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Hydrocodone bitartrate, homatropine methylbromide
Overview
What is Hydrocodone Bitartrate and Homatropine Methylbromide?
Hydrocodone bitartrate and homatropine methylbromide oral solution contains hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist.
Each spoonful (5 mL) of hydrocodone bitartrate and homatropine methylbromide oral solution contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP, for oral administration.
Hydrocodone bitartrate and homatropine methylbromide oral solution also contains: black currant flavor, citric acid, FD&C Red #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol solution and sucrose.
Hydrocodone Bitartrate
The chemical name for hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17- methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure:
Homatropine Methylbromide
The chemical name for homatropine methylbromide is 8-Azoniabicyclo [3.2.1]octane, 3-[(hydroxyphenyl-acetyl)oxy] -8,8-dimethyl-,bromide, endo-. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure:
What does Hydrocodone Bitartrate and Homatropine Methylbromide look like?
What are the available doses of Hydrocodone Bitartrate and Homatropine Methylbromide?
Oral solution: Each 5 mL contains hydrocodone bitartrate 5 mg; and homatropine methylbromide 1.5 mg, (3)
What should I talk to my health care provider before I take Hydrocodone Bitartrate and Homatropine Methylbromide?
How should I use Hydrocodone Bitartrate and Homatropine Methylbromide?
Hydrocodone bitartrate and homatropine methylbromide oral solution is indicated for the symptomatic relief of cough in patients 18 years of age and older.
Important Limitations of Use
Administer hydrocodone bitartrate and homatropine methylbromide oral solution by the oral route only.
Always use an accurate milliliter measuring device when administering hydrocodone bitartrate and homatropine methylbromide oral solution to ensure that the dose is measured and administered accurately. A household teaspoon is not an accurate measuring device and could lead to overdosage []. For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. Do not overfill. Rinse the measuring device with water after each use.
Advise patients not to increase the dose or dosing frequency of hydrocodone bitartrate and homatropine methylbromide oral solution because serious adverse events such as respiratory depression may occur with overdosage []. The dosage of hydrocodone bitartrate and homatropine methylbromide oral solution should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [].
What interacts with Hydrocodone Bitartrate and Homatropine Methylbromide?
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What are the warnings of Hydrocodone Bitartrate and Homatropine Methylbromide?
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What are the precautions of Hydrocodone Bitartrate and Homatropine Methylbromide?
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What are the side effects of Hydrocodone Bitartrate and Homatropine Methylbromide?
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What should I look out for while using Hydrocodone Bitartrate and Homatropine Methylbromide?
Hydrocodone bitartrate and homatropine methylbromide oral solution is contraindicated for:
Hydrocodone bitartrate and homatropine methylbromide oral solution is also contraindicated in patients with:
What might happen if I take too much Hydrocodone Bitartrate and Homatropine Methylbromide?
Clinical Presentation
Hydrocodone
Acute overdose 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, constricted pupils, and, in some cases, pulmonary edema, bradycardia, partial or complete airway obstruction, atypical snoring, hypotension, circulatory collapse, cardiac arrest, and death.
Hydrocodone 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 [].
Homatropine
Homatropine has broad, nonspecific anticholinergic / antimuscarinic activity that similar to, although less potent than, atropine. Overdosage of homatropine can cause mydriasis and cycloplegia (fixed and dilated pupils), dry mouth and eyes, decreased sweating, hyperthermia, flushing, headache, visual blurring, gastrointestinal symptoms, constipation, urinary retention, tachycardia and palpitations, anxiety, restlessness, agitation, hallucinations, convulsions, cardiac arrhythmias and coma. Anticholinergic agents can also precipitate acute narrow angle glaucoma.
Treatment of Overdose
Treatment of overdosage is driven by the overall clinical presentation, and consists of discontinuation of hydrocodone bitartrate and homatropine methylbromide oral solution together with institution of appropriate therapy. Give primary attention to the reestablishment of adequate respiratory exchange through provision of a patent and protected airway and the institution of assisted or controlled ventilation. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques. Gastric emptying may be useful in removing unabsorbed drug.
The opioid antagonists, naloxone and nalmefene, are specific antidotes for respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to hydrocodone overdose, administer an opioid antagonist. An antagonist should not be administered in the absence of clinically significant respiratory depression. Because the duration of opioid reversal is expected to be less than the duration of action of hydrocodone in hydrocodone bitartrate and homatropine methylbromide oral solution, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.
Hemodialysis is not routinely used to enhance the elimination of hydrocodone from the body.
Physostigmine may be used parenterally for the treatment of the signs and symptoms of homatropine toxicity.
How should I store and handle Hydrocodone Bitartrate and Homatropine Methylbromide?
Protect from light and moisture. [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Store the hospital unit-dose blister packages in the carton until contents have been used.Protect from light and moisture. [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Store the hospital unit-dose blister packages in the carton until contents have been used.Protect from light and moisture. [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.Store the hospital unit-dose blister packages in the carton until contents have been used.Hydrocodone bitartrate and homatropine methylbromide oral solution is available as a clear red colored oral solution in:Store oral solution at controlled room temperature 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. Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed. Hydrocodone bitartrate and homatropine methylbromide oral solution is available as a clear red colored oral solution in:Store oral solution at controlled room temperature 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. Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed. Hydrocodone bitartrate and homatropine methylbromide oral solution is available as a clear red colored oral solution in:Store oral solution at controlled room temperature 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. Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed. Hydrocodone bitartrate and homatropine methylbromide oral solution is available as a clear red colored oral solution in:Store oral solution at controlled room temperature 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. Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Hydrocodone
Hydrocodone is an opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act centrally on the cough center. In excessive doses, hydrocodone will depress respiration.
Homatropine
Homatropine is an anticholinergic that inhibits activity of the muscarinic acetylcholine receptor with less potency than atropine.
Non-Clinical Toxicology
Hydrocodone bitartrate and homatropine methylbromide oral solution is contraindicated for:Hydrocodone bitartrate and homatropine methylbromide oral solution is also contraindicated in patients with:
Hydrocodone bitartrate and homatropine methylbromide oral solution contains hydrocodone, a Schedule II controlled substance. As an opioid, hydrocodone bitartrate and homatropine methylbromide oral solution exposes users to the risks of addiction, abuse, and misuse []which can lead to overdose and death []
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed hydrocodone bitartrate and homatropine methylbromide oral solution. Addiction can occur at recommended dosages and if the drug is misused or abused. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression).
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing hydrocodone bitartrate and homatropine methylbromide oral solution. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug []. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
The following serious adverse events are described, or described in greater detail, in other sections:
The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of hydrocodone and/or homatropine. 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 to hydrocodone bitartrate and homatropine methylbromide oral solution include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation.
Other reactions include:
Anaphylaxis
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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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