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CODEINE AND CHLORPHENIRAMINE MALEATE ER

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Overview

What is CODEINE AND CHLORPHENIRAMINE MALEATE ER?

CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE are extended release tablets that contain 54.3 mg of codeine phosphate (equivalent to 40 mg of codeine) and 8 mg of chlorpheniramine maleate (equivalent to 5.6 mg of chlorpheniramine)..

Codeine phosphate [morphine3methyl ether phosphate (1:1) (salt)] hemihydrate, is a narcotic analgesic and antitussive. It has the following structural formula:

Chlorpheniramine maleate is 2-pyridinepropanamine, γ-(4-chlorophenyl)--dimethyl-, ()-2-butenedioate (1:1) and has the following chemical structure:

CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE are white to off-white, uncoated, standard round extended release matrix tablets.

Other ingredients: hypromellose, lactose monohydrate, cellulose microcrystalline, polysorbate 80, magnesium stearate, and colloidal silicon dioxide.



What does CODEINE AND CHLORPHENIRAMINE MALEATE ER look like?



What are the available doses of CODEINE AND CHLORPHENIRAMINE MALEATE ER?

Extended release (ER) tablet: contains 54.3 mg of codeine phosphate (equivalent to 40 mg of codeine) and 8 mg of chlorpheniramine maleate (equivalent to 5.6 mg of chlorpheniramine). ()

What should I talk to my health care provider before I take CODEINE AND CHLORPHENIRAMINE MALEATE ER?

How should I use CODEINE AND CHLORPHENIRAMINE MALEATE ER?

CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.

Important Limitations of Use

Not indicated for pediatric patients under 18 years of age

 

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What interacts with CODEINE AND CHLORPHENIRAMINE MALEATE ER?

Sorry No Records found


What are the warnings of CODEINE AND CHLORPHENIRAMINE MALEATE ER?

Sorry No Records found


What are the precautions of CODEINE AND CHLORPHENIRAMINE MALEATE ER?

Sorry No Records found


What are the side effects of CODEINE AND CHLORPHENIRAMINE MALEATE ER?

Sorry No records found


What should I look out for while using CODEINE AND CHLORPHENIRAMINE MALEATE ER?

Patients with known hypersensitivity to codeine, chlorpheniramine or any of the inactive ingredients of CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE. Persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to codeine.


What might happen if I take too much CODEINE AND CHLORPHENIRAMINE MALEATE ER?

No human overdosage data are available for CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE.

Codeine

Overdosage with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.

Codeine may cause miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.

Chlorpheniramine

Manifestations of chlorpheniramine overdosage may vary from central nervous system depression to stimulation. Central toxic effects are characterized by agitation, anxiety, delirium, disorientation, hallucinations, hyperactivity, sedation, and seizures. Severe overdosage may produce coma, medullary paralysis, and death. Peripheral toxicity includes hypertension, tachycardia, dysrhythmias, vasodilation, hyperpyrexia, mydriasis, urinary retention, and diminished gastrointestinal motility. Dry mouth, pharynx, bronchi, and nasal passages may be observed.

Impaired secretion from sweat glands following toxic doses of drugs with anticholinergic side effects may predispose to hyperthermia.

An adult ingested 400 mg chlorpheniramine with no reported serious adverse effects. Toxic psychosis, a possible class effect from overdose of sedating antihistamines, has been reported with accidental overdose of chlorpheniramine.

Treatment of overdosage consists of discontinuation of CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE together with institution of appropriate therapy.

Give primary attention to re-establishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression that may result from overdosage or unusual sensitivity to opioids including codeine. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory or circulatory depression. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

Hemodialysis is not routinely used to enhance the elimination of codeine or chlorpheniramine from the body. Urinary excretion of chlorpheniramine is increased when the pH of the urine is acidic; however, acid diuresis is NOT recommended to enhance elimination in overdose, as the risks of acidemia and acute tubular necrosis in patients with rhabdomyolysis far outweigh any potential benefits.


How should I store and handle CODEINE AND CHLORPHENIRAMINE MALEATE ER?

CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is supplied as white to off-white, uncoated, standard round tablet, debossed with on one side and on the other side. Supplied in bottles of 100 tablets: NDC 0722-7184-01.Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Keep this and all medicine out of reach of children.CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is supplied as white to off-white, uncoated, standard round tablet, debossed with on one side and on the other side. Supplied in bottles of 100 tablets: NDC 0722-7184-01.Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Keep this and all medicine out of reach of children.CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is supplied as white to off-white, uncoated, standard round tablet, debossed with on one side and on the other side. Supplied in bottles of 100 tablets: NDC 0722-7184-01.Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Keep this and all medicine out of reach of children.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Codeine

Chlorpheniramine

Non-Clinical Toxicology
Patients with known hypersensitivity to codeine, chlorpheniramine or any of the inactive ingredients of CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE. Persons known to be hypersensitive to certain other opioids may exhibit cross-sensitivity to codeine.

See Table 1 for clinically significant drug interactions with naproxen.

Table 1: Clinically Significant Drug Interactions with naproxen

Drug/Laboratory Test Interactions

Respiratory depression and death have occurred in children who received codeine in the post-operative period following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine (i.e., multiple copies of the gene for cytochrome P450 isoenzyme 2D6 or high morphine concentrations). Deaths have also occurred in nursing infants who were exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers of codeine.

Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (gene duplications denoted as *1/*1xN or *1/*2xN). 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 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs. Data are not available for other ethnic groups. 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 regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience signs of overdose (such as extreme sleepiness, confusion, or shallow breathing).

Children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to the respiratory depressant effects of codeine that has been rapidly metabolized to morphine. CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE is contraindicated for post-operative pain management in all pediatric patients undergoing tonsillectomy and/or adenoidectomy

When prescribing codeine-containing drugs, healthcare professionals should choose the lowest effective dose for the shortest period of time and inform patients and caregivers about these risks and the signs of morphine overdose.

Use of codeine, an opioid, may result in the following:

Use of chlorpheniramine, an antihistamine, may result in:

Adverse reactions listed below have been reported in the literature for codeine and chlorpheniramine and may be expected to occur with CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE. Also included are events that occurred during clinical pharmacokinetic studies (in a total of 66 healthy adult volunteers with either single or multiple dose exposure) with CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE and judged by the investigator to be related to study treatment. Because these reactions may be 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.

Allergic

Body as a whole

Cardiovascular

Dermatological System

Endocrine System

Gastrointestinal System

Genitourinary System

Nervous System

Respiratory

Special Senses

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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).