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Robaxacet Extra Strength (Methocarbamol Acetaminophen)
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Pharmacology
This product provides a dual approach to the management of discomforts associated with musculoskeletal disorders.
The mechanism of action of methocarbamol has not been established, but may be due to general CNS depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber. Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic.
Methocarbamol is metabolized to yield a dealkylated and a hydroxylated product. These two metabolites are found primarily as glucuronide and sulfate conjugates. The half-life of methocarbamol and its metabolites is about 2hours. Animal studies reveal that methocarbamol crosses the placental barrier and the blood-brain barrier. Acetaminophen is conjugated in the liver to form glucuronide and sulfate conjugates. Its plasma half-life has been reported to be from 1to 2hours.
This product provides a dual approach to the management of discomforts associated with musculoskeletal disorders.
The mechanism of action of methocarbamol has not been established, but may be due to general CNS depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber. Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic.
Methocarbamol is metabolized to yield a dealkylated and a hydroxylated product. These two metabolites are found primarily as glucuronide and sulfate conjugates. The half-life of methocarbamol and its metabolites is about 2hours. Animal studies reveal that methocarbamol crosses the placental barrier and the blood-brain barrier. Acetaminophen is conjugated in the liver to form glucuronide and sulfate conjugates. Its plasma half-life has been reported to be from 1to 2hours.
Indications
This Product Provides A Dual Approach To The Management Of Discomforts Associated With Musculoskeletal Disorders.
The Mechanism Of Action Of Methocarbamol Has Not Been Established, But May Be Due To General CNS Depression. It Has No Direct Action On The Contractile Mechanism Of Striated Muscle, The Motor End Plate Or The Nerve Fiber. Acetaminophen Is A Non-opiate, Non-salicylate Analgesic And Antipyretic.
Methocarbamol Is Metabolized To Yield A Dealkylated And A Hydroxylated Product. These Two Metabolites Are Found Primarily As Glucuronide And Sulfate Conjugates. The Half-life Of Methocarbamol And Its Metabolites Is About 2hours. Animal Studies Reveal That Methocarbamol Crosses The Placental Barrier And The Blood-brain Barrier. Acetaminophen Is Conjugated In The Liver To Form Glucuronide And Sulfate Conjugates. Its Plasma Half-life Has Been Reported To Be From 1to 2hours.
This Product Provides A Dual Approach To The Management Of Discomforts Associated With Musculoskeletal Disorders.
The Mechanism Of Action Of Methocarbamol Has Not Been Established, But May Be Due To General CNS Depression. It Has No Direct Action On The Contractile Mechanism Of Striated Muscle, The Motor End Plate Or The Nerve Fiber. Acetaminophen Is A Non-opiate, Non-salicylate Analgesic And Antipyretic.
Methocarbamol Is Metabolized To Yield A Dealkylated And A Hydroxylated Product. These Two Metabolites Are Found Primarily As Glucuronide And Sulfate Conjugates. The Half-life Of Methocarbamol And Its Metabolites Is About 2hours. Animal Studies Reveal That Methocarbamol Crosses The Placental Barrier And The Blood-brain Barrier. Acetaminophen Is Conjugated In The Liver To Form Glucuronide And Sulfate Conjugates. Its Plasma Half-life Has Been Reported To Be From 1to 2hours.
Contraindications
Hypersensitivity to methocarbamol or acetaminophen.
Hypersensitivity to methocarbamol or acetaminophen.
Safety Information / Warning
Do not exceed recommended dosage as severe liver damage due to acetaminophen toxicity may occur. Avoid alcohol.
Do not exceed recommended dosage as severe liver damage due to acetaminophen toxicity may occur. Avoid alcohol.
Precautions
Occupational Hazards: Until the potential for producing drowsiness and dizziness has been determined, the patient should be cautioned against the operation of motor vehicles or machinery.
Since methocarbamol may possess a general CNS depressant effect, patients receiving Robaxacet should be cautioned about combined effects with alcohol and other CNS depressants.
Drug Interactions : Methocarbamol may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Pregnancy: There are no adequate and well-controlled studies of Robaxacet in pregnant women. This product should be used during pregnancy only when, in the judgment of the physician, the potential benefits outweigh the potential hazards.
Lactation: It is not known whether methocarbamol or its metabolites are secreted in human milk; there is some indication that small quantities of acetaminophen are secreted.
Children: Safety and effectiveness in children 12years of age and younger have not been established.
Occupational Hazards: Until the potential for producing drowsiness and dizziness has been determined, the patient should be cautioned against the operation of motor vehicles or machinery.
Since methocarbamol may possess a general CNS depressant effect, patients receiving Robaxacet should be cautioned about combined effects with alcohol and other CNS depressants.
Drug Interactions : Methocarbamol may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Pregnancy: There are no adequate and well-controlled studies of Robaxacet in pregnant women. This product should be used during pregnancy only when, in the judgment of the physician, the potential benefits outweigh the potential hazards.
Lactation: It is not known whether methocarbamol or its metabolites are secreted in human milk; there is some indication that small quantities of acetaminophen are secreted.
Children: Safety and effectiveness in children 12years of age and younger have not been established.
Side Effects / Adverse Effects
The most common complaints to methocarbamol are drowsiness, nausea and dizziness or lightheadedness (seen in approximately 4to 5% of patients). The following reactions have been associated with the drug, some of them rarely; in some instances, causal relationships have not been established: headache, nasal congestion, blurred vision, rash, pruritus and urticaria.
Adverse reactions that have been associated with the use of acetaminophen include: nausea, vomiting or diarrhea. Rarely, hypersensitivity reactions have been reported, as manifested by thrombocytopenic purpura, hemolytic anemia and agranulocytosis.
Gastrointestinal discomfort may be minimized by taking the dose with food.
The most common complaints to methocarbamol are drowsiness, nausea and dizziness or lightheadedness (seen in approximately 4to 5% of patients). The following reactions have been associated with the drug, some of them rarely; in some instances, causal relationships have not been established: headache, nasal congestion, blurred vision, rash, pruritus and urticaria.
Adverse reactions that have been associated with the use of acetaminophen include: nausea, vomiting or diarrhea. Rarely, hypersensitivity reactions have been reported, as manifested by thrombocytopenic purpura, hemolytic anemia and agranulocytosis.
Gastrointestinal discomfort may be minimized by taking the dose with food.
Overdose
Symptoms: Methocarbamol: No deaths or major toxicity have been reported from overdosage with methocarbamol, administered parenterally or orally. One adult survived the deliberate ingestion of22to 30g of methocarbamol without serious toxicity. Another survived 30to 50g. The principal symptom was drowsiness in both cases. However, 3deaths have been reported when methocarbamol was combined with alcohol and other drugs.
Acetaminophen: Acetaminophen in massive overdosage may cause hepatic toxicity in some patients.
In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 5g. Importantly, young children seem to be more resistant than adults to the hepatotoxic effect of an acetaminophen overdose. Despite this, the measures outlined below should be initiated in any adult or child suspected of having ingested an acetaminophen overdose.
Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48to72hours postingestion.
Treatment: Methocarbamol: Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs and the administration of i.v. fluids, if necessary. There is no experience with forced diuresis or with dialysis in the treatment of methocarbamol overdose. Likewise, the usefulness of hemodialysis in managing methocarbamol overdose is unknown.
Acetaminophen: The stomach should be emptied promptly by lavage or by induction of emesis with syrup of ipecac. Patients' estimates of the quantity of a drug ingested are notoriously unreliable. Therefore, if an acetaminophen overdose is suspected, a serum acetaminophen assay should be obtained as early as possible, but no sooner than 4hours following ingestion. Liver function studies should be obtained initially and repeated at 24-hour intervals.
The antidote, N-acetylcysteine, should be administered as early as possible, and within 16hours of the overdose ingestion for optimal results. Following recovery, there are no residual, structural or functional hepatic abnormalities.
