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  3. 50 mg Viagra is the recommended dose.
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  5. Before taking Viagra, don’t drink grapefruit juice! This reduces the effect of Viagra.

 

Common use
Sildenafil Citrate affects the response to sexual stimulation. It acts by enhancing smooth muscle relaxation using nitric oxide, a chemical that is normally released in response to sexual stimulation. This smooth muscle relaxation allows increased blood flow into certain areas of the penis, which leads to an erection.
Sildenafil Citrate is applied for the treatment of erectile dysfunction (impotence) in men and pulmonary arterial hypertension.
Sildenafil Citrate may also be used for other purposes not listed above.

Dosage and direction
Usually the recommended dose is 50 mg. It is taken approximately 0,5-1 hour before sexual activity. Do not take Viagra more then once a day.
A high fat meal may delay the time of the effect of this drug.
Try not to eat grapefruit or drink grapefruit juice while you are being treated with Sildenafil Citrate.

Precautions
Before you start taking Sildenafil Citrate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.
Aged people may be more sensitive to the side effects of the drug.

Contraindications
Viagra is contraindicated in patients taking another medicine to treat impotence or using a nitrate drug for chest pain or heart problems.
This medicine should not be taken by women and children as well as in patients with a known hypersensitivity to any component of the tablet.

Possible side effect
The most common side effects are headache, flushing, heartburn, stomach upset, nasal stuffiness, lightheadedness, dizziness or diarrhea.
A serious allergic reaction to this drug is very rare, but seek immediate medical help if it occurs.
Many people using this medicine do not have serious side effects.
In case you notice any side effects not listed above, contact your doctor or pharmacist.

Drug interaction
This drug should not be used with nitrates and recreational drugs called «poppers» containing amyl or butyl nitrite; alpha-blocker medications; other medications for impotence; high blood pressure medicines, etc.
Consult your doctor or pharmacist for more details.

Missed dose
Viagra is used as needed, so you are unlikely to be on a dosing schedule.

Overdose
If you think you have used too much of this medicine seek emergency medical attention right away. The symptoms of overdose usually include chest pain, nausea, irregular heartbeat, and feeling light-headed or fainting.

Storage
Store your medicines at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store the drugs in the bathroom. Keep all drugs away from reach of children and pets.

Disclaimer
We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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What is this medicine?

SILDENAFIL CITRATE is used to treat erection problems in men. CavertaВ® is produced by Ranbaxy — one of world’s leading pharmacutical companies.

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What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • eye or vision problems, including a rare inherited eye disease called retinitis pigmentosa
  • heart disease, angina, high or low blood pressure, a history of heart attack, or other heart problems
  • kidney disease
  • liver disease
  • stroke
  • an unusual or allergic reaction to sildenafil, other medicines, foods, dyes, or preservatives

How should I take this medicine?

Take this medicine by mouth with a glass of water. The dose is usually taken 1 hour before sexual activity. You should not take the dose more than once per day. Do not take your medicine more often than directed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What may interact with this medicine?

Do not take this medicine with any of the following:

  • cisapride
  • methscopolamine nitrate
  • nitrates like amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
  • nitroprusside
  • other sildenafil products (Viagra, Revatio, Suhagra, etc.)

This medicine may also interact with the following:

  • certain drugs for high blood pressure
  • certain drugs for the treatment of HIV infection or AIDS
  • certain drugs used for fungal or yeast infections, like fluconazole, itraconazole, ketoconazole, and voriconazole
  • cimetidine
  • erythromycin

This list may not describe all possible interactions. Give your health care providers a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while taking this medicine?

If you notice any changes in your vision while taking this drug, call your doctor or health care professional as soon as possible.

Call your health care provider right away if you have any change in vision.

Contact you doctor or health care professional right away if the erection lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

If you experience symptoms of nausea, dizziness, chest pain or arm pain upon initiation of sexual activity after taking this medicine, you should refrain from further activity and call your doctor or health care professional as soon as possible.

Using this medicine does not protect you or your partner against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.

What side effects may I notice from this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • changes in hearing
  • changes in vision, blurred vision, trouble telling blue from green color
  • chest pain
  • fast, irregular heartbeat
  • men: prolonged or painful erection (lasting more than 4 hours)
  • seizures

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • diarrhea
  • flushing
  • headache
  • indigestion
  • stuffy or runny nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects.

Where can I keep my medicine?

Keep out of reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

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Sildenafil (Viagra) is used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men. Sildenafil (Revatio) is used to improve the ability to exercise in people with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Sildenafil is in a class of medications called phosphodiesterase (PDE) inhibitors. Sildenafil treats erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Sildenafil treats PAH by relaxing the blood vessels in the lungs to allow blood to flow easily.

If you are taking sildenafil to treat erectile dysfunction, you should know that it does not cure erectile dysfunction or increase sexual desire. Sildenafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).

How should this medicine be used?

Sildenafil comes as a tablet to take by mouth.

If you are taking sildenafil to treat erectile dysfunction, follow your doctor’s directions and the guidelines in this paragraph. Take sildenafil as needed before sexual activity. The best time to take sildenafil is about 1 hour before sexual activity, but you can take the medication any time from 4 hours to 30 minutes before sexual activity. Sildenafil usually should not be taken more than once every 24 hours. If you have certain health conditions or are taking certain medications, your doctor may tell you to take sildenafil less often. You can take sildenafil with or without food. However, if you take sildenafil with a high-fat meal, it will take longer for the medication to start to work.

If you are taking sildenafil to treat PAH, follow your doctor’s directions and the guidelines in this paragraph. You will probably take sildenafil three times a day with or without food. Take sildenafil at around the same times every day, and space your doses about 4 to 6 hours apart.

Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sildenafil exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are taking sildenafil for erectile dysfunction, your doctor will probably start you on an average dose of sildenafil and increase or decrease your dose depending on your response to the medication. Tell your doctor if sildenafil is not working well or if you are experiencing side effects.

If you are taking sildenafil for PAH, you should know that sildenafil controls PAH but does not cure it. Continue to take sildenafil even if you feel well. Do not stop taking sildenafil without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

Other uses for this medicine

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

 

  • tell your doctor and pharmacist if you are allergic to sildenafil or any other medications.
  • do not take sildenafil if you are taking or have recently taken nitrates (medications for chest pain) such as isosorbide dinitrate (Isordil), isosorbide mononitrate (Imdur, ISMO), and nitroglycerin (Nitro-BID, Nitro-Dur, Nitroquick, Nitrostat, others). Nitrates come as tablets, sublingual (under the tongue) tablets, sprays, patches, pastes, and ointments. Ask your doctor if you are not sure whether any of your medications contain nitrates.
  • do not take street drugs containing nitrates such as amyl nitrate and butyl nitrate (‘poppers’) while taking sildenafil.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax), and terazosin (Hytrin); amlodipine (Norvasc); certain antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); anticoagulants (‘blood thinners’) such as warfarin (Coumadin); certain barbiturates such as butalbital (in Esgic-Plus, in Fioricet, in Fiorinal, others) and secobarbital (Seconal); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); bosentan (Tracleer); cimetidine (Tagamet);efavirenz (Sustiva); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors including amprenavir (Agenerase), atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Fortovase, Invirase), and tipranavir (Aptivus); nevirapine (Viramune); other medications or devices to treat erectile dysfunction;medications for high blood pressure; certain medications for seizures including carbamazepine (Carbatrol, Epitol, Tegretol), phenobarbital, and phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); and rifampin (Rifadin, Rimactane). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with sildenafil, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • tell your doctor what herbal products you are taking or plan to take, especially St. John’s wort.
  • tell your doctor if you smoke, if you have ever had an erection that lasted for several hours, and if you have recently lost a large amount of body fluids (dehydration). This can happen if you are sick with fever, diarrhea, or vomiting; sweat a lot; or do not drink enough liquids. Also tell your doctor if you have or have ever had pulmonary veno-occlusive disease (PVOD; blockage of veins in the lungs); a stomach ulcer; heart, kidney, or liver disease; a heart attack; an irregular heartbeat; a stroke; chest pain; high or low blood pressure; high cholesterol; a bleeding disorder; blood circulation problems;blood cell problems such as sickle cell anemia (a disease of the red blood cells), multiple myeloma (cancer of the plasma cells), or leukemia (cancer of the white blood cells); conditions affecting the shape of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie’s disease); or diabetes. Also tell your doctor if you or any of your family members have or have ever had an eye disease such as retinitis pigmentosa (an inherited eye condition that causes loss of vision) or if you have ever had sudden severe vision loss, especially if you were told that the vision loss was caused by a blockage of blood flow to the nerves that help you see.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking sildenafil, call your doctor.
  • if you are having surgery, including dental surgery, tell your doctor or dentist that you are taking sildenafil.
  • if you are taking sildenafil to treat erectile dysfunction, tell your doctor if you have ever been advised by a health care professional to avoid sexual activity for medical reasons or if you have ever experienced chest pain during sexual activity. Sexual activity may be a strain on your heart, especially if you have heart disease. If you experience chest pain, dizziness, or nausea during sexual activity, call your doctor immediately and avoid sexual activity until your doctor tells you otherwise.
  • tell all your health care providers that you are taking sildenafil. If you ever need emergency medical treatment for a heart problem, the health care providers who treat you will need to know when you last took sildenafil.

