72 Agege Motor Road, Alakara, Mushin.
Tel: 01-81507361, 2663986, 234-8033018912, 08033054541
Dexcel Ltd, A Dexon Company, Or-Akiva, P.O.B. 50, Hadera 38100, Israel.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Caplet (NRN: 04-7067): Ofloxacin 200 mg
Pack size: 10's
Ofloxacin is a quinolone antimicrobial agent. The mechanism of action of Ofloxacin and other fluoroquinolone antimicrobials involves inhibition of bacterial topoisomerase IV and DNA gyrase (both of which are type II topoisomerases), enzymes required for DNA replication, transcription, repair and recombination.
Ofloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. Ofloxacin is often bactericidal at concentrations equal to or slightly greater than inhibitory concentrations.
Fluoroquinolones, including Ofloxacin, differ in chemical structure and mode of action from aminoglycosides, macrolides and β-lactam antibiotics, including penicillins. Fluoroquinolones may, therefore, be active against bacteria resistant to these antimicrobials.
For the treatment of bacterial infections, if these are due to Ofloxacin-sensitive pathogens. Infections of the respiratory tract including ear, nose and throat.
Infections of the kidney, urinary tract and genital organs, gonorrhoea. Infections of soft tissue and skin.
Hypersensitivity to ofloxacin or quinolones; pregnancy or breast-feeding; epileptics and patients suffering from convulsions; patients with pre-existing CNS lesions, or stroke.
Do not use this medicine in children or adolescents up to 18 years old.
Do not use this drug without consulting your physician if you suffer or have suffered in the past from impaired function of the liver, kidney, blood vessels or nervous system, if you are sensitive to certain food or drugs, inform your physician.
Use of this medicine may impair alertness. Caution should thereford be exercised when engaging in activities such as driving a car, operating dangerous machinery and in any othet activity which requires mental alertness.
Do not drink alcohol while under treatment with this drug. Patients who are being treated with Oflodex should not expose themselves unnecessarily to strong sunlight and should avoid UV rays (solarium)
If Oflodex is given for more than 2 weeks, blood, kidney and liver tests should be performed.
Notify your doctor in case of combination with medicines against hyperacidity of the stomach, sucralfate, didanosine (for AIDS) in chewable tablets or powder, iron or zinc preparations. In such cases Oflodex should be taken 2 hours before taking these preparations in order to avoid an attenuation of the Oflodex effect. The effect of coumarin derivatives may be intestified when taken concomitantly with Oflodex. It is recommended for those patients to be carefully monitored.
If used concomitantly with Theophylline, glibenclamide or other antidiabetic drugs, a possible rise of these drug levels in serum may occur.
In addition to the desired effect of the drug, some side effects may appear such as: stomach upsets, loss of appetite, nausea, vomiting, diarrhoea, headache, dizziness, sleep disorders, restlessness, confusion, acceleration of heartbeat (tachycardia), temporary decrease in blood pressure, cutaneous and mucosal reactions, itching and skin rashes, sweating and a possible porphyria attack. Fungal growth may be increased due to antibiotics treatment.
Side effects requiring special attention: In cases of severe, persistent diarrhoea, the possibility of pseudomembranous colitis should be considered. Discontinue treatment and refer immediately to your physician. Drowsiness, disorders of muscular coordination, convulsions, numbness and tingling (paraesthesiae), visual disorders (blurred vision, double vision, abnormal color vision), disorders of taste and smell, hearing disorders (noise in the ears), equilibrium disorders, circulatory collapse (due to decrease in blood pressure): rare, refer immediately to your physician. Psychotic reactions (anxiety, vivid dreaming sometimes amounting to nightmares, agitation, depression, hallucinations sometimes progressing to self-endangering behaviour), very rare: (in some instances, such reactions have occurred even after the first dose): discontinue treatment and refer immediately to your physician.
Reduction in the number of red and white blood cells, platelets, bone marrow depression, haemolytic anemia, impairment of liver function, increased blood levels of hepatic enzymes and bile pigments with jaundice, liver inflammation (hepatitis), impairment of renal function, (increase in creatinine level in the blood), acute allergic inflammation of the kidney (intestitial nephriritis): very rare, discontinue treatment and refer immediately to your physician. Reddening of the skin accompanied by heat sensations, vasculitis (sometimes with bleeding under the skin), erythema multiforme, Lyell's syndrome, haemorrhagic bullae: very rare, discontinue treatment and refer immediately to your physician.
Hypersensitivity to light, fever, allergic inflammation of the lungs (pneumonitis): very rare, discontinue treatment and refer to your physician. Anaphylactoid reactions (sometimes even after the first dose), which manifest in a rise in blood pressure, burning sensation in the eyes, tickling, nasal catarrh, swelling of the skin and mucous membrane, swelling of the face, tongue and larynx, difficulty in breathing, circulatory collapse, shock, very rare, discontinue treatment and refer to your physician in order to get immediate medical treatment.
Weakness (of special significance in patients with myasthenia gravis), muscle and joint pains, very rare, discontinue treatment and refer to your physician. Inflammation and rupture of Achilles tendon, very rare, but may occur during treatment with quinolones, and particularly in patients treated concomitantly with corticosteroids: discontinue treatment and refer to your physician. In patients with diabetes mellitus, changes in blood-sugar level may occur rarely, refer to your physician. Except in very rare instances (isolated cases of smell, taste and hearing disorders), the adverse effects observed subsided after discontinuation of Oflodex.
Dosage & Administration
According to physician's instructions only. The dosage range: 200-800 mg a day.
A dose of up to 400 mg a day can be taken once daily preferably in the morning. Higher doses should be divided to twice daily, morning and evening. The duration of treatment should not exceed 8 weeks.
In patients with impaired kidney or renal function, the physician will adjust the dosage according to their condition.
Directions for use: Oflodex should be swallowed whole, unchewed, with some liquid. It is recommended to take the medication on an empty stomach with some liquid.
Treatment should be continued for at least 3 days after the body temperature has returned to normal and the symptoms have subsided. Duration of treatment according to the physician and clinical picture. This drug should be taken at specified intervals as per the physician's directions and the full treatment should be completed.
Missed dose: If you have forgotten to take the medicine at the specified time, take a dose the moment you realize this but you should by no means take two doses at the same time. Do not discontinue therapy even condition improves, unless directed by your physician.
Store in a cool place.