Aspirin and Codeine (Empirin Codeine)
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Aspirin and Codeine (Empirin Codeine)

DRUG DESCRIPTION

Aspirin and Codeine
(acetylsalicylic acid and codeine)

(WARNING: May be habit forming)

Aspirin (acetylsalicylic acid) occurs as white crystals, commonly tabular or needle-like, or white, crystalline powder. It is odorless or has a faint odor. Its chemical name is: 2-(acetyloxy)benzoic acid. Its molecular formula is:

    C9H8O4 with a molecular weight of 180.16

Codeine is an alkaloid, obtained from opium or prepared from morphine by methylation. Codeine phosphate occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is odorless and is affected by light. Its chemical name is: 7,8-didehydro-4,5oe epoxy-3-methoxy-17~ methylmorphinan~6oe-ol phosphate (1 :1) (salt) hemihydrate. Its molecular formula is:

    C18H21NO3†H3PO4†1/2 H2O with a molecular weight of 406.37

Aspirin and codeine phosphate tablets for oral administration combine the following inactive ingredients: colloidal silicon dioxide, corn starch, microcrystalline cellulose, povidone, and stearic acid.

What are the possible side effects of aspirin and codeine (Empirin with Codeine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • dizziness, feeling like you might pass out;
  • severe nausea, vomiting, or stomach pain;
  • swelling, or pain lasting longer than 10 days;
  • shallow breathing, fast or slow...

Read All Potential Side Effects and See Pictures of Empirin Codeine »

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Aspirin and codeine phosphate tablets are indicated for the relief of mild, moderate, and moderate to severe pain.

DOSAGE AND ADMINISTRATION

Dosage is adjusted according to the severity of pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below when pain is severe or the patient has become tolerant to the analgesic effect of codeine. Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) phosphate tablets are given orally. The usual adult dose for Aspirin and Codeine (aspirin and codeine (aspirin and codeine) ) 30 mg is one or two tablets every four hours as required. The usual adult dose for Aspirin and Codeine (aspirin and codeine (aspirin and codeine) ) 60 mg is one tablet every four hours as required.

Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) phosphate tablets should be taken with food or a full glass of milk or water to lessen gastric irritation.

HOW SUPPLIED

Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) phosphate tablets are available as:

325 mg/30 mg...........white, round, unscored tablets, debossed "3984" on one side and "3" on the other packaged in bottles of 100 and 1000 tablets.

325 mg/60 mg.......... white, round, unscored tablets, debossed "3985" on one side and "4" on the other packaged in bottles of 100 and 500 taablets.

PHARMACIST: Dispense in a well-closed, light-resistant container as defined in the USP. Use child- resistant closure. Store at controlled room temperature 15°-30° C( 59°-86° F). PROTECT FROM MOISTURE.

CAUTION: Federal law prohibits dispensing without prescription.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Codeine

The most frequently observed adverse reactions to codeine include light-headedness, dizziness, drowsiness, nausea, vomiting, constipation and depression of respiration. Less common reactions to codeine include euphoria, dysphoria, pruritus and skin rashes.

Aspirin

Mild aspirin intoxication (salicylism) can occur in response to chronic use of large doses. Manifestations include nausea, vomiting, hearing impairment, tinnitus, diminished vision, headache, dizziness, drowsiness, mental confusion, hyperpnea, hyperventilation, tachycardia, sweating and thirst.

Therapeutic doses of aspirin can induce mild or severe allergic reactions manifested by skin rashes, urticaria, angioedema, rhinorrhea, asthma, abdominal pain, nausea, vomiting, or anaphylactic shock. A history of allergy is often lacking, and allergic reactions may occur even in patients who have previously taken aspirin without any ill effects. Allergic reactions to aspirin are most likely to occur in patients with a history of allergic disease, especially in patients with nasal polyps or asthma.

