Montelukast Sodium Granule

Montelukast Sodium Granule Manufacturers

• Dr.reddy’s Laboratories Limited
  

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  Montelukast Sodium Granule | Dr.reddy's Laboratories Limited

  

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  2.1 Asthma

  Montelukast sodium should be taken once daily in the evening. The following doses are recommended:

  For pediatric patients 2 to 5 years of age: one packet of 4 mg oral granules.

  For pediatric patients 12 to 23 months of age: one packet of 4 mg oral granules.  

  Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.  

  There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion.

  2.3 Allergic Rhinitis

  For allergic rhinitis, montelukast sodium should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs.  

  The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:

  For pediatric patients 2 to 5 years of age: one packet of 4 mg oral granules.  

  Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.  

  The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:

  For pediatric patients 2 to 5 years of age: one packet of 4 mg oral granules.

  For pediatric patients 6 to 23 months of age: one packet of 4 mg oral granules.  

  Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.

  2.4 Asthma and Allergic Rhinitis

  Patients with both asthma and allergic rhinitis should take only one montelukast sodium dose daily in the evening.

  2.5 Instructions for Administration of Oral Granules

  Montelukast sodium 4 mg (montelukast) oral granules can be administered either directly in the mouth, dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or mixed with a spoonful of cold or room temperature soft foods; based on stability studies, only applesauce, carrots, rice, or ice cream should be used. The packet should not be opened until ready to use. After opening the packet, the full dose (with or without mixing with baby formula, breast milk, or food) must be administered within 15 minutes. If mixed with baby formula, breast milk, or food, montelukast sodium oral granules must not be stored for future use. Discard any unused portion. Montelukast sodium oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration. However, liquids may be taken subsequent to administration. Montelukast sodium oral granules can be administered without regard to the time of meals.

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• Prasco Laboratories
  

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  Montelukast Sodium Granule | Par Pharmaceutical Inc.

  

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  The usual recommended starting dose of candesartan cilexetil is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candesartan cilexetil can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Patients requiring further reduction in blood pressure should be titrated to 32 mg. Doses larger than 32 mg do not appear to have a greater blood pressure lowering effect.

  Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily.

  Use in Renal Impairment: Dosing recommendations for candesartan cilexetil-hydrochlorothiazide in patients with creatinine clearance <30 mg/min cannot be provided (see SPECIAL POPULATIONS, Renal Insufficiency).

  Use in moderate to severe Hepatic Impairment: candesartan cilexetil-hydrochlorothiazide is not recommended for initiation because the appropriate starting dose, 8 mg, cannot be given. (see SPECIAL POPULATIONS, Hepatic Insufficiency).

  Replacement Therapy: The combination may be substituted for the titrated individual components.

  Dose Titration by Clinical Effect: A patient whose blood pressure is not controlled on 25 mg of hydrochlorothiazide once daily can expect an incremental effect from candesartan cilexetil-hydrochlorothiazide 16-12.5 mg. A patient whose blood pressure is controlled on 25 mg of hydrochlorothiazide but is experiencing decreases in serum potassium can expect the same or incremental blood pressure effects from candesartan cilexetil-hydrochlorothiazide 16-12.5 mg and serum potassium may improve.

  A patient whose blood pressure is not controlled on 32 mg of candesartan cilexetil can expect incremental blood pressure effects from candesartan cilexetil-hydrochlorothiazide 32-12.5 mg and then 32-25 mg. The maximal antihypertensive effect of any dose of candesartan cilexetil-hydrochlorothiazide can be expected within 4 weeks of initiating that dose.

  Candesartan cilexetil-hydrochlorothiazide may be administered with other antihypertensive agents.

  Candesartan cilexetil-hydrochlorothiazide may be administered with or without food.

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