HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE- hydrocodone bitartrate, homatropine methylbromide solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)

Available from:

Paddock Laboratories, LLC

INN (International Name):

HYDROCODONE BITARTRATE

Composition:

HYDROCODONE BITARTRATE 5 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 : Hydrocodone bitartrate and homatropine methylbromide oral solution is contraindicated for: Hydrocodone bitartrate and homatropine methylbromide oral solution is also contraindicated in patients with: Risk Summary Hydrocodone bitartrate and homatropine methylbromide oral solution is not recommended for use in pregnant women, including during or immediately prior to labor. Prolonged use of opioids during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.13), Clinical Considerations ]. There are no available data with hydrocodone bitartrate and homatropine methylbromide oral solution use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. Published studies with hydrocodone have reported inconsistent findings and have important methodological limitations (s

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

These highlights do not include all the information
needed to use HYDROCODONE BITARTRATE AND HOMATROPINE
METHYLBROMIDE ORAL SOLUTION® safely and effectively. See
full prescribing information for HYDROCODONE BITARTRATE AND
HOMATROPINE METHYLBROMIDE ORAL SOLUTION.Hydrocodone bitartrate
and homatropine methylbromide oral solution, for oral
administration, CIIInitial U.S. Approval: 1943

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HYDROCODONE BITARTRATE AND
HOMATROPINE METHYLBROMIDE- hydrocodone bitartrate, homatropine
methylbromide solution  Paddock
Laboratories, LLC
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Medication Guide
Hydrocodone bitartrate
(hye'' droe koe' done bye tar' trate) and homatropine
methylbromide (hoe mat' roe peen meth'' il broe' mide) oral
solution, for oral administration, C-II
What is the most important information
I should know about hydrocodone bitartrate and homatropine
methylbromide oral solution?
Hydrocodone bitartrate and homatropine
methylbromide oral solut

Read the complete document

Summary of Product characteristics

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE- HYDROCODONE
BITARTRATE, HOMATROPINE METHYLBROMIDE SOLUTION
PADDOCK LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYDROCODONE BITARTRATE AND
HOMATROPINE METHYLBROMIDE ORAL SOLUTION® SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
ORAL SOLUTION.
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION,
FOR ORAL ADMINISTRATION, CII
INITIAL U.S. APPROVAL: 1943
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
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
INDICATIONS AND USAGE
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 patients 18 years of age and
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE ORAL SOLUTION
EXPOSES USERS TO RISKS OF
ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH.
ASSESS PATIENT’S RISK BEFORE
PRESCRIBING AND MONITOR CLOSELY FOR THESE BEHAVIORS AND CONDITIONS.
(5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR WHEN USED IN PATIENTS AT HIGHER RISK. (5.2)
ACCIDENTAL INGESTION OF HYDROCODONE BITARTRATE AND HOMATROPINE
METHYLBROMIDE ORAL SOLUTION,
ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF HYDROCODONE.
(5.2)
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
HYDROCODONE BITARTRATE AND
HOMATROPINE METHYLBROMIDE ORAL SOLUTION. DOSING ERRORS CAN RESULT IN
ACCIDENTAL OVERDOSE AND
DEATH. (2,1, 5.5)
CONCOMITANT USE W