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hydrocodone bitartrate, chlorpheniramine maleate, pseudoephedrine hydrochloride

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Overview

What is Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl?

Hydrocodone bitartrate, pseudoephedrine hydrochloride, and chlorpheniramine maleate oral solution contains hydrocodone bitartrate (a semisynthetic centrally-acting opioid antitussive), chlorpheniramine maleate (an antihistamine), and pseudoephedrine hydrochloride (an indirect sympathomimetic amine).

Each 5 mL dose of hydrocodone bitartrate, pseudoephedrine hydrochloride, and chlorpheniramine maleate oral solution contains: hydrocodone bitartrate, USP, 5 mg; chlorpheniramine maleate, USP, 4 mg; and pseudoephedrine hydrochloride, USP, 60 mg.

Hydrocodone bitartrate, pseudoephedrine hydrochloride, 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:

Pseudoephedrine hydrochloride is benzenemethanol, α-[1-(methylamino)ethyl]-, [-(*,*)] hydrochloride and has the following chemical structure:



What does Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl look like?



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

Each 5 mL of hydrocodone bitartrate, pseudoephedrine hydrochloride, and chlorpheniramine maleate oral solution contains: hydrocodone bitartrate, USP, 5 mg; chlorpheniramine maleate, USP, 4 mg; and pseudoephedrine hydrochloride, USP, 60 mg. ()

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

How should I use Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl?

Hydrocodone bitartrate, pseudoephedrine hydrochloride, and chlorpheniramine maleate oral solution is indicated for relief of cough and nasal congestion associated with the common cold in adults 18 years of age and older.

Administer hydrocodone bitartrate, pseudoephedrine hydrochloride, and chlorpheniramine maleate oral solution by the oral route only. Measure hydrocodone bitartrate, pseudoephedrine hydrochloride, 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, Chlorpheniramine Maleate, and Pseudoephedrine HCl?

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What are the warnings of Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl?

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What are the precautions of Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl?

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

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

Hydrocodone bitartrate, pseudoephedrine hydrochloride, 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, Chlorpheniramine Maleate, and Pseudoephedrine HCl?

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


How should I store and handle Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl?

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].Hydrocodone bitartrate, pseudoephedrine hydrochloride, and chlorpheniramine maleate oral solution is supplied as a clear, colorless to light yellow, grape-flavored solution containing 5 mg hydrocodone bitartrate, 4 mg chlorpheniramine maleate, and 60 mg pseudoephedrine hydrochloride in each 5 mL. It is available in:White HDPE bottles of one pint (480 mL): NDC 60258-876-16Hydrocodone bitartrate, pseudoephedrine hydrochloride, and chlorpheniramine maleate oral solution is supplied as a clear, colorless to light yellow, grape-flavored solution containing 5 mg hydrocodone bitartrate, 4 mg chlorpheniramine maleate, and 60 mg pseudoephedrine hydrochloride in each 5 mL. It is available in:White HDPE bottles of one pint (480 mL): NDC 60258-876-16


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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.

Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. Pseudoephedrine hydrochloride is recognized as an effective agent for the relief of nasal congestion due to upper respiratory allergies or common cold. Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines. It has the potential for excitatory side effects.

Non-Clinical Toxicology
Hydrocodone bitartrate, pseudoephedrine hydrochloride, 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.

Prazosin hydrochloride has been administered without any adverse drug interaction in limited clinical experience to date with the following: (1) cardiac glycosides – digitalis and digoxin; (2) hypoglycemics – insulin, chlorpropamide, phenformin, tolazamide, and tolbutamide; (3) tranquilizers and sedatives – chlordiazepoxide, diazepam, and phenobarbital; (4) antigout – allopurinol, colchicine, and probenecid; (5) antiarrhythmics – procainamide, propranolol (see however), and quinidine; and (6) analgesics, antipyretics and anti-inflammatories – propoxyphene, aspirin, indomethacin, and phenylbutazone.

Addition of a diuretic or other antihypertensive agent to prazosin hydrochloride has been shown to cause an additive hypotensive effect. This effect can be minimized by reducing the prazosin hydrochloride dose to 1 to 2 mg three times a day, by introducing additional antihypertensive drugs cautiously, and then by retitrating prazosin hydrochloride based on clinical response.

Concomitant administration of prazosin hydrochloride with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension (see ).

Concomitant use of opioids, including hydrocodone bitartrate, pseudoephedrine hydrochloride, 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, pseudoephedrine hydrochloride, 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 pseudoephedrine, a sympathomimetic amine, may result in the following:

Use of chlorpheniramine, an antihistamine, may result in:

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

Other adverse reactions include:

Cardiovascular: Fast, or slow heartbeat, hypertension, hypotension, orthostatic hypotension, palpitations, shock-like state, syncope.

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.

Endocrine System: Changes in glucose utilization, decreased lactation, early menses, glycosuria, gynecomastia, hypoglycemia, increased appetite, increased libido, pheochromocytoma stimulation.

Special Senses: labyrinthitis, tinnitus, vertigo, hypermetropia, lacrimation increased, mydriasis, photophobia.

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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

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).