The information provided below corresponds to the official product information from Patient Information Leaflet provided by the manufacturer.
The text does not contain any of medical advices, mode of administration and prescription plans.
Before beginning any treatment, we kindly advise you to consult your healthcare provider.
Levaquin. Levaquin oral
What is generic Levaquin?
Generic Levaquin contains the active ingredient Levofloxacin which is a broad spectrum bactericidal antibiotic of fluroquinolone group. The medication is indicated for the treatment of bacterial infections: ENT infections (sinusitis, otitis), infections of the airways (chronic bronchitis, pneumonia), urogenital infections (pyelonephritis, prostatitis, urogenital chlamydiosis), infections of the skin and soft tissue (abscess, furunculosis).
Is generic Levaquin is the same as brand?
No. Generic Levaquin contains the same active ingredient Levofloxacin as brand medication, however excipients, color, shape of the tablets may differ. This may affect the pharmacokinetics of Levofloxacin.
How does the medication work?
Generic Levaquin oral is a synthetic broad spectrum antibacterial medication of the fluoroquinolone group, containing levofloxacin - levogyrate isomer of ofloxacin. Bactericidal effects arouses from the blocking the enzyme called DNA gyrase, inhibiting supercoiled and cross-linking of DNA, suppressing DNA synthesis. The medication causes deep morphological changes in cytoplasma, cell wall and membranes. Levaquin oral is active against wide variety of microorganisms including both in vitro and in vivo.
The spectrum of antibacterial activity includes:
Gram-positive microorganisms: Streptococcus pneumoniae peni I/S/R, Streptococci groups G, Enterococcus spp, Staphylococcus coagulase-negative methi-S(I), Staphylococcus aureus methi-S, , Staphylococcus epidermidis methi-S, Staphylococcus spp, Streptococcus agalactiae, Streptococcus pyogenes, Viridans streptococci peni - S/R, Staphylococcus spp, Listeria monocytogenes, Corynebacterium diphtheriae, Enterococcus faecalis.
Aerobic gram-negative microorganisms: Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella oxytoca, Enterobacter cloacae, Enterobacter spp, Citrobacter freundii, Pasteurella conis, Pasteurella dagmatis, Morganella morganii, Neisseria gonorrhoeae , Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, Eikenella corrodens, Enterobacter aerogenes, Acinetobacter baumannil, Acinetobacter spp, Serratia marcescens, Serratia spp., Klebsiella pneumoniae, Klebsiella spp, Moraxela catarrhalis, Acinetobacter baumannil, Acinetobacter spp, Pasteurella multocida, Pasteurella spp Pseudomonas aeruginosa, Pseudomonas spp, Salmonella spp, Providencia rettgeri, Enterobacter agglomerans, Actinobacillus actinomycetemcomitans, Neisseria meningitides, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Providencia spp
Anaerobic microorganisms: Ureaplasma urealyticum, Mycoplasma pneumonia, Peptostreptococcus, Bacteroides fragilis, Clostridium perfringens, Fusobacterium spp, Bartonella spp, Chlamydia pneumoniae, Chlamydia psittaci, Legionella pneumophila, Legionella spp, Mycobacterium leprae, Micobacterium tuberculosis, Bifidobacterium spp, Propionibacterum spp, Chlamydia trachomatis, Mycobacterium spp, Mycoplasma hominis, , Ricketsia spp, Veilonella spp.
Levofloxacin is rapidly and almost completely absorbed after oral administration. Food does not significantly effect on Levaquin oral absorption time. The bioavailability of the medication is nearly 100%. After administration Levofloxacin orally 500 mg maximal blood concentration is of 5,2-6,9 mg / ml and is achieved in 1.3 hours. Elimination time is 6-8 hours. The medication binds to plasma proteins by 30-40%, is well distributed in all organs and tissues: lungs, urogenital system, bronchial mucosa, sputum, prostate, polymorphonuclear leukocytes, alveolar macrophages. Levaquin oral is elimination out of the organism with kidney through the filtration and tubular secretion. After oral administration, approximately 87% of the dose is excreted with urine in unchanged form within 48 hours. Less than 4% is found in feces for the period of 72 hours.
