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

Human viral influenza is a highly contagious, acute and febrile respiratory disease which is rooted in the distant past and has long been recognized as a significant cause of morbidity and mortality in healthy adult populations and children. Influenza in children has been poorly documented because of its non-specific symptoms like fever, chills, sore throat, nasal congestion, cough, myalgia, and malaise, the large variety of other circulating viruses (often including a predominance of respiratory syncytial virus, also rhinovirus, parafluenza viruses, and adenovirus), the lack of a readily accessible diagnostic test and the perception that it is a benign illness in childhood. Nonetheless, it is recognized that school age children are the main source of the introduction of influenza into the household.

Depending on age, annual attack rates in children are 1.5- to 3.0-fold higher than in adults. During epidemic years, attack rates often exceed 40% in preschool children and 30% in school age children. Influenza may result in substantial morbidity even in healthy children. For children under 5 years of age, the rate of hospitalization for acute respiratory tract disease has been reported as 42.7 in 100,000. However, children with chronic medical conditions (asthma, cardiovascular disease, pulmonary disease, immunosuppression, cancer, renal disease, haemoglobinopathies, and neurological disease) and those born prematurely are 4 to 21 times more likely to be hospitalized with respiratory complications than healthy children during influenza predominant seasons.

Children can also be at risk of acquiring influenza-related complications like acute otitis media, febrile convulsions, sinusitis, bronchitis, bronchiolitis, croup, pneumonia (viral and bacterial) and Reye's syndrome.

Current treatment options of influenza in children have limitations. The M2 inhibitors, amantadine and rimantadine, have limited clinical use in pediatrics because of the rapid development of viral resistance, lack of activity against influenza B and only moderate clinical benefit without documented effects on complications.

Oseltamivir (Antiflu), a neuraminidase inhibitor has proven to be safe and effective for the prevention or treatment of all known influenza subtypes of influenza A and B virus, reducing the severity and duration of symptoms, use of paracetamol, the complications arising from influenza infection (otitis media, pneumonia, etc), hospitalization and antibiotic use pertaining to these complications, extent and quantity of viral shedding, and mortality.

Antiflu is indicated for the treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older who have been symptomatic for no more than 2 days and is indicated for the prophylaxis of influenza in patients 1 year and older.

The recommended oral dose of Antiflu Suspension is as follows:

Antiflu may be taken with or without food.

Antiflu Suspension is a bottle of 75 ml where each ml (on reconstitution) contains 12 mg Oseltamivir. Dosage measuring devices like a calibrated cup and an oral syringe is provided with the pack.

FORATEC Respules contain arformoterol, which is a newly developed long-acting beta 2 -agonist to be given via a nebulizer. It has been approved by USFDA for the maintenance treatment of c hronic obstructive pulmonary disease (COPD) . Arformoterol is the (R, R)-enantiomer of formoterol. It has more potent bronchodilator and some anti-inflammatory properties than racemic (R, R/S, S)-formoterol.

It has been shown to be as effective as other long-acting bronchodilators given by an MDI/DPI. In addition to tiotropium, it has demonstrated that greater bronchodilation can be achieved.

Until recently, the only short acting bronchodilator drugs were available in a nebulizer formulation.  FORATEC (Arformoterol) respule contains log acting beta agonist, hence a new treatment alternative for COPD patients.

All patients having persistent symptoms despite regular bronchodilator therapy via an MDI/DPI are suitable candidates for nebulized arformoterol therapy. Moreover, patients who are unable or unwilling to use other inhaler devices due to cognition problems or physical inabilities, or prefer nebulizer therapy are suitable candidates for FORATEC Respules.

FORATEC Respules are indicated for the long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD, including chronic bronchitis and emphysema.

The recommended dose of FORATEC Respules for COPD patients is 15 mcg administered twice a day (morning and evening) by nebulization.

Pattern hair loss or androgenic alopecia affects approximately 50% of the male population by the age of 40 and 50% of women by the age of 50 years, and currently only two treatments are approved by USFDA for androgenic alopecia i.e. finasteride and minoxidil.

Minoxidil is available in conventional solution form (TUGAIN SOLUTION 2/5/10) which is dispensed in bottle. It is also available in gel form (TUGAIN GEL 2/5) which was recently introduced by Cipla; available in a unique bag in bottle technology.

But, it had been challenging to deliver topical medications into the scalp. Currently available minoxidil formulations are effective to deliver minoxidil to the scalp, but the solvent used in them is propylene glycol, which may be allergic to androgenic alopecia patients, producing hypersensitive reactions (contact dermatitis). Thus, a propylene glycol – free formulation is preferred in such cases.

Keeping above points into the consideration and overcoming the challenges, Cipla now announces the introduction of minoxidil in foam formulation which is propylene glycol – free under the brand TUGAIN FOAM 2/5/10.

TUGAIN FOAM 2/5/10 contains minoxidil 2%, 5% and 10% respectively with hydrolyzed keratin in a unique thermolabile foam formulation. When applied topically, minoxidil stimulates hair growth in people who are suffering from pattern baldness. Hydrolyzed keratin strengthens the hair shaft of the regrowing hair and makes the hair smooth and glossy. It also forms a protective coat on the hair and shields it from dryness and damage due to heat, dust and moisture.

TUGAIN FOAM 2 is indicated for the treatment in men with male pattern baldness and women with female pattern baldness, whereas TUGAIN FOAM 5/10 is indicated for the treatment of androgenic alopecia only in men. Apply half a capful of TUGAIN FOAM twice daily at 12-hour intervals to the scalp, within the hair thinning area part the hair and gently massage the foam onto the scalp. Each can should last one month, if used as directed.

Apply TUGAIN FOAM when hair and scalp are clean and dry. Total daily dose should not exceed 2 gm (2 actuations) .The drug should not be massaged into the scalp and it should be applied gently. Hair dryer should not be used to speed the drying of TUGAIN FOAM as it may decrease the effectiveness. It should not be mixed with any hair oil. It should not be applied to any other parts of the body. Hands should be washed thoroughly after applying TUGAIN FOAM . Clinical experience with minoxidil indicate s that twice daily application for 4 or more months may be required before evidence of hair growth. It should be used for not less than 45 days to arrest hair fall.

TUGAIN FOAM 2/5/10 is available in a can of 60 gm.

The widespread use of protease inhibitors (PIs) in the treatment of HIV has resulted in the emergence of viral strains with extensive cross-resistance and decline in the effectiveness of the available PIs. So there was need for new PIs that are safe, easy to use, tolerable, and effective against both resistant and wild-type HIV strains which provide durable suppression in treatment-experienced HIV patients.

DARUVIR is the India 's first third generation protease inhibitor for treatment experienced patients. It contains 300 mg darunavir.

Indication: DARUVIR is indicated for the adult treatment-experienced patient.

Dose: The recommended oral dose of DARUVIR t ablets is 600 mg (two 300 mg tablets) taken with ritonavir 100 mg twice daily and with food.

The unique features of DARUVIR are:

Olopatadine hydrochloride is a novel anti allergic/ histamine H 1 receptor antagonistic drug.

It has a triple mode of action:

It has an additional property of inhibiting the release of tachykinins, thus can be safely administered to patients with allergic rhinitis and concomitant asthma.

Olopatadine has a quick onset of action and has a protein binding ratio of 54 to 55%.Olopatadine is one of the few renal clearance drugs in anti allergic drugs. Besides controlling symptoms of allergic rhinitis effectively, olopatadine has more than 90% improvement in all urticarial disorders.

Thus it can be used successfully in controlling symptoms of skin as well as nasal allergic disorders.

Dose: 1 tab twice daily.

MISOPROST 600 contains a single tablet of misoprostol 600 mcg and is indicated for the prevention of postpartum haemorrhage (PPH).

Misoprostol is a synthetic prostaglandin E1 analogue. It causes the cervix to soften and the uterus to contract. Prostaglandin E1 causes myometrial contractions by interacting with specific receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By interacting with prostaglandin receptors, misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.

For prevention of PPH, one tablet of MISOPROST 600 should be given orally immediately after cord clamping.

