Metaxalone

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Metaxalone Recall

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Side Effects & Adverse Reactions

Metaxalone may enhance the effects of alcohol and other CNS depressants.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Metaxalone is 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.

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History

There is currently no drug history available for this drug.

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Other Information

Metaxalone is available as an 800 mg, light pink to pink, capsule shaped, scored uncoated tablet.

Chemically, metaxalone is 5-[(3,5- dimethylphenoxy) methyl]-2-oxazolidinone. The empirical formula is C12H15NO3, 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.

Each tablet contains 800 mg metaxalone and the following inactive ingredients: calcium carbonate, FD&C Red #40, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone, silicone dioxide, sodium starch glycolate and sodium stearyl fumarate.

Sources

Metaxalone Manufacturers

Direct Rx

Metaxalone | Direct Rx

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Proficient Rx Lp

Metaxalone | Proficient Rx Lp

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Avkare, Inc.

Metaxalone | Avkare, Inc.

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Avpak

Metaxalone | Avpak

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Blenheim Pharmacal, Inc.

Metaxalone | Kroger Company

• take only as directed – see overdose warning • do not exceed 4 doses per 24 hours
adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

No Recall
Preferred Pharmaceuticals, Inc.

Metaxalone | Preferred Pharmaceuticals, Inc.

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Direct Rx

Metaxalone | Direct Rx

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Rebel Distributors Corp.

Metaxalone | Rebel Distributors Corp.

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
St. Marys Medical Park Pharmacy

Metaxalone | St. Marys Medical Park Pharmacy

DOSAGE AND ADMINISTRATION

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Physicians Total Care, Inc.

Metaxalone | Physicians Total Care, Inc.

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Blenheim Pharmacal, Inc.

Metaxalone | Blenheim Pharmacal, Inc.

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
H.j. Harkins Company, Inc.

Metaxalone | H.j. Harkins Company, Inc.

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Eon Labs, Inc.

Metaxalone | Eon Labs, Inc.

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Dispensing Solutions, Inc.

Metaxalone | Dispensing Solutions, Inc.

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Pd-rx Pharmaceuticals, Inc.

Metaxalone | Lupin Pharmaceuticals, Inc.

2.1 Hypertension
The recommended initial dose for patients not receiving a diuretic is 2.5 mg once a day. Adjust dose according to blood pressure response. The usual maintenance dosage range is 2.5 mg to 20 mg per day administered as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, consider an increase in dosage or twice daily administration. If blood pressure is not controlled with ramipril alone, a diuretic can be added.
2.3 Heart Failure Post-Myocardial Infarction
For the treatment of post-myocardial infarction patients who have shown signs of congestive heart failure, the recommended starting dose of ramipril is 2.5 mg twice daily (5 mg per day). A patient who becomes hypotensive at this dose may be switched to 1.25 mg twice daily. After one week at the starting dose, increase dose (if tolerated) toward a target dose of 5 mg twice daily, with dosage increases being about 3 weeks apart.

After the initial dose of ramipril, observe the patient under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. If possible, reduce the dose of any concomitant diuretic as this may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of ramipril does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension [see WARNINGS AND PRECAUTIONS (5.5), DRUG INTERACTIONS (7.1)].
2.4 General Dosing Information
Generally, swallow ramipril capsules whole. The ramipril capsule can also be opened and the contents sprinkled on a small amount (about 4 oz.) of applesauce or mixed in 4 oz. (120 mL) of water or apple juice. To be sure that ramipril is not lost when such a mixture is used, consume the mixture in its entirety. The described mixtures can be pre-prepared and stored for up to 24 hours at room temperature or up to 48 hours under refrigeration.

Concomitant administration of ramipril with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium [see WARNINGS AND PRECAUTIONS (5.8)].
2.5 Dosage Adjustment
Renal Impairment

Establish baseline renal function in patients initiating ramipril. Usual regimens of therapy with ramipril may be followed in patients with estimated creatinine clearance >40 mL/min. However, in patients with worse impairment, 25 % of the usual dose of ramipril is expected to produce full therapeutic levels of ramiprilat [see USE IN SPECIFIC POPULATIONS (8.6)].

Hypertension

For patients with hypertension and renal impairment, the recommended initial dose is 1.25 mg ramipril once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 5 mg.

Heart Failure Post-Myocardial Infarction

For patients with heart failure and renal impairment, the recommended initial dose is 1.25 mg ramipril once daily. The dose may be increased to 1.25 mg twice daily, and up to a maximum dose of 2.5 mg twice daily depending on clinical response and tolerability.

Volume Depletion or Renal Artery Stenosis

Blood pressure decreases associated with any dose of ramipril depend, in part, on the presence or absence of volume depletion (e.g., past and current diuretic use) or the presence or absence of renal artery stenosis. If such circumstances are suspected to be present, initiate dosing at 1.25 mg once daily. Adjust dosage according to blood pressure response.

No Recall
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Metaxalone | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Unit Dose Services

Metaxalone | Unit Dose Services

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Preferred Pharmaceuticals, Inc

Metaxalone | Preferred Pharmaceuticals, Inc.

Methimazole is administered orally. It is usually given in 3 equal doses at approximately 8-hour intervals.

Adults

The initial daily dosage is 15 mg for mild hyperthyroidism, 30 to 40 mg for moderately severe hyperthyroidism, and 60 mg for severe hyperthyroidism, divided into 3 doses at 8- hour intervals. The maintenance dosage is 5 to 15 mg daily.

Pediatric

Initially, the daily dosage is 0.4 mg/kg of body weight divided into 3 doses and given at 8-hour intervals. The maintenance dosage is approximately 1/2 of the initial dose.

No Recall
Stat Rx Usa Llc

Metaxalone | Stat Rx Usa Llc

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Corepharma, Llc

Metaxalone | Corepharma, Llc

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Remedyrepack Inc.

Metaxalone | Remedyrepack Inc.

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Rebel Distributors Corp

Metaxalone | Rebel Distributors Corp

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Stat Rx Usa Llc

Metaxalone | Stat Rx Usa Llc

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Bryant Ranch Prepack

Metaxalone | Bryant Ranch Prepack

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Amneal Pharmaceuticals, Llc

Metaxalone | Amneal Pharmaceuticals, Llc

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Clinical Solutions Wholesale

Metaxalone | Clinical Solutions Wholesale

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
American Health Packaging

Metaxalone | American Health Packaging

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Aidarex Pharmaceuticals Llc

Metaxalone | Aidarex Pharmaceuticals Llc

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Bluepoint Laboratories

Metaxalone | Bluepoint Laboratories

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Northwind Pharmaceuticals

Metaxalone | Northwind Pharmaceuticals

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Northwind Pharmaceuticals

Metaxalone | Northwind Pharmaceuticals

DOSAGE AND ADMINISTRATION

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Bryant Ranch Prepack

Metaxalone | Bryant Ranch Prepack

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall
Carilion Materials Management

Metaxalone | Carilion Materials Management

The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.

No Recall