Alfuzosin

Alfuzosin comes as an extended-release (long-acting) tablet to take by mouth. It is usually taken once a day, immediately after a meal. Do not take alfuzosin on an empty stomach. To help you remember to take alfuzosin, take it after the same meal every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take alfuzosin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Alfuzosin controls BPH but does not cure it. Continue to take alfuzosin even if you feel well. Do not stop taking alfuzosin without talking to your doctor.

Before taking alfuzosin,

• tell your doctor and pharmacist if you are allergic to alfuzosin, any other medications, or any of the ingredients in alfuzosin. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you are taking itraconazole (Sporanox), ketoconazole (Nizoral), or ritonavir (Norvir, in Kaletra). Your doctor will probably tell you not to take alfuzosin.
• tell your doctor if you have liver disease. Your doctor may tell you not to take alfuzosin.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone); aprepitant (Emend); atenolol (Tenormin); cimetidine (Tagamet); cisapride (not available in the U.S.); clarithormycin (Biaxin, in Prevpac); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac, others); disopyramide (Norpace);dofetilide (Tikosyn); efavirenz (Sustiva); erythromycin (E.E.S., E-Mycin, Erythrocin);fluconazole (Diflucan); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), and saquinavir (Fortovase, Invirase); hormonal contraceptives (birth control pills, rings, and patches); isoniazid (INH, Nydrazid); lovastatin (Adivicor, Altocor, Mevacor); medications for high blood pressure; medications for erectile dysfunction (ED) such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra); metronidazole (Flagyl); moxifloxacin (Avelox); nefazodone; other alpha blockers such as doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), and tamsulosin (Flomax); pimozide (Orap); procainamide (Procanbid, Pronestyl); quinidine (Quinidex); sertraline (Zoloft); sotalol (Betapace,); sparfloxacin (Zagam); thioridazine (Mellaril); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you or any member of your family have an irregular heartbeat; or if you have or have ever had prostate cancer; angina (chest pain); low blood pressure; or heart or kidney disease; and if you have ever become dizzy, fainted, or had low blood pressure after taking any medication.
• you should know that alfuzosin is only for use in men. Women should not take alfuzosin, especially if they are or could become pregnant or are breast-feeding. If a pregnant woman takes alfuzosin, she should call her doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking alfuzosin. If you need to have eye surgery at any time during or after your treatment, be sure to tell your doctor that you are taking or have taken alfuzosin.
• you should know that alfuzosin may cause dizziness, lightheadedness, and fainting, especially when you get up too quickly from a lying position. This is more common when you first start taking alfuzosin. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up. If these symptoms do not improve, call your doctor. Avoid driving, operating machinery, or performing dangerous tasks until you know how this medication affects you.

Alfuzosin may cause side effects. Tell your doctor if any of these symptoms or those listed in the SPECIAL PRECAUTIONS section are severe or do not go away:

• tiredness
• headache
• runny or stuffy nose
• pain
• stomach pain
• heartburn
• constipation
• nausea
• decrease in sexual ability
• sore throat, fever, chills, cough and other signs of infection

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• rash
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty swallowing or breathing
• chest pain
• fainting

Alfuzosin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• The most common side effects of alfuzosin are
  • dizziness,
  • headache,
  • tiredness,
  • postural hypotension, and
  • fainting.
• This side effects occur in fewer than 1 per every 15 patients.
• As with other alpha blockers, postural hypotension (decreasing blood pressure upon standing, with or without dizziness) may develop within a few hours following ingestion of alfuzosin and can cause fainting.
• Prostate cancer and benign prostatic hyperplasia can co-exist. Therefore, patients being treated for benign prostatic hyperplasia should be evaluated to exclude the presence of prostate cancer.

Possible serious side effects include

• chest pain,
• priapism (persistent painful penile erection),
• liver injury, and
• floppy eye syndrome.

Alfuzosin is taken once daily, immediately after the same meal each day. Tablets should not be chewed or crushed.

The most common side effects with alfuzosin are:

• dizziness
• headache
• tiredness

Call your doctor if you get any side effect that bothers you.

Alfuzosin can cause serious side effects. See "Drug Precautions" section.

These are not all the side effects of alfuzosin. For more information ask your doctor or pharmacist.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• amiodarone (Cordarone);
• aprepitant (Emend);
• atenolol (Tenormin);
• cimetidine (Tagamet);
• clarithormycin (Biaxin, in Prevpac);
• cyclosporine (Neoral, Sandimmune);
• danazol (Danocrine);
• delavirdine (Rescriptor);
• diltiazem (Cardizem, Dilacor, Tiazac, others);
• disopyramide (Norpace);
• dofetilide (Tikosyn);
• efavirenz (Sustiva);
• erythromycin (E.E.S., E-Mycin, Erythrocin);
• fluconazole (Diflucan);
• fluoxetine (Prozac, Sarafem);
• fluvoxamine (Luvox);
• HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), and saquinavir (Fortovase, Invirase);
• hormonal contraceptives (birth control pills, rings, and patches);
• isoniazid (INH, Nydrazid);
• lovastatin (Adivicor, Altocor, Mevacor);
• medications for high blood pressure;
• medications for erectile dysfunction (ED) such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);
• metronidazole (Flagyl);
• moxifloxacin (Avelox);
• nefazodone;
• other alpha blockers such as doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), and tamsulosin (Flomax);
• pimozide (Orap);
• procainamide (Procanbid, Pronestyl);
• quinidine (Quinidex);
• sertraline (Zoloft);
• sotalol (Betapace);
• sparfloxacin (Zagam);
• thioridazine (Mellaril);
• troleandomycin (TAO);
• verapamil (Calan, Covera, Isoptin, Verelan);
• and zafirlukast (Accolate).

