Levoxa – composition, dosage, indications, side effects

Proven content

Levoxa is a medicinal product used in urology, dermatology, venereology and otolaryngology. The drug is dispensed from a pharmacy on the basis of a prescription issued by a doctor. The active substance in Levoxa is levoloxacin, which is a quinolone antibiotic. This preparation works by killing the bacteria that cause infections in your body. What is the composition and how does Levoxa antibiotic work? What are the indications and contraindications for its use? What side effects can it cause? How to take Levoxa and with what preparations not to combine it?

Levoxa – general characteristics of the drug

Levoxa is a pharmaceutical product whose international name is Levofloxacinum. The active substance is levofloxacin, which is a quinolone antibiotic.

Levoxa has a bactericidal effect on microorganisms that cause infections in the sinuses, lungs, urinary tract, skin and prostate gland.

Levoxa is prescribed by a prescription to a specific person and cannot be passed on to other patients because it may harm another person, even though the symptoms are the same.

The drug is available in two forms: film-coated tablets and as a solution for infusion. Tablets contain a dose of 250 mg or 500 mg of the active substance, and 5 mg / ml of the substance in the infusion solution.

Levoxa tablets are available in a cardboard box containing an Aluminum / PVC blister in packs containing 1, 3, 7, 10, 14, 50, 200 tablets or in an HDPE bottle with an LDPE cap in a cardboard box containing 50 or 100 tablets.

The tablets are pink, oval, biconvex, with a breakline on one side and marked “L” on the other side, irrespective of the dose. The only difference is their size: the Levoxa 250 mg tablet is approximately 13 mm long and 6 mm wide, while the 500 mg Levoxa tablet is 16 mm long and 8 mm wide.

However, the drug in the form of a solution for infusion is sold in a cardboard box containing 1 or 5 vials of two sizes: a 50 ml or 100 ml vial.

The price of the drug Levoxa is not subject to refund and ranges from PLN 27 to PLN 34 depending on the size of the package.

Keep the drug out of the sight and reach of children at room temperature. In general, there are no special storage instructions, but the solution for infusion should be used immediately (within 3 hours) after opening the bottle in order to avoid microbial contamination.

The manufacturer of the drug is Actavis Group PTC ehf from Iceland.

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Levoxa – composition and action of the drug

The active substance in Levoxa is levofloxacin. Each tablet contains 250 mg of levofloxacin (Levofloxacin), corresponding to 256,23 mg of levofloxacin hemihydrate or 500 mg of levofloxacin (Levofloxacin), corresponding to 512,46 mg of levofloxacin hemihydrate.

The active substance is a synthetic chemotherapeutic agent with a broad spectrum of antibacterial activity. Due to its chemical structure, it belongs to the group of drugs called fluoroquinolones.

Levofloxacin works by inhibiting the activity of a bacterial enzyme that is necessary for the formation of the normal nucleic acid (DNA) structure of bacteria. Bacterial DNA is destabilized, leading to inhibition of division and death of the bacterial cell.

After oral administration, it is very well and quickly absorbed from the gastrointestinal tract. It penetrates well into organs and tissues (it penetrates poorly into the cerebrospinal fluid).

The strength of the antimicrobial activity of levofloxacin depends on the ratio of the maximum serum concentration (Cmax) or the area under the curve (AUC) to the minimum inhibitory concentration (MIC).

The active substance of the drug is supported by the excipients of Levoxa. The tablet core contains: sodium stearyl fumarate, crospovidone, colloidal anhydrous silica, copovidone, silicon microcrystalline cellulose, while the tablet coating contains: lactose monohydrate, hypromellose, titanium dioxide, triacetin, red iron oxide, yellow iron oxide.

The solution for infusion contains, in addition to levofloxacin, the following excipients: sodium chloride, hydrochloric acid, water for injections.

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Levoxa – indications for the use of the drug

Levoxa is a preparation intended for use in adults in the treatment of bacterial infections. Levoxa tablets are mainly indicated in the treatment of diseases such as:

1. sinus infection;
2. exacerbation of chronic bronchitis;
3. lung infections in patients with prolonged breathing problems or pneumonia;
4. acute pyelonephritis and complicated urinary tract infections;
5. prostate infection;
6. infection of the skin and subcutaneous tissue, including muscles.

The solution for infusion can be used to prevent or treat a lung disease called anthrax which can occur after contact with the bacteria that cause anthrax.

Levoxa film-coated tablets can be used to complete treatment in patients who have improved after initial treatment with intravenous levofloxacin.

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Levoxa – contraindications to the use of the drug

The Levoxa antibiotic, although there are indications for its use, may not always be used in every patient.

The main contraindication to the use of this drug is hypersensitivity, i.e. allergy to the active substance – levofloxacin or any other quinolone, such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this drug.

Contraindications to the use of Levoxa also include certain diseases and circumstances that may require you to completely abandon the drug or change the dosage of the preparation.

The use of Levox may require specific check-ups and a thorough medical history.

The preparation should not be used in cases of:

1. symptoms of an allergic reaction including: rash, swallowing or breathing difficulties, swelling of the lips, face, throat or tongue;
2. history of epilepsy;
3. you have ever had problems with your tendons such as tendinitis
4. if you are pregnant, plan to become pregnant or think you may be pregnant;
5. when a woman is breastfeeding;
6. child or adolescent patients in the period of growth.

Levoxa antibiotic is also contraindicated in the treatment of infections caused by methicillin-resistant Staphylococcus aureus (MRSA).

This preparation is contraindicated in the above situations, and in case of any doubts, consult your doctor or pharmacist before starting treatment with this drug.

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Levoxa – dosage and method of administration

Levoxa should be used in accordance with the doctor’s instructions, not exceeding the recommended doses, because it does not increase the effectiveness of the drug and may be harmful to health and life.

The doctor selects the dosage of the drug individually, depending on the indication, the severity of the infection and the patient’s kidney function.

In the case of film-coated tablets, your doctor will decide the dose you should take. The dose of the drug depends on the site of the infection, the duration of treatment and the severity of the infection. The dosage of Levoxa film-coated tablets for adults and the elderly is presented in the table below.

In some special patient groups, additional dosage adjustments are necessary.

Patients with impaired renal function should have individual doses adjusted to their health condition.

Levoxa antibiotic in the form of an infusion solution it is intended for use in a hospital and is given as an injection by your doctor or nurse. The injection is made into one of the patient’s veins and takes some time. The 250 mg solution for infusion is given over 30 minutes or more, and the 500 mg solution for infusion is given over 60 minutes or more.

In some special patient groups, additional dosage adjustments are necessary.

Levoxa antibiotic in the form of tablets should be taken orally, swallowed whole with water with or between meals. The preparation should be taken 2 hours before or 2 hours after taking iron salts, antacids or sucralfate, as these drugs reduce the absorption of the preparation.

In addition, you should avoid direct sunlight while taking Levoxa and for two days after you stop taking it. The patient’s skin becomes more sensitive to the sun while using the medicine, and may cause burns, tingling sensations and severe blistering of the skin. If the patient feels a weak or too strong effect of the drug, he should not change the dose himself, but ask the doctor who will decide on the dose and duration of the treatment.

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Levoxa – overdose or missed dose

Levoxa should always be used exactly as prescribed by your doctor. If you accidentally take too much medicine, immediately inform your doctor and go to the nearest hospital, taking the medicine pack with you.

If you take too much Levoxa solution, symptoms such as convulsions (seizures), confusion, dizziness, disturbances in consciousness, muscle tremors and heart problems leading to an irregular heartbeat, nausea, and heartburn may occur.

Overdose of Levoxa requires symptomatic treatment, as there is no antidote on the market.

When taking the medicine, a dose may also be missed. In such a situation, you should take the preparation as soon as you remember, unless it is almost time for the next dose. Never take a double dose to make up for a forgotten dose.

In addition, the patient should never stop taking the medicine on their own, even if the symptoms improve and the patient feels better. Premature discontinuation of treatment with the drug may cause the infection to recur, the patient’s condition may deteriorate, and the bacteria may become resistant to the drug.

After a few days of treatment with the intravenous solution, your doctor may decide to switch to tablets in order to complete the prescribed treatment cycle. Any doubts related to the use of the drug should be consulted with a doctor or pharmacist.

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Levoxa – side effects

Levoxa, like any antibiotic, can cause side effects that do not have to occur in every person using this medicine. After authorization of the medicinal product, it is important to report any suspected adverse reactions so that the benefit / risk balance of the medicinal product can be monitored.

The general classification of the frequency of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare ( ≥100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

The side effects are usually mild and transient, and the expected benefits of the drug are usually greater than the harm resulting from the side effects.

Side effects may appear while taking, but also up to several weeks after discontinuing the drug.

