Hydrocodone Bitartrate And Homatropine Methylbromide
Generic Name: hydrocodone bitartrate and homatropine methylbromide
Brand Names:
Hydrocodone Bitartrate And Homatropine Methylbromide
11 DESCRIPTION Hydrocodone bitartrate and homatropine methylbromide tablets and oral solution contain hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each tablet or spoonful (5 mL) of hydrocodone bitartrate and homatropine methylbromide contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP for oral administration.
Overview
11 DESCRIPTION Hydrocodone bitartrate and homatropine methylbromide tablets and oral solution contain hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each tablet or spoonful (5 mL) of hydrocodone bitartrate and homatropine methylbromide contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP for oral administration.
Uses
1 INDICATIONS AND USAGE Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in patients 18 years of age and older. Limitations of Use : Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)] . Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)] . Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
Dosage
2 DOSAGE AND ADMINISTRATION Adults 18 years of age and older: One (1) tablet or 5 mL of the oral solution every 4 to 6 hours as needed; not to exceed six (6) tablets or 30 mL in 24 hours. (2.2) Measure hydrocodone bitartrate and homatropine methylbromide oral solution with an accurate milliliter measuring device. (2.1, 5.5) Do not increase the dose or dosing frequency. (2.1) Prescribe for the shortest duration consistent with treatment goals.(2.3) Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology. (2.3) Reevaluate patient prior to refilling. (2.3) 2.1 Important Dosage and Administration Instructions Administer hydrocodone bitartrate and homatropine methylbromide by the oral route only.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Addiction, abuse, and misuse [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.3)] Life-threatening respiratory depression [see Warnings and Precautions (5.2, 5.3, 5.4, 5.8), Overdosage (10)] Accidental overdose and death due to medication errors [see Warnings and Precautions (5.5)] Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions (5.6)] Interactions with benzodiazepines and other CNS depressants [see Warnings and Precautions (5.8), Drug Interactions (7.1, 7.4)] Paralytic ileus, gastrointestinal adverse reactions [see Warnings and Precautions (5.9)] Increased intracranial pressure [see Warnings and Precautions...
Interactions
7 DRUG INTERACTIONS No specific drug interaction studies have been conducted with hydrocodone bitartrate and homatropine methylbromide. Serotonergic Drugs : Concomitant use may result in serotonin syndrome. Discontinue if serotonin syndrome is suspected. (7.5) Monoamine Oxidase Inhibitors (MAOIs) : Can potentiate the effects of hydrocodone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping an MAOI. (7.6) Muscle Relaxants : Avoid concomitant use. (7.7) Diuretics : Hydrocodone may reduce the efficacy of diuretics. Monitor for reduced effect. (7.8) Anticholinergic drugs : Concurrent use may cause paralytic ileus.
Warnings
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME Addiction, Abuse, and Misuse Hydrocodone bitartrate and homatropine methylbromide exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can l ead to overdose and death. 5 WARNINGS AND PRECAUTIONS Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients : Monitor closely, particularly during initiation of therapy. (5.4) Activities requiring mental alertness : Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. (5.6) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors : Avoid use. May increase intracranial pressure and obscure the clinical course of head injuries. (5.10) Seizures in patients with seizure disorders : Monitor during therapy. (5.11) Severe hypotension : Monitor during initiation of therapy. Avoid use in patients with circulatory shock. 4 CONTRAINDICATIONS Hydrocodone bitartrate and homatropine methylbromide is contraindicated for: All children younger than 6 years of age [see Warnings and Precautions (5.2, 5.3), Use in Specific Populations (8.4)] . Significant respiratory depression [see Warnings and Precautions (5.2)] .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Hydrocodone bitartrate and homatropine methylbromide tablets, USP are available as white to off-white, round shaped biconvex tablets, debossed “K” above bisect “55” on one side and plain on the other side and is available in: NDC 10702-055-03 Bottles of 30 NDC 10702-055-09 Bottles of 90 NDC 10702-055-01 Bottles of 100 NDC 10702-055-10 Bottles of 1000 Store tabl...
Frequently Asked Questions
What is Hydrocodone Bitartrate And Homatropine Methylbromide used for?▼
1 INDICATIONS AND USAGE Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in patients 18 years of age and older. Limitations of Use : Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)] . Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)] . Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
What are the side effects of Hydrocodone Bitartrate And Homatropine Methylbromide?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Addiction, abuse, and misuse [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.3)] Life-threatening respiratory depression [see Warnings and Precautions (5.2, 5.3, 5.4, 5.8), Overdosage (10)] Accidental overdose and death due to medication errors [see Warnings and Precautions (5.5)] Decreased mental alertness with impaired mental and/or physical abilities [see Warnings and Precautions (5.6)] Interactions with benzodiazepines and other CNS depressants [see Warnings and Precautions (5.8), Drug Interactions (7.1, 7.4)] Paralytic ileus, gastrointestinal adverse reactions [see Warnings and Precautions (5.9)] Increased intracranial pressure [see Warnings and Precautions...
What are the important warnings for Hydrocodone Bitartrate And Homatropine Methylbromide?▼
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; MEDICATION ERRORS; CYTOCHROME P450 3A4 INTERACTION; CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; INTERACTION WITH ALCOHOL; NEONATAL OPIOID WITHDRAWAL SYNDROME Addiction, Abuse, and Misuse Hydrocodone bitartrate and homatropine methylbromide exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can l ead to overdose and death. 5 WARNINGS AND PRECAUTIONS Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients : Monitor closely, particularly during initiation of therapy. (5.4) Activities requiring mental alertness : Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. (5.6) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors : Avoid use. May increase intracranial pressure and obscure the clinical course of head injuries. (5.10) Seizures in patients with seizure disorders : Monitor during therapy. (5.11) Severe hypotension : Monitor during initiation of therapy. Avoid use in patients with circulatory shock. 4 CONTRAINDICATIONS Hydrocodone bitartrate and homatropine methylbromide is contraindicated for: All children younger than 6 years of age [see Warnings and Precautions (5.2, 5.3), Use in Specific Populations (8.4)] . Significant respiratory depression [see Warnings and Precautions (5.2)] .
Related Medications
Aconite Napd2, Baptisia Tincd1, China Offd1, Eupatorium Perfd1, Filipendula Ulmd1
aconite napd2, baptisia tincd1, china offd1, eupatorium perfd1, filipendula ulmd1
Uses Temporarily relieves occasional elevated body temperature, joint discomfort and swelling, body aches, nausea, and vomiting.* *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.
Arnica Montana, Echinacea Angustifolia, Arsenicum Album, Belladonna, Berberis Vulgaris, Borrelia, Chlamydia, Hydrastis Canadensis, Lachesis Mutus, Lymphogranuloma, Mercurius Solubilis, Oophorinum, Phosphorus, Pneumococcinum, Pyrogenium, Silicea Terra
arnica montana, echinacea angustifolia, arsenicum album, belladonna, berberis vulgaris, borrelia, chlamydia, hydrastis canadensis, lachesis mutus, lymphogranuloma, mercurius solubilis, oophorinum, phosphorus, pneumococcinum, pyrogenium, silicea terra
USES: Temporarily relieves fever, nausea, vomiting and diarrhea.**
Penicillamine
penicillamine
Antirheumatic Agent [EPC]
DESCRIPTION Penicillamine, USP is a chelating agent used in the treatment of Wilson’s disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy (see INDICATIONS ). It is 3-mercapto-D-valine. It is a white, or practically white, crystalline powder, freely soluble in water, slightly soluble in alcohol, and insoluble in ether, acetone, benzene, and carbon tetrachloride.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.