COMPOSITION :
Moxifloxacin HCl Infusion 400 mg/250 ml, each 250 ml contains : Moxifloxacin HCl equivalent to Moxifloxacin 400 mg.
DESCRIPTIONS :
Moxifloxacin HCl contains Moxifloxacin HCl (equivalent to Moxifloxacin) as active ingredient is available in infusion 400 mg/250ml.
INDICATIONS :
Moxifloxacin IV is only for patients that cannot take oral administration. Moxifloxacin infusions 400 mg are indicated for the treatment of adults (≥ 18 years of age) for the following bacterial infections :
- Acute exacerbations of chronic bronchitis.
- Community acquired pneumonia.
- Acute bacterial sinusitis (adequately diagnosed).
- Complicated skin and skin structure infections who require initial parenteral therapy; followed by oral, in patients who are intolerance to alternative agents (especially Penicillin allergy) and when caused by organisms known to be susceptible to Moxifloxacin.
- Complicated intra-abdominal infections due to polymicrobial infections in patients who are intolerance to alternative agents; caused by organisms known to be susceptible to Moxifloxacin.
Moxifloxacin infusions 400 mg are indicated for the treatment of the above infections if they are caused by bacteria susceptible to Moxifloxacin. Consideration should be given of official guidance on the appropriate use of antibacterial agents. Moxifloxacin may only be used on prescription and under the constant supervision of doctor.
DOSAGE AND ADMINISTRATIONS :
Range of dose
- The recommended dose for Moxifloxacin is 400 mg once daily.
- No adjustment of dosage is required in the elderly.
- Efficacy and safety in children and adolescents have not been established (see contraindications).
- No dose adjustment in patient with any degree of renal impairment (including creatinine clearance ≤ 30 ml/minute/1.73m2).
- For treatment of complicated skin and skin structure infections requiring initial intravenous therapy followed by oral tablet administration of 400 mg Moxifloxacin tablet.
- For treatment of complicated intra-abdominal infections requiring initial intravenous therapy followed by oral administration of 400 mg Moxifloxacin tablet.
Method of administration
- The infusion solution should be infused intravenously over 60 minutes.
- Only be given directly, not to be administered simultaneously with other intravenous fluids
- If Moxifloxacin infusion solution is to be given with another drug, each drug should be given separately.
- Only clear solutions are to be used.
Duration of administration
Moxifloxacin infusion 400 mg and tablet should be used for the following treatment durations :
- Acute exacerbation of chronic bronchitis : 5 – 10 days
- Community acquired pneumonia : 10 days
- Acute sinusitis : 7 days
- Complicated skin and skin structure infections : 7 – 21 days (sequential IV/oral therapy)
- Complicated intra-abdominal infections : 5 – 14 days (sequential IV/oral therapy)
Moxifloxacin can be administered intravenously as initial intravenous administration, followed by oral tablet administration when allowed by the patient’s condition. The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded. Intravenous therapy may be limited for up to two to five days in therapy in the very ill patients and should be changed to oral therapy whenever possible as determined by the physician.
OVERDOSAGE :
There is no experience with Moxifloxacin in overdose. No specific countermeasures after accidental over dosage are recommended. General symptomatic therapy should be initiated.
CONTRAINDICATIONS :
- Known hypersensitivity to any component of the infusion or other Quinolones.
- Pregnancy and lactation (see section : Use during pregnancy and lactation).
- Patients below 18 years of age.
- Patient with a history of tendon disease/disorder related to Quinolone treatment.
- Congenital or documented acquired QT prolongation.
- Electrolyte disturbances, particularly in hypokalaemia.
- Clinically relevant bradycardia.
- Clinically relevant heart failure with reduced left-ventricular ejection fraction.
- Previous history of symptomatic arrhythmias.
Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval in particular class IA (example : Quinidine, Procainamide) and class III antiarrythmic agents (example : Amiodarone, Sotalol). Moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5 fold upper limit of normal and in patients with a creatinine clearance below 30 ml/minute/1.73m2 (serum creatinine > 265 µmol/l) or undergoing renal dialysis.
WARNINGS AND PRECAUTIONS :
- Quinolones are known to trigger seizures. Use should be with caution in patients with CNS disorders, which may predispose to seizures or lower the seizure threshold.
- If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
- Tendon inflammation and rupture may occur with Quinolone therapy, particularly in elderly patients and in those treated concurrently with Corticosteroids. At the first sign of pain or inflammation, patient should discontinue treatment with Moxifloxacin and rest the affected limb(s).
- Moxifloxacin, as with some other Quinolones and Macrolides, has been shown to prolong the QTc interval. Moxifloxacin should be used with caution in patients using concomitant medication that can reduce potassium and magnesium level.
- If signs of cardiac arrhythmia occur during treatment with Moxifloxacin, treatment should be stopped and an ECG should be performed.
- Liver function tests/investigations should be performed in cases where indications of liver dysfunction occur.
