The TV 58 imprint identifies a prescription oral tablet containing Tramadol Hydrochloride 50 mg. Manufactured by Teva Pharmaceuticals USA, tramadol is a centrally acting analgesic categorized as a Schedule IV controlled substance in the United States due to its potential for abuse, physical dependence, and addiction.
Physical Identification
Physical Parameter – Specification
- Active Ingredient – Tramadol Hydrochloride (50 mg)
- Form – Solid oral tablet
- Shape – Oval / Elliptical
- Color – White
- Imprint -TV on one side, 58 on the reverse side
- Manufacturer – Teva Pharmaceuticals USA
- Drug Class – Centrally Acting Opioid Analgesic / SNRI
- CSA Schedule – Schedule IV (Controlled Substance)
- If you possess a white pill with “5058” rather than “TV 58”, it may be Atorvastatin (a cholesterol medication). Always verify unidentified medications with a licensed pharmacist before taking them.
Mechanism of Action
Tramadol possesses a unique dual mechanism of action that sets it apart from traditional full-agonist opioids:
- Weak Opioid Receptor Agonism: Tramadol and its active metabolite (desmethyltramadol, or M1) bind weakly to opioid receptors in the central nervous system, inhibiting ascending pain pathways.
- Monoamine Reuptake Inhibition: Tramadol simultaneously inhibits the reuptake of both serotonin and norepinephrine in the brainstem and spinal cord. By increasing synaptic levels of these neurotransmitters, it enhances descending inhibitory pain pathways.
This synergistic interaction between the opioid and monoaminergic pathways provides effective analgesia for both nociceptive and neuropathic pain components.
Indications & Clinical Usage
Tramadol Hydrochloride 50 mg is indicated for the management of moderate to moderately severe pain in adults where alternative, non-opioid pain options (e.g., NSAIDs, acetaminophen) are inadequate or not tolerated.
- Contraindicated in Pediatrics: Tramadol is strictly contraindicated in all pediatric patients under 12 years of age, and in adolescents under 18 years undergoing tonsillectomy or adenoidectomy due to the risk of life-threatening respiratory depression.
Dosage Guidance
Dosing must be individualised to achieve optimal analgesia while minimizing adverse effects.
- Standard Immediate-Release Titration (Adults):
- Starting Dose: 25 mg to 50 mg taken orally every 4 to 6 hours as needed for pain.
- Maximum Dosage: Do not exceed 400 mg per day (8 tablets of 50 mg).
- Elderly Patients (75 Years): Total daily dose should not exceed 300 mg per day, administered in divided doses due to reduced drug clearance.
- Renal and Hepatic Impairment:
- Renal Impairment : Dosing interval should be extended to every 12 hours, with a maximum daily limit of 200 mg.
- Severe Hepatic Cirrhosis: Recommended dose is 50 mg every 12 hours.
Side Effects
Common Side Effects
- Central Nervous System: Dizziness, lightheadedness, drowsiness, headache, and fatigue.
- Gastrointestinal System: Nausea, vomiting, constipation, dry mouth, and indigestion.
- Dermatologic/General: Sweating, itching (pruritus), or flushing.
Serious Adverse Reactions
Seek immediate emergency medical care if you experience:
- Serotonin Syndrome: Agitation, fever, rapid heart rate, severe muscle stiffness, tremors, sweating, or hallucinations.
- Seizures: Tramadol significantly lowers the seizure threshold, even at recommended doses.
- Severe Respiratory Depression: Abnormally slow, shallow, or labored breathing.
- Adrenal Insufficiency: Nausea, vomiting, loss of appetite, fatigue, weakness, or severe dizziness resulting from long-term use.
Precautions & Boxed Warnings
FDA Boxed Warnings (Black Box)
- Addiction, Abuse, and Misuse: Risk of opioid use disorder, overdose, and fatal toxicity.
- Life-Threatening Respiratory Depression: Severe or fatal respiratory depression can occur, particularly during initial therapy or following dose increases.
- Accidental Ingestion: Ingestion of even one tablet by a child can lead to a fatal tramadol overdose.
- Neonatal Opioid Withdrawal Syndrome (NOWS): Chronic use during pregnancy can cause life-threatening opioid withdrawal in newborns.
- Concomitant Use with CNS Depressants: Combining tramadol with benzodiazepines, muscle relaxants, or alcohol causes severe sedation, respiratory depression, coma, and death.
- Ultra-Rapid Metabolism (CYP2D6): Individuals who are CYP2D6 ultra-rapid metabolizers process tramadol into its active M1 metabolite far more rapidly, leading to unexpectedly high opioid levels and severe toxicity.
Key Warnings & Interactions
- Seizure Risk: Avoid tramadol in patients with a history of seizure disorders, head trauma, or those taking medications that lower the seizure threshold (e.g., SSRIs, SNRIs, tricyclic antidepressants, antipsychotics).
- Avoid MAO Inhibitors: Do not take tramadol concurrently with, or within 14 days of taking, Monoamine Oxidase Inhibitors (MAOIs).
- Avoid Sudden Cessation: Abruptly stopping tramadol after continuous use causes dual-type withdrawal symptoms: classic opioid withdrawal (cramps, nausea, sweating) alongside atypical monoaminergic withdrawal (panic attacks, severe anxiety, paresthesia, and hallucinations). Always taper down under medical guidance.