LEVODHG 750

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LEVODHG 750

Keep out of reach of children.

Read all of this leaflet carefully before you start taking this medicine.

The drug is for prescription only.

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Active ingredient:

Levofloxacin (as levofloxacin hemihydrate) ....................... 750 mg

Excipients: Microcrystalline cellulose M101, wheat starch, povidone K30, colloidal silicon dioxide, sodium starch glycolate, talc, magnesium stearate, HPMC 606, HPMC 615, PEG 6000, titanium dioxide, yellow ferric oxide.

PHARMACEUTICAL FORM: Film coated tablet.

Product description: An oval, yellow, film-coated tablet, plain on both sides, intact edges.

THERAPEUTIC INDICATIONS:

Infections caused by levofloxacin susceptible microorganisms:

Nosocomial pneumonia, community acquired pneumonia, complicated skin and subcutaneous infections, complicated urinary tract infections or acute nephritis.

Acute exacerbation of chronic bronchitis

Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions (see the Warnings and Precautions) and for some patients acute exacerbation of chronic bronchitis is self-limiting, reserve levofloxacin for treatment of acute exacerbation of chronic bronchitis in patients who have no alternative treatment options.

Acute bacterial sinusitis

Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions (see Warnings and Precautions) and for some patients acute bacterial sinusitis is self-limiting, reserve levofloxacin for treatment of acute bacterial sinusitis in patients who have no alternative treatment options.

POSOLOGY AND METHOD OF ADMINISTRATION:

For oral use.

Nosocomial pneumonia: 750 mg once daily for 7 - 14 days.

Community acquired pneumonia: 750 mg once daily for 5 days.

Complicated skin and subcutaneous infections: 750 mg once daily for 7 - 14 days.

Complicated urinary tract infections or acute nephritis: 750 mg once daily for 5 days.

Acute exacerbation of chronic bronchitis: 500 mg once daily for 7 days. It is advised that suitable dosage form and content should be given.

Acute bacterial sinusitis: 750 mg once daily for 5 days.

Dosage in patients with renal failure:

- Creatinine clearance 20 - 49 ml/min: first dose: 750 mg, then: 750 mg every 48 hours.

- Creatinine clearance 10 - 19 ml/min: first dose: 750 mg, then: 500 mg every 48 hours.

Hemodialysis or CAPD: first dose: 750 mg, then: 500 mg every 48 hours.

Or as directed by the physician.

CONTRAINDICATIONS:

In patients with hypersensitive to levofloxacin, or other quinolones or any of the excipients.

In patients with epilepsy, G6PD deficiency, history of tendon disorders.

In children younger than 18 years of age.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE:

Disabling and potentially irreversible serious adverse reactions including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects.

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting levofloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.

Discontinue levofloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

Methicillin-resistant Staphylococcus aureus (MRSA)

Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including levofloxacin. Therefore levofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the organism to levofloxacin (and commonly recommended antibacterial agents for the treatment of MRSA-infections are considered inappropriate).

Levofloxacin may be used in the treatment of acute bacterial sinusitis and acute exacerbation of chronic bronchitis when these infections have been adequately diagnosed.

Resistance to fluoroquinolones of E. coli - the most common pathogen involved in urinary tract infections - varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in E. coli to fluoroquinolones.

Inhalation anthrax: Use in humans is based on in vitro Bacillus anthracis susceptibility data and on animal experimental data together with limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax.

Tendinitis and tendon rupture

Tendinitis may rarely occur. It most frequently involves the Achilles tendon and may lead to tendon rupture. Tendinitis and tendon rupture, sometimes bilateral, may occur within 48 hours of starting treatment with levofloxacin and have been reported up to several months after discontinuation of treatment. The risk of tendinitis and tendon rupture is increased in patients aged over 60 years, in patients receiving daily doses of 1000 mg and in patients using corticosteroids. The daily dose should be adjusted in elderly patients based on creatinine clearance. Close monitoring of these patients is therefore necessary if they are prescribed levofloxacin. All patients should consult their physician if they experience symptoms of tendinitis. If tendinitis is suspected, treatment with levofloxacin must be halted immediately, and appropriate treatment (e.g. immobilisation) must be initiated for the affected tendon.

