Loxicom Uses

• Loxicom indications
• Uses of Loxicom in details
• Loxicom description
• Loxicom dosage
• Loxicom interactions
• Loxicom side effects
• Loxicom contraindications

What is Loxicom?

Loxicom (Loxicom) is a nonsteroidal anti-inflammatory drug (NSAID). Loxicom works by reducing hormones that cause inflammation and pain in the body.

Loxicom is used to treat pain or inflammation caused by rheumatoid arthritis and osteoarthritis in adults. Loxicom is also used to treat juvenile rheumatoid arthritis in children who are at least 2 years old.

Loxicom may also be used for purposes not listed in this medication guide.

Loxicom indications

  Osteoarthritis (OA)

Loxicom is indicated for relief of the signs and symptoms of osteoarthritis.

  Rheumatoid Arthritis (RA)

Loxicom is indicated for relief of the signs and symptoms of rheumatoid arthritis.

  Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course

Loxicom is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older.

How should I use Loxicom?

Use Loxicom suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Loxicom suspension comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Loxicom suspension refilled.
• Take Loxicom suspension by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers).
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Shake gently before each use.
• Take Loxicom suspension with a full glass of water (8 oz/240 mL) as directed by your doctor.
• If you take cholestyramine, ask your doctor or pharmacist how to take it with Loxicom suspension.
• If you miss a dose of Loxicom suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Loxicom suspension.

Uses of Loxicom in details

Use: Labeled Indications

IV:

Pain: Management of moderate to severe pain in adults, alone or in combination with non-nonsteroidal anti-inflammatory drug analgesics.

Limitation of use: Because of delayed onset of analgesia, Loxicom (injection) alone is not recommended for use when rapid onset of analgesia is required

Oral:

Osteoarthritis: Relief of the signs and symptoms of osteoarthritis (OA); management of OA pain.

Rheumatoid arthritis (orally disintegrating tablet [ODT], tablet, and suspension only): Relief of signs and symptoms of rheumatoid arthritis (RA); relief of the signs and symptoms of pauciarticular or polyarticular course juvenile RA in patients ≥2 years of age (suspension) and in patients weighing ≥60 kg (ODT, tablet).

Off Label Uses

Gout, acute flares

Data from a single-blind, randomized, controlled trial supports the efficacy of Loxicom in the treatment of acute gout flares.

Based on the 2012 American College of Rheumatology guidelines for management of gout, NSAIDS are effective and recommended agents in the treatment of acute gout flares.

Loxicom description

Ratio-Loxicom is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve the symptoms of arthritis, primary dysmenorrhea, fever; and as an analgesic, especially where there is an inflammatory component. It is closely related to piroxicam. In Europe it is marketed under the brand names Movalis, Melox, and Recoxa. In North America it is generally marketed under the brand name Loxicom. In Latin America, the drug is marketed as Tenaron.

Loxicom dosage

General Dosing Instructions

Carefully consider the potential benefits and risks of Loxicom and other treatment options before deciding to use Loxicom. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

After observing the response to initial therapy with Loxicom, adjust the dose to suit an individual patient's needs.

In adults, the maximum recommended daily oral dose of Loxicom is 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended.

Loxicom may be taken without regard to timing of meals.

Osteoarthritis

For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of Loxicom is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

Rheumatoid Arthritis

For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of Loxicom is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

Juvenile Rheumatoid Arthritis (JRA) Pauciarticular And Polyarticular Course

For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of Loxicom is 7.5 mg once daily in children who weigh ≥ 60 kg. There was no additional benefit demonstrated by increasing the dose above 7.5 mg in clinical trials.

Loxicom tablets should not be used in children who weigh < 60 kg.

Renal Impairment

The use of Loxicom in subjects with severe renal impairment is not recommended.

In patients on hemodialysis, the maximum dosage of Loxicom is 7.5 mg per day.

Non-Interchangeability With Other Formulations of Loxicom

Loxicom Tablets have not shown equivalent systemic exposure to other approved formulations of oral Loxicom. Therefore, Loxicom Tablets are not interchangeable with other formulations of oral Loxicom product even if the total milligram strength is the same. Do not substitute similar dose strengths of Loxicom Tablets with other formulations of oral Loxicom product.

How supplied

Dosage Forms And Strengths

Loxicom (Loxicom) Tablets

• 7.5 mg: pastel yellow, round, biconvex, uncoated tablet containing Loxicom 7.5 mg. Impressed with the Boehringer Ingelheim logo on one side and the letter “M” on the other.
• 15 mg: pastel yellow, oblong, biconvex, uncoated tablet containing Loxicom 15 mg. Impressed with the tablet code “15” on one side and the letter “M” on the other.

Storage And Handling

Loxicom is available as a pastel yellow, round, biconvex, uncoated tablet containing Loxicom 7.5 mg or as a pastel yellow, oblong, biconvex, uncoated tablet containing Loxicom 15 mg. The 7.5 mg tablet is impressed with the Boehringer Ingelheim logo on one side, and on the other side, the letter “M”. The 15 mg tablet is impressed with the tablet code “15” on one side and the letter “M” on the other.

Loxicom (Loxicom) tablets 7.5 mg: NDC 0597-0029-01; Bottles of 100

Loxicom (Loxicom) tablets 15 mg: NDC 0597-0030-01; Bottles of 100

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep Loxicom tablets in a dry place.

Dispense tablets in a tight container.

Keep this and all medications out of the reach of children.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Revised: May 2016

Loxicom interactions

See also:
What other drugs will affect Loxicom?

ACE inhibitors: It is reported that the concomitant use of these drugs with Loxicom decreases the hypotensive effect of inhibitors of angiotensin converting enzyme.

Aspirin: Concomitant use of Loxicom with aspirin (1 g per day) increased the area under the curve (10%) and peak concentration (24%) of Loxicom. Clinically, it has reported an increase in the adverse effects of Loxicom to be used concomitantly with aspirin.

The use of Loxicom with low-dose aspirin increases the risk of gastrointestinal bleeding.

Cholestyramine: The pretreatment 4 days before administration of Loxicom, it increases the clearance of up to 50%.

Cimetidine: Concomitant administration of 200 mg of cimetidine does not alter the pharmacokinetics of 30 mg of Loxicom.

Digoxin: Administration of Loxicom at doses of 15 mg daily did not affect plasma concentrations of digoxin.

Furosemide: Clinical studies in post marketing has been observed that Loxicom decreases the natriuretic effect of thiazides.

Warfarin: The concomitant use of Loxicom increases the risk of bleeding.

Loxicom side effects

See also:
What are the possible side effects of Loxicom?

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Cardiovascular Thrombotic Events
• GI Bleeding, Ulceration, and Perforation
• Hepatotoxicity
• Hypertension
• Heart Failure and Edema
• Renal Toxicity and Hyperkalemia
• Anaphylactic Reactions
• Serious Skin Reactions
• Hematologic Toxicity

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

Osteoarthritis And Rheumatoid Arthritis

The Loxicom Phase 2/3 clinical trial database includes 10,122 OA patients and 1012 RA patients treated with Loxicom 7.5 mg/day, 3505 OA patients and 1351 RA patients treated with Loxicom 15 mg/day. Loxicom at these doses was administered to 661 patients for at least 6 months and to 312 patients for at least one year. Approximately 10,500 of these patients were treated in ten placebo- and/or activecontrolled osteoarthritis trials and 2363 of these patients were treated in ten placebo- and/or activecontrolled rheumatoid arthritis trials. Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups across Loxicom trials.

A 12-week multicenter, double-blind, randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of Loxicom with placebo and with an active control. Two 12-week multicenter, double-blind, randomized trials were conducted in patients with rheumatoid arthritis to compare the efficacy and safety of Loxicom with placebo.

Table 1a depicts adverse events that occurred in ≥ 2% of the Loxicom treatment groups in a 12-week placebo- and active-controlled osteoarthritis trial.

Table 1b depicts adverse events that occurred in ≥ 2% of the Loxicom treatment groups in two 12-week placebo-controlled rheumatoid arthritis trials.

Table 1a : Adverse Events (%) Occurring in ≥ 2% of Loxicom Patients in a 12-Week Osteoarthritis Placebo- and Active-Controlled Trial

Higher doses of Loxicom (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore, the daily dose of Loxicom should not exceed 15 mg.

Pediatrics

Pauciarticular And Polyarticular Course Juvenile Rheumatoid Arthritis (JRA)

Three hundred and eighty-seven patients with pauciarticular and polyarticular course JRA were exposed to Loxicom with doses ranging from 0.125 to 0.375 mg/kg per day in three clinical trials. These studies consisted of two 12-week multicenter, double-blind, randomized trials (one with a 12-week open-label extension and one with a 40-week extension) and one 1-year open-label PK study. The adverse events observed in these pediatric studies with Loxicom were similar in nature to the adult clinical trial experience, although there were differences in frequency. In particular, the following most common adverse events, abdominal pain, vomiting, diarrhea, headache, and pyrexia, were more common in the pediatric than in the adult trials. Rash was reported in seven ( < 2%) patients receiving Loxicom. No unexpected adverse events were identified during the course of the trials. The adverse events did not demonstrate an age or gender-specific subgroup effect.

The following is a list of adverse drug reactions occurring in < 2% of patients receiving Loxicom in clinical trials involving approximately 16,200 patients.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Loxicom. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions about whether to include an adverse event from spontaneous reports in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) number of reports, or (3) strength of causal relationship to the drug. Adverse reactions reported in worldwide post marketing experience or the literature include: acute urinary retention; agranulocytosis; alterations in mood (such as mood elevation); anaphylactoid reactions including shock; erythema multiforme; exfoliative dermatitis; interstitial nephritis; jaundice; liver failure; Stevens-Johnson syndrome; toxic epidermal necrolysis, and infertility female.

Loxicom contraindications

See also:
What is the most important information I should know about Loxicom?

Except under special circumstances, Loxicom should not be used when the following medical problem exists: Hypersensitivity to Loxicom, coronary artery bypass graft (CABG) surgery; treatment of perioperative pain in the setting of CABG surgery; nasal polyps associated with bronchospasm; aspirin-induced (high risk of severe allergic reaction); and previous allergic or anaphylactic reaction to aspirin or other NSAIDs.

Risk-benefit should be considered when the following medical problems exist: Active or preexisting gastrointestinal bleeding; active peptic ulcer disease; cardiovascular (CV) disease or risk factors for CV disease (may be at greater risk of serious CV thrombotic events; lowest effective dose of Loxicom for shortest duration should be used with physicians and patients remaining alert for development of signs and symptoms of such events); severe renal function impairment (long-term studies have not been done in patients with severe renal function impairment; use of Loxicom is not recommended in these patients; however, if Loxicom is used in patients with severe renal impairment, close monitoring is recommended).

Active ingredient matches for Loxicom:

Meloxicam in France, Norway, Sweden, United Kingdom.

References

1. DailyMed. "MELOXICAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "meloxicam". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "meloxicam". http://www.drugbank.ca/drugs/DB00814 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology