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Tramadol 50mg hydrochloride, sold under the brand name Ultram among others, is an opioid pain medication used to treat moderate to moderately severe pain. When taken by mouth in an immediate-release formulation, the onset of pain relief usually occurs within an hour. It is often combined with paracetamol (acetaminophen) as this is known to improve the efficacy of tramadol in relieving pain.
Common side-effects include: constipation, itchiness and nausea. Serious side-effects may include seizures, increased-risk of serotonin syndrome, decreased alertness, and drug addiction. A change in dosage may be recommended in those with kidney or liver problems. It is not recommended in those who are at risk of suicide. While not recommended in women who are breastfeeding, those who take a single dose should not generally stop breastfeeding.
It works by binding to the μ-opioid receptor and by acting as a serotonin–norepinephrine reuptake inhibitor (SNRI). Tramadol is in the benzenoid class. In the body it is converted to desmetramadol, which is a more potent opioid.
Tramadol was launched and marketed as “Tramal” by the German pharmaceutical company Grünenthal GmbH in 1977 in West Germany, and 20 years later it was launched in the UK, US, and Australia. It is marketed under many brand names worldwide.
Tramadol is used primarily to treat mild–severe pain, both acute and chronic.
Its analgesic effects take about one hour to come into effect and 2 h to 4 h to peak after oral administration with an immediate-release formulation. On a dose-by-dose basis tramadol has about one tenth the potency of morphine and is practically equally potent when compared with pethidine and codeine.
For pain moderate in severity, its effectiveness is equivalent to that of morphine; for severe pain it is less effective than morphine. These painkilling effects last for approximately 6 h.
Available dosage forms include liquids, syrups, drops, elixirs, effervescent tablets and powders for mixing with water, capsules, tablets including extended release formulations, suppositories, compounding powder, and injections.
Use of tramadol 50mg hydrochloride is not advised for people deficient in CYP2D6 enzymes. The enzymes are crucial to the therapeutic effects of tramadol, by means of enabling tramadol’s metabolism to desmetramadol.
Tramadol’s use in pregnancy is generally avoided as it may cause some reversible withdrawal effects in the newborn. A small prospective study in France found that, while there was an increased-risk of miscarriages, there were no major malformations reported in the newborn. Its use during lactation is also generally advised against, but a small trial found that infants breastfed by mothers taking tramadol 50mg hydrochloride were exposed to about 2.88% of the dose the mothers were taking. There was no evidence of this dose having a harmful effect on the newborn.
Its use as an analgesic during labour is generally advised against due to its long-onset of action (one hour). The ratio of the mean concentration of the drug in the fetus compared to that of the mother when it is given intramuscularly for labour pains has been estimated to be 94.
Its use in children is generally advised against, although it may be done under the supervision of a specialist. On September 21, 2015 the FDA started investigating the safety of tramadol 50mg hydrochloride in use in persons under the age of 17. The investigation was initiated because some of these people have experienced slowed or difficult breathing. The FDA lists age under 12 years old as a contraindication.
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