- Pseudomembranous colitis has been reported with the use of broad-spectrum antibiotic; therefore it is important to consider this diagnosis in patients who develop serious diarrhea during or after during Moxifloxacin. Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhea.
- Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
- Patients with a family history of, or actual defects in Glucose-6-phosphate dehydrogenase deficiency are prone to hemolytic reactions when treated with Quinolones. Therefore, Moxifloxacin should be used with caution in these patients.
- Quinolone have been shown to cause photosensitivity reactions in patients. However, studies have been shown that Moxifloxacin has no substantive potential to induce photosensitivity. Nevertheless patient should be advised to avoid exposures to either UV irradiation or extensive sunlight during treatment with Moxifloxacin.
- In some instances, the hypersensitivity and allergic reactions already occurred after the first administration and the doctor should be informed immediately. Anaphylactic reactions in very rare case instances can be progress to a life threatening shock, in some instances after the first administration. In these cases the treatment with Moxifloxacin has to be discontinued and medical treatment (e.g. treatment for shock) is required.
- As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTc prolonging medications. Elderly patients may also be more susceptible to drug associated effects on the QT interval.
- For patients with complicated pelvic disease (e.g. associated with a tubo ovarian or pelvic abscess), for whom an intravenous treatment is considered necessary treatment with Moxifloxacin 400 mg film coated tablet is not recommended.
- In patients for whom sodium intake is of medical concern (patients with congestive heart failure, renal failure, nephrotic syndrome, etc) the additional sodium load of the solution for infusion should be taken into account.
- QT prolongation may lead to an increased risk for ventricular arrhythmias including torsades de pointes. No cardiovascular morbidity or mortality attributable to QTc prolongation occurred with Moxifloxacin treatment in clinical studies with more than 8000 patients, however certain predisposing conditions may increase the risk for ventricular arrhythmias.
- In woman and elderly patients who both may be more susceptible to QTc prolonging drugs.
- Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with Moxifloxacin. Patients should be advised to contact their doctor immediately prior to continuing treatment if symptoms related to liver failure occur.
- Cases of bullous skin reactions like Steven-Johnson syndrome or toxic epidermal necrolysis have been reported with Moxifloxacin. Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
- Use during pregnancy and lactation :
The safety of use of Moxifloxacin in human pregnancy has not been evaluated. Reproduction studies performed in rats and monkeys did not reveal any evidence of teratogenicity or impairment of fertility. However, as with other Quinolones, Moxifloxacin has been shown to cause lesions in cartilage of the weight bearing joints of immature animals. The use of Moxifloxacin in pregnancy and nursing mothers is contraindicated (see contraindications).
- Effects on ability to drive and use machine :
Fluoroquinolones may result in an impairment of the patient’s ability to drive or operate machinery, due to CNS reactions (e.g. dizziness). Patients should be advised to see how they react to Moxifloxacin before driving or operating machinery.
DRUG INTERACTIONS :
- Concomitant use of drugs that induce bradycardia or hypokalaemia or drugs which induce QT prolongation (neuroleptic, certain anti-infective agents [some antimalarials, Azole antimycotics, Macrolides], certain antihistaminics [Terfenadine, Astemizole, Cisapride] should be considered carefully (see section warning and precaution). Antiarrythmic drugs class IA and III, are contraindicated (see section contraindications).
- No interactions have been occurred following concomitant administration of Moxifloxacin with : Warfarin, Ranitidine, Probenecid, oral contraceptives or Theophylline.
- Changes in INR (International Normalized Ratio) : Cases of increased anticoagulant activity have been reported in patients receiving anticoagulants concurrently with antibiotics, including Moxifloxacin.
ADVERSE REACTIONS :
| Clinical Description | Common
> 1% to < 10% |
Uncommon
> 0.1% to < 1% |
Rare
> 0.01% to < 0.1% |
Very rare
< 0.01% |
| General Disorders and Administration Site Conditions | ||||
| General feeling of illness | Feeling unwell
Unspecific pain Sweating |
|||
| Infusion site reactions | Injection and infusion site reactions | Infusion site (thrombo-) phlebitis | ||
| General disorders | Oedema | |||
| Infections and Infestations | ||||
| Antibiotic induced super-infections | Mycotic superinfections | |||
| Cardiovascular System Disorders | ||||
| Repolarisation disorders | QT prolongation in patients with hypokalaemia | QT prolongation | ||
| Unspecific arrhythmias | Palpitations
Tachycardia |
|||
| Ventricular arrhythmias | Ventricular tachyarrhythmias | Torsade de Pointes “cardiac arrest” (especially in patients with severe underlying proarrhythmic conditions such as clinically significant bradycardia, acute myocardial ischemia) | ||
| Unspecific cardiovascular symptoms | Vasodilation | Syncope
Hypertension Hypotension |
||
| Gastrointestinal Disorders | ||||
| Gastro-intestinal symptoms | Nausea
Vomiting Gastrointestinal and abdominal pain |
Anorexia
Constipation Dyspepsia Flatulence Gastroenteritis (excl. erosive gastroenteritis) Increased amylase |
Dysphagia
Stomatitis |
|
| Antibiotic induced diarrhea disorders | Diarrhea | Antibiotic associated colitis (in very rare cases associated with life threatening complications) | ||
| Hepatobiliary Disorders | ||||
| Mild to moderate hepatic reactions | Increase in transaminases | Hepatic impairment (incl. LDH increase)
Increased bilirubin Increased gamma-glutamyl-transferase Increase in blood alkaline phosphatase |
||
| Severe hepatic reactions | Jaundice
Hepatitis (predominantly cholestatic) |
Fulminant hepatitis potentially leading to life threatening liver failure (incl. fatal cases) | ||
| Blood and Lymphatic System Disorders | ||||
| Changes in blood cell counts | Anemia
Leucopenia(s) Neutropenia Thrombocytopenia Thrombocythemia |
|||
| Changes in coagulation | Prothrombin time prolonged/INR increased | Thromboplastin level abnormal | Prothrombin level increased/INR decreased
Prothrombin level/INR abnormal |
|
| Immune System Disorders | ||||
| Acute hypersensitivity reactions | Allergic reaction
Pruritus Rash Urticaria Blood eosinophilia |
Anaphylactic/ana-phylactoid reactions
Peripheral edema Allergic edema/angioedema (incl. laryngeal edema, potentially life threatening) |
Anaphylactic/ anaphylactoid shock (potentially life threatening) | |
| Metabolism and Nutritional Disorders | ||||
| Changes in Laboratory Parameters | Hyperlipidemia | Hyperglycemia
Hyperuricemia |
||
| Musculoskeletal, Connective Tissue and Bone Disorder | ||||
| Tendon disorders | Tendonitis | Tendon rupture | ||
| Unspecific joint and muscular disorders | Arthralgia
Myalgia |
Increased Muscle tone and cramping | Arthritis
Gait disturbance (caused by unspecific muscular or joint symptoms) Exacerbation of symptoms of myasthenia gravis |
|
| Nervous System Disorders | ||||
| Unspecific altered peripheral perception | Par- and/Dysesthesia | Hypoesthesia | Hyperesthesia | |
| Smell and taste disorder | Taste disorder (incl. ageusia in very rare cases) | Smell disorders (incl. anosmia) | ||
| Increased neurological activities | Headache
Dizziness |
Confusion and disorientation
Sleep disorder Tremor Vertigo |
Abnormal dreams
Disturbed coordination (incl. gait disturbances, esp. due to dizziness or vertigo; in very rare cases leading to fall with injuries, esp. in elderly) Seizures of various manifestations (incl. grandmal convulsions) |
|
| Decreased neurological activities | Somnolence | Disturbed attention
Speech disorders Amnesia |
||
| Psychiatric Disorders | ||||
| Behavioural disturbances | Anxiety reactions
Psychomotor Hyperactivity/agitation |
Emotional lability
Depression (in very rare cases potentially culminating in self-endangering behavior) Hallucination |
Depersonalization
Psychotic reaction (potentially culminating in self-endangering behavior) |
|
| Respiratory, Thoracic and Mediastinal Disorders | ||||
| Unspecific respiratory symptoms | Dyspnea (including asthmatic conditions) | |||
| Skin and Subcutaneous Tissue Disorders | ||||
| Bullous skin reactions | Bullous skin reactions like Steven-Johnson syndrome or toxic epidermal necrolysis (potentially life threatening) | |||
| Ear and Labyrinth Disorders | ||||
| Ear disorders | Vertigo | Tinitus | ||
| Eye Disorders | ||||
| Eye Disorders | Visual disturbances (especially in the course of CNS reactions) | |||
| Renal and Urinary Disorders | ||||
| Renal Impairment | Dehydration (caused by diarrhea or reduced fluid intake) | Renal impairment to renal failure (due to dehydration) esp. in elderly with pre-existing renal disorders | ||
The following undesirable effects have a higher frequency in the subgroup of IV/oral sequentially treated patients.
Common : Increased gamma-glutamyl-transferase.
Uncommon : Ventricular tachyarrythmias, hypotension, oedema, antibiotic associated colitis (in very rare cases associated with life threatening complications), seizures of various clinical manifestations (incl. grand mal convulsions, hallucination, renal impairment (which in some cases due to dehydration can lead to renal failure esp. in elderly with pre-existing renal disorders).
PRESENTATION :
Moxifloxacin HCl Infusion 400 mg/250 ml Box, 1 bottle @ 250 ml Reg. No. …
STORAGE :
STORE BELOW 30°C
At cool storage temperature precipitation may occur, which will re-dissolve at room temperature. It is therefore recommended not to store the infusion solution in a refrigerator.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
