COZAAR Powder and solvent for oral suspension (2018)
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Περιεχόμενα
Name of the medicinal product
COZAAR 2.5 mg/ml powder and solvent for oral suspension.
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 ...
Pharmaceutical form
Powder and solvent for oral suspension. White to off-white powder. The solvent is a cloudy, colourless liquid.
Therapeutic indications
Treatment of essential hypertension in adults and in children and adolescents 6–18 years of age. Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ...
Posology and method of administration
Posology Hypertension The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in sections 4.4 and 6.1. 2<sup>nd</sup> and 3<sup>rd</sup> trimester of pregnancy (see sections 4.4 and 4.6). Severe hepatic ...
Special warnings and precautions for use
Hypersensitivity Angiooedema. Patients with a history of angiooedema (swelling of the face, lips, throat, and/or tongue) should be closely monitored (see section 4.8). Hypotension and Electrolyte/Fluid ...
Interaction with other medicinal products and other forms of interaction
Other antihypertensive agents may increase the hypotensive action of losartan. Concomitant use with other substances which may induce hypotension as an adverse reaction (like tricyclic antidepressants, ...
Pregnancy and lactation
Pregnancy The use of losartan is not recommended during the first trimester of pregnancy (see section 4.4). The use of losartan is contraindicated during the 2<sup>nd</sup> and 3<sup>rd</sup> trimester ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. However, when driving vehicles or operating machines it must be borne in mind that dizziness or drowsiness may occasionally ...
Undesirable effects
Losartan has been evaluated in clinical studies as follows: In a controlled clinical trial in >3,000 adult patients 18 years of age and older for essential hypertension. In a controlled clinical trial ...
Overdose
Symptoms of intoxication Limited data are available with regard to overdose in humans. The most likely manifestation of overdose would be hypotension and tachycardia. Bradycardia could occur from parasympathetic ...
Pharmacodynamic properties
Pharmacotherapeutic group: Angiotensin II antagonists, plain ATC code: C09CA01 Losartan is a synthetic oral angiotensin-II receptor (type AT<sub>1</sub>) antagonist. Angiotensin II, a potent vasoconstrictor, ...
Pharmacokinetic properties
Absorption Following oral administration, losartan is well absorbed and undergoes first-pass metabolism, forming an active carboxylic acid metabolite and other inactive metabolites. The systemic bioavailability ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, genotoxicity and carcinogenic potential. In repeated dose toxicity studies, the administration ...
List of excipients
Powder: Microcrystalline cellulose (E460) Lactose monohydrate Pregelatinized maize starch Magnesium stearate (E572) Hydroxypropyl cellulose (E463) Hypromellose (E464) Titanium dioxide (E171) Solvent: ...
Incompatibilities
Not applicable.
Shelf life
2 years. After reconstitution: 4 weeks.
Special precautions for storage
Kit: Do not store above 25°C. Store in the original package. Store the prepared suspension in a refrigerator (at 2-8°C) for up to 4 weeks.
Nature and contents of container
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 ...
Special precautions for disposal and other handling
Losartan suspension is a white to off-white liquid when reconstituted with the supplied solution. Reconstitution of COZAAR oral suspension [for 200 ml of a 2.5 mg/ml suspension]: Add 200 ml of solvent ...
Marketing authorization holder
Merck Sharp and Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU, UK
Marketing authorization number(s)
PL 00025/0530
Date of first authorization / renewal of the authorization
10 March 2009/23 August 2013
Date of revision of the text
22 March 2018
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