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CODRIX

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Overview

What is CODRIX?

Acetaminophen and codeine is supplied in tablet form for oral administration.

Acetaminophen, 4'-hydroxyacetanalide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula:

Each tablet contains:

Acetaminophen 500 mg

Codeine phosphate 60 mg

In addition each tablet contains the following inactive ingredients: Colloidal silicon dioxide, crospovidone, croscarmellose sodium, FD&C #1 blue, FD&C red #40, FD&C yellow #5, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid.



What does CODRIX look like?



What are the available doses of CODRIX?

Sorry No records found.

What should I talk to my health care provider before I take CODRIX?

Sorry No records found

How should I use CODRIX?

CODRIX™ is indicated for the relief of mild to moderately severe pain.

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

The usual adult dosage is:

The usual dose of codeine phosphate in is 0.5 mg/kg.

Doses may be repeated up to every 4 hours.

The prescriber must determine the number of tablets per dose, and the maximum number of tablets per 24 hours based upon the above dosage guidance. This information should be conveyed in the prescription.

It should be kept in mind, however, that tolerance to codeine 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 but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.


What interacts with CODRIX?

This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.



What are the warnings of CODRIX?

Codeine is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.

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 the 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.

Codeine is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.


What are the precautions of CODRIX?

General

CODRIX™ should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, or prostatic hypertrophy.

Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2x2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regiments, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing.

The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups.

When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose.

Information for Patients

Codeine may impair 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 this product.

Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.

Codeine may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.

Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life threatening of fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Drug Interactions

This drug may enhance the effects of: other narcotic analgesics, alcohol, general anesthetic, tranquilizers such as chloridazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.

Drug/Laboratory Test Interactions

Codeine may increase serum amylase levels.

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies have been conducted in animals to determine whether acetaminophen and codeine have a potential for carcinogenesis or mutagenesis. No adequate studies have been conducted in animals to determine whether acetaminophen has a potential for impairment of fertility.

Acetaminophen and codeine have been found to have no mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow.

Pregnancy

Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. These signs usually appear during the first few days of life.

Labor and Delivery

Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see ). The effect of codeine, if any, on the later growth, development, and functional maturation of the child is unknown.

Nursing Mothers

Codeine is secreted into human milk. In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent. Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare. However, some women are ultra-rapid metabolizers of codeine. These women achieve higher-than-expected serum levels of codeine's active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants.

The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups.

The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Caution should be exercised when codeine is administered to a nursing woman. If a codeine containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect. Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby. Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding. (See )

ADVERSE REACTIONS

The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, 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 drug reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain, pruritus, rash, thrombocytopenia, agranulocytosis.

At higher doses codeine has most of the disadvantages of morphine including respiratory depression.


What are the side effects of CODRIX?

Sorry No records found


What should I look out for while using CODRIX?

This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.

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 the 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.

Codeine is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.


What might happen if I take too much CODRIX?

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


How should I store and handle CODRIX?