What special dietary instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

What should I do if I forget a dose?

If you are taking sildenafil for erectile dysfunction, you are unlikely to miss a dose since this medication is taken as needed, not on a regular dosing schedule.

If you are taking sildenafil for PAH, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Sildenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • heartburn
  • diarrhea
  • flushing (feeling of warmth)
  • nosebleeds
  • difficulty falling asleep or staying asleep
  • numbness, burning, or tingling in the arms, hands, feet, or legs
  • muscle aches
  • changes in color vision (seeing a blue tinge on objects or having difficulty telling the difference between blue and green)
  • sensitivity to light

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

  • sudden severe loss of vision (see below for more information)
  • blurred vision
  • sudden decrease or loss of hearing
  • ringing in ears
  • erection that is painful or lasts longer than 4 hours
  • dizziness or lightheadedness
  • fainting
  • chest pain
  • worsening shortness of breath
  • itching or burning during urination
  • rash

Some patients experienced a sudden loss of some or all of their vision after they took sildenafil or other medications that are similar to sildenafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are taking sildenafil, call your doctor immediately. Do not take any more doses of sildenafil or similar medications such as tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor.

There have been reports of heart attack, stroke, irregular heartbeat, bleeding in the brain or lungs, high blood pressure, and sudden death in men who took sildenafil for erectile dysfunction. Most, but not all, of these people had heart problems before taking sildenafil. It is not known whether these events were caused by sildenafil, sexual activity, heart disease, or a combination of these and other causes.Talk to your doctor about the risks of taking sildenafil.

Some patients experienced a sudden decrease or loss of hearing after they took sildenafil or other medications that are similar to sildenafil. The hearing loss usually involved only one ear and may not get better. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking sildenafil, call your doctor immediately. If you are taking sildenafil (Viagra) for erectile dysfunction, do not take any more doses of sildenafil (Viagra) or similar medications such as tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor. If you are taking sildenafil (Revatio) for PAH, do not stop taking your medication until you talk to your doctor.

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

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

American Society of Health-System Pharmacists, Disclaimer

AHFS® Consumer Medication Information. © Copyright, 2011. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

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ZYLOPRIM (allopurinol) has the following structural formula:

Structural Formula

ZYLOPRIM is known chemically as 1,5-dihydro-4H-pyrazolo [3,4-d]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Each scored white tablet contains 100 mg allopurinol and the inactive ingredients lactose, magnesium stearate, potato starch, and povidone. Each scored peach tablet contains 300 mg allopurinol and the inactive ingredients corn starch, FD&C Yellow No. 6 Lake, lactose, magnesium stearate, and povidone. Its solubility in water at 37°C is 80.0 mg/dL and is greater in an alkaline solution.

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It has been shown that reutilization of both hypoxanthine and xanthine for nucleotide and nucleic acid synthesis is markedly enhanced when their oxidations are inhibited by ZYLOPRIM and oxipurinol. This reutilization does not disrupt normal nucleic acid anabolism, however, because feedback inhibition is an integral part of purine biosynthesis. As a result of xanthine oxidase inhibition, the serum concentration of hypoxanthine plus xanthine in patients receiving ZYLOPRIM for treatment of hyperuricemia is usually in the range of 0.3 to 0.4 mg/dL compared to a normal level of approximately 0.15 mg/dL. A maximum of 0.9 mg/dL of these oxypurines has been reported when the serum urate was lowered to less than 2 mg/dL by high doses of ZYLOPRIM. These values are far below the saturation levels at which point their precipitation would be expected to occur (above 7 mg/dL).

