Salton Pharmaceuticals Ltd.
Saflox is indicated for Cystic fibrosis, Intra-abdominal infections, Meningitis, Peritonitis, Endocarditis, Anthrax, Otitis media, Septicaemia, Lower Respiratory Tract Infections, Cystitis, Gonorrhoea, Skin and skin structure infections, Nosocomial pneumonia, Urinary tract infections, Enteric fever, Bone and Joint Infections, Biliary tract infections, Surgical Prophylaxis, Gastroenteritis, Q fever, Acute Sinusitis, Cat scratch disease, Spotted fever, Typhus, Chanroid, Brucellosis, Typhoid and paratyphoid fever, Superficial ophthalmic infections, Otitis externa
Precautions and warnings
Epilepsy, history of CNS disorders; severe renal or hepatic dysfunction; G6PD deficiency; maintain adequate hydration; myasthaenia gravis. Caution when used in patients with QT prolongation or risk factors e.g. bradycardia, pre-existing cardiac disease or uncorrected electrolyte disturbances. Discontinue treatment if patients experience tendon pain, inflammation or rupture. Avoid usage in methicillin-resistant staphylococcus aureus (MRSA) infections due to high level of resistance. May impair ability to drive or operate machinery. Safety and efficacy have not been established in pregnant and lactating women. Not to be used in children
GI disturbances; headache, tremor, confusion, convulsions; rashes; joint pain; phototoxicity. Transient increases in serum creatinine. Haematological, hepatic and renal disturbances. Vasculitis, pseudomembranous colitis and tachycardia. Phototoxicity.
Potentially Fatal: Anaphylactoid reaction; cardiopulmonary arrest.
May increase plasma concentrations of CYP1A2 substrates (e.g. clozapine, ropinirole, theophylline). Enhances effect of oral anticoagulants (e.g. warfarin) and glibenclamide. Increased toxicity of methotrexate. Plasma concentrations may be increased by probenecid. Reduced absorption w/ oral multivitamins and mineral supplements containing divalent or trivalent cations (e.g. Fe, Zn, Ca) and antacids containing Al, Ca or Mg. Concomitant use w/ class IA antiarrhythmics (e.g. quinidine, procainamide), class III antiarrhythmics (e.g. amiodarone, sotalol), TCAs, macrolides and antipsychotics may result in additive effects on QT interval prolongation. Concurrent use w/ corticosteroids may increase risk of severe tendon disorders. Increased risk of CNS stimulation w/ NSAIDs. Altered serum concentrations of phenytoin.
Potentially Fatal: Marked elevation in serum levels of tizanidine which is associated w/ potentiated hypotensive and sedative effect.
Hypersensitivity. Not to be used concurrently with tizanidine. Avoid exposure to strong sunlight or sun lamps during treatment.
Mode of actions
Ciprofloxacin promotes breakage of double-stranded DNA in susceptible organisms and inhibits DNA gyrase, which is essential in reproduction of bacterial DNA.
Dosage & Administration
Adult Dose: For oral dosage & suspension: Urinary Tract infection: Acute uncomplicated: 250 mg twice daily for 3 days; Mild/Moderate: 250 mg twice daily for 7 to 14 days; Severe/Complicated: 500 mg twice daily for 7 to 14 days;
Chronic Bacterial Prostitis : 500 mg twice daily for 28 days;
Lower Respiratory Tract infection: Mild/Moderate: 500 mg twice daily for 7 to 14 days, Severe/Complicated : 750 mg twice daily for 7 to 14 days;
Acute Sinusitis : 500 mg twice daily for 10 days; Skin and Skin Structure infection: Mild/Moderate : 500 mg twice daily for 7 to 14 days, Severe/Complicated : 750 mg twice daily for 7 to 14 days,
Bone and joint infection: Mild/Moderate 500 mg twice daily for 4 to 6 weeks, Severe/Complicated : 750 mg twice daily for 4 to 6 weeks,
Intra Abdominal Infection: 500 mg twice daily for 7 to 14 days, Infectious Diarrhea: Mild/Moderate/Severe: 500 mg twice daily for 5 to 7 days, Typhoid Fever : 500 mg twice daily for 10 days,
Urethral & Cervical Gonococcal Infections: Uncomplicated: 250 mg Single dose.
For IV infusion : Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days;Severe or Complicated: 400 mg 12 hourly for 7-14 days;
Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days; Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days;
Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days; Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Comlicated: 400 mg 8 hourly for more than 4-6weeks;
Intra abdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days; Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for10 days:
Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.
Children and adolescents: RTI & GI infections: Neonate-15mg/kg twice daily, Child (1 month -18 years)-20mg/kg (max 750 mg) twice daily;
UTI: Neonate-10 mg/kg twice daily, Child (1 month -18 years)-10mg/kg (max 750 mg) twice daily;
Pseudomonal lower respiratory tract infection in cystic fibrosis: Child (1 month -18 years) - 20mg/kg (max 750 mg) twice daily; Anthrax (treatment & post exposure prophylaxis): Child (1 month -18 years) - 20mg/kg (max 750 mg) twice daily.
Pregnancy & Lactation
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks