Description
Indications of Zatral 10
Lower urinary tract symptoms (LUTS) such as urine frequency, nocturia, incomplete emptying, and urinary hesitancy are all symptoms of benign prostatic hyperplasia (BPH). Alfuzosin Hydrochloride is used to treat these symptoms.
Pharmaceutical Name
Eskayef Pharmaceuticals Ltd
Pharmacology
Zatral 10 is a selective antagonist of the post-synaptic α1 adrenergic receptor, which is present in the prostate, the bottom of the bladder, the neck of the bladder, the prostatic sac, and the prostatic urethra. Alfuzosin relaxes the tension of the smooth muscle of the prostate, the prostate capsule, the bladder neck and the proximal urethra. It competitively and selectively binds to postsynaptic α1-adrenergic receptors in the lower urinary tract. It can also relax sympathetic nerve stimulation, reduce resting urethral pressure, and inhibit sympathetic nerve stimulation caused by hypertonic urethra. As a urine selector, alfuzosin hydrochloride preferentially binds to prostate a1 receptors. Blocking these receptors can reduce BPH symptoms, improve urine flow, and reduce the possibility of hypertensive events.
Dosage & Administration
Benign prostatic hyperplasia (BPH): The recommended dose is 10 mg to be taken once daily after a meal.
Acute urinary retention (AUR): In patients 65 years and older, 10 mg daily after a meal to be taken from the first day of catheterisation. The treatment should be administered for 3-4 days, 2-3 days during catheterisation and 1 day after its removal. In this indication no benefit has been established in patients under 65 years of age or if treatment is extended beyond 4 days.
Interaction of Zatral 10
Contraindication combination: α1 receptor blocker. Combinations to consider: antihypertensive drugs, nitrates, strong CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir. When administered as a single dose under feeding conditions (high-fat food), repeated daily administration of 200 mg of ketoconazole for 7 days resulted in a 2.1-fold increase in Cmax and a 2.5-fold increase in the exposure of alfuzosin hydrochloride 10 mg. Other parameters such as tmax and t1 / 2 have not been modified. When alfuzosin 10 mg Cmax and AUC were given as a single dose under fed conditions, the 400 mg ketoconazole repeated daily for 8 days increased by 2.3 times and 3.0 times, respectively. The use of general anesthetics in patients receiving alfuzosin hydrochloride can cause severe hypotension. It is recommended to remove the tablets 24 hours before the operation.
Other forms of interaction: No pharmacodynamic or pharmacokinetic interactions between alfuzosin hydrochloride and the following drugs were observed in healthy volunteers: warfarin, digoxin, hydrochlorothiazide and atenolol you.
Contraindications
As with all α1-blockers in some subjects, especially in patients receiving antihypertensive drugs or nitrates, symptoms (dizziness, fatigue, dysfunction) may occur within a few hours after administration. Sweat) orthostatic hypotension. In this case, the patient should lie down until the symptoms completely disappear. These effects are short-lived, occur early in treatment, and generally do not prevent continued treatment. Patients should be warned of the possibility of such incidents. As with all α1-blockers, patients with acute heart failure should use alfuzosin hydrochloride with caution. Patients who have a significant hypotensive reaction to another alpha-1 blocker should exercise caution when using alfuzosin hydrochloride. Patients allergic to alpha 1 blockers should start treatment gradually. Patients receiving antihypertensive medications should use alfuzosin hydrochloride with caution. Blood pressure should be checked regularly, especially at the beginning of treatment. Patients with congenital QTc prolongation, a known history of acquired QTc prolongation, or who are taking medications known to prolong the QTc interval should be evaluated before and during alfuzosin hydrochloride administration. For coronary artery patients, specific treatment of coronary insufficiency should be continued. If angina pectoris recurs or worsens, treatment with alfuzosin should be discontinued.
Since there are no available clinical safety data in patients with severe renal insufficiency (creatinine clearance <30 ml/min), this group of patients should not be given alfuzosin hydrochloride 10 mg extended-release tablets. Patients should be advised to swallow the tablet whole. Any other methods of administration, such as grinding, crushing, chewing, crushing, or grinding into powder, should be prohibited. These behaviors can lead to inappropriate drug release and absorption, which can lead to early adverse reactions. The “intraoperative diskette iris syndrome” (IFIS, a variant of the small pupil syndrome) has been observed during cataract surgery in some patients who have been treated with α1 blockers or who have previously been treated with α1 blockers. Although the risk of this event for alfuzosin hydrochloride appears to be very low, the ophthalmologist should be informed about current or past use of α1-blockers before cataract surgery, because IFIS can lead to increased surgical complications. The ophthalmologist must be prepared to make possible modifications in his surgical technique. Alfuzosin hydrochloride 10 mg sustained-release tablets contain hydrogenated castor oil, which may cause stomach upset and diarrhea.
Side Effects of Zatral 10
Classification of expected frequencies: very common (<1/10), common (<1/100 to <1/10), uncommon (<1 / 1,000 to <1/100), rare (<1 / 10,000 to < 1 / 1,000), very rare (<1 / 10,000), unknown (cannot be estimated from the available data). In each frequency group, adverse effects are ranked in descending order of severity. Nervous system diseases: common: dizziness / dizziness, headache; uncommon: syncope, dizziness, malaise, drowsiness. Eye diseases: uncommon: abnormal vision; unknown: intraoperative floppy iris syndrome. Heart disease: Uncommon: tachycardia, palpitations, hypotension (postural); very rare: new-onset angina, exacerbation or recurrence in patients with previous coronary artery disease; not known: atrial fibrillation. Vascular diseases: Uncommon: hypotension (postural), flushing. Diseases of the blood and lymphatic system: unknown: neutropenia, thrombocytopenia. Respiratory, thoracic and mediastinal diseases: infrequent: rhinitis. Gastrointestinal diseases: common: nausea, abdominal pain; uncommon: diarrhea, dry mouth, vomiting; unknown: vomiting. Hepatobiliary disease: frequency unknown: liver cell damage, cholestatic liver disease. Diseases of the skin and subcutaneous tissue: uncommon: rash, itching; very rare: urticaria, angioedema. Reproductive system and breast diseases: frequency unknown: priapism. General diseases and conditions at the administration site: common: weakness; uncommon: redness, edema, chest pain.
Pregnancy & Lactation
This is not applicable due to the type of indication.
Precautions & Warnings
Patients using Alfuzosin may experience severe hypotension if they are given general anesthetics. The medications should be stopped at least 24 hours before surgery. Zatral 10 should be stopped if symptoms of angina pectoris appear or worsen.
Therapeutic Class
BPH/ Urinary retention/ Urinary incontinence.
Storage Conditions
Store in a cool and dry place, protected from light.
