AROSTAT-40/80
Febuxostat 40mg/80mg

AROSTAT 40: Each film coated tablets contain Febuxostat 40 mg.
AROSTAT 80: Each film coated tablets contain Febuxostat 80 mg.
Clinical Pharmacology:
Febuxostat is a non-purine selective inhibitor of xanthine oxidase. Xanthine oxidase is needed to oxidize successively hypoxanthine and xanthine to uric acid. Thus, febuxostat reduces the production of uric acid.
Febuxostat is used to lower hyperuricemia (high uric acid in the blood) in patient with gout.
Take Arostat only as directed by your doctor. You may take Arostat with or without food.
Your gout may get worse when you start using this medicine. Keep using Arostat even if this happens. Your doctor may give you other medicines to help prevent these gout attacks.
The dose of this medicine will depend on the severity of your medical condition. The usual adult dose is 40 mg or 80 mg once a day. Your doctor may increase your dose as needed.
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
It is especially important to tell your doctor or pharmacist if you are taking medicines containing any of the following substances as they may interact with Febuxostat:
- Mercaptopurine,Azathioprine - Inhibition of XO by febuxostat may cause increased plasma concentrations of these drugs leading to toxicity
- Theophylline
The common side effects include:
- abnormal liver test results
- diarrhoea
- headache
- rash
- nausea
- increase in gout symptoms-Gout flares are commonly observed soon after the start of treatment and during the first months. Thereafter, the frequency of gout flare decreases in a time-dependent manner.
- localised swelling due to retention of fluids in tissues (oedema)
Stop taking this medicine and contact your doctor immediately if the following rare side effects occur, because a serious allergic reaction might follow:
- anaphylactic reactions, drug hypersensitivity
- potentially life-threatening skin rashes characterised by formation of blisters and shedding of the skin and inner surfaces of body cavities, e.g. mouth and genitals, painful ulcers in the mouth and/or genital areas, accompanied by fever, sore throat and fatigue (StevensJohnson Syndrome/ Toxic Epidermal Necrolysis) or by enlarged lymph node liver enlargement, hepatitis (up to liver failure), raising of the white-cells count in the blood
- generalised skin rashes
Warnings and precautions
Talk to your doctor before taking Febuxostat :
- If you have or have had heart failure or heart problems
- If you have or have had renal disease and/or serious allergic reaction to Allopurinol (a medication used for the treatment of Gout)
- If you have or have had liver disease or liver function test abnormalities
- If you are being treated for high uric acid levels as a result of Lesch-Nyhan syndrome (a rare inherited condition in which there is too much uric acid in the blood)
- If you have thyroid problems.
Stop taking this medicine,if you experience allergic reactions to Febuxostat.
Children and adolescents
Safety and efficacy for children under the age of 18 have not been established.
Pregnancy and breast-feeding
Febuxostat should not be used during pregnancy. It is not known if Febuxostat may pass into human breast milk. You should not use Febuxostat if you are breast feeding, or if you are planning to breastfeed. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, talk with your doctor before taking this medicine.