Madol 100 Capsule
Tramadol Hydrochloride
100mg
QMED Pharma
| Pack size | 1 |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 16 NPR |
Available as:
Indications
Madol 100 Capsule is used for:
Moderate to severe pain, Postoperative pain
Adult Dose
Oral
Moderate to severe pain
Adult:
Immediate release
Chronic pain: 25 mg PO every morning initially; increased by 25-50 mg/day every 3 days up to 50-100 mg PO q4-6hr PRN; not to exceed 400 mg/day
Acute pain: 50-100 mg PO q4-6hr PRN; not to exceed 400 mg/day
Extended release
100 mg PO once daily initially; increased by 100 mg/day every 5 days; not to exceed 300 mg/day
Parenteral
Moderate to severe pain
Adult: IM/IV: 50-100 mg 4-6 hrly over 2-3 min.
Postoperative pain
Adult: Initially, 100 mg followed by 50 mg every 10-20 min if necessary, to a total of 250 mg in the 1st hr including initial dose. Thereafter, 50-100 mg 4-6 hrly up to a total daily dose of 600 mg.
Elderly: >75 yr Increase dosing interval.
Hepatic impairment: Severe: Immediate release, 50 mg PO q12hr; extended release not recommended
Child Dose
Moderate-to-Severe Pain
Immediate release
<17 years: Safety and efficacy not established
>17 years (acute): 50-100 mg PO q4-6hr PRN; not to exceed 400 mg/day
>17 years (chronic): 25 mg PO every morning initially; increased by 25-50 mg/day every 3 days as separate doses up to 50-100 mg PO q4-6hr PRN; not to exceed 400 mg/day
Extended release
<18 years: Safety and efficacy not established
Renal Dose
Renal impairment:
CrCl (ml/min) Dosage Recommendation
10-30 Increase dosing interval to 12 hrly.
<10 Contraindicated.
Administration
May be taken with or without food.
Contra Indications
Suicidal patients, acute alcoholism; head injuries; raised intracranial pressure; severe renal impairment; lactation.
Precautions
Patients who suffer from emotional disturbance or depression, history of epilepsy or risk of seizure, head injury, increased intracranial pressure. Renal and hepatic impairment. Elderly. Pregnancy and lactation. Patient Counselling May impair ability to drive or operate machinery. Monitoring Parameters Monitor pain relief, resp rate, BP, pulse rate; signs of tolerance, abuse, or suicidal ideation.
Lactation: Drug excreted at high concentration in breast milk; not recommended
Pregnancy-Lactation
Interactions
Increased risk of convulsions or serotonin syndrome w/ SSRI, serotonin-norepinephrine reuptake inhibitors (SNRI), TCA and other seizure threshold lowering drugs (e.g. bupropion, mirtazapine, tetrahydrocannabinol). Decreased serum concentrations w/ carbamazepine. May potentiate the anti-depressant effect of norepinephrine, 5-HT agonists or lithium. Increased INR and ecchymoses w/ coumarin derivatives (e.g. warfarin).
Potentially Fatal: Increased risk of seizure and serotonin syndrome w/ MAOIs.
Adverse Effects
Side effects of Tramadol Hydrochloride :
>10%
Constipation (24-46%),Nausea (24-40%),Dizziness (10-33%),Vertigo (26-33%),Headache (18-32%),Somnolence (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 (7-14%),Dyspepsia (5-13%),Asthenia (6-12%),Pruritus (8-11%)
1-10%
Diarrhea (5-10%),Dry mouth (5-10%),Sweating (6-9%),Hypertonia (1-5%),Malaise (1-5%),Menopausal symptoms (1-5%),Rash (1-5%),Urinary frequency (1-5%),Urinary retention (1-5%),Vasodilation (1-5%),Visual disturbance (1-5%)
<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,Bronchospasm,Flushing,Hypertension,Hypotension,Myocardial ischemia,Palpitation,Urticaria,Withdrawal syndrome
Potentially Fatal: Respiratory depression.
Mechanism of Action
Tramadol inhibits reuptake of norepinephrine, serotonin and enhances serotonin release. It alters perception and response to pain by binding to mu-opiate receptors in the CNS.
Note
Madol 100 100mg Capsule manufactured by QMED Pharma. Its generic name is Tramadol Hydrochloride. Madol 100 is availble in Nepal.
Farmaco Nepal drug index information on Madol 100 Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.