Butalbital, Aspirin, And Caffeine (Fiorinal)

Trade Name : Fiorinal

Allergan, Inc.

CAPSULE

Strength 5032540 mg/1mg/1mg/1

BUTALBITAL; ASPIRIN; CAFFEINE Barbiturates [CS],Barbiturate [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Butalbital, Aspirin, And Caffeine (Fiorinal) which is also known as Fiorinal and Manufactured by Allergan, Inc.. It is available in strength of 50; 325; 40 mg/1; mg/1; mg/1 per ml. Read more

Butalbital, Aspirin, And Caffeine (Fiorinal) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Fiorinal (Butalbital, Aspirin, and Caffeine Capsules, USP) is supplied in capsule form for oral administration.
  • Each capsule contains the following active ingredients:
  • Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula:u00a0
  • Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula:
  • Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula:
  • Inactive Ingredients:
  • Pharmacologically, Fiorinal combines the analgesic properties of aspirin with the anxiolytic and muscle relaxant properties of butalbital.
  • The clinical effectiveness of Fiorinal in tension headache has been established in double-blind, placebo-controlled, multi-clinic trials. A factorial design study compared Fiorinal with each of its major components. This study demonstrated that each component contributes to the efficacy of Fiorinal in the treatment of the target symptoms of tension headache (headache pain, psychic tension, and muscle contraction in the head, neck, and shoulder region). For each symptom and the symptom complex as a whole, Fiorinalu00a0was shown to have significantly superior clinical effects to either component alone.
  • Pharmacokinetics
  • The behavior of the individual components is described below.
  • Aspirin
  • The systemic availability of aspirin after an oral dose is highly dependent on the dosage form, the presence of food, the gastric emptying time, gastric pH, antacids, buffering agents, and particle size. These factors affect not necessarily the extent of absorption of total salicylates but more the stability of aspirin prior to absorption.
  • During the absorption process and after absorption, aspirin is mainly hydrolyzed to salicylic acid and distributed to all body tissues and fluids, including fetal tissues, breast milk, and the central nervous system (CNS). Highest concentrations are found in plasma, liver, renal cortex, heart, and lung. In plasma, about 50%-80% of the salicylic acid and its metabolites are loosely bound to plasma proteins.
  • The clearance of total salicylates is subject to saturable kinetics; however, first-order elimination kinetics are still a good approximation for doses up to 650 mg. The plasma half-life for aspirin is about 12 minutes and for salicylic acid and/or total salicylates is about 3 hours.
  • The elimination of therapeutic doses is through the kidneys either as salicylic acid or other biotransformation products. The renal clearance is greatly augmented by an alkaline urine as is produced by concurrent administration of sodium bicarbonate or potassium citrate.
  • The biotransformation of aspirin occurs primarily in the hepatocytes. The major metabolites are salicyluric acid (75%), the phenolic and acyl glucuronides of salicylate (15%), and gentisic and gentisuric acid (1%). The bioavailability of the aspirin component of Fiorinal is equivalent to that of a solution except for a slower rate of absorption. A peak concentration of 8.8 mcg/mL was obtained at 40 minutes after a 650 mg dose.
  • See for toxicity informationn
  • Butalbital
  • Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most of the 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%-88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products included parent drug (about 3.6% of the dose), 5-isobutyl-5-(2,3-dihydroxypropyl) 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% was conjugated.
  • The bioavailability of the butalbital component of Fiorinal is equivalent to that of a solution except for a decrease in the rate of absorption. A peak concentration of 2,020 ng/mL is obtained at about 1.5 hours after a 100 mg dose.
  • The plasma protein binding of butalbital is 45% over the concentration range of 0.5-20 mcg/mL. This falls within the range of plasma protein binding (20%-45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity indicating that there is no preferential distribution of butalbital into either plasma or blood cells.
  • See for toxicity informationn
  • Caffeine
  • Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.
  • Caffeine is cleared rapidly through metabolism and excretion in the urine. The plasma half-life is about 3 hours. Hepatic biotransformation prior to excretion results in about equal amounts of 1-methylxanthine and 1-methyluric acid. Of the 70% of the dose that has been recovered in the urine, only 3% was unchanged drug.
  • The bioavailability of the caffeine component for Fiorinal is equivalent to that of a solution except for a slightly longer time to peak. A peak concentration of 1,660 ng/mL was obtained in less than an hour for an 80 mg dose.
