Codeine Sulfate (Codeine Sulfate)

Trade Name : Codeine sulfate

West-Ward Pharmaceuticals Corp.

TABLET

Strength 15 mg/1

CODEINE SULFATE Full Opioid Agonists [MoA],Opioid Agonist [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Codeine Sulfate (Codeine Sulfate) which is also known as Codeine sulfate and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 15 mg/1 per ml. Read more

Codeine Sulfate (Codeine Sulfate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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5.3n- 5.15

Arrayn- Addiction, Abuse, and Misuse
Codeine Sulfate Tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing Codeine Sulfate Tablets, and monitor all patients regularly for the development of these behaviors and conditions n
Arrayn- Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to:
Arrayn- Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of Codeine Sulfate Tablets. Monitor for respiratory depression, especially during initiation of Codeine Sulfate Tablets or following a dose increase n
Arrayn- Accidental Ingestion
Accidental ingestion of even one dose of Codeine Sulfate Tablets, especially by children, can result in a fatal overdose of codeine n n- Arrayn- Array
Arrayn- Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children
Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism n n- Arrayn- Array
Arrayn- Neonatal Opioid Withdrawal Syndrome
Prolonged use of Codeine Sulfate Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available .
Arrayn- Interactions with Drugs Affecting Cytochrome P450 Isoenzymes
The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with Codeine Sulfate Tablets requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. .
Arrayn- Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death n
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
See full prescribing information for complete boxed warning.

Codeine Sulfate Tablets exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patientu2019s risk before prescribing and monitor regularly for these behaviors and conditions. ()
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. (n- Arrayn- )
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (n- Arrayn- )
Accidental ingestion of Codeine Sulfate Tablets, especially by children, can result in a fatal overdose of codeine. ()
Life-threatening respiratory depression and death have occurred in children who received codeine; most cases followed tonsillectomy and/or adenoidectomy and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. (n- Arrayn- ) Codeine Sulfate Tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy (). Avoid the use of Codeine Sulfate Tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.
Prolonged use of Codeine Sulfate Tablets during pregnancy can result in neonatal opioid withdrawal syndrome which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (n- Arrayn- )
The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with Codeine Sulfate Tablets requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. (n- Arrayn- , )
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (n- Arrayn- , )

Codeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.
Limitations of Use:
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses reserve Codeine Sulfate Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Codeine Sulfate Tablets are an opioid agonist, indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. ()
Limitations of Use ():
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve Codeine Sulfate Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

No data

Each 15 mg tablet for oral administration contains 15 mg of codeine sulfate USP. It is a white to off-white biconvex tablet with u201c15u201d debossed on the scored side and u201c54 613u201d debossed on the other side.
Each 30 mg tablet for oral administration contains 30 mg of codeine sulfate USP. It is a white to off-white biconvex tablet with u201c30u201d debossed on the scored side and u201c54 783u201d debossed on the other side.
Each 60 mg tablet for oral administration contains 60 mg of codeine sulfate USP. It is a white to off-white biconvex tablet with u201c60u201d debossed on the scored side and u201c54 412u201d debossed on the other side.
Tablets: 15 mg, 30 mg, and 60 mg ()

Codeine Sulfate Tablets are contraindicated for:
Codeine Sulfate Tablets are also contraindicated in patients with:

No data

Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
Adrenal Insufficiency
Severe Hypotension
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness

The following serious adverse reactions are described, or described in greater detail, in other sections:
The following adverse reactions associated with the use of codeine were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Serious adverse reactions associated with codeine were respiratory depression and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.
The most frequently observed adverse reactions with codeine administration included drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, sweating, and constipation.
Other adverse reactions included allergic reactions, euphoria, dysphoria, abdominal pain, and pruritis.
Other less frequently observed adverse reactions expected from opioid analgesics, including Codeine Sulfate Tablets, include:u00a0
Cardiovascular System
Digestive System
Nervous System
Skin and Appendages
Serotonin Syndrome
Adrenal Insufficiency
Anaphylaxis
Androgen Deficiencyn- [see Clinicaln- Pharmacology ()]
The most common adverse reactions include: drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, and sweating. ()

Table 1 includes clinically significant drug interactions with Codeine Sulfate Tablets.

Serotonergic Drugs:
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics:

No data

Pregnancy
Lactation

No data

Clinical Presentation:
Acute overdose with Codeine Sulfate Tablets can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations .
Treatment of Overdose:
In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to codeine overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to codeine overdose.
Because the duration of opioid reversal is expected to be less than the duration of action of codeine in Codeine Sulfate Tablets, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the productu2019s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.

Codeine Sulfate Tablets USP contain codeine, an opioid agonist, available for oral administration containing either 15 mg, 30u00a0mg, or 60 mg of codeine sulfate USP. The chemical name is morphinan-6-ol,7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-(5u03b1,6u03b1)-, sulfate (2:1) (salt), trihydrate. Its molecular formula is (CHNO) u2022 HSO u2022 3HO and its molecular weight is 750.85 g/mol.
Its structure is as follows:
Codeine sulfate trihydrate is a fine, white, crystalline powder which is soluble in water and insoluble in chloroform and ether.
The inactive ingredients in Codeine Sulfate Tablets USP include: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch and stearic acid.

No data

Carcinogenesis:
Two-year carcinogenicity studies have been conducted in F344/N rats and B6C3F1 mice. There was no evidence of carcinogenicity in male and female rats, respectively, at dietary doses up to 70 and 80 mg/kg/day of codeine (approximately 2 times the maximum recommended daily dose of 360 mg/day for adults on a mg/m basis) for two years. Similarly there was no evidence of carcinogenicity activity in male and female mice at dietary doses up to 400 mg/kg/day of codeine (approximately 5 times the maximum recommended daily dose of 360 mg/day for adults on a mg/m basis) for two years.
Mutagenesis:
Codeine was not mutagenic in thebacterial reverse mutation assay or clastogenic in theChinese hamster ovary cell chromosome aberration assay.
Impairment of Fertility:
No animal studies were conducted to evaluate the effect of codeine on male or female fertility.

Codeine Sulfate Tablets USP
15 mg tablet:n- supplied as white to off-white biconvex tablets with u201c15u201d debossed on the scored side and u201c54 613u201d debossed on the other side.
NDC 0054-0243-24: 10 x 10 Unit-Dose
30 mg tablet: supplied as white to off-white biconvex tablets with u201c30u201d debossed on the scored side and u201c54 783u201d debossed on the other side.
NDC 0054-0244-24: 10 x 10 Unit-Dose
NDC 0054-0244-25: Bottle of 100 Tablets
60 mg tablet: supplied as white to off-white biconvex tablets with u201c60u201d debossed on the scored side and u201c54 412u201d debossed on the other side.
NDC 0054-0245-25: Bottle of 100 Tablets
Storage
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F), excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). [See USP Controlled Room Temperature.]
Protect from moisture.
Dispense in a tight, light-resistant container as defined in the USP/NF.
Blisters are not child-resistant. Use child-resistant closure if dispensing to outpatient.
Store Codeine Sulfate Tablets securely and dispose of properly n

Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Storage and Disposal:
Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store Codeine Sulfate Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home Inform patients that leaving Codeine Sulfate Tablets unsecured can pose a deadly risk to others in the home.
Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Inform patients that medicine take-back options are the preferred way to safely dispose of most types of unneeded medicines. If no take back programs or DEA-registered collectors are available, instruct patients to dispose of Codeine Sulfate Tablets by following these four steps:
Inform patients that they can visit for additional information on disposal of unused medicines.
Addiction, Abuse, and Misuse:
Inform patients that the use of Codeine Sulfate Tablets, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death . Instruct patients not to share Codeine Sulfate Tablets with others and to take steps to protect Codeine Sulfate Tablets from theft or misuse.
Life-Threatening Respiratory Depression:
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Codeine Sulfate Tablets or when the dosage is increased, and that it can occur even at recommended dosages . Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Accidental Ingestion:
Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death .
Ultra-Rapid Codeine Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children:
Advise caregivers that Codeine Sulfate Tablets are contraindicated in all children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Advise caregivers of children 12 to 18 years of age receiving Codeine Sulfate Tablets to monitor for signs of respiratory depression .
Interactions with Benzodiazepines and Other CNS Depressants:
Inform patients and caregivers that potentially fatal additive effects may occur if Codeine Sulfate Tablets are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider n n .
Serotonin Syndrome:
Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications .
MAOI Interaction:
Inform patients not to take Codeine Sulfate Tablets while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Codeine Sulfate Tablets n n .
Adrenal Insufficiency:
Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms n n .
Important Administration Instructions:
Instruct patients how to properly take Codeine Sulfate Tablets.
Important Discontinuation Instructions:
In order to avoid developing withdrawal symptoms, instruct patients not to discontinue Codeine Sulfate Tablets without first discussing a tapering plan with the prescriber n
Hypotension:
Inform patients that Codeine Sulfate Tablets may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) n n .
Anaphylaxis:
Inform patients that anaphylaxis has been reported with ingredients contained in Codeine Sulfate Tablets. Advise patients how to recognize such a reaction and when to seek medical attention .
Pregnancy:
Neonatal Opioid Withdrawal Syndromen- [see Warnings and Precautions (n- Arrayn- ), Use in Specific Populations ()]
Embryo-Fetal Toxicity:n- [see Use in Specific Populations ()]
Lactation:
Advise women that breastfeeding is not recommended during treatment with Codeine Sulfate Tablets [.
Infertility:
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible .
Driving or Operating Heavy Machinery:
Inform patients that Codeine Sulfate Tablets may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication n n .
Constipation:
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention .
Distr. by: n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10005657/13
Revised October 2019

10005657/13
Revised October 2019

Codeine Sulfate Tablets USP, 15 mg
0054-0243-24, Rx only

Codeine Sulfate Tablets USP, 30 mg
0054-0244-25, Rx only

Codeine Sulfate Tablets USP, 60 mg
0054-0245-25, Rx only

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Codeine Sulfate (Codeine Sulfate)

Trade Name : Codeine sulfate

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Codeine Sulfate (Codeine Sulfate)

Trade Name : Codeine sulfate

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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Swiss Drugs

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