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VALCEPT: The Potent and Convenient Anti-CMV Agent

Cytomegalovirus (CMV) is a common pathogen in immunocompromised hosts. The virus may affect different body systems including the central nervous system, respiratory tract and gastrointestinal tract.

Valganciclovir is an orally administered prodrug of the standard anti-CMV drug ganciclovir, and provides greater systemic ganciclovir exposure than oral ganciclovir. It is as effective as intravenous (IV) ganciclovir for the treatment of AIDS-related CMV retinitis, and oral ganciclovir for the prophylaxis of CMV infection and disease in high-risk solid organ transplant recipients. Valganciclovir has a similar tolerability profile to that of oral or IV ganciclovir, without the adverse events related to IV or indwelling catheter access associated with the use of IV ganciclovir, cidofovir and foscarnet.

The simple and convenient once-daily valganciclovir regimen offers potential for improved patient compliance.The greater systemic exposure achieved with oral valganciclovir may reduce the risk of viral resistance when used for prophylaxis in high-risk solid organ transplant recipients. Further, the use of oral valganciclovir instead of IV ganciclovir may provide significant cost savings.

Overall, valganciclovir has significant advantages over ganciclovir. Thus, when used as prophylaxis against CMV infection and disease in high-risk solid organ transplant recipients or as induction and maintenance therapy of CMV retinitis in AIDS patients, oral valganciclovir is an attractive alternative to other available anti-CMV drugs.

Ocugard: For Your Eyes Only

As long as we are alive, eating and breathing in a polluted world, our bodies will have to contend with free radicals and we will need antioxidants to help reduce the impact and minimize the damage they cause. Normally, the body can handle free radicals, but if antioxidants are unavailable, or if the free-radical production becomes excessive, damage can occur. Of particular importance is that free radical damage accumulates with age.

As we get older our eyes have a harder time fighting off free radicals that cause oxidative stress damage. Aging process brings about anatomical changes in the eye, which results in physiological changes simultaneously.

Ocugard is a comprehensive blend of essential carotenoids, free radicascavengers, multivitamins and other vital ingredients designed for protection of eyes against age related macular degeneration (AMD), cataract, glaucoma and diabetic retinopathy. Ocugard thus plays an important role in preventing the damage to the human eye due to destructive action of free radicals as it contains antioxidants.

Ocugard plays an important role in preventing the damage to the human eye due to destructive action of free radicals as it vital ocular antioxidants like rutin , alpha-lipoic acid , ginkgo biloba extracts , bilberry extracts , lutein , zeaxanthin , zinc ,selenium , vitamin C , vitamin E and beta-carotene .

Indications

  • Ocugard can be given as an adjunct in patients with age related macular degeneration.
  • Patients sufferings / at high risk from cataract.
  • Patients suffering / at high risk from glaucoma.
  • Postoperative patients of cataract or glaucoma.
  • Diabetic patients as a prophylaxis against cataract.
  • Patients with idiopathic raised intraocular pressure, and in patients with diabetic retinopathy.

What is the recommended dosage of Ocugard?
The recommended dosage of Ocugard is two tablets at a time daily or as recommended by the doctor.

Warnings
Current and Former Smokers:
Consult your eye care professional about the risks associated with smoking and using beta-carotene.

NICOTEX - An aid to smoking cessation

Smoking was thought to be a very lucrative phenomenon once. Formerly regarded solely as a “lifestyle choice,” smoking is now recognized as a chronic, relapsing disorder caused because of addiction. Large number of diseases has been associated with chronic smoking, causing a great amount of mortality and morbidity. By stopping as early as possible, there can be a reduction in the risk of cancer, lung and heart disease. There is also a reduction in the damage caused to the lungs. The introduction of nicotine replacement therapy (NRT) to cut down addiction, has successfully led to a decrease in the mortality and morbidity and to better quality of life in tobacco users.

Nicotex contains nicotine polacrilex and is available in two strengths as 2mg and 4mg chewing gums. The principal mechanism of action of Nicotex is to partially replace the nicotine formally obtained from tobacco. It provides small and sustained quantities of nicotine without the harmful gases of smoking, to reduce the severity of withdrawal symptoms and cravings. Second possible mechanism of benefit has been suggested to be the potential for nicotine medications to desensitize nicotinic anticholinergic receptors (nAchRs). Such desensitization would result in a reduced effect of nicotine from cigarettes, such that if a person relapses to smoking while taking NRT, the cigarette would be less satisfying and the person less likely to resume. Hence NRT also provide a coping mechanism, making cigarettes less rewarding to smoke.

