MOBIC Tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Boehringer Ingelheim Pharmaceuticals, Inc.

Λέξεις κλειδιά

0597-0029 0597-0030

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1. Indications and Usage

1.1 Osteoarthritis (OA) MOBIC is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA) MOBIC is indicated for relief of ...

2. Dosage and Administration

2.1 General Dosing Instructions Carefully consider the potential benefits and risks of MOBIC and other treatment options before deciding to use MOBIC. Use the lowest effective dosage for the shortest duration ...

3. Dosage Forms and Strengths

MOBIC (meloxicam) Tablets: 7.5 mg: pastel yellow, round, biconvex, uncoated tablet containing meloxicam 7.5 mg. Impressed with the Boehringer Ingelheim logo on one side and the letter M on the other. ...

4. Contraindications

MOBIC 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 ...

5. Warnings and Precautions

5.1 Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic ...

6. Adverse Reactions

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, ...

6.1. 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 ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of MOBIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to ...

7. Drug Interactions

See Table 3 for clinically significant drug interactions with meloxicam. See also Warnings and Precautions (5.2, 5.6, 5.11) and Clinical Pharmacology (12.3). Table 3. Clinically Significant ...

8.1. Pregnancy

Risk Summary Use of NSAIDs, including MOBIC, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including MOBIC, in pregnant ...

8.2. Lactation

Risk Summary There are no human data available on whether meloxicam is present in human milk, or on the effects on breastfed infants, or on milk production. The developmental and health benefits of breastfeeding ...

8.3. Females and Males of Reproductive Potential

Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including MOBIC, may delay or prevent rupture of ovarian follicles, which has been associated with reversible ...

8.4. Pediatric Use

The safety and effectiveness of meloxicam in pediatric JRA patients from 2 to 17 years of age has been evaluated in three clinical trials [see Dosage and Administration (2.3), Adverse Reactions (6.1) ...

8.5. Geriatric Use

Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly ...

8.6. Hepatic Impairment

No dose adjustment is necessary in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment have not been adequately studied. Since meloxicam is significantly metabolized ...

8.7. Renal Impairment

No dose adjustment is necessary in patients with mild to moderate renal impairment. Patients with severe renal impairment have not been studied. The use of MOBIC in subjects with severe renal impairment ...

10. Overdosage

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal ...

11. Description

MOBIC (meloxicam) is a nonsteroidal anti-inflammatory drug (NSAID). Each pastel yellow MOBIC tablet contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- ...

12.1. Mechanism of Action

Meloxicam has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of MOBIC, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase ...

12.3. Pharmacokinetics

Absorption The absolute bioavailability of meloxicam capsules was 89% following a single oral dose of 30 mg compared with 30 mg IV bolus injection. Following single intravenous doses, dose-proportional ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis There was no increase in tumor incidence in long-term carcinogenicity studies in rats (104 weeks) and mice (99 weeks) administered meloxicam at oral doses up to 0.8 mg/kg/day in rats and ...

14. Clinical Studies

14.1 Osteoarthritis and Rheumatoid Arthritis The use of MOBIC for the treatment of the signs and symptoms of osteoarthritis of the knee and hip was evaluated in a 12-week, double-blind, controlled trial. ...

16.1. How Supplied

MOBIC is available as a pastel yellow, round, biconvex, uncoated tablet containing meloxicam 7.5 mg or as a pastel yellow, oblong, biconvex, uncoated tablet containing meloxicam 15 mg. The 7.5 mg tablet ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep MOBIC tablets in a dry place. Dispense tablets in a tight container. Keep this and all ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families or their caregivers of the following information ...

BOXED WARNING SECTION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious ...