COZAAR Powder and solvent for oral suspension Ref.[6965] Active ingredients: Losartan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Merck Sharp and Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Product name and form

COZAAR 2.5 mg/ml powder and solvent for oral suspension.

Pharmaceutical Form

Powder and solvent for oral suspension.

White to off-white powder.

The solvent is a cloudy, colourless liquid.

Qualitative and quantitative composition

Each sachet of powder for oral suspension delivers 500 mg of losartan potassium.

After reconstitution, each ml suspension contains 2.5 mg of losartan potassium.

One bottle of reconstituted suspension (200 ml) contains 500 mg of losartan potassium.

Excipient: Each ml suspension contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, 50.6 mg sorbitol, and 1.275 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Losartan

Losartan is a synthetic oral angiotensin-II receptor (type AT1) antagonist. Antihypertensive activity and suppression of plasma aldosterone concentration are maintained, indicating effective angiotensin II receptor blockade.
List of Excipients

Powder:

Microcrystalline cellulose (E460)
Lactose monohydrate
Pregelatinized maize starch
Magnesium stearate (E572)
Hydroxypropyl cellulose (E463)
Hypromellose (E464)
Titanium dioxide (E171)

Solvent:

Microcrystalline cellulose
Carboxymethylcellulose sodium
Citric acid anhydrous
Purified water
Xantham gum (E415)
Methylhydroxybenzoate (E218)
Sodium phosphate monobasic monohydrate
Potassium sorbate (E202)
Carrageenan calcium sulfate, trisodium phosphate
Flavor berry citrus sweet
Glycerin
Propylhydroxybenzoate (E216)
Sodium citrate anhydrous
Saccharin sodium
Sorbitol (E420)antifoam AF emulsion (contains water, polydimethylsiloxane, C-14-18, mono- and di-glycerides, polyethylene glycol stearate, and polyethylene glycol.)

Pack sizes and marketing

The following components are packed in a kit:

  • A single aluminum foil sachet filled with powder containing 500 mg losartan potassium. The sachet material consists of the following materials, from outside to inside and product contact layer: PET/Ink/ Adhesive/Foil/Adhesive/PE
  • a 473 ml white, high-density polyethylene (HDPE) bottle of solvent,
  • a 240 ml amber transparent or clear polyethylene terephthalate (PET) bottle with polypropylene child resistant closure for mixing the suspension,
  • a 10 ml oral dosing polypropylene syringe packed individually with a low density polyethylene push-in bottle neck adapter (PIBA) in a poly bag.

Marketing authorization holder

Merck Sharp and Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK

Marketing authorization dates and numbers

PL 00025/0530

10 March 2009/23 August 2013

Drugs

Drug Countries
COZAAR Brazil, Canada, Cyprus, Germany, Ecuador, Spain, Finland, France, Hong Kong, Croatia, Ireland, Mexico, Netherlands, Poland, Singapore, Turkey, United Kingdom, United States, South Africa
 
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