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].

Use of hydrocodone bitartrate is associated with the following:

• Respiratory depression [see WARNINGS AND PRECAUTIONS and OVERDOSAGE]
• Drug dependence [see WARNINGS AND PRECAUTIONS and Drug Abuse And Dependence]
• Increased intracranial pressure [see WARNINGS AND PRECAUTIONS]
• Decreased mental alertness with impaired mental and/or physical abilities [see WARNINGS AND PRECAUTIONS]
• Paralytic ileus [see WARNINGS AND PRECAUTIONS]

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.

Included as part of the PRECAUTIONS section.

• If you have an allergy to Obredon or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have a cough with a lot of mucous.
• If you have a long-term cough caused by smoking or being around smoke, or lung problems like asthma or emphysema.
• If you have had a recent head injury, brain injury or tumor, or raised pressure in the brain.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking Obredon within 14 days of those drugs can cause very bad high blood pressure.
• If you are taking any of these drugs: Linezolid or methylene blue.

This is not a list of all drugs or health problems that interact with this medicine.

Tell the doctor and pharmacist about all of your child's drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take Obredon with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take Obredon for longer than you were told by your doctor.
• Avoid driving and doing other tasks or actions that call for alertness while you take this medicine. Talk with your doctor.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• This medicine may be habit-forming with long-term use.
• If you have been taking Obredon on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking this medicine all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
• Do not take Obredon with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
• Keep away from children. Accidental exposure may cause death. If a child takes this medicine by accident, get medical help right away.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Obredon (hydrocodone and guaifenesin).
• If you are 65 or older, use this medicine with care. You could have more side effects.
• The use of hydrocodone in children younger than 6 years has led to deadly breathing problems. Talk with the doctor.
• This medicine is not approved for use in children younger than 18 years of age. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Obredon while you are pregnant.
• Using this medicine for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.
• Tell your doctor if you are breast-feeding or plan to breast-feed. This medicine passes into breast milk and may harm your baby.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Obredon, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Obredon. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Obredon (hydrocodone and guaifenesin).

Review Date: October 4, 2017

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.

Hydrocodone Bitartrate

Hydrocodone Bitartrate is a centrally-acting opioid antitussive and analgesic . It is affected by light and occurs as fine white crystals or crystalline powder which is derived from the opium alkaloid, thebaine. Its chemical name is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5); and may be represented by the following structural formula:

C 18H 21NO 3 • C 4H 6O 6 • 2½H 2O MW= 494.50

Guaifenesin

Guaifenesin is an expectorant and occurs as a white powder. Its chemical name is 3-(2-methoxyphenoxy)-1,2- propanediol, and may be represented by the following structural formula:

C 10H 14O 4 MW= 198.22

Applies to guaifenesin / hydrocodone: oral capsule, oral liquid, oral solution, oral syrup, oral tablet, oral tablet extended release

Along with its needed effects, guaifenesin / hydrocodone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking guaifenesin / hydrocodone:

• Difficult or troubled breathing
• irregular, fast or slow, or shallow breathing
• pale or blue lips, fingernails, or skin

Some side effects of guaifenesin / hydrocodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• dizziness
• feeling of warmth
• headache
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• sleepiness or unusual drowsiness
• sudden sweating

Applies to guaifenesin / hydrocodone: oral capsule, oral liquid, oral syrup, oral tablet, oral tablet extended release

Nervous system

One study has suggested that the respiratory depression caused by hydrocodone may be of benefit in the treatment of dyspnea related to chronic obstructive pulmonary disease and restrictive lung disease. However, the potential for the precipitation of respiratory insufficiency makes such use of hydrocodone hazardous and such use should be undertaken, if at all, only with extreme caution.[Ref]

Nervous system side effects of guaifenesin have included dizziness and headache. Central nervous system adverse effects of hydrocodone have included mental depression, dizziness, lightheadedness, respiratory depression (which is sometimes fatal), stupor, delirium, somnolence, agitation, and dysphoria.[Ref]

Other

Other side effects of hydrocodone have included withdrawal symptoms, such as agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting and sweating, after either abrupt cessation or fast tapering of narcotic analgesics.[Ref]

Gastrointestinal

Gastrointestinal side effects of guaifenesin have included upset stomach and vomiting with higher than recommended doses. Doses recommended for expectoration are rarely associated with gastrointestinal upset. Gastrointestinal side effects of hydrocodone have included nausea, vomiting, constipation, and dry mouth.[Ref]

Genitourinary

Genitourinary side effects of hydrocodone have included ureteral spasm, spasm of vesicle sphincters, and urinary retention.[Ref]

Dermatologic

Dermatologic side effects of guaifenesin have included rash. Narcotic-induced rash has also been reported.[Ref]

Some side effects of Obredon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.