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Butalbital and Acetaminophen Tablets
Overview
What is BUPAP?
Each BUPAP Tablet for oral administration, contains Butalbital, USP 50 mg and Acetaminophen, USP 300 mg.
In addition each BUPAP Tablet contains the following inactive ingredients: Pregelatinized Starch, Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, D&C Yellow #10 Lake, and FD&C Red #40 Lake.
Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula:
Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
What does BUPAP look like?
What are the available doses of BUPAP?
Sorry No records found.
What should I talk to my health care provider before I take BUPAP?
Sorry No records found
How should I use BUPAP?
BUPAP Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
BUPAP Tablets: 1 or 2 tablets every four hours. Total daily dosage should not exceed 6 tablets.
Extended and repeated use of these products is not recommended because of the potential for physical dependence.
What interacts with BUPAP?
- This product is contraindicated under the following conditions:
- •
- •
What are the warnings of BUPAP?
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Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
Hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Serious skin reactions
Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Hypersensitivity/anaphylaxis
There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting, There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue BUPAP Tablets immediately and seek medical care if they experience these symptoms. Do not prescribe BUPAP Tablets for patients with acetaminophen allergy.
What are the precautions of BUPAP?
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General
BUPAP Tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.
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Information for patients
This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.
Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.
Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.
• Do not take BUPAP Tablets if you are allergic to any of its ingredients.
• If you develop signs of allergy such as a rash or difficulty breathing stop taking BUPAP Tablets and contact your healthcare provider immediately.
• Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.
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Laboratory tests
In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.
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Drug interactions
The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.
Butalbital and acetaminophen may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
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Drug/laboratory test interactions
Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
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Carcinogenesis, mutagenesis, impairment of fertility
No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.
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Pregnancy
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Pregnancy Category C: Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital and acetaminophen can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. These products should be given to a pregnant woman only when clearly needed.
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Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Butalbital was found in the infant's serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.
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Nursing mothers
Barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital and acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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Pediatric use
Safety and effectiveness in children below the age of 12 have not been established.
What are the side effects of BUPAP?
Frequently Observed: The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.
Infrequently Observed: All adverse events tabulated below are classified as infrequent.
Central Nervous: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.
Autonomic Nervous: dry mouth, hyperhidrosis.
Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.
Cardiovascular: tachycardia.
Musculoskeletal: leg pain, muscle fatigue.
Genitourinary: diuresis.
Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.
Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.
The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the section.
Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.
What should I look out for while using BUPAP?
This product is contraindicated under the following conditions:
Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
Hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Serious skin reactions
Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Hypersensitivity/anaphylaxis
There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting, There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue BUPAP Tablets immediately and seek medical care if they experience these symptoms. Do not prescribe BUPAP Tablets for patients with acetaminophen allergy.
What might happen if I take too much BUPAP?
Following an acute overdosage of butalbital and acetaminophen, toxicity may result from the barbiturate or the acetaminophen.
How should I store and handle BUPAP?
Topiramate extended-release capsules should be stored in a tightly-closed container at 20 to 25°C (68 to 77°F). Excursions permitted between 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Protect from moisture.Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401Yellowish round, unscored tablets with on one side and plain on the other, in bottles of 100 (NDC 0095-3000-01). Each tablet contains butalbital, USP 50 mg and acetaminophen, USP 300 mg.Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.For Medical Information or to report Adverse eventscontact 1-800-321-4576.Manufactured for:ECR Pharmaceuticals,a division of Valeant Pharmaceuticals North America LLCBridgewater, NJ 08807 USABupap is a trademark of Valeant Pharmaceuticals International, Inc., or its affiliates.©Valeant Pharmaceuticals North America LLC Rev. 09/169417401
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
This combination drug product is intended as a treatment for tension headache.
It consists of a fixed combination of butalbital and acetaminophen. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.
Pharmacokinetics: The behavior of the individual components is described below.
Butalbital: Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.
Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2,3-dihydroxy-propyl) barbituric acid (about 24% of the dose), 5-allyl-5 (3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated.
See for toxicity information.
Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.
See for toxicity information.
Non-Clinical Toxicology
This product is contraindicated under the following conditions:Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
Hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.
The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.
Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.
Serious skin reactions
Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Hypersensitivity/anaphylaxis
There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting, There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue BUPAP Tablets immediately and seek medical care if they experience these symptoms. Do not prescribe BUPAP Tablets for patients with acetaminophen allergy.
The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.
Butalbital and acetaminophen may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.
BUPAP Tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.
Frequently Observed: The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.
Infrequently Observed: All adverse events tabulated below are classified as infrequent.
Central Nervous: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.
Autonomic Nervous: dry mouth, hyperhidrosis.
Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.
Cardiovascular: tachycardia.
Musculoskeletal: leg pain, muscle fatigue.
Genitourinary: diuresis.
Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.
Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.
The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the section.
Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
Interactions
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