دوزين 1 مجم 20 قرص

دوزين 1 مجم 20 قرص

12.00 جنيها

معلومات الدواء

الإسم التجاري

Dosin 1mg 20 tab - دوزين 1 مجم 20 قرص

الإسم العلمي 

Doxazosin

الشركات المنتجة

Eipico,
تكوين


كل قرص يحتوي على:

دوكسازوسين ميسيلات ................................................ ... 1.2 مجم أو 2.4 مجم أو 4.8 مجم

يكافئ دوكسازوسين ............................................... ...... 1 مجم أو 2 مجم أو 4 مجم

مكونات غير فعالة:

مونوهيدرات اللاكتوز ، بوفيدون K25 ، بولي سوربات 80 ، السليلوز الجريزوفولفين ، نشا الصوديوم جلايكولات ، ثاني أكسيد السيليكون الغرواني ، ستيرات المغنيسيوم.



مؤشرات العلاجية


ارتفاع ضغط الدم:

يشار إلى DOSIN لعلاج ارتفاع ضغط الدم ويمكن استخدامه كعامل وحيد للتحكم في ضغط الدم لدى غالبية المرضى. في المرضى الذين لا يخضعون للسيطرة الكافية على علاج واحد خافض للضغط ، يمكن استخدام DOSIN مع عامل مدرات للبول الثيازيدية ، أو عامل منع مستقبلات بيتا الأدرينالية ، أو مناهض الكالسيوم أو مثبط الإنزيم المحول للأنجيوتنسين.

تضخم البروستاتا الحميد:

يشار إلى DOSIN لعلاج انسداد مجرى البول والأعراض المرتبطة بتضخم البروستاتا الحميد (BPH).

يمكن استخدام DOSIN في مرضى تضخم البروستاتا الحميد الذين يعانون من ارتفاع ضغط الدم أو ضغط الدم.



الجرعة وطريقة الاستعمال


يمكن تناول DOSIN في الصباح أو في المساء.

ارتفاع ضغط الدم:

يستخدم DOSIN في نظام مرة واحدة يوميًا: الجرعة الأولية هي 1 مجم ، لتقليل احتمالية انخفاض ضغط الدم الوضعي و / أو الإغماء (انظر التحذيرات والاحتياطات). يمكن بعد ذلك زيادة الجرعة إلى 2 مجم بعد أسبوع أو أسبوعين إضافيين من العلاج وبعد ذلك ، إذا لزم الأمر ، إلى 4 مجم.

غالبية المرضى الذين يستجيبون ل DOSIN سيفعلون ذلك بجرعة 4 ملغ أو أقل. يمكن زيادة الجرعة إذا لزم الأمر إلى 8 مجم أو الجرعة القصوى الموصى بها وهي 16 مجم.

تضخم البروستاتا الحميد:

الجرعة الأولية الموصى بها من DOSIN هي 1 مجم تعطى مرة واحدة يوميًا ، لتقليل احتمالية انخفاض ضغط الدم الوضعي و / أو الإغماء (انظر التحذيرات والاحتياطات). اعتمادًا على ديناميكيات البول لدى المريض وأعراض تضخم البروستاتا الحميد ، يمكن زيادة الجرعة بعد ذلك إلى 2 مجم وبعد ذلك إلى 4 مجم وحتى الحد الأقصى للجرعة الموصى بها وهي 8 مجم. فترة المعايرة الموصى بها هي أسبوع إلى أسبوعين. الجرعة المعتادة الموصى بها هي 2-4 ملغ يومياً.

الأطفال:

لم يتم إثبات سلامة وفعالية DOSIN عند الأطفال.

كبار السن:

جرعة البالغين العادية.

مرضى القصور الكلوي:

نظرًا لعدم وجود تغيير في الحرائك الدوائية في المرضى الذين يعانون من اختلال وظائف الكلى ، يوصى بالجرعة المعتادة للبالغين من DOSIN.

دوسين غير قابل للتبديل.

مرضى القصور الكبدي:

توجد بيانات محدودة فقط في المرضى الذين يعانون من ضعف في الكبد وعن تأثير الأدوية المعروفة بتأثيرها على التمثيل الغذائي الكبدي (مثل سيميتيدين). كما هو الحال مع أي دواء يتم استقلابه بالكامل بواسطة الكبد ، يجب إعطاء DOSIN بحذر للمرضى الذين لديهم دليل على ضعف وظائف الكبد (انظر التحذيرات والاحتياطات وخصائص حركية الدواء)
Composition


Each tablet contains:

Doxazosin mesylate ................................................... 1.2 mg, 2.4 mg, or 4.8 mg

Equivalent to Doxazosin ..................................................... 1 mg, 2 mg, or 4 mg

Inactive ingredients:

Lactose monohydrate, povidone K25, polysorbate 80, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate.



