Xatral
Xatral - General Information
Xatral (INN, provided as the hydrochloride salt) is an alpha-adrenergic blocker used to treat benign prostatic hyperplasia (BPH). It works by relaxing the muscles in the prostate and bladder neck, making it easier to urinate. [Wikipedia]
Pharmacology of Xatral
Xatral is an alpha-adrenergic blocking agent used to treat hypertension and benign prostatic hyperplasia. Accordingly, alfuzosin is a selective inhibitor of the alpha1 subtype of alpha adrenergic receptors. In the human prostate, alfuzosin antagonizes phenylephrine (alpha1 agonist)-induced contractions, in vitro, and binds with high affinity to the alpha1c adrenoceptor, which is thought to be the predominant functional type in the prostate. Studies in normal human subjects have shown that alfuzosin competitively antagonized the pressor effects of phenylephrine (an alpha1 agonist) and the systolic pressor effect of norepinephrine. The antihypertensive effect of alfuzosin results from a decrease in systemic vascular resistance and the parent compound alfuzosin is primarily responsible for the antihypertensive activity.
Xatral for patients
UROXATRAL (Alfuzosin hydrochloride extended-release tablets)
Read the Patient Information that comes with UROXATRAL before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or your treatment. You and your doctor should talk about all your medicines, including UROXATRAL, now and at your regular checkups.
What is the most important information I should know about UROXATRAL?
UROXATRAL can cause:
· a sudden drop in blood pressure, especially when you start treatment. This may lead to fainting, dizziness, or lightheadedness. Do not drive, operate machinery, or do any dangerous activities until you know how UROXATRAL affects you. This is especially important if you already have a problem with low blood pressure or take medicines to treat high blood pressure. If you begin to feel dizzy or lightheaded, lie down with your legs and feet up, and if your symptoms do not improve call your doctor.
What is UROXATRAL?
UROXATRAL is a prescription medicine that is called an "alpha-blocker". UROXATRAL is used in adult men to treat the symptoms of benign prostatic hyperplasia (BPH). UROXATRAL may help to relax the muscles in the prostate and the bladder which may lessen the symptoms of BPH and improve urine flow.
Before prescribing UROXATRAL, your doctor may examine your prostate gland and do a blood test called a prostate specific antigen (PSA) test to check for prostate cancer. Prostate cancer and BPH can cause the same symptoms. Prostate cancer needs a different treatment.
UROXATRAL is not for use in women or children.
Some medicines called "alpha-blockers" are used to treat high blood pressure. UROXATRAL has not been studied for the treatment of high blood pressure.
Who should not take UROXATRAL?
Do not take UROXATRAL if you:
have liver problems
are taking antifungal drugs like ketoconazole or HIV drugs called protease inhibitors
are already taking an alpha-blocker for either high blood pressure or prostate problems
are a woman
are a child under the age of 18
are allergic to UROXATRAL The active ingredient is alfuzosin hydrochloride. See the end of this leaflet for a complete list of ingredients in UROXATRAL.
Before taking UROXATRAL, tell your doctor:
if you have liver problems
if you have kidney problems
if you or any family members have a rare heart condition known as congenital prolongation of the QT interval.
about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Some of your other medicines may affect the way you respond or react to UROXATRAL.
if you have had low blood pressure, especially after taking another medicine. Signs of low blood pressure are fainting, dizziness, and lightheadedness.
if you have a heart problem called angina (pain in your chest, jaw, or arm).
What you need to know while taking UROXATRAL (alfuzosin HCl) tablets
If you have an eye surgery for cataract (clouding of the eye) planned, tell your ophthalmologist that you are using UROXATRAL or have previously been treated with an alpha-blocker.
How do I take UROXATRAL?
Take UROXATRAL exactly as your doctor prescribes it.
Take one UROXATRAL tablet after the same meal each day. UROXATRAL should be taken just after eating food. Do not take it on an empty stomach.