What is Levaquin used for?
Levaquin oral is indicated for the treatment of bacterial infections in adults in case when bacteria are sensitive to levofloxacin:
- ENT infections (sinusitis, otitis media)
- Inflammation and infections of the lower respiratory system: aggravation of chronic bronchitis, community-acquired pneumonia
- Complicated and uncomplicated urogenital infections (including pyelonephritis)
- Infections of the genitals (urogenital chlamydiosis)
- Acute and chronic bacterial prostatitis
- Infections of the skin and soft tissue (furunculosis, abscess, festered atheroma)
How the medication is taken?
The correct and appropriate dose of Levaquin oral depends on several factors such as age, gender, weight, type of the infection, severity of the infection, how the body responds to the indicated doses, drug intolerance. Levofloxacin tablets are taken orally one or two times daily. Tablets should be taken before meal without chewing and washing down with sufficient amount of fluids. If necessary, tablet can be split in a half. Try to take the medication at the same time each day; this will help to keep an even level of the medication in your blood. Make sure to finish your course of treatment; do not stop taking the medicine if it seems that the infection is passed away. The dose for patients with kidney disease should be reduced and adjusted according to creatinine clearance index.
When the medication should not be taken?
- Known individual intolerance (including a history of hypersensitivity) of levofloxacin or other quinolones;
- Epilepsy or seizures
- Tendons damage associated with quinolones treatment
- Children or adolescents under 18 years of age
- Rheumatoid arthritis
- Transplantation of the lung, heart or liver
- Kidney diseases (renal failure, kidney dysfunction)
- Low potassium blood levels
Pregnancy (Levofloxacin is a pregnancy category C meaning that is unsafe to the drug during pregnancy)
Breastfeeding (levofloxacin can pass through breast milk). Therefore the medication should be avoided in breastfeeding mothers
The medication should be used with caution in patients with:
- Prolonged QT interval
- Known reactions of hypersensibilization
- Liver disease
Levaquin oral special cautions
- The medication can cause severe side effects. Seek immediate medical attention if you develop any side effects associated with this remedy. Make sure to inform your doctor if you noticed any signs of liver damage such as jaundice, yellowing of the skin and eyes.
- Like all quinolones the medication can cause tendon damage
- Patients over 60 years of age which have organs transplantation have a high risk of tendon damage
- Livaquin oral may cause a lot of central nervous system disorders (see Levaqion side effects)
- Levaqion can cause nerve damage
- The medication can change the heart rhythm
- Overuse of antibiotic may lead to development of superinfection and yeast infection
- The medication can provoke the attacks of seizures
- Do not drive or operate any machinery while the treatment
Which are Livaquin oral side effects?
The medication can cause a lot of side effects. Seek immediate medical attention if you develop any of the following side effects:
Skin reactions and general hypersensitivity reactions
Sometimes: itching and redness of the skin.
In rare cases: hypersensitivity reactions (anaphylaxis and anaphylactoid reaction) with symptoms such as urticaria, bronchoconstriction, and possible severe asthma.
In very rare cases: swelling of the skin and mucous membranes (eg, in the face and throat), sudden drop in blood pressure and shock, hypersensitivity to sunlight and UV radiation (see "Cautions"); allergic pneumonitis, vasculitis.
In some cases: severe rash with blistering, such as Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome) and exudative erythema multiforme. General hypersensitivity reactions may occasionally proceed to mild skin reactions. The above-mentioned reaction may develop after the first dose a few minutes or hours after administration of the drug.
