Overview
Tilidin 20x 50/4mg is a potent analgesic medication designed to manage moderate to severe pain. Manufactured by Hexal AG, a renowned pharmaceutical company, this product combines tilidine hydrochloride and naloxone hydrochloride to provide effective pain relief while minimizing the risk of opioid misuse.
Active Ingredients
- Tilidine Hydrochloride (50 mg per tablet)
- Mechanism of Action: Tilidine is a synthetic opioid analgesic. It works by binding to opioid receptors in the brain and spinal cord, altering the perception and response to pain.
- Purpose: Effective pain management for various conditions such as chronic pain, postoperative pain, and severe injury-related pain.
- Naloxone Hydrochloride (4 mg per tablet)
- Mechanism of Action: Naloxone is an opioid antagonist. It blocks the effects of opioids on the brain and is included to counteract the potential misuse and abuse of tilidine.
- Purpose: Prevents euphoria associated with opioid abuse, ensuring the medication is used solely for pain relief.
Indications
Tilidin 20x 50/4mg is indicated for the management of:
- Chronic pain conditions
- Acute pain episodes
- Postoperative pain
- Severe injuries requiring opioid-level pain relief
Dosage and Administration
- Standard Dosage: The recommended dosage is one tablet taken orally every 4 to 6 hours as needed for pain relief. The exact dosage and frequency should be determined by a healthcare provider based on the severity of the pain and the patient’s medical history.
- Administration: Tablets should be swallowed whole with a sufficient amount of water. Do not crush, chew, or dissolve the tablets to avoid tampering with the controlled-release mechanism.
Pharmacokinetics
- Absorption: Tilidine is rapidly absorbed from the gastrointestinal tract. It undergoes extensive first-pass metabolism in the liver to its active metabolite, nortilidine.
- Distribution: Tilidine and its metabolites are widely distributed throughout the body, including crossing the blood-brain barrier.
- Metabolism: Primarily metabolized in the liver to its active form, nortilidine.
- Excretion: Excreted mainly via the kidneys, with a half-life of approximately 3 to 5 hours for tilidine and its active metabolites.
Contraindications
- Hypersensitivity to tilidine, naloxone, or any of the excipients in the formulation.
- Patients with severe respiratory depression or obstructive airway disease.
- Acute intoxication with alcohol, hypnotics, analgesics, opioids, or psychotropic drugs.
- Patients with severe hepatic or renal impairment.
Warnings and Precautions
- Addiction and Abuse: While naloxone reduces the risk of abuse, tilidine remains an opioid and can be addictive. Use with caution in patients with a history of substance abuse.
- Respiratory Depression: High doses or concurrent use with other central nervous system depressants can cause significant respiratory depression.
- Head Injury and Increased Intracranial Pressure: Use with caution in patients with head injuries or conditions that may increase intracranial pressure.
- Liver and Kidney Function: Monitor liver and kidney function in patients with pre-existing conditions or those on long-term therapy.
Side Effects
Common side effects may include:
- Nausea and vomiting
- Dizziness and light-headedness
- Constipation
- Sweating
- Dry mouth
Serious side effects, which require immediate medical attention, include:
- Respiratory depression
- Severe hypotension
- Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)
Drug Interactions
- CNS Depressants: Concomitant use with other central nervous system depressants (e.g., benzodiazepines, alcohol) can enhance sedative effects and increase the risk of respiratory depression.
- MAO Inhibitors: Avoid use with MAO inhibitors or within 14 days of stopping such treatment due to the risk of serotonin syndrome.
- Anticholinergic Drugs: Concomitant use may increase the risk of urinary retention and severe constipation.
Storage
- Store at room temperature (15-30°C / 59-86°F).
- Keep out of reach of children.
- Protect from moisture and direct sunlight.
Packaging
Tilidin 20x 50/4mg is available in blister packs containing 20 tablets, ensuring easy and secure dispensing.
Manufacturer Information
Hexal AG
A reputable manufacturer in the pharmaceutical industry, Hexal AG is committed to providing high-quality medications designed to meet the needs of patients and healthcare providers. Their extensive research and rigorous quality control standards ensure the efficacy and safety of their products.
For more information or to report adverse effects, please contact Hexal AG’s customer service or refer to the included patient information leaflet.
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