  • See for toxicity informationn
  • Fiorinal is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Fiorinal in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
  • Fiorinal is contraindicated under the following conditions:
  • Therapeutic doses of aspirin can cause anaphylactic shock and other severe allergic reactions. It should be ascertained if the patient is allergic to aspirin, although a specific history of allergy may be lacking.
  • Significant bleeding can result from aspirin therapy in patients with peptic ulcer or other gastrointestinal lesions, and in patients with bleeding disorders. Aspirin administered preoperatively may prolong the bleeding time. Butalbital is habit-forming and potentially abusable. Consequently, the extended use of Fiorinal is not recommended. Results from epidemiologic studies indicate an association between aspirin and Reyeu2019s Syndrome. Caution should be used in administering this product to children, including teenagers, with chicken pox or flu.
  • No data
  • The most frequent adverse reactions are drowsiness and dizziness. Less frequent adverse reactions are lightheadedness and gastrointestinal disturbances including nausea, vomiting, and flatulence. A single incidence of bone marrow suppression has been reported with the use of Fiorinal. Several cases of dermatological reactions including toxic epidermal necrolysis and erythema multiforme have been reported.
  • Controlled Substance
  • Fiorinal is controlled by the Drug Enforcement Administration and is classified under Schedule III.
  • Abuse and Dependence
  • Butalbital
  • Barbiturates may be habit-forming:
  • The toxic effects of acute overdosage of Fiorinal are attributable mainly to its barbiturate component, and, to a lesser extent, aspirin. Because toxic effects of caffeine occur in very high dosages only, the possibility of significant caffeine toxicity from Fiorinal overdosage is unlikely.
  • Signs and Symptoms
  • Symptoms attributable to include drowsiness, confusion, and coma; respiratory depression; hypotension; hypovolemic shock. Symptoms attributable to include hyperpnea; acid-base disturbances with development of metabolic acidosis; vomiting and abdominal pain; tinnitus; hyperthermia; hypoprothrombinemia; restlessness; delirium; convulsions. may cause insomnia, restlessness, tremor, and delirium; tachycardia and extrasystoles.
  • Treatment
  • Treatment consists primarily of management of barbiturate intoxication and the correction of the acid-base imbalance due to salicylism. Vomiting should be induced mechanically or with emetics in the conscious patient. Gastric lavage may be used if the pharyngeal and laryngeal reflexes are present and if less than 4 hours have elapsed since ingestion. A cuffed endotracheal tube should be inserted before gastric lavage of the unconscious patient and when necessary to provide assisted respiration. Diuresis, alkalinization of the urine, and correction of electrolyte disturbances should be accomplished through administration of intravenous fluids such as 1% sodium bicarbonate in 5% dextrose in water. Meticulous attention should be given to maintaining adequate pulmonary ventilation. The value of vasopressor agents such as Norepinephrine or Phenylephrine Hydrochloride in treating hypotension is questionable since they increase vasoconstriction and decrease blood flow. However, if prolonged support of blood pressure is required, Norepinephrine Bitartrate (Levophed) may be given I.V. with the usual precautions and serial blood pressure monitoring. In severe cases of intoxication, peritoneal dialysis, hemodialysis, or exchange transfusion may be lifesaving. Hypoprothrombinemia should be treated with Vitamin K, intravenously.
  • Up-to-date information about the treatment of overdose can often be obtained from a Certified Regional Poison Control Center. Telephone numbers of Certified Regional Poison Control Centers are listed in the Physiciansu2019 Desk Reference.
  • Toxic and Lethal Doses (for adults)n- u00a0u00a0u00a0u00a0 Butalbital:n- u00a0u00a0u00a0u00a0 Aspirin:u00a0 u00a0u00a0u00a0u00a0n- u00a0u00a0u00a0u00a0 Caffeine:u00a0u00a0u00a0u00a0
  • One or 2 capsules every 4 hours. Total daily dose should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
  • Fiorinaln- Arrayn- (Butalbital, Aspirin, and Caffeine Capsules, USP)
  • Bottles of 100 are supplied with child-resistant closures. (NDC 0023-6146-01)
  • Below 25u00b0C (77u00b0F); tight container. Protect from moisture.
  • Rx only
  • For all medical inquiries contact:
  • Allergan
  • Medical Communications
  • 1-800-678-1605
  • Distributed by:
  • Allergan USA, Inc.
  • Madison, NJ 07940
  • u00a9 2018 Allergan. All rights reserved.
  • FIORINAL is a registered trademark ofu00a0Allergan Sales, LLC.
  • Allergan and its design are trademarks of Allergan, Inc.
  • All trademarks are the property of their respective owners.
  • Content Updated: June 2018
  • v1.0USPI6146
  • NDC 0023-6146-01Fiorinalu00a0(Butalbital, Aspirin, and Caffeine Capsules, USP)100 CapsulesRx only

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