Metaxalone

Primus Pharmaceuticals
Human Prescription Drug
NDC 68040-712

Metaxalone is a human prescription drug labeled by 'Primus Pharmaceuticals'. National Drug Code (NDC) number for Metaxalone is 68040-712. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Metaxalone drug includes Metaxalone - 640 mg/1 . The currest status of Metaxalone drug is Active.

Drug Information:

Drug NDC:	68040-712
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Metaxalone
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Metaxalone
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Primus Pharmaceuticals
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	METAXALONE - 640 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	NDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	01 Feb, 2023
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	20 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	NDA022503
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Primus Pharmaceuticals
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	2627781
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000175730 N0000175737
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	1NMA9J598Y
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Muscle Relaxant [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Centrally-mediated Muscle Relaxation [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class:	Centrally-mediated Muscle Relaxation [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
68040-712-38	100 TABLET in 1 BOTTLE (68040-712-38)	01 Feb, 2023	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Product Elements:

Metaxalone metaxalone metaxalone metaxalone alginic acid fd&c yellow no. 6 lactose monohydrate magnesium stearate povidone propylene glycol alginate light pink to pink m640

Drug Interactions:

7 drug interactions cns depressants the sedative effects of metaxalone tablets and other cns depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. therefore, caution should be exercised with patients who take more than one of these cns depressants simultaneously. serotonergic drugs serotonin syndrome has resulted from concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range [see warnings and precautions (5.3) ]. if concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. discontinue metaxalone tablets if serotonin syndrome is suspected. examples of serotonergic drugs include: selective serotonin reuptake inhibitors (ssris), serotonin and norepinephrine reuptake inhibitors (snris), tricyclic antidepressants (tcas), triptans, 5-ht3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotoni Read more...

n neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (mao) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). cns depressants : use with caution. the sedative effects of metaxalone tablets and other cns depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. ( 7 )

Indications and Usage:

1 indications and usage metaxalone tablets are indicated in adults and pediatric patients 13 years of age and older as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. metaxalone is a muscle relaxant indicated in adult and pediatric patients 13 years of age and older as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. ( 1 )

Warnings and Cautions:

5 warnings and precautions serotonin syndrome : cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range and with metaxalone as a single agent taken at doses higher than the recommended dose. ( 5.1 ) central nervous system (cns) depression : metaxalone tablets may impair mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a motor vehicle, and may enhance the effects of alcohol and other cns depressants. ( 5.2 ) hepatic and renal impairment : metaxalone tablets should be administered with caution to patients with mild to moderate hepatic and renal impairment. ( 5.3 ) 5.1 serotonin syndrome cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range [see dru Read more...

g interactions (7) ] and with metaxalone as a single agent taken at doses higher than the recommended dose [see overdosage (10) ] . serotonergic drugs include selective serotonin reuptake inhibitors (ssris), serotonin and norepinephrine reuptake inhibitors (snris), tricyclic antidepressants (tcas), triptans, 5-ht3 receptor antagonists, opioids (particularly fentanyl, meperidine, and methadone), drugs that affect the serotonergic neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and drugs that impair metabolism of serotonin (including monoamine oxidase (mao) inhibitors, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) [see drug interactions (7) ] . serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). the onset of symptoms generally occurs within several hours to a few days, but may occur later than that. discontinue metaxalone tablets if serotonin syndrome is suspected. 5.2 central nervous system (cns) depression metaxalone tablets may enhance the effects of alcohol and other cns depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants) and may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle, especially when used with alcohol or other cns depressants. therefore, metaxalone tablets should be used with caution in patients who take one or more of these cns depressants. [see drug interactions (7) ] elderly patients may be especially susceptible to cns effects. 5.3 hepatic and renal impairment patients metaxalone tablets are metabolized by the liver and excreted in the urine. use caution when administering metaxalone tablets in patients with mild to moderate hepatic or renal impairment. consider monitoring of liver and renal function in these patients. metaxalone tablets are contraindicated in patients with severe hepatic or renal impairment [see contraindications (4) and use in specific populations (8.6 , 8.7) ].