Fertolet is Letrozole 2.5 mg for oral use, indicated for the Induction of ovulation in women with anovulatory infertility and Breast cancer, for the treatment of advanced/metastatic breast cancer (hormone receptor positive or receptor status unknown) in post-menopausal women as first line treatment.

Letrozole is a specific nonsteroidal aromatase inhibitor. It inhibits the aromatase enzyme by competitively binding to the haem of the cytochrome P450 subunit of the enzyme, resulting in a reduction of estrogen biosynthesis in all tissues.

Estrogen exerts a negative feedback on the hypothalamic-pituitary axis and decreases the release of FSH from the pituitary gland. Letrozole acts by blocking the synthesis of estrogen. Administration of letrozole in the early part of the menstrual cycle results in release of FSH from the pituitary gland. Letrozole acts by blocking the feedback, thereby increasing gonadotropin secretion and resulting in stimulation of ovarian follicle. Letrozole leads to induction of ovulation in women with anovoluatory infertility. Letrozole does not deplete estrogen receptor or produce a negative effect on the endometrium. Addition of letrozole to gonadotropins decreases gonadotropin requirements, increases the number of preovulatory follicles, and decreases endometrial thickness without a negative effect on pregnancy rates.

For Induction of ovulation in anovulatory infertility Fertolet is administered o nly for women of reproductive age with anovulatory infertility and the recommended dosage is 2.5 mg once daily for 5 days (days 3 to 7 of the menstrual cycle); for 3 consecutive cycles or till occurrence of pregnancy whichever is earlier. If ovulation does not occur after 3 courses of therapy, further treatment with letrozole is not recommended and the patient should be reevaluated.

For treatment of breast cancer the recommended dose of Fertolet is 2.5 mg once daily. Treatment with Fertolet should continue as long as tumour response is seen.

The global burden of cardiovascular disease (CVD) is increasing steadily. The problem is even worse in low-income and middle-income countries; 4/5 th of all cardiovascular-related events occur in these countries. It is expected that by 2010, 60% of world's heart disease would occur in India , which can have a huge impact on the economy of our country. Therefore, the need of the hour is to contain this epidemic of CVD in India .

Although efficacy of the recommended secondary CVD prevention therapies viz. statins, beta blockers, renin-angiotensin system (RAS) blockers and aspirin are well-known, there is underutilization of these therapies. Adding to this is the fact that adherence to drug therapy in chronic diseases like CVD is very low, which is responsible for adverse clinical outcomes. Both these factors can prove to be a hurdle in effective secondary prevention of CVD.

Studies have proven beyond doubt that utilization of statins, beta blockers, RAS blockers and aspirin yields significant mortality benefits as compared to non-utilization of all these four classes of drugs in patients with CVD. The introduction of STARPILL ; a revolutionary single tablet which contains all these four drug classes- aspirin 75 mg, atenolol 50 mg, losartan 50 mg and atorvastatin 10 mg would therefore represent an optimal, cost-effective tool to reduce the rising burden of CVD in India. STARPILL is indicated in patients at high risk of vascular disease. The recommended dose of STARPILL is one tablet once daily and the maximum dosage should not exceed two tablets once daily. Just taking one tablet of STARPILL daily can reduce the risk of mortality up to 90% in CVD patients.

MONTAIR LC KID Tablets is a combination of Montelukast sodium, an antileukotriene & Levocetirizine hydrochloride which is a third generation antihistamine for the treatment of Allergic Rhinitis .

Allergic Rhinitis (AR) is one of the most commonly diagnosed health disorders among children with prevalence reported to be as high as 40%. Commonly called hay fever, is defined as inflammation of the nasal membranes that occurs when an allergic individual encounters an airborne allergen such as pollen, mold, dust mites, animal dander etc. It is characterized by a symptom complex that consists of any combination of the following: sneezing, nasal congestion, nasal itching, and rhinorrhea. The eyes, ears, sinuses, and throat can also be involved. AR is not a life-threatening condition; however symptoms can have a profound effect on a child's health, behavior, sleep patterns, ability to learn, take part in physical activities/sports thereby significantly impairing child's quality of life and contributing to a number of indirect costs. Also, it is reported that AR and asthma frequently coexist in children.

