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ORBIVAN
Overview
What is ORBIVAN?
ORBIVAN™ Butalbital, Acetaminophen and Caffeine Capsules USP are supplied in hard-gelatin capsule form for oral administration.
Each capsule contains the following active ingredients:
Butalbital USP……………………50 mgAcetaminophen USP…………….300 mgCaffeine USP……………………..40 mg
Inactive Ingredients:
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate of molecular weight 212.25. It has the following structural formula:
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic of molecular weight 151.16. It has the following structural formula:
Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant of molecular weight 194.19. It has the following structural formula:
What does ORBIVAN look like?
What are the available doses of ORBIVAN?
Sorry No records found.
What should I talk to my health care provider before I take ORBIVAN?
Sorry No records found
How should I use ORBIVAN?
ORBIVAN™ Butalbital, Acetaminophen and Caffeine capsules 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.
One or 2 capsules every 4 hours as needed. Total daily dosage should not exceed 6 capsules.
Extended and repeated use of this product is not recommended because of the potential for physical dependence.
What interacts with ORBIVAN?
This product is contraindicated under the following conditions:
– Hypersensitivity or intolerance to any component of this product
– Patients with porphyria.
What are the warnings of ORBIVAN?
Cyclobenzaprine HCl may enhance the effects of alcohol, barbiturates, and other CNS depressants.
What are the precautions of ORBIVAN?
General
ORBIVAN™ Butalbital, acetaminophen, and caffeine capsules 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.
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.
For information on use in geriatric patients, see.
Laboratory Tests
In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.
Drug Interactions
The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.
Butalbital, acetaminophen, and caffeine 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.
Drug/Laboratory Test Interactions
Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
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.
Pregnancy
Pregnancy Category C:
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.
Nursing Mothers
Caffeine, 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, acetaminophen, and caffeine, 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.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 12 have not been established.
Geriatric Use
Clinical studies of butalbital, acetaminophen and caffeine capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
What are the side effects of ORBIVAN?
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.
Array
Central Nervous System:
Array
Autonomic Nervous System:
Array
Gastrointestinal:
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Cardiovascular:
Array
Musculoskeletal:
Array
Genitourinary:
Array
Miscellaneous:
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.
Array
Acetaminophen:
Array
Caffeine:
What should I look out for while using ORBIVAN?
This product is contraindicated under the following conditions:
– Hypersensitivity or intolerance to any component of this product
– Patients with porphyria.
Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
What might happen if I take too much ORBIVAN?
Following an acute overdosage of butalbital, acetaminophen, and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.
How should I store and handle ORBIVAN?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].ORBIVAN™ Butalbital, Acetaminophen, and Caffeine Capsules USP 50 mg/300 mg/40 mgContaining 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a green cap, printed with AP, and a yellow body, printed with 661. The capsules are supplied in bottles of 100 capsules (NDC 59702-661-01) and in unit dose pouches for patient trial available only through physician offices [NDC 59702-661-12].Store at 20 to 25C (68 to 77 F) [see USP Controlled Room Temperature]; Dispense in a tight, light-resistant container.*Trademark of Medical Economics Company, Inc.Rx onlyMfg. for: Atley Pharmaceuticals, Inc.Ashland, VA 230057029 Rev. 03/10ORBIVAN™ Butalbital, Acetaminophen, and Caffeine Capsules USP 50 mg/300 mg/40 mgContaining 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a green cap, printed with AP, and a yellow body, printed with 661. The capsules are supplied in bottles of 100 capsules (NDC 59702-661-01) and in unit dose pouches for patient trial available only through physician offices [NDC 59702-661-12].Store at 20 to 25C (68 to 77 F) [see USP Controlled Room Temperature]; Dispense in a tight, light-resistant container.*Trademark of Medical Economics Company, Inc.Rx onlyMfg. for: Atley Pharmaceuticals, Inc.Ashland, VA 230057029 Rev. 03/10ORBIVAN™ Butalbital, Acetaminophen, and Caffeine Capsules USP 50 mg/300 mg/40 mgContaining 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a green cap, printed with AP, and a yellow body, printed with 661. The capsules are supplied in bottles of 100 capsules (NDC 59702-661-01) and in unit dose pouches for patient trial available only through physician offices [NDC 59702-661-12].Store at 20 to 25C (68 to 77 F) [see USP Controlled Room Temperature]; Dispense in a tight, light-resistant container.*Trademark of Medical Economics Company, Inc.Rx onlyMfg. for: Atley Pharmaceuticals, Inc.Ashland, VA 230057029 Rev. 03/10ORBIVAN™ Butalbital, Acetaminophen, and Caffeine Capsules USP 50 mg/300 mg/40 mgContaining 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a green cap, printed with AP, and a yellow body, printed with 661. The capsules are supplied in bottles of 100 capsules (NDC 59702-661-01) and in unit dose pouches for patient trial available only through physician offices [NDC 59702-661-12].Store at 20 to 25C (68 to 77 F) [see USP Controlled Room Temperature]; Dispense in a tight, light-resistant container.*Trademark of Medical Economics Company, Inc.Rx onlyMfg. for: Atley Pharmaceuticals, Inc.Ashland, VA 230057029 Rev. 03/10ORBIVAN™ Butalbital, Acetaminophen, and Caffeine Capsules USP 50 mg/300 mg/40 mgContaining 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a green cap, printed with AP, and a yellow body, printed with 661. The capsules are supplied in bottles of 100 capsules (NDC 59702-661-01) and in unit dose pouches for patient trial available only through physician offices [NDC 59702-661-12].Store at 20 to 25C (68 to 77 F) [see USP Controlled Room Temperature]; Dispense in a tight, light-resistant container.*Trademark of Medical Economics Company, Inc.Rx onlyMfg. for: Atley Pharmaceuticals, Inc.Ashland, VA 230057029 Rev. 03/10ORBIVAN™ Butalbital, Acetaminophen, and Caffeine Capsules USP 50 mg/300 mg/40 mgContaining 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a green cap, printed with AP, and a yellow body, printed with 661. The capsules are supplied in bottles of 100 capsules (NDC 59702-661-01) and in unit dose pouches for patient trial available only through physician offices [NDC 59702-661-12].Store at 20 to 25C (68 to 77 F) [see USP Controlled Room Temperature]; Dispense in a tight, light-resistant container.*Trademark of Medical Economics Company, Inc.Rx onlyMfg. for: Atley Pharmaceuticals, Inc.Ashland, VA 230057029 Rev. 03/10ORBIVAN™ Butalbital, Acetaminophen, and Caffeine Capsules USP 50 mg/300 mg/40 mgContaining 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a green cap, printed with AP, and a yellow body, printed with 661. The capsules are supplied in bottles of 100 capsules (NDC 59702-661-01) and in unit dose pouches for patient trial available only through physician offices [NDC 59702-661-12].Store at 20 to 25C (68 to 77 F) [see USP Controlled Room Temperature]; Dispense in a tight, light-resistant container.*Trademark of Medical Economics Company, Inc.Rx onlyMfg. for: Atley Pharmaceuticals, Inc.Ashland, VA 230057029 Rev. 03/10ORBIVAN™ Butalbital, Acetaminophen, and Caffeine Capsules USP 50 mg/300 mg/40 mgContaining 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a green cap, printed with AP, and a yellow body, printed with 661. The capsules are supplied in bottles of 100 capsules (NDC 59702-661-01) and in unit dose pouches for patient trial available only through physician offices [NDC 59702-661-12].Store at 20 to 25C (68 to 77 F) [see USP Controlled Room Temperature]; Dispense in a tight, light-resistant container.*Trademark of Medical Economics Company, Inc.Rx onlyMfg. for: Atley Pharmaceuticals, Inc.Ashland, VA 230057029 Rev. 03/10ORBIVAN™ Butalbital, Acetaminophen, and Caffeine Capsules USP 50 mg/300 mg/40 mgContaining 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a green cap, printed with AP, and a yellow body, printed with 661. The capsules are supplied in bottles of 100 capsules (NDC 59702-661-01) and in unit dose pouches for patient trial available only through physician offices [NDC 59702-661-12].Store at 20 to 25C (68 to 77 F) [see USP Controlled Room Temperature]; Dispense in a tight, light-resistant container.*Trademark of Medical Economics Company, Inc.Rx onlyMfg. for: Atley Pharmaceuticals, Inc.Ashland, VA 230057029 Rev. 03/10ORBIVAN™ Butalbital, Acetaminophen, and Caffeine Capsules USP 50 mg/300 mg/40 mgContaining 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a green cap, printed with AP, and a yellow body, printed with 661. The capsules are supplied in bottles of 100 capsules (NDC 59702-661-01) and in unit dose pouches for patient trial available only through physician offices [NDC 59702-661-12].Store at 20 to 25C (68 to 77 F) [see USP Controlled Room Temperature]; Dispense in a tight, light-resistant container.*Trademark of Medical Economics Company, Inc.Rx onlyMfg. for: Atley Pharmaceuticals, Inc.Ashland, VA 230057029 Rev. 03/10
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, acetaminophen, and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.
Non-Clinical Toxicology
This product is contraindicated under the following conditions:– Hypersensitivity or intolerance to any component of this product
– Patients with porphyria.
Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.
The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.
Butalbital, acetaminophen, and caffeine 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.
ORBIVAN™ Butalbital, acetaminophen, and caffeine capsules 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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