Hydrocodone Bitartrate and Homatropine Methylbromide 1.5 mg/1
Hydrocodone Bitartrate and Homatropine Methylbromide · TABLET · Novel Laboratories, Inc.
Hydrocodone Bitartrate and Homatropine Methylbromide is a tablet containing hydrocodone bitartrate and homatropine methylbromide at 1.5 mg/1, taken oral. Manufactured by Novel Laboratories, Inc..
Key Facts
- Brand Name
- Hydrocodone Bitartrate and Homatropine Methylbromide
- Generic Name
- Hydrocodone Bitartrate and Homatropine Methylbromide
- NDC Code (Product)
40032-118- Manufacturer
- Novel Laboratories, Inc.
- Strength
- 1.5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA091528
- Marketing Start
- 09/23/2014
Recall History
Novel Laboratories, Inc.
Failed Impurities/Degradation Specifications
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Torrent Pharma Inc
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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. Hydrocodone bitartrate and homatropine methylbromide is a combination of hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist, indicated for the symptomatic relief of cough in patients 18 years of age and older. (1) Limitations of Use (1) Not indicated for pediatric patients under 18 years of age. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve hydrocodone bitartrate…
Dosage & Administration
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. 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 [see Warnings and Precautions (5.5)] . For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate measuring device and can provi…
Contraindications
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)] . Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.4)] . Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.9)] . Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in hydrocodone bitartrate and homatropine methylbromide [see Adverse Reactions (6)] . Children younger than 6 years of age. (4) Significant respiratory depression. (4) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4) Known or suspected gastrointestinal obstruction, including paralytic ileus. (4) Hypersensitivity to hydrocodone, homatropine, or any of the inactive ingredients in hydrocodone bitartrate and homatropine methylbromide. (4)
Drug 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. (5.9, 7.9) 7.1 Alcohol Concomitant use of alcohol with hydrocodone bitartrate and homatropine methylbromide can result in an increase of hydrocodone plasma levels and potentially fatal overdose of hydrocodone. Instruct patients not to consume alcoholic beverages or use prescription or nonprescription products containing alcohol while on hydrocodone bitartrate and homatropine methylbromide therapy [see Warnings and Precautions (5.8), Clinical Pharmacology (12.3)] . 7.2 Inhibitors of CYP3A4 and CYP2D6 The concomitant use of hydrocodone bitartrate a…
Adverse Reactions
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 (5.10)] Obscured clinical course in patients with head injuries [see Warnings and Precautions (5.10)] Seizures [see Warnings and Precautions (5.11)] Severe hypotension [see Warnings and Precautions (5.12)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.13)] Adrenal insufficiency [see Warnings and Precautions (5.14)] The following adverse reactions have been identified during…
Frequently Asked Questions
What is Hydrocodone Bitartrate and Homatropine Methylbromide used for?
Hydrocodone Bitartrate and Homatropine Methylbromide contains Hydrocodone Bitartrate and Homatropine Methylbromide. It is a tablet taken oral. Consult your doctor for specific uses.
Is Hydrocodone Bitartrate and Homatropine Methylbromide a controlled substance?
Yes, Hydrocodone Bitartrate and Homatropine Methylbromide is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Hydrocodone Bitartrate and Homatropine Methylbromide?
The generic name for Hydrocodone Bitartrate and Homatropine Methylbromide is Hydrocodone Bitartrate and Homatropine Methylbromide. There are 1 other brand versions of Hydrocodone Bitartrate and Homatropine Methylbromide.
What is the NDC code for Hydrocodone Bitartrate and Homatropine Methylbromide 1.5 mg/1?
The NDC (National Drug Code) for Hydrocodone Bitartrate and Homatropine Methylbromide 1.5 mg/1 is 40032-118, listed by Novel Laboratories, Inc..
Other Hydrocodone Bitartrate and Homatropine Methylbromide Dosages
- Hydrocodone Bitartrate and Homatropine Methylbromide1.5 mg/5mL40032-810
- Hydrocodone Bitartrate and Homatropine Methylbromide1.5 mg/5mL64950-371
- Hydrocodone Bitartrate and Homatropine Methylbromide1.5 mg/164950-206
- Hydrocodone Bitartrate and Homatropine Methylbromide1.5 mg/110702-055
- Hydrocodone Bitartrate and Homatropine Methylbromide1.5 mg/5mL10702-150
- Hydrocodone Bitartrate and Homatropine Methylbromide1.5 mg/5mL0121-1036
- Hydrocodone Bitartrate and Homatropine Methylbromide1.5 mg/143386-118
Other Hydrocodone Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)