Drugplain

Hydromet 1.5 mg/5mL

hydrocodone bitartrate and homatropine methylbromide · SOLUTION · Actavis Pharma, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Hydromet is a solution containing hydrocodone bitartrate and homatropine methylbromide at 1.5 mg/5mL, taken oral. Manufactured by Actavis Pharma, Inc..

Key Facts

Brand Name
Hydromet
Generic Name
hydrocodone bitartrate and homatropine methylbromide
NDC Code (Product)
0472-1030
Manufacturer
Actavis Pharma, Inc.
Strength
1.5 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
ANDA088017
Marketing Start
09/30/2002

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

chronic kidney disease64 reports
acute kidney injury38 reports
renal failure35 reports
nausea29 reports
fatigue27 reports
pneumonia20 reports
vomiting19 reports
death18 reports
diarrhoea18 reports
drug ineffective18 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Hydrocodone bitartrate and homatropine methylbromide oral solution is indicated for the symptomatic relief of cough in adult 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, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve hydrocodone bitartrate and homatropine methylbromide oral solution for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough. Hydrocodone bitartrate and homatropine methylbromide oral solution is a combination of hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist, indicated for the symptomatic relief of cough in adult patients 18 years of age and older. ( 1 ) Limitations of Use Not indicated for pediatric patients under 18 years of age. ( 1 ) Because of t…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION A du l ts 18 years of age and older: 5 mL of the oral solution every 4 to 6 hours as needed; not to exceed 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 ) Do not rapidly reduce or abruptly discontinue in a physically-dependent patient. ( 2.3 ) 2.1 Important Dosage and Administration Instructions 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 [see Warnings and Precautions ( 5.5 )] . For prescriptions where a measuring device is …

Contraindications

4 CONTRAINDICATIONS Hydrocodone bitartrate and homatropine methylbromide oral solution is contraindicated for: All pediatric patients 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 oral solution [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 oral solution. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS No specific drug interaction studies have been conducted with hydrocodone bitartrate and homatropine methylbromide oral solution. 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 ) Mu s cle Relaxants : Avoid concomitant use. (7.7 ) D iuretics : Hydrocodone may reduce the efficacy of diuretics. Monitor for reduced effect. (7.8 ) A n ticholinergic drugs : Concurrent use may cause paralytic ileus. ( 5.9 , 7.9 ) 7.1 Alcohol Concomitant use of alcohol with hydrocodone bitartrate and homatropine methylbromide oral solution 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 oral solution therapy [see Warnings and Precautions ( 5.8 ), Clinical Pharmacology ( 12.3 )] . 7.2 Inhibitors of CYP3A…

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 reac…

Frequently Asked Questions

What is Hydromet used for?

Hydromet contains hydrocodone bitartrate and homatropine methylbromide. It is a solution taken oral. Consult your doctor for specific uses.

Is Hydromet a controlled substance?

Yes, Hydromet is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Hydromet?

The generic name for Hydromet is hydrocodone bitartrate and homatropine methylbromide. There are 8 other brand versions of hydrocodone bitartrate and homatropine methylbromide.

What is the NDC code for Hydromet 1.5 mg/5mL?

The NDC (National Drug Code) for Hydromet 1.5 mg/5mL is 0472-1030, listed by Actavis Pharma, Inc..

Product NDC

0472-1030

Package NDC

0472-1030-16

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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