Therapeutic Indications


Hypertension:

DOSIN is indicated for the treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. In patients inadequately controlled on single antihypertensive therapy, DOSIN may be used in combination with a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an angiotensin-converting enzyme inhibitor.

Benign prostatic hyperplasia:

DOSIN is indicated for the treatment of urinary outflow obstruction and symptoms associated with benign prostatic hyperplasia (BPH).

DOSIN may be used in BPH patients who are either hypertensive or normotensive.



Dosage and Administration


DOSIN may be administered in the morning or the evening.

Hypertension:

DOSIN is used in a once daily regimen: the initial dose is 1 mg, to minimize the potential for postural hypotension and/or syncope (see Warnings and Precautions). Dosage may then be increased to 2 mg after an additional 1-2 weeks of therapy and thereafter, if necessary, to 4 mg.

The majority of patients who respond to DOSIN will do so at a dose of 4 mg or less. Dosage can be further increased if necessary to 8 mg or the maximum recommended dose of 16 mg.

Benign prostatic hyperplasia:

The recommended initial dosage of DOSIN is 1 mg given once daily, to minimise the potential for postural hypotension and/or syncope (see Warnings and Precautions). Depending on the individual patient's urodynamics and BPH symptomatology, dosage may then be increased to 2 mg and thereafter to 4 mg and up to the maximum recommended dose of 8 mg. The recommended titration interval is 1-2 weeks. The usual recommended dose is 2-4 mg daily.

Children:

The safety and efficacy of DOSIN in children have not been established.

Elderly:

Normal adult dosage.

Patients with renal impairment:

Since there is no change in pharmacokinetics in patients with impaired renal function, the usual adult dose of DOSIN is recommended.

Dosin is not dialysable.

Patients with hepatic impairment:

There are only limited data in patients with liver impairment and on the effect of drugs known to influence hepatic metabolism (e.g. cimetidine). As with any drug wholly metabolized by the liver, DOSIN should be administered with caution to patients with evidence of impaired liver function (see Warnings and Precautions and Pharmacokinetic properties).

Contraindications


DOSIN is contraindicated in:

Patients with a known hypersensitivity to quinazolines (e.g. prazosin, terazosin, doxazosin), or any of the excipients.

Patients with a history of orthostatic hypotension.

Patients with benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladder stones.

During lactation (for the hypertension indication only, see Pregnancy and Lactation).

Patients with hypotension (for benign prostatic hyperplasia indication only).

DOSIN is contraindicated as monotherapy in patients with either overflow bladder or anuria with or without progressive renal insufficiency.



Warnings and Precautions


Postural Hypotension/Syncope:

Initiation of Therapy - In relation with the alpha-blocking properties of doxazosin, patients may experience postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness (syncope), particularly with the commencement of therapy (see Dosage and Administration).

Therefore, it is prudent medical practice to monitor blood pressure on initiation of therapy to minimize the potential for postural effects.

When instituting therapy with any effective alpha-blocker, the patient should be advised how to avoid symptoms resulting from postural hypotension and what measures to take should they develop. The patient should be cautioned to avoid situations where injury could result, should dizziness or weakness occur during the initiation of DOSIN therapy.

Use in patients with acute cardiac conditions:

As with any other vasodilatory anti-hypertensive agent, it is prudent medical practice to advise caution when administering DOSIN to patients with the following acute cardiac conditions:

Pulmonary oedema due to aortic or mitral stenosis.

High-output cardiac failure.

Right-sided heart failure due to pulmonary embolism or pericardial effusion.

Left ventricular heart failure with low filling pressure.

Use in hepatically-impaired patients:

As with any drug wholly metabolized by the liver, DOSIN should be administered with particular caution to patients with evidence of impaired hepatic function (see Dosage and Administration). Since there is no clinical experience in patients with severe hepatic impairment, use in these patients is not recommended.

Use with PDE-5 Inhibitors:

Concomitant administration of DOSIN with phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, and vardenafil) should be done with caution as both drugs have vasodilating effects and may lead to symptomatic hypotension in some patients. To reduce the risk of orthostatic hypotension, it is recommended to initiate the treatment with phosphodiesterase-5-inhibitors only if the patient is hemodynamically stabilized on alpha-blocker therapy. Furthermore, it is recommended to initiate phosphodiesterase-5-inhibitor treatment with the lowest possible dose and to respect a 6-hour time interval from intake of DOSIN.

