Obredon

Name: Obredon

Dosing & Uses

Dosage Forms & Strengths

oral solution: Schedule II

  • (2.5mg/200mg)/5mL

Cough

Indicated for symptomatic relief of cough and to loosen mucus associated with the common cold/flu

10 mL (ie, 5mg hydrocodone/400 mg guaifenesin) PO q4-6hr; not to exceed 6 doses (60 mL) in 24 hr

<18 years: Safety and efficacy not established

Patient Handout

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Overdose

No human overdosage data are available for OBREDON Oral Solution.

Hydrocodone

Overdosage with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, dizziness, ringing in the ears, confusion, blurred vision, eye problems, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdose, apnea, circulatory collapse, cardiac arrest and death may occur.

Guaifenesin

Overdosage with guaifenesin can cause depression of the central nervous system. While present in polypharmacy overdoses, one case of overdose with only significant levels of guaifenesin has been reported. Symptoms included slurred speech, shallow respirations, reduced heart rate with rhythm sinus bradycardia, followed by asystole.

Treatment of overdosage consists of discontinuation of OBREDON Oral Solution together with institution of appropriate therapy. Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression which may result from overdosage or unusual sensitivity to opioids including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory depression. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.

Uses of Obredon

  • It is used to thin mucus so it can be taken from the body by coughing.
  • It is used to relieve coughing.

Indications and Usage for Obredon

Obredon Oral Solution is indicated for symptomatic relief of cough and to loosen mucus associated with the common cold.

Important Limitations of Use:
Not indicated for pediatric patients under 18 years of age [see Pediatric Use ( 8.4)] .

Drug Abuse and Dependence

Controlled Substance

Obredon Oral Solution is a Schedule II controlled prescription containing hydrocodone bitartrate and should be prescribed and administered with caution.

Abuse

Hydrocodone can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of Obredon Oral Solution, and it should be prescribed and administered with the same degree of caution appropriate to the use of other opioid drugs.

Abuse of guaifenesin has been linked to the formation of kidney stones composed of the major metabolite β-(2-methoxyphenoxy) lactic acid.

Dependence

Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, Obredon Oral Solution should be prescribed and administered with caution.

Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued oral opioid use, although some mild degree of physical dependence may develop after a few days of opioid therapy.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and reproductive studies have not been conducted with Obredon Oral Solution; 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. In 2 year studies in F344/N rats and B6C3F1 mice, codeine showed no evidence of tumorigenicity at dietary doses up to 70 and 400 mg/kg/day, respectively (approximately 23 and 65 times, respectively, the MRHDD of hydrocodone on a mg/m 2 basis).

Guaifenesin:

Carcinogenicity, genotoxicity, or reproductive toxicology studies have not been conducted with guaifenesin

Clinical Studies

Efficacy studies were not conducted with Obredon Oral Solution. Efficacy of Obredon Oral Solution is based on demonstration of bioequivalence to the individual comparator products [see CLINICAL PHARMACOLOGY ( 12.3)] .

How Supplied/Storage and Handling

Obredon Oral Solution is supplied as a clear, raspberry flavored liquid containing 2.5 mg hydrocodone bitartrate and 200 mg guaifenesin in each 5 mL. It is available in:

White HDPE bottles of 16 fl oz. (473 mL): NDC 69166-0523-16 (raspberry flavored)

White HDPE bottles of 4 fl oz. (118 mL): NDC 69166-0523-04 (raspberry flavored)

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.

Principal Display Panel-4 fl oz. Bottle

4 fl oz. Bottle Label

NDC 69166-0523-04

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

4 fl oz. (118 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 for:
Accelis Pharma
East Windsor, NJ 08520

400823 05/2015

Obredon 
hydrocodone bitartrate and guaifenesin solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69166-523
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 2.5 mg  in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
GLYCERIN  
METHYLPARABEN  
POTASSIUM CITRATE  
POTASSIUM SORBATE  
PROPYLENE GLYCOL  
PROPYLPARABEN  
WATER  
SACCHARIN SODIUM  
Product Characteristics
Color      Score     
Shape Size
Flavor RASPBERRY Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:69166-523-16 473 mL in 1 BOTTLE
2 NDC:69166-523-04 118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205474 12/30/2014
Labeler - NOVOTEC PHARMA LLC (079460110)
Establishment
Name Address ID/FEI Operations
Sovereign Pharmaceuticals, LLC 623168267 manufacture(69166-523)
Revised: 06/2015   NOVOTEC PHARMA LLC
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