of chronic hepati tis B as mentioned below.

ENTAVIR tabl ets are i ndicated for the treatment of chronic hepatitis B virus i nfection in adults(= 16 years of age ) with evidence of acti ve viral replication and either evidence of persi stent elevations in serum ami notransferases (ALT or AST) or histologi cally acti ve disease.

ENTAVIR tabl ets should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).

Recommended Dosage

Compensated Liver Disease

The recommended dose of entecavir for chronic hepati tis B vi rus i nfection in nucleoside treatment-nave

adults and adol escents 16 years of age and older is 0.5 mg once daily.

The recommended dose of entecavir in adults and adol escents (at l east 16 years of age) wi th a history of hepatitis B viremia while receivi ng lamivudine or known l amivudi ne or telbivudine resistance mutations rtM204I/V wi th or wi thout rtL180M, rtL80I/V, or rtV173L i s 1 mg once daily.

Decompensated Liver Disease

The recommended dose of entecavir for chronic hepati tis B vi rus i nfection in adults with decompensated liver disease is 1 mg once daily.

Dosage adjustment is recommended for pati ents wi th creati nine clearance l ess than 50 mL/min, incl udi ng pati ents on hemodi alysi s or continuous ambulatory peritoneal dial ysis (CAPD).

The optimal duration of treatment wi th entecavi r for pati ents with chronic hepatitis B virus i nfection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.

January 2011

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FORACORT AUTOHALER- Make a Smarter Choice

Foracort Autohaler is the world's fi rst breath-actuated inhaler containing a combi nation of formoterol wi th budesonide.

Foracort Autohaler contains 6 mcg of formoterol and 200 mcg of budesonide. This combination is an effecti ve and conveni ent option for the maintenance treatment of patients with asthma in whom dual asthma mai ntenance therapy is warranted. The use of formoterol wi th budesonide for both daily maintenance therapy and as-needed relief of breakthrough symptoms usi ng a si ngl e i nhaler is a new approach to asthma management and is indicated in patients wi th persistent asthma. Thi s treatment strategy significantly reduces the rate of severe asthma exacerbations compared with the traditional approach of using an inhaled corticosteroid with long-acting beta agonist (ICS/LABA) wi th a short-acting beta agonist (SABA) and achieves equi valent daily symptom control compared with high dose of ICS/LABA plus separate SABA for relief.

Foracort is al ready available as a dry powder inhaler (DPI) in the form of Rotacaps to be used with a Rotahal er or a Revolizer and as a pressurised metered dose inhaler (pMDI).

The Autohaler overcomes the key probl em of the pMDI viz. coordination of actuation with inhalation and does not rely on the pati ent`s inspiratory effort to aerosolize the dose of medication unlike dry powder i nhal ers. Autohal er is acti vated at low flow rates of 22-30 l/sec. Studi es have shown that the Autohaler is easi er to use and to teach as compared to pMDIs and some of the DPIs. It can also be used by children who are wheezing, older patients with severe airflow obstruction and those wi th arthriti s. Autohaler contains 300 doses, which ensures long term medication for the patient, thus offers better adherence and compliance.

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MOXICIP KT: Where power Breeds Safety

Indi a has experienced an exponenti al increase in the number of cataract surgeries. An estimated 0.5 million cataract surgeries were done in 19811982; thi s i ncreased to 4.8 million i n 2006 wi th 90% intraocular lens acceptance. Infl ammation has always been accepted as a natural consequence of the cataract surgical procedures and also these procedures are associ ated wi th a risk of infection. These consequences are generally treated wi th anti-infl ammatory (steroids) and anti-i nfective eye drops. But the adverse consequences associ ated with long term use of steroids and the resistance and effi cacy issues associated with the use of older generation antiinfectives warrants the need for a combination wherei n Power Will Breed Safety.

MOXICIP KT contai ns Moxifloxacin, a genetically smart, broad spectrum fluoroquinolone and Ketorol ac a potent anti-infl ammatory and analgesic non steroidal anti i nflammatory. The combination of these drugs has positive therapeutic effect on postoperative i nflammation and prevention of postoperative infection following cataract surgery. Also the presence of an anti-i nfl ammatory and antibiotic agent in a si ngle ophthalmic product overcomes any potential 'washout effect' that may be seen when separate medications are used. In addition, the combination also leads to better compliance, patient comfort and safety. The reduced number of admi nistrations with this combi nation may be of particul ar benefi t for elderly patients, who make up the majority of cataract surgery cases.

