lortab- Hydrocodone Bitartrate

Ensure accuracy when prescribing, dispensing, and administering LORTAB ELIXIR. Dosing errors due to confusion between mg and mL, and other hydrocodone bitartrate and acetaminophen oral solutions of different concentrations can result in accidental overdose and death [see WARNINGS, DOSAGE AND ADMINISTRATION].

Addiction, Abuse, and Misuse
LORTAB ELIXIR exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing LORTAB ELIXIR, and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS].

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see WARNINGS]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to

complete a REMS-compliant education program,
counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,
emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and
consider other tools to improve patient, household, and community safety.his explanation buy lortab online
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of LORTAB ELIXIR. Follow patients for signs of respiratory depression, especially during initiation of LORTAB ELIXIR or following a dose increase [see WARNINGS].

Accidental Ingestion
Accidental ingestion of LORTAB ELIXIR, especially by children, can result in a fatal overdose of LORTAB ELIXIR [see WARNINGS].

Neonatal Opioid Withdrawal Syndrome
Prolonged use of LORTAB ELIXIR during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS].

Cytochrome P450 3A4 Interaction
The concomitant use of LORTAB ELIXIR with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Follow patients receiving LORTAB ELIXIR and any cytochrome P450 3A4 inhibitor or inducer for signs and symptoms of respiratory depression and sedation [see CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS; DRUG INTERACTIONS].

Hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see WARNINGS, OVERDOSAGE].

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 [see WARNINGS, PRECAUTIONS; DRUG INTERACTIONS].

Reserve concomitant prescribing of LORTAB ELIXIR and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and sedation.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: certain pain medications (mixed opioid agonist/antagonists such as pentazocine, nalbuphine, butorphanol), naltrexone.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, oxycodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Other medications can affect the removal of hydrocodone/acetaminophen from your body, which may affect how hydrocodone/acetaminophen works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), mifepristone, HIV medications (such as ritonavir), rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.