OBREDON (Page 7 of 9)

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 2 basis, 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 2 basis).

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

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.

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

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