Overview

Our product comprises of Levocetirizine and Ambroxol . This combination of medication works effectively against respiratory tract infections/allergies by inhibiting histamine receptors and reducing the mucus formation & improvement of the following Symptoms of allergic conditions , Hay fever , Ear-round allergies ,Dust or pet allergies , Reddish itchy weals, Swelling in the skin, Inflammation of the mucous membrane of the nose,Respiratory tract diseases & Thickened mucus cough .

Indications

• Respiratory tract diseases
• Thickened mucus cough
• Symptoms of allergic conditions
• Hay fever
• Ear-round allergies
• Dust or pet allergies
• Reddish itchy weals
• Swelling in the skin

Contraindications

Although rare but the following conditions have to be considered before taking the medication

In patients with gastric ulceration

Patient with known hypersensitivity

Patients with end stage renal disease

WARNING AND PRECAUTION

Do consult the physician if suffering from epilepsy before taking the drug

Consult your doctor if you have a history of allergic reactions of skin, severe liver or kidney problems

Do not exceed the stated dose

The use is not recommended in children less than 6 years

Precaution is recommended if alcohol is taken concomitantly

Pharmacology

Pharmacodynamic properties of AMBROXOL HCl

Ambroxol

is a clinically proven systemically active mucolytic agent. Ambroxol is a potent inhibitor of the neuronal Na+ channels. When administered orally onset of action occurs after about 30 minutes. The breakdown of acid mucopolysaccharide fibers makes the sputum thinner and less viscous and therefore more easily removed by coughing. Although sputum volume eventually decreases, its viscosity remains low for as long as treatment is maintained. Alteplase initiates local fibrinolysis and dissolution of clots by binding to fibrin in a thrombus and the fibrin-bound plasminogen is converted to plasmin.

Pharmacodynamic properties of LEVOCETIRIZINE

Levocetirizine

is an antihistaminic drug. It is the R-enantiomer of cetirizine, is a potent and selective antagonist of peripheral H1-receptors.Binding studies revealed that levocetirizine has high affinity for human H1- receptors (Ki = 3.2 nmol/l). Levocetirizine has an affinity 2-fold higher than that of cetirizine (Ki = 6.3 nmol/l). Levocetirizine dissociates from H1-receptors with a half life of 115 ± 38 min.Pharmacodynamic studies in healthy volunteers demonstrate that, at half the dose, levocetirizine has comparable activity to cetirizine, both in the skin and in the nose.

PHARMACOKINETICS PROPERTIES

Pharmacokinetic properties of AMBROXOL HCl

Absorption:

It is absorped approx. 60% to the first pass effect. Plasma concentrations are in a linear relationship to the dose. Peak plasma levels are attained after 0.5 to 3 hours.

Distribution:

Ambroxol is distributed swiftly and extensively from the blood into the tissues. The highest active ingredient concentrations are measured in the lung.

Metabolism:

Ambroxol is metabolized in the liver mainly by conjugation.

Elimination:

Total clearance is in the region of 600 ml/min, and renal clearance is 8% of total clearance.

Pharmacokinetic properties of LEVOCETIRIZINE

Absorption:

Steady state achieved after 2 days.

Distribution:

Levocetirizine is 90% bound to plasma proteins.

Metabolism:

Metabolism is less than 14% and by aromatic oxidation, N- and O-dealkylation, and taurine conjugation.

Elimination:

The half life is about 8 to 9 h. Elimination is 85.4% and 12.9% via urine and feces, respectively.

Interactions

• Drug- drug interaction may be seen with pseudoephedrine or theophylline
• Avoid taking the combination with Aspirin
• Avoid taking any other antiallergic with the drug
• Concomitant administration of Ambroxol and antibiotics (amoxicillin, cefuroxime, erythromycin, and doxycycline) leads to higher concentration of the antibiotic in the pulmonary tissue.
• Co-administration of Ambroxol and cough-suppressing preparations is not recommended.