Swallow the UROXATRAL tablet whole. Do not crush, split, or chew UROXATRAL tablets.
If you take too much UROXATRAL call your local poison control center or emergency room right away.
What are the possible side effects of UROXATRAL? The most common side effects with UROXATRAL are:
tiredness
Call your doctor if you get any side effect that bothers you.
These are not all the side effects of UROXATRAL. For more information ask your doctor or pharmacist.
How do I store UROXATRAL?
Store UROXATRAL between 59° F and 86° F (15° C and 30° C).
Protect from light and moisture.
Keep UROXATRAL and all medicines out of the reach of children.
General information about UROXATRAL:
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use UROXATRAL for a condition for which it was not prescribed. Do not give UROXATRAL to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about UROXATRAL. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about UROXATRAL that is written for health professionals.
You may also visit our website at www.UROXATRAL.com or call 1-800-446-6267.
What are the ingredients of UROXATRAL?
Active Ingredient: alfuzosin hydrochloride
Inactive Ingredients: colloidal silicon dioxide (NF), ethylcellulose (NF), hydrogenated castor oil (NF), hydroxypropyl methylcellulose (USP), magnesium stearate (NF), mannitol (USP), microcrystalline cellulose (NF), povidone (USP), and yellow ferric oxide (NF).
Xatral Interactions
Drug-Drug Interactions: The pharmacokinetic and pharmacodynamic interactions between UROXATRAL and other alpha-blockers have not been determined. However, interactions may be expected, and UROXATRAL should NOT be used in combination with other alpha-blockers.
Xatral Contraindications
Alfuzosin should not be used in patients with moderate or severe hepatic insufficiency, (Childs-Pugh categories B and C) since alfuzosin blood levels are increased in these patients. Alfuzosin should not be co-administered with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased. Alfuzosin is contraindicated in patients known to be hypersensitive to alfuzosin hydrochloride or any component of Alfuzosin tablets.
Additional information about Xatral
Xatral Indication: For the treatment of the signs and symptoms of benign prostatic hyperplasia.
Mechanism Of Action: Xatral acts by inhibiting the postsynaptic alpha(1)-adrenoceptors on vascular smooth muscle. This inhibits the vasoconstrictor effect of circulating and locally released catecholamines (epinephrine and norepinephrine), resulting in peripheral vasodilation.
Drug Interactions: Itraconazole The antifungal increases the effect of alfuzosin
Ketoconazole The antifungal increases the effect of alfuzosin
Ritonavir Ritonavir increases the effect/toxicity of alfuzosin
Vardenafil Risk of significant hypotension with this association
Food Interactions: Take after a meal (always the same meal), product bioavailability is reduced when taken on an empty stomach.
Generic Name: Alfuzosin
Synonyms: Alfusosine
Drug Category: Antihypertensive Agents
Drug Type: Small Molecule; Approved
Other Brand Names containing Alfuzosin: Uroxatral; Xatral;
Absorption: Absorption is 50% lower under fasting conditions
Toxicity (Overdose): Side effects are dizziness (due to postural hypotension), upper respiratory tract infection, headache, and fatigue.
Protein Binding: 82%-90%
Biotransformation: Hepatic. Alfuzosin undergoes extensive metabolism by the liver, with only 11% of the administered dose excreted unchanged in the urine. Alfuzosin is metabolized by three metabolic pathways: oxidation, O-demethylations, and N-dealkylation. The metabolites are not pharmacologically active. CYP3A4 is the principal hepatic enzyme isoform involved in its metabolism.
Half Life: 10 hours
Dosage Forms of Xatral: Tablet, extended release Oral
Chemical IUPAC Name: N-[3-[(4-amino-6,7-dimethoxyquinazolin-2-yl)-methylamino]propyl]oxolane-2-carboxamide
Chemical Formula: C19H27N5O4
Alfuzosin on Wikipedia: https://en.wikipedia.org/wiki/Alfuzosin
Organisms Affected: Humans and other mammals
