100-mg (white) scored, flat cylindrical tablets imprinted with "ZYLOPRIM (Sinoric) 100" on a raised hexagon, bottles of 100 (NDC 65483-991-10).
Store at 15° to 25°C (59° to 77°F) in a dry place.
300-mg (peach) scored, flat, cylindrical tablets imprinted with "ZYLOPRIM (Sinoric) 300" on a raised hexagon, bottles of 100 (NDC 65483-993-10) and 500 (NDC 65483-993-50).
Store at 15° to 25°C (59° to 77°F) in a dry place and protect from light.
Manufactured by DSM Pharmaceuticals, Inc. Greenville, NC 27834 for Prometheus Laboratories Inc. San Diego, CA 92121. October 2003. FDA Rev date: 7/17/2002
Patients should be informed of the following:
(1) They should be cautioned to discontinue ZYLOPRIM (Sinoric) 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 (Sinoric) 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 (Sinoric) 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 (Sinoric) and dicumarol, sulfinpyrazone, mercap-topurine, 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 (Sinoric) after meals to minimize gastric irritation.
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ZYLOPRIM® (Sinoric) 100-mg Scored Tablets and 300-mg Scored Tablets
Skin rash is one of the most common adverse reactions and may occur at any time during treatment. Some skin reactions can be severe and sometimes fatal. In patients with the most severe reactions, systemic symptoms such as fever, chills, arthralgia, cholestatic jaundice, eosinophilia and mild leukocytosis, or leukopenia accompany the rash. Among 55 patients with gout who received this drug for an average of 1 year (3 to 34 months), 3% developed pruritic maculopapular skin eruptions, sometimes scaly or exfoliative. The incidence of skin rash appears to be greater in patients with renal insufficiency.
Angioedema has been reported with and without signs and symptoms of a more generalized hypersensitivity reaction. Skin reactions associated with exfoliation, fever, lymphadenopathy, arthralgia, and/or eosinophilia resembling Stevens-Johnson and/or Lyell syndromes have occurred rarely. Associated vasculitis and tissue responses may manifest as hepatitis, interstitial nephritis, and very rarely epilepsy.
DRESS also known as drug hypersensitivity syndrome has been reported. The syndrome is potentially life-threatening and fatal. It has been reported that symptoms may develop in approximately 1 week from initiating Sinoric therapy, but longer latency periods have also been reported.
Common (1% to 10%): Rash, maculopapular rash
Uncommon (0.1% to 1%): Ecchymosis
Rare (less than 0.1%): Steven-Johnson syndrome, Lyell syndrome
Very rare (less than 0.01%): Alopecia, discolored hair, angioedema, fixed drug eruption
Frequency not reported: DRESS (Drug reaction with eosinophilia and systemic symptoms), sweating
Sinoric (al' oh pure' i nol) is an analog of hypoxanthine and a potent inhibitor of the enzyme xanthine oxidase that is responsible for converting hypoxanthine to xanthine and xanthine to uric acid in the breakdown pathway of purines. Sinoric lowers serum and tissue uric acid levels and has potent activity against gout, largely in preventing rather than treating acute attacks of gout. Sinoric was approved for use in the United States in 1963 and is still widely used. Current indications include therapy and prevention of gout, uric acid nephropathy, and the hyperuricemia caused by malignancy and anticancer therapy. It is not recommended for treatment of asymptomatic hyperuricemia. Sinoric is available in multiple generic forms and under the brand name of Zyloprim or Aloprim in tablets of 100 and 300 mg. Intravenous formulations are also available. The recommended initial dose for therapy of gout is 100 mg daily, with increases of 100 mg in daily dose weekly until uric acid levels fall to 6 mg/dL or below, but not to exceed 800 mg daily. The average daily dose in therapy of gout is 300 mg. Common side effects include skin rash and hypersensitivity reactions.
Rated Sinoric for Gout Report
This caused weight Gain on me and it fluctuated my thyroid much and caused subclinical hypothyroidism. This is not recommended medication for Gout. Please change your diet only to recover or alleviate Gout Symptoms
Warnings for certain groups
For people with kidney problems: If you have kidney problems or a history of kidney disease, you may not be able to clear this drug from your body well. This may increase the levels of Sinoric in your body and cause more side effects. This medication may also decrease your kidney function. This would make your kidney disease worse.