Overall, NRT offers low abuse potential and adherence advantages because of the ease of usage. NRT can be used and is considered relatively safe during pregnancy or in patients with unstable cardiac disease, if the alternative is smoking. Medicinal nicotine is unlikely to be more harmful in this context than continued intake of nicotine (and the associated tar, carbon monoxide, and other harmful products) from cigarettes.

INDICATIONS
Nicotex chewing gum is indicated for smoking cessation therapy.

DOSAGE AND ADMINISTRATION

If 25 or more cigarettes a day; use 4 mg nicotine gum.
Less than 25 cigarettes a day; use 2 mg nicotine gum.

Use according to the following 12 week schedule:  

Weeks 1-6

Weeks 7-9

Weeks 10-12

1 gum every 1 to 2 hours

1 gum every 2 to 4 hours

1 gum every 4 to 8 hours

Do not exceed more than 24 gums a day.

Over a 12-week period, NICOTEX allows the body to gradually adjust to have less nicotine. Fewer and fewer gums of NICOTEX will be required until no longer needed. This means that it will leave the smoker, smoke-free in 12 weeks.

NEBIZIDE: Drops Down Pressure. Exceptionally

In practice, the blood pressure goals set by hypertension management guidelines are not being achieved in majority of patients. One important reason for poor hypertension control rates is the inability of monotherapy to achieve blood pressure goals in many patients. Therefore, combination therapy is the need in nearly 2/3 rd of hypertensives to attain the target blood pressure levels.

One of the most common combination therapies for hypertension comprises a b blocker with a thiazide diuretic. Nebizide is a fixed dose combination of 5 mg nebivolol and 12.5 mg hydrochlorothiazide. Nebivolol is an outstanding, third generation highly selective b blocker with NO-mediated vasodilation whereas hydrochlorothiazide is a time-tested diuretic which has been used clinically for more than 45 years. Studies have shown the combination to offer additive BP reduction as compared to both monotherapies with no increase in adverse events. Further, the beneficial effects on lipids and glucose metabolism due to unique NO-mediated vasodilation with nebivolol can counteract the adverse effects of hydrochlorothiazide on lipids and glucose, thereby offering an advantage over other b blocker-diuretic combinations. In addition, the combination can also improve endothelial function on account of NO-mediated vasodilation with nebivolol and can yield added improvements in left ventricular function.

The recommended dose of NEBIZIDE is one tablet daily. In patients with severe renal impairment (CICr <30 mL/min) and moderate hepatic impairment, the initial dose of nebivolol should not exceed 2.5 mg of nebivolol in NEBIZIDE . NEBIZIDE is being made available across the country.

SOTALAR: Safely Resets the PACE OF LIFE

Cardiac arrhythmias are a major source of morbidity and mortality in the developing and the developed world. Although amiodarone is one of the oldest drugs with extensive evidence on its efficacy, its diverse adverse effect profile can limit its long-term use. Amongst other antiarrhythmic drugs, sotalol is a unique antiarhythmic drug. It is a class III antiarrhythmic; in addition to blocking the potassium channels, it is a non-selective b blocker.

Unlike amiodarone, sotalol has high bioavailability of 100%, no pharmacokinetic drug interactions and no need for any loading doses. Sotalol has been shown to be superior to amiodarone in ventricular arrhythmias and in supraventricular arrhythmias, sotalol has comparable efficacy with superior safety profile as compared to amiodarone. Sotalol has been demonstrated to be superior to b blockers in ventricular arrhythmias. Further, sotalol is also superior or at least comparable to class I drugs (procainamide, quinidine, propafenone, quinidine, mexiletinie, imipramine, piremenol) in ventricular and supraventricular arrhythmias. The major advantage of sotalol over amiodarone is that it does not exhibit multiorgan toxic side effects seen with long-term use of amiodarone

