Author: James Anderson

Lortab Oral Solution: Package Insert Prescribing Info

Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Hydrocodone bitartrate oral solution can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing hydrocodone bitartrate and acetaminophen oral solution in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE). There are no standard opioid tapering schedules that are suitable for all patients.

  1. The dose of this medication will be different for different patients.
  2. If you think there has been an overdose, call your poison control center or get medical care right away.
  3. Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses.
  4. Hydrocodone works in the brain to change how your body feels and responds to pain.
  5. Do not await acetaminophen assay results before initiating treatment.

Contact local state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Hydrocodone Bitartrate and Acetaminophen Oral Solution. Addiction can occur at recommended dosages and if the drug is misused or abused. Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease absorption if acetaminophen is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected.

Overdose

A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic see WARNINGS/Withdrawal, DRUG ABUSE AND DEPENDENCE. Titrate the dosage of Hydrocodone Bitartrate and Acetaminophen Oral Solution slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression see WARNINGS. 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. Accidental ingestion of even one dose of Hydrocodone Bitartrate and Acetaminophen Oral Solution especially by children, can result in respiratory depression and death due to an overdose of Hydrocodone Bitartrate and Acetaminophen Oral Solution. 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 PRECAUTIONS, Information for Patients. Inform patients that LORTAB ELIXIR could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs.

Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose

If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Inform patients and caregivers of this potential interaction, educate them on the signs and symptoms of respiratory depression (including sedation).

CLINICAL PHARMACOLOGY

Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction. If concomitant use is necessary, consider increasing the Hydrocodone Bitartrate and Acetaminophen Oral Solution dosage until stable drug effects are achieved. If a CYP3A4 inducer is discontinued, consider Hydrocodone Bitartrate and Acetaminophen Oral Solution dosage reduction and evaluate patients at frequent intervals for signs of respiratory depression and sedation. Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. This condition differs from tolerance, which is the need for increasing doses of opioids to maintain a defined effect see Dependence.

Patients receiving narcotics, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and acetaminophen oral solution may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Get medical help right away if you take too much acetaminophen (overdose), even if you feel well.

Lortab Oral Solution Dosage and Administration

Hydrocodone bitartrate and acetaminophen oral solution contains 7.5 mg of hydrocodone bitartrate and 325 mg of acetaminophen per 15 mL. Initiate treatment with Hydrocodone Bitartrate and Acetaminophen Oral Solution at a dose of 15 milliliters (equivalent to 7.5 mg hydrocodone bitartrate ) every 4 to 6 hours as needed for pain. Titrate the dose based upon the individual patient’s response to their initial dose of Hydrocodone Bitartrate and Acetaminophen Oral Solution.

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Hydrocodone Bitartrate and Acetaminophen Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Hydrocodone is a semi-synthetic opioid agonist with relative selectivity for the mu-opioid (µ) receptor, although it can interact with other opioid receptors at higher doses. It is of utmost importance that the dose of LORTAB ELIXIR be administered accurately. Given the variability of the household spoon measure it is strongly recommended that caregivers obtain and use a calibrated measuring device. Initiate the dosing regimen for each patient individually; taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse see WARNINGS.

If you suspect that you or someone else may have taken more than the prescribed dose of this medicine, contact your local poison control center or emergency room immediately. Following a 10 mg oral dose of hydrocodone administered to five adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone, acetaminophen, or any other component of this product. Meticulous attention should be given to maintaining adequate pulmonary ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis may be considered. If hypoprothrombinemia occurs due to acetaminophen overdose, vitamin K should be administered intravenously.

Lortab 2.5 Mg-500 Mg Tablet – Uses, Side Effects, and More

Because respiratory depression may be greater than otherwise expected, decrease the dosage of Hydrocodone Bitartrate and Acetaminophen Oral Solution and/or the muscle relaxant as necessary. Follow such patients for signs of sedation and respiratory depression, particularly when initiating therapy with hydrocodone and acetaminophen tablets and oral solution. Hydrocodone Bitartrate and Acetaminophen Oral Solution may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) see PRECAUTIONS; Drug Interactions.