Ktromoxx

Uses

Ketorolac Tromethamine is indicated for the short-term management of moderate to severe acute post-operative pain. Ketorolac ophthalmic solution helps relieve pain, inflammation, and light sensitivity after ocular surgery. It may also be used to decrease eye inflammation or redness caused by seasonal allergies.

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.

Ktromoxx is also used to associated treatment for these conditions: Acute 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 Ktromoxx works

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

Ktromoxx dosage

Tablet: Recommended dose is 10 mg every 4-6 hours. It should be used short-term only (up to 7 days) and are not recommended for chronic use. Doses exceeding 40 mg/day is not recommended.Injection: Ketorolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Ketorolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours. Single-Dose Treatment-IM Dosing (Adult): Patients <65 years of age: One dose of 60 mg. Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 30 mg. IV Dosing (Adult): Patients <65 years of age: One dose of 30 mg. Patients >65 years of age, renally impaired and/or less than 50 kg of body weight: One dose of 15 mg. IV or IM Dosing (2 to 16 years of age): IM Dosing: One dose of 1 mg/kg up to a maximum of 30 mg. IV Dosing: One dose of 0.5 mg/kg up to a maximum of 15 mg. Multiple-Dose Treatment (IV or IM)- Patients <65 years of age: The recommended dose is 30 mg Ketorolac injection every 6 hours. The maximum daily dose should not exceed 120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Ketorolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine. Conversion from Parenteral to Oral Therapy: Ketorolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Ketorolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Ketorolac IM should be replaced by Ketorolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days. Eye Drops: Adults: 1 drop in each eye 4 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

Commonly occurring side effects are nausea, vomiting, gastro-intestinal bleeding, melana, peptic ulcer, pancreatitis, anxiety, drowsiness, headache, excessive thirst, fatigue, bradycardia, hypertension, palpitation, chest pain, infertility in female and pulmonary edema.

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

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

Caution should be exercised in patients over the age of 65 years. Caution should also be taken in patients with active or suspected peptic ulcer or gastrointestinal bleeding or asthma and liver dysfunction. Eye Drops: Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health. Lopadol ophthalmic solution should not be administered while wearing contact lenses.

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

Other NSAIDs or aspirin: Increase the side effects of ketorolac Tromethamine.Anti-coagulants: Enhance anti-coagulant effect. Beta Blocker: Reduce the anti-hypertensive effect . ACE Inhibitors: Increase the risk of renal impairment. Methotrexate: Enhance the toxicity of methotrexate.

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

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

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

US FDA Pregnancy category of Ketorolac Tromethamine is C. So, Ketorolac Tromethamine should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

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

Contraindication

Ketorolac is contraindicated in patients having hypersensitivity to this drug or other NSAIDs. It should not be used in children under 16 years of age. lt is also contraindicated as prophylactic analgesic before surgery.

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

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

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

Keep in a dry place away from light and heat. Keep out of the reach of children.

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

Innovators Monograph

You find simplified version here Ktromoxx