Store the kit at 2°-8°C (36°-46°F) and protect from light.ArrayStore the kit at 2°-8°C (36°-46°F) and protect from light.ArrayCODRIX™, (acetaminophen and codeine phosphate tablets, USP), 500 mg/60 mg are peach, oval tablets, imprinted with the “” on one side and “713” on other side.Bottles of 100 Tablets       NDC 62022-713-01Bottles of 500 Tablets       NDC 62022-713-05Bottles of 1000 Tablets      NDC 62022-713-50Store at controlled room temperature, 15 to 30°C (59 to 86°F) [see USP].Dispense in tight, light-resistant container as defined in the USP.Manufactured by:Fort Lauderdale, FL 33314Manufactured for:Weston, FL 33314Rev. date: 08/077237CODRIX™, (acetaminophen and codeine phosphate tablets, USP), 500 mg/60 mg are peach, oval tablets, imprinted with the “” on one side and “713” on other side.Bottles of 100 Tablets       NDC 62022-713-01Bottles of 500 Tablets       NDC 62022-713-05Bottles of 1000 Tablets      NDC 62022-713-50Store at controlled room temperature, 15 to 30°C (59 to 86°F) [see USP].Dispense in tight, light-resistant container as defined in the USP.Manufactured by:Fort Lauderdale, FL 33314Manufactured for:Weston, FL 33314Rev. date: 08/077237CODRIX™, (acetaminophen and codeine phosphate tablets, USP), 500 mg/60 mg are peach, oval tablets, imprinted with the “” on one side and “713” on other side.Bottles of 100 Tablets       NDC 62022-713-01Bottles of 500 Tablets       NDC 62022-713-05Bottles of 1000 Tablets      NDC 62022-713-50Store at controlled room temperature, 15 to 30°C (59 to 86°F) [see USP].Dispense in tight, light-resistant container as defined in the USP.Manufactured by:Fort Lauderdale, FL 33314Manufactured for:Weston, FL 33314Rev. date: 08/077237CODRIX™, (acetaminophen and codeine phosphate tablets, USP), 500 mg/60 mg are peach, oval tablets, imprinted with the “” on one side and “713” on other side.Bottles of 100 Tablets       NDC 62022-713-01Bottles of 500 Tablets       NDC 62022-713-05Bottles of 1000 Tablets      NDC 62022-713-50Store at controlled room temperature, 15 to 30°C (59 to 86°F) [see USP].Dispense in tight, light-resistant container as defined in the USP.Manufactured by:Fort Lauderdale, FL 33314Manufactured for:Weston, FL 33314Rev. date: 08/077237CODRIX™, (acetaminophen and codeine phosphate tablets, USP), 500 mg/60 mg are peach, oval tablets, imprinted with the “” on one side and “713” on other side.Bottles of 100 Tablets       NDC 62022-713-01Bottles of 500 Tablets       NDC 62022-713-05Bottles of 1000 Tablets      NDC 62022-713-50Store at controlled room temperature, 15 to 30°C (59 to 86°F) [see USP].Dispense in tight, light-resistant container as defined in the USP.Manufactured by:Fort Lauderdale, FL 33314Manufactured for:Weston, FL 33314Rev. date: 08/077237CODRIX™, (acetaminophen and codeine phosphate tablets, USP), 500 mg/60 mg are peach, oval tablets, imprinted with the “” on one side and “713” on other side.Bottles of 100 Tablets       NDC 62022-713-01Bottles of 500 Tablets       NDC 62022-713-05Bottles of 1000 Tablets      NDC 62022-713-50Store at controlled room temperature, 15 to 30°C (59 to 86°F) [see USP].Dispense in tight, light-resistant container as defined in the USP.Manufactured by:Fort Lauderdale, FL 33314Manufactured for:Weston, FL 33314Rev. date: 08/077237CODRIX™, (acetaminophen and codeine phosphate tablets, USP), 500 mg/60 mg are peach, oval tablets, imprinted with the “” on one side and “713” on other side.Bottles of 100 Tablets       NDC 62022-713-01Bottles of 500 Tablets       NDC 62022-713-05Bottles of 1000 Tablets      NDC 62022-713-50Store at controlled room temperature, 15 to 30°C (59 to 86°F) [see USP].Dispense in tight, light-resistant container as defined in the USP.Manufactured by:Fort Lauderdale, FL 33314Manufactured for:Weston, FL 33314Rev. date: 08/077237


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

This product combines the analgesic effects of a centrally acting analgesic, codeine, with the peripherally acting analgesics, acetaminophen.

Non-Clinical Toxicology
This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen.

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 the 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.

Codeine is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.

This drug may enhance the effects of: other narcotic analgesics, alcohol, general anesthetic, tranquilizers such as chloridazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.

CODRIX™ should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, head injuries, elevated intracranial pressure, acute abdominal conditions, hypothyroidism, urethral stricture, Addison's disease, or prostatic hypertrophy.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).