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Metaxalone (Metaxalone)

Trade Name : Metaxalone

Amneal Pharmaceuticals of New York LLC

TABLET

Strength 800 mg/1

METAXALONE Centrally-mediated Muscle Relaxation [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Metaxalone (Metaxalone) which is also known as Metaxalone and Manufactured by Amneal Pharmaceuticals of New York LLC. It is available in strength of 800 mg/1 per ml. Read more

Metaxalone (Metaxalone) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Metaxaloneu00a0tablets are available as an 800 mg oval, convex pink tablet.
  • Chemically, metaxalone is 5-[(3,5-dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is CHNO, 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.n
  • Each tablet contains 800 mg metaxalone and the following inactive ingredients: alginic acid, ammonium calcium alginate, B-Rose Liquid, corn starch, and magnesium stearate.
  • No data
  • Metaxalone tabletsu00a0are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.
  • Known hypersensitivity to any components of this product.
  • Known tendency to drug induced, hemolytic, or other anemias.
  • Significantly impaired renal or hepatic function.
  • 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 :) and with metaxalone as a single agent taken at doses higher than the recommended dose (see ). 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 n ).
  • 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 if serotonin syndrome is suspected.
  • Risks from Concomitant Use with Alcohol or other CNS Depressants
  • The sedative effects of metaxalone and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants (TCAs)) may be additive. Exercise caution with patients who take more than one of these CNS depressants simultaneously. Follow patients closely for signs and symptoms of respiratory depression and sedation (see n ).
  • Metaxalone should be administered with great care to patients with pre-existing liver damage.u00a0 Serial liver function studies should be performed in these patients.n False-positive Benedict's tests, due to an unknownu00a0reducing substance, have been noted.u00a0 A glucose-specific test will differentiate findings.n Taking metaxalone tablets with food may enhance general CNS depression; elderly patients may be especially susceptible to this CNS effect (see n n u00a0and n n ).
  • The most frequent reactions to metaxalone include:
  • CNS
  • Digestive
  • Other adverse reactions are:
  • Immune System
  • Hematologic
  • Hepatobiliary
  • CNSn- Arrayn- Arrayn- Arrayn- Arrayn- Arrayn- Array
  • 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 and ).
  • When determining the LD in rats and mice, progressive sedation, hypnosis, and finally respiratory failure were noted as the dosage increased. In dogs, no LD could be determined as the higher doses produced an emetic action in 15 to 30 minutes.
  • Treatment
  • The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.
  • Metaxalone tablets areu00a0available as an 800 mg oval,u00a0convex, pink tablet with one side debossed andu00a0other side debossed .They are available as follows:n Bottles of 100:u00a0 u00a0 u00a0 u00a0 u00a0u00a0 NDC 0115-1748-01Bottles of 500:u00a0 u00a0 u00a0 u00a0 u00a0u00a0 NDC 0115-1748-02
  • Store at Controlled Room Temperature, between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F). n n n
  • 2035-03
  • Manufactured By:n Jhunan, Taiwan
  • Distributed By:n Bridgewater, NJ 08807
  • Rev. 11-2018-00
  • No data

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