PROBENECID-AFT Film coated tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
PROBENECID-AFT, Probenecid 500 mg film coated tablets.
Qualitative and quantitative composition
Each tablet contains 500 mg Probenecid. For full list of excipients, see section 6.1.
Pharmaceutical form
Probenecid-AFT tablets are yellow capsule-shaped, film coated tablets, bisected on one side and plain on the other.
Therapeutic indications
Gout Probenecid is a uricosuric agent for the treatment of hyperuricaemia in all stages of gout and gouty arthritis except a presenting acute attack. Asymptomatic hyperuricaemia seems to occur in a significant ...
Posology and method of administration
Gout Probenecid therapy should not be initiated until an acute gouty attack has subsided. Should an acute attack be precipitated during therapy, the drug may be continued without changing the dosage, and ...
Contraindications
Hypersensitivity to probenecid or to any of the excipients listed in section 6.1. Persons with known blood dyscrasias. Persons with uric acid kidney stones. Children under 2 years of age. Therapy with ...
Special warnings and precautions for use
Use with caution in patients with a history of peptic ulcer. The appearance of hypersensitivity reactions requires cessation of probenecid therapy. If probenecid is given with methotrexate, the dosage ...
Interaction with other medicinal products and other forms of interaction
In patients on probenecid the use of acetylsalicylic acid in either small or large doses is contraindicated because it antagonises the uricosuric action of probenecid. In patients on probenecid who require ...
Pregnancy and lactation
Category B2. Probenecid crosses the placental barrier and appears in cord blood. The use of any medicine in women of childbearing potential requires that the anticipated benefit be weighed against possible ...
Effects on ability to drive and use machines
Although this medicine is unlikely to affect your ability to drive or operate machinery, a few people may be impaired and care should be taken.
Undesirable effects
<u>Central Nervous System:</u> Headache, dizziness <u>Gastrointestinal:</u> Nausea, anorexia, vomiting <u>Genitourinary:</u> Urinary frequency, in gouty patients exacerbation of gout, and uric acid stones ...
Overdose
In the event of overdosage, symptomatic and supportive measures should be employed along with gastric lavage. If signs of central nervous excitation are present, a short-acting barbituate may be given ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antigout preparations ATC code: M04AB01 Probenecid is a uricosuric and renal tubular blocking agent. It inhibits the tubular reabsorption of urate, thus increasing the urinary ...
Pharmacokinetic properties
Absorption Probenecid is completely absorbed after oral administration. Peak plasma levels are reached in two to four hours. Distribution Between 85 and 95% of probenecid is bound to plasma albumin; the ...
Preclinical safety data
Not data available.
List of excipients
Maize starch Microcrystalline cellulose(102) Sodium Starch glycollate Colloidal anhydrous silica Magnesium stearate Povidone K-30 Stearic acid (micronised) Opadry yellow YS-1-2063 Opadry clearYS-1-7006 ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store below 30°C.
Nature and contents of container
Probenecid Tablet 500 mg is packed in Milky White 100 cc HDPE Bottles & Milky White 38 mm HDPE caps with induction wad, which is labeled with Printed Sticker Labels. Silica Gel Bags is used in packing ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
AFT Pharmaceuticals Ltd, PO BOX 33203, Takapuna, Auckland, Email: customer.service@aftpharm.com
Date of first authorization / renewal of the authorization
04/02/2010
Date of revision of the text
April 2018
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