WARNING - MAY BE HABIT FORMING

Codeine is an alkaloid obtained from opium or prepared from morphine by methylation and occurs as white crystals. Codeine effloresces slowly in dry air and is effected by light. The chemical name of codeine phosphate is 7,8-Didehydro-4,5alpha-epoxy-3-methoxy-17-methylmorphinan-6alpha-ol phosphate (1:1)(salt) hemihydrate and has the empirical formula of C18H21NO3·H3PO4·1/2H20. Its molecular weight is 406.4.

Each soluble tablet contains 30 mg (0.074 mmol) or 60 mg (0.15 mmol) of codeine phosphate. These tablets also contain lactose and sucrose.

Soluble tablets of codeine phosphate are freely soluble in water. They are intended for the preparation of solutions for parenteral administration. These tablets are not sterile. Codeine phosphate is an analgesic.

Codeine phosphate is an analgesic indicated for the relief of mild to moderate pain.

For Analgesia: Dosage should be adjusted according to the severity of the pain and the response of the patient.

Adults: 15 to 60 mg every 4 to 6 hours (usual adult dose, 30 mg).

Children: 1 Year of Age and Older - 0.5 mg/kg of b.d. weight or 15 mg/m2 of b.d. surface every 4 to 6 hours.

Soluble tablets codeine phosphate are administered subcutaneously or intramuscularly.

Solutions for injection should be prepared with sterile water and filtered through a 0.22 membrane filter.

Note: Do not use the solution if it is more than slightly discolored or contains a precipitate.

No information provided.

The most frequent adverse reactions include lightheadedness, dizziness, sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in non ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.

Other adverse reactions include euphoria, dysphoria, constipation, and pruritus.

Drug Abuse and Dependence

Controlled Substance: Codeine phosphate is a Schedule II narcotic.

Dependence

Although much less potent in this regard than morphine, codeine can produce drug dependence a.d. therefore, has the potential for being abused. Patients given 60 mg codeine every 6 hours for 2 months usually show some tolerance and mild withdrawal symptoms. Development of the dependent state is recognized by an increased tolerance to the analgesic effect and the appearance of purposive phenomena (complaints, pleas, demands, or manipulative actions) shortly before the time of the next scheduled dose. A patient in withdrawal should be treated in a hospital environment. Usually, it is necessary only to provide supportive care with administration of a tranquilizer to suppress anxiety. Severe symptoms of withdrawal may require administration of a replacement narcotic.

Codeine in combination with other narcotic analgesics, general anesthetics, phenothiazines, tranquilizers, sedative-hypnotics, or other CNS depressants (including alcohol) has additive depressant effects. When s.c. combination therapy is contemplated, the dosage of one or both agents should be reduced.

No information provided.

General

Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal-fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure. Furthermore, narcotics produce adverse reactions that may obscure the clinical course in patients with head injuries.

Acute Abdominal Conditions: The administration of codeine or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Special-Risk Patients: Codeine should be given with caution to certain patients, s.c. as the elderly or debilitated and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, and prostatic hypertrophy or urethral stricture.

Kidney or Liver Dysfunction: Codeine phosphate may have a prolonged cumulative effect in patients with kidney or liver dysfunction.

Information for the Patient

Codeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, s.c. as driving a car or operating machinery. Codeine in combination with other narcotic analgesics, phenothiazines, sedative hypnotics, and alcohol has additive depressant effects.

Pregnancy

Pregnancy Category C Animal reproduction studies have not been conducted with codeine phosphate. It is also not known whether codeine phosphate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. On the basis of the historical use of codeine phosphate during all stages of pregnancy, there is no known risk of fetal abnormality. Codeine phosphate should be given to a pregnant woman only if clearly needed.

Labor and Delivery

The use of codeine phosphate in obstetrics may prolong labor. It passes the placental barrier and may produce depression of respiration in the newborn. Resuscitation a.d. in severe depression, the administration of naloxone may be required.

Nursing Mothers

Codeine appears in the milk of nursing mothers. Caution should be exercised when it is administered to a nursing woman.

Signs and Symptoms

Codeine is metabolized to morphine and its effects are similar to those of morphine and other opiate analgesics. Respiratory depression, sedation and miosis and common symptoms of overdose. Other symptoms include nausea, vomiting, skeletal muscle flaccidity, bradycardia, hypotension, and cool, clammy skin. Apnea and death may ensue; children have had apnea after doses as small as 5 mg/kg. Noncardiac pulmonary edema may develop opioid overdose, and monitoring of heart filling pressure may be helpful.

Treatment

To obtain up-to-date information about the treatment of overdose, a good resource is your Certified Regional Control Center. Telephone numbers of certified poison control centers are listed in the beginning of Physicians GenRx. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

Naloxone antagonizes most effects of codeine. Protect the airway as Naloxone may induce vomiting. Naloxone has a shorter duration of action than codeine; repeated doses may be needed. In patients who abuse opioids chronically, a withdrawal syndrome may be manifest on administration of naloxone. This may include yawning, tearing, restlessness, sweating, dilated pupils, piloerection, vomiting, diarrhea, and abdominal cramps. This syndrome usually abates quickly as the effect of naloxone dissipates.

Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.

Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of codeine phosphate.

Hypersensitivity to codeine.

Codeine phosphate is a centrally active analgesic. When administered parenterally, 120 mg of codeine phosphate produces an analgesic response equivalent to that from 10 mg of morphine. Other actions include respiratory depression; depression of the cough center; release of antidiuretic hormone; activation of the vomiting center; pupillary constriction; a decrease in gastric, pancreatic, and biliary secretion; a reduction in intestinal motility; an increase in biliary tract pressure; and an increased amplitude of ureteral contractions.

Onset of analgesia following intramuscular or subcutaneous administration occurs within 10 to 30 minutes. The effect persists for 4 to 6 hours.

Most of a dose of codeine is excreted within 24 hours, 5% to 15% as unchanged codeine and the remainder as a product of glucuronide conjugates of codeine and its metabolites.

Codeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, s.c. as driving a car or operating machinery. Codeine in combination with other narcotic analgesics, phenothiazines, sedative hypnotics, and alcohol has additive depressant effects.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

CODEINE PHOSPHATE - INJECTION

(KO-deen FOSS-fate)

USES: This medication is used to treat mild to moderately severe pain. Codeine phosphate is a narcotic pain reliever. It acts on certain centers in the brain to give you pain relief.

HOW TO USE: This medication is given by injection into a muscle or under the skin, usually every 4 hours or exactly as prescribed by your doctor. Learn the proper way to give injections. If you have any questions about the use of this medication, consult your doctor or pharmacist.

The dosage is based on your medical condition and response to treatment. If you are extremely drowsy after using this medication, consult your doctor or pharmacist promptly. Your dosage may need to be lowered. Pain medications work best if they are used when the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

Before using this medication, check it visually for particles or discoloration. If either is present, do not use the liquid.

Learn to store and discard needles and medical supplies safely. Consult your pharmacist.

This medication may cause dependence, especially if it has been used regularly for an extended time or if it has been used in high doses. In such cases, withdrawal reactions (e.g., runny nose, sweating, restlessness, widened pupils, loss of appetite, "goose bumps," irritability, shakiness) may occur if you suddenly stop this drug. To prevent withdrawal reactions when stopping extended, regular treatment with this drug, gradually reduce the dosage as directed. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Tell your doctor if your pain persists or worsens after 24 hours when first starting this medication or after a dose change.

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, tiredness, or dry mouth may occur. Less common side effects may include pain/redness at the injection site and sweating. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, and drink plenty of water. If you become constipated while using this drug, consult your pharmacist for help with selecting a laxative (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, difficulty staying awake, mental/mood changes (e.g., nervousness, agitation, hallucinations, confusion), vision problems, flushing of the face, slow/irregular heartbeat, fast heartbeat, dizziness when standing, fainting, trouble starting the flow of urine, decreased sexual interest/ability.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using codeine phosphate injection, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications; or to sulfites; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, asthma attack), certain bowel diseases (e.g., paralytic ileus, toxic megacolon, acute abdomen), intoxication with medications that depress the nervous system or your breathing (e.g., brain/respiratory depressants such as alcohol or tranquilizers/sedatives), heart rhythm problems, heart failure due to long-term lung disease, brain disorders (e.g., head injury/tumor, increased intracranial pressure), uncontrolled seizures, a certain type of infectious diarrhea (pseudomembranous colitis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: seizures, lung diseases (e.g., chronic obstructive pulmonary disease-COPD, low oxygen in the blood, high carbon dioxide in the blood), low blood pressure, alcohol withdrawal, disease of the pancreas (e.g., pancreatitis), mental/mood disorders (e.g., toxic psychosis), a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of regular use/abuse of drugs/alcohol, kidney disease, liver disease, adrenal gland problems (e.g., Addison's disease), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism), a severe loss of body water (dehydration), sleep apnea.

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or taking part in any other activity that requires alertness. Avoid alcoholic beverages because they may increase the risk of side effects.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially slow/shallow breathing, low blood pressure, and drowsiness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: buprenorphine, butorphanol, nalbuphine, pentazocine, naltrexone.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting codeine phosphate.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other medications for pain, warfarin, cimetidine.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: antihistamines that cause drowsiness (e.g., diphenhydramine), anti-anxiety drugs (e.g., alprazolam, diazepam), anti-seizure drugs (e.g., carbamazepine), medicine for sleep (e.g., sedatives, hypnotics), muscle relaxants (e.g., methocarbamol), other narcotic pain relievers (e.g., morphine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone), tranquilizers.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow breathing, slow heartbeat, cold/clammy skin, loss of consciousness, bluish skin/lips/nails.

NOTES: Do not share this medication with others. It is against the law.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, take it as soon as you remember and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature below 104 degrees F (40 degrees C) away from light. Protect from freezing. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.