The renal clearance of hypoxanthine and xanthine is at least 10 times greater than that of uric acid. The increased xanthine and hypoxanthine in the urine have not been accompanied by problems of nephrolithiasis. Xanthine crystalluria has been reported in only three patients. Two of the patients had Lesch-Nyhan syndrome, which is characterized by excessive uric acid production combined with a deficiency of the enzyme, hypoxanthineguanine phosphoribosyltransferase (HGPRTase). This enzyme is required for the conversion of hypoxanthine, xanthine, and guanine to their respective nucleotides. The third patient had lymphosarcoma and produced an extremely large amount of uric acid because of rapid cell lysis during chemotherapy.

ZYLOPRIM is approximately 90% absorbed from the gastrointestinal tract. Peak plasma levels generally occur at 1.5 hours and 4.5 hours for ZYLOPRIM and oxipurinol respectively, and after a single oral dose of 300 mg ZYLOPRIM, maximum plasma levels of about 3 mcg/mL of ZYLOPRIM and 6.5 mcg/mL of oxipurinol are produced.

Approximately 20% of the ingested ZYLOPRIM is excreted in the feces. Because of its rapid oxidation to oxipurinol and a renal clearance rate approximately that of glomerular filtration rate, ZYLOPRIM has a plasma half-life of about 1 to 2 hours. Oxipurinol, however, has a longer plasma half-life (approximately 15 hours) and therefore effective xanthine oxidase inhibition is maintained over a 24-hour period with single daily doses of ZYLOPRIM. Whereas ZYLOPRIM is cleared essentially by glomerular filtration, oxipurinol is reabsorbed in the kidney tubules in a manner similar to the reabsorption of uric acid.

The clearance of oxipurinol is increased by uricosuric drugs, and as a consequence, the addition of a uricosuric agent reduces to some degree the inhibition of xanthine oxidase by oxipurinol and increases to some degree the urinary excretion of uric acid. In practice, the net effect of such combined therapy may be useful in some patients in achieving minimum serum uric acid levels provided the total urinary uric acid load does not exceed the competence of the patient’s renal function.

Hyperuricemia may be primary, as in gout, or secondary to diseases such as acute and chronic leukemia, polycythemia vera, multiple myeloma, and psoriasis. It may occur with the use of diuretic agents, during renal dialysis, in the presence of renal damage, during starvation or reducing diets, and in the treatment of neoplastic disease where rapid resolution of tissue masses may occur. Asymptomatic hyperuricemia is not an indication for treatment with ZYLOPRIM (see INDICATIONS AND USAGE).

Gout is a metabolic disorder which is characterized by hyperuricemia and resultant deposition of monosodium urate in the tissues, particularly the joints and kidneys. The etiology of this hyperuricemia is the overproduction of uric acid in relation to the patient’s ability to excrete it. If progressive deposition of urates is to be arrested or reversed, it is necessary to reduce the serum uric acid level below the saturation point to suppress urate precipitation.

Administration of ZYLOPRIM generally results in a fall in both serum and urinary uric acid within 2 to 3 days. The degree of this decrease can be manipulated almost at will since it is dose-dependent. A week or more of treatment with ZYLOPRIM may be required before its full effects are manifested; likewise, uric acid may return to pretreatment levels slowly (usually after a period of 7 to 10 days following cessation of therapy). This reflects primarily the accumulation and slow clearance of oxipurinol. In some patients a dramatic fall in urinary uric acid excretion may not occur, particularly in those with severe tophaceous gout. It has been postulated that this may be due to the mobilization of urate from tissue deposits as the serum uric acid level begins to fall.

The action of ZYLOPRIM differs from that of uricosuric agents, which lower the serum uric acid level by increasing urinary excretion of uric acid. ZYLOPRIM reduces both the serum and urinary uric acid levels by inhibiting the formation of uric acid. The use of ZYLOPRIM to block the formation of urates avoids the hazard of increased renal excretion of uric acid posed by uricosuric drugs.