MOXICIP KT contains Moxifloxacin 0.5% (anti-i nfective) and Ketorolac 0.5% (anti-inflammatory non steroidal). It i s the World's fi rst antibiotic and NSAID combi nation to be preservative free and with HEC (Hydroxyethyl cellulose). HEC is a polymer which acts as a viscosity enhancer improvi ng the retention time of the drug.

INDICATIONS For NSAID-responsive inflammatory ocul ar conditions for which a NSAID is indicated and where bacterial i nfection or a risk of bacteri al ocular infection exists.

The use of a combination drug wi th an anti- i nfective component is i ndi cated where the ri sk of superfici al ocular infection is hi gh or where there is an expectation that potential ly dangerous numbers of bacteri a will be present in the eye.

DOSAGE AND ADMINISTRATION One drop in affected eye three times a day

MOXICIP KT: Highlights

First a Combination of

o o y y y y

Moxifloxacin: A broad spectrum, potent, 8 methoxy fluoroquinolone. Ketorolac: A potent anti i nfl ammatory and analgesic agent

A combi nation wi th HEC advantage which i ncreases the drug retention time A combi nation wi th no preservati ve which resul ts i n No corneal toxicity A combi nation which can be used for wide array of indications A combi nation which will provide Pati ent compliance and Long term usage.

December 2010

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LACSYP: Differences Do Matter

Consti pation affects almost everyone at one ti me or another and is a symptom caused by various factors that are not always discernable. Constipation is marked by a multi tude of presentations, ranging from an i nability to pass stools to less than three stools i n a week. Pati ents often i ncl ude difficulty in passing stools, hard stool s, and the sensation of incompl ete bowel movement as constipation.

Although constipation is more often than not a temporary condition, it affects around 30% of the population at some point of time. Very commonl y, constipation is caused due to lifestyl e choices such as inacti vity, low fiber, ignoring the urge, or even dehydration. However, medication, surgeries and pregnancies are also common causes of constipation. Though the symptoms associ ated wi th constipation are often intermittent and mild, they may be chronic, difficult to treat and debilitating.

Lacsyp (lactitol ) is a second-generation disaccharide agent used frequently as a laxative. Described first i n 1979, this pl easant tasti ng, non-absorbabl e sugar is used as an arti ficial sweetener in food preparations. Like its analog, lactulose, lactitol too is used for the treatment of hepatic encephalopathy and constipation. Both have been shown to be equally efficacious; however, lactitol i s without certain discomforts associ ated wi th l actulose. Although effective, many patients are intolerant to l actulose because of its nauseatingly sweet taste and, quite often, the intestinal discomfort associ ated with bloati ng and abdomi nal pain adds an unnecessary burden on patients.

The predictable cathartic effect of lactitol, unlike l actulose, has made it the clear choi ce of pati ents in comparative trials. Rapid resolution of hepatic encephalopathy, an end-stage liver disease complication, extends the benefits of thi s non-absorbabl e sugar beyond pati ent tol erability and palatability. Being non-absorbable, the potential for systemic side effects are limited. Dosi ng wi th this agent has no effect on the blood sugar levels even i n patients with diabetes.

Lacsyp offers a sweet and preferred option to manage conditions from as troubl esome as constipation to serious condi tions like hepatic encephalopathy.

December 2010

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Vertipress - Suppressing Vertigo, Balancing Lives

Vertigo or gi ddi ness is a disturbance of the sense of equilibrium and movements, where the person feels that either his surroundi ngs are going round him or he himself is rotating. The symptoms of vertigo are due to dysfunction of the vestibular system in the i nner ear. Defini tive treatment of vertigo depends on treating the underlyi ng cause.

Vertipress (Betahisti ne hydrochlori de) is a drug indicated i n the treatment of Meniere's disease and more generally of peripheral vertigo disorders of di fferent ori gins. Addi tionally, betahistine also takes care of ti nnitus and deafness associ ated with Meniere's disease.

The mechanism of action of betahistine is based on its interacti on wi th H weak H

1

and H 3 receptors. Betahisti ne has a

receptor agonist action and a potent antagoni stic effect on H

receptors.

