Lumirelax

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Lumirelax uses

• Description:
• Clinical pharmacology:
• Indications and usage:
• Contraindications:
• Warnings:
• Precautions:
• Adverse reactions
• Overdosage
• Dosage and administration:
• How supplied:
• Lumirelax reviews

Lumirelax TABLETS, USP

Rev. 03/11

Rx Only

DESCRIPTION:

Lumirelax Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is:

The chemical name for Lumirelax is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C₁₁H₁₅NO₅. Its molecular weight is 241.24.

Lumirelax is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane.

Each tablet, for oral administration, contains 500 mg or 750 mg of Lumirelax, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate.

Lumirelax structural formula

CLINICAL

Pharmacology:

The mechanism of action of Lumirelax in humans has not been established, but may be due to general central nervous system depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

Pharmacokinetics :

In healthy volunteers, the plasma clearance of Lumirelax ranges between 0.20 and 0.80 L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%.

Lumirelax is metabolized via dealkylation and hydroxylation. Conjugation of Lumirelax also is likely. Essentially all Lumirelax metabolites are eliminated in the urine. Small amounts of unchanged Lumirelax also are excreted in the urine.

Special Populations :

Elderly

The mean elimination half-life of Lumirelax in elderly healthy volunteers (mean (± SD) age, 69 (± 4) years) was slightly prolonged compared to a younger (mean (± SD) age, 53.3 (± 8.8) years), healthy population (1.5 (±0.4) hours versus 1.1 (±0.27) hours, respectively). The fraction of bound Lumirelax was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively).

Renally Impaired

The clearance of Lumirelax in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (±SD) elimination half-life in these two groups was similar: 1.2 (±0.6) versus 1.1 (±0.3) hours, respectively.

Hepatically Impaired

In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of Lumirelax was reduced approximately 70% compared to that obtained in 8 age- and weight-matched normal subjects. The mean (±SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (±1.62) hours and 1.11 (±0.27) hours, respectively. The percent of Lumirelax bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects.

INDICATIONS AND USAGE:

Lumirelax Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of Lumirelax has not been clearly identified, but may be related to its sedative properties. Lumirelax does not directly relax tense skeletal muscles in man.

CONTRAINDICATIONS:

Methocarbamol Tablets are contraindicated in patients hypersensitive to Lumirelax or to any of the tablet components.

WARNINGS:

Since Lumirelax may possess a general CNS depressant effect, patients receiving Lumirelax Tablets should be cautioned about combined effects with alcohol and other CNS depressants.

Safe use of Lumirelax Tablets has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to Lumirelax. Therefore, Lumirelax Tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards.

Use in Activities Requiring Mental Alertness :

Lumirelax may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that Lumirelax therapy does not adversely affect their ability to engage in such activities.

PRECAUTIONS:

Information for Patients:

Patients should be cautioned that Lumirelax may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery.

Because Lumirelax may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.

Drug Interactions:

See WARNINGS and PRECAUTIONS for interaction with CNS drugs and alcohol.

Lumirelax may inhibit the effect of pyridostigmine bromide. Therefore, Lumirelax should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.

Drug /Laboratory Test Interactions:

Lumirelax may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid using nitrosonaphthol reagent and in screening tests for urinary vanillylmandelic acid (VMA) using the Gitlow method.

Carcinogenesis, Mutagenesis, Impairment of Fertility :

Long-term studies to evaluate the carcinogenic potential of Lumirelax have not been performed. No studies have been conducted to assess the effect of Lumirelax on mutagenesis or its potential to impair fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with Lumirelax. It is also not known whether Lumirelax can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methocarbamol Tablets should be given to a pregnant woman only if clearly needed.

Safe use of Lumirelax Tablets has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congential abnormalities following in utero exposure to Lumirelax. Therefore, Lumirelax Tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards.

Nursing Mothers

Lumirelax and/or its metabolites are excreted in the milk of dogs; however, it is not known whether Lumirelax or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lumirelax Tablets are administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Lumirelax Tablets in pediatric patients below the age of 16 have not been established.

ADVERSE REACTIONS

Adverse reactions reported coincident with the administration of Lumirelax include:

Body as a Whole : Anaphylactic reaction, angioneurotic edema, fever, headache

Car d iovascular System : Bradycardia, flushing, hypotension, syncope, thrombophlebitis

Digestive System : Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting

Hemic and Lymphatic S ystem : Leukopenia

Immune System : Hypersensitivity reactions

Nervous System : Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo

Skin and Special Senses : Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria

To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

Limited information is available on the acute toxicity of Lumirelax. Overdose of Lumirelax is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma.

In post-marketing experience, deaths have been reported with an overdose of Lumirelax alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.

Treatment:

Management of overdose includes symptomatic and supportive treatment. Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown.

DOSAGE AND ADMINISTRATION:

500 mg – Adults: Initial dosage, 3 tablets q.i.d.; maintenance dosage, 2 tablets q.i.d.

750 mg – Adults: Initial dosage, 2 tablets q.i.d.; maintenance dosage, 1 tablet q.4h. or 2 tablets t.i.d.

Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered.) Thereafter, the dosage can usually be reduced to approximately 4 grams a day.

HOW SUPPLIED:

Lumirelax Tablets 500 mg: White, Round Tablets; Debossed “West-ward 290” on one side and Scored on the other side.

Bottles of 100 tablets

Bottles of 500 tablets

Bottles of 1000 tablets

Unit Dose Box of 100 tablets

Lumirelax Tablets 750 mg: White, Capsule Shaped Tablets; Debossed “WEST-WARD 292” on one side and Scored on the other side.

Bottles of 100 tablets

Bottles of 500 tablets

Bottles of 1000 tablets

Unit Dose Box of 100 tablets

Store at 20-25^oC (68-77^oF). Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured by:

West-ward Pharmaceutical Corp.

Eatontown, NJ 07724

Revised March 2011

Lumirelax pharmaceutical active ingredients containing related brand and generic drugs:

• Methocarbamol

Lumirelax available forms, composition, doses:

• Cream; Topical; Methocarbamol 10%
• Tabsule; Oral; Methocarbamol 500 mg

Lumirelax destination | category:

• Human:
• Skeletal muscle relaxants

Lumirelax Anatomical Therapeutic Chemical codes:

• M03BA03 - Methocarbamol

Lumirelax pharmaceutical companies:

• Alpharma
• Tradiphar Laboratoire

References

1. Dailymed."METHOCARBAMOL TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. Dailymed."METHOCARBAMOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
3. "methocarbamol". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Lumirelax?

Depending on the reaction of the Lumirelax after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Lumirelax not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Lumirelax addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Lumirelax, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Lumirelax consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology