Oflicin

Company Name: Memphis Company for Pharm. and Chem. Ind.

Trade Name: Oflicin Film Coated Tablets

Generic Name: Ofloxacin

Composition:
Each tablet contains:
Ofloxacin 200 mg
Microcrystalline cellulose PH101 (Avicel PH101) 152 mg
Croscarmellose sodium (Ac-di-sol)  20 mg
Maize starch 20 mg
Talc  3 mg
Magnesium stearate 5 mg
Film coat per tablet:
Eudragit L100 5 mg
Equivalent to Eudragit L12. 5 40 mg
Castor oil  0.7 mg
Ethyl alcohol 0.01 ml

 
Pharmaceutical Form: Film coated tablets

Pharmacological Actions:
Mechanism of action:
Oflicin tablets contain ofloxacin, a fluorinated carboxy quinolone. Ofloxacin exerts its action on susceptible microorganisms by inhibiting DNA gyrase which is a critical catalyst in the duplication, transcription and repair of bacterial DNA.

Pharmacokinetics:
Following oral administration of Oflicin, maximum serum concentrations are achieved after one to two hours and its bioavailability is 98%. The amount of the drug absorbed increases, proportionally with the dose. Elimination is mainly by renal excretion, clearance is reduced in patients with impaired renal function.

Indications:
-    Oflicin tablets are indicated for the treatment of adults with mild to moderate infections of:-
-    Uncomplicated skin and skin structure infections due to staphylococcus aureus, streptococcus pyogenes or proteus mirabilis.
-    Acute bacterial exacerbation of chronic bronchitis or community acquired pneumonia due to Haemophilus influenza or streptococcus pneumonia.
-    Mixed infections of the urethra and cervix due to Neisseria gonorrhoeae and chlamydia trachomatis.
-    Acute, uncomplicated urethral and cervical gonorrhoeae due to Neisseria gonorrhoeae.
-    Nongonococcal urethritis and cervicitis due to chlamydia trachomatis.
-    Acute pelvic inflammatory disease (including severe infection) due to chlamydia trachomatis and/or Neisseria gonorrhoeae.
-    Complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter diversus or Pseudomonas aeruginosa.
-    Uncomplicated cystitis due to Citrobacter diversus, Enterobacter aerogenes Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or  Pseudomonas aeruginosa .
-    Prostatitis due to E. Coli.

Dosage and Administration:
-    The usual dose of Oflicin is 200 mg to 400 mg every 12 hours.

Patients with normal renal function:

Infection Unit Dose Frequency Duration Daily Dose

Acute Bacterial Exacerbation of Chronic Bronchitis

 400 mg  every 12 hours 10 days 800 mg
Community Acquired Pneumonia  400 mg  every 12 hours 10 days 800 mg
Uncomplicated Skin and Skin Structure Infections  400 mg every 12 hours 10 days 800 mg
Acute, Uncomplicated Urethral and Cervical Gonorrhea  400 mg  single dose  1 day 400 mg
Nongoncoccal Cervicitis / Urethritis due to C. trachomatis  300 mg  every 12 hours  7 days 600 mg
Mixed Infection of the urethra and cervix due to C. trachomatis and N. gonorrheae  300 mg  every 12 hours  7 days 600 mg
Acute Pelvic Inflammatory disease  400 mg  every 12 hours 10-14 days 800 mg
Uncomplicated Cystitis due to E. coli or K. pneumoniae  200 mg  every 12 hours 3 days 400 mg
Uncomplicated cystitis due to other approved pathogens  200 mg  every 12 hours 7 days 400 mg
Complicated UTI's  200 mg  every 12 hours 10 days 400 mg
Prostatitis due to E. coli  300 mg  every 12 hours 6 weeks 600 mg

-The dose should be adjusted for patients with altered renal function or severe liver function disorders.

Patients with Impaired Renal Function:
- Dosage should be adjusted for patients with a creatinine clearance < 50 ml/min.

- After a normal initial dose, dosage should be adjusted as follows:

Creatinine clearance Maintenance dose Frequency
20 – 50 ml/min the usual recommended unit dose every 24 hours
< 20 ml / min half the usual recommended unit dose every 24 hours

       
Patients with cirrhosis:
The excretion of Oflicin may be reduced in patients with severe liver function disorders (e.g. cirrhosis with or without ascitis).
A maximum dose of 400 mg of Oflicin per day should therefore not be exceeded.

Contraindications:
Oflicin tablets are contraindicated in persons with a history of hypersensitivity to ofloxacin or members of the quinolone group of antimicrobial agents.

Side effects:
Some of the following side effects may occur in some cases:
Cardiovascular system: Tachycardia, hypotension.

Endocrine/Metabolic: Hyper-or hypoglycemia, especially in diabetic patients on insulin or oral hypoglycemic agents.

Gastrointestinal system:
Hepatic dysfunction including: Jaundice, hepatitis, pseudomembranous colitis.

Genital/Reproductive system: Vaginal candidiasis.

Hematopoietic: Anemia, agranulocytosis, leukopenia, thrombocytopenia.

Musculoskeletal: Tendinitis/rupture, weakness.

Nervous system: Agitation, restlessness, peripheral neuropathy, ataxia.

Respiratory system: Bronchospasm.

Skin/Hypersensitivity: Anaphylactic reactions, exfoliative dermatitis, conjunctivitis, photosensitivity.

Special senses: Blurred vision.

Urinary system: Renal calculi, hematuria.

Laboratory:
Serum chemistry: Elevation of serum triglycerides/serum cholesterol, liver function tests.

Urinary: Albuminuria.

Drug interactions:
-    Administration of antacids containing calcium, magnesuim or aluminuim, sucralfate, multivitamins or metal cations with Oflicin may interfere with its absorption. These agents should not be taken within the two-hour period before or after Oflicin administration.
-    Most quinolone antimicrobial drugs inhibit cytochrome P450 enzyme activity. This may result in a prolong half-life for some drugs that are also metabolized by this system.
-    The concomitant administration of a non –steroidal anti- inflammatory drug with Oflicin may increase the risk of CNS stimulation and convulsive seizures.
-    Concomitant administartion of Oflicin with theophylline may prolong the half–life of theophylline, elevate serum theophylline levels and increase the risk of theophylline-related adverse reactions.
-    Oflicin have been reported to enhance the effects of the oral anticoagulant warfarin.
-    Since disturbances of blood glucose, including hyperglycemia and hypoglycemia have been reported, careful monitoring of blood glucose is recommended when antidiabetic agents are used concomitantly with Oflicin.

Precautions & warnings:
- The safety and efficacy of Oflicin in children and adolescents (under the age of 18 years), pregnant women and lactating women have not been established.
- Serious hypersensitivity reactions such as fever, rash, renal or hepatic failure, anemia or thrombocytopenia, hypotension, angioedema and air way  obstruction have been reported with Oflicin. Some reactions were accompanied by cardiovascular collapse, shock, seizure, loss of consciousness, tingling, dyspnea, urticaria/hives, itching and other serious skin reactions. The drug should be discontinued immediately at the first appearance of a skin rash.
- Oflicin may cause central nervous system stimulation which leads to tremors, agitation, anxiety, confusion, hallucinations, paranoia, depression, nightmares and insomnia.
- Oflicin should be used with caution in patients with a known or suspected CNS disorder that may predispose to seizures, severe cerebral arteriosclerosis and epilepsy.
- Pseudomembranous colitis has been reported with Oflicin and may range in severity from mild to life-threatening.
- Convulsions, increased intracranial pressure and toxic psychosis have been reported in patients receiving Oflicin.
- Ruptures of the shoulder, hand and Achilles tendons have been reported with oflicin.

•    Adequate hydration of patients receiving Oflicin should be maintained to prevent the formation of a highly concentrated urine.
•    Oflicin is administered with caution in the presence of renal or hepatic insufficiency. In patients with impaired renal function, alteration of the dosage regimen is necessary.
•    Moderate to severe phototoxicity reactions have been reported with Oflicin in patients exposed to direct sunlight. So excessive sunlight should be avoided.
•    A possible interaction between oral hypoglycemic drugs or with insulin resulting in a potentiation of the hypoglycemic action of these drugs.

Overdosage:
In the event of an acute overdose, the stomach should be emptied.
The patient should be observed and appropriate hydration maintained.

Therapeutic category: Antibacterial agent.

Legal category: POM

Package:
Box of 10 tablets in 2 blisters.

Storage:
Store at a temperature not exceeding 30° C in a dry place, protect from light.

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.