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FDA Drug Import News

Import Rules Regarding Personal Medicine Orders:

Current FDA policy is not a law or a regulation, but serves as guidance for FDA personnel.

The importation of certain unapproved prescription medications for personal use may be allowed in some circumstances where these factors apply:


    1). The Drug is for personal use and is a 3-month supply or less and not for resale or commercialization.

    2). If no drug commercialization or drug promotion to U.S. residents by pharmacy companies involved in the distribution of the necessary drug exists.

    3). If an individual seeking to import the drug affirms in writing, that it is for the patient's private use and provides the name and address of the licensed American physician responsible for treatment.

    4). Provides evidence that the drug is for continuation of a treatment begun in a foreign country.

    5). The intended use is for a serious condition for which effective treatment may not be available domestically.

    6). If the product is not considered to represent an unreasonable health issue.

    7). Overnite FedEx shipments require copy of your identification and the prescription.

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Alfuzosin {generic UROXATRAL} 10mg x 30s Tablets Alfusin

Alfuzosin {generic UROXATRAL} 10mg x 30s Tablets Alfusin
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Price: $26.00
Product ID : alfuzosin_10x30s
Manufacturer: CIPLA
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Description

Alfuzosin (generic UROXTRAL) 10mg Tablets

Patient Education - English

 

  • Generic Name: alfuzosin
  • Pronounced: al FUE zoe sin
  • Brand Name: Uroxatral

What is the most important information I should know about alfuzosin?

 

You should not use alfuzosin if you are allergic to it, if you have severe liver disease, or if you are also using ketoconazole (Nizoral), itraconazole (Sporanox), or ritonavir (Norvir). Do not take alfuzosin with other similar medicines such as doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin).

Alfuzosin may cause dizziness or fainting. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Alfuzosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using alfuzosin before surgery unless your surgeon tells you to.

There are many other drugs that can interact with alfuzosin. Tell your doctor about all medications you use.

What is alfuzosin?

Alfuzosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Alfuzosin relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Alfuzosin is used to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

Alfuzosin may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking alfuzosin?

 

You should not use alfuzosin if you are allergic to it, or if you have:

  • severe liver disease;
  • if you are also taking similar medicines such as doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin); or
  • if you are also using ketoconazole (Nizoral), itraconazole (Sporanox), or ritonavir (Norvir).

If you have any of these other conditions, you may need an alfuzosin dose adjustment or special tests:

  • prostate cancer;
  • liver disease;
  • kidney disease;
  • a personal or family history of Long QT syndrome;
  • angina (chest pain);
  • coronary artery disease (hardened arteries);
  • a history of low blood pressure (even when caused by taking medications); or
  • if you are taking certain medicines to treat HIV or AIDS.

Alfuzosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using alfuzosin before surgery unless your surgeon tells you to.

Although this medication is not for use in women, alfuzosin is not expected to harm an unborn baby. If you are a woman using this medication, tell your doctor if you are pregnant or breast-feeding.

Alfuzosin is not for use in children.

How should I take alfuzosin?

 

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Alfuzosin is usually taken once a day, just after a meal. Try to take this medication at the same time each day. Do not take it on an empty stomach.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

Alfuzosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. Call your doctor if you have severe dizziness or feel like you might pass out.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

Your blood pressure and prostate will need to be checked often. Visit your doctor regularly.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

 

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include extreme dizziness or fainting.

What should I avoid while taking alfuzosin?

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

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of alfuzosin.

What are the possible side effects of alfuzosin?

 

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using alfuzosin and call your doctor at once if you have a serious side effect such as:

  • new or worsening chest pain;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • feeling like you might pass out; or
  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • mild dizziness;
  • headache;
  • tired feeling; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. Y

What other drugs will affect alfuzosin?

Many drugs can interact with alfuzosin. Below is just a partial list. Tell your doctor if you are using:

  • atenolol (Tenormin);
  • arsenic trioxide (Trisenox);
  • cimetidine (Tagamet);
  • conivaptan (Vaprisol);
  • diltiazem (Cardizem CD, Cartia XT, Tiazac);
  • droperidol (Inapsine);
  • enoxacin (Penetrex);
  • imatinib (Gleevec);
  • isoniazid (for treating tuberculosis);
  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam); or telithromycin (Ketek);
  • an antidepressant such as amitriptylline (Elavil, Vanatrip), clomipramine (Anafranil), desipramine (Norpramin), or nefazodone;
  • an antifungal medication such as clotrimazole (Mycelex Troche) o voriconazole (Vfend);
  • anti-malaria medications such as chloroquine (Arelan) or mefloquine (Lariam);
  • a nitrate heart medication, such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), or isosorbide mononitrate (Imdur, ISMO, Monoket);
  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;
  • heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), ibutilide (Corvert), procainamide (Pronestyl), propafenone (Rythmol), quinidine (Quin-G), or sotalol (Betapace);
  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir);
  • medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran);
  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);
  • migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig); or
  • narcotic medication such as methadone (Dolophine, Methadose).

This list is not complete and there are many other drugs that can interact with alfuzosin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about alfuzosin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Pill Pictures

Uroxatral (alfuzosin) 10 mg

Uroxatral (alfuzosin) 10 mg


 

Alfuzosin is in a group of drugs called alpha-adrenergic blockers. Alfuzosin helps relax the muscles in the prostate and bladder neck, making it easier to urinate.

Alfuzosin is used to treat benign prostatic hyperplasia (enlarged prostate).

Alfuzosin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about alfuzosin?

Do not use alfuzosin if you have severe liver disease, or if you are also using ketoconazole (Nizoral), itraconazole (Sporanox), or ritonavir (Norvir). Alfuzosin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Stop using alfuzosin and call your doctor at once if you have new or worsening chest pain, or if you feel light-headed.

Alfuzosin can affect the pupils of your eyes during cataract surgery. If you have cataract surgery during your treatment with alfuzosin, tell the surgeon ahead of time that you are taking this medication. Do not stop using alfuzosin before surgery unless your surgeon tells you to.

What should I discuss with my healthcare provider before taking alfuzosin?

You should not use alfuzosin if you have:

  • severe liver disease; or

  • if you are also using an antifungal medication such as ketoconazole (Nizoral), itraconazole (Sporanox), or ritonavir (Norvir).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take alfuzosin:

  • prostate cancer;

  • liver disease;
  • kidney disease;
  • a personal or family history of Long QT syndrome;

  • angina (chest pain);

  • coronary artery disease (such as arteriosclerosis);

  • low blood pressure;

  • a history of an allergic reaction to alfuzosin;

  • if you are taking another alpha-blocker such as terazosin (Hytrin), prazosin (Minipress), doxazosin (Cardura), or guanadrel (Hylorel) for high blood pressure or prostate problems;

  • if you are taking certain medicines to treat HIV or AIDS.

FDA pregnancy category B. Although alfuzosin is not for use in women, this medication is not expected to be harmful to an unborn baby. If you are a woman using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether alfuzosin passes into breast milk, or if it could harm a nursing baby. If you are a woman using this medication, do not take alfuzosin without telling your doctor if you are breast-feeding a baby.

How should I take alfuzosin?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take each dose with a full glass of water. Alfuzosin should be taken just after eating food. Take alfuzosin after the same meal each day. Do not take it on an empty stomach. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or crushing the pill would cause too much of the drug to be released at one time.

It is important to use alfuzosin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Alfuzosin can affect the pupils of your eyes during cataract surgery. If you have cataract surgery during your treatment with alfuzosin, tell the surgeon ahead of time that you are taking this medication. Do not stop using alfuzosin before surgery unless your surgeon tells you to.

Store alfuzosin at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include weakness, dizziness, a fast but weak pulse, cold or clammy skin, and feeling light-headed or fainting.

What should I avoid while taking alfuzosin?

Alfuzosin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Alfuzosin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using alfuzosin and call your doctor at once if you have any of these serious side effects:

  • new or worsening chest pain;

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • feeling like you might pass out; or

  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • dizziness or drowsiness;

  • headache, tired feeling;

  • warmth, redness, or tingly feeling under your skin;

  • mild stomach pain, diarrhea, constipation; or

  • sore throat, cough, runny or stuffy nose.

 

Alfuzosin Dosing Information

Usual Adult Dose for Benign Prostatic Hyperplasia:

10 mg orally once a day immediately after the same meal each day.

What other drugs will affect alfuzosin?

Before taking alfuzosin, tell your doctor if you are taking any other medications to treat high blood pressure or prostate problems.

Tell your doctor about all other medications you use, especially:

  • atenolol (Tenormin);

  • cimetidine (Tagamet);

  • conivaptan (Vaprisol);

  • diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);

  • diltiazem (Cardizem CD, Cartia XT, Tiazac);

  • enoxacin (Penetrex);

  • imatinib (Gleevec);

  • isoniazid (for treating tuberculosis);

  • an antidepressant such as nefazodone;

  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);

  • an antifungal medication such as clotrimazole (Mycelex Troche) voriconazole (Vfend);

  • a nitrate heart medication, such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), or isosorbide mononitrate (Imdur, ISMO, Monoket);

  • heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quinaglute, Quinidex, Quin-Release), or verapamil (Calan, Covera, Isoptin, Verelan); or

  • HIV/AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), or saquinavir (Invirase).

This list is not complete and there may be other drugs that can interact with alfuzosin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

 

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