Symptoms: Methocarbamol: No deaths or major toxicity have been reported from overdosage with methocarbamol, administered parenterally or orally. One adult survived the deliberate ingestion of22to 30g of methocarbamol without serious toxicity. Another survived 30to 50g. The principal symptom was drowsiness in both cases. However, 3deaths have been reported when methocarbamol was combined with alcohol and other drugs.
Acetaminophen: Acetaminophen in massive overdosage may cause hepatic toxicity in some patients.
In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 5g. Importantly, young children seem to be more resistant than adults to the hepatotoxic effect of an acetaminophen overdose. Despite this, the measures outlined below should be initiated in any adult or child suspected of having ingested an acetaminophen overdose.
Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48to72hours postingestion.
Treatment: Methocarbamol: Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs and the administration of i.v. fluids, if necessary. There is no experience with forced diuresis or with dialysis in the treatment of methocarbamol overdose. Likewise, the usefulness of hemodialysis in managing methocarbamol overdose is unknown.
Acetaminophen: The stomach should be emptied promptly by lavage or by induction of emesis with syrup of ipecac. Patients' estimates of the quantity of a drug ingested are notoriously unreliable. Therefore, if an acetaminophen overdose is suspected, a serum acetaminophen assay should be obtained as early as possible, but no sooner than 4hours following ingestion. Liver function studies should be obtained initially and repeated at 24-hour intervals.
The antidote, N-acetylcysteine, should be administered as early as possible, and within 16hours of the overdose ingestion for optimal results. Following recovery, there are no residual, structural or functional hepatic abnormalities.
Recommended Dosage
Robaxacet Tablets/Caplets: Adults and Children over 12years: 2caplets/tablets 4times daily. Three caplets/tablets 4times daily may be used in severe conditions for 1to3days. These dosage recommendations provide 3.2 and 4.8g, respectively, methocarbamol and 2.6 and 3.9g, respectively, acetaminophen/day.
Robaxacet Extra Strength: Adults and Children over 12years: 2caplets 4times daily. This recommended dosage provides 3.2g methocarbamol and 4g acetaminophen/day.
Robaxacet Tablets/Caplets: Adults and Children over 12years: 2caplets/tablets 4times daily. Three caplets/tablets 4times daily may be used in severe conditions for 1to3days. These dosage recommendations provide 3.2 and 4.8g, respectively, methocarbamol and 2.6 and 3.9g, respectively, acetaminophen/day.
Robaxacet Extra Strength: Adults and Children over 12years: 2caplets 4times daily. This recommended dosage provides 3.2g methocarbamol and 4g acetaminophen/day.
Supplied / Packaging
Robaxacet Extra Strength: Each green and white caplet, green layer scored and engraved “EX”, and white layer engraved “W-R”, contains: methocarbamol 400mg and acetaminophen 500mg. Nonmedicinal ingredients: cellulose, cornstarch, crospovidone, D&C Yellow No.10, FD&C Blue No.1, magnesium stearate, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate and stearic acid. Energy: <1kJ (<1kcal). Sodium: <1mmol (0.46mg). Bottles of40. Boxes of18. Store at room temperature (15to 30°C).
Robaxacet Extra Strength: Each green and white caplet, green layer scored and engraved “EX”, and white layer engraved “W-R”, contains: methocarbamol 400mg and acetaminophen 500mg. Nonmedicinal ingredients: cellulose, cornstarch, crospovidone, D&C Yellow No.10, FD&C Blue No.1, magnesium stearate, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate and stearic acid. Energy: <1kJ (<1kcal). Sodium: <1mmol (0.46mg). Bottles of40. Boxes of18. Store at room temperature (15to 30°C).
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Brand Name
Robaxacet Extra Strength
Robaxacet Extra Strength
Generic Name
Methocarbamol Acetaminophen
Methocarbamol Acetaminophen
General Indications
Skeletal Muscle Relaxant Analgesic
Skeletal Muscle Relaxant Analgesic