Clostridium difficile-associated disease

Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with levofloxacin (including several weeks after treatment), may be symptomatic of Clostridium difficile-associated disease (CDAD). CDAD may range in severity from mild to life threatening, the most severe form of which is pseudomembranous colitis. It is therefore important to consider this diagnosis in patients who develop serious diarrhoea during or after treatment with levofloxacin. If CDAD is suspected or confirmed, levofloxacin should be stopped immediately and appropriate treatment initiated without delay (e.g. oral metronidazole or vancomycin). Medicinal products inhibiting the peristalsis are contraindicated in this clinical situation.

Patients predisposed to seizures

Quinolones may lower the seizure threshold and may trigger seizures. Levofloxacin is contraindicated in patients with a history of epilepsy and, as with other quinolones, should be used with extreme caution in patients predisposed to seizures, or concomitant treatment with active substances that lower the cerebral seizure threshold, such as theophylline. In case of convulsive seizures, treatment with levofloxacin should be discontinued.

Patients with G-6-phosphate dehydrogenase deficiency

Patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity may be prone to haemolytic reactions when treated with quinolone antibacterial agents. Therefore, if levofloxacin has to be used in these patients, potential occurrence of haemolysis should be monitored.

Hypersensitivity reactions

Levofloxacin can cause serious, potentially fatal hypersensitivity reactions (e.g. angioedema to anaphylactic shock), occasionally following the initial dose. Patients should discontinue treatment immediately and contact their physician or an emergency physician, who will initiate appropriate emergency measures.

Severe bullous reactions

Cases of severe bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with levofloxacin. Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.

Dysglycaemia

As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g., glibenclamide) or with insulin. Cases of hypoglycaemic coma have been reported. In diabetic patients, careful monitoring of blood glucose is recommended.

Prevention of photosensitisation

Photosensitisation has been reported with levofloxacin. It is recommended that patients should not expose themselves unnecessarily to strong sunlight or to artificial UV rays (e.g. sunray lamp, solarium), during treatment and for 48 hours following treatment discontinuation in order to prevent photosensitisation.

Patients treated with vitamin K antagonists

Due to possible increase in coagulation tests (PT/INR) and/or bleeding in patients treated with levofloxacin in combination with a vitamin K antagonist (e.g. warfarin), coagulation tests should be monitored when these drugs are given concomitantly.

Psychotic reactions

Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin. In very rare cases these have progressed to suicidal thoughts and self-endangering behaviour- sometimes after only a single dose of levofloxacin. In the event that the patient develops these reactions, levofloxacin should be discontinued and appropriate measures instituted. Caution is recommended if levofloxacin is to be used in psychotic patients or in patients with a history of psychiatric disease.

QT interval prolongation

Caution should be taken when using fluoroquinolones, including levofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example:

- Congenital long QT syndrome

- Concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics).

- Uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesemia)

- Cardiac disease (e.g. heart failure, myocardial infarction, bradycardia)

Elderly patients and women may be more sensitive to QTc-prolonging medications. Therefore, caution should be taken when using fluoroquinolones, including levofloxacin, in these populations.

Peripheral neuropathy

Sensory or sensorimotor peripheral neuropathy have been reported in patients receiving fluoroquinolones, including levofloxacin, which can be rapid in its onset. Levofloxacin should be discontinued if the patient experiences symptoms of neuropathy in order to prevent the development of an irreversible condition.

Hepatobiliary disorders

Cases of hepatic necrosis up to fatal hepatic failure have been reported with levofloxacin, primarily in patients with severe underlying diseases, e.g. sepsis. Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen.