ZYLOPRIM can substantially reduce serum and urinary uric acid levels in previously refractory patients even in the presence of renal damage serious enough to render uricosuric drugs virtually ineffective. Salicylates may be given conjointly for their antirheumatic effect without compromising the action of ZYLOPRIM. This is in contrast to the nullifying effect of salicylates on uricosuric drugs.

ZYLOPRIM also inhibits the enzymatic oxidation of mercaptopurine, the sulfur-containing analogue of hypoxanthine, to 6-thiouric acid. This oxidation, which is catalyzed by xanthine oxidase, inactivates mercaptopurine. Hence, the inhibition of such oxidation by ZYLOPRIM may result in as much as a 75% reduction in the therapeutic dose requirement of mercaptopurine when the two compounds are given together.

INDICATIONS AND USAGE

THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA.

ZYLOPRIM reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS).

ZYLOPRIM is indicated in:

  1. the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy).
  2. the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with ZYLOPRIM should be discontinued when the potential for overproduction of uric acid is no longer present.
  3. the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.

CONTRAINDICATIONS

Patients who have developed a severe reaction to ZYLOPRIM should not be restarted on the drug.

WARNINGS

ZYLOPRIM SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR OTHER SIGNS WHICH MAY INDICATE AN ALLERGIC REACTION. In some instances a skin rash may be followed by more severe hypersensitivity reactions such as exfoliative, urticarial, and purpuric lesions, as well as Stevens-Johnson syndrome (erythema multiforme exudativum), and/or generalized vasculitis, irreversible hepatotoxicity, and, on rare occasions, death.

In patients receiving PURINETHOL® (mercaptopurine) or IMURAN® (azathioprine), the concomitant administration of 300 to 600 mg of ZYLOPRIM per day will require a reduction in dose to approximately one-third to one-fourth of the usual dose of mercaptopurine or azathioprine. Subsequent adjustment of doses of mercaptopurine or azathioprine should be made on the basis of therapeutic response and the appearance of toxic effects (see CLINICAL PHARMACOLOGY).

A few cases of reversible clinical hepatotoxicity have been noted in patients taking ZYLOPRIM, and in some patients, asymptomatic rises in serum alkaline phosphatase or serum transaminase have been observed. If anorexia, weight loss, or pruritus develop in patients on ZYLOPRIM, evaluation of liver function should be part of their diagnostic workup. In patients with pre-existing liver disease, periodic liver function tests are recommended during the early stages of therapy.

Due to the occasional occurrence of drowsiness, patients should be alerted to the need for due precaution when engaging in activities where alertness is mandatory.

The occurrence of hypersensitivity reactions to ZYLOPRIM may be increased in patients with decreased renal function receiving thiazides and ZYLOPRIM concurrently. For this reason, in this clinical setting, such combinations should be administered with caution and patients should be observed closely.

PRECAUTIONS

General: An increase in acute attacks of gout has been reported during the early stages of administration of ZYLOPRIM , even when normal or subnormal serum uric acid levels have been attained. Accordingly, maintenance doses of colchicine generally should be given prophylactically when ZYLOPRIM is begun. In addition, it is recommended that the patient start with a low dose of ZYLOPRIM (100 mg daily) and increase at weekly intervals by 100 mg until a serum uric acid level of 6 mg/dL or less is attained but without exceeding the maximum recommended dose (800 mg per day). The use of colchicine or anti-inflammatory agents may be required to suppress gouty attacks in some cases. The attacks usually become shorter and less severe after several months of therapy. The mobilization of urates from tissue deposits which cause fluctuations in the serum uric acid levels may be a possible explanation for these episodes. Even with adequate therapy with ZYLOPRIM, it may require several months to deplete the uric acid pool sufficiently to achieve control of the acute attacks.

A fluid intake sufficient to yield a daily urinary output of at least 2 liters and the maintenance of a neutral or, preferably, slightly alkaline urine are desirable to (1) avoid the theoretical possibility of formation of xanthine calculi under the influence of therapy with ZYLOPRIM and (2) help prevent renal precipitation of urates in patients receiving concomitant uricosuric agents.

