Butalbital, Aspirin, Caffeine and Codeine Phosphate (Page 4 of 4)

DRUG ABUSE AND DEPENDENCE

Butalbital, Aspirin, Caffeine and Codeine Phosphate Capsules are controlled by the Drug Enforcement Administration and is classified under Schedule III.

Codeine

Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.

Butalbital

Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1,500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

OVERDOSAGE

The toxic effects of acute overdosage of Butalbital, Aspirin, Caffeine and Codeine Phosphate Capsules are attributable mainly to the barbiturate and codeine components, and, to a lesser extent, aspirin. Because toxic effects of caffeine occur in very high dosages only, the possibility of significant caffeine toxicity from this combination product is unlikely.

Signs and Symptoms.

Symptoms attributable to acute barbiturate poisoning include drowsiness, confusion, and coma; respiratory depression; hypotension; shock. Symptoms attributable to acute aspirin poisoning include hyperpnea; acid-base disturbances with development of metabolic acidosis; vomiting and abdominal pain; tinnitus, hyperthermia; hypoprothrombinemia; restlessness; delirium; convulsions. Acute caffeine poisoning may cause insomnia, restlessness, tremor, and delirium; tachycardia and extrasystoles. Symptoms of acute codeine poisoning include the triad of: pinpoint pupils, marked depression of respiration, and loss of consciousness. Convulsions may occur.

Treatment

The following paragraphs describe one approach to the treatment of overdose with this combination product. However, because strategies for the management of an overdose continually evolve, consultation with a regional Poison Control Center is strongly encouraged.

Treatment consists primarily of management of barbiturate intoxication, reversal of the effects of codeine, 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 and 5% dextrose in water.

Meticulous attention should be given to maintaining adequate pulmonary ventilation. Correction of hypotension may require the administration of levarterenol bitartrate or phenylephrine hydrochloride by intravenous infusion. In severe cases of intoxication, peritoneal dialysis, hemodialysis, or exchange transfusion may be lifesaving. Hypoprothrombinemia should be treated with vitamin K, intravenously.

Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration.

Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated with opioid overdose. Typically, a dose of 0.4 mg to 2 mg is given parenterally and may be repeated if an adequate response is not achieved. Since the duration of action of codeine may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.

Toxic and Lethal Doses

Butalbital: toxic dose 1 g (adult); lethal dose 2 g to 5 g
Aspirin: toxic blood level greater than 30 mg/100 mL;
lethal dose 10 to 30 g (adult)

Caffeine: toxic dose greater than 1 g; lethal dose unknown

Codeine: lethal dose 0.5 to 1 g (adult)

DOSAGE AND ADMINISTRATION

1 or 2 capsules every 4 hours. 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.

HOW SUPPLIED

Each yellow and blue Butalbital, Aspirin, Caffeine and Codeine Phosphate Capsule USP 50 mg/325 mg/ 40 mg/30 mg is imprinted JSP 507

Bottles of 100 NDC 50564-507-01

Bottles of 500 NDC 50564-507-05

Store and Dispense

Below 25°C (77°F); in a tight, light resistant container.

Manufactured by:
Jerome Stevens Pharmaceuticals
Bohemia, NY 11716

Rev. 08/07
MG #11583

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE
butalbital, aspirin, caffeine and codeine phosphate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50564-507
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Codeine Phosphate (Codeine) Codeine 30 mg
Butalbital (Butalbital) Butalbital 50 mg
Caffeine (Caffeine) Caffeine 40 mg
Aspirin (Aspirin) Aspirin 325 mg
Inactive Ingredients
Ingredient Name Strength
D&C Yellow #10
D&C Yellow #10 Aluminum Lake
D&C Red #33
D&C Red #28
FD&C Blue #2 Aluminum Lake
FD&C Blue #10 Aluminum Lake
FD&C Red #40 Aluminum Lake
Gelatin
Microcrystalline Cellulose
Pregelatinized Starch
Talc
Titanium Dioxide
Stearic Acid
Colloidal Silicon Dioxide
Product Characteristics
Color YELLOW (YELLOW) , BLUE (BLUE) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code JSP507
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50564-507-01 100 CAPSULE (100 CAPSULE) in 1 BOTTLE, PLASTIC None
2 NDC:50564-507-05 500 CAPSULE (500 CAPSULE) in 1 BOTTLE, PLASTIC None
Labeler — Jerome Stevens Pharmaceuticals

Revised: 10/2007 Jerome Stevens Pharmaceuticals

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