Use in patients undergoing cataract surgery:

The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural complications during the cataract operation, current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.

Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption:

Patients with these problems should not take this medicine.



Drug Interactions


Phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil): Concomitant administration of doxazosin with a PDE-5 inhibitor may lead to symptomatic hypotension in some patients (see Warnings and Precautions).

Doxazosin is highly bound to plasma proteins (98%). In vitro data in human plasma indicates that doxazosin has no effect on protein binding of the drugs tested (digoxin, phenytoin, warfarin or indomethacin).

Conventional doxazosin has been administered without any adverse drug interaction in clinical experience with thiazide diuretics, furosemide, beta-blocking agents, non-steroidal anti-inflammatory drugs, antibiotics, oral hypoglycaemic drugs, uricosuric agents, or anticoagulants. However, data from formal drug/drug interaction studies are not present.

Doxazosin potentiates the blood pressure lowering activity of other alpha-blockers and other antihypertensives.

The administration of doxazosin with cimetidine resulted in an increase in mean AUC of doxazosin, and no statistically significant changes in mean Cmax and mean half-life of doxazosin.



Pregnancy and Lactation


For the Hypertension indication:

Use during Pregnancy:

As there are no adequate and well-controlled studies in pregnant women, the safety of doxazocin during pregnancy has not yet been established. Accordingly, during pregnancy, DOSIN should be used only when, in the opinion of the physician, the potential benefit outweighs the potential risk.

Use during Lactation:

There is no information about the excretion of the drug into the milk of lactating women. The clinical safety of doxazosin during lactation has not been established, consequently DOSIN is contraindicated in nursing mothers.



For the Benign Prostatic Hyperplasia indication:

This section is not applicable.



Effects on ability to drive and to use machines


The ability to drive or use machinery may be impaired, especially when initiating therapy.



Undesirable Effects


Hypertension:

In clinical trials involving patients with hypertension, the most common reactions associated with doxazosin therapy were of a postural type (rarely associated with fainting) or non-specific.

Benign prostatic hyperplasia:

Experience in controlled clinical trials in BPH indicates a similar adverse event profile to that seen in hypertension.

The following undesirable effects have been observed and reported during treatment with doxazosin with the following 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).

Infections and infestations:

Common: Respiratory tract infection, urinary tract infection.

Blood and the Lymphatic system disorders:

Very rare: Leukopenia, thrombocytopenia.

Immune system disorders:

Uncommon: Allergic drug reaction.

Metabolism and Nutrition disorders:

Uncommon: Gout, increased appetite, anorexia.

Psychiatric disorders:

Uncommon: Agitation, depression, anxiety, insomnia, nervousness.

Nervous system disorders:

Common: Somnolence, dizziness, headache.

Uncommon: Cerebrovascular accident, hypoesthesia, syncope, tremor.

Very rare: Postural dizziness, paresthesia.

Eye disorders:

Very rare: Blurred vision.

Unknown: Intraoperative floppy iris syndrome (see Warnings and Precautions).

Ear and Labyrinth disorders:

Common: Vertigo.

Uncommon: Tinnitus.

Cardiac disorders:

Common: Palpitation, tachycardia.

Uncommon: Angina pectoris, myocardial infarction.

Very rare: Bradycardia, cardiac arrhythmias.

Vascular disorders:

Common: Hypotension, postural hypotension.

Very rare: Hot flushes.

Respiratory, Thoracic and Mediastinal disorders:

Common: Bronchitis, cough, dyspnoea, rhinitis.

Uncommon: Epistaxis.

Very rare: Bronchospasm.

Gastrointestinal disorders:

Common: Abdominal pain, dyspepsia, dry mouth, nausea.

Uncommon: Constipation, flatulence, vomiting, gastroenteritis, diarrhea.

Hepatobiliary disorders:

Uncommon: Abnormal liver function tests.

Very rare: Cholestasis, hepatitis, jaundice.

Skin and Subcutaneous tissue disorders:

Common: Pruritus.

Uncommon: Skin rash.

Very rare: Urticaria, alopecia, purpura.

Musculoskeletal, Connective tissue and Bone disorders:

Common: Back pain, myalgia.

Uncommon: Arthralgia.