Dosage and administration: Ini tial oral treatment is 8 to 16 mg three times daily, taken with food.

Maintenance doses are generally in the range of 24 mg to 48 mg daily.

Vertipress is not recommended for use in i ndividuals below 18 years of age.

December 2010

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Febucip The Selective, Non-purine XO inhibitor

Gout is a disorder of puri ne metabolism and resul ts from urate crystal deposition i n and around the joints caused by longstandi ng hyperuricaemia.

Febuxostat is a xanthine oxi dase inhibi tor and achieves i ts therapeutic effect by decreasing serum uric acid (sUA). It i s the fi rst agent approved i n the Uni ted States for the treatment of gout since allopurinol was first marketed in 1964. It is

y y y

Non-purine analogue - does not structurally resemble purines and pyrimidi nes. Selective selectively inhibits xanthi ne oxidase and not the other additional enzymes of the puri ne and pyri midine pathway. Potent inhibi ts both the oxidized and reduced forms of xanthine oxidase.

Febuxostat is indicated for the chronic management of hyperuricaemia in patients wi th gout.

For the treatment of hyperuricaemi a i n patients with gout, FEBUCIP is recommended at a dosage of 40 mg or 80 mg once daily.

The recommended starting dose is 40 mg once daily. For pati ents who do not achieve a sUA < 6 mg/dL after 2 weeks wi th 40 mg, FEBUCIP 80 mg is recommended. FEBUCIPcan be taken without regard to food or antacid use.

Gout flares may occur after i niti ation of FEBUCIP due to changing sUA levels, resulti ng in mobilization of urate from tissue deposi ts. Fl are prophyl axi s with an NSAID or colchi cine is recommended upon i niti ation of therapy with FEBUCIP . Prophyl actic therapy may be benefici al for up to 6 months. If a gout flare occurs duri ng FEBUCIP treatment, they need not be di sconti nued. The gout flare should be managed concurrentl y, as appropriate for the individual patient.

Febuxostat is contraindicated i n patients being treated with azathioprine, mercaptopuri ne or theophylline.

No dose adjustment is necessary in pati ents wi th mild or moderate renal and hepatic impai rment . Caution should

be exercised i n severe renal and hepatic impairment patients.

FEBUCIP is available in 2 strengths - 40 mg and 80 mg.

November 2010

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SORNIP cream Answering the Unanswered

Psoriasis is a lifelong disease that waxes and wanes over time. It affects 1 to 3% of the world's population. People with psori asi s have to live with this chronic di sease for which there is no known cure. Adequate treatment can, however, relieve the symptoms and maintai n remission. During thei r lifetime, patients will undergo a range of treatment options to achi eve the desi red goals.

Vari eties of systemic and topical agents are available for the treatment of psoriasis, but the l atter remains the mainstay of treatment for most patients, especi ally those wi th limited disease. But, many of these agents have certai n limi tations.

There is a constant research for an optimum therapeutic option. An innovative formul ation, SORNIP cream which contains the resi n extract of the Boswellia serrata tree is i ntroduced for the treatment of mild to moderate psori asi s. The active i ngredient inSORNIP cream is the 3-0-acetyl keto beta boswellic acid.

SORNIP cream has beneficial effects i n psoriasis because of its anti-i nfl ammatory and immunomodulatory activity; thus, i t slows down or normalizes the excessi ve keratinocyte proliferation and reduces the inflammation associ ated with psori asi s.

SORNIP cream can be used as a monotherapy to treat mild and localized psoriasis. It may have a potential to be used as a combination therapy for pati ents with moderate and severe disease. It can also be used duri ng the steroid-free holiday periods and as a maintenance treatment option.

SORNIP cream is required to be applied as a thi n l ayer on the psoriati c l esions three times daily (of which one application should be before bedti me).

It i s availabl e i n a 30 gm lami tube pack.

October 2010

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Cipla Launches PIRFENEX (Pirfenidone 200 mg) in India for Idiopathic Pulmonary Fibrosis

Idiopathi c pulmonary fibrosis (IPF) is an i nevi tably progressive form of lung disease, wi th a dismal prognosis for which, until recently, there were no effective and approved treatments.IPF has a medi an survival from diagnosis of 2.8-4.2 years which is less than many cancers. In idiopathi c pul monary fibrosi s, epithelial injury by an unknown inciting agent in a susceptible host and abnormal wound healing leads to fibroproliferative and infl ammatory changes in the l ungs. Eventually this leads to severe dyspnoea i n the patient with most patients dyi ng of respiratory failure.

