ACETAMINOPHEN and CODEINE PHOSPHATE (Acetaminophen and Codeine Phosphate)

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Trade Name: Acetaminophen and Codeine Phosphate

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals,Inc.

Presentation: SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 120; 12 mg/5mL; mg/5mL

Storage and handling

ACETAMINOPHEN; CODEINE PHOSPHATE Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE -THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOD WITHDRAWAL SYNDROME; DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Arrayn- Risk of Medication Errors
Ensure accuracy when prescribing, dispensing, and administering acetaminophen and codeine phosphate oral solution. Dosing errors due to confusion between mg and mL, and other codeine containing oral products of different concentrations can result in accidental overdose and deathu00a0[see n n n n n n , n n n n n n ].n n n n n n
Arrayn- Addiction, Abuse, and Misuse
Acetaminophen and codeine phosphate oral solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing acetaminophen and codeine phosphate oral solution, and monitor all patients regularly for the development of these behaviors and conditionsu00a0[see n n n n n n ].n n n n n n
Arrayn- Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of acetaminophen and codeine phosphate oral solution. Monitor for respiratory depression, especially during initiation of acetaminophen and codeine phosphate oral solution or following a dose increaseu00a0[see n n n n n n ].n n n n n n
Arrayn- Accidental Ingestion
Accidental ingestion of acetaminophen and codeine phosphate oral solution, especially by children, can result in a fatal overdose of acetaminophen and codeine phosphate oral solutionu00a0[see n n n n n n ].n n n n n n
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 polymorphismu00a0[see n n n n n n ].u00a0 Acetaminophen and codeine phosphate oral solution is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomyu00a0[see n n n n n n ].u00a0 Avoid the use of acetaminophen and codeine phosphate oral solution 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.n n n n n n
Arrayn- Neonatal Opioid Withdrawal Syndrome
Prolonged use of acetaminophen and codeine phosphate oral solution 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 availableu00a0[see n n n n n n ].n n n n n n
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 acetaminophen and codeine phosphate oral solution requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine [see n n n n n n ; n n n n n n ].n n n n n n
Arrayn- Hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see n n n n n n ].n n n n n n
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 [see n n n n n n ; n n n n n n ].n n n n n n

Acetaminophen and Codeine Phosphate Oral Solution is pharmacologically classified as an analgesic.
Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non- opioid, non-salicylate analgesic and antipyretic. It has the following structural formula:
Codeine phosphate, 7,8-didehydro-4,5u03b1-epoxy-3-methoxy-17-methylmorphinan-6u03b1-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is an opioid agonist. It has the following structural formula:

FD&C Red No. 40, FD&C Yellow No. 6 (Sunset Yellow), flavoring, glycerin,u00a0n propylene glycol, purified water, sodium saccharin, and sucrose.

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Acetaminophen and codeine phosphate oral solution is 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 [see n n n n n n ],u00a0reserve acetaminophen and codeine phosphate oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:n nn n nn

Acetaminophen and codeine phosphate oral solution is contraindicated for:
Acetaminophen and codeine phosphate oral solution is contraindicated in patients with:

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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 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.n n n n n n Serious adverse reactions associated with codeine are respiratory depression and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.n nn n nn
The most frequently observed adverse reactions with codeine administration include drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, sweating, and constipation.
Other adverse reactions include allergic reactions, euphoria, dysphoria, abdominal pain, pruritis, rash, thrombocytopenia, and agranulocytosis.
Other less frequently observed adverse reactions expected from opioid analgesics, including acetaminophen and codeine phosphate oral solution:
Cardiovascular system
Digestive System
Nervous system
Skin and Appendages

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Following an acute overdosage, toxicity may result from codeine or acetaminophen.

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Individually titrate acetaminophen and codeine phosphate oral solution to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving acetaminophen and codeine phosphate oral solution to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see n n n n n n ]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.n nn n nn
If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the acetaminophen and codeine phosphate oral solution dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

When a patient who has been taking acetaminophen and codeine phosphate oral solution regularly and may be physically dependent no longer requires therapy with acetaminophen and codeine phosphate oral solution, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue acetaminophen and codeine phosphate oral solution in a physically-dependent patient [see n n n n n n ].n nn n nn

Acetaminophen and Codeine Phosphate Oral Solution USP (orange-yellow color, cherry flavor) is supplied in the following oral dosage forms:
NDC 66267-997-04 Bottles of 4 oz

Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container with a child-resistant closure.

Pharmaceutical Associates, Inc.
R11/17

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of ACETAMINOPHEN and CODEINE PHOSPHATE (Acetaminophen and Codeine Phosphate) which is also known as Acetaminophen and Codeine Phosphate and Manufactured by NuCare Pharmaceuticals,Inc.. It is available in strength of 120; 12 mg/5mL; mg/5mL.

ACETAMINOPHEN and CODEINE PHOSPHATE (Acetaminophen and Codeine Phosphate) 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.