SOTALAR (sotalol) is available as 40 and 80 mg tablets and 10 mg/ml injections. SOTALAR tablets are indicated in life-threatening ventricular arrhythmias, non-sustained ventricular tachyarrhythmias, prophylaxis of supraventricular arrhythmias following cardiac surgery and for maintenance of sinus rhythm following conversion of atrial fibrillation or flutter. The initiation dose of SOTALAR tablets is 80 mg/day in single or two divided doses which can be increased at intervals of 2-3 days to 160-320 mg/day in two divided doses given at 12 hour intervals. SOTALAR injections are indicated in acute and life-threatening arrhythmias, programmed electrical stimulation in inducible ventricular and supraventricular arrhythmias and in those who are unable to take SOTALAR tablets. In acute arrhythmias, dosage for SOTALAR injections is 0.5-1.5 mg/kg. In programmed electrical stimulation, an initial bolus of 1.5 mg/kg of SOTALAR injection should be given, followed with maintenance infusion between 0.2-0.5 mg/kg/hour. For substitution in place of SOTALAR tablets, an infusion of SOTALAR injections between 0.2-0.5 mg/kg/hour should be used.

Urifast – The BID Nitrofurantoin

Urinary tract infection is an inflammatory response of the urothelium to bacterial invasion. UTI occur commonly in females and can affect various organs like bladder, kidney, urethra etc. Most common UTI is uncomplicated cystitis. Short term antibiotics are the 1 st line treatment option for uncomplicated UTI. The major concerns in the management of UTI are recurrence and resistance.

Urifast is nitrofurantoin monohydrate/macrocrystals. It is a novel formulation, the older formulations being nitrofurantoin microcrystals and nitrofurantoin macrocrystals. Urifast has better GI tolerability and twice daily dosing as compared to the older formulations, which improves compliance.

Urifast has urine specific action. It has highest susceptibility to the common urinary pathogen Escherichia coli and least resistance, when compared with other commonly used antibiotics.

Urifast capsules consist of:

  • 25 mg of immediate release Nitrofurantoin macrocrystals
  • 75 mg of sustained release Nitrofurantoin monohydrate

Indications
Urifast is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.

Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric ascesses.

Dosage and Administration
Urifast capsules should be taken with food.

Adults and pediatric patients over 12 years: One 100 mg capsule every 12 hours for seven days.

Available as:
Strip of 10 capsules

Highlights:  

  • Urifast is effective against the most common pathogens which cause UTI, Escherichia coli and Staphylococcus saprophyticus.
  • Urifast has urine specific action
  • Urifast has similar efficacy and better compliance than Nitrofurantoin macrocrystals
  • Urifast has highest susceptibility against Escherichia coli
  • Urifast has least resistance even after >50 yrs
RISOFOS 75: Empowering Bones

The prevalence of osteoporosis is estimated at over 200 million people worldwide. With increasing longevity of the Indian population, it is now being realized that, as in the West, osteoporotic fractures are a major cause of morbidity and mortality in the elderly. Based on 2001 census, approximately 163 million Indians are above the age of 50. Even conservative estimates suggest that of these, 20 per cent of women and about 10-15 per cent of men would be osteoporotic.

There are different treatment options now available to decrease the risk of osteoporosis and related fractures, but they require long term adherence and compliance.

Due to poor long term adherence to medication therapies for chronic diseases, maximizing compliance should be a primary focus of clinical management. A monthly therapy with vertebral, nonvertebral, and hip fracture reduction efficacy would give physicians another treatment option.

RISOFOS 75 (Risedronate sodium) is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism . It has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. Risedronate treatment reduces bone turnover (activation frequency, i.e., the rate at which bone remodeling sites are activated) and bone resorption at remodeling sites.

RISOFOS 75 is indicated for the treatment and prevention of osteoporosis in postmenopausal women. The recommended regimen is:

One 75 mg tablet orally, taken on two consecutive days each month (2CDM).

Risedronate 75 mg 2CDM is non-inferior and is as well tolerated as 5 mg daily in postmenopausal women with osteoporosis.

IF1: Come Back To Life

Ocular allergy occurs in approximately 15%-20% of the general population. Seasonal allergic conjunctivitis (SAC) is the most common form of this disease. Transient ocular itching and hyperemia, the primary signs and symptoms of SAC, are manifested typically during the spring, summer.

IF1 contains olopatadine 0.2%, which is a long-acting multiple-action topical agent with mast cell stabilizing and antihistaminic properties.

Olopatadine is the first dual-action agent approved by the US FDA combining antihistaminic properties with mast-cell stabilizing activity, thus creating an eye-drop with strong immediate efficacy as well as long-lasting therapy.

