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Normon S.A. - Sapin

ANASTROZOLE NORMON
BISOPROLOL NORMON
DESLORATIDINE NORMON
ESCITALOPRAM NORMON
ESOMEPRAZOLE NORMON
ESTECINA Inj.
ESTECINA Tablets
FIXIM
GASTRIMUT
LAMOTRIGINE NORMON
LETROZOLE NORMON
LEVOFLOXACIN NORMON
LIDOCAINE 2% EPINEPHRINE NORMON
NORMOCEF
NORMOPRIL
PARACETAMOL NORMON
SIMVASTATIN NORMON
TOPAGAN

Forms and presentation
Solution for IV infusion: Bottle of 100 ml: Box of 1.

Composition
Each ml contains: Levofloxacin: 5mg. Excipients: sodium chloride, hydrochloric acid or sodium hydroxide and water for injection.

Properties
Levofloxacin Normon belongs to a group of drugs known as fluoquinolones, an antibiotic with bactericide activity.

Indications
This drug is used only in adults the treatment of the following bacterial infections when caused by sensitive microorganisms: Community-acquired pneumonia, complicated infections of the urinary tract, including pyelonephritis, chronic bacterial prostatitis, skin and soft tissue infections.

Contraindications
Hypersensitivity to levofloxacin or to any of the other components of this drug. Epilepsy or a disease that can cause convulsions (head traumas, cerebrovascular accident, etc.). Tendinitis. Pregnancy and lactation. Children or adolescents in periods of growth.

Precautions
Caution is advised in patients with brain injury, as the risk of convulsions may increase with concomitant use of Levofloxacin Normon.
Avoid strong sun light or artificial UV light exposure.
If pseudomembranous colitis is suspected, suspend therapy and establish suitable treatment.
On rare occasions, Levofloxacin Norman can cause pain and tendonitis which frequently affects the Achilles tendon, leading to rupture of the tendon, especially in elderly patients or patients who are on treatment with corticosteroids.
Levofloxacin should be used with caution in patients suffering from G6PD deficiency, as patients may be predisposed to haemolysis when treated with antibiotic drugs of the quinolone family.
This drug contains 354mg of sodium per 100ml, which should be taken into consideration with patients on low sodium diets.
Levofloxacin Normon should not be mixed with certain solutions (e.g. sodium bicarbonate) or heparin.
Children: Children and adolescents should not use Levofloxacin Normon due to the risk of producing lesions to joint cartilage.
Elderly: Levofloxacin Normon may cause pain or inflammation of the tendons.
Renal insufficiency: Lower doses may be required than with normal renal activity.

Drug interactions
It is not recommended to use Levofloxacin Normon at the same time as other drugs such as: Theophyline, fenbufen or similar NSAIDs (convulsive threshold may decrease), and oral anticoagulant drugs (vitamin K antagonists, such as warfarin).

Ability to drive and use machine
Due to the possibility of side effects such as dizziness, somnolence or sight disorders, Levofloxacin Normon can reduce the capacity to carry out certain tasks, such as driving or handling machinery.

Pregnancy and lactation
Pregnancy: Safety of Levofloxacin Normon during pregnancy has not been studied. Levofloxacin Normon should not be used in pregnant women.
Lactation: It is excreted in breast milk and should not be used in breastfeeding women.

