COMPOSITION :
Moxifloxacin HCl Film coated caplet 400 mg, each film coated caplet contains : Moxifloxacin HCl equivalent to Moxifloxacin 400 mg.
DESCRIPTIONS :
Moxifloxacin HCl contains Moxifloxacin HCl (equivalent to Moxifloxacin) as active ingredient is available in film coated caplet 400 mg.
INDICATIONS :
Moxifloxacin HCl Film coated caplet are indicated for the treatment of adults (≥ 18 years of age) for the following bacterial infections :
- Upper respiratory tract infection
- Acute exacerbations of chronic bronchitis
- Community acquired pneumonia
- Acute sinusitis
- Skin and soft tissue infection
Moxifloxacin is indicated for the treatment of infections caused by bacteria susceptible to Moxifloxacin.
DOSAGE AND ADMINISTRATIONS :
The recommended dosage of one tablet Moxifloxacin 400 mg once daily. No dose adjustment for the elderly.
No dose adjustment for patients with renal failure (creatinine clearance ≤ 30 ml/minute/1.73 m2).
For the treatment of skin and soft tissue infections required initial administration of intravenous therapy followed by administration of 400 mg Moxifloxacin tablets.
Efficacy and safety of Moxifloxacin in children and adolescents has not been established.
Method of administration :
The film coated caplet should be swallowed whole with sufficient liquid and may be taken independent of meals.
Duration of administration :
For the treatment of the following infections, Moxifloxacin 400 mg caplets should be used for :
- Acute exacerbation of chronic bronchitis during 5 – 10 days.
- Community acquired pneumonia during 10 days.
- Acute sinusitis during 7 days.
- Complicated skin and skin structure infections during 7 – 21 days.
The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.
OVERDOSAGE :
There is no particular treatment for Moxifloxacin overdosage. General symptomatic therapy should be initiated. ECG monitoring should be carried out, because of the possibility of QT interval prolongation. Concomitant administration the activated carbon with Moxifloxacin 400 mg will reduce systemic bioavailability of the drug over 80%. The use of activated carbon early after oral administration within absorption may prevent an increase of systemic exposure to Moxifloxacin in cases of oral overdosage.
CONTRAINDICATIONS :
- Patients who are hypersensitive with Moxifloxacin, other quinolones or excipients.
- Pregnancy and lactation.
- Children and adolescents in the growth phase.
- Patients with a history of tendon disease/interference related to quinolone treatment.
- Changes in cardiac electrophysiology have been observed after exposure of Moxifloxacin, in the form of QT prolongation. Therefore, Moxifloxacin is contraindicated in patients with :
- Congenital or history QT prolongation.
- Electrolyte disturbances, particularly hypokalemia that can not be repaired.
- Clinically relevant bradycardia.
- Heart failure is clinically relevant, with a decrease ejection fraction in left ventricular.
- A history of arrhythmia with symptoms.
- Patients who use other drugs that may prolong the QT interval.
- Patients with impaired hepatic function (Child Pugh C) and in patients with elevated transaminases (ULN increased > 5 fold).
WARNINGS AND PRECAUTIONS :
- QTc interval prolongation and clinical conditions that potentially prolong the QTc :
Moxifloxacin shown to prolong the QTc interval on the electrocardiogram of some patients. Women tend to have a baseline QTc interval longer than men, so they may be more sensitive to drugs that may prolong the QTc. Elderly patients may also be more susceptible to drug-related QT interval. Drugs that can reduce potassium levels should be used with caution in patients receiving Moxifloxacin.
Moxifloxacin should be used with caution in patients with conditions proarrhythmic progress (especially women and elderly patients), such as acute myocardial ischaemia or QT prolongation, since this can lead to increased risk of ventricular arrhythmias (including torsade de pointes) and cardiac arrest. QT prolongation may increased with the increase of drug concentration. Therefore, it should not exceed the recommended dosage.
If signs of cardiac arrhythmia occur during treatment with Moxifloxacin, treatment should be stopped and an ECG should be performed.
