Manufacturer/Distributor: Bio-pharma
Generic Name: Tramadol hydrochloride 100mg
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Dolorex is a pain relieving medicine. It is used to manage persistent, moderate to severe chronic pain that requires continuous, around-the-clock treatment. Dolorex is generally administered by a healthcare professional. You should not self-administer this medicine at home. The dose and duration will depend on what you are taking it for and how well it helps your symptoms. The most common side effects of this medicine include injection site reactions (such as pain, redness, and swelling), headache, drowsiness, fatigue, vomiting, constipation, dry mouth, and sweating. If any of these side effects persist or get worse, you should let your doctor know. Your doctor may be able to suggest ways of preventing or reducing the symptoms. Before using it, you should let your doctor know if you have problems with your heart, liver, or kidneys. Let your doctor also know about all the other medicines you are taking because they may affect, or be affected by, this medicine. If you are pregnant or breastfeeding, it is important to ask the advice of your doctor before taking this medicine. Your doctor may also regularly monitor your kidney function, liver function, and levels of blood components if you are taking this medicine for long-term treatment.
Uses of Dolorex
Side effects of Dolorex
Common
How to use Dolorex
Your doctor or nurse will give you this medicine. Kindly do not self administer.
How Dolorex works
Dolorex is an opioid analgesic (pain reliever) which works by blocking transmission of pain signals to the brain to lower pain perception.
What if you forget to take Dolorex?
If you miss a dose of Dolorex, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Quick Tips
Brief Description
Indication
Moderate to severe pain, Postoperative pain
Administration
May be taken with or without food.
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.
Contraindication
Suicidal patients, acute alcoholism; head injuries; raised intracranial pressure; severe renal impairment; lactation.
Mode 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.
Precaution
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
Side Effect
>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.
Interaction
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.
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