Some patients with pre-existing renal disease or poor urate clearance have shown a rise in BUN during administration of ZYLOPRIM. Although the mechanism responsible for this has not been established, patients with impaired renal function should be carefully observed during the early stages of administration of ZYLOPRIM and the dosage decreased or the drug withdrawn if increased abnormalities in renal function appear and persist.

Renal failure in association with administration of ZYLOPRIM has been observed among patients with hyperuricemia secondary to neoplastic diseases. Concurrent conditions such as multiple myeloma and congestive myocardial disease were present among those patients whose renal dysfunction increased after ZYLOPRIM was begun. Renal failure is also frequently associated with gouty nephropathy and rarely with hypersensitivity reactions associated with ZYLOPRIM. Albuminuria has been observed among patients who developed clinical gout following chronic glomerulonephritis and chronic pyelonephritis.

Patients with decreased renal function require lower doses of ZYLOPRIM than those with normal renal function. Lower than recommended doses should be used to initiate therapy in any patients with decreased renal function and they should be observed closely during the early stages of administration of ZYLOPRIM . In patients with severely impaired renal function or decreased urate clearance, the half-life of oxipurinol in the plasma is greatly prolonged. Therefore, a dose of 100 mg per day or 300 mg twice a week, or perhaps less, may be sufficient to maintain adequate xanthine oxidase inhibition to reduce serum urate levels.

Bone marrow depression has been reported in patients receiving ZYLOPRIM, most of whom received concomitant drugs with the potential for causing this reaction. This has occurred as early as 6 weeks to as long as 6 years after the initiation of therapy of ZYLOPRIM . Rarely, a patient may develop varying degrees of bone marrow depression, affecting one or more cell lines, while receiving ZYLOPRIM alone.

Information for Patients: Patients should be informed of the following:

(1) They should be cautioned to discontinue ZYLOPRIM and to consult their physician immediately at the first sign of a skin rash, painful urination, blood in the urine, irritation of the eyes, or swelling of the lips or mouth. (2) They should be reminded to continue drug therapy prescribed for gouty attacks since optimal benefit of ZYLOPRIM may be delayed for 2 to 6 weeks. (3) They should be encouraged to increase fluid intake during therapy to prevent renal stones. (4) If a single dose of ZYLOPRIM is occasionally forgotten, there is no need to double the dose at the next scheduled time. (5) There may be certain risks associated with the concomitant use of ZYLOPRIM and dicumarol, sulfinpyrazone, mercaptopurine, azathioprine, ampicillin, amoxicillin, and thiazide diuretics, and they should follow the instructions of their physician. (6) Due to the occasional occurrence of drowsiness, patients should take precautions when engaging in activities where alertness is mandatory. (7) Patients may wish to take ZYLOPRIM after meals to minimize gastric irritation.

Laboratory Tests: The correct dosage and schedule for maintaining the serum uric acid within the normal range is best determined by using the serum uric acid as an index.

In patients with pre-existing liver disease, periodic liver function tests are recommended during the early stages of therapy (see WARNINGS).

ZYLOPRIM and its primary active metabolite, oxipurinol, are eliminated by the kidneys; therefore, changes in renal function have a profound effect on dosage. In patients with decreased renal function or who have concurrent illnesses which can affect renal function such as hypertension and diabetes mellitus, periodic laboratory parameters of renal function, particularly BUN and serum creatinine or creatinine clearance, should be performed and the patient’s dosage of ZYLOPRIM reassessed.

The prothrombin time should be reassessed periodically in the patients receiving dicumarol who are given ZYLOPRIM.

Drug Interactions: In patients receiving PURINETHOL (mercaptopurine) or IMURAN (azathioprine), the concomitant administration of 300 to 600 mg of ZYLOPRIM per day will require a reduction in dose to approximately one third to one fourth of the usual dose of mercaptopurine or azathioprine. Subsequent adjustment of doses of mercaptopurine or azathioprine should be made on the basis of therapeutic response and the appearance of toxic effects (see CLINICAL PHARMACOLOGY).

It has been reported that ZYLOPRIM prolongs the half-life of the anticoagulant, dicumarol. The clinical basis of this drug interaction has not been established but should be noted when ZYLOPRIM is given to patients already on dicumarol therapy.