- Hypersensitivity/allergic reactions :
Hypersensitivity or allergic reactions due to fluoroquinolones administration have been reported, including the first administration of Moxifloxacin. Anaphylactic reactions can progress to shock, even after the first administration. In these cases Moxifloxacin should be discontinued and appropriate treatment should be initiated (e.g., treatment for shock). - Severe liver reactions :
Fulminant hepatitis cases that could potentially cause liver damage (including fatal cases) have been reported to be associated with Moxifloxacin. Patients should consult a doctor before continuing treatment if appear signs and symptoms of fulminant liver disease such as asthenia that growing rapidly associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy. Liver function tests should be done in case of liver dysfunction. - Serious bullous skin reactions :
The case of bullous skin reactions such as Steven-Johnson or toxic epidermal necrolysis have been reported to be associated with Moxifloxacin. Patients should consult a doctor or health provider immediately before continuing treatment if skin reactions and/or mucosa occurs. - Prevention of photosensitive reactions :
quinolone shown to cause photosensitivity reactions. Patients are advised to avoid exposure, against UV light irradiation or excessive sunlight during treatment with Moxifloxacin. - Psychiatric reactions :
Psychiatric reactions may occur even after the first administration of quinolone, including Moxifloxacin. In very rare cases, depression or psychotic reactions have developed into suicidal thoughts and self-injurious behavior such as suicide attempts. If these reactions occur, Moxifloxacin should be discontinued and appropriate measures should be carried out. The use of Moxifloxacin in psychotic patients or in patients with a history of psychiatric illness should be cautious. - Rupture tendon, tendon inflammation :
Rupture and tendon inflammation may occur with quinolone treatment including Moxifloxacin, particularly in elderly patients and in co-administration with corticosteroids. At the first sign of pain or inflammation, patients should discontinue Moxifloxacin treatment, rest the limb pain and consult a physician or health provider immediately to initiate appropriate treatment (e.g., immobilisation) against the tendon. Cracks and inflammation of the tendon may occur even up to several months after discontinuation of treatment quinolone including Moxifloxacin. - Visual impairment :
In case of visual impairment or effects on the patient’s eyes, should consult an ophthalmologist immediately. - Diarrhea due to antibiotics including colitis :
Diarrhea due to antibiotics (Antibiotic-Associated Diarrhea (AAD)) and colitis due to antibiotics (Antibiotic-Associated Colitis (AAC)), including pseudomembranous colitis and diarrhea because Clostridium difficile, has been reported associated with the use of broad spectrum antibiotics including Moxifloxacin and severity levels of mild diarrhea to fatal colitis. Therefore, it is important to consider this diagnosis in patients who develop serious diarrhea during or after the use of Moxifloxacin. If AAD or AAC is suspected, ongoing treatment with antibacterial drugs, including Moxifloxacin, should be discontinued and the measures appropriate treatment should be started. Furthermore, appropriate infection control measures should be taken to reduce the risk of transmission. Drugs inhibiting peristalsis are contraindicated in patients with serious diarrhea. - Peripheral neuropathy :
Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias or weakness have been reported in patients receiving quinolone. Patients treated with Moxifloxacin should inform your doctor or health provider prior to continuing treatment if symptoms of neuropathy develops as pain, burning, tingling, numbness or weakness.
- Pediatric population :
Because of the side effects of cartilage in juvenile animals and the lack of safety data as well as the appropriate dose adjustments, Moxifloxacin should only be used in children and adolescents infected with Mycobacterium tuberculosis if the benefits outweigh the risks and there is no alternative treatment. Moxifloxacin is also not suitable for children and adolescents with body weight < 33 kg, since dose adjustment can not be created. - Patients with impaired liver function :
No dosage adjustment for mild, moderate or severe liver dysfunction. Experience the use of Moxifloxacin in patients with impaired liver function are limited. However, since metabolic disorders associated with impaired liver function may lead to QT prolongation, Moxifloxacin should be used with caution in these patients. - Patients tended to seizures :
quinolone known to trigger seizures. quinolone should be used with caution in patients with Central Nervous System (CNS) disorders or the presence of other risk factors that may lead to seizures or lower the seizure threshold. In case of seizures, treatment with Moxifloxacin should be discontinued and appropriate measures to do. - Patients with myasthenia gravis :
Moxifloxacin should be used with caution in patients with myasthemia gravis because the symptoms can be worsen. - Patients with dehydrogenase glucose-6-phosphate deficiency :
Patients who suffering or have a history of dehydrogenase glucose-6-phosphate deficiency susceptible to haemolytic reactions when treated with quinolone. Therefore, Moxifloxacin should be used with caution in these patients.
- Patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption :
Moxifloxacin contains less lactose. Patients with problems of galactose intolerance, rare inherited, Lapp lactase deficiency or glucose-galactose malabsorption may experience symptoms of intolerance and may not use this drug. - Patients with impaired renal function :
Elderly patients with renal disorders should be careful use of Moxifloxacin if they are unable to maintain adequate fluid intake, because dehydration can be increased the risk of renal failure. - Patients with pelvic inflammatory :
For patients with pelvic inflammatory complex (for example, on tuboovarian or pelvic abscess), which required intravenous medication, treatment with oral Moxifloxacin is not recommended.