Recent studies have demonstrated that the treatment of AR with concomitant administration of an antileukotriene (montelukast) and an antihistamine (levocetirizine), shows significantly better symptom relief compared with either of the drugs alone.

The cysteinyl leukotrienes (LTC 4 , LTD 4 , LTE 4 ) which are potent inflammatory eicosanoids have been correlated with the pathophysiology of allergic rhinitis as well as asthma. In AR, cysteinyl leukotrienes (CysLTs) are released from the nasal mucosa after allergen exposure during both early- and late-phase reactions. These important mediators bind to cysteinyl leukotriene type-1 (CysLT 1 ) receptors and are associated with symptoms of AR. Intranasal challenge with CysLTs has been shown to increase nasal airway resistance and symptoms of nasal obstruction. Montelukast is an orally active compound that binds with high affinity and selectivity to the CysLT 1 receptor. Montelukast is a leukotriene receptor antagonist which inhibits physiologic actions of LTD 4 at the CysLT 1 receptor.

Levocetirizine is the R-enantiomer of cetirizine. It is an orally active, potent, selective and long acting H 1 -histamine receptor antagonist with no anticholinergic activity (Drugs with anticholinergic activity inhibit muscarinic acetylcholine receptors and can produce both peripheral effects like constipation, dry mouth, tachycardia, urinary retention, reduced sweating and central effects like cognitive and memory impairment, confusion, delirium, headache, blurred vision, dizziness and drowsiness). Levocetirizine has a 2-fold higher affinity for H 1 receptor than that of cetirizine. Levocetirizine blocks histamine receptors thereby preventing histamines from binding to histamine receptors. This in turn prevents the release of other inflammatory mediators and hence provides relief from the effects; viz. nasal itching, sneezing & rhinorrhea. It is minimally sedating and safe compared to the first and second generation antihistamines.

INDICATIONS
MONTAIR LC KID Tablets are indicated for relief of symptoms of allergic rhinitis (seasonal and perennial), as prophylaxis in seasonal allergic rhinitis and treatment of comorbid asthma & allergic rhinitis in pediatric patients 2 to 5 years of age.

DOSAGE AND ADMINISTRATION
Children: (2-5 years)
One tablet once daily

Due to the lack of data, the administration of the product to infants and toddlers aged less than 2 years is not recommended.

Chronic hepatitis B is a major public health problem affecting up to 400 million people globally. Complications of chronic hepatitis B, including liver failure and hepatocellular carcinoma, result in 1.2 million deaths per year, making it the tenth leading cause of mortality worldwide; hence, it can aptly be termed “the silent killer”.

Tenofovir disoproxil fumarate, a nucleotide reverse transcriptase inhibitor, is already the gold standard for anti–HIV therapy since its approval as an antiretroviral in 2001. The drug also has potent activity against the hepatitis B virus and received approval in 2008 from the U.S. Federal Drug Administration and the European Commission (EMEA), and is now approved in India as a treatment for chronic hepatitis B in adults. The European Association for the Study of the Liver (EASL) Clinical Practice Guidelines, 2009, recommends the use of tenofovir disoproxil fumarate confidently as first-line monotherapy in patients with chronic hepatitis B.

Tenofovir disoproxil fumarate fulfills the criteria of an ideal anti-hepatitis B virus drug in all aspects. Its formidable antiviral efficacy spans a wide spectrum of patient subgroups and can tackle both the wild-type and precore -core mutants in treatment-naïve as well as treatment-experienced patients. Till date, resistance to tenofovir disoproxil fumarate has not been detected in patients of chronic hepatitis B and it has been safe and well tolerated.

TENVIR is indicated for the treatment of chronic hepatitis B in adults with compensated liver disease .

Recommended Dose
For treatment of chronic hepatitis B : The dose of TENVIR is 300 mg once daily taken orally, without regard to food. The dosing interval of tenofovir disoproxil fumarate should be adjusted in patients with baseline creatinine clearance <50 mL/min.