Hydrocodone Bitartrate and Chlorpheniramine Maleate

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Overview

What is Hydrocodone Bitartrate and Chlorpheniramine Maleate?

Hydrocodone bitartrate and chlorpheniramine maleate oral solution contains hydrocodone bitartrate (a semisynthetic centrally-acting opioid antitussive) and chlorpheniramine maleate (an antihistamine).

Each 5 mL dose of hydrocodone bitartrate and chlorpheniramine maleate oral solution contains: hydrocodone bitartrate, USP, 5 mg and chlorpheniramine maleate, USP, 4 mg.

Hydrocodone bitartrate and chlorpheniramine maleate oral solution also contains: citric acid anhydrous, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium saccharin, and sucrose.

Hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [ ( , )]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5); also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5); a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine; and may be represented by the following structural formula:

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

What does Hydrocodone Bitartrate and Chlorpheniramine Maleate look like?

What are the available doses of Hydrocodone Bitartrate and Chlorpheniramine Maleate?

Each 5 mL of hydrocodone bitartrate and chlorpheniramine maleate oral solution contains: hydrocodone bitartrate, USP, 5 mg and chlorpheniramine maleate, USP, 4 mg ( )

What should I talk to my health care provider before I take Hydrocodone Bitartrate and Chlorpheniramine Maleate?

How should I use Hydrocodone Bitartrate and Chlorpheniramine Maleate?

Hydrocodone bitartrate and chlorpheniramine maleate oral solution is a combination of hydrocodone bitartrate, an antitussive, and chlorpheniramine maleate, a histamine-1 (H ) receptor antagonist, indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold ( )

Limitations of Use:

Not indicated for pediatric patients under 18 years of age ( )

Administer Hydrocodone bitartrate and chlorpheniramine maleate oral solution by the oral route only. Measure hydrocodone bitartrate and chlorpheniramine maleate oral solution with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose .

What interacts with Hydrocodone Bitartrate and Chlorpheniramine Maleate?

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What are the warnings of Hydrocodone Bitartrate and Chlorpheniramine Maleate?

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What are the precautions of Hydrocodone Bitartrate and Chlorpheniramine Maleate?

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What are the side effects of Hydrocodone Bitartrate and Chlorpheniramine Maleate?

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What should I look out for while using Hydrocodone Bitartrate and Chlorpheniramine Maleate?

Hydrocodone bitartrate and chlorpheniramine maleate oral solution is contraindicated in:

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 . Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.

What might happen if I take too much Hydrocodone Bitartrate and Chlorpheniramine Maleate?

No human overdosage data are available for hydrocodone bitartrate and chlorpheniramine maleate oral solution.

Hydrocodone

Overdosage with hydrocodone 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.

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 hydrocodone bitartrate and chlorpheniramine maleate oral solution together with institution of appropriate therapy. Primary attention should be given to the reestablishment 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 which may result from overdosage or unusual sensitivity to opioids including hydrocodone. 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 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 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 benefit.

How should I store and handle Hydrocodone Bitartrate and Chlorpheniramine Maleate?

Dispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure.Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELYDispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure.Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELYDispense in a tight, light-resistant container as defined in USP/NF, with a child-resistant closure.Store at controlled room temperature between 20°-25°C (68°-77°F), see USP Controlled Room Temperature.KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELYHydrocodone bitartrate and chlorpheniramine maleate oral solution is supplied as a clear, colorless to light yellow, grape-flavored solution containing 5 mg hydrocodone bitartrate and 4 mg chlorpheniramine maleate in each 5 mL. It is available in:White HDPE bottles of one pint (480 mL): NDC 42192-612-16Store solution 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.Hydrocodone bitartrate and chlorpheniramine maleate oral solution is supplied as a clear, colorless to light yellow, grape-flavored solution containing 5 mg hydrocodone bitartrate and 4 mg chlorpheniramine maleate in each 5 mL. It is available in:White HDPE bottles of one pint (480 mL): NDC 42192-612-16Store solution 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.Hydrocodone bitartrate and chlorpheniramine maleate oral solution is supplied as a clear, colorless to light yellow, grape-flavored solution containing 5 mg hydrocodone bitartrate and 4 mg chlorpheniramine maleate in each 5 mL. It is available in:White HDPE bottles of one pint (480 mL): NDC 42192-612-16Store solution 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.Hydrocodone bitartrate and chlorpheniramine maleate oral solution is supplied as a clear, colorless to light yellow, grape-flavored solution containing 5 mg hydrocodone bitartrate and 4 mg chlorpheniramine maleate in each 5 mL. It is available in:White HDPE bottles of one pint (480 mL): NDC 42192-612-16Store solution 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.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone will depress respiration. Hydrocodone can produce miosis, euphoria, and physical and physiological dependence.

Chlorpheniramine is an antihistamine drug (H receptor antagonist) that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.

Non-Clinical Toxicology

Hydrocodone bitartrate and chlorpheniramine maleate oral solution is contraindicated in:

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 . Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.

Aminoglutethimide

Amphotericin B injection and potassium-depleting agents:

Anticholinesterases

Anticoagulants, oral

Antidiabetics

Antitubercular drugs

Cholestyramine

Cyclosporine

Digitalis glycosides

Estrogens, including oral contraceptives

Hepatic Enzyme Inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampin)

Hepatic Enzyme Inhibitors (e.g., ketoconazole, macrolide antibiotics such as erythromycin and troleandomycin)

Ketoconazole

Nonsteroidal anti-inflammatory agents (NSAIDs)

Skin tests

Concomitant use of opioids, including hydrocodone bitartrate and chlorpheniramine maleate oral solution, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol . Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol. Advise both patients and caregivers about the risks of respiratory depression and sedation if hydrocodone bitartrate and chlorpheniramine maleate oral solution is used with benzodiazepines, alcohol, or other CNS depressants .

Use of hydrocodone bitartrate, a semisynthetic opioid, may result in the following:

Use of chlorpheniramine, an antihistamine, may result in:

The following adverse reactions have been identified either during clinical trials of hydrocodone bitartrate and/or chlorpheniramine maleate or during their use post-approval. 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.

The most common adverse reactions of hydrocodone bitartrate and chlorpheniramine maleate oral solution include: Sedation, somnolence, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, nausea, psychic dependence, mood changes; blurred, double, or other visual disturbances; confusion, headache, euphoria, facial dyskinesia, feeling faint, lightheadedness, agitation, irritability, tremor.

Other adverse reactions include:

Respiratory: Dryness of the pharynx and respiratory passages, occasional tightness of the chest, laryngismus, wheezing, or troubled breathing.

Gastrointestinal System: Nausea and vomiting (more frequent in ambulatory than in recumbent patients), constipation, abdominal distension, abdominal pain, acute pancreatitis, dry mouth, dyspepsia, epigastric distress, and/or loss of appetite.

Genitourinary System: Ureteral spasm, spasm of vesicle sphincters, urinary retention, dysuria, urinary frequency, urinary hesitancy.

Dermatological System: Skin rash, pruritus, erythema, urticaria, excessive perspiration.

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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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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).

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