PIRFENEX (Pirfenidone) is the first and only approved drug for the treatment of IPF. Pi rfenidone exerts i ts effect by down regulati ng the transcription of key profibrotic growth factors including TGF- , reducing inflammatory cytoki nes such as TNF-E and through reduction i n lipid peroxidation and oxidative stress. It is a novel anti-fibrotic drug which through clinical tri als has shown to slow down progression of this terminal disease as measured by decline i n forced vital capaci ty over 36-72 weeks and stabilizes lung function. As per a recent Cochrane analysis, pirfeni done is the onl y drug which improves progression free survival in IPF patients by 30%. In general, in these clinical trials, pirfenidone was safe and well tolerated.

Hence i ntroduction of pi rfenidone offers hope and opens up a new path in the treatment of IPF patients.

PANSTAL: Ensures the Real Value of Food

Pancreatic Exocri ne i nsufficiency (PEI) is caused by a generalized reduction i n pancreatic enzyme production and delivery, l eadi ng to severe i mpairment in fat absorption with steatorrhoea (greasy foul smelling stools).

PEI is associ ated wi th conditions like chronic pancreati tis, after pancreatic or major gastro i ntestinal surgery, obstruction of pancreati c or common bile duct and cysti c fibrosis.

Symptoms and signs other than steatorrhoea include abdominal cramps after meals, abdomi nal bloating, malabsorption, weight loss and even chronic mal nutri tion if left untreated. About 80% of patients after pancreatic surgery and 50% of patients with chronic pancreati tis develop PEI associ ated maldigestion in 10 to 12 years from the onset of the disease. Hence recognition of this condition and an appropriate replacement therapy is highly relevant to avoid malnutrition-rel ated morbidi ty and mortality.

The management of PEI i ncl udes correction of the underlying cause or di sease, di etary supervi sion and oral admi nistration of pancreatic enzyme repl acement therapy (PERT).

PERT aims at provi ding pancreatic enzymes i n the duodenal lumen with sufficient active lipase at the time of gastric emptying of nutrients. These pancreatic enzymes then help break down fats, proteins and carbohydrates in food, thereby acting as a replacement for digesti ve enzymes physiologically secreted by the pancreas.

Key highlights: PANSTAL CAPSULES

y y y

Have enteric-coated granules to avoid acid-mediated i nacti vati on of lipase and ensure gastric emptying of enzymes in parallel with nutri ents. Release the active pancreatic enzymes withi n the proximal intestine with a hi gh therapeutic efficacy. Are widely accepted as the therapy of choi ce for mal digestion secondary to pancreatic exocri ne insuffici ency of any aetiology.

Each capsule contains: Pancreatin IP 150 mg equivalent to: Lipase .. 10,000 PhEur uni ts Amylase 8,000 PhEur units Protease 600 PhEur uni ts (as enteri c coated granules)

PANSTAL Capsules are i ndicated for patients wi th pancreatic exocri ne i nsufficiency, which is often associ ated with the following: chronic pancreatitis , after pancreatectomy or gastrointestinal bypass surgery, ductal obstruction from a neoplasm (pancreas or common bile duct) and cystic fibrosis.

The dosage of PANSTAL Capsules should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.

Generally for children (below 6 years of age) usual i nitial starting dosage is up to onePANSTAL Capsule per meal or snack. For adults and children (over 6 years of age) the usual i nitial starting dosage is one to two PANSTAL Capsules per meal or snack.

PANSTAL Capsule should be taken during meals or snacks , wi th suffici ent fluid. The capsules can be swallowed whole, or for ease of admi nistration they may be opened and the granules taken with fluid or soft food (apple puree or mashed vegetables) but wi thout chewi ng followed with a gl ass of water or juice to ensure compl ete ingestion.

October 2010

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Rosulip-F: A Class Apart Combination

Stati n therapy is cl early established as an effective treatment for loweri ng LDL-C levels and is the cornerstone of dyslipidemi a management. However, 60% of vascular complications still occur despi te statin therapy. Hence, this means that a particular residual risk still persists which we must effectively address to reduce the clinical and economic burden. This residual risk can be effectively tackl ed with a statin-fibrate combination. Also, statin and fenofibrate therapy have been associated wi th reduction in the risk of various macrovascular and microvascular complications of diabetes.

Rosuvastatin is the most potent statin wi th a safety profile comparable to other statins, while fenofibrate is effective i n loweri ng TG and i ncreasing HDL-C. The combination ofrosuvastatin and fenofibrate therefore constitutes an optimal therapeutic approach for providing optimal treatment of atherogenic dyslipidemia and managing vascularcomplications.

ROSULIP-F i s availabl e i n two strengths: ROSULIP-F5 (5 mg rosuvastatin wi th 145 mg fenofi brate) and ROSULIP-F10 (10 mg rosuvastati n with 145 mg fenofibrate).

INDICATIONS ROSULIP-F i s i ndicated as an adjunct to diet for treatment of mixed dyslipidemi a, hyperchol esterolemi a and hypertriglyceri demi a.

DOSAGE AND ADMINISTRATION Patients should be placed on an appropri ate lipid-lowering di et before receivi ngROSULIP-F , and should continue this di et during treatment. The recommended dosage is one tablet once daily

ROSULIP-F cannot be used to i niti ate dosing i n patients having mild to moderate impaired renal function and should be admini stered onl y after evaluati ng the effects of rosuvastatin and fenofibrate on renal function and lipid levels.

October 2010

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Pararcip: Infusing Relief

Pain is a major concern i nfl uenci ng every aspect of life. Pain is often called the fifth vi tal si gn i n conjunction wi th temperature, pulse, respiration and blood pressure. Though pain serves the useful purpose of warning it imposes several emotional, physi cal and economical stresses on the patient. Thereby, there is a need to ease the sufferi ng and i mprove the quality of life of those living with pain.

Introducing PARACIP solution for infusion, containing 1g paracetamol for intravenous i nfusion.

Paracetamol has been widely used for over a century as an effecti ve analgesic and as an antipyretic agent. Its efficacy and tolerability are well established and i n contrast to other analgesics, i t has a favourable safety profile.

PARACIP can also be used as an effective component in mul timodal analgesi a i n combination with opioids and NSAIDs.

PARACIP sol ution for i nfusion is indicated for

y y

The short-term treatment of moderate pai n, especially following surgery The short-term treatment of fever, when administration by i ntravenous route is clinically justifi ed by an urgent need to treat pai n or hyperthermia and/or when other routes of admi nistration are not possible.

DOSAGE AND ADMINISTRATION

PARACIP i s available as a 100ml sol ution for i nfusion containi ng 1g paracetamol.

PARACIP should be administered as a 15-mi nute i ntravenous infusion, and is for single use in one patient only.

PARACIP sol ution for i nfusion should not be mi xed with other medici nal products

Paracetamol 1 g per administration, i.e. one 100 ml vial, can be used up to four times a day. The minimum interval between each admi nistration must be 4 hours in patients without hepatic impairment. In patients with renal and/or hepatic impairment the minimum interval between doses must not be less than 6 hours.

The maxi mum daily dose from all sources of paracetamol must not exceed 4 g.

September 2010

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FLOSOFT: Smart & Safe

Infl ammation is the body's protective response to a stimulus it recognizes as offensive. While infl ammation is protective for the body as a whole, the i nfl ammatory processes can cause scarring and damage to the surroundi ng healthy ti ssue. Corticosteroids are used to preserve the normal structure of the tissues. They were developed in the 1940s, and till date remain the most potent agents for managing i nfl ammation. Fluorometholone is one such steroi d used for the management of inflammatory and allergic condi tions of the eye.

Earlier fluorometholone was available as an alcohol derivative but now even the acetate derivative is available. The derivati ves of steroid base (acetate, alcohol and phosphate) i nfl uence the bioavailability i.e. they determi ne the ability of steroid to penetrate the anterior chamber. Acetate and Alcohol derivatives are soluble in hydrophobic media whereas phosphate derivative is sol uble i n hydrophilic media. In the normal eye, an acetate deri vati ve penetrates the best through the cornea, followed by alcohols, and then phosphates.

The derivati ves of steroid base (acetate, alcohol and phosphate) also i nfl uence the bioactivity of that steroid so accordingly fluorometholone acetate shows superior anti i nfl ammatory activity in the cornea than fluorometholone alcohol.

