Community-acquired respiratory tract infections cause considerable morbidity and mortality. Most of these are upper respiratory tract infections with approximately one third of RTI's involving 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 visits and increased patient satisfaction.

Azithromycin is the sole member of the macrolide sub-class—the azalides. Due to its altered chemical structure, azithromycin is characterized by a broader spectrum of activity (covering gram positive, gram negative, anaerobes, atypicals and many others), lower incidence 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 antibiotics.

Azithromycin is approved for use in the treatment of acute exacerbations of chronic bronchitis (AECB), mild-to-moderate community acquired pneumonia (CAP), acute bacterial sinusitis, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections and pelvic inflammatory disease (PID).

Azithromycin is available as 250 mg, 500 mg oral tablets, 500 mg IV injection and 2 gms sustained release with microsphere technology.

Microsphere technology is an advanced drug delivery system that uses microspherical shaped particles to release the drug slowly in the lower GI tract. Azithromycin is embedded in the microspheres, which enable the delivery of azithromycin as a complete course of therapy in a single dose. The microspheres minimize the release of azithromycin in the stomach, thereby minimizing GI side effects; instead, they pass through the stomach immediately and into the small intestine where the active ingredient is slowly released.

Azithromycin demonstrated good clinical and bacteriological efficacy in AECB, CAP, acute bacterial sinusitis, pharyngitis / tonsillitis, uncomplicated skin and skin structure infections and PID and was generally well tolerated. Thus, Azithromycin is a good option for the treatment of adult and adolescent patients.

Dosage and Administration:

Oral tablets in Adults  

Injection in Adults  

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

AZIPRO (azithromycin for injection) should not be given as a bolus or as an intramuscular injection.

Azithromycin sustained release
AZIPRO should be taken as a single 2 g dose.

AZIPRO (azithromycin SR) should be used within 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)

August 2010

Experience relief with never before ease

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

Levosalbutamol or (R)-salbutamol is the pure, therapeutically active isomer of salbutamol. It is a potent bronchodilator, effective at half the dose of salbutamol with a quick onset of action. The entire bronchodilatory activity of racemic salbutamol is attributable to (R)salbutamol. (S) salbutamol has been shown to have no bronchodilatory or bronchoprotective activity. In fact studies have shown that (S) salbutamol might have pro-inflammatory properties.

Levosalbutamol is available as Levolin rotacaps to be used with Rotahaler/Revolizer, pressurized metered dose inhaler (pMDI), respules to be used with nebulizer. Now levosalbutamol is also available as Levolin Autohaler. It is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children with reversible obstructive airway disease.

Levolin Autohaler overcomes the key problem of the pMDI viz. coordination of actuation with inhalation and does not rely on the patient`s inspiratory effort to aerosolize the dose of medication unlike dry powder inhalers. Levolin Autohaler is activated at low flow rates of 22-30 l/sec. Studies have shown that the Autohaler TM is easier 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 with arthritis. Autohaler TM 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 complete therapy for patients, viz. controller and reliever as Seroflo Autohaler and Levolin Autohaler respectively.

For more information on autohaler device, log onto: www.ciplaautohaler.com

July 2010

Migraine is a common, frequently incapacitating, headache disorder characterized by episodic attacks of moderate-to-severe headaches, and various combinations of neurological, gastrointestinal and/or autonomic nervous system dysfunction. It is estimated that migraine affects 12% of the general population. It is 3-time more common in females as compared to males; with prevalence of 18% in women and 6% in men. It is a disabling condition and incurs a heavy toll in terms of treatment costs, patient disability, and patient quality of life. In fact, World Health Organization has labeled severe migraine, along with quadriplegia, psychosis and dementia, as the most disabling chronic condition.

