Drug Uses
Tramadol
...is used to relieve moderate to moderately severe pain. It also may be used to treat pain caused by surgery and chronic conditions such as cancer or joint pain. Tramadol works by decreasing the brain's perception and response to pain. It also reduces the size or magnitude of the pain signal passed from one nerve to another. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
How Taken
Tramadol
...comes as a tablet to take it orally. It usually is taken every 4-6 hours as needed. It may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Tramadol exactly as directed. Tramadol can be habit-forming. Do not take a larger dose take it more often, or for a longer period than your doctor tells you to.
Warnings/Precautions
Before taking Tramadol, tell your doctor if you have kidney disease; liver disease; or a history of alcohol or drug dependence.
You may not be able to take Tramadol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Tramadol is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant.
It is also not known whether Tramadol passes into breast milk. Do not take Tramadol without first talking to your doctor if you are breast-feeding a baby.
If you are over 75 years of age, you may be more likely to experience side effects from Tramadol. The maximum daily dose of Tramadol for people over 75 years of age is 300 mg.
Tramadol is not approved by the FDA for use by children younger than 16 years of age.
Missed Dose
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Possible Side Effects
Although side effects from Tramadol are not common, they can occur. The most frequently reported events were in the central nervous system (Migraine, Speech disorders) and gastrointestinal system (Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure). Tell your doctor if any of these symptoms are severe or do not go away: dizziness, headache, drowsiness, blurred vision, upset stomach, vomiting, and diarrhea. If you experience any of the following symptoms, call your doctor immediately: fast heartbeat, redness, swelling, and itching of the face, numbness or tingling of the hands and feet, difficulty breathing, changes in urination, seizures.
Storage
Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
Overdose
Seek emergency medical attention. Symptoms of a Tramadol overdose include difficulty breathing; shallow, weak breathing; and seizures.
More Information
Do not drink alcohol while taking Tramadol. Alcohol may cause a dangerous decrease in breathing and/ or liver problems when used during treatment with Tramadol.
Use caution when driving, operating machinery, or performing other hazardous activities. Tramadol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
Avoid sleeping pills, tranquilizers, sedatives, and antihistamines except under the supervision of your doctor. These drugs may increase drowsiness caused by Tramadol.
More Information
Tramadol
...is a synthetic analogue of codeine. It is a central analgesic with a low affinity for opioid receptors. Its selectivity for mu receptors has recently been demonstrated, and the M1 metabolite of tramadol, produced by liver O-demethylation, shows a higher affinity for opioid receptors than the parent drug. The rate of production of this M1 derivative (O-demethyl tramadol), is influenced by a polymorphic isoenzyme of the debrisoquine-type, cytochrome P450 2D6 (CYP2D6).
More Information
In a post-marketing-surveillance study the use of a sustained-release tramadol preparation (Tramal long 100, 150, 200 mg) was investigated in 3153 patients. The intention was to comply with the legal obligation to carry out product surveillance and to collect data on prescribing behaviour. We focused our attention on drug safety and efficacy. Tramal long was used mainly for severe and very severe pain. The most frequently reported causes of pain were diseases of the locomotor system (49.9%), tumours (24.3%), traumas and fractures (10.1%), and neurogenic (9.3%). The mean daily dose was 235.7 mg, usually divided into two doses. The analgesic effect was described as very good or good by 82.5% of the patients.
More Information
Tramadol
...is a synthetic opioid with a structure of (±)-trans-2 [(di-methylamino)methyl] 1-(m-methox-yphenyl) cyclohexanol hydrochloride. Its analgesic activity is mediated through an agonist action at all types of opioid receptors with some µ receptor selectivity. In addition it inhibits noradrenaline uptake and stimulates serotonin release. Increased concentrations of these neurotransmitters in the descending pathways enhance the analgesic response. Up to 60% of the analgesic activity of tramadol is thought to be mediated through its nonopioid actions.[1] Tramadol has minimal respiratory depressant effect, probably because of its multiple routes of action. Its haemodynamic effects are negligible.
Tramadol has been used for postoperative pain relief in a large variety of surgical procedures by various routes. Baraka et al used it epidurally in major abdominal surgeries with good effect.[2] Delilkan used it in gynaecological surgery.[3] Laminectomy for prolapsed intervertebral disc results in severe postoperative pain requiring large amounts of parenteral opioid analgesics for control. This study was designed to compare the efficacy of epidural tramadol with that of epidural morphine for postoperative analgesia in patients undergoing laminectomy.
Disclaimer
This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.
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What are the differences between Tramadol brand-name drugs and Tramadol generic drugs?
You probably know that pharmaceutical companies carry out extensive research and clinical testing to win approval from the Food and Drug Administration for new drugs. The new drug is then protected by patent for at least 10 years. Hence, a brand-name drug. When the patent expires another drug company can "copy the recipe" for Tramadol brand drug. This "copy" is called a generic drug. The FDA requires that generic drugs have the same active chemical composition, be dispensed in the same dosage form such as a tablet or capsule and be taken in the same dosage as the brand-name drug.
Different definition / meanings for the word "new drug application":
An application requesting FDA approval to market a new drug for human use in interstate commerce. The application must contain, among other things, data from specific technical viewpoints for FDA review--including chemistry, pharmacology, medical, biopharmaceutics, statistics, and, for anti-infectives, microbiology.
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