1. Uses of Ultracet tab
What is Ultracet used for?
Ultracet contains 37.5 mg of tramadol hydrochloride combined with 325 mg of paracetamol. As a centrally acting analgesic, it is indicated for the management of moderate to severe pain when alternative treatments are ineffective.
2. Dosage and Administration
Adults and Children Over 16 Years Old
- Recommended for patients requiring a combination of tramadol and paracetamol to manage moderate to severe pain.
- The dosage is adjusted based on the severity of pain and individual response.
- Maximum dose: 1–2 tablets every 4–6 hours, with a daily limit of 8 tablets.
- Can be taken with or without food.
- For long-term treatment, regular monitoring is required to assess the need for continued use.
Children Under 16 Years Old
- The safety and efficacy of Ultracet in children under 16 years have not been established.
Elderly Patients: No significant differences in safety or pharmacokinetics have been observed in elderly patients (aged 65 and older). Patients under 75 with normal liver and kidney function do not require dose adjustments. Patients over 75 may experience delayed drug elimination and may require dosage adjustments.
Patients with Renal Impairment: In patients with creatinine clearance <30 ml/min, dosing intervals should be extended, with a maximum of 2 tablets every 12 hours.
Patients with Liver Impairment: Ultracet should not be used in patients with severe liver impairment. For mild to moderate liver impairment, dosage adjustments should be considered.
3. Adverse Effects
Ultracet may cause the following side effects:
- General Reactions: Fatigue, flushing, weakness.
- Nervous System: Tremors, headaches.
- Gastrointestinal System: Constipation, diarrhea, abdominal pain, dry mouth, bloating, nausea.
- Psychiatric Disorders: Anxiety, loss of appetite, insomnia, agitation.
- Skin and Subcutaneous Tissue: Increased sweating, itching, rash.
- Cardiovascular System: May worsen hypertension.
- Cardiac Arrhythmias: Palpitations, arrhythmia, tachycardia.
- Hepatic and Biliary System: Abnormal liver function tests.
- Visual Disturbances: Altered vision.
4. Precautions and Warnings
4.1 Contraindications
Do not use Ultracet in the following cases:
- Hypersensitivity to tramadol, paracetamol, or any component of the drug.
- Allergy to opioid medications.
- Acute intoxication with alcohol, narcotics, sleeping pills, or central nervous system depressants.
- Patients taking monoamine oxidase inhibitors (MAOIs) or those who have discontinued MAOIs within the past two weeks.
- Severe liver impairment, uncontrolled epilepsy.
4.2 Precaution
- Seizures: There have been reports of seizure risks after treatment with tramadol. The risk increases when using a dose higher than recommended or when taken with the following drugs: tricyclic antidepressants (cyclobenzaprine, promethazine), selective serotonin reuptake inhibitors (SSRIs, appetite suppressants, antidepressants), opioids, MAO inhibitors, sedatives, etc. The risk of seizures also increases in patients with a history of seizures or epilepsy.
- Anaphylactoid Reactions: Patients with a history of anaphylactic reactions to codeine or opioids may have an increased risk of similar reactions.
- Respiratory Depression: Caution should be taken when using Ultracet tab in patients at risk of respiratory depression. High doses of tramadol combined with anesthetics, sedatives, or alcohol may lead to respiratory depression.
- Use with Central Nervous System Depressants: Caution and dose reduction are necessary for patients taking central nervous system depressants such as opioids, alcohol, anesthetics, phenothiazines, sedatives, or sleeping pills.
- Increased Intracranial Pressure, Head Injury: Caution is required when treating patients with head injuries or increased intracranial pressure.
- Opioid Addiction: Ultracet should not be used in opioid-dependent patients. Tramadol in the drug may cause relapse in individuals previously addicted to opioids.
- Use with Alcohol: Chronic heavy alcohol use increases the risk of liver toxicity when overdosing on paracetamol.
- Withdrawal Symptoms: Symptoms may occur if the drug is stopped suddenly, including excessive anxiety, panic attacks, hallucinations, tinnitus, and paresthesia.
- Patients with Renal Impairment: For patients with a serum creatinine clearance below 30 mL/min, the dosing interval of Ultracet tab should be adjusted to no more than 2 tablets every 12 hours.
- Patients with Liver Impairment: The drug is not recommended for use in patients with severe liver impairment.
- Skin Reactions: Rare but severe skin reactions such as Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, and toxic epidermal necrolysis may occur. Patients should stop using the drug immediately if symptoms of skin reactions appear.
- Risk of Hyponatremia: More common in patients with existing risk factors, such as elderly patients or those taking sodium-lowering drugs.
- Tolerance and Dependence: Physical and psychological dependence can occur even at therapeutic doses. The need for opioid pain management should be regularly evaluated. Do not exceed the recommended dose or use it with other drugs containing tramadol or paracetamol.
- Pregnant Women: Ultracet crosses the placental barrier and may harm the fetus. Therefore, its use is contraindicated in pregnant women.
- Breastfeeding Women: The drug is not recommended for use in breastfeeding women, as its safety and efficacy in infants have not been studied.
5. Drug Interactions
Ultracet may interact with the following medications:
- CYP2D6 Inhibitors (e.g., fluoxetine, quinidine, bupropion, paroxetine).
- CYP3A4 Inhibitors (e.g., antifungals, macrolide antibiotics).
- CYP3A4 Inducers (e.g., carbamazepine, rifampicin, phenytoin).
- Centrally Acting Analgesics (e.g., codeine, morphine).
- Serotonin Reuptake Inhibitors (e.g., antidepressants).
- Monoamine Oxidase Inhibitors (e.g., tranylcypromine, phenelzine, linezolid).
- Muscle Relaxants (risk of respiratory depression and neuromuscular impairment).
- Diuretics (reduced efficacy of diuretics).
- Digoxin, Warfarin (possible increased anticoagulant effects).
- Drugs that lower the seizure threshold (e.g., bupropion, SSRIs, antipsychotics, tricyclic antidepressants).
- Opioid Antagonist-Agonists (e.g., nalbuphine, buprenorphine, pentazocine) – may reduce Ultracet's analgesic effect.
Ultracet tablets contain paracetamol and tramadol, making them effective for treating moderate to severe pain. To ensure safe and effective treatment, patients must follow their healthcare provider’s guidance and be aware of potential side effects and interactions.
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