Migraine management has two way approach: a) prophylactic therapy – when the patient has frequent migraine attacks ( > 2 attacks in a month) medication is used to prevent the future migraine attack; b) abortive therapy – when the patient has rare migraine attacks, drugs are used only after the attack to reduce pain, associated symptoms & improve 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 class of triptans; sumatriptan, rizatriptan & naratriptan were available in India . Cipla took an initiative not only to introduce a new triptan ie. zolmitriptan in India but it has launched zolmitriptan in nasal form, with brand name ZOLMIST. This revolutionary drug-device combination offers several advantages over oral and parenteral formulations in migraine patients.

The key benefit of using zolmitriptan in nasal formulation is the rapid onset-of-action. Relief from migraine is obtained as early as 10 minutes post-dose of intranasal zolmitriptan. Studies have shown that zomitriptan nasal spray yields consistent and significantly higher headache response rates, relief from migraine symptoms and pain-free rates as compared to placebo and oral zolmitriptan. Besides, higher number of patients were able to return back to their normal routine in just 2 hrs post zolmitriptan use. Apart from the efficacy, patient satisfaction is an important parameter in migraine therapy. Patient satisfaction studies with zolmitriptan nasal spray show that around 70-80% of patients are satisfied with intranasal zolmitriptan. Speed of onset and efficacy were the 2 key factors cited by many patients preferring zolmitriptan nasal spray over their previous therapy. Zolmitriptan has a good tolerability profile with no major adverse event. Both safety & efficacy for intranasal zolmitriptan 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 it in future.

One vial of ZOLMIST contains seven metered doses of zolmitriptan. 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 addition to the list of India 's first brands by Cipla , targets to offer quick & consistent benefits in migraine patients & help migraine patients to head towards relief in minutes .

July 2010

Nestacort (Deflazacort) is a novel safe and efficacious oral steroid.

Deflazacort is as efficacious as the other orally available steroids such as prednisolone, methyl prednisolone, betamethasone etc. in treating various inflammatory as well as immune related disorders.

Deflazacort has a relatively lesser incidence of side effects than compared to the other oral steroids, thus making it a safer molecule than compared to the other oral steroids.

• It has a lesser negative impact on the growth profile of children then compared to other oral steroids.
• It does not interfere with the calcium absorption and therefore there is lesser incidence of osteoporosis and fractures when used for a long time.
• It prevents fat accumulation and worsening of the lipid profile.
• Lesser impact on the glucose metabolism, therefore suitable in children with juvenile diabetes.

Hence because of its safety profile, deflazacort can be used safely for long term treatment of various chronic inflammatory disorders.

Doses: Doses vary widely in different diseases and different patients. In more serious and life-threatening conditions, high doses of Deflazacort may need to be given. When Deflazacort is used long term in relatively benign chronic diseases, the maintenance dose should be kept as low as possible.

5ml of Nestacort Syrup contains 6 mg of Deflazacort.

June 2010

Osteoporosis is a progressive systemic disease resulting in increased bone fragility and susceptibility to fractures at vertebral and nonvertebral sites.

Therapeutic adherence is a key factor influencing the effectiveness of treatment in 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.

Once monthly dosing With RISOFOS 150 (Risedronate sodium) is a new alternative in the therapy of osteoporosis and represents an important step towards an improvement in the adherence to treatment.

Risedronate is a pyridinyl bisphosphonate that has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, risedronate increases apoptosis of osteoclasts.

Risedronate reduces both vertebral and nonvertebral fracture risks.

RISOFOS 150 is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

The recommended regimen is one 150 mg tablet taken orally once a month.

Risedronate 150 mg once a month is non-inferior and is as well tolerated as 5 mg daily in postmenopausal women with osteoporosis.

June 2010

Patients with osteoporosis who adhere to any drug therapy experience a significantly lower fracture rate. Therefore, there is a need to ensure correct intake of bisphosphonates together with calcium/vitamin D 3 supplementation, which may enhance adherence. The complex dosage regimen could be simplified by providing these individual drugs in an integrated pack.

RISOFOS Kit is one such endeavour of Cipla.

A weekly unit of RISOFOS Kit consists of the following:
1 Risedronate s odium tablet (orange tablet)
Each film-coated tablet contains:
Risedronate Sodium Hemi-Pentahydrate equivalent to Risedronate Sodium … 35 mg

RISOFOS Kit is indicated for Prevention and Treatment of Postmenopausal osteoporosis and Treatment of osteoporosis in men. The risedronate 35 mg tablet should be taken orally on the same day each week. The calcium/vitamin D 3 tablets should be taken twice daily each day for 6 days per week, starting on the day after the risedronate 35 mg tablet is taken.

June 2010

Therapy with protease Inhibitors may be associated with high pill burdens, gastrointestinal side effects, perturbation of lipid levels and abnormal glucose metabolism and in some cases, food and hydration requirements.

The current approach to ART is not only driven by maximizing the antiviral efficacy but by reducing metabolic complications.

SYNTHIVAN Tablets are fixed-dose combination tablets containing atazanavir 300 mg and ritonavir100 mg.

Studies have conclusively shown that combination of atazanavir and ritonavir improves the lipid and glycemic profile, while maintaining virological control in HIV infected patients. In addition, its good gastrointestinal tolerability and a regimen of one tablet once daily (along with two other NRTIs) should improve patient adherence.

Dose: 1 tablet once daily

SYNTHIVAN Highlights

June 2010

The gastrointestinal (GI) tract is home to the largest population of microorganisms in the body; over 400 different species of bacteria are present in the intestines. Although most of these organisms are part of the normal commensal flora, some may play a role in various organic and functional GI diseases making it necessary to find an agent to tackle these problems without disturbing the delicate natural balance of GI flora.

Rixmin (rifaximin) is a synthetic antibiotic derived from rifamycin. It is designed so as to have low gastrointestinal absorption while retaining good antibacterial activity. Like rifamycin, rifaximin acts on the beta-subunit of the deoxy ribo nucleic acid (DNA) – dependent ribonucleic acid (RNA) polymerase enzyme of microorganisms to inhibit RNA synthesis.

Its broad spectrum of activity against aerobic and anaerobic gram-negative and positive microorganisms has been well documented in published literature over the years. Fecal levels after oral administration of the antibiotic range between 4,000 and 8,000 µg/g of stool, which is 160-250 times higher than the MIC 90 for various bacterial enteropathogens.

As the GI tract is the primary therapeutic target, this antibiotic will have little use outside the enteric area and can thus minimize both antimicrobial resistance and systemic adverse events.

Apart from its use to treat infectious diarrhea it has recently received FDA approval for the treatment of hepatic encephalopathy, a common but serious complication in patients with liver cirrhosis.

Rixmin opens a new chapter in non absorbed oral antibiotic therapy, limiting the development of resistance and potential for systemic side effects, with uncompromised efficacy.

June 2010

Urolithiasis is a condition in which one or more stones are formed in the urinary system. Patients usually present with extreme pain (renal colic), the pain may spread to the groin, nausea, vomiting and hematuria (blood may appear in the urine) may occur, there can be burning sensation during urination, fever and chills may accompany. There are several risk factors which causes stones like hypocitraturia, hypercalciuria, hyperoxaluria, hyperuricosuria etc. Urinary stone treatment (surgical/medical) may give stone free status but the metabolic abnorm ali ties remain which may lead to recurrent stone formation, the commonest metabolic abnorm ali ty being hyperoxaluria. The recurrence of kidney stones reaches 50-70% in 10years. Urinary stones may lead to complications like urinary tract infections and renal impairment. Ston1B 6 has an added benefit over Ston1 as it contains pyridoxine hydrochloride (Vitamin B 6 ). Pyridoxine is a co-factor of the Alanine-Glyoxylate-Transaminase (AGT) enzyme. Pyridoxine increases the activity of the enzyme AGT, thus glyoxylate is converted to glycine rather than oxalate, which decreases the urinary oxalate level. Thus it prevents recurrence of calcium oxalate stones by treating the basic metabolic abnorm ali ty hyperoxaluria.

STON1B ₆ is Potassium citrate, magnesium citrate and pyridoxine hydrochloride (Vitamin B ₆ ) oral solution

Each 5ml contains:
Pyridoxine hydrochloride: 20mg
Potassium citrate: 1100mg
Magnesium citrate: 375mg
Each 1ml contains:
Approx. 1mEq magnesium ion, 2mEq of potassium ion, 3 mEq of citrate ion and 4mg of pyridoxine hydrochloride

Indications

STON1B ₆

Dosage
3 teaspoons (15ml) diluted with 1 glass of water, twice daily.

Available as
200ml bottle

Highlights

Gastroparesis and dyspepsia are some of the most common dysmotility conditions encountered in clinical practice, which arise due to decreased transit. With very high prevalence reported worldwide it is important that these conditions be treated effectively.

Gastrointestinal prokinetics are drugs most commonly used to treat conditions arising out of decreased motility. As effective as these drugs are, not all of them are completely safe, several studies have in fact shown that cisapride (a partial 5-HT 4 receptor agonist) can induce dose-dependent cardiac adverse effects. Prokinetics are also known to cause hyperprolactinemia and extrapyramidal side effects as a result of their action on targeted receptors.

To tackle these problems a new highly selective prokinetic, cinitapride, was developed. Cinmove (cinitapride) a new age prokinetic with a much reduced and very selective antidopaminergic profile and marked gastrointestinal excitatory effects mediated via serotonergic mechanisms. By its stimulatory action on the 5-HT 4 receptors and its inhibitory action on the 5-HT 2 receptors and along with that a reduced and selective action on the dopamine D 2 receptors it is able to circumvent the hyperprolactinemia and extrapyramidal side effects otherwise seen. This unique action may be the reason for its stronger action in the GI tract as compared to metoclopramide.

Unlike other prokinetics that works only from the lower esophageal sphincter to the stomach or perhaps the duodenum, cinitapride works right from the lower esophageal sphincter to the small intestine. In trials cinitapride was not able to increase the level of the hormone prolactin significantly after administration, highlighting the drug's effectiveness and encouraging safety record.

Clinical studies with cinitapride have demonstrated clear therapeutic efficacy at all levels of the gastrointestinal tract with minimal side effects comparable to placebo.

April 2010

Furamist AZ is the latest and the most advanced combination nasal spray for treating allergic rhinitis containing Fluticasone Furoate (27.5mcg) and Reformulated Azelastine hydrochloride (140mcg).

Optimal treatment of patients with allergic rhinitis can be achieved only by managing both the early phase reaction (EPR) and late phase reaction (LPR). An H 1 receptor antagonist most effectively manages the symptoms observed in the EPR where as the effects of the LPR are best managed with corticosteroids.

Fluticasone Furoate is a novel glucocorticoid with high systemic clearance, high receptor affinity and low oral bioavailability. It is effective in controlling the nasal as well as ocular symptoms of allergic rhinitis.

Reformulated azelastine with a sorbitol based vehicle and sucralose as a taste masking agent was developed to reduce the bitter taste of the original azelastine hydrochloride.

Clinical studies conducted for safety, tolerability and pharmacokinetic parameters of reformulated azelastine was similar to original azelastine. Antihistamines relieve pruritus, sneezing rhinorrhoea and ocular symptoms but do not control nasal stuffiness. Intranasal corticosteroids can attenuate all nasal symptoms, but are most effective against rhinorrhoea and stuffiness. Thus the treatment that combines an antihistamine and a corticosteroid nasal spray may maximize clinical efficacy.

Therefore the ideal pharmacological therapy for allergic rhinitis would be a drug that possessed not only H 1 receptor antagonist activity but also anti-inflammatory activity. The recommended dosage of Furamist-AZ for adults and children 5 years and older is 1 spray/nostril twice daily.

April 2010

PULMOPRES (tadalafil) is a selective cyclic guanosine monophosphate- specific phosphodiesterase type 5 inhibitor that is effective in improving exercise ability, the time to clinical worsening and health-related quality of life (HR-QOL) scores in patients with pulmonary arterial hypertension (PAH).

In a large, 16-week, randomized, double-blind, placebo-controlled, multicentre, phase III trial (PHIRST) in patients aged ‡14 years with PAH (WHO group I), tadalafil 40 mg once daily (the recommended dosage) significantly increased the mean placebo-corrected 6-minute walk distance (6MWD) by 33m from baseline (primary endpoint). In treatment-naive patients, tadalafil 40 mg once daily significantly increased the mean placebo-corrected 6MWD by 44m at week 16, whereas in patients receiving bosentan 125mg twice daily as background therapy there was a mean change of 23 m, which was not significant. Both the time to the first occurrence of clinical worsening and the incidence of clinical worsening were significantly reduced in recipients of tadalafil 40mg once daily compared with recipients of placebo.

Furthermore, at week 16, tadalafil improved most HR-QOL outcomes from baseline to a significantly greater extent than placebo. Preliminary data from an extension of the PHIRST trial suggest that the improvements in 6MWD are maintained for up to 1 year in recipients of tadalafil 20 or 40 mg once daily. Treatment with tadalafil was generally well tolerated, with adverse events that were transient in nature and of mild to moderate intensity.

The recommended dosage of tadalafil in patients with PAH is 40 mg once daily administered as two 20 mg tablets with or without food. Dividing the 40 mg dose over the course of the day is not recommended. Tadalafil is contraindicated in patients receiving concomitant organic nitrates, is not recommended in patients with pulmonary veno-occulsive disease and should be used with caution in patients with certain co-morbid conditions who could be adversely affected by its vasodilatory effects.

April 2010

Today health care associated infections (HAI) are of great concern they influence approx 9% of all hospital admissions. It is estimated that 45% of HAI occur in ICU patients and 50–60% of all HAI's are caused by antibiotic resistant bacteria.

The major culprits of causing health care associated infections are Pseudomonas aeruginosa, MRSA and ESBL's producing E. coli and Klebsiella pneumoniae and there is an increasing rate of resistance seen against these organisms. Nearly 70% of ICU infections are caused due to micro-organisms resistant to one or more antibiotics. These infections lead to higher rates of hospitalization, longer hospital stay, and increase in the cost of treatment and thus increased economic burden.

Currently, antibiotic like Carbapenem, 3 rd and 4 th generation Cephalosporin's, Aminoglycoside and Fluoroquinolones are among the common drugs used in the ICU's setups and an increasing trend of resistance to these antibiotics have also been reported in various articles. Thus antibiotic drug choice remains difficult in the present scenario.

The introduction of the new quinolones has created a new and exciting era in antimicrobial chemotherapy. Quinolones are a very important family of antibacterial agents that are widely prescribed for the treatment of infections in humans. Since their discovery in the early 1960s, the quinolone group of antibacterial has generated considerable clinical and scientific interest.

Pazufloxacin is an injectable new-quinolone that was first produced in Japan , it is anticipated to give excellent clinical effect since blood concentration is higher than known quinolone antibacterial. Due to its structure it is considered to be safe and well tolerable compared to other quinolones and cephalosporins. It exhibits a broad spectrum including Cephalosporin, carbapenem and amino glycoside resistance bacteria. It even covers ESBL's producing E. coli and Klebsiella . Pazufloxacin is capable of tackling almost all important Community as well as Nosocomial pathogens and hence could be an empirical choice for treating various severe and intractable infections and also those which do not respond to other drugs . Because of its attributes it is said to be a substitute drug similar to third generation cephem group or carbapenem group drugs.

Pazufloxacin is approved for treating indications like, Secondary infections in trauma, burn or surgical wound, etc. Pneumonia, lung abscess, and secondary infections in chronic respiratory lesion, complicated cystitis, pyelonephritis, and prostatitis (acute and chronic symptoms), Peritonitis and intraperitoneal abscess, Cholecystitis, cholangitis, and liver abscess, Uterine adnexitis and parametritis.

Pazflo is available as 500mg/100ml solution for intravenous infusion in FFS packaging. Usually for adults the recommended dose of PAZFLO Intravenous Infusion in most infections is 500 mg twice a day administered as an intravenous infusion over 30–60 minutes. Depending on the age, symptoms and severity of infection, the dose of the drug may be reduced to 300 mg twice a day. The total duration of therapy with the drug should not exceed 14 days.

April 2010

Deflazacort: 6mg and 30mg tablets

Deflazacort is a novel safe and efficacious oral steroid.

Deflazacort is as efficacious as the other orally available steroids such as prednisolone, methyl prednisolone, hydrocortisone etc. in treating various inflammatory as well as immune related disorders. Deflazacort has a relatively lesser incidence of side effects than compared to the other oral steroids.

It is a relatively safer molecule then compared to the other oral steroids.

Hence because of its safety profile, deflazacort can be used for long term treatment of various chronic inflammatory disorders.

Doses: Doses vary widely in different diseases and different patients. In more serious and life-threatening conditions, high doses of Deflazacort may need to be given. When Deflazacort is used long term in relatively benign chronic diseases, the maintenance dose should be kept as low as possible.

March 2010

Postprandial hyperglycaemia is one of the earliest abnormalities of glucose homeostasis associated with type 2 diabetes and has been associated with increased risk of microvascular and macrovascular complications. Postprandial glucose is also a better predictor of deaths from all causes and cardiovascular disease as compared to FPG.

Prandial (voglibose) is a mouth dissolving alpha-glucosidase inhibitor, which delays carbohydrate absorption. It is used in the management of postprandial hyperglycaemia in type 2 diabetes.

The mode of action of voglibose is very different from insulin sensitizers and insulin secretagogues. The antihyperglycemic action of miglitol results from a reversible inhibition of membrane bound intestinal α-glucoside hydrolase enzymes. Membrane-bound intestinal a- glucosidases hydrolyze oligosaccharides and disaccharides to glucose and other monosaccharides in the brush border of the small intestine. In diabetic patients, this enzyme inhibition results in delayed glucose absorption and lowering of postprandial hyperglycaemia. Thus the blood glucose lowering effect of voglibose is independent of presence of insulin.

Clinical trials with voglibose (usually 0.2 or 0.3 mg three times daily) as monotherapy or in combination with other oral hypoglycaemic agents in patients with type 2 diabetes mellitus have consistently demonstrated a significant improvement in glycaemic control for periods of 12-36 months. Voglibose has also been shown to lower the risk of progression to diabetes. Voglibose therapy is also associated with improvement in endothelial dysfunction and oxidative stress.

Voglibose is a more potent inhibitor of a- glucosidases as compared to acarbose. In comparative studies, voglibose had similar efficacy as compared to acarbose at lower therapeutic doses (0.2 and 0.3 mg). The incidence of gastrointestinal adverse events (abdominal distention and flatulence) with voglibose was much lower than acarbose. Voglibose shows a better effect on lipid profile as compared to acarbose.

Voglibose is generally well tolerated and, unlike insulin secretagogues, is not associated with bodyweight gain or hypoglycaemia when administered as monotherapy. There is no primary failure associated with voglibose and its action is independent of duration and severity of type 2 diabetes.

Prandial is a mouth dissolving formulation of voglibose which results in rapid dissolution and fast onset of action. It can be considered alone as well as in combination with other oral hypoglycaemic agents for postprandial hyperglycaemia management.

INDICATION:
Prandial is indicated for the management of postprandial hyperglycaemia in type 2 diabetics

DOSAGE & ADMINISTRATION:
The recommended dose of Prandial is 1 tablet of 0.2 mg or 0.3 mg thrice daily just before each meal.