This is not a complete list of drug interactions with alfuzosin. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. There are no well-done studies that have been done in humans with alfuzosin. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol with this medicine can cause side effects.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For alfuzosin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to alfuzosin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Alfuzosin is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of alfuzosin in the elderly. However, elderly patients are more like to have age-related kidney or liver problems, which may require caution in patients receiving alfuzosin.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking alfuzosin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using alfuzosin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Atazanavir
• Bepridil
• Boceprevir
• Cisapride
• Clarithromycin
• Cobicistat
• Conivaptan
• Darunavir
• Dronedarone
• Fluconazole
• Fosamprenavir
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Mesoridazine
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Ritonavir
• Saquinavir
• Sparfloxacin
• Telaprevir
• Telithromycin
• Terfenadine
• Thioridazine
• Tipranavir
• Ziprasidone

Using alfuzosin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Azithromycin
• Bedaquiline
• Buserelin
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clomipramine
• Clozapine
• Crizotinib
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Efavirenz
• Escitalopram
• Fingolimod
• Flecainide
• Fluoxetine
• Foscarnet
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Ivabradine
• Lapatinib
• Leuprolide
• Levofloxacin
• Lumefantrine
• Mefloquine
• Methadone
• Metronidazole
• Moxifloxacin
• Nafarelin
• Netupitant
• Nilotinib
• Norfloxacin
• Nortriptyline
• Ofloxacin
• Ondansetron
• Paliperidone
• Panobinostat
• Pasireotide
• Pazopanib
• Pimavanserin
• Pitolisant
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Ribociclib
• Salmeterol
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Tadalafil
• Telavancin
• Tetrabenazine
• Tizanidine
• Toremifene
• Trazodone
• Trifluoperazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vemurafenib
• Vinflunine
• Zuclopenthixol

Using alfuzosin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Alprenolol
• Atenolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bucindolol
• Carteolol
• Carvedilol
• Celiprolol
• Dilevalol
• Diltiazem
• Esmolol
• Labetalol
• Levobunolol
• Mepindolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Propranolol
• Sildenafil
• Talinolol
• Tertatolol
• Timolol
• Vardenafil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of alfuzosin. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain) or
• Heart rhythm problems (e.g., congenital or acquired QT prolongation), or history of or
• Postural hypotension (low blood pressure)—Use with caution. May make these conditions worse.

• Cataract surgery—An eye problem called Intraoperative Floppy Iris Syndrome (IFIS) has occurred in patients who are taking or who have recently taken alfuzosin when they are having cataract surgery. You should tell your ophthalmologist (eye doctor) before your surgery if you are taking or have taken alfuzosin in the previous months.

• Kidney disease or
• Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, moderate or severe—Should not be used in patients with this condition.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about alfuzosin, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about alfuzosin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using alfuzosin.

Review Date: October 4, 2017

Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia.

Important Limitations of Use

Alfuzosin hydrochloride extended-release tablets, USP are not indicated for the treatment of hypertension.

Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in pediatric population.

Each Alfuzosin hydrochloride extended-release tablet, USP contains 10 mg Alfuzosin hydrochloride, USP as the active ingredient. Alfuzosin hydrochloride is a white to almost white powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane.

Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino]propyl]tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of Alfuzosin hydrochloride is C19H27N5O4•HCl. The molecular weight of Alfuzosin hydrochloride is 425.9. Its structural formula is:

The tablet also contains the following inactive ingredients: hypromellose, lactose monohydrate, povidone, colloidal silicon dioxide and magnesium stearate.

Meets USP Dissolution test 4.

Refer to adult dosing.

Alpha-/Beta-Agonists: Alpha1-Blockers may diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Similarly, Alpha-/Beta-Agonists may antagonize Alpha1-Blocker vasodilation. Monitor therapy

Alpha1-Agonists: Alpha1-Blockers may diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Monitor therapy

Alpha1-Blockers: May enhance the antihypertensive effect of other Alpha1-Blockers. Avoid combination

Aprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Beta-Blockers: May enhance the orthostatic hypotensive effect of Alpha1-Blockers. The risk associated with ophthalmic products is probably less than systemic products. Exceptions: Levobunolol; Metipranolol. Monitor therapy

Blood Pressure Lowering Agents: Alfuzosin may enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Bosentan: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Alfuzosin. Avoid combination

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dapoxetine: May enhance the orthostatic hypotensive effect of Alpha1-Blockers. Monitor therapy

Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates. Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Highest Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Idelalisib: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Mitotane: May decrease the serum concentration of CYP3A4 Substrates. Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Moderate Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

Netupitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Nitroglycerin: Alfuzosin may enhance the hypotensive effect of Nitroglycerin. Monitor therapy

Palbociclib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Alpha1-Blockers. Management: Ensure patient is stable on one agent prior to initiating the other, and always initiate combination using the lowest possible dose of the drug being added. When tadalafil is used for treatment of BPH, concurrent alpha 1-blockers are not recommended. Consider therapy modification

Protease Inhibitors: May increase the serum concentration of Alfuzosin. Avoid combination

Rilmenidine: Alpha1-Blockers may enhance the hypotensive effect of Rilmenidine. Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

St John's Wort: May decrease the serum concentration of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates. Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Telaprevir: May increase the serum concentration of Alfuzosin. Avoid combination

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Urine flow, blood pressure, PSA

Animal data have failed to reveal evidence of teratogenicity or embryotoxicity at maternal doses up to 250 mg/kg/day. There are no approved indications for use of this drug in females. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug is not indicated for use in female patients. AU TGA pregnancy category: B2 US FDA pregnancy category: B