Oflomac (Tablets) Instructions for Use

Marketing Authorization Holder

Macleods Pharmaceuticals Ltd. (India)

ATC Code

J01MA01 (Ofloxacin)

Active Substance

Ofloxacin (Rec.INN registered by WHO)

Dosage Form

Oflomac

Film-coated tablets, 200 mg: 10, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, oval, biconvex.

Excipients: microcrystalline cellulose, lactose, sodium lauryl sulfate, povidone, sodium carboxymethyl starch, crospovidone, colloidal silicon dioxide, purified talc, magnesium stearate.

Shell composition hypromellose, purified talc, titanium dioxide, magnesium stearate, quinoline yellow dye, macrogol 6000, diethyl phthalate.

6 pcs. – blisters (10) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.

Clinical-Pharmacological Group

Antibacterial drug of the fluoroquinolone group

Pharmacotherapeutic Group

Antimicrobial agent – fluoroquinolone

Pharmacological Action

Broad-spectrum antimicrobial agent of the fluoroquinolone group. The bactericidal action of ofloxacin is associated with the blockade of the DNA gyrase enzyme in bacterial cells.

It is highly active against most gram-negative bacteria: Escherichia coli, Salmonella spp., Shigella spp., Proteus spp., Morganella morganii, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Mycoplasma spp., Legionella pneumophila, Acinetobacter spp., and also Chlamydia spp.

Active against some gram-positive microorganisms (including Staphylococcus spp., Streptococcus spp., especially beta-hemolytic streptococci).

Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp. are moderately sensitive to ofloxacin.

Anaerobic bacteria (except Bacteroides urealyticus) are not sensitive to ofloxacin.

Resistant to the action of β-lactamases.

Pharmacokinetics

After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract. Food intake slightly affects the extent of absorption but may slow its rate. C_max in blood plasma is reached after 2 hours.

Protein binding is 25%. Ofloxacin is widely distributed in body tissues and fluids (organs of the urinary system, genital organs, prostate gland, lungs, ENT organs, gallbladder, bones, skin).

It is excreted in the urine unchanged (about 80% in 24 hours). Ofloxacin concentrations in the urine significantly exceeded the MIC₉₀ for most microorganisms after the last dose (300 mg twice daily for 14 days). A small part of the active substance (about 4%) is excreted in the feces. T_1/2 is 6 hours.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to ofloxacin, including: diseases of the lower respiratory tract, ear, throat, nose, skin, soft tissues, bones, joints, infectious and inflammatory diseases of the abdominal organs (except for bacterial enteritis) and pelvis, kidney and urinary tract infections, prostatitis, gonorrhea.

ICD codes

Dosage Regimen

It is set individually, taking into account the severity and localization of the infection, and the sensitivity of the pathogen.

Orally prescribed in a daily dose of 200-800 mg, frequency of administration 2 times/day. For patients with impaired renal function (creatinine clearance 20-50 ml/min) the first dose is 200 mg, then 100 mg every 24 hours. With creatinine clearance less than 20 ml/min, the first dose is 200 mg, then 100 mg every 48 hours.

Adverse Reactions

From the digestive system nausea, vomiting, diarrhea, abdominal pain and cramps, loss of appetite, dry mouth, flatulence, gastrointestinal dysfunction, constipation; rarely – liver dysfunction, liver necrosis, jaundice, hepatitis, intestinal perforation, pseudomembranous colitis, gastrointestinal bleeding, disorders of the oral mucosa, heartburn, increased activity of liver enzymes, including GGT and LDH, increased serum bilirubin level.

From the nervous system insomnia, dizziness, fatigue, drowsiness, nervousness; rarely – convulsions, anxiety, cognitive changes, depression, abnormal dreams, euphoria, hallucinations, paresthesia, syncope, tremor, confusion, nystagmus, suicidal thoughts or attempts, disorientation, psychotic reactions, paranoia, phobia, agitation, aggressiveness, emotional lability, peripheral neuropathy, ataxia, coordination disorders, exacerbation of extrapyramidal disorders, speech disorder.