March 2010

With the advent of numerous resistant ‘superbugs', such as vancomycin-resistant enterococci (VRE), methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP), an alarm has started to resound. In addition, new ‘opportunistic' multidrug-resistant (MDR) bacteria have risen to prominence, and are recognized increasingly as important pathogens in both the nosocomial and community settings. Morbidity, mortality and length of hospital stay have increased among critically ill pediatric patients, where infections are resistant to first-line and second-line empirical therapies. i.e. the emergence of resistant strains are no longer predictably susceptible to standard first-line antimicrobials such as oxacillin or vancomycin.

The development of antibiotic -resistant pathogens has created the need for new antibiotics effective against Gram-positive organisms. Linezolid, a synthetic antimicrobial agent is the first agent in a new class of drugs called oxazolidinones and is chemically unrelated to currently available agents and inhibits bacterial protein synthesis. It was approved for pediatric use by the Food and Drug Administration in December 2002. It offers an effective alternative for infections caused by VRE, MRSA, DRSP and other antibiotic-resistant Gram-positive bacteria.

Several literatures have shown that linezolid could be considered alternative to vancomycin as it is clinically and microbiologically as effective as vancomycin across infections caused by presumed or documented resistant Gram-positive pathogens across all pediatric age groups including neonates and is safer and better tolerated than vancomycin with fewer drug-related events.

LINOSPAN 100 DT is World's First linezolid dispersible tablet of 100 mg available in Fantastic Frescofort Flavour and is presented as a strip pack of 10 tablets.

LINOSPAN 100 DT offers administration advantages as it is an oral formulation which is 100% bioavailable which further allows rapid switch over from LINOSPAN 100 ml IV injection or vancomycin IV thereby facilitating early hospital discharge and decrease in the length of hospital stay .

LINOSPAN 100 DT is indicated for the treatment of nosocomial pneumonia caused by MRSA, MSSA and MDRSP, bacteremic community-acquired pneumonia caused by MSSA and MDRSP, vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia and complicated/ uncomplicated skin and skin structure infections caused by MRSA and MSSA.

In infants and children up to 11 years of age, the recommended dose of linezolid is 10 mg/kg every 8 hours. Children older than 12 years of age may be treated using the guidelines for adults, i.e 600 mg every 12 hours. Pre-term neonates less than 7 days of age should receive the pediatric dose of 10 mg/kg at an interval of every 12 hours, to account for the slower rate of elimination.

The duration of treatment for most of the infections like pneumonia including community acquired pneumonia and skin infections is 10-14 days. It is advised to give therapy for 14-28 days in vancomycin resistant enterococcal infections.

LINOSPAN 100 DT has to be dispersed in a teaspoonful (5 ml) of boiled and cooled water before administration. It may be taken with or without food.

March 2010

Shampoo forms the foundation of any hair care regimen and is also the most frequently prescribed treatment for hair and scalp. Also in clinical dermatology the most common question asked is “What is the best way to clean my hair”?

The different qualities demanded from a shampoo now go beyond cleansing. Various benefits are expected, and the shampoo has to be tailored to variations associated with hair quality, age, hair care habits, and specific problems related to the condition of the scalp. The relationship between technology and medical therapy is reflected in such shampoo formulations.

In addition to the above mentioned advances, the consumers have also expressed a need for enhanced cosmetic appeal. All this and much more have led to launch of Xgain a pH-balanced 2 in 1 volumizing shampoo.

Besides the cleansing and conditioning properties of Xgain shampoo, the conditioners in the shampoo gives a healthy and stronger hair which has more bulk i.e. volume. They actually penetrate into the cuticle and cortex of the hair fibres and facilitate realignment of the hair shaft. The anti-static agent incorporated in Xgain shampoo also supports to deliver volumised hair. Xgain shampoo also consists of various nutrients like hydrolyzed wheat protein, dexpanthenol, vitamin E, almond oil, wheat germ oil and jojoba seed oil. They nourish the hair from root to tip by their anti-oxidant properties. Along with these benefits Xgain shampoo is also endowed in providing luster, texture, colour protectant, improved manageability and a shield from environmental damage.

Directions for use:

Wet hair. Apply Xgain shampoo, massage slowly and lather. Rinse thoroughly. Repeat if required.

Xgain shampoo is available in a bottle of 60 ml.

Statins are the most effective drugs available for lowering LDL and have revolutionized cardiovascular medicine. However, despite the widespread use of statins, many patients do not attain LDL goals and this is especially true in high and very high-risk patients in whom the LDL goals are even lower. Therefore, there is a demand for more potent statins.

Rosuvastatin is the most potent statin for reducing LDL and was approved by US FDA in August 2003. Rosuvastatin monotherapy may allow patients to attain LDL goals earlier and may help avoid combination therapy or potential adverse effects of high-dose statin therapy. Further, rosuvastatin has several advantages over all other statins- highest affinity for HMG-CoA reductase, greater increase in HDL and fewer clinically significant drug interactions. In addition, rosuvastatin is the only statin to be approved by the US FDA for slowing the progression of atherosclerosis. The safety profile of rosuvastatin is similar to other statins.

Recently, the JUPITER trial which showed significant reduction in cardiovascular events with rosuvastatin in healthy people with normal LDL and high C-reactive protein has added a new perspective in primary prevention therapy for statins. These results have the potential to revise guidelines and can have a huge impact on clinical practice.

ROSULIP is currently available in two strengths: ROSULIP 5 (5 mg rosuvastatin) and ROSULIP 10 (10 mg rosuvastatin). The dosage range of ROSULIP is 5-40 mg once daily at any time of the day and independent of food.

Hypertension and hypercholesterolemia are the most common major risk factors for cardiovascular disease (CVD). Approximately 40% of patients with hypertension have been reported to have hypercholesterolemia. Alarmingly, in agreement with the western population, even in our country, a significant proportion of patients have both hypertension and dyslipidemia. An analysis revealed that hypercholesterolemia was present in 57% and hypertriglyceridemia in 30% of Indian patients while 37% of patients had LDL ≥ 130 mg/d l.

Both hypertension and dyslipidemia result in endothelial dysfunction and consequently lead to the development of atherosclerosis. Hence, there is a strong synergy between hypertension and dyslipidemia in the development of CVD. P resence of high cholesterol in men with SBP ≥ 160 mg/dl has shown to dramatically increase the risk of CVD by 10-fold . This dramatic rise in CVD is through the interplay of hypertension & dyslipidemia via the renin angiotensin aldosterone system (RAAS). Therefore, combining ARB and statin seems to be an ideal choice for the management of coexisting hypertension with hyperlipidemia.

CRESLIP , a combination of 40 mg telmisartan and 10 mg atorvastatin, has been launched by Cipla in November 2009 for the management of coexisting hypertension and hyperlipidemia.

Telmisartan is a highly selective angiotensin II receptor blocker which has shown to provide 24-hr BP control even in the last 6 hrs of the dosing interval. Besides, telmisartan also acts as a partial PPAR gamma agonist which imparts some important benefits with the molecule like antiatherosclerotic property, improvement in lipid profile, improvement in insulin sensitivity etc.

The second component of CRESLIP is the most widely used statin, atorvastatin. Atorvastatin has shown to improve lipid profile effectively in a wide range of patients. It has shown to reduce CV events & also exhibits antiatherosclerotic, antioxidant property etc

The recommended dosage is one tablet of CRESLIP once daily. The maximum dose should not exceed two tablets of CRESLIP once daily. Patients with depletion of intravascular volume should have their condition corrected or CRESLIP should be initiated under close medical supervision. In p atients with biliary obstructive disorders or hepatic impairment, CRESLIP should be given under close medical supervision.

February 2010