Acetaminophen, Caffeine and Dihydrocodeine Bitartrate (Page 3 of 3)

OVERDOSAGE

Following an acute overdosage with Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets, toxicity may result from the dihydrocodeine, acetaminophen, or, less likely, caffeine component. An overdose is a potentially lethal polydrug overdose situation, and consultation with a regional poison control center is recommended. A listing of the poison control centers can be found in standard references such as the Physician’s Desk Reference®.

Signs and Symptoms and Laboratory Findings

Toxicity from dihydrocodeine is typical of opioids and includes pinpoint pupils, respiratory depression, and loss of consciousness. Convulsions, cardiovascular collapse, and death may occur. A single case of acute rhabdomyolysis associated with an overdose of dihydrocodeine has been reported. With acetaminophen , dose-dependent potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may occur. Early symptoms of hepatotoxicity include nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours after ingestion. Acute caffeine poisoning may cause insomnia, restlessness, tremor, delirium, tachycardia, extrasystoles, and seizures.

Because overdose information on this combination product is limited, it is unclear which of the signs and symptoms of toxicity would manifest in any particular overdose situation.

Treatment

Immediate treatment of an overdosage of Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced with syrup of ipecac, if the patient is alert and has adequate laryngeal reflexes. Oral activated charcoal should follow. The first dose of charcoal should be accompanied by an appropriate cathartic. Gastric lavage may be necessary. Hypotension is usually hypovolemic and should be treated with fluids. Endotracheal intubation and artificial respiration may be necessary. Peritoneal or hemodialysis may be necessary. If hypoprothrombinemia occurs, Vitamin K should be administered.

A pure opioid antagonist, such as naloxone or nalmefene, is a specific antidote against respiratory depression which results from opioid overdose. Opioid antagonists should not be given in the absence of clinically significant respiratory or circulatory depression secondary to opioid overdose. They should be administered cautiously to persons who are known, or suspected to be, physically dependent on any opioid agonist including Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The prescribing information for the specific opioid antagonist should be consulted for details of their proper use.

In adults and adolescents, regardless of the quantity of acetaminophen reported to have been ingested, acetylcysteine should be administered immediately if 24 hours or less have elapsed from the reported time of ingestion. It is not advisable to await the plasma concentration determination of acetaminophen before administering acetylcysteine. Serum liver enzyme levels should be measured. Therapy in children involves a similar treatment scheme; however, a regional Poison Control Center should be contacted.

No specific antidote is available for caffeine. In addition to the supportive measures above, administration of demulcents such as aluminum hydroxide gel may diminish gastrointestinal irritation. Seizures may be treated with intravenous diazepam or a barbiturate.

DOSAGE AND ADMINISTRATION

The usual adult dosage is one (1) Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablet orally every four (4) hours, as needed. Dosage should be adjusted according to the severity of the pain and the response of the patient. No more than one tablet should be taken in a four hour period. No more than five (5) doses, or five (5) tablets should be taken in a 24-hour period.

HOW SUPPLIED

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets, containing acetaminophen 712.8 mg, caffeine 60 mg and dihydrocodeine bitartrate* 32 mg, (*Warning: May be habit-forming), are supplied in bottles of 100 tablets NDC 0525-0032-01, and in bottles 500 tablets, NDC 0525-0032-05. Tablets are lavender, oval-shaped, single-scored and are debossed “PAL” on one side and “032” on the other side.

Store at controlled room temperature, 15°-30°C (59°-86°F). Protect from moisture.

Dispense in a tight, light-resistant container with a child resistant closure.

Manufactured by:

MIKART, INC.

Atlanta, GA 30318

Rev. 02/99 Code 790Z00

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE
acetaminophen, caffeine and dihydrocodeine bitartrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0525-0032
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 712.8 mg
CAFFEINE (CAFFEINE) CAFFEINE 60 mg
DIHYDROCODEINE BITARTRATE (CODEINE) CODEINE 32 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
CROSPOVIDONE
D & C RED # 30 ALUMINUM LAKE
D & C RED #27 ALUMINUM LAKE
FD & C BLUE # 1 ALUMINUM LAKE
MAGNESIUM STEARATE (POWDER)
MICROCRYSTALLINE CELLULOSE
POVIDONE
PREGELATINIZED STARCH
STEARIC ACID
Product Characteristics
Color PURPLE (LAVENDER) Score 2 pieces
Shape OVAL (OVAL) Size 19mm
Flavor Imprint Code PAL;032
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0525-0032-05 500 TABLET (500 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:0525-0032-01 100 TABLET (100 TABLET) in 1 BOTTLE, PLASTIC None
Labeler — MIKART, INC.

Revised: 10/2006 MIKART, INC.

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