Hydrocodone Bitartrate and Ibuprofen (Page 4 of 11)

PRECAUTIONS

Masking of Inflammation and Fever

The pharmacological activity of hydrocodone bitartrate and ibuprofen in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.

Ophthalmological Effects

Blurred or diminished vision, scotomata, and changes in color vision have been reported with oral ibuprofen. Discontinue ibuprofen if a patient develops such complaints, and refer the patient for an ophthalmologic examination that includes central visual fields and color vision testing.

Information for Patients

Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Patients, families, or their caregivers should be informed of the following information before initiating therapy with hydrocodone bitartrate and ibuprofen and periodically during the course of ongoing therapy.

1. Storage and Disposal

Because of the risks associated with accidental ingestion, misuse and abuse, advise patients to store hydrocodone bitartrate and ibuprofen tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home (see WARNINGS, DRUG ABUSE AND DEPENDENCE). Inform patients that leaving hydrocodone bitartrate and ibuprofen tablets unsecured can pose a deadly risk to others in the home.

Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused hydrocodone bitartrate and ibuprofen tablets should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines.

2. Addiction, Abuse, and Misuse

Inform patients that the use of hydrocodone bitartrate and ibuprofen, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death (see WARNINGS: Addiction, Abuse, and Misuse). Instruct patients not to share hydrocodone bitartrate and ibuprofen with others and to take steps to protect hydrocodone bitartrate and ibuprofen from theft or misuse.

3. Life-Threatening Respiratory Depression

Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting hydrocodone bitartrate and ibuprofen or when the dosage is increased, and that it can occur even at recommended dosages.

Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose (see WARNINGS, Life Threatening Respiratory Depression).

4. Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose

Discuss with the patient and caregiver the availability of naloxone for the emergency treatment of opioid overdose, both when initiating and renewing treatment with hydrocodone bitartrate and ibuprofen. Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program) (see WARNINGS, Life-Threatening Respiratory Depression; DOSAGE AND ADMINISTRATION).

Educate patients and caregivers on how to recognize the signs and symptoms of an overdose.

Explain to patients and caregivers that naloxone’s effects are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered (see OVERDOSAGE).

If naloxone is prescribed, also advise patients and caregivers:

  • How to treat with naloxone in the event of an opioid overdose
  • To tell family and friends about their naloxone and to keep it in a place where family and friends can access it in an emergency
  • To read the Patient Information (or other educational material) that will come with their naloxone. Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do.

5. Accidental Ingestion

Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death (see WARNINGS: Life-Threatening Respiratory Depression).

6. Interactions with Benzodiazepines and Other CNS Depressants

Inform patients and caregivers that potentially fatal additive effects may occur if hydrocodone bitartrate and ibuprofen is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider (see WARNINGS: Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants, PRECAUTIONS: Drug Interactions).

7. Serotonin Syndrome

Inform patients that opioids 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 healthcare providers if they are taking, or plan to take serotonergic medications (see PRECAUTIONS: Drug Interactions).

8. MAOI Interaction

Inform patients to avoid taking hydrocodone bitartrate and ibuprofen while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking hydrocodone bitartrate and ibuprofen (see PRECAUTIONS: Drug Interactions).

9. Adrenal Insufficiency

Inform patients that opioids 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: Adrenal Insufficiency).

10. Important Administration Instructions

Instruct patients how to properly take hydrocodone bitartrate and ibuprofen. For the short-term (generally less than 10 days) management of acute pain, the recommended dose of hydrocodone bitartrate and ibuprofen is one tablet every 4 to 6 hours, as necessary. Inform patients that the dosage should not exceed 5 tablets in a 24-hour period (see DOSAGE AND ADMINISTRATION).

11. Important Discontinuation Instructions

In order to avoid developing withdrawal symptoms, instruct patients not to discontinue hydrocodone bitartrate and ibuprofen tablets without first discussing a tapering plan with the prescriber (see DOSAGE AND ADMINISTRATION).

12. Hypotension

Inform patients that hydrocodone bitartrate and ibuprofen 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: Severe Hypotension).

13. Anaphylaxis

Inform patients that anaphylaxis has been reported with ingredients contained in hydrocodone bitartrate and ibuprofen. Advise patients how to recognize such a reaction and when to seek medical attention (see CONTRAINDICATIONS,WARNINGS: Anaphylactic Reactions).

14. Pregnancy

Neonatal Opioid Withdrawal Syndrome

Inform female patients of reproductive potential that prolonged use of hydrocodone bitartrate and ibuprofen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated (see Boxed Warning,WARNINGS: Neonatal Opioid Withdrawal Syndrome,PRECAUTIONS: Pregnancy).

Embryo-Fetal Toxicity

Inform female patients of reproductive potential that hydrocodone bitartrate and ibuprofen can cause fetal harm and to inform the prescriber of a known or suspected pregnancy. Inform pregnant women to avoid use of hydrocodone bitartrate and ibuprofen and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with hydrocodone bitartrate and ibuprofen is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours (see WARNINGS: Fetal Toxicity, PRECAUTIONS: Pregnancy).

15. Lactation

Advise nursing mothers to monitor infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Instruct nursing mothers to seek immediate medical care if they notice these signs (see PRECAUTIONS: Nursing Mothers).

16. Infertility

Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible. Advise female patients of reproductive potential who desire pregnancy that NSAIDs, including hydrocodone bitartrate and ibuprofen, may be associated with a reversible delay in ovulation (see PRECAUTIONS: Carcinogenicity, Mutagenicity, Impairment of Fertility).

17. Driving or Operating Heavy Machinery

Inform patients that hydrocodone bitartrate and ibuprofen may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication (see WARNINGS: Risks of Driving and Operating Machinery).

18. Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention (see ADVERSE REACTIONS: Clinical Trials Experience).

19. Cardiovascular Thrombotic Events

Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately (see WARNINGS: Cardiovascular Thrombotic Events).

20. Gastrointestinal Bleeding, Ulceration, and Perforation

Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their healthcare provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation).

21. Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop hydrocodone bitartrate and ibuprofen and seek immediate medical therapy (see WARNINGS: Hepatotoxicity).

22. Heart Failure and Edema

Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur (see WARNINGS: Heart Failure and Edema).

23. Serious Skin Reactions, including DRESS

Advise patients to stop taking hydrocodone bitartrate and ibuprofen immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible (see WARNINGS).

24. Avoid Concomitant use of NSAIDs

Inform patients that the concomitant use of hydrocodone bitartrate and ibuprofen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation,PRECAUTIONS: Drug Interactions). Alert patients that NSAIDs may be present in “over the counter” medications for treatment of colds, fever, or insomnia.

25. Use of NSAIDS and Low-Dose Aspirin

Inform patients not to use low-dose aspirin concomitantly with hydrocodone bitartrate and ibuprofen until they talk to their healthcare provider (see PRECAUTIONS: Drug Interactions).

26. Ophthalmological Effects

Instruct patients to report any signs of blurred vision or other eye symptoms (see PRECAUTIONS: Ophthalmological Effects).

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