Some patients are unable to take aspirin or other salicylates without developing nausea or vomiting. Occasional patients respond to aspirin (usually in large doses) with dyspepsia or heartburn, which may be accompanied by occult bleeding. Excessive bruising or bleeding is sometimes seen in patients with mild disorders of primary hemostasis who regularly use low doses of aspirin.

Prolonged use of aspirin can cause painless erosion of gastric mucosa, occult bleeding and infrequently, iron-deficiency anemia. High doses of aspirin can exacerbate symptoms of peptic ulcer and occasionally, cause extensive bleeding.

Excessive bleeding can follow injury or surgery in patients with or without known bleeding disorders who have taken therapeutic doses of aspirin within the preceding 10 days. Hepatotoxicity has been reported in association with prolonged use of large doses of aspirin in patients with lupus erythematosus, rheumatoid arthritis and rheumatic disease. Bone marrow depression, manifested by weakness, fatigue, or abnormal bruising or bleeding, has occasionally been reported. In patients with glucose-6-phosphate dehydrogenase deficiency, aspirin can cause a mild degree of hemolytic anemia. In hyperuricemic persons, low doses of aspirin may reduce the effectiveness of uricosuric therapy or precipitate an attack of gout.

DRUG ABUSE AND DEPENDENCE

Like other medications containing a narcotic analgesic, aspirin and codeine (aspirin and codeine (aspirin and codeine) ) phosphate tablets are controlled by the Drug Enforcement Administration and is classified under Schedule III.

Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) can produce drug dependence of the morphine type; therefore, it has a potential for being abused. Psychic dependence, physical dependence and tolerance may develop on repeated administration.

The dependence liability of codeine has been found to be too small to permit a full definition of its characteristics. Studies indicate that addiction to codeine is extremely uncommon and requires very high parenteral doses.

When dependence on codeine occurs at therapeutic doses, it appears to require from one to two months to develop, and withdrawal symptoms are mild. Most patients on long-term oral codeine therapy show no signs of physical dependence upon abrupt withdrawal.

Read the Empirin Codeine (aspirin and codeine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) phosphate tablets may enhance the effects of:

(1) monoamine oxidase (MAO) inhibitors,
(2) oral anticoagulants, causing bleeding by inhibiting prothrombin formation in the liver and displacing anticoagulants from plasma protein binding sites,
(3) oral antidiabetic agents and insulin, causing hypoglycemia by contributing an additive effect, and by displacing the oral antidiabetic agents from secondary binding sites,
(4) 6-mercaptopurine and methotrexate, causing bone marrow toxicity and blood dyscrasias by displacing these drugs from secondary binding sites,
(5) penicillins and sulfonamides, increasing their blood levels by displacing these drugs from protein binding sites,
(6) non-steroidal anti-inflammatory agents, increasing the risk of peptic ulceration and bleeding by contributing additive effects,
(7) other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression,
(8) corticosteroids, potentiating steroid anti-inflammatory effects by displacing steroids from protein binding sites. Aspirin intoxication may occur with corticosteroid withdrawal because steroids promote renal clearance of salicylates.

Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) phosphate tablets may diminish the effects of: uricosuric agents such as probenecid and sulfinpyrazone, reducing their effectiveness in the treatment of gout. Aspirin competes with these agents for protein binding sites. Aspirin and its metabolites may be caused to accumulate in the body, perhaps to toxic levels, by para-aminosalicylic acid, furosemide, and vitamin C.

Drug/Laboratory Test Interactions

Aspirin: Aspirin may interfere with the following laboratory determinations in blood: serum amylase, fasting blood glucose, carbon dioxide, cholesterol, protein, protein bound iodine, uric acid, prothrombin time, bleeding time, and spectrophotometric detection of barbiturates.

Aspirin may interfere with the following laboratory determinations in urine: glucose, 5-hydroxyindoleacetic acid, Gerhardt ketone, vanillylmandelic acid (VMA), protein, uric acid, and diacetic acid.

Codeine: Codeine may increase serum amylase levels.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Therapeutic doses of aspirin can cause anaphylactic shock and other severe allergic reactions. A history of allergy is often 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.

In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of patients with head injuries.

Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions. Results from pilot epidemiologic studies suggest an association between aspirin and Reye-Syndrome. Caution should be used in administering this product to children, including teenagers, with chicken pox or flu.

PRECAUTIONS

General

Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) phosphate tablets should be prescribed with caution for certain special-risk patients such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, gallbladder disease or gallstones, respiratory impairment, cardiac arrhythmias, inflammatory disorders of the gastrointestinal tract, hypothyroidism, Addison†s disease, prostatic hypertrophy or urethral stricture, coagulation disorders, head injuries, or acute abdominal conditions. Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) phosphate tablets should not be prescribed for long-term therapy unless specifically indicated.

Precautions should be taken when administering salicylates to persons with known allergies. Hypersensitivity to aspirin is particularly likely in patients with nasal polyps, and relatively common in those with asthma.

Laboratory Tests

Hypersensitivity to aspirin cannot be detected by skin testing or radioimmunoassay procedures. The primary screening tests for detecting a bleeding tendency are platelet count, bleeding time, activated partial thromboplastin time and prothrombin time. In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate long-term studies have been conducted in animals to determine whether codeine has a potential for carcinogenesis, mutagenesis, or impairment of fertility. Adequate long-term studies have been conducted in mice and rats with aspirin, alone or in combination with other drugs, in which no evidence of carcinogenesis was seen. No adequate studies have been conducted in animals to determine whether aspirin has a potential for mutagenesis or impairment of fertility.

Pregnancy

Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with aspirin and codeine. It is also not known whether aspirin and codeine (aspirin and codeine (aspirin and codeine) ) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) should be given to a pregnant woman only if clearly needed.

Reproductive studies in rats and mice have shown aspirin to be teratogenic and embryocidal at four to six times the human therapeutic dose. Studies in pregnant women, however, have not shown that aspirin increases the risk of abnormalities when administered during the fist trimester of pregnancy. In controlled studies involving 41,337 pregnant women and their offspring, there was no evidence that aspirin taken during pregnancy caused stillbirth, neonatal death or reduced birth weight. In controlled studies of 50,282 pregnant women and their offspring, aspirin administration in moderate and heavy doses during the first four lunar months of pregnancy showed no teratogenic effect.

Reproduction studies have been performed in rabbits and rats at doses at up to 150 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to codeine.

Nonteratogenic Effects: Therapeutic doses of aspirin in pregnant women close to term may cause bleeding in mother, fetus, or neonate. During the last six months of pregnancy, regular use of aspirin in high doses may prolong pregnancy and delivery.

Labor and Delivery

Ingestion of aspirin prior to delivery may prolong delivery or lead to bleeding in the mother or neonate. Use of codeine during labor may lead to respiratory depression in the neonate.

Nursing Mothers

Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of the potential for serious adverse reactions in nursing infants from aspirin and codeine (aspirin and codeine (aspirin and codeine) ) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Severe intoxication, caused by overdose of aspirin and codeine, may produce: skin eruptions, dyspnea, vertigo, double vision, delusions, hallucinations, garbled speech, excitability, restlessness, delirium, constricted pupils, a positive Babinski sign, respiratory depression (slow and shallow breathing; Cheyne-Stokes respiration), cyanosis, clammy skin, muscle flaccidity, circulatory collapse, stupor and coma. In children, difficulty in hearing, tinnitus, dim vision, headache, dizziness, drowsiness, confusion, rapid breathing, sweating, thirst, nausea, vomiting, hyperpyrexia, dehydration and convulsions are prominent signs. The most severe manifestations from aspirin result from cardiovascular and respiratory insufficiency secondary to acid-base and electrolyte disturbances, complicated by hyperthermia and dehydration. The most severe manifestations from codeine are associated with respiratory depression.

Respiratory alkalosis is characteristic of the early phase of intoxication with aspirin while hyperventilation is occurring, but is quickly followed by metabolic acidosis in most people with severe intoxication. This occurs more readily in children. Hypoglycemia may occur in children who have taken large overdoses. Other laboratory findings associated with aspirin intoxication include ketonuria, hyponatremia, hypokalemia, and occasionally, proteinuria. A slight rise in lactic dehydrogenase and hydroxybutyric dehydrogenase may occur.

Concentrations of aspirin in plasma above 30 mg/100 mL are associated with toxicity. (See CLINICAL PHARMACOLOGY section for information on factors influencing aspirin blood levels.) The single lethal dose of aspirin in adults is probably about 25-30 g, but is not known with certainty.

The toxic plasma concentration of codeine is not known with certainty. Experimental production of mild to moderate CNS depression in healthy, nontolerant subjects occurred at plasma concentrations of 0.05-0.19 mg/100 mL when codeine was given by intravenous infusion. The single lethal dose of codeine in adults is estimated to be from 0.5-1.0 g. It is also estimated that 5 mg/kg could be fatal in children. Hemodialysis and peritoneal dialysis can be performed to reduce the body aspirin content. Codeine is theoretically dialyzable but the procedure has not been clinically established.

Treatment of overdosage consists primarily of support of vital functions, management of codeine-induced respiratory depression, increasing salicylate elimination, and correcting the acid-base imbalance due primarily to salicylism.

In a comatose patient, primary attention should be given to establishment of adequate respiratory exchange through provisions of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone is a specific antidote for respiratory depression which may result from Overdose or unusual sensitivity to narcotics. Therefore, an appropriate dose of an antagonist should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of aspirin and codeine (aspirin and codeine (aspirin and 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.

Gastric emptying (Syrup of Ipecac) and/or lavage is recommended as soon as possible after ingestion, even if the patient has vomited spontaneously. (Apomorphine should not be used as an emetic for aspirin and codeine (aspirin and codeine (aspirin and codeine) ) , since it may potentiate hypotension and respiratory depression.) Administration of activated charcoal as a slurry is beneficial after lavage and or emesis, if less than three hours have passed since ingestion. Charcoal adsorption should not be employed prior to emesis or lavage.

Severity of aspirin intoxication is determined by measuring the blood salicylate level. Acid-base status should be closely followed with serial blood gas and serum pH measurements. Fluid and electrolyte balance should also be regularly monitored.

A serum salicylate level of 30 mg/100 mL or higher indicates a need for enhanced salicylate excretion that can be achieved through body-fluid supplementation and urine alkalinization if renal function is normal. In mild intoxication, urine flow can be increased by forcing oral fluids and giving potassium citrate capsules. (DO NOT GIVE BICARBONATE BY MOUTH SINCE IT INCREASES THE R.T. OF SALICYLATE ABSORPTION.)

In severe cases, hyperthermia and hypovolemia, as well as respiratory depression are the major immediate threats to life. Children should be sponged with tepid water. Replacement fluid should be administered intravenously and augmented with sufficient bicarbonate to correct acidosis, with monitoring of plasma electrolytes and pH, to promote alkaline diuresis of salicylate if renal function is normal. Complete control may also require infusion of glucose to control hypoglycemia. Potassium deficiency may also be corrected through the infusion, once adequate urinary output is assured. Plasma or plasma expanders may be needed if fluid replacement is insufficient to maintain normal blood pressure or adequate urinary output.

In patients with renal insufficiency or in cases of life-threatening intoxication, dialysis is usually required. Peritoneal dialysis or exchange-transfusion is indicated in infants and young children, and hemodialysis in older patients. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as needed.

