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Codeine Sulfate is a prescription medicine used to treat the symptoms of mild to moderately severe pain.


Description

What is Codeine Sulfate and how is it used?

Codeine Sulfate is a prescription medicine used to treat the symptoms of mild to moderately severe pain. Codeine Sulfate may be used alone or with other medications.

Codeine Sulfate belongs to a class of drugs called Antitussives; Antitussives, Narcotic; Opioid Analgesics.

It is not known if Codeine Sulfate is safe and effective in children younger than 12 years of age.

What are the possible side effects of Codeine Sulfate?

Codeine Sulfate may cause serious side effects including:

  • noisy breathing,
  • sighing,
  • shallow breathing,
  • breathing that stops during sleep,
  • slow heart rate,
  • weak pulse,
  • lightheadedness,
  • confusion,
  • unusual thoughts or behavior,
  • feeling extreme happiness or sadness,
  • convulsions (seizure),
  • problems with urination,
  • nausea,
  • vomiting,
  • loss of appetite,
  • dizziness,
  • worsening tiredness or weakness,
  • agitation,
  • hallucinations,
  • fever,
  • sweating,
  • fast heart rate,
  • muscle stiffness,
  • twitching,
  • loss of coordination, and
  • diarrhea

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Codeine Sulfate include:

  • feeling dizzy,
  • drowsiness,
  • constipation,
  • nausea,
  • vomiting, and
  • stomach pain

Tell the doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Codeine Sulfate. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

Codeine description

Chemically, codeine is Morphinan-6-ol,7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-(5α,6α)-, sulfate (2:1) (salt), trihydrate. Its empirical formula is C18H21NO3 and its molecular weight is 299.36.  Its structure is as follows:

 

Codeine sulfate - Structural Formula Illustration

 

Each tablet contains 15, 30, or 60 mg of codeine sulfate and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch, and stearic acid.

The relief of pain (analgesia) is a primary goal for enhancing the quality of life of patients and for increasing the ability of patients to engage in day to day activities. Codeine, an opioid analgesic, was originally approved in the US in 1950 and is a drug used to decrease pain by increasing the threshold for pain without impairing consciousness or altering other sensory functions. Opiates such as codeine are derived from the poppy plant, Papaver somniferum (Papaveraceae).4

Codeine is utilized as a central analgesic, sedative, hypnotic, antinociceptive, and antiperistaltic agent, and is also recommended in certain diseases with incessant coughing.Label,4

INDICATIONS

sulfate is an opioid analgesic indicated for the relief of mild to moderately severe pain where the use of an opioid analgesic is appropriate.

Codeine sulfate is a form of this drug that is commonly used. It is available in tablet form Label and indicated for the relief of mild to moderately severe pain, where the use of an opioid analgesic is appropriate Label.

The solution form is used by itself or combined in a syrup with other drugs and is used as a cough suppressant in adults aged 18 and above 1112.

DOSAGE AND ADMINISTRATION

Selection of patients for treatment with codeine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Physicians should individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management.

Individualization Of Dosage

As with any opioid drug product, adjust the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience. In the selection of the initial dose of codeine sulfate, attention should be given to the following:

  • the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously;
  • the reliability of the relative potency estimate used to calculate the equivalent codeine sulfate dose needed;
  • the patient’s degree of opioid tolerance;
  • the general condition and medical status of the patient;
  • concurrent medications;
  • the type and severity of the patient’s pain;
  • risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction or diversion.

The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Continual re-evaluation of the patient receiving codeine sulfate is important, with special attention to the maintenance of pain control and the relative incidence of side effects associated with therapy. During chronic therapy, especially for noncancer-related pain, the continued need for the use of opioid analgesics should be re-assessed as appropriate.

During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between physician, other members of the healthcare team, the patient, and the caregiver/family.

Initiation Of Therapy

The usual adult dosage for tablets is 15 mg to 60 mg repeated up to every four hours as needed for pain. The maximum 24 hour dose is 360 mg.

The initial dose should be titrated based upon the individual patient’s response to their initial dose of codeine. This dose can then be adjusted to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the codeine by the patient.

It should be kept in mind, however, that tolerance to codeine sulfate can develop with continued use and that the incidence of untoward effects is dose-related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain and are associated with an appreciably increased incidence of undesirable side effects.

Cessation Of Therapy

When the patient no longer requires therapy with codeine sulfate, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

HOW SUPPLIED

Dosage Forms And Strengths

Each 15 mg tablet for oral administration contains 15 mg of codeine sulfate, USP. It is a white, biconvex tablet scored on one side, with strength-indicating number “15” debossed on the scored side and product identification number “54 613” debossed on the other side.

Each 30 mg tablet for oral administration contains 30 mg of codeine sulfate, USP. It is a white, biconvex tablet scored on one side, with strength-indicating number “30” debossed on the scored side and product identification number “54 783” debossed on the other side.

Each 60 mg tablet for oral administration contains 60 mg of codeine sulfate, USP. It is a white, biconvex tablet scored on one side, with strength-indicating number “60” debossed on the scored side and product identification number “54 412” debossed on the other side.

Storage And Handling

Codeine Sulfate

15 mg Tablet: white, biconvex tablets scored on one side, with strength-indicating number “15” debossed on the scored side and product identification number “54 613” debossed on the other side.

Unit dose, 25 tablets per blister card

NDC 0054-8155-24: 4 Cards per Carton

30 mg Tablet: white, biconvex tablets scored on one side, with strength-indicating number “30” debossed on the scored side and product identification number “54 783” debossed on the other side.

Unit dose, 25 tablets per blister card

NDC 0054-4156-24: 4 Cards per Carton
NDC 0054-0244-25: Bottles of 100 Tablets

60 mg Tablet: white, biconvex tablets scored on one side, with strength-indicating number “60” debossed on the scored side and product identification number “54 412” debossed on the other side.

NDC 0054-4157-25: Bottles of 100 Tablets

Storage

Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F).

Protect from moisture and light.

Dispense in well-closed container as defined in the USP/NF.

Blisters are not child-resistant. Use child-resistant closure if dispensing to outpatient.

All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.

General effects

This medication is a weak narcotic pain reliever and cough suppressant that is similar to morphine and hydrocodone. A small amount of ingested codeine is converted to morphine in the body. Codeine increases tolerance to pain, reducing existing discomfort. In addition to decreasing pain, codeine also causes sedation, drowsiness, and respiratory depression 4.

Antitussive activity

This drug has shown antitussive activity in clinical trials 6 and has been effective in cough secondary to tuberculosis and insomnia due to coughing 4. Codeine suppresses the cough reflex through a direct effect on the cough center in the medulla 13.

Effects on intestinal motility

This drug may reduce intestinal motility through both a local and possibly central mechanism of action 14. This may possibly lead to constipation 13. The chronic use of opioids, including codeine sulfate, may lead to obstructive bowel disease, particularly in patients with underlying disorders of intestinal motility Label.

Effects on the central nervous system

This medication is an opioid analgesic with uses similar to those of morphine, but is much less potent as an analgesic. Its primary site of action is at the mu opioid receptors distributed throughout the central nervous system. The sedative activities of codeine are less potent than those of morphine 13. Codeine may cause respiratory system depression by the activation of μ-opioid receptors at specific sites in the central nervous system 8.

Effects on blood pressure

This drug poses an increased risk of compromised ability to maintain blood pressure due to peripheral vasodilation and other mechanisms Label.

Effects on chronic cancer pain and other types of pain

This medication  is an opioid analgesic with similar indications to those of morphine, however, is much less potent in its pain alleviating properties. Its primary action takes place at the mu opioid receptors, which are distributed throughout the central nervous system. The average duration of action is about 4 hours 13.

Regular dosing of opioid analgesics such as codeine in patients with severe cancer pain has been well documented to improve symptoms 47.

Mechanism of action

This medication is a selective agonist for the mu opioid receptor, but with a much weaker affinity to this receptor than morphine, a more potent opioid drug. Codeine binds to mu-opioid receptors, which are involved in the transmission of pain throughout the body and central nervous system Label4. The analgesic properties of codeine are thought to arise from its conversion to Morphine, although the exact mechanism of analgesic action is unknown at this time Label13.

Absorption

Absorption

This medication is absorbed from the gastrointestinal tract. The maximum plasma concentration occurs 60 minutes after administration Label.

Food Effects

When 60 mg codeine sulfate was given 30 minutes post-ingestion of a high high-calorie meal, there was no significant change in the absorption of codeine Label.

Steady-state concentration

The administration of 15 mg codeine sulfate every 4 hours for 5 days lead to steady-state concentrations of codeine, morphine, morphine-3-glucuronide (M3G) and morphine-6-glucuronide (M6G) within 48 hours Label.

Volume of distribution

Apparent volume of distribution: about 3-6 L/kg, showing an extensive distribution of the drug into tissues Label.

Protein binding

7-25% bound to plasma proteins Label.

Metabolism

Approximately 70 to 80% of the ingested dose of codeine is metabolized in the liver by conjugation with glucuronic acid to codeine-6­ glucuronide (C6G) and by O-demethylation to morphine (about 5-10%) and N-demethylation to norcodeine (about 10%) respectively. UDP-glucuronosyltransferase (UGT) 2B7 and 2B4 are the major metabolic enzymes mediating the glucurodination of codeine to the metabolite, codeine 6 glucuronide.

Cytochrome P450 2D6 is the major enzyme responsible for the transformation of codeine to morphine and P450 3A4 is the main enzyme mediating the conversion of codeine to norcodeine. Morphine and norcodeine are then further metabolized by conjugation with glucuronic acid.

The glucuronide metabolites of morphine are morphine-3-glucuronide (M3G) and_ morphine-6-glucuronide _(M6G). Morphine and M6G have been proven to have analgesic activity in humans. The analgesic activity of C6G in humans is not known at this time. Norcodeine and M3G are generally not considered to have analgesic properties Label.

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Route of elimination

About 90% of the total dose of codeine is excreted by the kidneys. Approximately 10% of the drug excreted by the kidneys is unchanged codeine Label.

The majority of the excretion products can be found in the urine within 6 hours of ingestion, and 40-60 % of the codeine is excreted free or conjugated, approximately 5 to 15 percent as free and conjugated morphine, and approximately 10-20% free and conjugated norcodeine 13.

Half-life

Plasma half-lives of codeine and its metabolites have been reported to be approximately 3 hours Label.

Clearance

Renal clearance of codeine was 183 +/- 59 ml min-1 in a clinical study 5.

Renal impairment may decrease codeine clearance Label.

Toxicity

Oral LD50: 427 mg kg-1 (rat) MSDS.

Overdose/toxicity

Symptoms of opioid toxicity may include confusion, somnolence, shallow breathing, constricted pupils, nausea, vomiting, constipation and a lack of appetite. In severe cases, symptoms of circulatory and respiratory depression may ensue, which may be life-threatening or fatal 10Label.

Teratogenic effects

This drug is classified as a pregnancy Category C drug. There are no adequate and well-controlled studies completed in pregnant women. This drug should only be used during pregnancy if the potential benefit outweighs the potential risk of the drug to the fetus Label.

This drug has shown embryolethal and fetotoxic effects in the hamster, rat as well as mouse models at about 2-4 times the maximum recommended human dose Label. Maternally toxic doses that were about 7 times the maximum recommended human dose of 360 mg/day, were associated with evidence of bone resorption and incomplete bone ossification. Codeine did not demonstrate evidence of embrytoxicity or fetotoxicity in the rabbit model at doses up to 2 times the maximum recommended human dose of 360 mg/day based on a body surface area comparison Label.

Nonteratogenic effects

Neonatal This drug withdrawal has been observed in infants born to addicted and non-addicted mothers who ingested This drug -containing medications in the days before delivery. Common symptoms of narcotic withdrawal include irritability, excessive crying, tremors, hyperreflexia, seizures, fever, vomiting, diarrhea, and poor feeding. These signs may be observed shortly following birth and may require specific treatment Label.

This drug (30 mg/kg) given subcutaneously to pregnant rats during gestation and for 25 days after delivery increased the rate of neonatal mortality at birth. The dose given was 0.8 times the maximum recommended human dose of 360 mg/day Label.

The use in breastfeeding/nursing

This drug is secreted into human milk. The maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants Label.

IMPORTANT WARNING:

This drug may be habit forming. Take This drug exactly as directed. Do not take more of it, take it more often, or take it in a different way than directed by your doctor. While taking this drug , discuss with your healthcare provider your pain treatment goals, length of treatment, and other ways to manage your pain.

Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse codeine if you have or have ever had any of these conditions. Talk to your healthcare provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

This drug may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to take codeine. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), a head injury or any condition that increases the amount of pressure in your brain.

The risk that you will develop breathing problems may be higher if you are an older adult or are weak or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

When This drug was used in children, serious and life-threatening breathing problems such as slow or difficulty breathing and deaths were reported. This drug should never be used to treat pain or a cough in children younger than 18 years of age. If your child is currently prescribed a cough and cold medicine containing codeine, talk to your child’s doctor about other treatments.

Taking certain medications during your treatment with codeine may increase the risk that you will experience breathing problems or other serious, life-threatening breathing problems, sedation, or coma. Tell your doctor if you are taking or plan to take any of the following medications: certain antibiotics such as erythromycin (Erytab, Erythrocin); certain antifungal medications including ketoconazole; benzodiazepines such as alprazolam (Xanax), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), and triazolam (Halcion); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); certain medications for human immunodeficiency virus (HIV) including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); medications for mental illness or nausea; other medications for pain; muscle relaxants; phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rimactane, in Rifamate); sedatives; sleeping pills; or tranquilizers.

Your doctor may need to change the dosages of your medications and will monitor you carefully. If you take codeine with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Drinking alcohol or using street drugs during your treatment with codeine also increases the risk that you will experience these serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment.

Tell your doctor if you are pregnant or plan to become pregnant. If you take codeine regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby’s doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

Do not allow anyone else to take your medication. Codeine may harm or cause death to other people who take your medication, especially children.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with codeine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

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