Since the excretion of oxipurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxipurinol and thus lower the degree of inhibition of xanthine oxidase. The concomitant administration of uricosuric agents and ZYLOPRIM has been associated with a decrease in the excretion of oxypurines (hypoxanthine and xanthine) and an increase in urinary uric acid excretion compared with that observed with ZYLOPRIM alone. Although clinical evidence to date has not demonstrated renal precipitation of oxypurines in patients either on ZYLOPRIM alone or in combination with uricosuric agents, the possibility should be kept in mind.

The reports that the concomitant use of ZYLOPRIM and thiazide diuretics may contribute to the enhancement of allopurinol toxicity in some patients have been reviewed in an attempt to establish a cause-and-effect relationship and a mechanism of causation. Review of these case reports indicates that the patients were mainly receiving thiazide diuretics for hypertension and that tests to rule out decreased renal function secondary to hypertensive nephropathy were not often performed. In those patients in whom renal insufficiency was documented, however, the recommendation to lower the dose of ZYLOPRIM was not followed. Although a causal mechanism and a cause-and-effect relationship have not been established, current evidence suggests that renal function should be monitored in patients on thiazide diuretics and ZYLOPRIM even in the absence of renal failure, and dosage levels should be even more conservatively adjusted in those patients on such combined therapy if diminished renal function is detected.

An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with ZYLOPRIM compared to patients who are not receiving both drugs. The cause of the reported association has not been established.

Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of ZYLOPRIM. However, in a well-controlled study of patients with lymphoma on combination therapy, ZYLOPRIM did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine, and/or mechlorethamine.

Tolbutamide’s conversion to inactive metabolites has been shown to be catalyzed by xanthine oxidase from rat liver. The clinical significance, if any, of these observations is unknown.

Chlorpropamide’s plasma half-life may be prolonged by ZYLOPRIM, since ZYLOPRIM and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if ZYLOPRIM and chlorpropamide are given concomitantly in the presence of renal insufficiency.

Rare reports indicate that cyclosporine levels may be increased during concomitant treatment with ZYLOPRIM. Monitoring of cyclosporine levels and possible adjustment of cyclosporine dosage should be considered when these drugs are co-administered.

Drug/Laboratory Test Interactions: ZYLOPRIM is not known to alter the accuracy of laboratory tests.

Pregnancy

Teratogenic Effects: Pregnancy Category C. Reproductive studies have been performed in rats and rabbits at doses up to twenty times the usual human dose (5 mg/kg per day), and it was concluded that there was no impaired fertility or harm to the fetus due to allopurinol. There is a published report of a study in pregnant mice given 50 or 100 mg/kg allopurinol intraperitoneally on gestation days 10 or 13. There were increased numbers of dead fetuses in dams given 100 mg/kg allopurinol but not in those given 50 mg/kg. There were increased numbers of external malformations in fetuses at both doses of allopurinol on gestation day 10 and increased numbers of skeletal malformations in fetuses at both doses on gestation day 13. It cannot be determined whether this represented a fetal effect or an effect secondary to maternal toxicity. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Experience with ZYLOPRIM during human pregnancy has been limited partly because women of reproductive age rarely require treatment with ZYLOPRIM. There are two unpublished reports and one published paper of women giving birth to normal offspring after receiving ZYLOPRIM during pregnancy.

Nursing Mothers: Allopurinol and oxipurinol have been found in the milk of a mother who was receiving ZYLOPRIM. Since the effect of allopurinol on the nursing infant is unknown, caution should be exercised when ZYLOPRIM is administered to a nursing woman.

Pediatric Use: ZYLOPRIM is rarely indicated for use in children with the exception of those with hyperuricemia secondary to malignancy or to certain rare inborn errors of purine metabolism (see INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION).

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The Latin term impotentia coeundi describes simple inability to insert the penis into the vagina. It is now mostly replaced by more precise terms.[vague] The study of erectile dysfunction within medicine is covered by andrology, a sub-field within urology.

 

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The National Association of Boards of Pharmacy (NABP) was established in 1904 to assist state licensing boards in developing, implementing, and enforcing uniform standards to protect the Public Health. NABP’s member boards of pharmacy are grouped into eight districts that include all 50 United States, the District of Columbia, Guam, Puerto Rico, the Virgin Islands, eight Canadian provinces, and New Zealand.

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