More Information About - Utramal 100 mg Suppository 100mg
Description
Generic Name
Tramadol Hydrochloride
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
Indication
Moderate to severe pain, Postoperative pain
Contra Indication
Suicidal patients, acute alcoholism; head injuries; raised intracranial pressure; severe renal impairment; lactation.
FDA has not yet classified the drug into a specified pregnancy category.
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.
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.
Pregnancy Category Note
Pregnancy & Lactation
Pregnancy: Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth; observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly
Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported with tramadol during post-approval use of tramadol immediate-release products
Pregnancy
Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome; available data in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage; observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly
Labor and delivery
Use of tramadol during labor may lead to respiratory depression in the neonate
Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates; an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate; use is not recommended in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate; opioid analgesics, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions; however, this effect is not consistent and may be offset by increased rate of cervical dilation, which tends to shorten labor; monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression
Lactation
Tramadol and its active metabolite, O-desmethyltramadol (M1), are present in human milk; there are published studies and cases that have reported excessive sedation, respiratory depression, and death in infants exposed to codeine via breast milk; women who are ultra-rapid metabolizers of tramadol achieve higher than expected serum levels of opioids, potentially leading to higher levels of M1 in breast milk that can be dangerous in their breastfed infants; in women with normal tramadol metabolism (normal CYP2D6 activity), the amount of tramadol secreted into human milk is low and dose-dependent
Because of potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, breastfeeding is not recommended during treatment
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
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