Exacerbation of myasthenia gravis

Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in patients with myasthenia gravis. Postmarketing serious adverse reactions, including deaths and the requirement for respiratory support, have been associated with fluoroquinolone use in patients with myasthenia gravis. Levofloxacin is not recommended in patients with a known history of myasthenia gravis.

Vision disorders

If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.

Superinfection

The use of levofloxacin, especially if prolonged, may result in overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.

Interference with laboratory tests

In patients treated with levofloxacin, determination of opiates in urine may give false-positive results. It may be necessary to confirm positive opiate screens by more specific method.

Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and, therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis.

Since levofloxacin is excreted mainly by the kidneys, the dose of levofloxacin should be adjusted in patients with renal impairment.

Excipients: The product contains wheat starch which is safe in patients with celiac disease. Other allergy cases should not use it.

USE IN PREGNANCY AND LACTATION:

Levofloxacin must not be used in pregnant women.

The product is contraindicated in breast-feeding women.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:

The drug should be used with caution in drivers and machine users because of possibility of headache, vertigo, tension, agitation.

INTERACTIONS:

Levofloxacin absorption is significantly reduced when antacids, sucralfate, metal cations, multivitamins are administered concomitantly with LEVODHG tablets. These agents should be taken at least 2 hours before or after oral levofloxacin administration.

Theophylline levels should be closely monitored and appropriate dosage adjustments made when levofloxacin is co-administered.

Levofloxacin enhances the effects of vitamin K antagonist (e.g. warfarin) and the risk of hypoglycemia when concomitantly administered with hypoglycaemic drugs and increases the risk of CNS irritation and seizures when co-administered with NSAIDs.

Calcium carbonate, digoxin, glibenclamide, ranitidine: The differences, however, are not considered to be clinically significant. Therefore, no dosage adjustment is required for levofloxacin or the medicine mentioned above when administered concomitantly.

Ciclosporin: The half-life of ciclosporin was increased by 33% when coadministered with levofloxacin.

Caution should be exercised when levofloxacin is coadministered with drugs that affect the tubular renal secretion such as probenecid and cimetidine, especially in renal impaired patients.

Levofloxacin reduces the effects of BCG, mycophenolate, sulfonylurea, typhoid vaccines.

UNDESIRABLE EFFECTS:

The information given below is based on data from clinical studies in more than 8300 patients and on extensive post marketing experience.

Frequencies are defined using the following convention: very common (≥ 1/10), common (≥ 1/100,  < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

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Contact information

System organ class

Common

(≥1/100 to <1/10)

Uncommon

(≥1/1,000 to <1/100)

Rare

(≥1/10,000 to <1/1,000)

Not known

Infections and infestations

 

Fungal infection including Candida infection

Pathogen resistance

   

Blood and lymphatic system disorders

 

Leukopenia

Eosinophilia

Thrombocytopenia

Neutropenia

Pancytopenia

Agranulocytosis

Haemolytic anaemia

Immune system disorders

   

Angioedema

Hypersensitivity

Anaphylactoid shock

Metabolism and nutrition disorders

 

Anorexia

Hypoglycaemia particularly in diabetic patients

Hyperglycaemia

Hypoglycaemic coma

Psychiatric disorders

Insomnia

Anxiety

Confusional state

Nervousness

Psychotic reactions (with e.g. hallucination, paranoia)

Depression

Agitation

Abnormal dreams

Nightmares

Psychotic disorders with self-endangering behaviour including suicidal ideation or suicide attempt

DHG Pharmaceutical Joint-Stock Company

Address: 288 Bis, Nguyen Van Cu Street, An Hoa Ward, Ninh Kieu District, Can Tho City

Representative: Mr Masashi Nakaura            

Contact: +84.292.3891433 – 3890802

Email: dhgpharma@dhgpharma.com.vn

Business registration certificate: No. 1800156801 issued by Can Tho City Department of Planning and Investment on January 2, 2020

License for setting up general information website No. 07/GP-TTĐT issued by Can Tho City Department of Information and Communications on May 31, 2017

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