Biomeflacine Pefloxacin Tablets 400mg

BIOMEFLACINE 400®
Pefloxacin Tablets 400mg


COMPOSITION

Each Film coated tablet contains:
Pefloxacin Measilate dehydrate BP
eq. to Pefloxacin 400mg
Excipients q.s.

 
PHARMACOLOGICAL CLASSIFICATION

Broad spectrum antibiotics

 
PHARMACOLOGICAL ACTION

Pefloxacin is a quinolones carboxylic acid derivative which has a broad spectrum of antibacterial activity against both Gram-positive and Gram-negative bacteria.

Pefloxacin experts its effects by inhibiting the bacterial DNAgyrase, which is responsible for coiling the genetic material as a prerequisite for bacterial multiplication.

The mode of action, range of activities, duration of action and MIC levels have been established mainly by means of in vitro studies using bacterial isolates.

Pefloxacin is readily absorbed and excreted mainly unchanged in the urine. The serum elimination half-life is approximately 6 to 8 hours.

Following oral administration, pefloxacin peak serum concentrations are reached within one or two hours. The plasma level usually achieved by the recommended dosage regimens (3 to 4 micrograms/mL) is in excess of the average MIC which is 1 to 2 micrograms/mL for susceptible organisms.

Pefloxacin has a low (9.4%) plasma protein binding.

Pefloxacin that are normally resistant are:

Peptococcus, Peptostreptococcus, Eubacterium spp., Fusobacterium spp and Treponema palladium.

 
INDICATIONS

BIOMEFLACINE 400 Tablets are indicated for the treatment of the following bacterial infection, if these are due to Pefloxacin-sensitive pathogens:

(I) Lower respiratory tract infections caused by Haemophilus influenza. Haemophilus parainfluenza, Escherichia coli, Kiebsiella pneumonia, Enterobacter cloacae, Proteus mirabilis and Pseudomoas aeruginosa.

(II) Infection of the urinary tract.

(III) Sexually transmitted disease: Acute uncomplicated urethral gonorrhea, urethritis and cervicilis due to Chlamydia trachomatis. Mixed infections of the urethra and cervix due to Chlamydia trachomatis and Neisseria gonorrhea.

 
CONTRAINDICATIONS

Hypersensitivity to Pefloxacin or related chemotherapeutic agents of the quinolone derivative group.

BIOMEFLACINE-400 Tablets should not be administered to pregnant or lactating women.

BIOMEFLACINE-400 Tablets should not be administered to patients with cerebral convulsive disorders.

BIOMEFLACINE-400 is contra-indicated in epileptics. BIOMEFLACINE-400 must not be used in patients with pre existing central nervous system lesions involving a lowered conversant threshold e.g. after cerebrocraninal injuries, inflammations in the region of the central nervous system or in children or adolescents in the growth phase (see WARNINGS).

In patients with a history of tendon disorders related to floroquinolone administration.

 
WARNINGS

Even when used as instructed, BIOMEFLACINE-400 Tablets may alter reactivity to such an extent that the ability to drive vehicles or operate machinery may be impaired.
Clostridium difficile-associated disease:

Diarhoea, particularly if severe and/or persistent occurring during treatment or in the initial weeks following treatment with Pefloxacin or with various other antibiotics, but especially broad spectrum antibiotics, may be symptomatic of Clostridium difficile-associated disease, the most severe form of which is pseudo-membranous colitis.

If a diagnosis of pseudomembranous colitis is suspected, Pefloxacin should be stopped immediately and appropriate specified antibiotic therapy should be started without delay (e.g. vancomycin or metronidazole).

Tendinitis, less frequency observed, may occasionally Iead to rupture, involving more particularly Achilles tendon and occurring especially in elderly patients. Rupture seems to be favoured by treatment with corticosteroids. The onset of signs of tendinitis requires to stop the treatment, to rest both Achilles tendons by appropriate immobilization or special heel pieces and to take orthopedic advice.

Pefloxacin may aggravate myasthenia gravis.

Pefloxacin may negative the isolation of Mycobacterium tuberculosis, giving false negative results, in the bacteriological diagnosis of tuberculosis. The serum concentration of Pefloxacin should be monitored in patients with severe renal impairment and hemodialysis patients. Although this has not been reported, the possibility cannot be ruled out that fluoroquinolones may trigger an attack of porphyria in predisposed patients.

 
DOSAGE AND DIRECTION FOR USE

BIOMERACINE-400 Tablets should be swallowed with a little liquid. They may be taken on an empty stomach or with meals. The dosage should be determined according to the sensitivity of the causative organism and the severity of the Infection.

The following dosages are recommended:

Uncomplicated Cystitis:

100mg twice daily for 3-7 days.

Pyelonephritis:

200mg twice daily for 5-7 days.

Infection of the lower respiratory tract:

400mg twice daily for 7-10 days. The daily dose may be altered depending on the severity of the infection.

Uncomplicated urethral and cervical gonorrhea:

A single dose of 400mg.

Urethritis and cervicitis due to Chlamydia trachomatis:

600mg daily in divided doses for up to7 days.

For patients with impaired renal function and elderly patients, the dosage of BIOMEFLACINE-400 Tablets should be adjusted according to the degree of impairment With a creatinine clearance of less than 50mL to 20mL/minute, a normal single dose should be administered every 24 hours, e.g. 200mg once daily.

With a creatinine clearance of less than 20mL/minute, the normal single dose should be given initially. This dose should then be reduced to half and administered every 24 hours, e.g. 200mg initially thereafter 100mg once daily.

 
SIDE-EFFECTS AND SPECIAL PRECAUTIONS

There have been symptoms such as facial oedema, swollen tongue, glottal oedema, tachycardia, dyspnea and signs of imminent stock and acute anaphylaxis. In the event of such reactions.

BIOMEFLACINE-400 Tablets should be discontinued immediately. Medical treatment (therapy for shock) is imperative.

Disturbances of the nervous system, headache, dizziness and restlessness are the most common.

Others include drowsiness, insomnia, weakness, sleep disturbances, nightmares, unsteady gait and tremor (disturbance of muscular coordination), numbness and tingling in the limbs (par aesthesia), peripheral neuropathy, visual disturbances such as double vision and abnormal colour vision, disturbances of the senses of taste and small, hallucinations, convulsions, psychotic reactions, agitation, anxiety, depression and confusion. These reactions have occurred mainly in elderly patients and patients with impaired renal function, but not exclusively, in some cases these reactions have occurred already after the first dose. In the event of such adverse reactions, BIOMEFLACINE-400

Tablets should be discontinued immediately and the doctor informed.

There have been reports of pain in Joints and muscles.

Other side-effects: There have been cases of changes in the blood picture (leucopenia, eosinophilis, agranulocytosis,) thrombocytopenia, anaemia, transient increases in liver enzyme and/or bilirubin and in serum creatinine. Crystalluria as well as interstitial nephritis and hepatitis may also occur.

Myalgia; gynarcomastia and cardiovascular effects including tachycardia have been reported. Gastro-intestinal symptoms may occur (gastric or abdominal symptoms, abdominal pain, loss of appetite, nausea, vomiting, diarrhoea). If severe and persistent diarrhea occurs during or after (therapy, the physician should be informed because in few cases this may point to a serious intestinal disorder (pseudomembranous colitis) which require immediate treatment. In such cases, BIOMEFLACINE-40 Tablets must be discontinued immediately and suitable therapy initialed.

In addition to rash and pruritis, hypersensitivity-type reactions affecting the skin have included, less frequently vasculitis, arhtyema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Photosensitivity has occurred.

 
INTERACTIONS

Steady state theophylline levels may increase when Pefloxacin and theophylline are given concurrently. Concomitant administration of Pefloxacin with theophylline may prolong the half-life of theophylline, elevate serum theophylline levels and may increase the risk of theophylline-related adverse reactions.

Products inhibiting peristaIsis are contraindicated.

If antacids containing aluminium, including sucralfate and magnesium hydroxide, aluminium phosphate or calcium, zinc, iron, are taken at the same time, absorption of Pefloxacin may be reduced. Patients undergoing concomitant treatment with coumarin derivatives should be monitored carefully.

Excessive rises or falls in blood sugar levels may occur less frequently especially in patients with diabetes mellitus. Pefloxacin may cause a slight increase in serum concentrations of glubenclamide if administered concomitantly.

Particularly in case of high dose therapy, mutual impairment of excretion and an increase in serum levels must be considered when quinolones are administered together with other medicines that also undergo renal tubular secretion (such asprobenecid, cimetidine, furosemide or methotrexate).

 
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

See (Side-effect, and Special Precautions). Treatment is symptomatic and supportive.

 
STORAGE INSTRUCTIONS

Store below 30oC, Protect From light.

Keep out of reach of Children.

 

PRESENTATION

BIOMEFLACINE-400: 1 x 10 Tablets in AIu/Alu.

 

Manufactured by

Bharat Parenterals Ltd.

Vill. Haripura, Ta. Savli,

Dist. Vadodara – 391 520

Gujarat, India.

 

Manufactured for

BIOMEDICINE S.P.N.L.

No 16 Anionwu Street Odoakpu

P. O. Box 7846 Onitsha, Nigeria

sckivspharm@yahoo.com