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  • Xatral
    / Sanofi


    Active Ingredient
    Alfuzosin (HCl) 2.5 mg, 5 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    30 X 2.5 mg

    partial basket chart 8802 24063

    Sustained-Release Tablets

    56 X 5 mg

    partial basket chart 85259 24064

    Prolonged-Release Tablets

    30 X 10 mg

    partial basket chart 26593 24065

    Related information


    Dosage

    Adults: Xatral SR 5mg: The usual dose is one Xatral® SR 5 mg tablet morning and evening. Xatral 2.5mg: The recommended dosage is one tablet Xatral 2.5mg three times daily. The dose may be increased to a maximum of 4 tablets (10mg) per day depending on the clinical response.
    Elderly patients: (over 65 years) or patients treated for hypertension: Xatral 2.5mg: as a systematic precaution, it is recommended that treatment be started with one Xatral 2.5 mg tablet morning and evening and that the dosage then be increased on the basis of the patient’s individual response, without exceeding the maximum dosage of 4 Xatral 2.5 mg tablets daily. Xatral SR 5mg: As a systematic precaution,it is recommended that treatment be started with one Xatral® SR 5 mg tablet in the evening and that the the dosage then be increased on the basis of the patient individual response, without exceeding the maximum dosage of one Xatral SR 5mg tablet morning and evening. Patients with liver failure: It is recommended that therapy be commence with one Xatral 2.5 mg tablet per day and that the dosage then be increased on the basis of the patient’s individual response, without exceeding one Xatral 2.5 mg tablet twice daily.


    Indications

    Functional symptomatic benign prostatic hypertrophy as when surgery delayed, during severe symptomatic adenoma especially in the elderly.


    Contra-Indications

    This medicinal product must not be administered in the following situations: Hypersensitivity to alfuzosin and/or any of the other ingredients of the product.
    Postural hypotension, Combination with other alpha-blockers, Severe liver failure (class C in the Child-Pugh classification), Severe kidney failure (Creatinine clearance < 30 ml/min).


    Special Precautions

    Care should be taken when alfuzosin is administered to patients who have experienced marked hypotension following administration of another alpha-1 blocker. Alfuzosin should be administered carefully to patients being treated with antihypertensives. Blood pressure should be monitored regularly especially at the beginning of treatment. In patients with coronary disease, alfuzosin should not be prescribed alone. The specific coronary insufficiency treatment should be continued. If angina pectoris recurs or worsens, alfuzosin treatment should be discontinued. Intraoperative Floppy Iris Syndrome (IFIS, a small pupil syndrome variant) has been observed during cataract surgery in some patients previously or currently treated with some alphablockers. Although the risk of this event with Xatral XL 10mg appears very low, ophthalmic surgeons should be informed in advance of cataract surgery of current or past use of alpha-1blockers, as IFIS may lead to increased procedural complications. The ophthalmologists should be prepared for possible modifications to their surgical technique. Patients must be informed that the Xatral SR 5mg tablets must be swallowed whole. The tablets must not be crunched, chewed, crushed or ground into a powder. Doing so could lead to inappropriate release and absorption of the medicinal product consequently causing unwanted effects which may be of early onset.
    For full details see prescribing information.


    Side Effects

    Nervous system disorders: Common: lightheadedness faintness/ dizziness, headache, vertigo.
    Gastrointestinal disorders:  Common: nausea, abdominal pain, diarrhea, dry mouth.
    Skin & subcutaneous tissue disorders:  Uncommon: skin rashes, pruritus.
    General disorders:  Common: asthenia, malaise.
    Vascular disorders: Common: postural hypotension.
    For full details see prescribng information.


    Drug interactions

    Contraindicated combination: Alpha-receptor blockers (such as prazosin, trimazosin, urapidil): Enhanced hypotensive effect. Risk of severe postural hypotension.
    Combination requiring precautions for use: Phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil) Risk of postural hypotension, particularly in elderly subjects. Treatment should be initiated at the lowest recommended dose and adjusted gradually if necessary.
    Combinations to be taken into consideration:
    Antihypertensives Enhanced hypotensive effect. Higher risk of postural hypotension. Potent CYP3A4 inhibitors such as Ketoconazole, itraconazole, ritonavir, clarithromycin, erythromycin Risk of increased plasma alfuzosin concentrations and increased undesirable effects – Nitrates, nitrites and related drugs (isosorbide dinitrate, isosorbide, linsidomine, molsidomine, nicorandil, nitroglycerin) Increased risk of hypotension, particularly postural. The administration of general anaesthetics to patients receiving Xatral SR 5mg or Xatral 2.5mg could cause profound hypotension. It is recommended that Xatral SR 5mg or Xatral 2.5mg be withdrawn 24 hours before surgery. No pharmacodynamic or pharmacokinetic interaction has been observed in healthy volunteers between alfuzosin with the following drugs: warfarin, digoxin, hydrochlorothiazide and atenolol.


    Pregnancy and Lactation

    The therapeutic indication does not apply to women. It is not known whether alfuzosin is safe during pregnancy nor whether it is excreted in breast milk.


    Overdose

    In the event of overdose, the patient should be hospitalized and kept lying down. Standard treatment for hypotension should be instituted. As alfuzosin is highly protein bound, it is not easily dialyzable.


    Manufacturer
    Sanofi Winthrop Industrie, France
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