Montelukast Sodium + Levocetirizine Hydrochloride Tablets

Composition

Montelukast Sodium 10mg + Levocetirizine Hydrochloride 5mg

Overdose and Treatment:

• No specific data is available on the overdose of the combination, but overdose cases have been reported with individual molecules.
• Overdose symptoms may include drowsiness, agitation, restlessness (in children), thirst, headache, vomiting, and psychomotor hyperactivity with Montelukast.
• Levocetirizine overdose may result in drowsiness (in adults) and initial agitation and restlessness followed by drowsiness (in children).
• Standard measures to remove unabsorbed drugs, including gastric lavage, should be considered in case of overdose.

Uses:

• Treatment of symptoms associated with allergic conditions such as hay fever, ear-round allergies, dust or pet allergies, reddish itchy weals, and swelling in the skin.
• Management of asthma, including exercise-induced asthma, chronic asthma, seasonal allergic rhinitis, and perennial allergic rhinitis.

Pharmacological Properties:

• The combination tablet contains Montelukast sodium and Levocetirizine dihydrochloride along with various excipients.
• Montelukast is a cysteinyl leukotriene receptor antagonist that inhibits the physiologic action of leukotrienes, important pro-asthmatic mediators.
• Levocetirizine is a potent and selective antagonist of peripheral H1-receptors, providing relief from allergy symptoms.
• Both drugs have specific pharmacokinetic properties regarding absorption, distribution, metabolism, and elimination.

Interactions with Enzyme Inducers:

When enzyme inducers such as phenobarbital or rifampin are co-administered with Montelukast and Levocetirizine dihydrochloride, potential pharmacokinetic interactions may occur. However, no specific data is available for the combination of Montelukast and Levocetirizine dihydrochloride. It is essential to monitor patients closely for any signs of altered drug effects or toxicity when using these medications concomitantly with enzyme inducers.

Pharmacokinetic Interaction Studies:

• In vitro data suggests that Levocetirizine is unlikely to produce pharmacokinetic interactions through inhibition or induction of liver drug-metabolizing enzymes.
• No in vivo drug-drug interaction studies have been performed with Levocetirizine. However, drug interaction studies with racemic cetirizine, a related compound, have been conducted.
• Pharmacokinetic interaction studies performed with racemic cetirizine showed no significant interaction with various drugs, including antipyrine, pseudoephedrine, erythromycin, azithromycin, ketoconazole, and cimetidine.
• However, a small decrease in the clearance of cetirizine was observed with a high dose of theophylline. Interaction with higher theophylline doses could have a more substantial effect.
• Ritonavir, an antiretroviral medication, increased the plasma exposure of cetirizine, leading to increased half-life and decreased clearance of cetirizine. The disposition of ritonavir remained unchanged.

Side Effects:

• Common side effects may include cough, dry mouth, fever, diarrhea, fatigue, and sleepiness.
• These side effects are possible but do not always occur. Some may be rare but serious. Consult a doctor if any side effects persist or worsen.

Pregnancy and Lactation:

• There are no adequate and well-controlled studies of Montelukast or Levocetirizine in pregnant women. Hence, the combination is not recommended during pregnancy.
• Levocetirizine is excreted in breast milk, so the combination is also not recommended during lactation.

Effects on Ability to Drive and Use Machines:

• Levocetirizine at the recommended dose has shown no evidence of impairing mental alertness, reactivity, or driving ability in comparative clinical trials.
• However, somnolence, fatigue, and asthenia have been reported in some patients during levocetirizine therapy, cautioning against engaging in hazardous activities requiring complete mental alertness and motor coordination.
• Concurrent use of levocetirizine with alcohol or other central nervous system depressants should be avoided to prevent additional reductions in alertness and impairment of central nervous system performance.

Undesirable Effects:

• While there is no specific data available on the combination, individual molecules have reported side effects.
• Common side effects of Montelukast include dyspepsia, abdominal pain, rash, dizziness, headache, fatigue, fever, cough, and nasal congestion, among others.
• Levocetirizine may cause somnolence, fatigue, nasopharyngitis, dry mouth, and pharyngitis, with additional uncommon adverse reactions like asthenia or abdominal pain.
• Severe adverse reactions, though rare, have been reported with both Montelukast and Levocetirizine, including hypersensitivity reactions, hepatic eosinophilic infiltration, psychiatric disorders, nervous system disorders, respiratory disorders, gastrointestinal disorders, hepatobiliary disorders, skin and subcutaneous tissue disorders, musculoskeletal disorders, and general disorders.

Precautions & How to Use:

• Inform your doctor about your current list of medications, allergies, pre-existing diseases, and current health conditions before using this drug.
• Take the medication as directed by your doctor or follow the directions on the product insert. Dosage is based on your condition.
• Important counseling points:
  • Avoid driving or operating heavy machinery, especially if you experience sleepiness or fatigue.
  • Levocetirizine / Montelukast is not recommended for the prevention of exercise-induced bronchospasm.
  • It is also not recommended for patients who are already taking asthma medications.
  • Use caution if you have epilepsy, fits, kidney failure, or other underlying health conditions.
  • Take the medication at bedtime, as directed.

Storage Conditions

• Store this medicine below 30°C.
• Try to protect it from light and moisture.
• Keep it away from the reach of children and pets.