FLOSOFT contains Fluorometholone acetate 0.1%. It is the World's fi rst formulation wi th SOC (Stabilized Oxychlorocompl ex) as the preservative. SOC is introduced as an ophthalmi c preservative i n 1996. Once it enters the eye, it breaks into water and salt i.e. sodium and potassium ions (NaCl), these components are already found in natural tears. Also i t has no effect on mammalian cells. Hence i t is more comfortable than other preservatives (Benzalkonium chloride).

INDICATIONS FLOSOFT (fluorometholone acetate ophthal mic suspension) is indicated for use in the treatment of steroid responsive i nflammatory condi tions of the palpebral and bulbar conjuncti va, cornea, and anterior segment of the eye.

DOSAGE AND ADMINISTRATION Shake Well Before Using. One to two drops i nstilled into the conjunctival sac(s) four ti mes daily. During the initial 24 to 48 hours the dosage may be safel y i ncreased to two drops every two hours. If no improvement after two weeks, consult physician. Care should be taken not to discontinue therapy prematurely.

FLOSOFT: Highlights

1. 2. 3. 4. 5.

World's first formulation of Fl uorometholone acetate with SOC as a preservati ve Particle Si ze between 1-3 : Uniform Particle distribution and No agglomeration As effecti ve as Prednisolone and Dexamethasone in reducing corneal inflammation Shows superior anti i nfl ammatory effect i n the cornea as compared to Fluorometholone al cohol Fluorometholone acetate has low propensity to elevate IOP, therefore

o o o

Can be given to old age pati ents suffering from gl aucoma Can be given to Steroid responders Can al so be given in chroni c therapy, requi ring longer period of ti me

September 2010

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IMUDROPS: TREAT BEYOND THE SURFACE

Dry eye is a multifactorial disease of the tears and ocul ar surface that results in symptoms of discomfort, visual disturbance and tear film instability with potenti al damage to the ocul ar surface. It is accompanied by i ncreased osmolari ty of the tear film and inflammation of the ocular surface.

A number of anti-i nfl ammatory agents have been evaluated for treatment of patients with dry eye, including cyclosporine-A, pimecrolimus, tacrolimus, and corticosteroids.

Cyclospori ne may represent the first product for dry eye that actually treats the cause and not the symptoms of dry eye.

To i mprove delivery of cyclospori ne to ocular tissues, a microemulsion formulation i n castor oil is developed that produces sustai ned cyclosporine concentrations suffi cient for immunomodul ation .

IMUDROPS : Technology features

y y y

Unique micro emulsion technology provides cyclosporine particl e size of less than 1 micron Better, faster absorption and penetration Negligible local irritation, burning and stinging reaction

Topical cyclospori ne emulsion has also been i nvestigated for the treatment of other ocul ar surface disorders that may have an immune based inflammatory component. In these trial s , cyclosporine 0.05% ophthalmi c emulsion has shown efficacy for management of posterior blephari tis , ocular rosacea , post-L ASIK dry eye , contact l ens intol erance , atopic keratoconjunctivi tis, graft versus host disease and herpeti c stromal kerati tis . As these disorders are often refractory to another available treatments , ophthal mic cyclospori ne is a welcome non toxic adjunct or repl acement to potentially toxic topical or systemic i mmunosuppressi ve therapi es.

Cyclosporine ( IMUDROPS) Key HIGHLIGHTS

y y y

Potent immunomodul ator that acts sel ectively and locally US FDA approved treatment for KCS Signi ficant breakthrough i n the management of dry eyes

y y y y

Immunomodulatory, lacrimogenic and mucin enhanci ng property Restores the body's ability to produce natural healthy tears Stops the progression of dry eye disease Signi ficant decrease i n the artificial tears use

IMUDROPS : Indications and Usage To i ncrease tear production in pati ents whose tear production is presumed to be suppressed due to ocular infl ammation associ ated wi th keratoconjunctivitis sicca.

IMUDROPS : Dosage and Administration

y y y y

Invert the unit dose vial a few times to obtain a uniform, microemulsion before usi ng. Instill one drop of Imudrop ophthalmic microemulsion twice a day in each eye approxi matel y 12 hrs apart. Imudrops can be used concomitantly wi th artifici al tears, allowing a 15 mi nute i nterval between products. Discard vial i mmediately after use.

September 2010

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AZIPRODelivers the Difference

Communi ty-acqui red respiratory tract infections cause consi derable morbidi ty and mortality. Most of these are upper respiratory tract infections wi th approxi matel y one third of RTI's i nvol ving the lower respiratory tract. The use of short-course antimicrobial therapy has potential economic benefits, including reduced acquisition cost, improved adherence (compliance), reduced adverse events, reduced office visi ts and i ncreased patient satisfaction.

Azithromycin is the sol e member of the macrolide sub-classthe azalides. Due to i ts altered chemi cal structure, azithromyci n i s characterized by a broader spectrum of activi ty (covering gram positive, gram negati ve, anaerobes, atypicals and many others), lower i nci dence of adverse events and drug interactions and an excellent pharmacokinetic profile. The patients are also able to complete a course of azithromycin within a shorter timeframe as compared to other antibioti cs.

Azi thromycin is approved for use i n the treatment of acute exacerbations of chronic bronchitis (AECB), mild-tomoderate community acquired pneumonia (CAP), acute bacteri al sinusitis, pharyngitis/tonsillitis, uncomplicated ski n and skin structure infections and pelvic inflammatory disease (PID).

Azi thromycin is available as 250 mg, 500 mg oral tablets, 500 mg IV injection and 2 gms sustai ned release wi th

microsphere technology.

Microsphere technology is an advanced drug delivery system that uses microspherical shaped particl es to release the drug slowly in the lower GI tract. Azi thromycin is embedded i n the microspheres, which enabl e the delivery of azithromyci n as a complete course of therapy i n a single dose. The microspheres minimi ze the rel ease of azithromyci n i n the stomach, thereby mini mizing GI side effects; instead, they pass through the stomach immediately and into the small intesti ne where the active i ngredient i s slowly released.

Azi thromycin demonstrated good clinical and bacteriological efficacy i n AECB, CAP, acute bacterial sinusitis, pharyngitis / tonsillitis, uncomplicated skin and ski n structure infections and PID and was generally well tolerated. Thus, Azithromyci n is a good option for the treatment of adul t and adolescent patients.

Dosage and Administration:

Oral tablets in Adults

CAP (mild severity) Pharyngi tis/tonsillitis (second line therapy) Skin/ski n structure (uncomplicated)

500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.

500 mg OD x 3 days OR AECB (mild to moderate) 500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5. Acute bacteri al sinusitis 500 mg OD x 3 days

Injection in Adults

CAP

500 mg as a single daily dose by the IV route for at l east two days.

IV therapy should be followed by azi thromycin by the oral route at a si ngl e, daily dose of 500 mg, admi nistered as two 250-mg tabl ets to complete a 7- to 10-day course of therapy. 500 mg as a single daily dose by the IV route for one or two days. IV therapy should be followed by azithromycin by the Pelvic inflammatory disease oral route at a single, daily dose of 250 mg to complete a 7day course of therapy.

The infusate concentration and rate of i nfusion for AZIPRO (azithromycin for i njection) should be either 1 mg/mL over 3 hours or 2 mg/mL over 1 hour.

AZIPRO (azi thromycin for i njection) should not be given as a bolus or as an i ntramuscul ar i njection.

Azi thromycin sustained rel ease

AZIPRO should be taken as a si ngl e 2 g dose.

AZIPRO (azi thromycin SR) should be used wi thin 12 hours of mixing (do not refrigerate) and be taken on an empty stomach (at least 1 hour before or 2 hours following a meal)

LEVOLIN AUTOHALER

Experience relief with never before ease

Levolin (levosalbutamol) Autohaler is the world's first - easy to use, breath actuated i nhaler (BAI).

Levosalbutamol or (R)-salbutamol i s the pure, therapeutically active isomer of salbutamol. It is a potent bronchodilator, effective at half the dose of salbutamol wi th a quick onset of action. The enti re bronchodilatory activity of racemic salbutamol is attri butable to (R)salbutamol. (S) salbutamol has been shown to have no bronchodilatory or bronchoprotecti ve activity. In fact studi es have shown that (S) salbutamol mi ght have proinfl ammatory properties.

