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

 

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

 

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:

Body Weight (kg)	Body Weight (lbs)	Per Dose Recom-mendation (mg)	Recommended Volumes for Treatment (5 Day Regimen)- Twice Daily	Recommended Volumes for Prophylaxis (10 Day Regimen)-Once Daily
</=15 kg	</=33 lbs	30 mg	2.5 mL (1/2 tsp)	2.5 mL (1/2 tsp)
>15 kg - 23 kg	>33 lbs – 51 lbs	45 mg	3.8 mL (3/4 tsp)	3.8 mL (3/4 tsp)
>23 kg - 40 kg	>51 lbs - 88 lbs	60 mg	5.0 mL (1 tsp)	5.0 mL (1 tsp)
>40 kg	>88 lbs	75 mg	6.2 mL (1 1/4 tsp)	6.2 mL (1 1/4 tsp)

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.

Dec 2009

 

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.

 

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

It has a triple mode of action:

• It has a high selective affinity for the H 1 receptors only, hence causing relatively weak drowsiness.
• It stabilizes the mast cells and reduces the release of histamine.
• In vitro studies have shown that olopatadine has anti inflammatory properties by inhibiting the release of Arachidonic Acid and by suppressing the formation of leukotrienes and thromboxane A 2.

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.