MOLOXCIN

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MOLOXCIN 400

COMPOSITION:

Moxifloxacin HCl ........... equivalent to 400 mg of moxifloxacin 

Excipients q.s .................................................................. 1 tablet

(Lactose monohydrate, microcrystalline cellulose M101, croscarmellose sodium, aerosil, magnesium stearate, HPMC 606, HPMC 615, PEG 6000, talc, titanium dioxide, red ferric oxide).

DOSAGE FORM: Film coated tablets.

PRESENTATION:  Box of 1 blister x 10 tablets.

PHARMACODYNAMICS:

Moxifloxacin is a synthetic antibiotic belonging to fluoroquinolones group. Moxifloxacin has activity against both Gram-positive and Gram-negative microorganisms. The bactericidal action of moxifloxacin results from inhibition of the bacterial DNA.

Moxifloxacin has greater activity in vitro against Streptococcus pneumoniae (including penicillin-resistant strains) than many other fluroquinolones (e.g., ciprofloxacin, levofloxacin, ofloxacin) while generally retaining the activity of these drugs against Gram-negative bacteria and etiologic agents of atypical pneumonia (e.g., Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella spp.). Moxifloxacin is active against in vitro and in clinical infections against most strains of Staphylococcus aureus (methicillin-sensitive strains), Streptococcus pyogenes, Haemophilus influenzae, H. parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae and Mycoplasma pneumoniae.

Mechanism of resistance: In vitro resistance to moxifloxacin is acquired through a stepwise process by target site mutations. Cross-resistance has been observed between moxifloxacin and other fluoroquinolones against Gram-negative bacteria. Gram-positive bacteria resistant to other fluoroquinolones may, however, still be susceptible to moxifloxacin.

PHARMACOKINETICS:

Moxifloxacin is well absorbed from the gastrointestinal tract. The absolute bioavailability of moxifloxacin is approximately 90%. Co-administration with a meal does not affect the absorption of moxifloxacin; therefore, it can be given before or after a meal. Moxifloxacin is widely distributed throughout the body; it has been detected in the saliva, nasal and bronchial secretions, sinus mucosa, skin blister fluid, subcutaneous tissue, skeletal muscle following a 400-mg dose. Tissue concentrations usually outweigh plasma concentrations. The mean elimination half-life from plasma is about 12 hours, so moxifloxacin should be given once a day.

INDICATIONS:

Treatment of infections caused by moxifloxacin susceptible bacteria: community acquired pneumonia, skin and skin structure infections.

Acute exacerbation of chronic bronchitis

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

Bacterial acute sinusitis

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

CONTRAINDICATIONS:

Hypersensitivity to moxifloxacin and other quinolones or to any components of the drug.

Children aged less than 18 years.

In patients with known prolongation of the QT interval and patients receiving Class 1A (quinidine, procainamide,…), Class III (amiodarone, sotalol,…) antiarrhythmic agents.

WARNINGS AND PRECAUTIONS:

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 moxifloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.

Discontinue moxifloxacin 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.

Moxifloxacin has been shown to prolong the QT interval of the electrocardiogram; therefore, caution should be exercised when moxifloxacin is given concurrently with cisapride, erythromycin, tricyclic antidepressants, and antipsychotics. 

Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions, such as bradycardia, acute myocardial ischemia; in patients with known or suspected CNS disorders e.g severe cerebral arteriosclerosis, epilepsy.

Fluoroquinolones, including moxifloxacin, are associated with increased risk of tendinitis and tendon rupture in all age groups. This risk is further increased in older adults (usually those older than 60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.

Other factors that may independently increase risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients receiving fluoroquinolones who did not have any of these risk factors.

Fluoroquinolone-associated tendinitis and tendon rupture most frequently involve the Achilles tendon and may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (shoulder), hand, biceps, thumb, and other tendon sites also have been reported.

Tendon rupture can occur during or following fluoroquinolone therapy and has been reported up to several months after completion of therapy.

Advise patients to rest and refrain from exercise and contact a clinician at the first sign of tendinitis or tendon rupture (e.g., pain, swelling, or inflammation of a tendon or weakness or inability to use a joint). Discontinue moxifloxacin if pain, swelling, inflammation, or rupture of a tendon occur.

PREGNANCY AND LACTATION:

Do not indicate the drug to pregnant women.

Breast-feeding is contraindicated during moxifloxacin therapy.

VEHICLE DRIVERS AND MACHINERY OPERATORS:

Cautions should be taken when driving vehicles and operating machinery.

INTERACTIONS:

Decreased absorption of oral moxifloxacin if given concomitantly with antacids, iron preparations or multivitamins containing sucralfate or zinc; oral administration should be taken at least 4 hours before or 8 hours after these preparations. Moxifloxacin has been reported to enhance anticoagulant effects in patients receiving concomitant warfarin and moxifloxacin.

The concomitant administration of a nonsteroidal anti-inflammatory drug (NSAID) with moxifloxacin may increase the risks of CNS stimulation and convulsions.

The drug may induce resonant effect of QT interval.

ADVERSE EFFECTS:

Frequently: Vomiting, diarrhea. Vertigo.

Infrequently: Abdominal pain, dryness of mouth, dyspepsia, mild taste disorder. Headache, convulsion, depression, confusion, tremor, insomnia, restlessness, anxiety, somnolence. Itching, erythema. Increased amylase and lactate dehydrogenase. Arthralgia, myalgia.

Rarely: QT interval prolongation. Achilles tendon rupture and other tendon rupture. C.difficile-associated diarrhea. Hallucinations, vision disorders, neurasthenia.

Directions for treatment of ADRs: Moxifloxacin should be discontinued immediately if any signs of hypersensitivity reactions, nervous undesirable effects (such as seizures, depression, confusion, hallucinations, tremor); pains, arthritis or sprains occur.

Signs of GI disorders such as nausea, vomiting, abdominal pain, taste disturbances are usually mild and do not need any medical intervention. If signs of pseudomembranous colitis occur, monitor the severity of diarrhea. Patients who develop serious diarrhoea should be treated with another appropriate antibiotic.

Inform your physician about any adverse effects occur during the treatment.

OVERDOSAGE:

There is no specific antidote. Symptomatic and supportive treatment should be applied. In the event of acute overdose, the stomach should be emptied and adequate hydration maintained. ECG monitoring is recommended.

DOSAGE & ADMINISTRATION:

The drug is administered orally and can be taken with or without food.

The adult recommended dose is 400 mg once daily

Duration of administration:

                                                                                                Mild to moderate community acquired pneumonia: 10 days.

                                                                                                Skin and skin structure infections: 7 days.

                                                                                                Acute exacerbation of chronic bronchitis: 5 days.

                                                                                                Bacterial acute sinusitis: 10 days.

Dosage for patients with renal and hepatic impairment: No adjustment of dosage is required in patients with mild to moderate renal and hepatic impairment and in the elderly. Moxifloxacin has not been studied in patients with renal impairment on dialysis or in patients with severely impaired hepatic function.

Or as directed by the physician.

Read the directions carefully before use.

Consult the physician for more information.

This drug is for prescription only.

Shelf-life: 24 months from the manufacturing date.

Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

Specifications:  Manufacturer's.

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