Olopatadine is a relatively selective histamine H 1 antagonist and an inhibitor of the release of histamine from the mast cells. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated. Olopatadine decreases adhesion molecule expression results in decreased leukocyte infiltration and prevention of other events which lead to inflammatory process associated with allergy

Olopatadine is devoid of effects on alpha-adrenergic, dopaminergic, and muscarinic type 1 and 2 receptors.

Indications
Olopatadine hydrochloride 0.2% ophthalmic solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis.

Dosage and Administration
The recommended dose of olopatadine 0.2% is one drop in each affected eye once a day

IF1 Highlights

(1)Potent anti-histaminic ability and mast cell stabilizing activity

  • Olopatadine 0.2% has also demonstrated its ability to act as a potent antihistamine, on a level superior to other selective H1 antihistamines
  • Olopatadine is the first topical ophthalmic anti-allergy agent that has clinically shown mast-cell stabilization in human eyes.

(2) Fast Acting
Reduces itching symptoms within 3 minutes of administration to the eyes

(3) Long lasting relief
Dual mechanism of action gives an immediate and a long lasting relief for upto 24 hrs

(4) Comparison with other dual acting agents

  • Olopatadine has been shown to inhibit 96% of histamine release from human conjunctival mast cells in vitro , even at 10 times the clinically maximally effective dose.
  • On the other hand, results for other dual acting agents revealed a biphasic response, whereby low concentrations suppressed histamine release, but as the concentration was increased, histamine release was actually stimulated.

(5) Soothes the eyes

  • Olopatadine 0.2% formulation contains povidone, which makes it soothing and well tolerated on the ocular surface.
  • Olopatadine 0.2% can be used in allergic conjunctivitis patients with mild to moderate dry eye also.

(6) Convenient dosing

  • Simple once a day dosing – helps in increasing patient compliance
  • Safe and well tolerated, improves quality of life of patients with allergic conjunctivitis.
XYLISTIN : Come Back To Life

First Time in India

XYLISTIN (Colistimethate sodium) belongs to polymyxins, a group of polypeptide antibiotics discovered 5 decades ago in Japan . Polymyxins consist of 5 chemically different compounds (polymyxin A-E), of which polymyxin B and E were developed for clinical use. Colistimethate sodium is polymyxin E. However, the intravenous formulations of polymyxins were gradually withdrawn in most parts of the world in the early 1980s, because of the reported high incidence of nephrotoxicity and neurotoxicity. Subsequently its use was restricted mainly for the treatment of lung infections due to multi-drug resistant (MDR) gram-negative bacteria in cystic fibrosis.

However, there has been an unprecedented increase in multidrug resistant and carbapenem resistant Pseudomonas aeruginosa , Acinetobacter baumannii and Klebsiella pneumoniae , including ESBLs and metallo-betalactamses (MBLs) , while the last two decades have seen a marked decline in the discovery and development of novel antibiotics, which has led to the revival of colistimethate sodium in human medicine.

The toxicity observed in early clinical use with colistimethate sodium was due to using very high doses than now recommended, co-administration of nephrotoxic and neurotoxic drugs and failure to modify doses in renally impaired patients.

Indication
XYLISTIN is indicated for treatment of MDR and carbapenem resistant gram negative infections.

Dosage
Normal renal function
In Children and Adults (Upto 60 kg)
50,000-75,000 International Units in three divided doses.

Over 60 kg
1-2 Million international units (MIU) thrice a day.

Impaired renal function
Mild (Cr Cl 20-50 mL/min): 1-2 MIU q 8hr.
Moderate (Cr Cl 10-20 mL/min): 1 MIU q 12-18 hr.
Severe (Cr Cl less than10 mL/min): 1 MIU q 18-24 hr.

Solution for single use only and to be infused over a period of 30 minutes.

XYLISTIN HIGHLIGHTS  

  • Exhibits rapid bactericidal and anti-endotoxin activity.
  • Narrow spectrum highly effective antibiotic against Pseudomonas aeruginosa , Acinetobacter baumannii and Klebsiella pneumoniae .
  • Stable to all beta-lactamases including ESBLs, Amp-C and MBLs.
  • Exhibits maximum synergy with piperacillin and ceftazidime against MDR Pseudomonas aeruginosa .
  • Exhibits maximum synergy with meropenem, sulbactam and rifampicin against MDR Acinetobacter baumannii.
  • Effective therapeutic option against otherwise untreatable Pseudomonas aeruginosa and Acinetobacter baumannii infections.
  • No nephrotoxicty and neurotoxicty on more than 4 weeks of administration.
  • Quick diuresis with IV mannitol and exchange transfusion may enhance renal clearance in setting of overdose.
TRIOHALE - 3 2 1 of COPD treatment

 

Chronic Obstructive Pulmonary Disease (COPD) deserves special attention due to its high prevalence and significant associated mortality. The road from diagnosis to death from COPD is not an easy one and it makes life miserable for the patient as well as for the family members.