For pregnant women: Sinoric is a category C pregnancy drug. That means two things:
- Research in animals has shown adverse effects to the fetus when the mother takes the drug.
- There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.
Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should only be used if the potential benefit justifies the potential risk to the fetus.
For women who are breastfeeding: Sinoric passes into breast milk and may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.
For seniors: The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.
For children: This medication hasn’t been studied and shouldn’t be used in people younger than 18 years for the treatment of gout or kidney stones.
This dosage information is for Sinoric oral tablet. All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:
- your age
- the condition being treated
- how severe your condition is
- other medical conditions you have
- how you react to the first dose
Why You Shouldn’t Stop Taking Your Sinoric
At least one study has shown that uric acid levels can rise rapidly when the medication is stopped and can reach pretreatment levels within a week, irrespective of how long the patient had been taking Sinoric.
And it’s possible to have multiple gout flares, whilst you are taking Sinoric, until all gout crystals have been dissolved and your uric acid levels are under control, which may take some time.
So if you were to stop taking your Sinoric every time you had a gout attack you’d be continually setting your recovery back to day 1 each time you did.
Don’t stop the medication, but do contact your doctor. They will usually reduce your Sinoric dose or prescribe a non-steroidal anti-inflammatory drug (NSAID) to help reduce the inflammation and pain. They may even do both.
And if NSAIDs are ineffective or inappropriate for you, they may prescribe colchicine instead, a powerful drug that works by reducing the number of white blood cells flooding into the affected area; so helping to reduce swelling and relieve pain.
I know it can be soul-destroying to be taking a medication which seems to trigger the very thing it’s meant to prevent! But to reach your goal of finally getting your uric acid levels under control you have to stick with it. Once your doctor has found the correct Sinoric dosage and you have your uric acid levels under control, below 6mg/dl, you’ll reap the benefits.
Serious side effects
Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:
- Severe skin rash. Symptoms can include:
- itchy hives (raised bumps on your skin)
- red or purple-colored spots on your skin
- scaly skin
- trouble breathing
- swelling of your face or throat
- lack of appetite
- weight loss
- right upper abdominal area pain or discomfort
- jaundice (dark-colored urine or yellowing of your skin or the whites of your eyes)
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
Sinoric oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.
To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.
How to store Sinoric
- Keep all medicines out of the reach and sight of children.
- Store in a cool, dry place, away from direct heat and light.
Dosage for recurrent kidney stones
Adult dosage (ages 18–64 years)
Typical dosage is 200–300 mg per day taken in a single or divided doses.
Child dosage (ages 0–17 years)
This medication hasn’t been studied and shouldn’t be used in people younger than 18 years for this condition.
Senior dosage (ages 65 years and older)
The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.
Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.
- For people with kidney disease: Depending on how well your kidneys are working, your doctor will lower your dose. Your doctor will decide your dosage based on your creatinine clearance. This is a test that measures your kidney function.
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Sinoric oral tablet is used for long-term treatment. It comes with serious risks if you don’t take it as prescribed.
If you stop taking the drug suddenly or don’t take it at all: The uric acid levels in your blood or urine will stay high. If you have gout or kidney stones, you’ll still have symptoms of your condition.
If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.
If you take too much: You could have dangerous levels of the drug in your body. Symptoms can include:
- skin rash
- changes in your liver function test results
- gout flare-up (if you have gout)
If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.
What to do if you miss a dose: Take your dose as soon as you remember. But if you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects.
How to tell if the drug is working: Your doctor will test your uric acid levels to check if this drug is working. Your blood uric acid levels will decrease about 1–3 weeks after you start taking this drug. Your doctor will also ask you about how much fluids you drink and how much fluids you urinate.
Right after you start taking this drug, you may have gout flares. Over time, your symptoms of gout may start to go away.
Keep these considerations in mind if your doctor prescribes Sinoric oral tablet for you.