Allergic reactions skin rash, itching; rarely – angioedema, urticaria, vasculitis, allergic pneumonitis, anaphylactic shock, erythema multiforme, Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, conjunctivitis.

From the reproductive system itching in the external genital area in women, vaginitis, vaginal discharge; rarely – burning, irritation, pain and rash in the genital area in women, dysmenorrhea, menorrhagia, metrorrhagia, vaginal candidiasis.

From the cardiovascular system rarely – cardiac arrest, edema, arterial hypertension, arterial hypotension, palpitation, vasodilation, cerebral thrombosis, pulmonary edema, tachycardia.

From the urinary system rarely – dysuria, frequent urination, urinary retention, anuria, polyuria, kidney stone formation, renal failure, nephritis, hematuria, albuminuria, candiduria.

From the musculoskeletal system rarely – arthralgia, myalgia, tendinitis, muscle weakness, exacerbation of myasthenia.

From metabolism rarely – thirst, weight loss, hyper- or hypoglycemia (especially in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents), acidosis, increase in serum triglycerides, cholesterol, potassium.

From the respiratory system rarely – cough, nasal discharge, respiratory arrest, dyspnea, bronchospasm, stridor.

From the senses rarely – hearing impairment, tinnitus, diplopia, nystagmus, impaired visual acuity, taste and smell disorders, photophobia.

Dermatological reactions rarely – photosensitivity, hyperpigmentation, vesiculobullous eruptions.

From the hematopoietic system rarely – anemia, bleeding, pancytopenia, agranulocytosis, leukopenia, reversible bone marrow depression, thrombocytopenia, thrombocytopenic purpura, petechiae, ecchymoses, increased prothrombin time.

Other chest pain, pharyngitis, increased body temperature, body aches; rarely – asthenia, chills, general malaise, nosebleed, increased sweating.

Contraindications

Hypersensitivity to ofloxacin or other quinolone derivatives; tendon damage during previous treatment with fluoroquinolones, epilepsy (including history), lowered seizure threshold, chronic renal failure (creatinine clearance <50 ml/min); pregnancy, breastfeeding period; children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Should be used with caution in patients with impaired liver function. Do not exceed the daily dose of 400 mg.

Use in Renal Impairment

Should be used with caution in patients with impaired renal function.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

In elderly patients, it should be used with caution, taking into account the state of renal function.

Special Precautions

During treatment, blood glucose levels should be monitored. During long-term therapy, renal and liver functions, and peripheral blood picture should be periodically monitored.

When using ofloxacin, adequate hydration of the body should be ensured, and the patient should not be exposed to UV radiation.

In experimental studies, no mutagenic potential was identified. Long-term studies to determine the carcinogenicity of ofloxacin have not been conducted.

In studies on young animals of several species, Ofloxacin caused arthropathy and osteochondrosis.

The safety and efficacy of the drug in children and adolescents under 18 years of age have not been established.

Effect on ability to drive vehicles and mechanisms

During the use of the drug, patients should exercise caution when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use with antacids containing calcium, magnesium or aluminum, with sucralfate, with preparations containing divalent and trivalent cations such as iron, or with multivitamins containing zinc, impaired absorption of quinolones is possible, leading to a decrease in their concentration in the body. These drugs should not be used within 2 hours before or within 2 hours after taking ofloxacin.

With simultaneous use of ofloxacin and NSAIDs, the risk of developing a stimulating effect on the central nervous system and convulsions increases.

With simultaneous use with theophylline, an increase in its plasma concentration (including at steady state) and an increase in T_1/2 are possible. This increases the risk of adverse reactions associated with the action of theophylline.

With simultaneous use of ofloxacin with beta-lactam antibiotics, aminoglycosides and metronidazole, an additive interaction was noted.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.