ROXITHROMYCIN-ARX roxithromycin 300 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

roxithromycin, Quantity: 300 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: glucose; propylene glycol; colloidal anhydrous silica; hyprolose; maize starch; povidone; hypromellose; magnesium stearate; titanium dioxide; purified talc

Administration route:

Oral

Units in package:

5 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults: Roxithromycin is indicated for the treatment of the following types of mild to moderately severe infections in adults caused by or likely to be caused by susceptible microorganisms: Upper respiratory tract infection: acute pharyngitis, tonsillitis, and sinusitis. Lower respiratory tract infection: acute bronchitis and acute exacerbation of chronic bronchitis; community acquired pneumonia. Skin and skin structure infections. Nongonococcal urethritis. Children: Roxithromycin 150 mg tablets are indicated for the treatment of the following mild to moderately severe infections in children caused by or likely to be caused by susceptible micro-organisms: Acute pharyngitis. Acute tonsillitis. Impetigo. Appropriate culture and susceptibility tests should be performed when necessary to determine organism susceptibility and thus treatment suitability. Therapy with roxithromycin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

Product summary:

Visual Identification: White to off white round biconvex film-coated tablet plain on both side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2020-05-04