The understanding of COPD has increased tremendously in past few years and contrary to the nomenclature which actually is a misnomer; it is not just limited to the lungs. There are significant associated systemic co morbidities. Also, COPD is not only about airflow limitation but also about other significant changes occurring in the lungs like mucociliary dysfunction, structural damage and abnormal airway inflammation, making it a truly a multi component disease. All these things act in synergy with each other to set in what we can truly call as the Vicious cycle of COPD.

As the understanding of the disease enhanced so did the drug therapy. Previously anticholinergics were considered the only treatment for COPD. They continue to remain the backbone for bronchodilation in COPD; however the role of beta2 bronchodilators and inhaled corticosteroids has been well established. All these drugs take care of the different aspects of the pathophysiology of COPD thereby giving comprehensive control than what the individual drugs could achieve. Infact, researches in the UK in their news letter PULSE dated January 2008, have published their interesting findings on the INSPIRE study and urged for the development for a triple drug inhaler for severe COPD.

Keeping all these things in mind Cipla is proud to launch the world's first triple drug combination inhaler TRIOHALE for the treatment of severe COPD. By doing so we are achieving good control and also enhancing the patient compliance.

INDICATIONS
TRIOHALE Inhaler is indicated as third line treatment of severe cases of COPD when monotherapy and second line therapy with two drugs do not respond adequately.

DOSAGE & ADMINISTRATION

TRIOHALE Inhaler

Adults
The recommended dosage is the inhalation of two puffs, once daily. It is recommended to use TRIOHALE inhaler with the Zerostat /Zerostat-V spacer.

Foracort forte - Empowered to breathe easy

 

Foracort forte is a combination product containing higher dose of formoterol (12 mcg) and budesonide (400 mcg) for management of COPD and also severe asthma. The higher dose of formoterol in Foracort forte is keeping in mind the recommendation that bronchodilators are the first line management of COPD.

Treatment of COPD depends on the severity of the disease, with short acting bronchodilators being recommended for as required use in mild COPD and long acting bronchodilators for regular therapy in patients with moderate COPD. The GOLD guidelines recommend the use of inhaled corticosteroids in addition to bronchodilators especially in patients with severe to very severe COPD (FEV 1< 50%) and repeated exacerbations.

Exacerbations have a significant impact on the disease as well as the patient, resulting in hospitalizations, reduced quality of life and even mortality. Each exacerbation of COPD results in as much muscle mass damage in the chest as 3 years of ageing and also reportedly a loss in lung function of around 8 ml. Thus exacerbations have adverse effects on the patient's health and also on the severity of the underlying disease, subsequently worsening the patient's condition, which takes a long time to recover.

Inhaled corticosteroids exert anti inflammatory effects in airways by a ttenuating neutrophil activation & recruitment, reducing CD8/CD4 lymphocyte ratio and inflammatory mediators interleukin-8 (IL 8), tumor necrosis factor-alpha (TNF-a). Thus helping to reduce the frequency and severity of exacerbations and helping to improve symptoms and quality of life in patients with COPD.

The combination of formoterol/budesonide in patients with COPD (FEV 1 <50%), has shown number of clinical benefits – reduction in severe exacerbations and oral steroid courses, improvement in FEV 1, reduction in symptoms and improvement in quality of life (SGRQ score).

Indications

Asthma
Foracort Forte is indicated in the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting beta 2 -agonist) is appropriate:

- patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting beta 2 -agonists.

or

- patients already adequately controlled on both inhaled corticosteroids and long-acting beta 2 -agonists.

COPD

Symptomatic treatment of patients with severe COPD (FEV 1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Dosage & Administration

Asthma
Foracort Forte is not intended for the initial management of asthma

Recommended doses:

Adults (18 years and older): 1 inhalation/Rotacap twice daily. Some patients may require up to a maximum of 2 inhalations/Rotacaps twice daily.

