Fiorinal-C (ASA – Caffeine – Codeine – Butalbital)

FIORINAL®-C 1/4, 1/2

Novartis Pharmaceuticals

ASA – Caffeine – Codeine – Butalbital

Analgesic – Sedative

Indications And Clinical Uses: The relief of acute and chronic pain of mild, moderate, or severe degree, which is accompanied by tension or anxiety and in all indications where a simultaneous sedative and analgesic action is required, such as: tension headache, musculoskeletal pain, including low back pain, postoperative, post partum pain, dysmenorrhea, pain associated with dental procedures, neoplastic disease or trauma.

Contra-Indications: Porphyria, gastrointestinal ulceration and hypersensitivity to any of the components. Overdosage of, or intoxication due to alcohol, hypnotics, analgesics and psychotropic drugs.

Precautions: Because of its ASA content, Fiorinal-C should be used with caution in patients with a history of bleeding tendencies or peptic ulceration.

A possible association between Reye’s syndrome and the use of salicylates has been suggested but not established. Reye’s syndrome has also occurred in many patients not exposed to salicylates. However, caution is advised when prescribing salicylate-containing medications for children, teenagers and young adults with influenza or chickenpox.

Long-term use of preparations containing barbiturates and/or codeine may lead to habituation and physical dependence. Fiorinal-C, because of its codeine and butalbital content, should be avoided in patients with head injury, in whom a depressed CNS is suspected. Similarly, it should not be used in patients with actual or a predisposition towards respiratory depression.

Occupational Hazards: Barbiturate containing preparations may impair the mental and/or physical alertness required for the efficient performance of hazardous tasks such as driving a vehicle or operating machinery.

Should be used with caution in patients with impaired liver and renal functions or in osteomalacia and osteoporosis.

Pregnancy and Lactation: During pregnancy and lactation, Fiorinal-C should be taken only as prescribed.

Drug Interactions: The concomitant use of alcohol or other CNS depressants may have and additive effect, and patients should be warned accordingly.

The prolonged ingestion of barbiturates gives rise to enzyme induction. This increases the rate of metabolism of certain drugs, including oral anticoagulants and oral contraceptives, thus reducing their effectiveness.

Note: Fiorinal products have the potential for being abused and should be avoided in chronic pain states leading to continuous daily use.

Adverse Reactions: Drowsiness, dizziness, nausea, vomiting, constipation, skin rash and miosis are possible adverse effects.

Symptoms And Treatment Of Overdose: Symptoms: 1) Acute barbiturate poisoning: drowsiness, confusion and coma, with reduced or absent reflexes; prominent, persistent respiratory depression; hypotension, followed by circulatory collapse and a typical shock like state in severe intoxication; respiratory complications, renal failure, and, possibly, death. 2) Acute ASA poisoning: principal toxic effects include hypercapnia; acid-base disturbances with the development of metabolic acidosis, especially in children; and gastrointestinal irritation with vomiting and abdominal pain. Also, acetone odor in breath, tinnitus, sweating, hyperthermia, dehydration, hypoprothrombinemia with spontaneous bleeding, restlessness, delirium, convulsions and coma may occur. 3) Acute caffeine poisoning: insomnia, restlessness, tinnitus and flashes of light; tachycardia and extrasystoles; tremor, delirium and coma, following high doses in the region of 10 g. Death has not been reported with caffeine overdosage. 4) Acute codeine poisoning: symptoms will be more pronounced with the capsules containing the higher doses. These include the triad of: pinpoint pupils, marked depression of respiration, and loss of consciousness.

Note: Because large doses of barbiturate alone may cause marked respiratory and CNS depression, an even more profound depressant effect may be expected after an overdosage of Fiorinal-C.

The dangers of Fiorinal-C overdosage are increased when the drug is ingested in the presence of alcohol, phenothiazines, minor tranquilizers and/or narcotics.

Treatment: The management of acute Fiorinal-C overdosage may involve the treatment of the toxic effects of all its constituents, with the possible exception of caffeine, which is toxic in very high doses only. Generally, it is the management of the barbiturate intoxication, the correction of the acid-base imbalance due to salicylism, and the reversal of the effects of codeine which demand most attention. The therapeutic procedures most commonly employed are:

Elimination of the offending drug: 1) Emesis: If the patient is conscious, induce vomiting with syrup of ipecac (15 to 30 mL). 2) Perform gastric lavage followed by the administration of activated charcoal if the pharyngeal and laryngeal reflexes are present and if less than 4 hours have elapsed since ingestion. Do not attempt gastric lavage on the unconscious patient unless cuffed endotracheal intubation has been performed to prevent aspiration and pulmonary complications. 3) Catharsis: Following gastric lavage, a saline cathartic (sodium or magnesium sulfate 30 g in 250 mL of water) may be introduced and left in the stomach. 4) Encourage diuresis by administration of i.v. fluids assisted, if necessary, by 100 to 150 mL 25% mannitol solution given slowly i.v. Note: Mannitol should not be mixed with blood in a transfusion set, as red cell crenation and agglutination may occur. 5) Alkalinization of the urine (see caution): I.V. isotonic sodium bicarbonate solution accelerates urinary excretion of barbiturates. Maximum alkalinization may be more successfully attained if the sodium bicarbonate infusion is accompanied by acetazolamide 250 mg given as a single i.v. injection every 6 hours. (Caution: Perform urinary alkalinization with care in children.) 6) Peritoneal dialysis and hemodialysis have been used with success in acute barbiturate intoxication and may be life saving. However, before embarking on either method, weigh the risks inherent to these procedures against the risk of not using them at all.

Maintenance of adequate pulmonary ventilation: Respiratory depression is an early and often profound manifestation of acute barbiturate poisoning. Meticulous attention to this aspect of treatment is essential. Perform pharyngeal and tracheal suction diligently to remove excess mucous secretions. Judicious administration of oxygen is also indicated. However, oxygen without assisted respiration must be used with caution, as its use in hypoventilation hypoxia may result in further respiratory depression and hypercapnia. In more critical cases, endotracheal intubation or tracheotomy, with or without assisted respiration, may be necessary.

Correction of hypotension: Vigorous treatment is essential, as circulatory collapse and renal failure are frequent causes of death. 1) Mild cases: The usual head down position and other supportive measures may be adequate. 2) Severe cases: Vasopressors (dopamine, levarterenol) may be given i.v. with the usual precautions and serial blood pressure monitoring.

Narcotic antagonism: naloxone injection may reverse the respiratory depression caused by codeine and should be used until respiration improves.

Note: Respiratory depression caused by barbiturates will not respond to narcotic antagonists. Unwitting overdosage with narcotic antagonists may occur in an attempt to reverse respiratory depression caused by mixed barbiturate-codeine intoxication.

Special features due to salicylate overdosage: 1) The prominent features of salicylate intoxication are metabolic acidosis and electrolyte disturbance, and these require evaluation and correction. Sodium bicarbonate 400 mg (5 mEq)/kg as a 1% solution in 5% dextrose water is not only effective in correcting acidosis, but effectively and rapidly accelerates salicylate excretion by the kidneys. The administration of sodium bicarbonate must be carefully monitored with frequent blood pH and plasma CO2 content determinations, as large amounts of sodium bicarbonate may result in severe alkalosis, particularly in children. THAM, an osmotic alkalinizing diuretic, also greatly increases the excretion of salicylate. This is given as a 0.3 molar solution at a rate not exceeding 5 mL/kg/hour. Potassium deficiency may occur and should be corrected. 2) Treat hyperthermia and dehydration with ice packs and i.v. fluids. 3) Treat hypoprothrombinemia with vitamin K1 50 mg given daily i.v. 4) Hemodialysis, peritoneal dialysis or exchange transfusion are indicated in very severe salicylate intoxication. However, in Fiorinal-C overdosage, these measures are indicated mainly for barbiturate intoxication but would be effective for both.

General supportive measures: 1) Good nursing care is of prime importance, particularly in the comatose patient, and should include regular observation and accurate recording of the vital signs and depth of coma, maintenance of a free airway, frequent turning, and other routine measures usually adopted with unconscious patients. 2) Careful supervision and recording of fluid intake and output is essential. 3) Take blood samples to determine barbiturate blood concentrations and for electrolyte and other pertinent blood studies.

Dosage: Adults: 1 or 2 capsules at once, followed if necessary, by 1 capsule every 3 to 4 hours, up to 6 capsules daily, or as prescribed.

Availability And Storage: Fiorinal-C 1/4 Capsules: Each hard gelatin oblong capsule, white opaque body with blue opaque cap, printed with FIORINAL C 1/4 and

in black ink contains: butalbital, USP 50 mg, caffeine, USP 40 mg, ASA, USP 330 mg, codeine phosphate, USP 15 mg. Nonmedicinal ingredients: cornstarch, microcrystalline cellulose, stearic acid and talc. Bottles of 100 and 500.

Fiorinal-C 1/2 Capsules: Each hard gelatin oblong capsule, light blue opaque with blue opaque cap, printed with FIORINAL C 1/2 and

in black ink contains: butalbital, USP 50 mg, caffeine, USP 40 mg, ASA, USP 330 mg and codeine phosphate, USP 30 mg. Nonmedicinal ingredients: cornstarch, microcrystalline cellulose, stearic acid and talc. Bottles of 100 and 500.

FIORINAL®-C 1/4, 1/2 Novartis Pharmaceuticals ASA – Caffeine – Codeine – Butalbital Analgesic – Sedative

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