Side effects
Cardiac disorders: Rare: hypotension, tachycardia.Very rare: circulatory collapse (anaphylactic shock). Isolated cases: heart disorders that can possibly lead to abnormal heart rate.
Blood disorders: Infrequent: increase or decrease in white corpuscle count. Rare: decrease in platelet count, leading to a tendency to bruise and bleed easily. Very rare: granulocytosis. Isolated cases: haemolytic anaemia, pancytopenia.
Nervous system disorders: Infrequent: headache, dizziness, somnolence, sleep disorders. Rare: paraesthesia, trembling, agitation, anxiety, depression, psychotic reactions, seizures and confusion. Very rare: sight and hearing disorders, taste and smell disorders, swelling, psychiatric problems including hallucinations and changes of mood, movement disorders including difficulties with gait.
Gastrointestinal disorders: Frequent: nausea, diarrhoea. Infrequent: anorexia, dyspepsia, vomiting, abdominal pain. Rare: diarrhoea with blood which in very rare cases may indicate enterocolities, including pseudomembranous colitis. Very rare: hypoglycemia, which may be important in diabetic patients who are being treated with hypoglycaemic drugs.
Renal and urinary disorders: Very uncommon: abnormal values in blood tests due to kidney problems. Very common: kidney function problems and, occasionally, renal failure that may result from interstitial nephritis.
Skin disorders and SC tissue: frequent: itching and rash. Rare: general allergic reactions (anaphylactic/anaphylactoid reactions) which can occasionally occur minutes or hrs after the first dose, with symptoms that may be wheals, irritation or rash and dyspnea/bronchospasm. Very rare: sudden drop in blood pressure or shock, allergic skin reactions such as photosensitivity. Isolated cases: Stevens-Johnson syndrome, Lyell's syndrome and exudative erythema multiforme.
Muscle, bone and tendon disorders: Rare: tendonitis (e.g. Achilles tendon), joint and muscle pain. Very rare: ruptured tendon (e.g. Achilles tendon).This adverse reaction may occur within 48 hrs of starting treatment and may occur in both extremities. Muscle weakness, which may be particularly notable in patients with myasthenia gravis. Isolated cases: rhabdomyolysis.
Hepatobiliary disorders: Frequent: increase in hepatic enzyme levels. Infrequent: abnormal analysis values due to kidney or liver problems. Very rare: inflammation of the liver.
Other reactions: Infrequent: general weakness. Very rare: fever, allergic inflammation of the minor blood vessels or pulmonary allergic reactions.
Some drugs in the family to which Levofloxacin Normon belongs may induce attacks of porphyria in patients with porphyria. Thus; this may also occur with Levofloxacin Normon.

Dosage and administration
Levofloxacin Normon should only be administrated by slow IV infusion. Infusion time for 500mg (100ml) should not be less than 60 minutes. The normal dose is:

Patients with normal kidney function (Clcr > 50ml/min):

Indication

Daily Dose (depending on severity)

Community-acquired pneumonia

500mg once or twice daily

Complicated urinary tract infections, including pyelonephritis

250 mg once a day

Chronic bacterial prostatitis

500 mg once a day

Skin and soft tissue infections

500 mg twice daily

In the case of severe infection, an increase in dose should be considered.
 
Elderly patients and patients with impaired hepatic function but normal kidney function should receive the same dose as normal adults.
 
Dosage in patients with renal insufficiency (Clcr < 50ml/ min):
 

 

250mg/24h

500mg/24h

500mg/12h

Clcr

Initial dose 250mg

Initial dose 500mg

Initial dose 500mg

50-20 ml/min

Then: 125mg/24h

Then: 250mg/24h

Then: 250mg/12h

19-10 ml/min

Then: 125mg/48h

Then: 125mg/24h

Then: 125mg/12h

< 10 ml/min (including haemodialysis and CAPD)

Then: 125 mg/48h

Then: 125mg/24h

Then: 125mg/24h

Additional doses after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD) are not required.
 
Levofloxacin Normon may be administered alone or with one of the following solutions: 0.9% sodium chloride solution; 5% glucose; 2.5% glucose in Ringer solution; combination solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).The validity period of the product in the different solutions is a maximum of 8 hrs at 25°C.
Length of treatment: The length of treatment is determined by the clinical status and response to treatment. As with all antibacterial agents, treatment with Levofloxacin Normon should be continued for a minimum of 2-3 days after body temperature has returned to normal and symptoms have disappeared.

Overdosage

An accidental overdose could lead to symptoms in the CNS, such as confusion, dizziness, alteration to consciousness and seizures and heart disorders, which could cause abnormal heart rate. In case of overdose, the treatment will depend on the symptoms. Levofloxacin is not eliminated from the body by dialysis. There is no specific antidote.

Storage conditions

Store below 30°C. Keep the bottle in the outer packaging in order to protect it from light.

Origin: Spain
Laboratories: Normon
Distributor: Droguerie Phenicia
Year of submission: 2009
Number & Year of Registration: 219537/2010