FORTZAAR Tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
FORTZAAR Tablet.
2. Qualitative and quantitative composition
Each FORTZAAR Tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide. FORTZAAR contains 8,48 mg (0,216 mEq) of potassium. FORTZAAR contains 126,26 mg lactose hydrous per tablet. For the ...
3. Pharmaceutical form
FORTZAAR tablets are light yellow, oval shaped, film-coated tablets, with 747 on one side and plain on the other side, approximately 15,49 mm long and 8,76 mm wide.
4.1. Therapeutic indications
FORTZAAR is indicated for the treatment of hypertension in patients established on identical doses of the individual agents.
4.2. Posology and method of administration
The maximum dose is one tablet of FORTZAAR (100 mg losartan potassium and 25 mg hydrochlorothiazide) once daily (see section 4.1). The maximum antihypertensive effect is usually attained within three weeks ...
4.3. Contraindications
Hypersensitivity to losartan, hydrochlorothiazide or any of the other ingredients of FORTZAAR. A history of angioedema related to previous therapy with ACE inhibitors or angiotensin receptor blockers (ARBs). ...
4.4. Special warnings and precautions for use
<b>Should a woman become pregnant while receiving FORTZAAR, the treatment should be stopped promptly and switched to a different class of antihypertensive medicine (See sections 4.3 and 4.6).</b> Dual ...
4.5. Interaction with other medicinal products and other forms of interaction
LOSARTAN POTASSIUM In clinical pharmacokinetic trials no interactions of clinical significance have been identified with hydrochlorothiazide, digoxin, warfarin, cimetidine, phenobarbital (see hydrochlorothiazide, ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential / Contraception in males and females Women of childbearing age should ensure effective contraception while on FORTZAAR. Pregnancy FORTZAAR is contraindicated for use during ...
4.7. Effects on ability to drive and use machines
No studies on the reactions on the ability to drive and use machines have been performed. However, when driving vehicles or operating machinery it must be borne in mind that dizziness or drowsiness may ...
4.8. Undesirable effects
Adverse reactions from clinical trials In controlled clinical trials for essential hypertension, the following adverse experiences were reported in patients treated with FORTZAAR and are shown in decreasing ...
4.9. Overdose
LOSARTAN POTASSIUM The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should ...
5.1. Pharmacodynamic properties
<b>Pharmacological classification:</b> A 7.1.3. Other hypotensives Losartan potassium is an angiotensin II receptor (type AT1) antagonist, and hydrochlorothiazide is a diuretic. LOSARTAN Angiotensin II, ...
5.2. Pharmacokinetic properties
LOSARTAN Absorption Following oral administration, losartan undergoes first-pass metabolism, forming an active carboxylic acid metabolite and other inactive metabolites. The systemic bioavailability of ...
5.3. Preclinical safety data
N/A
6.1. List of excipients
Inactive Ingredients: carnauba wax, hydroxypropyl cellulose, microcrystalline cellulose, hypromellose, lactose hydrous, magnesium stearate, pregelatinised starch, quinolone yellow aluminium lake, titanium ...
6.2. Incompatibilities
N/A
6.3. Shelf life
36 months.
6.4. Special precautions for storage
Store at or below 30°C. Keep well closed. This medicine does not require any special storage conditions.
6.5. Nature and contents of container
FORTZAAR tablets are supplied in blister packs of 30.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
MSD (Pty) Ltd, 117 16th Road, Halfway House, South Africa, 1685
8. Marketing authorization number(s)
34/7.1.3/0281
9. Date of first authorization / renewal of the authorization
20 February 2001
10. Date of revision of the text
7 May 2021
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