Metaxalone

Generic

Generic for Skelaxin

ID: 65162055310

NaN

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📜 Prescription Required

FORM

Tablet

STRENGTH

800 mg

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TL;DR — Quick Summary

Key facts from the full medication guide below

RECENT MAJOR CHANGES SECTION 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS

🩺What it's for

Metaxalone tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older. Metaxalone is a muscle relaxant indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions in adults and pediatric patients 13 years of age and older.

💊How to take it

The recommended dosage of metaxalone in adults and pediatric patients 13 years of age and older is 800 mg orally three to four times a day [see Use in Specific Populations (8)]. Metaxalone tablets 800 mg are not substitutable on a mg to mg basis with metaxalone tablets, 640 mg [see Clinical Pharmacology (12.3)]. When it is appropriate to switch: Switch only in patients who have been taking metaxalone tablets, 640 mg on an empty stomach.

ℹ️Common side effects

The following adverse reactions associated with the use of metaxalone were identified in clinical studies or post-marketing reports. Because some of these reactions were 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. The most frequent reactions to metaxalone were: CNS: drowsiness, dizziness, headache, and nervousness or "irritability".

⚠️Serious risks

Serotonin Syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of metaxalone (within the recommended dosage range) and other serotonergic drugs and with the use of metaxalone as the only serotonergic drug taken at a dosage higher than the recommended dosage. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dosage increases.

📋Interactions & cautions

False-positive Benedict's tests, due to an unknown reducing substance, have been noted in metaxalone-treated patients. A glucose-specific test will differentiate findings.

📦Storage & missed dose

Metaxalone Tablets USP, 800 mg are supplied as light pink to pink, capsule shaped, scored uncoated tablet with debossing AN on the left side of the scoring and 553 on the right side of the scoring. Other side of the tablet is plain. They are available as follows: Bottles of 100: NDC 65162-553-10 Bottles of 500: NDC 65162-553-50 Store at 20 to 25 C (68 to 77 F); excursions permitted between 15 to 30 C (59 to 86 F) [see USP Controlled Room Temperature].

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Metaxalone pharmacokinetics were evaluated in two groups of healthy volunteers that received a single oral dose of 800 mg of metaxalone or 400 mg of metaxalone (0.5 times the approved recommended dose). Metaxalone pharmacokinetic parameters are presented below as mean (% CV) unless otherwise specified. Observed metaxalone peak plasma concentrations (Cmax) and area under the curve (AUC) are shown in Table 1. Doubling the dose of metaxalone from 400 mg (0.5 times the approved recommended dose) to 800 mg resulted in a proportional increase in metaxalone Cmax and AUC. Table 1: Metaxalone Exposure after a Single-Dose of Metaxalone Under Fasting Conditions Dose Cmax 2 AUC 2 400 mg1 983 (53) ng/mL 7,479 (51) ng h/mL 800 mg 1,816 (43) ng/mL 15,044 (46) ng h/mL 1 0.5 times the approved recommended dose 2 Mean (% CV) Absorption The absolute bioavailability of metaxalone is not known. Peak plasma metaxalone concentrations occurred at a mean Tmax of 3.3 hours (1.5 to 5 hours) of metaxalone under fasted conditions. The single-dose pharmacokinetic parameters of metaxalone in two groups of healthy volunteers who received 400 mg or 800 mg of metaxalone are shown in Table 1. Effect of Food: Peak plasma metaxalone concentrations were noted at a mean Tmax of 4.3 hours (1.5 to 12 hours) under fed conditions. The mean Tmax under fasting and fed conditions was 3.3 and 4.3 hours, respectively. Metaxalone exposure was increased and the half-life (t1/2) was decreased following metaxalone administration with a high fat meal as shown in Table 2. The increase in metaxalone exposure coinciding with a reduction in half-life may be attributed to more complete absorption of metaxalone in the presence of a high fat meal. Table 2: Relative Changes in Metaxalone Exposure, T max , and t 1/2 Following Metaxalone Administration with a High Fat Meal Compared to Fasting Dose Cmax(ng/mL) AUC0-t(ng h/mL) AUC0-INF(ng h/mL) Tmax (hrs) t1/2 (hrs) 400 mg* 78% 24% 15% 30% 73% 800 mg 94% 46% 42% 63% 48% * 0.5 times the approved recommended dose. Distribution Metaxalone apparent volume of distribution is approximately 800 Liters; however, plasma protein binding is unknown. Elimination Metaxalone mean SD terminal t1/2 is 9 4.8 hours and apparent clearance is approximately 67 34 L/h under fasted conditions. Metabolism: Metaxalone is primarily metabolized by CYP1A2, CYP2D6, CYP2E1, and CYP3A4 and, to a lesser extent, CYP2C8, CYP2C9, and CYP2C19. Excretion: Metaxalone is metabolized by the liver and excreted in the urine as unidentified metabolites. Specific Populations The effect of renal impairment and hepatic impairment on metaxalone pharmacokinetics is unknown [see Use in Specific Populations (8.6, 8.7)]. Geriatric Patients: The effects of age on the pharmacokinetics of metaxalone were determined following administration of 800 mg of metaxalone under fasted and fed conditions. Age had a significantly greater effect on metaxalone pharmacokinetics under fasted conditions than under fed conditions. Bioavailability under fasted conditions increased with age. Metaxalone bioavailability under fasted and fed conditions in the three groups of healthy volunteers of varying age is shown in Table 3. Table 3: Metaxalone Pharmacokinetic Parameters under Fasted and Fed Conditions in Three Age Groups Following Oral Administration of 800 mg of Metaxalone Mean Age in Years ( SD) 26 9 Years Old 39 11 Years Old 72 5 Years Old Fasted vs. Fed State Fasted Fed Fasted Fed Fasted Fed C max (ng/mL)1 1,816 (43) 3,510 (41) 2,719 (46) 2,915 (55) 3,168 (43) 3,680 (59) T max (hours)1 3 (39) 4.9 (4.8) 3 (40) 8.7 (91) 2.6 (30) 6.5 (67) AUC 0-t (ng h/mL)1 14,531 (47) 20,683 (41) 19,836 (40) 20,482 (37) 23,797 (45) 24,340 (48) AUC (ng h/mL)1 15,045 (46) 20,833 (41) 20,490 (39) 20,815 (37) 24,194 (44) 24,704 (47) 1 Mean values (% CV) Male and Female Patients: The exposure of metaxalone was significantly higher in females compared to males as evidenced by Cmax. (2,115 ng/mL versus 1,335 ng/mL) and AUC (17,884 ng h/mL versus 10,328 ng h/mL) following administration of 800 mg of metaxalone under fasted conditions. The mean half-life was 11.1 hours in females and 7.6 hours in males. The apparent volume of distribution of metaxalone was approximately 22% higher in males than in females. Drug Interaction Studies In Vitro Studies: Metaxalone does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4. Metaxalone does not induce CYP1A2, CYP2B6, and CYP3A4.

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