COMPOSITION :
Ciprofloxacin HCl Monohydrate Film coated tablet 500 mg, each film coated tablet contains : Ciprofloxacin HCl monohydrate equivalent to Ciprofloxacin 500 mg.
DESCRIPTIONS :
Ciprofloxacin HCl Monohydrate with active ingredient Ciprofloxacin HCl monohydrate (equivalent to Ciprofloxacin) available in 500 mg film coated tablet.
INDICATIONS :
Infections caused by Ciprofloxacin sensitive bacteria such as :
- Urinary tract infections, including prostatitis.
- Urethritis and gonorrheal cervicitis.
- Gastrointestinal tract infections including thypoid fever caused by S. thypii. An eradication effect of Ciprofloxacin in chronic thypoid carrier still unknown.
- Respiratory tract infections except pneumonia caused by streptococcus.
- Skin and soft tissue infections.
- Bones and joints infections.
DOSAGE AND ADMINISTRATIONS :
Adults :
- Mild/moderate urinary tract infections : 2 x 250 mg daily.
- Severe urinary tract infections : 2 x 500 mg daily.
- Mild/moderate respiratory tract infections, bone and joints, skin and soft tissue infections : 2 x 250 – 500 mg daily.
- Severe respiratory tract infections, bone and joints, skin and soft tissue infections : 2 x 500 – 750 mg daily.
- Chronic prostatitis : 2 x 500 mg.
- Gastrointestinal infections : 2 x 500 mg daily.
- Acute gonorrhoeae : 250 mg as single dose.
- To achieve an adequate serum level in acute osteomyelitis, the administration dose should not be less than 2 x 750 mg daily.
Duration of therapy depends on the severity of infection, clinical improvement and bacteriological. In acute infections, the duration of therapy is usually 5 – 10 days. It is recommended to continue the course of treatment for at least 3 days after symptoms have been reduced or have disappeared.
Dosage for renal impairment :
If creatinine clearance < 20 ml/minute, the normal daily recommended dose should be given only once or each dose should be halved if given twice a day.
CONTRAINDICATIONS :
Ciprofloxacin is contraindicated for :
- Patients with hypersensitivity to Ciprofloxacin or other Quinolone derivatives.
- Pregnancy and lactation.
- Children under 12 years old.
WARNINGS AND PRECAUTIONS :
- Ciprofloxacin should be swallowed whole with adequate amount of plain water to prevent crystalluria.
- Caution should be exercised in patients with renal impairment (lihat DOSAGE AND ADMINISTRATIONS).
- The administered dose should not exceed the recommended dose.
- Ciprofloxacin should be given carefully in elderly patients.
- In case of epilepsy and in patients with history of CNS disorders (e.g., low-threshold of seizure, history of convulsion, lower blood circulation to brain and stroke), Ciprofloxacin should only be given if the potential benefits exceed potential risks, since these patients are endangered of possible central nervous side effects.
- Despite usage as prescribed by the physicians, this drug may influence patients response in ability to drive and operate machinery. This condition will be more severe if this drug is used concomitantly with alcohol.
- Like other antimicrobial agents, prolonged use of Ciprofloxacin may cause overgrowth of non-susceptible microorganisms.
- Excessive sunlight exposure should be avoided. Treatment should be discontinued if photosensitivity occcurs.
DRUG INTERACTIONS :
- Aluminium or Magnesium Hydroxide-containing antacids may reduce the absorption of Ciprofloxacin. Therefore, Ciprofloxacin should be taken 1 – 2 hours before or at least 4 hours after the administration of antacids. This restriction does not apply to antacids which is not containing Aluminium or Magnesium hydroxide.
- The concomittant administration of Ciprofloxacin with Theophylline may increase plasma Theophylline levels, causing side effects of Theophylline. If this combination treatment cannot be avoided, plasma Theophylline level should be monitored and the dosage of Theophylline should be reduced. If Theophylline level cannot be monitored, the administration of Ciprofloxacin should be avoided.
- The elevation of serum creatinine level is temporary observed in concomitant administration of Ciprofloxacin with Cyclosporine. In this case, serum creatinine level should be frequently monitored (twice a week).
- Any possibility of interaction in concomitant administration of Ciprofloxacin with Probenecid should be considered.
- Concomittant administration of Ciprofloxacin and oral anticoagulants may elongate bleeding time.
- Concomittant administration of Ciprofloxacin with Metoclopramide may accelerate the absorption of Ciprofloxacin.
ADVERSE REACTIONS :
- Gastrointestinal effects :
Nausea, diarrhea, vomiting, gastrointestinal disorders, dyspepsia, abdominal pain, flatulence, anorexia, disphagia. If severe diarrhea are persistent during or after treatment, patient should contact their healthcare provider because those symptoms maybe cover up the others serious illness (pseudomembranous colitis) which need emergency measure. In this case Ciprofloxacin should be discontinued and regarding changing to another drugs which more appropriates (such as Vancomycin peroral 4 x 250 mg daily). Drugs which inhibiting peristaltic are contraindicated.
- Nervous system effects :
Dizziness, headache, tiredness, insomnia, agitation and tremor.
Very rarely : Peripheral paralgesia, sweating, convulsions, anxiety states, nightmares, confusion, depression, hallucinations, impaired taste and smell, visual disturbances, (e.g., double vision, color vision). This reaction sometimes appear after the first use of Ciprofloxacin. In this case, Ciprofloxacin has to be discontinued and patient should contact their healthcare provider.
- Hipersensitivity reactions :
Skin reactions i.e., skin redness, pruritus, drug fever. Anaphylaxis/anaphylactoid reactions (e.g., facial edema, vascular and larynx, dyspnea which is more severe leading to life-threatening shock). In this case, Ciprofloxacin should be discontinued and medical emergency measures (e.g., rising shock) to have to be done immediately.
- Renal/urogenital effects :
Interstitial nephritis, kidney failure including trancient kidney failure, polyuria, urinary retention, urethal bleeding, vaginitis and acidosis.
- Liver effects :
Hepatitis, very rare : Extensive liver disorders, e.g., liver necrosis.
- Cardiovascular effects :
Rare : Tachycardia, palpitation, atrial flutter, ventricular ectopi, syncope, hypertension angina pectoris, infark myocardial, cardiopulmonary arrest, cerebral thrombosis, hot flushes, migraine and collapse.
- Haematological effects :
Eosinophilia, leukocytopenia, leukocytosis, anaemia, granulocytopenia. Very rare : Thrombocytopenia, thrombocytosis, prothrombin disorder.
- Effects on laboratory parameter/urinary sediments :
Transaminase and Alkaline Phosphatase concentration in blood may be temporarily increased; cholestatic icterus may occur mainly in patient which suspected; increasing Urea concentration, creatinine and bilirubin may be transiently increased; hyperglycemia; In individual cases : Crystalluria and haematuria.
- Others :
Rare : Joint pain, general feeling of weakness, muscular pains, tendovaginitis, mild photosensitivity, tinnitus, hearing disturbances especially to high frequency, epistaxis, laryngeal or pulmonary edema, haemoptysis, dyspnea, bronchospasm and pulmonary embolism.
PRESENTATION :
Ciprofloxacin HCl Monohydrate Film coated tablet 500 mg
Box, 10 blisters @ 10 film coated tablets Reg. No. GKL0202332317A1
STORAGE :
STORE BELOW 30°C, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