Adolescents (12-17 years): 1 inhalation/Rotacap twice daily.

Children under 12 years: Efficacy and safety have not been fully studied in children. Foracort Forte is not recommended for children under 12 years of age.

Foracort Forte should be used as Formoterol/Budesonide maintenance therapy only. Lower strengths are available for the Formoterol/Budesonide maintenance and reliever therapy regimen.

COPD

Recommended doses:

Adults: 1 inhalation/Rotacap twice daily.

VORITEK - Technology Unparalleled

Invasive fungal infections are a growing problem, especially in the settings of critical care and compromised immune function. The rising incidence of fungal infections has resulted in the development of voriconazole, a new triazole antifungal.

Voriconazole is a broad-spectrum azole, approved for the primary treatment of invasive aspergillosis, can didi asis and infections caused by Scedosporium apiospermum and Fusarium spp.

Lack of nephrotoxicity and excellent oral bioavailability are the attractive features of voriconazole in patients with reversible renal dysfunction who can tolerate oral therapy.

Voriconazole is indicated for use in the treatment of the following fungal infections:

  1. Invasive Aspergillosis. Mainly due to Aspergillus fumigatus, as well as due to other species of Aspergillus.
  2. Candidemia in nonneutropenic patients, disseminated Candida infections in skin and infections in abdomen, kidney, bladder wall, and wounds as well as esophageal can didi asis
  3. Serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in patients intolerant of, or refractory to, other antifungal therapy.

Co administration of voriconazole with Rifampin and Rifabutin (anti-TB drugs), Ritonavir and Efavirenz (anti-HIV drugs), Carbamazepine (anti-epileptic drug) and long-acting barbiturates, Ergot alkaloids (ergotamine and dihydroergotamine) is contraindicated .

Co administration of voriconazole with Phenytoin, Cyclosporine, Methadone, Tacrolimus, Warfarin, Omeprazole, Benzodiazepines, HMG-CoA Reductase Inhibitors, Dihydropyridine Calcium-Channel Blockers, Sulfonylurea oral hypoglycemics & Vinca Alkaloids may require dose adjustment .

DOSAGE AND ADMINISTRATION

Voriconazole Tablets should be taken at least one hour before, or one hour following, a meal.

The powder for injection is reconstituted with 19 mL of Water for Injection to obtain an extractable volume of 20 mL of clear concentrate containing 10 mg/mL of voriconazole.

NOT FOR IV BOLUS INJECTION

Table 1 Recommended Dosing Regimen

Infection

Loading Dose

Maintenance Dose

IV
IV
Oral a

Invasive Aspergillosis

6 mg/kg q12h for the first 24 hours

4 mg/kg q12h

200 mg q12h

Candidemia in nonneutropenic patients and other deep tissue Candida infections

6 mg/kg q12h for the first 24 hours

3-4 mg/kg q12h b

200 mg q12h

Esophageal Can didi asis

c

c

200 mg q12h

Scedosporiosis and Fusariosis

6 mg/kg q12h for the first 24 hours

4 mg/kg q12h

200 mg q12h

a Patients who weigh 40 kg or more should receive an oral maintenance dose of 200 mg voriconazole every 12 hours. Adult patients who weigh less than 40 kg should receive an oral maintenance dose of 100 mg every 12 hours.

b In clinical trials, patients with candidemia received 3 mg/kg q12h as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg as salvage therapy. Appropriate dose should be based on the severity and nature of the infection.

c Not evaluated in patients with esophageal can didi asis.

If patient response is inadequate, the oral maintenance dose may be increased from 200 mg every 12 hours to 300 mg every 12 hours.

For adult patients weighing less than 40 kg, the oral maintenance dose may be increased from 100 mg every 12 hours to 150 mg every 12 hours.

If patients are unable to tolerate 300 mg orally every 12 hours, the oral maintenance dose is reduced by 50 mg steps to a minimum of 200 mg every 12 hours (or to 100 mg every 12 hours for adult patients weighing less than 40 kg).

If patients are unable to tolerate 4 mg/kg IV, the intravenous maintenance dose is reduced to 3 mg/kg every 12 hours.

Duration of therapy should be based on the severity of the patient's underlying disease, recovery from immunosuppression, and clinical response.

