OFOLIP-OZ Tablet

OFOLIP-OZ

PRESENTATION:
Ofloxacin IP 200 mg
Ornidazole IP 250 mg

PACKING AVAILABLE:
(10 x 10) Alu-Alu


Indications



It is indicated for the treatment of a wide variety of infections caused by susceptible gram +ve and gram -ve organisms along with anaerobes and protozoa:-
⇒ Gynaecological infections including prophylaxis in gynaecological surgeries.
⇒ Surgical prophylaxis and surgical wound infections.
⇒ Respiratory tract infections like lung abscess, aspiration pneumonia, empyema and bronchiectasis.
⇒ ENT infections like chronic sinusitis, chronic suppurative otitis media, cholesteatoma and mastoiditis.
⇒ Orofacial and Dental infections.
⇒ Dermatological infections like cellulitis, breast and other cutaneous abscesses, angrene, diabetic and decubitus ulcers.
⇒ Intra-abdominal infections and diarrhoeas of mixed bacterial and protozoal origin.

Pharmacology



Pharmacodynamics:- This combination has vitro activity against a broad spectrum of gram-positive and gram negative aerobic and anaerobic bacteria. Ofloxacin is thought to exert a bactericidal effect on susceptible microorganisms by inhibiting DNA gyrase, an essential enzyme that is a critical catalyst in the duplication, transcription, and repair of bacterial DNA. Ofloxacin has been shown to be active against most strains of the following microorganisms both in vitro and in specific clinical infections.
Gram-positive Aerobes:- Staphylococcus aureus, Streptococcus pneumoniae, and Streptococcus pyogenes.
Gram-negative Aerobes:- Citrobacter diversus, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Proteus mirabilis, Pseudomonas aeruginosa
Other:- Chlamydia trachomatis. Ornidazole is a 5-nitroimidazole derivative with actions similar to Metronidazole and Tinidazole and is used in the treatment of susceptible Protozoal Infections and also in
Anaerobic Bacterial Infections:- It is effective against Protozoa including Entamoeba histolytica, Giardia lambia and Trichomonas sp and Bacteria such as Bacteriodes spp., Anaerobic cocci, Fusobacterium spp., Clostridum spp., and Gardenerlla vaginalis. It acts by damage of DNA strands or inhibition of their synthesis

Pharmacokinetics:



Both Ofloxacin and Ornidazole are almost completely absorbed from the small intestine when administered orally both having almost 100% bioavailability. Subsequent plasma concentrations of Ofloxacin are obtained in 1-2 hours after oral administration. Peak plasma concentrations of Ornidazole are obtained within 2 hours of administration.The plasma elimination of Ornidazole is 12 to 15 hours and less than 15% is bound to plasma proteins. It is widely distributed in body tissues and fluids. Ornidazole is metabolised in the liver and is excreted in the urine mainly as metabolites and conjugates and to a lesser extent in the faces.

Contraindication



Hypersensitivity to the quinolone group or the nitroimidazole group of compounds and in those patients with a history of blood dyscrasias.

Warning and Precautions



Fluoroquinolones, including ofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently occurs in patients over 60. Ofloxacin should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon.
The drug should be discontinued immediately at the first appearance of skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ofloxacin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colonleading to overgrowth of C. difficile.C. difficile produces toxins A and B which contribute to the development of CDAD.
Prescribing ofloxacin tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Adequate hydration of patients receiving ofloxacin should be maintained to prevent the formation of a highly concentrated urine.

Ornidazole: Caution should be exercised in patients with diseases of the CNS, e.g., epilepsy or multiple sclerosis.

Drug Interactions



Ofloxacin:-

Antacids, Sucralfate, Metal Cations, Multivitamins:-
Quinolones form chelates with alkaline earth and transition metal cations. Administration of quinolones with antacids containing calcium, magnesium, or aluminum, with sucralfate, with divalent or trivalent cations such as iron, or with multivitamins containing zinc These agents should not be taken within the two-hour period before or within the two-hour period after ofloxacin administration.

Cimetidine:- Cimetidine has demonstrated interference with the elimination of some quinolones. This interference has resulted in significant increases in half-life and AUC of some quinolones. The potential for interaction between ofloxacin and cimetidine has not been studied.
Drugs metabolized by Cytochrome P450 enzymes Most quinolone antimicrobial drugs inhibit cytochrome P450 enzyme activity. This may result in a prolonged half-life for some drugs that are also metabolized by this system (e.g., cyclosporine, theophylline/methylxanthines, warfarin) when co-administered with quinolones.
Non-steroidal anti-inflammatory drugs:- The concomitant administration of a non-steroidal anti-inflammatory drug with a quinolone, including ofloxacin, may increase the risk of CNS stimulation and convulsive seizures.
Theophylline:- Steady-state theophylline levels may increase when ofloxacin and theophylline are administered concurrently. As with other quinolones, concomitant administration of ofloxacin may prolong the half-life of theophylline, elevate serum theophylline levels, and
Antidiabetic agents (e.g., insulin, glyburide/glibenclamide):- Since disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concurrently with quinolones and an antidiabetic agent, careful monitoring of blood glucose is recommended when these agents are used concomitantly.

Ornidazole:-

In contrast to other nitroimidazole derivatives, ordinazole does not inhibit aldehyde dehydrogenase and is therefore not incompatible with alcohol. However, ornidazole potentiates the effect of coumarin-type oral anticoagulants.
Pregnancy:- There are, however, no adequate and well-controlled studies in pregnant women.Ofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers:- Because of the potential for serious adverse reactions from ofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
It should not be given to pediatric patients as the safety of the drug is not well established

Side Effects



Nausea, headache, insomnia are the most common side effects associated with the formulation.
Abdominal pain and cramps, chest pain, decreased appetite, dry mouth, dysgeusia, fatigue, flatulence, gastrointestinal distress, nervousness, pharyngitis, pruritus, fever, rash, sleep disorders, somnolence, trunk pain, vaginal discharge, visual disturbances, and constipation.

Over Dosage



Overdosage may develop drowsiness, nausea, dizziness, hot and cold flushes, subjective facial swelling and numbness, slurring of speech, and mild to moderate disorientation. No specific antidote is known. The administration of diazepam is recommended if cramps occur.