Pelvic inflammation can be caused by Neisseria gonorrhoeae resistant to fluoroquinolone. Therefore, Moxifloxacin should be given in conjunction with other suitable antibiotics (e.g., cephalosporins), excluded for Neisseria gonorrhoeae resistant to Moxifloxacin. If clinical improvement is not achieved after 3 days of treatment, continued treatment should be reconsidered.
- Interference in the biological test :
Moxifloxacin treatment may give false negative results against Mycobacterium spp. culture by suppressing mycobacterial growth.
- Patients with MRSA infections :
Moxifloxacin is not recommended for the treatment of MRSA infections. In cases of MRSA infections, or suspected by MRSA, appropriate antibacterial treatment should be initiated. - Pregnancy and breastfeeding :
Pregnancy
No research has been done on the safety of Moxifloxacin in pregnancy. Moxifloxacin should only be used in pregnancy if benefits outweigh the risks and no alternative treatments are available. A reversible joint injury occurs in children receiving some quinolones, but this effect has not been reported to the fetus. Animal studies show reproductive toxicity. The potential risk to humans is unknown.
Breastfeeding
The use of Moxifloxacin during breastfeeding is contraindicated. Like other quinolones, Moxifloxacin is shown to cause lesions in cartilage joints in animals. Moxifloxacin is secreted into breast milk.
- Effects on drivers and use machine :
There is no research on the effects of Moxifloxacin on the ability to drive and run the engine. However, fluoroquinolone including Moxifloxacin may have an impact on the patient’s ability to drive or run the engine due to reactions to the Central Nervous System (CNS), e.g., dizziness, temporary or acute loss of vision and transient loss of consciousness (syncope). Patients advisable to see how their reaction to Moxifloxacin before driving or run the engine.
DRUG INTERACTIONS :
- Interactions mediated by P450 cytochrome :
Moxifloxacin does not occur interact with metabolism through the cytochrome P450 enzyme.
There is no interaction after co-administration Moxifloxacin with Ranitidin, Probenecid, oral contraceptives, calcium supplements, Morphine are administered parenterally, Theophylline, Cyclosporine or Itraconazole.
- Rifampicin :
When administered simultaneously with a multiple dose of Rifampicin, AUC Moxifloxacin decreased by approximately 30%. These clinical consequences are unknown and no dose adjustments are recommended for concurrent use. These clinical consequences are unknown and no dose adjustments are recommended for concurrent use. - Rifapentine :
When administered simultaneously with a multiple dose of Rifapentine, AUC Moxifloxacin decreased by 17%. These clinical consequences are unknown and no dose adjustments are recommended for concurrent use. - Drugs that prolong QT :
The additive effect on the QT interval extension of Moxifloxacin and other drugs that prolong the QT interval can not be ignored. For example :
- Class IA antiarhythmias (e.g., Quinidine, Hydroquinidine, Disopyramide).
- Class III antiarhythmias (e.g., Amiodarone, Sotalol, Dofetilide, Ibutilide).
- Neuroleptic (such as Phenothiazine, Pimozide, Sertindole, Haloperidol, Sultopride).
- Tricyclic antidepressant drugs.
- Specific antimicrobial (Sparfloxacin, Erythromycin IV, Pentamidine, antimalaria, especially Halofantrine).
- Specific antihistamine (Terfenadine, Astemizol, Mizolastine).
Others (especially Cisapride, Bepridil).
This effect can lead to an increased risk of ventricular arrhythmias, especially torsade de pointes. Therefore, Moxifloxacin is contraindicated in patients treated with this drug.
- Bivalent and trivalent cations :
Chelates such as iron, aluminium and magnesium can inhibit Moxifloxacin absorption. Concomitant administration or administration in drugs which containing these cation in Moxifloxacin intake may reduce Moxifloxacin exposure approximately 25 – 60%.
The time interval separating at least 6 hours between administration of drugs containing bivalent or trivalent cations (e.g., antacids containing magnesium or aluminum, Didanosine, Sucralfate and medicines containing iron or zinc) with Moxifloxacin administration.
Calcium does not affect Moxifloxacin exposure, and supplements containing calcium can be given simultaneously with Moxifloxacin.
- Change of INR (International Normalized Ratio) :
A large number of cases showed an increase in oral anticoagulant activity reported in patients receiving antibiotics, particularly fluoroquinolone, macrolide, Tetracycline, Cotrimoxazole and some cephalosporins. It is difficult to evaluate whether the infection or the antibiotic treatment that causes disruption INR (International Normalized Ratio). INR should be frequently monitored in patients given Warfarin or other anticoagulants.
- Interactions with food :
Moxifloxacin has no interaction with food including dairy products. - Warfarin :
There is no interaction during concomitant use with Warfarin on prothrombin time and other coagulation parameters. - Digoxin :
Pharmacokinetics of Digoxin is not affected by Moxifloxacin (and vice versa). - Antidiabetes :
No clinical interaction between Glibenclamide and Moxifloxacin.
ADVERSE REACTIONS :
- Infection and Infestation :
Common : Superinfection due to resistant bacteria or fungi, e.g. oral and vaginal candidiasis.
- Lymphatic and blood system disorders :
- Uncommon : Anemia, leukopenia, neutropenia, thrombocytopenia, eosinophilia, increased INR.
- Very rare : Decreased INR, agranulocytosis.
- Immune system disorders :
- Uncommon : Allergic reactions.
- Rare : Anaphylaxis, angioedema.
- Metabolic and nutritional disorders :
- Uncommon : Hyperlipidemia.
- Rare : Hyperglycemia, hyperuricemia.
- Psychiatric disorders :
- Uncommon : Anxiety reactions, psychomotor hyperactivity/restlessness.
- Rare : Unsteady emotions, depression, hallucinations.
- Very rare : Depersonalization, psychosis.
- Nervous system disorders :
- Common : Headache, dizziness.
- Uncommon : Paraesthesia, impaired taste, confusion and disorientation, insomnia, drowsiness, tremor, vertigo.
- Rarely : Hypoaesthesia, olfactory disorders, abnormal dreams, impaired coordination (including gait disturbances, mainly due to dizziness or vertigo), seizures including grand mal seizures, distracted attention, speech disorders, amnesia.
- Very rarely : Hyperaesthesia.
- Eye disorders :
- Rare : Visual disturbances include diplopia and blurred vision (especially in relation to central nervous system reactions).
- Very rare : Temporary loss of vision (especially in relation to central nervous system reactions).
- Impaired hearing and labyrinth functions :
- Rare : Tinnitus, hearing loss including deafness (usually reversible).
- Cardiac disorders :
- Uncommon : QT prolongation, palpitations, tachycardia, atrial fibrillation, angina pectoris.
- Rare : Ventricular tachyarrhythmias, syncope.
- Very rare : Torsade de pointes, heart attack.
- Vascular disorders :
- Uncommon : Vasodilatation.
- Rare : Hypertension, hypotension.
- Respiratory, thorax and mediastinal disorders :
Uncommon : Dyspnea (including asthma condition). - Indigestion :
- Common : Nausea, vomiting, abdominal pain, diarrhea.
- Uncommon : Anorexia, constipation, dyspepsia, bloating, gastritis, increased amylase.
- Rare : Dysphagia, stomatitis, colitis due to antibiotics (including pseudomembranous colitis, in very rare cases associated with life-threatening complications).
- Liver and gallbladder disorders :
- Common : Increased transaminase.
- Rare : Increased bilirubin, increased gamma-glutamyl-transferase, increased blood alkaline phosphate, jaundice, hepatitis (especially cholestasis).
- Very rare : Fulminant hepatitis which has the potential to cause life-threatening liver damage (including fatal cases).
- Skin and subcutaneous tissue disorders :
- Common : Increased transaminase.
- Uncommon : Pruritus, rash, urticaria, dry skin.
- Very rare : Bullous skin reaction, including Steven-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).
- Musculoskeletal, connective tissue and bone disorders :
- Uncommon : Arthralgia, myalgia.
- Rare : Tendinitis, muscle spasms, muscle twitching, muscle weakness.
- Very rare : Rupture tendon, arthritis, muscle stiffness, exacerbation of myasthenia gravis symptoms.
- Renal and urinary tract disorders :
- Uncommon : Dehydration.
- Rare : Impaired renal function (including elevated BUN and creatinine), renal failure.
- General disturbances and drug administration site conditions :
- Uncommon : Asthenia, fatigue, sweating, pain conditions (including pain in back, chest, pelvis and limbs).
- Rare : Edema.
There are very rare cases of side effects reported after treatment with other floroquinolone, which may also occur during treatment with Moxifloxacin, namely hypernatremia, hypercalcemia, haemolytic anemia, rhabdomyolysis, photosensitivity reactions, peripheral neuropathy.
PRESENTATION :
Moxifloxacin HCl Film coated caplet 400 mg Box, 2 strips @ 10 film coated caplets
Reg. No. GKL1702355209A1
STORAGE :
STORE BELOW 30ºC
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
