Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride

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Overview

What is Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride?

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

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

Hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride oral solution also contains: citric acid anhydrous, glycerin, grape flavor, bitter mask 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:

Hydrocodone Bitartrate

CHN0 • CH0 • 2.5 H0

Molecular weight – 494.5

Chlorpheniramine maleate is 2-pyridinepropanamine, γ-(4-chlorophenyl)-,-dimethyl-,

()-2-butenedioate (1:1) and has the following chemical structure:

Chlorpheniramine Maleate

CHCIN • CH0

Molecular weight – 390.86

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

Pseudoephedrine Hydrochloride

CHNO • HCI

Molecular weight – 201.69

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

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

Each 5 mL of hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride 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 Hydrochloride?

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

Hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride 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, chlorpheniramine maleate and pseudoephedrine hydrochloride oral solution by the oral route only. Measure hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride 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 Hydrochloride?

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

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

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

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

Hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride oral solution is contraindicated in:

Patients with narrow angle glaucoma, urinary retention, severe hypertension, or severe coronary artery disease.

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

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

Pseudoephedrine:

Overdosage with sympathomimetics such as pseudoephedrine may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscle weakness and tenseness, anxiety, restlessness, and insomnia. Many patients can present a toxic psychosis with delusion and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsion, coma, and respiratory failure.

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 anticholingeric 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, chlorpheniramine maleate and pseudoephedrine hydrochloride 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, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride?

Protect OMNIPAQUE Imaging Bulk Package from exposure to sunlight.Store OMNIPAQUE Imaging Bulk Package at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Imaging Bulk Package may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect OMNIPAQUE Imaging Bulk Package from exposure to sunlight.Store OMNIPAQUE Imaging Bulk Package at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Imaging Bulk Package may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect OMNIPAQUE Imaging Bulk Package from exposure to sunlight.Store OMNIPAQUE Imaging Bulk Package at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Imaging Bulk Package may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect OMNIPAQUE Imaging Bulk Package from exposure to sunlight.Store OMNIPAQUE Imaging Bulk Package at controlled room temperature, 20°-25°C (68°- 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].OMNIPAQUE Imaging Bulk Package may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride 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 0574--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, chlorpheniramine maleate and pseudoephedrine hydrochloride 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 0574--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, chlorpheniramine maleate and pseudoephedrine hydrochloride 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 0574--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, chlorpheniramine maleate and pseudoephedrine hydrochloride 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 0574--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 (H1 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, chlorpheniramine maleate and pseudoephedrine hydrochloride oral solution is contraindicated in:

Patients with narrow angle glaucoma, urinary retention, severe hypertension, or severe coronary artery disease.

Changes in contraceptive effectiveness associated with co-administration of other products:

a. Anti-infective agents and anticonvulsants

Contraceptive effectiveness may be reduced when hormonal contraceptives are co-administered with antibiotics, anticonvulsants, and other drugs that increase the metabolism of contraceptive steroids. This could result in unintended pregnancy or breakthrough bleeding. Examples include rifampin, barbiturates, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, and griseofulvin.

b. Anti-HIV protease inhibitors

Several of the anti-HIV protease inhibitors have been studied with co-administration of oral combination hormonal contraceptives; significant changes (increase and decrease) in the plasma levels of the estrogen and progestin have been noted in some cases. The safety and efficacy of combination oral contraceptive products may be affected with co-administration of anti-HIV protease inhibitors. Healthcare providers should refer to the label of the individual anti-HIV protease inhibitors for further drug-drug interaction information.

c. Herbal products

Herbal products containing St. John’s Wort (hypericum perforatum) may induce hepatic enzymes (cytochrome P450) and p-glycoprotein transporter and may reduce the effectiveness of contraceptive steroids. This may also result in breakthrough bleeding.

Increase in plasma levels of estradiol associated with co-administered drugs:

Co-administration of atorvastatin and certain combination oral contraceptives containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels.

Changes in plasma levels of co-administered drugs:

Combination hormonal contraceptives containing some synthetic estrogens (e.g., ethinyl estradiol) may inhibit the metabolism of other compounds. Increased plasma concentrations of cyclosporine, prednisolone, and theophylline have been reported with concomitant administration of combination oral contraceptives. Decreased plasma concentrations of acetaminophen and increased clearance of temazepam, salicylic acid, morphine and clofibric acid, due to induction of conjugation have been noted when these drugs were administered with combination oral contraceptives.

Concomitant use of opioids, including hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride 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, chlorpheniramine maleate and pseudoephedrine hydrochloride 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, chlorpheniramine maleate and pseudoephedrine hydrochloride 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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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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