Prednate Dm

Uses

Difluprednate is used for the treatment of inflammation and pain associated with ocular surgery. It is also used for the treatment of uveitis, ocular surface diseases, e.g. blepharitis & corneal inflammation.

Moxifloxacin is used for the treatment of adults (>18 years of age) with infections caused by susceptible strains of the designated microorganisms in the conditions listed below-

• Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus infuenzae or Moraxella catarrhalis.
• Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus infuenzae, Haemophilus parainfuenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus or Moraxella catarrhalis
• Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains), Haemophilus infuenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae or Chlamydophilia pneumoniae.
• Uncomplicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogen.
• Complicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae or Enterobacter cloacae.
• Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron or Peptostreptococcus species.

Prednate Dm is also used to associated treatment for these conditions: Anterior Uveitis (AU), Endogenous Anterior Uveitis, Eye Pain, Ocular Inflammation, Pain of the eyeAcute Exacerbation of Chronic Bronchitis (AECB), Bacterial Conjunctivitis, Community Acquired Pneumonia (CAP), Plague, Postoperative Inflammatory Response, Sinusitis, Skin Infections, Ocular bacterial infections, Post-operative infection

How Prednate Dm works

Corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins (lipocortins). It is postulated that these proteins control the biosynthesis of potent mediators of infammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

The bactericidal action of moxifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

Dosage

Prednate Dm dosage

For the treatment of inflammation and pain associated with ocular surgery: Instill 1 drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period, followed by 2 times daily for a week and then a taper based on the response.

For the treatment of endogenous anterior uveitis: Instill 1 drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated.

For blepharitis: Instill 1 drop into the conjunctival sac of the affected eyes 2 times daily for 1 week & then once daily for 1 week.

For pseudophakic cystoid macular edema: Instill 1 drop into the conjunctival sac of the affected eyes 2 times daily.

The dose of Moxifloxacin is 400 mg once every 24 hours. The duration of therapy depends on the type of infection as described bellow-

• In Acute Bacterial Sinusitis: Moxifloxacin 400 mg is given once daily for 10 days.
• In Acute Bacterial Exacerbation of Chronic Bronchitis: Moxifloxacin 400 mg is given once daily for 5 days.
• In Community Acquired Pneumonia: Moxifloxacin 400 mg is given once daily for 7-14 days.
• In Uncomplicated Skin & Skin Structure infections: Moxifloxacin 400 mg is given once daily for 7 days.
• In Complicated Skin & Skin Structure infections: Moxifloxacin 400 mg is given once daily for 7-21 days.
• In Complicated Intra-Abdominal infections: Moxifloxacin 400 mg is given once daily for 5-14 days.

Moxifloxacin 400 mg IV infusion can be administered intravenously for the entire treatment duration. Alternatively, therapy may be initial intravenous administration, followed by oral administration when clinically indicated. The recommended duration of treatment for the indication being treated should not be exceeded. The solution for infusion should be infused intravenously over 60 minutes.

Side Effects

Glaucoma with optic nerve damage, visual acuity & field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur.

The following one or more side effects may be observed: tendinopathy and tendon rupture, QT prolongation, hypersensitivity reactions, Clostridium difficile-associated diarrhea, peripheral neuropathy, photosensitivity, phototoxicity etc.

Toxicity

Preclinical pharmacokinetic and toxicity studies have established that difluprednate ophthalmic emulsion 0.05% given 4 times a day is not toxic to the eye.

Symptoms of overdose include CNS and gastrointestinal effects such as decreased activity, somnolence, tremor, convulsions, vomiting, and diarrhea. The minimal lethal intravenous dose in mice and rats is 100 mg/kg.

Precaution

• For ophthalmic use only.
• If this product is used for 10 days or longer, intraocular pressure should be monitored.
• Fungal infections of the cornea are particularly prone to develop coincidentally with long-term use of steroid topically.
• Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity & visual field, and in posterior subcapsular cataract formation.
• Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

Moxifloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Moxifloxacin should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon.

Interaction

Specific drug interaction studies have not been conducted with Difluprednate 0.05% ophthalmic emulsion.

No quinolone should be co-administered with any solution containing multivalent cations (e.g. magnesium) through the same intravenous line. Antacids, iron and adsorbents reduce absorption of Moxifloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Volume of Distribution

• 1.7 to 2.7 L/kg

Elimination Route

Difluprednate penetrates the corneal epithelium rapidly and effectively. Low systemic absorption.

Well absorbed from the gastrointestinal tract. Absolute oral bioavailability is approximately 90%. Food has little effect on absorption.

Half Life

11.5-15.6 hours (single dose, oral)

Clearance

• 12 +/- 2 L/hr

Elimination Route

78.5% of radioactivity was excreted aftert 24 hours, and 99.5% by 7 days after a single dose of labeled difluprednate instilled in the right eyes of pigmented rabbits.

Approximately 45% of an oral or intravenous dose of moxifloxacin is excreted as unchanged drug (~20% in urine and ~25% in feces).

Pregnancy & Breastfeeding use

Use in pregnancy: Use of difluprednate in pregnancy has not been evaluated. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation: It is not known whether difluprednate passes into breast milk. Caution should be exercised when it is administered to a nursing mother.

Pregnancy Category C. Moxifloxacin is not recommended during pregnancy & lactation.

Contraindication

Difluprednate is contraindicated in most viral diseases of the cornea and conjunctiva, mycobacterial infection of the eye and fungal diseases of ocular structures.

Moxifloxacin is contraindicated in persons with a history of hypersensitivity to Moxifloxacin or any member of the quinolone class of antimicrobial agents and any component of this formulation.

Special Warning

Use in children: Safety and effectiveness in pediatric patients have not been established.

Elderly: No adjustment of dosage is required in the elderly.

Children: Efficacy and safety of Moxifloxacin IV infusion in children and adolescent have not been established.

Acute Overdose

Over dosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.

In the events of an acute overdose, the stomach should be emptied. The patient should be kept under observation and appropriate hydration should be maintained.

Storage Condition

Store between 15 to 30° C. Protect from light and moisture. Keep away from reach of children.

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