CONTRAINDICATIONS

Aspirin and codeine (aspirin and codeine (aspirin and codeine) ) phosphate is contraindicated under the following conditions:

(1) hypersensitivity or intolerance to aspirin or codeine,
(2) severe bleeding, disorders of coagulation or primary hemostasis, including hemophilia, hypoprothrombinemia, von Willebrand†s disease, the thrombocytopenias, thrombasthenia and other ill-defined hereditary platelet dysfunctions, as well as such associated conditions as severe vitamin K deficiency and severe liver damage,
(3) anticoagulant therapy, and
(4) peptic ulcer, or other serious gastrointestinal lesions.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Aspirin

The analgesic, anti-inflammatory and antipyretic effects of aspirin are believed to result from inhibition of the synthesis of certain prostaglandins. Aspirin interferes with clotting mechanisms primarily by diminishing platelet aggregation; at high doses prothrombin synthesis can be inhibited.

Aspirin in solution is rapidly absorbed from the stomach and from the upper small intestine. About 50 percent of an oral dose is absorbed in 30 minutes and peak plasma concentrations are reached in about 40 minutes. Higher than normal stomach pH or the presence of food slightly delays absorption.

Once absorbed, aspirin is mainly hydrolyzed to salicylic acid and distributed to all body tissues and fluids, including fetal tissue, breast milk and the central nervous system (CNS). Highest concentrations are found in plasma, liver, renal cortex, heart and lung. From 50 to 80 percent of the salicylic acid and its metabolites in plasma are loosely bound to proteins. The plasma half- life of total salicylate is about 3.0 hours, with a 650 mg dose. Higher doses of aspirin cause increases in plasma salicylate half- life. Metabolism 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%).

Almost all of a therapeutic dose of aspirin is excreted through the kidneys, either as sailcylic acid or the above mentioned metabolic products. Renal clearance of salicylates is greatly augmented by an alkaline urine, as is produced by concurrent administration of sodium bicarbonate or potassium citrate.

Toxic salicylate blood levels are usually above 30 mg/ 100 mL. The single lethal dose of aspirin in normal adults is approximately 25- 30 g, but patients have recovered from much larger doses with appropriate treatment.

Codeine

Codeine probably exerts its analgesic effect through actions on opiate receptors in the CNS. Codeine is readily absorbed from the gastrointestinal tract, and a therapeutic dose reaches peak analgesic effectiveness in about 2 hours and persists for 4 to 6 hours. Oral codeine (60 mg) given to healthy males has been shown to achieve peak blood levels of 0.016 mg/100 mL at approximately one hour post-dose. The codeine plasma half-life for a 60 mg oral dose is about 2.9 hours. Blood levels causing CNS depression begin at 0.05-0.19 mg/100 mL. The single lethal dose of codeine in adults is estimated to be approximately 0.5-1.0 g. Codeine is rapidly distributed from blood to body tissues and taken up preferentially by parenchymatous organs such as liver, spleen and kidney. It passes the blood-brain barrier and is found in fetal tissue and breast milk.

The drug is not bound by plasma proteins nor is it accumulated in body tissues. Codeine is metabolized in liver to morphine and norcodeine, each representing about 10 percent of the administered dose of codeine. About 90 percent of the dose is excreted within 24 hours, primarily through the kidneys. Urinary excretion products are free and glucuronide-conjugated codeine (about 70%), free and conjugated norcodeine (about 10%), free and conjugated morphine (about 10%), normorphine (under 4%) and hydrocodone (<1%). The remainder of the dose appears in the feces.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Aspirin and codeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking aspirin and codeine (aspirin and codeine (aspirin and codeine) ) . Alcohol and other CNS depressants may produce an additive CNS depression when taken with aspirin and codeine (aspirin and codeine (aspirin and codeine) ) , and should be avoided.

Codeine may be habit-forming when used over long periods or in high doses. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Aspirin and codeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking aspirin and codeine (aspirin and codeine (aspirin and codeine) ) . Alcohol and other CNS depressants may produce an additive CNS depression when taken with aspirin and codeine (aspirin and codeine (aspirin and codeine) ) , and should be avoided.