Levosalbutamol is available as Levolin rotacaps to be used with Rotahal er/Revolizer, pressuri zed metered dose inhal er (pMDI), respules to be used wi th nebulizer. Now l evosalbutamol is also available as Levolin Autohaler. It is indicated for the treatment or prevention of bronchospasm in adul ts, adolescents and children wi th reversibl e obstructive ai rway disease.

Levolin Autohaler overcomes the key problem of the pMDI vi z. coordination of actuation wi th i nhal ation and does not rel y on the patient`s inspi ratory effort to aerosolize the dose of medication unlike dry powder inhal ers. Levolin Autohaler is activated at low flow rates of 22-30 l /sec. Studi es have shown that the Autohaler TM is easi er to use and to teach as compared to pMDIs and some of the DPIs. It can also be used by children who

are wheezing, older patients with severe ai rflow obstruction and those with arthritis. AutohalerTM contains 300 doses, which ensures long term preventive inhalation for the patient, thus offers better adherence and compliance.

Now, Autohaler TM is available as a compl ete therapy for patients, viz. controller and reliever as Seroflo Autohaler and Levolin Autohaler respectively.

For more i nformation on autohal er device, log onto: www.cipl aautohaler.com

July 2010

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ZOLMIST: Head to Relief in Minutes

Migraine is a common, frequentl y i ncapacitating, headache disorder characterized by episodic attacks of moderate-to-severe headaches, and various combi nations of neurological, gastrointesti nal and/or autonomic nervous system dysfunction. It is esti mated that migraine affects 12% of the general popul ation. It is 3-time more common in females as compared to males; with prevalence of 18% i n women and 6% in men. It is a disabling condition and incurs a heavy toll in terms of treatment costs, patient di sability, and patient quality of life. In fact, World Health Organization has label ed severe migraine, along wi th quadripl egi a, psychosis and dementia, as the most disabling chronic condi tion.

Migraine management has two way approach: a) prophylactic therapy when the patient has frequent migrai ne attacks ( > 2 attacks i n a month) medication is used to prevent the future migraine attack; b) abortive therapy when the patient has rare migraine attacks, drugs are used onl y after the attack to reduce pain, associated symptoms & i mprove quality of life.

Triptans are used for abortive treatment of migraine & is a drug which should be used only when the diagnosis of migraine is confirmed as it is a drug specific for migraine treatment. From the cl ass of triptans; sumatriptan, rizatriptan & naratriptan were available in Indi a . Cipl a took an initi ative not onl y to introduce a new triptan ie. zolmi triptan i n India but it has l aunched zolmi triptan i n nasal form, with brand nameZOLMIST. This revol utionary

drug-device combination offers several advantages over oral and parenteral formulations in migraine pati ents.

The key benefit of using zolmitriptan in nasal formul ation is the rapid onset-of-action.Relief from migraine is obtained as early as 10 minutes post-dose of intranasal zolmi triptan. Studies have shown that zomi triptan nasal spray yi elds consi stent and significantly higher headache response rates, relief from migrai ne symptoms and painfree rates as compared to pl acebo and oral zolmi triptan. Besides, higher number of pati ents were able to return back to thei r normal routi ne in just 2 hrs post zolmitriptan use. Apart from the efficacy, patient satisfaction is an important parameter in migraine therapy. Pati ent satisfaction studi es wi th zol mitriptan nasal spray show that around 70-80% of patients are satisfied with intranasal zolmitriptan. Speed of onset and efficacy were the 2 key factors ci ted by many patients preferring zolmitriptan nasal spray over thei r previous therapy. Zolmitriptan has a good tol erability profile wi th no major adverse event. Both safety & efficacy for i ntranasal zol mitriptan has been evaluated & established for a period of one year.

In fact, ZOLMIST has been studied in Indian patients & it was found to be effective & safe for migraine treatment. Overall 74% of patients in the study were satisfied with ZOLMIST& 84% were willing to use i t i n future.

One vial of ZOLMIST contains seven metered doses of zolmitri ptan. The recommended dose of ZOLMIST is one spray (i.e. 5 mg). If headache returns, the dose may be repeated only after 2 hours. The maximum dosage of ZOLMIST should not exceed more than two sprays (i.e. 10 mg) in 24 hours.

Thus, ZOLMIST , which is a new addi tion to the list of India 's first brands by Cipla , targets to offer quick & consistent benefits in mi grai ne patients & hel p migraine patients to head towards relief in minutes .

July 2010