Meloxicam 7.5 mg/1
Meloxicam · TABLET · Exelan Pharmaceuticals Inc.
Meloxicam is a tablet containing meloxicam at 7.5 mg/1, taken oral. Manufactured by Exelan Pharmaceuticals Inc..
Key Facts
- Brand Name
- Meloxicam
- Generic Name
- Meloxicam
- NDC Code (Product)
76282-152- Manufacturer
- Exelan Pharmaceuticals Inc.
- Strength
- 7.5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077927
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Marketing Start
- 04/14/2015
Recall History
Boehringer Ingelheim Pharmaceuticals, Inc.
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
Reliable Rexall-A Compounding Pharmacy
Lack of Processing Controls
South Coast Specialty Compounding, Inc.
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
HERON THERAPEUTICS, INC.
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Apotex Corp.
Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Meloxicam tablet USP is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3 ) 1.1 Osteoarthritis (OA Meloxicam tablets USP are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies ( 14.1 )] . 1.2 Rheumatoid Arthritis (RA) Meloxicam tablets USP are indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies ( 14.1 )] . 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Meloxicam tablets USP are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg [see Dosage and Administration ( 2.4 ) and Clinical Studies ( 14.2 )] .
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ( 2.1 ) OA ( 2.2 ) and RA (2.3): Starting dose: 7.5 mg once daily Dose may be increased to 15 mg once daily JRA ( 2.4 ): 7.5 mg once daily in children ≥60 kg Meloxicam Tablets are not interchangeable with approved formulations of oral meloxicam even if the total milligram strength is the same ( 2.6 ) 2.1 General Dosing Instructions Carefully consider the potential benefits and risks of meloxicam tablets and other treatment options before deciding to use meloxicam tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions ( 5 )] . After observing the response to initial therapy with meloxicam tablets, adjust the dose to suit an individual patient's needs. In adults, the maximum recommended daily oral dose of meloxicam tablets is 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] . Meloxicam tablets may be taken without regard…
Contraindications
4 CONTRAINDICATIONS Meloxicam is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see Warnings and Precautions ( 5.7 , 5.9 ) ] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ( 5.7 , 5.8 ) ] In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions ( 5.1 ) ] Known hypersensitivity to meloxicam or any components of the drug product ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4 ) In the setting of CABG surgery ( 4 )
Drug Interactions
7 DRUG INTERACTIONS See Table 3 for clinically significant drug interactions with meloxicam. See also Warnings and Precautions ( 5.2 , 5.6 , 5.12 ) and Clinical Pharmacology ( 12.3 ) . Drugs that Interfere with Hemostasis Clinical Impact: Meloxicam and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of meloxicam and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of meloxicam with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions ( 5.12 )]. Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therap…
Adverse Reactions
6 ADVERSE REACTIONS Most common (≥5% and greater than placebo) adverse events in adults are diarrhea, upper respiratory tract infections, dyspepsia, and influenza-like symptoms ( 6.1 ) Adverse events observed in pediatric studies were similar in nature to the adult clinical trial experience ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Boxed Warning and Warnings and Precautions ( 5.1 ) ] GI Bleeding, Ulceration, and Perforation [see Boxed Warning and Warnings and Precautions ( 5.2 ) ] Hepatotoxicity [see Warnings and Precautions ( 5.3 ) ] Hypertension [see Warnings and Precautions ( 5.4 ) ] Heart Failure and Edema [see Warnings and Precautions ( 5.5 ) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions ( 5.6 ) ] Anaphylactic Reactions [see Warnings and Precautions ( 5.7 ) ] Serious Skin Reactions [see Warnings and Precautions ( 5.9 ) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [ see Warnings and Precautions ( 5.1…
Frequently Asked Questions
What is Meloxicam used for?
Meloxicam contains Meloxicam. It is a tablet taken oral. Consult your doctor for specific uses.
Is Meloxicam a controlled substance?
Meloxicam is not classified as a controlled substance by the DEA.
What is the generic name for Meloxicam?
The generic name for Meloxicam is Meloxicam. There are 8 other brand versions of Meloxicam.
What is the NDC code for Meloxicam 7.5 mg/1?
The NDC (National Drug Code) for Meloxicam 7.5 mg/1 is 76282-152, listed by Exelan Pharmaceuticals Inc..