MedPath
HSA Approval

COLCITEX TABLET 0.6 mg

SIN12301P

COLCITEX TABLET 0.6 mg

COLCITEX TABLET 0.6 mg

May 23, 2003

ALCARE PHARMACEUTICALS PTE LTD

ALCARE PHARMACEUTICALS PTE LTD

Regulatory Information

ALCARE PHARMACEUTICALS PTE LTD

ALCARE PHARMACEUTICALS PTE LTD

Therapeutic

Prescription Only

Formulation Information

TABLET

**Dosage and administration :** Colcitex should be started at the first warning of an acute attack; a delay of a few hours impairs its effectiveness. The usual adult dose is 1 or 2 tablets initially, followed by 1 tablet every 1 to 2 hours until pain is relieved or nausea, vomiting, or diarrhea develops. Some physicians prescribe 2 tablets every 2 hours. Since the number of doses required may range from 6 to 16, the total dosage is variable. As interval treatment, 1 tablet may be taken 1 to 4 times a week for the mild or moderate case, once or twice daily for the severe case. If an acute attack of gout occurs while the patient is taking Colcitex as maintenance therapy, an alternative drug should be instituted in preference to increasing the dose of Colcitex.

ORAL

Medical Information

**Indications and Usage :** Colcitex is indicated for the treatment of gout. It is effective in relieving the pain of acute attacks, especially if therapy is begun early in the attack and in adequate dosage. Many therapists use Colcitex as interval therapy to prevent acute attacks of gout. It has no effect on nongouty arthritis or on uric acid metabolism.

**Contraindications :** Colcitex is contraindicated in patients with gout who also have serious gastrointestinal, renal, hepatic, or cardiac disorders. Colcitex should not be given in the presence of combined renal and hepatic disease.

M04AC01

colchicine

Manufacturer Information

ALCARE PHARMACEUTICALS PTE LTD

THE UNITED DRUG (1996) CO LTD

Active Ingredients

COLCHICINE

0.6 mg

Colchicine

Documents

Package Inserts

PI COLCITEX-SN (proposed).pdf

Approved: March 20, 2023

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