Overview:
Tilidin 20x 150/12mg is a powerful analgesic medication manufactured by Sandoz, designed to manage moderate to severe pain. It combines Tilidine, a synthetic opioid, with Naloxone to mitigate the potential for abuse.
Composition:
Active Ingredients:
- Tilidine Hydrochloride: 150 mg
- Naloxone Hydrochloride: 12 mg
Inactive Ingredients:
- Microcrystalline cellulose
- Lactose monohydrate
- Magnesium stearate
- Croscarmellose sodium
- Povidone
- Other excipients for tablet formulation
Mechanism of Action:
Tilidine is a centrally acting opioid analgesic. It works by binding to the opioid receptors in the brain and spinal cord, which alters the perception and response to pain.
Naloxone, an opioid antagonist, is included to counteract the potential euphoric effects of Tilidine, thereby reducing the risk of misuse and addiction. Naloxone acts by blocking the opioid receptors, ensuring that the analgesic effect of Tilidine is achieved without the typical opioid-induced euphoria.
Indications:
Tilidin 20x 150/12mg is indicated for the management of:
- Moderate to severe acute pain
- Chronic pain conditions where other pain management options have been inadequate
- Post-operative pain
Dosage and Administration:
Dosage:
- The typical adult dose is one tablet taken every 6 to 8 hours, as needed for pain relief.
- The maximum daily dose should not exceed four tablets (600 mg of Tilidine and 48 mg of Naloxone).
Administration:
- Tablets should be swallowed whole with a sufficient amount of water.
- Can be taken with or without food.
- Dosage should be adjusted according to the severity of pain and the patient’s response to treatment.
Contraindications:
- Hypersensitivity to Tilidine, Naloxone, or any other component of the product.
- Patients with severe respiratory depression.
- Patients with acute or severe bronchial asthma or hypercapnia.
- Known or suspected gastrointestinal obstruction, including paralytic ileus.
Warnings and Precautions:
- Use with caution in patients with a history of substance abuse or dependency.
- May cause respiratory depression; monitor patients for signs of respiratory distress.
- Caution in patients with head injury or increased intracranial pressure.
- Use with caution in patients with hepatic or renal impairment.
- Avoid abrupt discontinuation; tapering the dose is recommended to prevent withdrawal symptoms.
Potential Side Effects:
Common:
- Nausea
- Vomiting
- Dizziness
- Drowsiness
- Constipation
Serious:
- Respiratory depression
- Severe allergic reactions
- Seizures
- Dependency and withdrawal symptoms upon abrupt discontinuation
Drug Interactions:
- CNS depressants: Increased risk of respiratory depression, sedation.
- MAO inhibitors: Possible severe and unpredictable reactions.
- Serotonergic drugs: Increased risk of serotonin syndrome.
Storage:
- Store at room temperature, between 20°C to 25°C (68°F to 77°F).
- Keep in a tightly closed container, away from moisture and light.
- Keep out of reach of children.
Packaging:
- Each box contains 20 tablets of Tilidin 150/12 mg.
- Blister packs ensure the integrity and freshness of each dose.
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