The following side effects include:

1. common (1 in 10 patients): sleep problems, headache, dizziness, nausea, vomiting, diarrhea, increased levels of certain liver enzymes in the blood;
2. uncommon (1 in 100 patients): changes in the number of other bacteria or fungi, infection with fungi of the genus Candida (which may require treatment), changes in the number of white blood cells shown up in some blood tests (leukopenia, eosinophilia), restlessness, confusion, nervousness, sleepiness, tremor, spinning sensation ( dizziness), shortness of breath (dyspnoea), changes in taste, loss of appetite, upset stomach or indigestion, stomach pain, flatulence or constipation, itching and skin rash, hives, excessive sweating (hyperhidrosis) joint or muscle pain, abnormal blood tests due to liver problems (increased bilirubin), abnormal kidney results (increased creatinine), general weakness
3. rare (1 in 1 patients): increased bruising and bleeding due to a decrease in the number of blood platelets (thrombocytopenia), low white blood cell count (neutropenia), excessive immune response (hypersensitivity), tingling sensation in the hands and feet (paraesthesia), hearing problems (tinnitus), blurred vision, unusual rapid heartbeat (tachycardia), palpitations, low blood pressure (hypotension), muscle weakness; this is important in patients with myasthenia gravis (a rare disease of the nervous system), kidney failure which may be due to an allergic reaction in the kidney called interstitial nephritis, fever, sharply defined erythematous spots with or without blisters developing within hours of administration of levofloxacin;
4. unknown frequency: Reduction in red blood cells (anemia), this can make the skin pale or yellow due to damage to red blood cells, decrease in all types of blood cells, fever, sore throat and a general feeling of being unwell that will not go away, increased blood sugar (hyperglycaemia), changes in sense of smell, loss of smell or taste (olfactory hallucinations, anosmia, lack of taste), problems with movement and walking (dyskinesia, extrapyramidal disorder), temporary loss of consciousness or fainting (syncope), temporary loss of vision, inflammation of the eye, disturbance or loss of hearing, abnormal fast heart rate, life-threatening irregular heartbeat including cardiac arrest, difficulty breathing or wheezing (bronchospasm), allergic lung reactions, inflammation of the pancreas, inflammation of the liver, increased sensitivity of the skin to sunlight and ultraviolet radiation ( allergy to light), inflammation of the blood vessels which supply blood to the body due to an allergic reaction, inflammation of the lining of the mouth (stomatitis), muscle damage and breakdown, redness and swelling of the joints (arthritis), pain including back, chest and limb pain , bouts of metabolic disease, persistent headache with mild intracranial hypertension.

If you notice any of the above or other symptoms during or after treatment with Levoxa antibiotics, please inform your doctor or pharmacist immediately. It allows continued monitoring of the benefit / risk balance of the medicinal product.

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Levoxa – interactions with other pharmaceuticals

The initiation of treatment with the use of Levoxa antibiotic requires a detailed history of all currently and recently taken medications, including over-the-counter medications.

The use of certain drugs at the same time as Levoxa can cause serious side effects.

Before taking the drug, tell your doctor or pharmacist about all the drugs you are taking or have recently taken, and about any drugs you plan to start taking.

Before taking Levoxa antibiotic, the patient should inform the doctor about the use of medicines such as:

1. warfarin – used to thin the blood, which may make you more prone to bleeding;
2. corticosteroids – sometimes called steroids for inflammation, you may be more prone to developing inflammation and / or damage to your tendons;
3. ciclosporin – used after organ transplant, you may be more prone to the side effects of ciclosporin,
4. theophylline – used for breathing problems, you may be more prone to seizures
5. drugs that affect the heart rhythm – antiarrhythmic drugs such as: quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone;
6. drugs used to treat depression – tricyclic antidepressants such as: amitriptyline and imipramine;
7. non-steroidal anti-inflammatory drugs for pain and inflammation – such as: acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen and indomethacin;
8. drugs for mental disorders – antipsychotics;
9. drugs for bacterial infections – macrolide antibiotics, such as: erythromycin, azithromycin and clarithromycin;
10. cimetidine – used to treat ulcers and heartburn;
11. probenecid – used to treat gout.

Levoxa antibiotic must not be used concomitantly with iron tablets, zinc supplements, antacids, didanosine (an antiviral medicine for HIV infection) and sucralfate (used for stomach ulcers) as they reduce the absorption of levofloxacin taken by mouth.

In addition, the use of Levoxa may affect the results of laboratory tests. Urine tests for opioids may lead to false-positive results in patients taking Levoxa.

If your doctor has prescribed a urine test, you should inform your doctor that you are taking this medicine. In addition, it may lead to false-negative results in some tests used by laboratories to detect tuberculosis-causing bacteria.

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