CIPREC

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Category
Quinolone Antibiotic
Type
General Anaesthetic
Package
Box of 2 strips @ 10 caplets
Reg. No. : DKL0632400909A1
Composition
Ciprofloxacin Hydrochloride equivalent to Ciprofloxacin 500 mg
Indication
CIPREC® is indicated for the treatment of infections caused by susceptible microorganisms to Ciprofloxacin :
- Urinary tract infections, including prostatitis.
- Urethritis and cervicitis gonorrhoeae.
- Gastro-intestinal infections, including typhoid fever caused by Salmonella typhi. The efficacy of Ciprofloxacin in the eradication of the chronic thyphoid carrier state has not been demonstrated.
Respiratory tract infections, except pneumonia caused by Streptococcus pneumoniae.
- Skin and soft tissue infections.
- Bone and joint infections.
Dossage
Adults :
- Mild/moderate urinary tract infections : 250 mg twice daily.
- Severe urinary tract infections : 500 mg twice daily.
- Mild/moderate respiratory, bone, joint, skin, soft tissue infections : 250 to 500 mg twice daily.
- Severe respiratory, bone, joint, skin, soft tissue infections : 500 to 750 mg twice daily.
- Chronic prostatitis : 500 mg twice daily.
- Gastrointestinal infections : 500 mg twice daily.
- Acute gonorrhoea : a single dose of 250 mg.
- To achieve the adequate dose in acute osteomyelitis, dose not less than 750 mg twice daily.

Precaution
- Effects on gastro-intestinal
Nausea, vomiting, diarrhoea, gastro-intestinal disturbance, dyspepsia, abdominal pain, flatulence, anorexia, dysphagia. Consult to medical immediately if severe diarrhea occur or persistent during or after treatment, because this symptoms may cover the seriously disorders (pseudomembranous colitis) that need immediately action. If these occur, administration of Ciprofloxacin should be discontinued and change with other suitable drugs (ex. Vancomycin per oral, 250 mg tablet, 4 times daily). The inhibitor peristalsis drugs are contra-indicated to Ciprofloxacin.
- Effects on central nervous system
Dizziness, headache, weakness, insomia, agitation, tremor. Very rarely : peripheral paralgesia, sweating, seizure, anxiety, nightmares, confusion, depression, hallucinations, impaired taste and smell, disturbed vision (e.g. double vision, change in color perception. Those reactions occurred after taking Ciprofloxacin for the first time. In this case, Ciprofloxacin should be discontinued and consult to medical immediately.
- Hypersensitivity reactions
Skin reactions, e.g. rash, pruritus, drugs fever. Anaphylactic / anaphylactoid reactions (e.g. edema of the face, vascular and larynx, severe dyspnea to dangerous shock). In this case, treatment with Ciprofloxacin should be discontinued, medical emergency action (ex. shock treatment) should be done immediately.
- Effects on renal/urogenital
Interstitial nephritis, renal failure, transient renal failure, polyuria, urinary retention, urethral bleeding, vaginitis and acidosis.
- Effects on hepatic
Hepatitis, very rarely : liver disorders including hepatic necrosis.
- Effects on cardiovascular system
Rarely : tachycardia, palpitation, atrial flutter, ventricular ectopy, syncope, hypertension, angina pectoris, myocardial infarction, cardiopulmonary arrest, cerebral thrombosis, rash of face, migraine.
- Other adverse reactions
Rarely : joint pain, malaise, musculoskeletal pain, tendovaginitis, mild photosensitivity, tinnitus, impairment of hearing particularly at high frequencies, epistaxis, laryngeal or pulmonary edema, hemoptysis, dyspnea, bronchospasm, pulmonary embolism.
- Effects on hematologics
Eosinophilia, leucopenia, leucocytosis, anemia, granulocytopenia.
Very rarely : thrombocytopenia, thrombocytosis, altered prothrombin levels.
- Effect on laboratory results / urine deposit
Plasma levels of transaminase and alkaly phosphatase may increase temporary; cholestic icterus may occur particularly in patients who disorder experienced; increase of urea, creatinine & bilirubin levels transiently; hyperglycemia; in certain case : crystalluria and hematuria.
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FLOXACAP

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Category
Quinolone Antibiotic
Type
Quinolones
Package
FLOXACAP® Film-Coated Tablet
Box of 3 strips @ 6 tablets.
Reg. No.: DKL0932403317A1

FLOXACAP® Infusion
Softbag with net contents 100 mL.
Reg. No.: DKL1032405449A1
Composition
FLOXACAP® Film-Coated Tablet
Each film-coated tablet contains :
Levofloxacin Hemihydrate equivalent to 500 mg of Levofloxacin.

FLOXACAP® Infusion
Each 100 mL solution contains:
Levofloxacin Hemihydrate equivalent to Anhydrous Levofloxacin 50 mg
Water for injection ad 100 mL
Osmolarity: 290 mOsm/L
Indication
Treatment for patients = 18 years of age of the following infections due to Levofloxacin susceptible microorganisms:
- Acute maxillary sinusitis.
- Acute exacerbation of chronic bronchitis.
- Community-acquired pneumonia.
- Complicated urinary tract infection including mild to moderate pyelonephritis.
- Uncomplicated skin and skin structure infections (mild to moderate).
- Levofloxacin i.v. is only given to the patients who are unable to tolerate the oral dosage form.
Dossage
Dosage :
Oral
Common dose are 250 - 500 mg once daily (every 24 hour) in patients with normal renal functions (creatinine clearance > 80 mL/minute). Duration of administration between 7 - 14 days (depends on the level of infection).
Precaution
- If hypersensitivity reactions (skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, swelling of the lips, tongue, face, tightness of the throat, hoarseness) or other symptoms of allergy occur, the drug should be discontinued.
- Should be used with caution in patients with renal insufficiency (creatinine clearance < 50 mL/minute), adjustment of the dosage regimen is necessary to avoid the accumulation of Levofloxacin.
- Observe caution while operating an automobile or machinery or performing other tasks requiring coordination.
- Discontinue treatment and inform their physician if they experience pain, inflammation, or rupture of a tendon.
- Avoid excessive sunlight while receiving Levofloxacin and discontinue therapy if phototoxicity occurs.
- Diabetic patients which being treated with insulin or an oral antidiabetic agent and hypoglycemic reaction occurs, they should discontinue Levofloxacin and consult a physician.
- Should be used with caution in any patient with a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold (e.g. severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizures threshold.
- Convulsion and toxic psychoses have been reported in patients receiving quinolones (including Levofloxacin). Quinolones may also cause increase intracranial pressure and central nervous system stimulation which may lead to restlessness, lightheadedness, tremors, hallucinations, depression, paranoia and nightmares. If these reactions occur, the drug should be discontinued.
- Serious and fatal hypersensitivity reactions often occur following the first dose. Some reactions have been accompanied by urticaria, itching and other serious skin reactions, dyspnea, respiratory obstruction, angioedema, hypotension, shock and cardiovascular collapse. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
- Treatment with antibacterial agents (including Levofloxacin) alters the normal flora of the colon and may cause overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of colitis.
- Pseudomembranous colitis has been reported with nearly all antibacterial agents (including Levofloxacin), and may range in severity from mild to life threatening. Therefore, it is importantto consider this diagnosis in patients who present with diarrhea subsequent to the administration of any other antibacterial agent.
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