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Hydrocodone Bitartrate and Guaifenesin

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Overview

What is OBREDON?

OBREDON Oral Solution contains hydrocodone bitartrate (a centrally-acting opioid antitussive) and guaifenesin (an expectorant).

Each 5 mL dose of OBREDON Oral Solution contains: hydrocodone bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg.

OBREDON Oral Solution also contains: artificial raspberry flavor, citric acid, glycerin, methylparaben, potassium citrate, potassium sorbate, propylene glycol, propylparaben, purified water, and saccharin sodium.



What does OBREDON look like?



What are the available doses of OBREDON?

Oral Solution: Each 5 mL contains hydrocodone bitartrate, USP, 2.5 mg; and guaifenesin, USP, 200 mg.( )

What should I talk to my health care provider before I take OBREDON?

How should I use OBREDON?

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

Important Limitations of Use:

[see Pediatric Use ( )]


What interacts with OBREDON?

Sorry No Records found


What are the warnings of OBREDON?

Sorry No Records found


What are the precautions of OBREDON?

Sorry No Records found


What are the side effects of OBREDON?

Sorry No records found


What should I look out for while using OBREDON?

OBREDON Oral Solution is contraindicated in:

WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death . Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.


What might happen if I take too much OBREDON?

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.


How should I store and handle OBREDON?

Topiramate Tablets USP should be stored in tightly-closed containers at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.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 69166-523-16 (raspberry flavored)White HDPE bottles of 4 fl oz. (118 mL): NDC 69166-523-04 (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.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 69166-523-16 (raspberry flavored)White HDPE bottles of 4 fl oz. (118 mL): NDC 69166-523-04 (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.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 69166-523-16 (raspberry flavored)White HDPE bottles of 4 fl oz. (118 mL): NDC 69166-523-04 (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.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 69166-523-16 (raspberry flavored)White HDPE bottles of 4 fl oz. (118 mL): NDC 69166-523-04 (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.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 69166-523-16 (raspberry flavored)White HDPE bottles of 4 fl oz. (118 mL): NDC 69166-523-04 (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.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough center. In excessive doses, hydrocodone will depress respiration. Hydrocodone can produce miosis, euphoria, and physical and physiological dependence.

Guaifenesin is an expectorant the action of which promotes or facilitates the removal of secretions from the respiratory tract. The precise mechanism of action of guaifenesin is not known; however, it is thought to act as an expectorant by increasing the volume and reducing the viscosity of secretions in the trachea and bronchi. In turn, this may increase the efficiency of the cough reflex and facilitate removal of the secretions.

Non-Clinical Toxicology
OBREDON Oral Solution is contraindicated in:

WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death . Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.

Mineral oil interferes with the absorption of fat-soluble vitamins, including vitamin D preparations.

Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with ergocalciferol may cause hypercalcemia.

Concomitant use of opioids, including OBREDON Oral Solution, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol .

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol.

Advise both patients and caregivers about the risks of respiratory depression and sedation if OBREDON Oral Solution is used with benzodiazepines, alcohol, or other CNS depressants .

Use of hydrocodone bitartrate is associated with the following:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most common adverse reactions experienced by subjects taking a single dose of OBREDON Oral Solution in the clinical setting include the following: Central Nervous System: headache, dizziness, sedation (somnolence); Gastrointestinal System: nausea, diarrhea; Cardiovascular System: decreased blood pressure; Vascular System: hot flush.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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