Ciprofloxacin tablets are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below.

Please see DOSAGE AND ADMINISTRATION for specific recommendations.

---

Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Ciprofloxacin hydrochloride is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antimicrobial agents, or any of the product components.Concomitant administration with tizanidine is contraindicated.

(See PRECAUTIONS, Drug Interactions.)

---

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Fluoroquinolones, including ciprofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages.

This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair.

Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.

Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors.

Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported.

Ciprofloxacin should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon.

Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

The following US Branded drugs contain CIPROFLOXACIN

---

CIPRO -- BAYER HEALTHCARE PHARMACEUTICALS INC

CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER -- BAYER HEALTHCARE PHARMACEUTICALS INC

CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER -- BAYER PHARMACEUTICALS CORP

CIPROFLOXACIN IN DEXTROSE 5% -- HIKMA FARMACEUTICA (PORTUGAL) SA

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER -- ACS DOBFAR INFO SA

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER -- BAXTER HEALTHCARE CORP

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER -- BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER -- CLARIS LIFESCIENCES LTD

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER -- HOSPIRA INC

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER -- TEVA PARENTERAL MEDICINES INC

CIPRO XR -- BAYER HEALTHCARE PHARMACEUTICALS INC

CIPROFLOXACIN EXTENDED RELEASE -- ANCHEN PHARMACEUTICALS INC

CIPROFLOXACIN EXTENDED RELEASE -- DR REDDYS LABORATORIES LTD

CIPROFLOXACIN EXTENDED RELEASE -- MYLAN PHARMACEUTICALS INC

CIPROFLOXACIN EXTENDED RELEASE -- SANDOZ INC

CIPRODEX -- ALCON INC