OBREDON
These highlights do not include all the information needed to use OBREDON safely and effectively. See full prescribing information for OBREDON. OBREDON (hydrocodone bitartrate and guaifenesin) oral solution CII Initial U.S. Approval: 2014
f73fdec5-d330-4d8c-894b-d0bcf5490624
HUMAN PRESCRIPTION DRUG LABEL
Dec 15, 2023
Sovereign Pharmaceuticals, LLC
DUNS: 623168267
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocodone Bitartrate and Guaifenesin
PRODUCT DETAILS
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel-16 fl oz. Bottle
16 fl oz. Bottle Label
NDC -58716-433-16
OBREDON (hydrocodone bitartrate and guaifenesin) oral solution CII
2.5 mg/ 200 mg per 5 mL
Contains:
Hydrocodone Bitartrate ... 2.5 mg/5 mL
WARNING: May be habit forming.
Guaifenesin ..................... 200 mg/5 mL
Rx Only
16 fl oz. (473 mL)
**USUAL DOSAGE:**See Package Insert for Complete Dosage Recommendations.
Dispense in a tight, light-resistant container with a child-resistant closure.
WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
Manufactured by:
Sovereign Pharmaceuticals, LLC
06/2018
BOXED WARNING SECTION
INDICATIONS & USAGE SECTION
1 INDICATIONS AND USAGE
OBREDON is indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older.
Important 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, reserve OBREDON 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.
OBREDON is a combination of hydrocodone, an opioid agonist; and guaifenesin, an expectorant, indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older. ( 1)
Important 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 OBREDON 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 & ADMINISTRATION SECTION
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
Administer OBREDON by the oral route only
Always use an accurate milliliter measuring device when administering OBREDON 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 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 OBREDON because serious adverse events such as respiratory depression may occur with overdosage [ see Warnings and Precautions ( 5.2), Overdosage ( 10) ]. The dosage of OBREDON should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [ see Dosage and Administration ( 2.3), Warnings and Precautions ( 5.4) ].
2.2 Recommended Dosage
Adults and adolescents 18 years of age and older:10 mL every 4 to 6 hours, not to exceed 6 doses (60 mL) in 24 hours.
2.3 Monitoring, Maintenance, and Discontinuation of Therapy
Prescribe OBREDON for the shortest duration that is consistent with individual patient treatment goals [ see Warnings and Precautions ( 5.1) ].
Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy [ see Warnings and Precautions ( 5.2) ].
Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [ see Warnings and Precautions ( 5.4) ]. If a patient requires a refill, reevaluate the cause of the cough and assess the need for continued treatment with OBREDON, the relative incidence of adverse reactions, and the development of addiction, abuse, or misuse [ see Warnings and Precautions ( 5.1) ].
Do not abruptly discontinue OBREDON in a physically-dependent patient [ see Drug Abuse and Dependence ( 9.3) ]. When a patient who has been taking OBREDON regularly and may be physically dependent no longer requires therapy with OBREDON, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.
Adults 18 years of age and older:10 mL every 4 to 6 hours as needed, not to exceed 6 doses (60 mL) in 24 hours. ( 2.2)
- Measure OBREDON with an accurate milliliter measuring device. ( 2.1, 5.5)
- Do not increase the dose or dosing frequency. ( 2.1)
DOSAGE FORMS & STRENGTHS SECTION
3 DOSAGE FORMS AND STRENGTHS
Oral Solution: Each 5 mL contains hydrocodone bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg [ see Description ( 11) ].
Oral solution: Each 5 mL contains hydrocodone bitartrate 2.5 mg; and guaifenesin 200 mg.( 3)
NONCLINICAL TOXICOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity, mutagenicity, and fertility studies have not been conducted with OBREDON; however, published information is available for the individual active ingredients or related active ingredients.
Hydrocodone
Carcinogenicity studies were conducted with codeine, an opiate related to
hydrocodone. Two-year studies in F344/N rats and B6C3F1 mice were conducted to
assess the carcinogenic potential of codeine. No evidence of tumorigenicity
was observed in male and female rats at codeine dietary doses up to 70 and 80
mg/kg/day (approximately equivalent to 40 and 45 times the MRHD of hydrocodone
on a mg/m 2basis, respectively). No evidence of tumorigenicity was observed in
male and female mice at codeine dietary doses up to 400 mg/kg/day
(approximately equivalent to 110 times the MRHD of hydrocodone on a mg/m
2basis).
Mutagenicity studies with hydrocodone have not been conducted.
Fertility studies with hydrocodone have not been conducted.
Guaifenesin
Carcinogenicity, mutagenicity, and fertility studies with guaifenesin have not
been conducted
HOW SUPPLIED SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
OBREDON (hydrocodone bitartrate and guaifenesin) 2.5 mg/200 mg per 5mL is a
clear, raspberry flavored oral solution supplied as:
White HDPE bottles of 4 fl oz (118 mL): NDC 58716-433-04
White HDPE bottles of 16 fl oz (473 mL): NDC 58716-433-16
Store solution at 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.