Codeine may be habit-forming when used over long periods or in high doses. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

DRUG DESCRIPTION

Aspirin and Codeine
(acetylsalicylic acid and codeine)

(WARNING: May be habit forming)

Aspirin (acetylsalicylic acid) occurs as white crystals, commonly tabular or needle-like, or white, crystalline powder. It is odorless or has a faint odor. Its chemical name is: 2-(acetyloxy)benzoic acid. Its molecular formula is:

    C9H8O4 with a molecular weight of 180.16

Codeine is an alkaloid, obtained from opium or prepared from morphine by methylation. Codeine phosphate occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is odorless and is affected by light. Its chemical name is: 7,8-didehydro-4,5oe epoxy-3-methoxy-17~ methylmorphinan~6oe-ol phosphate (1 :1) (salt) hemihydrate. Its molecular formula is:

    C18H21NO3†H3PO4†1/2 H2O with a molecular weight of 406.37

Aspirin and codeine phosphate tablets for oral administration combine the following inactive ingredients: colloidal silicon dioxide, corn starch, microcrystalline cellulose, povidone, and stearic acid.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

DRUG DESCRIPTION

Aspirin and Codeine
(acetylsalicylic acid and codeine)

(WARNING: May be habit forming)

Aspirin (acetylsalicylic acid) occurs as white crystals, commonly tabular or needle-like, or white, crystalline powder. It is odorless or has a faint odor. Its chemical name is: 2-(acetyloxy)benzoic acid. Its molecular formula is:

    C9H8O4 with a molecular weight of 180.16

Codeine is an alkaloid, obtained from opium or prepared from morphine by methylation. Codeine phosphate occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is odorless and is affected by light. Its chemical name is: 7,8-didehydro-4,5oe epoxy-3-methoxy-17~ methylmorphinan~6oe-ol phosphate (1 :1) (salt) hemihydrate. Its molecular formula is:

    C18H21NO3†H3PO4†1/2 H2O with a molecular weight of 406.37

Aspirin and codeine phosphate tablets for oral administration combine the following inactive ingredients: colloidal silicon dioxide, corn starch, microcrystalline cellulose, povidone, and stearic acid.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

DRUG DESCRIPTION

Aspirin and Codeine
(acetylsalicylic acid and codeine)

(WARNING: May be habit forming)

Aspirin (acetylsalicylic acid) occurs as white crystals, commonly tabular or needle-like, or white, crystalline powder. It is odorless or has a faint odor. Its chemical name is: 2-(acetyloxy)benzoic acid. Its molecular formula is:

    C9H8O4 with a molecular weight of 180.16

Codeine is an alkaloid, obtained from opium or prepared from morphine by methylation. Codeine phosphate occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is odorless and is affected by light. Its chemical name is: 7,8-didehydro-4,5oe epoxy-3-methoxy-17~ methylmorphinan~6oe-ol phosphate (1 :1) (salt) hemihydrate. Its molecular formula is:

    C18H21NO3†H3PO4†1/2 H2O with a molecular weight of 406.37

Aspirin and codeine phosphate tablets for oral administration combine the following inactive ingredients: colloidal silicon dioxide, corn starch, microcrystalline cellulose, povidone, and stearic acid.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Empirin Codeine Patient Information Including Side Effects

Brand Names: Empirin with Codeine

Generic Name: aspirin and codeine (Pronunciation: AS pir in and KOE deen)

What is aspirin and codeine (Empirin Codeine)?

Codeine is in a group of drugs called narcotic pain relievers.

Aspirin is a less potent pain reliever and is also a fever reducer.

The combination of aspirin and codeine is used to treat moderate to severe pain.

Aspirin and codeine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of aspirin and codeine (Empirin Codeine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • dizziness, feeling like you might pass out;
  • severe nausea, vomiting, or stomach pain;
  • swelling, or pain lasting longer than 10 days;
  • shallow breathing, fast or slow heartbeat;
  • feeling light-headed, fainting;
  • pale skin, easy bruising or bleeding;
  • wheezing, chest tightness, trouble breathing;
  • decreased hearing or ringing in the ears;
  • seizure (convulsions); or
  • dizziness, confusion, unusual thoughts or behavior.