Formulation
Voritek 50 and 200 tabs containing 50 mg and 200 mg voriconazole respectively

Voritek injection: Each vial contains Voriconazole 200mg (as sterile freeze dried powder for reconstitution with 20 ml sterile water for injection)

NEBICIP: Exceptional β Blocker with Dual Action

β blockers have been in clinical use for over 40 years and their usefulness for the management of cardiovascular diseases is well established. NEBICIP contains nebivolol, a novel, potent, third generation β blocker with the highest degree of β 1 selectivity amongst all currently available β blockers. Nebivolol also has a unique ability of stimulating nitric oxide (NO) production which causes vasodilation and improves endothelial function.

Nebivolol has demonstrated antihypertensive efficacy similar to that of other β blockers and other classes of antihypertensive drugs. Furthermore, nebivolol has been shown to significantly reduce the mortality and morbidity in elderly patients with chronic heart failure (CHF). In addition, nebivolol maintains or improves left ventricular function in patients with hypertension and also has anti-anginal efficacy.

NEBICIP is available in two strengths, NEBICIP 2.5 and NEBICIP 5 . It is indicated in hypertension and in elderly patients (age ≥ 70 years) with stable mild and moderate CHF. The recommended starting dose in hypertension is one tablet of NEBICIP 5 once daily, with or without food, which can be increased at 2-week intervals up to 40 mg. In severe renal impairment (CICr < 30 ml/min) and moderate hepatic impairment, recommended initial dose is one tablet of NEBICIP 2.5 once daily; upward titration should be performed cautiously if needed. In CHF, the initial dose is half-tablet of NEBICIP 2.5 , to be increased to one tablet of NEBICIP 2.5 once daily, then to one tablet of NEBICIP 5 once daily and then to 10 mg once daily.

DESIROX - Simple…Once Daily…Dispersible

Patients with chronic anaemias such as thalassaemia, sickle cell disease, congenital rare anaemias and myelodysplastic syndromes require regular blood transfusions in order to improve both quality of life and survival. Humans are unable to eliminate the iron released from the breakdown of transfused red blood cells and the excess iron is deposited as haemosiderin and ferritin in the liver, spleen, endocrine organs and myocardium. The accumulation of toxic quantities of iron causes tissue damage and leads to complications such as heart failure, diabetes, hypothyroidism and liver failure. Morbidity and mortality in regularly transfused thalassaemia patients are due primarily to the effects of iron overload rather than to the underlying disease.

Iron chelators mobilize tissue iron by forming soluble, stable complexes that are then excreted in the faeces and/or urine. Although desferrioxamine has been available for the past 40 years, its poor oral bioavailability and short plasma half-life necessitate parenteral administration and prolonged infusions. Further, therapy was expensive and cumbersome, and led to significant non-compliance.

The introduction of the world's first oral iron chelator, deferiprone, by Cipla in 1995 revolutionised the treatment of iron overload, and brought the benefits of oral iron chelation  therapy within  reach of thousands of patients globally.

DESIROX ( Deferasirox) is yet another breakthrough in oral iron chelation therapy. Its once-daily dosing and availability as a dispersible tablet are unique features, and represent an important advance in therapy.

CEFTORIN - A Change for Excellence

Treatment of lower respiratory infections like community acquired pneumonia and acute exacerbations of chronic bronchitis are becoming a tough challenge due to increase in resistance. Newer cephalosporin like cefditoren pivoxil (CEFTORIN) has several attributes that make it an excellent choice for treating lower respiratory tract infections.

Cefditoren pivoxil is a novel third-generation oral cephalosporin with a broad spectrum of activity against pathogens, including both Gram-positive and Gram-negative bacteria; moreover it is the most potent antibacterial and is stable to hydrolysis by many common ß-lactamases. Cefditoren pivoxil is active against PRSP as well as MDRSP .

Cefditoren pivoxil is approved for use in the treatment of acute exacerbations of chronic bronchitis (AECB), mild-to-moderate community acquired pneumonia (CAP), acute maxillary sinusitis, acute pharyngitis/tonsillitis and uncomplicated skin and skin structure infections.

Cefditoren pivoxil demonstrated good clinical and bacteriological efficacy in AECB, CAP, acute maxillary sinusitis, acute pharyngitis / tonsillitis and uncomplicated skin and skin structure infections and was generally well tolerated. Thus, cefditoren pivoxil is a good option for the treatment of adult and adolescent patients with specific respiratory tract or skin infections, particularly if there is concern about Streptococcus pneumoniae with decreased susceptibility to penicillin, or ß-lactamase mediated resistance among the common community-acquired pathogens.

CEFTORIN is available as 200 mg oral tablets. And the recommended dose for Cefditoren is 200 – 400 mg bid in treatment of mild to moderate infections in adults and adolescents (12 years of age or older)

CRESAR-R: Dual Inhibition with Multiple Benefits

Since activation of renin angiotensin system (RAS) plays a key role in the progression of renal and cardiovascular diseases, inhibitors of RAS [angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs)] are now first-line treatments for progressive renal disease and hypertensive target organ damage.

The primary rationale justifying the use of ACE inhibitor and ARB combination is to ensure a more specific and complete RAS blockade. Clinical studies have demonstrated that ACE inhibitors and ARBs have specific renoprotective effects independent of BP reduction which include reduced risk of ESRD, reduced proteinuria and increased serum albumin levels and improvement in survival.

Amongst ACE inhibitors, ramipril has an extensive body of evidence regarding its clinical efficacy and safety. Amongst ARBs, telmisartan is an extensively used ARB on account of its unique properties. Hence, telmisartan and ramipril represents promising combination for providing renoprotection in high-risk hypertensives viz., hypertensives with diabetic and non-diabetic chronic kidney disease and diabetic hypertensives.

CRESAR-R is the fixed-dose combination of telmisartan and ramipril from Cipla available in two strengths, CRESAR-R 2.5 (telmisartan 40 mg plus ramipril 2.5 mg) and CRESAR-R 5 (telmisartan 40 mg plus ramipril 5 mg). The usual recommended dosage is one tablet of CRESAR-R 2.5 or CRESAR-R 5 . In severe renal impairment or haemodialysis, a lower starting dose of one tablet of CRESAR-R 2.5 once daily should be used which may be titrated upward to a maximum of one tablet of CRESAR R 5 once daily . In mild to moderate hepatic impairment, dosage should not exceed one tablet of CRESAR-R 2.5/5 once daily.

ZorDox - Making a Focused Approach

ZorDox (Doxofylline) is a novel methylxanthine bronchodilator characterized by the presence of a dioxolane group in position 7, which differentiates it from theophylline.

The mechanism of action of Doxofylline is similar to theophylline which results in inhibition of phosphodiesterase enzymes followed by the increase of intracellular concentrations of cyclic AMP that causes smooth muscle relaxation. But, in contrast to theophylline, doxofylline has much lower affinities towards adenosine A1 and A2 receptors, which accounts for its better safety profile.

Bronchodilator activities of doxofylline have been demonstrated in clinical trials involving patients with either asthma or COPD. Data from clinical trials have confirmed that doxofylline is associated with less GI, cardiac and central nervous system untoward effects. Doxofylline has been confirmed to be a safe alternative to the classical xanthine derivatives. Due to its favorable safety profile, the therapeutic range of doxofylline is significantly wider with respect to that of theophylline.

Indications
ZorDox is indicated for the treatment of bronchial asthma and chronic obstructive pulmonary disease (COPD) in adults.

Dosage and Administration
Adults
ZorDox tablet should be taken as one tablet (400 mg) two times a day. The dosage may be increased to thrice daily according to the prescribing physician.

Duoset – Get Active, Get Going

First Time In India

COPD medication in pack of ten rotacaps

Duoset is the combination of widely used anticholinergic (Ipratropium) and short acting beta 2 -agonist Levosalbutamol, which is pure isomer of salbutamol, for Chronic Obstructive Pulmonary Disease (COPD) management. The guidelines state that “Bronchodilators are central to the symptomatic management of COPD”.

Duoset being available in a pack of ten rotacaps, helps to cater to the need of the primary care practitioner in providing a cost effective therapy. This would help the primary care practitioner to initiate the ideal therapy – inhaled bronchodilators which are the first line of treatment for COPD patients.

Indication
Duoset is indicated for use in patients with COPD and on a regular inhaled bronchodilator, who continue to have evidence of bronchospasm and require a second bronchodilator.

Dosage & Administration
The dosage of Duoset is one rotacap four times a day. Patients may take additional inhalations as required; however the total number of rotacaps should not exceed 6 in 24 hours. Duoset Rotacaps should be used only with the Cipla Rotahaler.