Overview
Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg / 500 mg are a powerful combination medication used to relieve moderate to severe pain. The combination of hydrocodone, an opioid analgesic, and acetaminophen, a non-opioid pain reliever, provides effective pain management for patients who require potent relief.
Active Ingredients
- Hydrocodone Bitartrate (5 mg): Hydrocodone is a semi-synthetic opioid derived from codeine. It works by binding to specific receptors in the brain and spinal cord, altering the perception and response to pain. Hydrocodone is known for its efficacy in managing severe pain, making it a preferred choice among healthcare providers for patients with significant pain conditions.
- Acetaminophen (500 mg): Also known as paracetamol, acetaminophen is a widely used over-the-counter pain reliever and fever reducer. It works by inhibiting the production of prostaglandins in the brain, which are chemicals that promote inflammation, pain, and fever. The combination of acetaminophen with hydrocodone enhances the overall analgesic effect, allowing for better pain control with lower doses of hydrocodone.
Indications
Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the relief of moderate to severe pain. They are often prescribed for conditions such as:
- Postoperative pain
- Injury-related pain
- Severe chronic pain conditions
- Cancer-related pain
- Severe pain that is not adequately managed by other pain relievers
Mechanism of Action
The combination of hydrocodone and acetaminophen provides a dual mechanism of action:
- Hydrocodone: As an opioid, hydrocodone binds to mu-opioid receptors in the central nervous system. This binding action inhibits the transmission of pain signals and alters the emotional response to pain, resulting in pain relief.
- Acetaminophen: This non-opioid analgesic works by inhibiting the cyclooxygenase (COX) enzyme in the brain, which is involved in the synthesis of prostaglandins. Prostaglandins play a key role in the sensation of pain and inflammation. By reducing prostaglandin production, acetaminophen helps alleviate pain and reduce fever.
Dosage and Administration
The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dose should not exceed six tablets. It is important to follow the prescribed dosage and not to exceed the recommended amount to avoid the risk of overdose and serious side effects.
Side Effects
Common side effects of Hydrocodone Bitartrate and Acetaminophen Tablets include:
- Drowsiness
- Dizziness
- Nausea
- Vomiting
- Constipation
- Lightheadedness
Severe side effects, although rare, may include:
- Respiratory depression
- Severe hypotension
- Serotonin syndrome
- Allergic reactions such as rash, itching, or swelling
Warnings and Precautions
- Addiction, Abuse, and Misuse: Hydrocodone is an opioid, which can be habit-forming. The medication should be used only by the person for whom it was prescribed, and it should be kept out of reach of others.
- Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with the use of Hydrocodone Bitartrate and Acetaminophen Tablets. Patients should be monitored for respiratory depression, especially during initiation or following a dose increase.
- Accidental Ingestion: Accidental ingestion of even one dose of Hydrocodone Bitartrate and Acetaminophen Tablets, especially by children, can result in a fatal overdose.
- Neonatal Opioid Withdrawal Syndrome: Prolonged use of Hydrocodone Bitartrate and Acetaminophen Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which can be life-threatening if not recognized and treated.
- 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.
Contraindications
- Patients with a known hypersensitivity to hydrocodone, acetaminophen, or any other component of the product.
- Patients with significant respiratory depression.
- Patients with acute or severe bronchial asthma or hypercarbia.
- Patients with known or suspected gastrointestinal obstruction, including paralytic ileus.
Drug Interactions
Hydrocodone Bitartrate and Acetaminophen Tablets may interact with other medications, which can alter how the drugs work or increase the risk of serious side effects. Some notable drug interactions include:
- CNS Depressants: Concurrent use with other central nervous system depressants (such as benzodiazepines, other opioids, alcohol, and illicit drugs) can increase the risk of profound sedation, respiratory depression, coma, and death.
- MAO Inhibitors: The use of Hydrocodone Bitartrate and Acetaminophen Tablets within 14 days following the use of monoamine oxidase inhibitors (MAOIs) can increase the risk of serotonin syndrome.
- Anticholinergic Drugs: Concurrent use with anticholinergic drugs can result in increased risk of urinary retention and severe constipation, which may lead to paralytic ileus.
Special Populations
- Pregnancy: Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome, which can be life-threatening if not recognized and treated. Hydrocodone Bitartrate and Acetaminophen Tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Lactation: Hydrocodone is present in breast milk. Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, nursing is not recommended during treatment with Hydrocodone Bitartrate and Acetaminophen Tablets.
- Pediatric Use: The safety and effectiveness in pediatric patients have not been established.
- Geriatric Use: Elderly patients may be more sensitive to the effects of this drug. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.
Storage and Handling
Store at 20° to 25°C (68° to 77°F) in a tight, light-resistant container. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP.
Conclusion
Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg / 500 mg offer a powerful and effective solution for managing moderate to severe pain. The combination of hydrocodone and acetaminophen provides a synergistic effect, enhancing pain relief while minimizing the required dose of opioid. However, due to the potential for addiction, misuse, and serious side effects, it is crucial to use this medication responsibly and under appropriate guidance.
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