Less serious side effects may include:

  • constipation;
  • nausea, vomiting;
  • dizziness, tired feeling;
  • headache;
  • sweating;
  • increased thirst; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Empirin Codeine (aspirin and codeine) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about aspirin and codeine (Empirin Codeine)?

Codeine may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid taking any over-the-counter medication without first asking your doctor or pharmacist. Aspirin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much aspirin. Read the label of any other medicine you are using to see if it contains aspirin.

Avoid drinking alcohol while taking aspirin and codeine. Alcohol may increase your risk of stomach bleeding while taking aspirin.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, antidepressants, or seizure medication can add to sleepiness caused by codeine, or could slow your breathing. Tell your doctor if you need to use any of these other medicines while you are taking aspirin and codeine.

Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Side Effects Centers

Empirin Codeine Patient Information including How Should I Take

What should I tell my healthcare provider before taking aspirin and codeine (Empirin Codeine)?

Do not use this medication if you are allergic to aspirin or codeine.

Codeine may be habit-forming and should be used only by the person it was prescribed for. Aspirin and codeine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Before using aspirin and codeine, tell your doctor if you are allergic to any drugs, or if you have:

  • asthma, COPD, sleep apnea, or other breathing disorders;
  • kidney disease;
  • liver disease;
  • a history of head injury or brain tumor;
  • epilepsy or other seizure disorder;
  • a bleeding or blood clotting disorder;
  • a stomach ulcer or intestinal disorder;
  • underactive thyroid;
  • Addison's disease or other adrenal gland disorder;
  • enlarged prostate, urination problems;
  • curvature of the spine;
  • mental illness; or
  • a history of drug or alcohol addiction.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take aspirin and codeine.

FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Aspirin and codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to anyone under 18 without the advice of a doctor. Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome.

How should I take aspirin and codeine (Empirin Codeine)?

Take this medication exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Take this medicine with a full glass of water.

Take with food or milk to ease stomach upset.

You may have withdrawal symptoms when you stop using aspirin and codeine after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using aspirin and codeine. You may need to stop using the medicine for a short time.

Store aspirin and codeine at room temperature away from moisture and heat.

Keep track of how many tablets have been used from each new bottle of this medicine. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

Side Effects Centers

Empirin Codeine Patient Information including If I Miss a Dose

What happens if I miss a dose (Empirin Codeine)?

Since aspirin and codeine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Empirin Codeine)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of aspirin and codeine can be fatal.

Overdose symptoms may include extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dark urine, pale skin, easy bruising or bleeding, confusion, cold and clammy skin, fainting, weak pulse, seizure (convulsions), blue lips, shallow breathing, or no breathing.

What should I avoid while taking aspirin and codeine (Empirin Codeine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid taking any over-the-counter medication without first asking your doctor or pharmacist. Aspirin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much aspirin. Read the label of any other medicine you are using to see if it contains aspirin.

Avoid drinking alcohol while taking aspirin and codeine. Alcohol may increase your risk of stomach bleeding while taking aspirin.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, antidepressants, or seizure medication can add to sleepiness caused by codeine, or could slow your breathing. Tell your doctor if you need to use any of these other medicines while you are taking aspirin and codeine.

What other drugs will affect aspirin and codeine (Empirin Codeine)?

Many drugs can interact with asprin and codeine. Below is just a partial list. Tell your doctor if you are using:

  • glycopyrrolate (Robinul);
  • mepenzolate (Cantil);
  • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
  • a bronchodilator such as ipratroprium (Atrovent) or tiotropium (Spiriva); or
  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and there may be other drugs that can interact with aspirin and codeine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about aspirin and codeine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.06. Revision date: 12/15/2010.

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