PATIENT MEDICATION INFORMATION SECTION
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Addiction, Abuse, and Misuse
Inform patients that the use of OBREDON, even when taken as recommended, can
result in addiction, abuse, and misuse, which can lead to overdose and death [ see Warnings and Precautions ( 5.1) ]. Instruct patients not to share OBREDON
with others and to take steps to protect OBREDON Oral Solution from theft or
misuse.
Important Dosing and Administration Instructions
Instruct patients how to measure and take the correct dose of OBREDON. Advise
patients to measure OBREDON with an accurate milliliter measuring device.
Patients should be informed that a household teaspoon is not an accurate
measuring device and could lead to overdosage. Advise patients to ask their
pharmacist to recommend an appropriate measuring device and for instructions
for measuring the correct dose [ see Dosage and Administration ( 2.1), Warnings and Precautions ( 5.5) ]. Advise patients not to increase the dose or
dosing frequency of OBREDON because serious adverse events such as respiratory
depression may occur with overdosage [ see Warnings and Precautions ( 5.2), Overdosage ( 10) ].
Life-Threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression,
including information that the risk is greatest when starting OBREDON and that
it can occur even at recommended dosages [ see Warnings and Precautions ( 5.2)] . Advise patients how to recognize respiratory depression and to seek
medical attention if breathing difficulties develop.
Accidental Ingestion
Inform patients that accidental ingestion, especially by children, may result
in respiratory depression or death [ see Warnings and Precautions ( 5.2) ].
Instruct patients to take steps to store OBREDON securely and to properly
dispose of unused OBREDON in accordance with the local state guidelines and/or
regulations.
Activities Requiring Mental Alertness
Advise patients to avoid engaging in hazardous tasks that require mental
alertness and motor coordination such as operating machinery or driving a
motor vehicle as OBREDON may produce marked drowsiness [ see Warnings and Precautions ( 5.6) ].
Interactions with Benzodiazepines and Other Central Nervous System
Depressants, Including Alcohol
Inform patients and caregivers that potentially fatal additive effects may
occur if OBREDON is used with benzodiazepines or other CNS depressants,
including alcohol. Advise patients to avoid concomitant use of OBREDON with
benzodiazepines or other CNS depressants and instruct patients not to consume
alcoholic beverages, as well as prescription and over-the-counter products
that contain alcohol, during treatment with OBREDON [ see Warnings and Precautions ( 5.8), Drug Interactions ( 7.1, 7.4) ].
Constipation
Advise patients of the potential for severe constipation [ see Warnings and Precautions ( 5.9), Adverse Reactions ( 6) ].
Anaphylaxis
Inform patients that anaphylaxis has been reported with ingredients contained
in OBREDON. Advise patients how to recognize such a reaction and when to seek
medical attention [ see Contraindications ( 4), Adverse Reactions ( 6) ].
MAOI Interaction
Inform patients not to take OBREDON while using or within 14 days of stopping
any drugs that inhibit monoamine oxidase. Patients should not start MAOIs
while taking OBREDON [ see Drug Interactions ( 7.6) ].
Hypotension
Inform patients that OBREDON may cause orthostatic hypotension and syncope.
Instruct patients how to recognize symptoms of low blood pressure and how to
reduce the risk of serious consequences should hypotension occur (e.g., sit or
lie down, carefully rise from a sitting or lying position) [ see Warnings and Precautions ( 5.12) ].
Pregnancy
Advise patients that use of OBREDON is not recommended during pregnancy [ see Use in Specific Populations ( 8.1) ].
Neonatal Opioid Withdrawal Syndrome
Inform female patients of reproductive potential that use of OBREDON during
pregnancy can result in neonatal opioid withdrawal syndrome, which may be
life-threatening if not recognized and treated [ see Warnings and Precautions ( 5.13), Use in Specific Populations ( 8.1) ].
Embryo-Fetal Toxicity
Inform female patients of reproductive potential that OBREDON can cause fetal
harm and to inform their healthcare provider of a known or suspected pregnancy
[ see Use in Specific Populations ( 8.1) ].
Lactation
Advise women that breastfeeding is not recommended during treatment with
OBREDON [ see Use in Specific Populations ( 8.2) ].
Infertility
Inform patients that chronic use of opioids, such as hydrocodone, a component
of OBREDON, may cause reduced fertility. It is not known whether these effects
on fertility are reversible [ see Use in Specific Populations ( 8.3) ].
Adrenal Insufficiency
Inform patients that OBREDON could cause adrenal insufficiency, a potentially
life-threatening condition. Adrenal insufficiency may present with non-
specific symptoms and signs such as nausea, vomiting, anorexia, fatigue,
weakness, dizziness, and low blood pressure. Advise patients to seek medical
attention if they experience a constellation of these symptoms [ see Warnings and Precautions ( 5.14) ].
Serotonin Syndrome
Inform patients that OBREDON could cause a rare but potentially life-
threatening condition resulting from concomitant administration of
serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to
seek medical attention right away if symptoms develop. Instruct patients to
inform their physicians if they are taking, or plan to take serotonergic
medications. [ see Adverse Reactions ( 6), Drug Interactions ( 7.5) ].
Disposal of Unused OBREDON
Advise patients to properly dispose of unused OBREDON. Advise patients to
throw the drug in the household trash following these steps. 1) Remove them
from their original containers and mix them with an undesirable substance,
such as used coffee grounds or kitty litter (this makes the drug less
appealing to children and pets, and unrecognizable to people who may
intentionally go through the trash seeking drugs). 2) Place the mixture in a
sealable bag, empty can, or other container to prevent the drug from leaking
or breaking out of a garbage bag, or to dispose of in accordance with local
state guidelines and/or regulations.
Manufactured by:
Sovereign Pharmaceuticals, LLC
Fort Worth, TX 76118
U.S. Patent numbers 9,549,907; 9,808,431; 10,105,324
SPL MEDGUIDE SECTION
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Medication Guide | |
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What is the most important information I should know about OBREDON? OBREDON is not for children under 18 years of age. OBREDON can cause serious side effects, including: ***Addiction, abuse and misuse.**Taking OBREDON or other medicines that contain an opioid can cause addiction, abuse and misuse, which can lead to overdose and death. This can happen even if you take OBREDON exactly as prescribed by your healthcare provider. Your risk of addiction, abuse, and misuse is increased if you or a family member has a history of drug or alcohol abuse or addiction, or mental health problems.
*Do notshare your OBREDON with other people.
* Keep OBREDON in a safe place away from children.
***Life-threatening breathing problems (respiratory depression).**OBREDON can cause breathing problems (respiratory depression) that can happen at any time during treatment and can lead to death. Your risk of breathing problems is greatest when you first start taking OBREDON, are taking other medicines that can cause breathing problems, have certain lung problems, are elderly or have certain other health problems.**Children are at higher risk for respiratory depression.**Breathing problems can happen even if you take OBREDON exactly as prescribed by your healthcare provider. ***Keep OBREDON in a safe place away from children.**Accidental use of even 1 dose of OBREDON, especially by a child, is a medical emergency and can cause breathing problems (respiratory depression) which can lead to death. If a child accidentally takes OBREDON, get emergency medical help right away.
***Overdose and death due to medicine dosing errors.**Overdose and death can happen if you measure the wrong dose of OBREDON. Always use an accurate milliliter (mL) measuring device to measure the correct amount of OBREDON.Do notuse a household teaspoon to measure your medicine. You may accidentally take too much. You can ask your pharmacist for the measuring device you should use and how to measure the correct dose.
*Breathing problems (respiratory depression) that can lead to death and opioid withdrawalcan happen if you start taking or stop taking other medicines while taking OBREDON, including:
* certain antibiotics
* certain medicines to treat a fungal infection
* certain medicines to treat Human Immunodeficiency Virus (HIV)-1 infection, Acquired Immune Deficiency Syndrome (AIDS), or Hepatitis C
* rifampin
* carbamazepine
* phenytoin *Severe drowsiness, breathing problems (respiratory depression), coma and deathcan happen in people who take OBREDON with benzodiazepines or other central nervous system depressants, including alcohol. *Do nottake benzodiazepines or any medicine that can cause drowsiness or sleepiness during treatment with OBREDON. *Do notdrink alcohol or take prescription or over-the-counter medicines that contain alcohol during treatment with OBREDON. ***Opioid withdrawal in a newborn.**Use of OBREDON during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. You should not take OBREDON if you are pregnant. Tell your healthcare provider right away if you are pregnant or think you may be pregnant. | |
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What is OBREDON?
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Who should not take OBREDON? OBREDON is not for children under 18 years of age.See“What is the most important information I should know about OBREDON?” Do not take OBREDON if you:
Ask your healthcare provider if you have any questions about this information. | |
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Before you take OBREDON, tell your healthcare provider about all of your medical conditions, including if you:
**Tell your healthcare provider about all the medicines you take,**including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking OBREDON with certain other medicines can cause side effects or affect how well OBREDON or the other medicines work. Do not start or stop taking other medicines without talking to your healthcare provider. Especially tell your healthcare provider if you:
Ask your healthcare provider if you are not sure if you take one of these medicines. | |
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How should I take OBREDON? *See “What is the most important information I should know about OBREDON?”
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What should I avoid while taking OBREDON?
Avoid the use of OBREDON if you:
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What are the possible side effects of OBREDON? OBREDON can cause serious side effects, including:
The most common side effects of OBREDON include:
These are not all the possible side effects of OBREDON. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |
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How should I store OBREDON?
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How should I dispose of OBREDON? Remove unused OBREDON from the container and mix it with an undesirable, non- toxic substance such as cat litter or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw it away in the household trash. You can also follow your state or local guidelines on how to safely throw away OBREDON. | |
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General information about the safe and effective use of OBREDON. | |
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What are the ingredients in OBREDON? **Active ingredients:**hydrocodone bitartrate and guaifenesin **Inactive ingredients:**artificial raspberry flavor, citric acid, glycerin, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, and saccharin sodium. Manufactured by: Sovereign Pharmaceuticals, LLC, Fort Worth, TX 76118 | |
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This Medication Guide has been approved by the U.S. Food and Drug Administration. |
Revised: April 2018 |