Often: nausea, diarrhea. Sometimes: loss of appetite, vomiting, abdominal pain, digestive disorders. Rare: bloody diarrhea, which in very rare cases can be a sign of inflammation of the intestine and even pseudomembranous colitis (see "Cautions").
Very rare: low blood sugar levels (hypoglycemia), which has particular significance for patients with diabetes mellitus, possible signs of hypoglycemia: "ravenous appetite, nervousness, sweating, trembling.
Central nervous system
Occasionally: headache, dizziness and / or numbness, drowsiness, sleep disturbances.
Rare: depression, anxiety, psychotic reactions (eg, hallucinations), discomfort (eg, paresthesia in hands), tremor, psychotic reactions such as hallucinations and depression, seizures and confusion.
Very rare: blurred vision and hearing, a violation of taste and smell sensitivity, reduction of tactile sensitivity.
Rare: increased heart rate, blood pressure reduction.
Very rare: vascular collapse. In some cases: lengthening of the interval QT.
Effects on the muscles, tendons and bones
Rare: tendon injury (including tendonitis), joint and muscle pain, rhabdomyolysis
Very rare: tendon rupture (eg Achilles tendon), this side effect can occur within 48 hours after treatment and may be bilateral in nature (see "Cautions"), muscle weakness, which is of particular importance for patients suffering from asthenic bulbar palsy.
Effects on liver and kidney
Often: increased activity of liver enzymes (eg, alanine aminotransferase and aspartate aminotransferase). Rare: increased bilirubin and creatinine in serum (a sign of liver or kidney dysfunction). Very rare: hepatic reactions
Effect on blood
Occasionally: Increased number of eosinophils, decreased leukocytes counts
In rare cases: neutropenia, thrombocytopenia, which may be accompanied by increased bleeding.
In very rare cases: agranulocytosis and the development of severe infection (persistent or recurrent fever, sore throat and persistent deterioration of the well-being).
In some cases: hemolytic anemia, pancytopenia.
Other side effects
Sometimes: general weakness (asthenia).
In very rare cases: fever, allergic pneumonitis.
The most common Levaquin oral side effects include:
- Yeast infection
- Water retention
- Chest pain
- Vaginal irritation
- Shortness of breath
Which are Levaquin oral overdose symptoms:
Do not exceed the recommended doses of the medication. In case of overdose seek immediate medical attention. The symptoms of overdose include: disorders of the CNS (confusion, dizziness, seizures), gastrointestinal disorders (nausea, vomiting, damage of the mucous linings), coordination problems, tremor, droopy eyelids
How the medication can interact with other drugs:
Levaquin oral may interact with a wide variety of drugs. Levofloxacin should not be taken in:
- Antacids (Aluminium oxide, calcium, magnesium antacids)
- Arrhythmia drugs like amiodarone, sotalol, procainamide, quinidine
- Non-hormonal anti-inflammatory drugs like Aspirin, Ibuprofen, Paracetamol, Diclofenac, Naproxen, Celecoxib, Etodolac, Ketoprofen, Ketorolac, Indomethacin
- Blood thinners (Warfarin)
- Xantines (theophylline)
- Hypertension drug (quinapril)
- Typhoid vaccine
- Duodenal ulcer treatment (Sucralfate)
- Hyperphosphataemia treatment (Sevelamer)
- Diabetes drugs
- Corticohormons such as hydrocortisone, prednisolone, methylprednisolone, dexamethasone, bethametasone
How the medication should be stored?
You should store the medication at dry and protected from light place out of reach of children. Store at room temperature
Which is the manufacturer of generic Levaquin?
The medication is made by Cadila.
What is the difference between generic Levaquin and brand one?
Generic Levaquin contains the same active ingredient as brand preparation, possesses the same therapeutic effect, indications, contraindications. The difference is in manufacturer, form of the tablet, excipients, and tablet's shape. Pharmacokinetics may also differ
This info corresponds to official PIL provided by legal manufacturer and reviewed by: Dr. Rohit Bansali N.