MOXIVID Film Coated Caplet

Moxifloxacin HCl 400 mg

Category:

COMPOSITION :

Moxivid Film coated caplet 400 mg, each film coated caplet contains : Moxifloxacin HCl equivalent to Moxifloxacin 400 mg.

 

DESCRIPTIONS :

Moxivid contains Moxifloxacin HCl (equivalent to Moxifloxacin) as active ingredient is available in film coated caplet 400 mg.

 

INDICATIONS :

Moxivid Film coated caplet are indicated for the treatment of adults (≥ 18 years of age) for the following bacterial infections :

  • Upper respiratory tract infection
  1. Acute exacerbations of chronic bronchitis
  2. Community acquired pneumonia
  3. 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 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 :
    1. Congenital or history QT prolongation.
    2. Electrolyte disturbances, particularly hypokalemia that can not be repaired.
    3. Clinically relevant bradycardia.
    4. Heart failure is clinically relevant, with a decrease ejection fraction in left ventricular.
    5. 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 neuropati :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.

 

PRESENTATION :

Moxivid Film coated caplet 400 mg                                          Box, 1 strip @ 10 film coated caplets

Reg. No. : DKL1702355109A1

 

STORAGE :

STORE BELOW 30oC

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :

PT. BERNOFARM

Sidoarjo – Indonesia

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