Trap 50 C

Description

Trap 50 Capsule: Essential Information

Trap 50 Capsule contains 50mg of Tramadol Hydrochloride and is manufactured by Siddhartha Pharmaceuticals Pvt. Ltd.

Uses (Indications)

Trap 50 Capsule is prescribed for:

• Moderate to severe pain
• Postoperative pain

Dosage Guidelines

Important: Always follow your healthcare provider’s instructions for dosage. This information is for general understanding only.

Adult Dosing

• Oral (by mouth) for Moderate to Severe Pain:
  • Immediate Release:
    • Chronic Pain: Start with 25 mg daily in the morning. Your doctor may increase this by 25-50 mg/day every 3 days, up to 50-100 mg every 4-6 hours as needed. Do not exceed 400 mg per day.
    • Acute Pain: Take 50-100 mg every 4-6 hours as needed. Do not exceed 400 mg per day.
  • Extended Release: Start with 100 mg once daily. Your doctor may increase this by 100 mg/day every 5 days. Do not exceed 300 mg per day.
• Parenteral (IM/IV Injection) for Moderate to Severe Pain:
  • Administer 50-100 mg every 4-6 hours over 2-3 minutes.
• Parenteral (IM/IV Injection) for Postoperative Pain:
  • Initially, 100 mg, followed by 50 mg every 10-20 minutes if necessary, for a total of 250 mg in the first hour (including the initial dose). Thereafter, 50-100 mg every 4-6 hours, up to a total daily dose of 600 mg.

Special Considerations

• Elderly (over 75 years): The dosing interval may need to be increased.
• Hepatic (Liver) Impairment:
  • Severe Impairment: For immediate release, 50 mg orally every 12 hours. Extended release is not recommended.

Child Dosing

• Moderate-to-Severe Pain (Immediate Release):
  • Under 17 years: Safety and efficacy have not been established.
  • Over 17 years (Acute): 50-100 mg orally every 4-6 hours as needed. Do not exceed 400 mg per day.
  • Over 17 years (Chronic): 25 mg orally every morning initially; increased by 25-50 mg/day every 3 days as separate doses up to 50-100 mg orally every 4-6 hours as needed. Do not exceed 400 mg per day.
• Extended Release:
  • Under 18 years: Safety and efficacy have not been established.

Renal (Kidney) Impairment

Administration

Trap 50 Capsule may be taken with or without food.

Contraindications (Who should NOT use this medication)

Do not use Trap 50 Capsule if you are:

• A suicidal patient.
• Suffering from acute alcoholism.
• Have head injuries.
• Have raised intracranial pressure.
• Have severe renal impairment.
• Lactating (breastfeeding).

Precautions (Use with caution)

Use Trap 50 Capsule cautiously if you have:

• Emotional disturbance or depression.
• A history of epilepsy or a risk of seizures.
• A head injury or increased intracranial pressure.
• Renal or hepatic impairment.
• Are elderly.
• Are pregnant or lactating.

Patient Counseling: This medication may impair your ability to drive or operate machinery.

Monitoring: Your doctor may monitor your pain relief, respiratory rate, blood pressure, pulse rate, and look for signs of tolerance, abuse, or suicidal ideation.

Lactation: The drug is excreted at high concentrations in breast milk and is not recommended for breastfeeding mothers.

Drug Interactions

Taking Trap 50 with certain other medications can increase risks:

• Increased risk of convulsions or serotonin syndrome: When taken with SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), TCAs, and other drugs that lower the seizure threshold (e.g., bupropion, mirtazapine, tetrahydrocannabinol).
• Decreased serum concentrations: With carbamazepine.
• May potentiate the antidepressant effect of norepinephrine, 5-HT agonists, or lithium.
• Increased INR and bruising (ecchymoses): With coumarin derivatives (e.g., warfarin).

Potentially Fatal Interactions:

• Increased risk of seizure and serotonin syndrome when taken with MAOIs (Monoamine Oxidase Inhibitors).

Adverse Effects (Side Effects)

Side effects of Tramadol Hydrochloride can include:

Very Common (>10%):

• Constipation (24-46%)
• Nausea (24-40%)
• Dizziness (10-33%)
• Vertigo (26-33%)
• Headache (18-32%)
• Somnolence (drowsiness) (7-25%)
• Vomiting (9-17%)
• Agitation (7-14%)
• Anxiety (7-14%)
• Emotional lability (7-14%)
• Euphoria (7-14%)
• Hallucinations (7-14%)
• Nervousness (7-14%)
• Spasticity (muscle stiffness) (7-14%)
• Dyspepsia (indigestion) (5-13%)
• Asthenia (weakness) (6-12%)
• Pruritus (itching) (8-11%)

Common (1-10%):

• Diarrhea (5-10%)
• Dry mouth (5-10%)
• Sweating (6-9%)
• Hypertonia (increased muscle tone) (1-5%)
• Malaise (general discomfort) (1-5%)
• Menopausal symptoms (1-5%)
• Rash (1-5%)
• Urinary frequency (1-5%)
• Urinary retention (1-5%)
• Vasodilation (widening of blood vessels) (1-5%)
• Visual disturbance (1-5%)

Less Common (<1%):

• Abnormal gait, Amnesia, Cognitive dysfunction, Depression, Difficulty in concentration, Dysphoria, Dysuria, Fatigue, Hallucinations, Menstrual disorder, Motor system weakness, Orthostatic hypotension, Paresthesia, Seizures, Suicidal tendencies, Syncope, Tachycardia, Tremor.

Frequency Not Defined:

• Abnormal electrocardiogram (ECG), Angioedema (swelling), Bronchospasm, Flushing, Hypertension (high blood pressure), Hypotension (low blood pressure), Myocardial ischemia (reduced blood flow to heart), Palpitation, Urticaria (hives), Withdrawal syndrome.

Potentially Fatal:

• Respiratory depression (severely slowed breathing).

Mechanism of Action (How it works)

Tramadol works by inhibiting the reuptake of norepinephrine and serotonin, and by enhancing serotonin release. It alters the perception and response to pain by binding to mu-opiate receptors in the central nervous system (CNS).

Important Disclaimer

The information on Trap 50 50mg Capsule from the Farmaco Nepal drug index is for informational purposes only. It is not intended for diagnosis, medical advice, or treatment, and should not be used as a substitute for professional medical judgment. Always consult with a healthcare professional for any health concerns or before making any decisions related to your health or treatment.