Tradename

International non-proprietary name

Montelucast + Levocetirizine Hydrochloride, Montelucast + Levocetirizine Hydrochloride

Compound

Each film-coated tablet contains:

active substance: Montelukast sodium USP equation for montelukast 5 mg, Levocetirizine hydrochloride 2.5 mg excipients: Q . S

Colour: Titanium Dioxide BP

Each film-coated tablet contains:

active substance: Montelukast sodium USP equation for montelukast 10 mg, Levocetirizine hydrochloride 5 mg excipients: Q . S

Colour: Tartrazine

Dosage form Tablets.

Pharmacological properties

Mechanism of action

Levocetirizine + Montelukast is a combination of two drugs: Levocetirizine and Montelukast, which makes sneezing easier and runny nose, caused allergies. Levocetirizine is an antiallergic agent that blocks the chemical messenger (histamine), responsible per runny nose, lacrimation and sneezing. Montelukast is a leukotriene antagonist. It works by blocking another chemical messenger (leukotriene). This reduces inflammation (swelling) of the airways and nose and improves symptoms.

Indications for use

Levocetirizine + Montelukast is used for sneezing and runny nose due to allergies, hay fever and allergic states skin.

Contraindications

Tablets LAMONTE contraindicated patients With known hypersensitivity to montelukast, levocetirizine, other piperazine derivatives or any of the excipients. It is also contraindicated in patients with severe renal insufficiency with creatinine clearance less than 10 ml / min and in patients on hemodialysis. Children aged 6 months to 11 years with impaired renal function should not prescribe the drug. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption not should accept it medicine.

Special instructions and precautions

Montelukast Eosinophilic conditions:

At patients receiving montelukast, maybe be observed systemic eosinophilia, sometimes emerging clinical signs vasculitis, characteristic for syndrome Charg-Strauss, state, which often being treated systemic therapy corticosteroids. These events were usually, but not always, associated With decrease therapy with oral corticosteroids. Physicians should be alert for eosinophilia, vasculitic rash, worsening lung symptoms, cardiac complications and/or neuropathy in their patients. Causal relationship between montelukast and these main states not installed.

Patients with known aspirin sensitivity should continue avoid reception aspirin or nonsteroidal anti-inflammatory funds in time reception montelukast.

Neuropsychiatric events

Reported about neuropsychiatric phenomena at adults, teenagers and children, hosted montelukast. Post-marketing reports of montelukast use include agitation, aggressive behavior or hostility, anxiety, depression, disorientation, sleep disturbances, hallucinations, insomnia, irritability, anxiety, somnambulism, and tremor. Clinical data from some post-marketing reports regarding montelukast, are consistent With action drug.

Patients and prescribers should be prepared to neuropsychiatric events. Patients should be instructed to notify the treating physician doctor, if these changes will happen. Doctors must thoroughly assess the risks and benefits of continuing treatment with montelukast if occurrence such phenomena.

Levocetirizine:

Comparative clinical studies are not revealed proof- evidence that levocetirizine at the recommended dose impairs mental alertness, reactivity, or driving ability. Clinical studies have reported the occurrence of drowsiness, fatigue and asthenia in some patients during therapy with levocetirizine. Patients should be warned against engaging in hazardous activities requiring full mental alertness and motor coordination, such as like operating machinery or driving a car after taking inside levocetirizine. Should avoid simultaneous the use of levocetirizine with alcohol or other drugs that depress the central nervous system, since this maybe lead to additional decrease attention and additional deterioration activities central nervous systems. Urinary retention has been reported in post-registration period use of levocetirizine. Levocetirizine should be used with caution in patients with predisposing factors for urinary retention (eg, spinal cord disease). brain, hyperpla- prostatic disease), since levocetirizine may increase the risk of urinary retention. Stop if occurs delay urine.

Side effect

Nausea, Diarrhea, Dryness in mouth, Fatigue, Head pain, Skin rash, Drowsiness, Vomit

Interaction with other drugs

Montelukast:

Montelukast may be given with other drugs commonly used to prevent and treat chronic asthma. AT research medicinal interactions The recommended clinical dose of montelukast did not have a clinically significant effect on the pharmacokinetics of the following drugs: theophylline, prednisolone, prednisolone, oral contraceptives (norethindrone one mg/ethinylestradiol 35 mcg), terfenadine, digoxin and warfarin.

Area under the plasma montelukast concentration curve ( AUC ) decreased approximately on the 40% at patients With simultaneous   application   phenobarbital.   Because the   montelukast is metabolized by CYP 3 A 4, caution should be exercised, especially in children, while the use of montelukast with inductors CYP 3 A 4, such how phenytoin, phenobarbital and rifam-picin.

Although additional research on specific interactions no action has been taken, montelukast has been used concomitantly with a wide range of commonly prescribed drugs in clinical research without signs clinical unwanted interactions. These drugs included thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory funds, benzodiazepines and decongestants funds.

Research in vitro showed what montelukast is powerful inhibitor CYP 2C8 . _ Tem not less, data clinical drug interaction studies involving montelukast and rosiglitazone (representative probe substrate medicines, which in mostly metabolized CYP 2C8 ) _ showed that montelukast does not inhibit CYP 2 C 8 in vivo . Thus, montelukast is not expected to significantly alter the metabolism of drugs metabolized by this enzyme (e.g., paclitaxel, rosiglitazone and repaglinide).

Research in vitro showed that montelukast is CYP substrate 2 C 8 and, to a lesser extent, 2 C 9 and 3 A 4. In a clinical study medicinal interactions With participation montelukast and gemfibrozil (an inhibitor of CYP 2 C 8 and 2 C 9) gemfibrozil increased the systemic exposure of montelukast by 4.4 times. When combined with gemfibrozil or other potent inhibitors of CYP 2 C 8, routine dose adjustment of montelukast is not required, but doctor must know about capabilities amplification side reactions.

Based on data in no clinically significant drug interactions are expected in vitro with less potent inhibitors of CYP 2 C 8 (eg, trimethoprim). Simultaneous use of montelukast with itraconazole, a strong inhibitor of CYP 3 A 4, did not lead to a significant increase in the systemic exposure of montelukast.

Levocetirizine:

Data in vitro show that it is unlikely that levocetirizine causes pharmacokinetic interactions through inhibition or induction of liver enzymes that metabolize medicinal funds. Research drug interactions in vivo with levocetirizine was carried out. Drug interaction studies have been conducted with racemic   cetirizine.

Pharmacokinetic interaction studies conducted with racemic cetirizine have shown that cetirizine does not interact with antipyrine, pseudoephedrine, erythromycin. nom, glipizide and diazepam, azithromycin, ketoconazole and cimetidine. It was noted small