Rare: Muscle cramps, muscle weakness.

Renal and Urinary disorders:

Common: Cystitis, urinary incontinence.

Uncommon: Dysuria, micturition frequency, hematuria, polyuria, urinary incontinence.

Rare: Polyuria.

Very rare: Increased diuresis, micturition disorder, nocturia.

Reproductive system and Breast disorders:

Uncommon: Impotence.

Very rare: Gynecomastia, priapism.

UnKnown: Retrograde ejaculation.

General disorders and Administration site conditions:

Common: Asthenia, chest pain, influenza-like symptoms, peripheral oedema, fatigue, malaise.

Uncommon: Pain, facial oedema.

Very rare: Fatigue, malaise.

Investigations:

Uncommon: Increased weight.



Overdose


Should overdosage lead to hypotension, the patient should be immediately placed in a supine, head down position. Other supportive measures may be appropriate in individual cases.

If this measure is inadequate, shock should first be treated with volume expanders. If necessary, vasopressor should then be used. Renal function should be monitored and supported as needed.

Since doxazosin is highly protein bound, dialysis is not indicated.



Pharmacological Properties


Pharmacodynamic properties:

DOSIN is a potent and selective post-junctional alpha-1-adrenoceptor antagonist. This action results in a decrease in systemic blood pressure. DOSIN is appropriate for oral administration in a once daily regimen in patients with essential hypertension.

Doxazosin has been shown to be free of adverse metabolic effects. DOSIN is suitable for use in patients with coexistent diabetes mellitus, gout and insulin resistance.

DOSIN is suitable for use in patients with co-existent asthma, left ventricular hypertrophy and in elderly patients. Treatment with doxazosin has been shown to result in regression of left ventricular hypertrophy, inhibition of platelet aggregation and enhanced activity of tissue plasminogen activator. Additionally, it improves insulin sensitivity in patients with impairment.

Doxazosin, in addition to its antihypertensive effect, has in long-term studies produced a modest reduction in plasma total cholesterol, LDL-cholesterol and triglyceride concentrations and therefore may be of particular benefit to hypertensive patients with concomitant hyperlipidaemia.

Administration of doxazosin to patients with symptomatic BPH results in a significant improvement in urodynamics and symptoms. The effect in BPH is thought to result from selective blockade of the alpha-adrenoceptors located in the muscular stroma and capsule of the prostate, and in the bladder neck.

Pharmacokinetic properties:

Absorption: Following oral administration in humans (young male adults or the elderly of either sex), doxazosin is well absorbed and approximately two thirds of the dose is bioavailable.

Biotransformation/Elimination: Approximately 98% of doxazosin is protein-bound in plasma.

Doxazosin is extensively metabolized in man and in the animal species tested, with the faeces being the predominant route of excretion.

The mean plasma elimination half-life is 22 hours, thus making the drug suitable for once daily administration.

After oral administration of doxazosin, the plasma concentrations of the metabolites are low. The most active (6' hydroxy) metabolite is present in man at one fortieth of the plasma concentration of the parent compound, which suggests that the antihypertensive activity is in the main due to doxazosin.

There are only limited data in patients with liver impairment and on the effects of drugs known to influence hepatic metabolism (e.g. cimetidine). In a clinical study in 12 subjects with moderate hepatic impairment, single dose administration of doxazosin resulted in an increase in AUC of 43% and a decrease in apparent oral clearance of 40%. As with any drug wholly metabolized by the liver, DOSIN should be administered with caution to patients with impaired liver function (see Warnings and Precautions).



Storage


Store in a dry place at a temperature not exceeding 30°C.



Packaging


Dosin 1 mg Tablets: Box containing 2 blisters of 10 tablets each.

Dosin 2 mg Tablets: Box containing 2 blisters of 10 tablets each.

Dosin 4 mg Tablets: Box containing 2 blisters of 10 tablets each.

تنبيه بخصوص المعلومات المتوفرة علي موقع دليل الدواء

بينما نعمل دائما علي تنقيح وتحسين البيانات المعروضة علي موقعنا إلا أننا ننصح دائما بعدم تعاطي أي دواء بدون إستشارة الطبيب المختص، ولا يتحمل الموقع أي مسئولية ناتجة عن سوء استخدام الأدوية بدون استشارة المختص، في حال وجدت أي بيانات خاطئة أو سعر دواء غير صحيح برجاء الإتصال بنا لتصحيحه.
الإبلاغ عن مشكلة

البدائل

26 دواء
اسم الدواء
السعر