Dosage and Administration:

2 dosage and administration the recommended dose for adults and pediatric patients 13 years of age and older is one 640 mg tablet three to four times a day. the recommended dose for adults and pediatric patients 13 years of age and older is one 640 mg tablet three to four times a day. ( 2 )

Dosage Forms and Strength:

3 dosage forms and strengths metaxalone tablet is available as a 640 mg oval, peach-colored tablet, debossed on one side with m640 and plain on the other side. tablets: 640 mg. ( 3 )

Contraindications:

4 contraindications the use of metaxalone tablets is contraindicated in the following conditions: known hypersensitivity to any components of this product. known tendency to drug-induced, hemolytic, or other anemias. patients with severely impaired renal or hepatic function. â¢ known hypersensitivity to any components of this product. ( 4 ) â¢ known tendency to drug induced, hemolytic, or other anemias. ( 4 ) â¢ patients with severely impaired renal or hepatic functions. ( 4 )

Adverse Reactions:

6 adverse reactions the most frequent reactions to metaxalone tablets include: cns: drowsiness, dizziness, headache, and nervousness or âirritabilityâ, digestive: nausea, vomiting, gastrointestinal upset. other adverse reactions are: immune system: hypersensitivity reaction, rash with or without pruritus, hematologic: leucopenia; hemolytic anemia, hepatobiliary: jaundice. cns: cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range and with metaxalone as a single agent taken at doses higher than the recommended dose [see warnings and precautions (5.1) , drug interactions (7) , and overdosage (10) ] . anaphylactoid reactions have been reported with metaxalone. the most common adverse reactions to metaxalone tablets include drowsiness, dizziness, headache, and nervousness or âirritabilityâ, nausea, vomiting, gastrointestinal upset. ( Read more...

6 ) serotonin syndrome: a potentially life-threatening condition, has been reported during concomitant use of serotonergic drugs with metaxalone used within the recommended dosage range and with metaxalone as a single agent taken at doses higher than the recommended dose. ( 6 ) to report suspected adverse reactions, contact primus pharmaceuticals, inc. at 1-877-526-4040 and www.primusrx.com or fda at 1-800-fda-1088 or www.fda.gov/medwatch .

Drug Interactions:

Use in Specific Population:

8 use in specific populations 8.1 pregnancy risk summary there are no available data on metaxalone use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes despite decades of metaxalone use. reproduction studies in rats have not revealed evidence of impaired fertility or harm to fetus due to metaxalone . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. 8.2 lactation risk summary there are no data on the presence of metaxalone or its metabolite in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breas Read more...

tfeeding should be considered along with the motherâs clinical need for metaxalone and any potential adverse effects on the breastfed infant from metaxalone or from the underlying maternal condition. 8.4 pediatric use safety and effectiveness in children 12 years of age and below have not been established. 8.5 geriatric use the effects of age on the pharmacokinetics of metaxalone tablets have not been evaluated. 8.6 hepatic impairment formal pharmacokinetic studies using metaxalone tablets have not been conducted in patients with hepatic impairment. since metaxalone undergoes hepatic metabolism, metaxalone tablets should be used with caution in patients with mild to moderate hepatic impairment. metaxalone tablets are contraindicated in patients with severe hepatic impairment. [see contraindications (4) and warnings and precautions (5.3) ] 8.7 renal impairment formal pharmacokinetic studies using metaxalone tablets have not been conducted in patients with renal impairment. since metaxalone is excreted in the urine as unidentified metabolites, metaxalone tablets should be used with caution in patients with mild to moderate renal impairment. metaxalone tablets are contraindicated in patients with severe renal impairment. [see contraindications (4) and warnings and precautions (5.3) ]

Use in Pregnancy:

8.1 pregnancy risk summary there are no available data on metaxalone use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes despite decades of metaxalone use. reproduction studies in rats have not revealed evidence of impaired fertility or harm to fetus due to metaxalone . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Pediatric Use:

8.4 pediatric use safety and effectiveness in children 12 years of age and below have not been established.

Geriatric Use:

8.5 geriatric use the effects of age on the pharmacokinetics of metaxalone tablets have not been evaluated.

Overdosage:

10 overdosage deaths by deliberate or accidental overdose have occurred with metaxalone, particularly in combination with antidepressants, and have been reported with this class of drug in combination with alcohol. serotonin syndrome has been reported when metaxalone was used at doses higher than the recommended dose [see warnings and precautions (5.1) and adverse reactions (6) ] . treatment â gastric lavage and supportive therapy. consultation with a regional poison control center is recommended.

Description:

11 description metaxalone tablet is a muscle relaxant available as a 640 mg oval, peach-colored tablet, debossed on one side with m640 and plain on the other side. the tablets are for oral administration. each tablet contains 640 mg metaxalone and the following inactive ingredients: alginic acid, fd&c yellow #6, lactose monohydrate, magnesium stearate, propylene glycol alginate and povidone. chemically, metaxalone is 5-[(3, 5- dimethylphenoxy) methyl]-2-oxazolidinone. the empirical formula is c 12 h 15 no 3 , which corresponds to a molecular weight of 221.25. the structural formula is: metaxalone is a white to almost white, odorless crystalline powder freely soluble in chloroform, soluble in methanol and in 96% ethanol, but practically insoluble in ether or water. structure

Clinical Pharmacology:

12 clinical pharmacology 12.1 mechanism of action the mechanism of action of metaxalone in humans has not been established, but may be due to general central nervous system depression. metaxalone has no direct action on the contractile mechanism of striated muscle, the motor end plate, or the nerve fiber. 12.3 pharmacokinetics absorption in a relative bioavailability study in healthy adult volunteers, the c max (peak plasma concentration) and auc (extent of absorption) values of metaxalone from metaxalone tablets, 640 mg were found to be similar to those from skelaxin Â® 800 mg tablets. after a single dose of metaxalone tablets, 640 mg, under fasted conditions, mean c max and auc values were 2 mcg/ml and 16 mcg.h/ml, respectively. the time-to-peak plasma concentration (t max ) occurred at 3 h (range 1.5-12h). the plasma half-life in adult healthy subjects was about 5 hours after administration of metaxalone tablets. effect of food : compared to fasted condition, the presence of a hig Read more...

h fat meal resulted in 23% increase in c max with no change in auc, and a t max of 8h (range 3.5-24h). distribution although plasma protein binding and absolute bioavailability of metaxalone are not known, the apparent volume of distribution (v/f ~ 800 l) and lipophilicity (log p = 2.42) of metaxalone suggest that the drug is extensively distributed in the tissues. elimination metabolism hepatic cytochrome p450 enzymes play a role in the metabolism of metaxalone. specifically, cyp1a2, cyp2d6, cyp2e1, and cyp3a4 and, to a lesser extent, cyp2c8, cyp2c9, and cyp2c19 appear to metabolize metaxalone. metaxalone does not significantly inhibit major cyp enzymes such as cyp1a2, cyp2a6, cyp2b6, cyp2c8, cyp2c9, cyp2c19, cyp2d6, cyp2e1, and cyp3a4. metaxalone does not significantly induce major cyp enzymes such as cyp1a2, cyp2b6, and cyp3a4 in vitro . excretion metaxalone is metabolized by the liver and excreted in the urine as unidentified metabolites. specific populations age: the effects of age on the pharmacokinetics of metaxalone tablets have not been evaluated. gender: females exhibited higher systemic exposure compared to males following administration of metaxalone tablets under fasted state in healthy volunteers. the c max and auc were both found to be about 40% greater in females compared to males.

14 clinical studies efficacy studies were not conducted with metaxalone tablets. the efficacy of metaxalone tablets, 640 mg is based on demonstration of similar systemic exposures to the reference drug, skelaxinÂ® 800 mg tablets [see clinical pharmacology (12.3) ].

Nonclinical Toxicology:

13 nonclinical toxicology 13.1 carcinogenesis, mutagenesis, impairment of fertility carcinogenesis long-term studies to evaluate the carcinogenic potential of metaxalone have not been conducted. mutagenesis studies to evaluate the mutagenic potential of metaxalone have not been conducted. impairment of fertility reproduction studies in rats have not revealed evidence of impaired fertility or harm to the fetus due to metaxalone.

How Supplied:

16 how supplied/storage and handling metaxalone tablets, 640 mg are available as oval, peach-colored tablets, debossed on one side with m640 and plain on the other side. it is packaged as: bottle of 100 tablets, ndc 68040-712-38 store at 20Â°c to 25Â°c (68Â°f to 77Â°f), excursions permitted to 15Â°c-30Â°c (59Â°f-86Â°f). [see usp controlled room temperature].

Information for Patients:

17 patient counseling information driving or operating heavy machinery advise patients that metaxalone tablets may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle, especially when used with alcohol and other cns depressants. elderly patients may be especially susceptible to cns effects. serotonin syndrome inform patients that metaxalone tablets could cause a rare but potentially life-threatening condition resulting from administration of doses higher than the recommended dose or from concomitant administration of serotonergic drugs with metaxalone tablets used within the recommended dosage range. warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. instruct patients to inform their healthcare providers if they are taking, or plan to take, serotonergic medications. 21503-03 rev 08/2022 1274c00-08/22 distributed by: primus pharmaceutical Read more...

s, inc. scottsdale, az 85253

Package Label Principal Display Panel:

Principal display panel ndc 68040-712-38 metaxalone tablets 640 mg rx only sealed for your protection 100 tablets label

Comments/ Reviews:

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