Acetaminophen, Caffeine and Dihydrocodeine Bitartrate

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE- acetaminophen, caffeine and dihydrocodeine bitartrate tablet
MIKART, INC.

Rx only

Code 790Z00

Rev. 02/99

DESCRIPTION

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets are supplied in tablet form for oral administration.

Each tablet contains:

Acetaminophen………………………………………………….712.8 mg

Caffeine……………………………………………………………60 mg

Dihydrocodeine Bitartrate*……………………………………32 mg

(*Warning: May be habit forming)

Acetaminophen (4′-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Image from Drug Label Content

C8 H9 NO2 M.W. = 151.17

Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula:

Image from Drug Label Content

C8 H10 N4 O2 (anhydrous) M.W. = 194.19

Dihydrocodeine bitartrate (4,5α-Epoxy-3-methoxy-17-methylmorphinan-6α-ol (+)-tartrate), an odorless, fine white powder is an opioid analgesic. It has the following structural formula:

Image from Drug Label Content

C18 H23 NO3• C4 H6 O6 M.W. = 451.48

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, D&C Red #27 Aluminum Lake, D&C Red #30 Aluminum Lake, and FD&C Blue #1 Aluminum Lake.

CLINICAL PHARMACOLOGY

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets contain dihydrocodeine which is a semi-synthetic narcotic analgesic related to codeine, with multiple actions qualitatively similar to those of codeine; the most prominent of these involve the central nervous system and organs with smooth muscle components. The principal action of therapeutic value is analgesia.

This combination product also contains acetaminophen, a non-opiate, non-salicylate analgesic, and antipyretic.

This combination product contains caffeine as an analgesic adjuvant. Caffeine is also a central nervous system and cardiovascular stimulant.

INDICATIONS AND USAGE

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets are indicated for the relief of moderate to moderately severe pain.

CONTRAINDICATIONS

This combination product is contraindicated in patients with hypersensitivity to dihydrocodeine, codeine, acetaminophen, caffeine, or any of the inactive components listed above, or in any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitative equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus.

WARNINGS

Usage in Ambulatory Patients

Dihydrocodeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.

Respiratory Depression

Respiratory depression is the most dangerous acute reaction produced by opioid agonist preparations, although it is rarely severe with usual doses. Opioids decrease the respiratory rate, tidal volume, minute ventilation, and sensitivity to carbon dioxide. Respiratory depression occurs most frequently in elderly or debilitated patients, usually after large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. This combination product should be used with caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale and in patients with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or respiratory depression. In such patients alternative non-opioid analgesics should be considered, and opioids should be administered only under careful medical supervision at the lowest effective dose.

Head Injury

This combination product should be used cautiously in the presence of head injury or increased intracranial pressure. The effects of opioids on pupillary response and consciousness may obscure neurologic signs of increases in intracranial pressure in patients with head injuries. The respiratory depressant effects including carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions, or other causes of increased intracranial pressure.

Hypotensive Effect

Dihydrocodeine, like all opioid analgesics, may cause hypotension in patients whose ability to maintain blood pressure has been compromised by a depleted blood volume or who receive concurrent therapy with drugs such as phenothiazines or other agents which compromise vasomotor tone. Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets may produce orthostatic hypotension in ambulatory patients. This combination product should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Drug Dependence

Dihydrocodeine can produce drug dependence of the codeine type and has the potential of being abused (see DRUG ABUSE AND DEPENDENCE).

PRECAUTIONS

General

Selection of patients for treatment with Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets should be governed by the same principles that apply to the use of similar opioid/non-opioid fixed combination analgesics. As with any such opioid analgesic, the dosing regimen should be adjusted for each patient (see DOSAGE AND ADMINISTRATION). This combination product should be used with caution in elderly or debilitated patients or those with any of the following conditions: acute alcoholism; adrenocortical insufficiency (e.g., Addison’s disease); asthma; central nervous system depression or coma; chronic obstructive pulmonary disease; decreased respiratory reserve (including emphysema, severe obesity, cor pulmonale, or kyphoscoliosis); delirium tremens; head injury; hypotension; increased intracranial pressure; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; and toxic psychosis. The benefits and risks of using opioids in patients taking monoamine oxidase inhibitors and in those with a history of drug abuse should be carefully considered. The administration of an analgesic containing an opioid may obscure the diagnosis or clinical course in patients with acute abdominal conditions. This combination product may aggravate convulsions in patients with convulsive disorders and, like all opioids, may induce or aggravate seizures in some clinical settings.

Acetaminophen is relatively non-toxic at therapeutic doses, but should be used with caution in patients with severe renal or hepatic disease.

Care should be observed when using large doses of acetaminophen in malnourished patients or those with a history of chronic alcohol abuse because they may be more susceptible to hepatic damage similar to that observed with toxic overdosage.

Caffeine in high doses may produce central nervous system and cardiovascular stimulation and gastrointestinal irritation.

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