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Manobaxine TABLETS, USP
Manobaxine 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 Manobaxine is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24.
Manobaxine 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 Manobaxine, 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.
The mechanism of action of Manobaxine 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.
In healthy volunteers, the plasma clearance of Manobaxine 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%.
Manobaxine is metabolized via dealkylation and hydroxylation. Conjugation of Manobaxine also is likely. Essentially all Manobaxine metabolites are eliminated in the urine. Small amounts of unchanged Manobaxine also are excreted in the urine.
The mean elimination half-life of Manobaxine 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 Manobaxine was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively).
The clearance of Manobaxine 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.
In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of Manobaxine 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 Manobaxine bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects.
Manobaxine 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 Manobaxine has not been clearly identified, but may be related to its sedative properties. Manobaxine does not directly relax tense skeletal muscles in man.
Methocarbamol Tablets are contraindicated in patients hypersensitive to Manobaxine or to any of the tablet components.
Since Manobaxine may possess a general CNS depressant effect, patients receiving Manobaxine Tablets should be cautioned about combined effects with alcohol and other CNS depressants.
Safe use of Manobaxine 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 Manobaxine. Therefore, Manobaxine 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.
Manobaxine 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 Manobaxine therapy does not adversely affect their ability to engage in such activities.
Patients should be cautioned that Manobaxine may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery.
Because Manobaxine may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.
See WARNINGS and PRECAUTIONS for interaction with CNS drugs and alcohol.
Manobaxine may inhibit the effect of pyridostigmine bromide. Therefore, Manobaxine should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.
Manobaxine 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.
Long-term studies to evaluate the carcinogenic potential of Manobaxine have not been performed. No studies have been conducted to assess the effect of Manobaxine on mutagenesis or its potential to impair fertility.
Animal reproduction studies have not been conducted with Manobaxine. It is also not known whether Manobaxine 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 Manobaxine 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 Manobaxine. Therefore, Manobaxine 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.
Manobaxine and/or its metabolites are excreted in the milk of dogs; however, it is not known whether Manobaxine or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Manobaxine Tablets are administered to a nursing woman.
Safety and effectiveness of Manobaxine Tablets in pediatric patients below the age of 16 have not been established.
Adverse reactions reported coincident with the administration of Manobaxine 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.
Limited information is available on the acute toxicity of Manobaxine. Overdose of Manobaxine 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 Manobaxine alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.
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.
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.
Manobaxine 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
Manobaxine 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 20-25oC (68-77oF). Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724
Revised March 2011
Depending on the reaction of the Manobaxine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Manobaxine 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 Manobaxine 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.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology