Agabaxin Levofloxacin Hemihydrate Tablet

AGABAXIN
Levofloxacin Tablets 500mg

 

Composition

Each film coated tablet contains:

Levofloxacin Hemihydrate Equivalent to Levofloxacin 500mg

Escipents q s.

Colour Aproved Colour used.

 

Description

Levofloxacin belongs to the class of medications called quinolones. It is an antibiotic used for the treatment of certain bacterial infections. It is most commonly used to treat infections of the bladder, kidney, prostate, sinus, skin, and lung.

 

Clinical Pharmacology

Levofloxacin inhibits bacterial type II topoisomerases, topoisornerase IV and DNA gyrase. Levofloxacin, like other fluoroquinolones, inhibits the A subunits of DNA gyrase, two subunits encoded by the gyrA gene. This results in strand breakage on a bacterial chromosome, supercoiling, and resealing; DNA replication and transcription is inhibited.

 

Indication and Usage

Levofloxacin is an antibiotic which is used to treat bacterial infections of the:
• sinuses, lungs, kidneys and waterworks, prostate gland, skin and soft tissues (including fat and muscle).

 

Contraindication

Do not take Levofloxacin Tablets if you:
• are allergic (hypersensitive) to levofloxacin or to any of the other ingredients in the tablets (listed in section 6) or are allergic to similar antibiotic medicines such as ciprofloxacin or ofloxacin, have epilepsy, have taken levofloxacin or a similar medicine before and had problems with your tendons (e g tendonitis), are a child or a growing teenager, are pregnant, trying to become pregnant or are breast-feeding.

 

DRUG INTERACTION

Levofloxacin is known to interact with other drugs like aluminium hydroxide and oxide, cyclosporin A, fenbufen, probenecid, theophylline, warfarin (Na). These interactions are sometimes beneficial and sometimes may pose threats to life. Always consult your physician for the change of dose regimen or an alternative drug of choice that may strictly be required.

 

Warnings

Talk to your doctor before taking Levofloxacin Tablets if you:

• have previously had epilepsy or have had brain damage in the past (such as a stroke) as you may have an increased chance of having seizures (fits). Make sure you have told your doctor all of your medical history.

• have a rare and inherited condition which affects the enzyme glucose-6-phosphate dehydrogenase (G-6-PD), as you may be more likely to suffer from blood problems if you are given levofloxacin

• have kidney disease/damage, as the doctor may want to give you a lower dose of levofloxacin.

• are taking drugs to stop your blood clotting (such as warfarin), as your doctor will want to monitor how well your blood clots whilst you are also taking levofloxacin.

• have ever had mental health problems, have ever had heart problems (see below section Heart problems), are diabetic, have ever had liver problems.

 

Use in pregnancy & Lactation

Pregnancy

This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, stop taking it immediately and call your doctor.

Breast-feeding

Levofloxacin may pass into breast milk. If taking levofloxacin is considered essential, stop breast-feeding.

Children and adolescents

The safety and effectiveness of levofloxacin for children and adolescents younger than 18 years of age have not been established. Levofloxacin should not be used by those who have not reached puberty, since it may affect the normal growth of bones.

 

Precautions

Before using this medication, tell your doctor or pharmacist your medical history, especially of diabetes, heart problems (such as chest pain, recent heart attack), joint/tendon problems (such as tendonitis, bursitis), kidney disease, myasthenia gravis, nervous system disorder (such as peripheral neuropathy), seizure disorder, conditions that increase your risk of seizures (such as brain/head injury, brain tumors, stroke).

 

Adverse reaction

Stevens Johnson syndrome, epidermal necrolysis, tendon rupture, QT prolongation, flatulence, dizziness, diarrhea, anxiety, restlessness, constipation, abdominal pain, confusion, pruritus, hallucination, dyspepsia.

 

Side Effects

Nausea, diarrhoea, constipation, headache, insomnia, inj. site reactions (IV). Ophthalmic transient decrease in vision, ocular burning, ocular pain or sensation, headache, fever pharyngitis, photophobia, Anaphylaxis.

 

Symptoms of overdose and antidote

In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.

Antidote

In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Antacids may be used for protection of gastric mucosa. Haemodialysis, including peritoneal dialysis and CAPD, are not effective in removing levofloxacin from the body. No specific antidote exists.

 

Dosage and administration

Usual Adult Dose for Nosocomial Pneumonia: 750mg orally or IV every 24 hours for 7 to 14 days.

Usual Adult Dose for Bronchitis, Acute bacterial exacerbation of chronic bronchitis: 500mg orally or IV once a day for 7 days.

Usual Adult Dose for Skin or Soft Tissue Infection, Uncomplicated: 500mg orally or IV once a day for 7 to 10 days, Complicated: 750mg orally or IV once a day for 7 to 14 days.

Usual Adult Dose for Prostatitis, Chronic bacterial prostatitis: 500 mg orally or IV every 24 hours for 28 days. Levofloxacin is not recommended for pediatric patients 6 months of age or older.

 

Storage

Store below 30oC in a dry place, protect from light.

KEEP ALL MEDICINES OUT OF REACH OF CHILDREN

 

Presentation

In a box of 1 blister of 10 tablets each.

 

NAFDAC Reg. No.: B4-5169

 


Manufactured in India by

Maxheal Laboratories Pvt. Ltd.

H.O. Maxheal House, Goregaon-W, Mumbai-090

Factory:2-7/80-85, SURSEZ, Sachin, Gujarat-394230

www.maxheal.in

 

Marketed by

GRACE BASE PHARMACY AND STORES LTD.

232 Clifford Road by East Aba, Abia State, Nigeria

gracebasepharm@yahoo.com

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