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Tramadol (ultram) and Gelonida - Potent Painkillers

Copyright (c) 2008 Vlad Kott

Tramadol (Ultram) is prescribed to relieve moderate to moderately severe pain, to treat pain caused by surgery and chronic conditions such as cancer or joint pain. It works by decreasing the body’s sense of pain.

Gelonida is a narcotic analgesic used to treat or prevent moderate to severe pain.

* Most important fact about Tramadol (Ultram)

You should not drive a car, operate machinery, or perform any other potentially hazardous activities until you know how Tramadol Ultram affects you.

It’s important to take Tramadol exactly as prescribed. Do not increase the dosage or length of time you take Ultram without your doctor’s approval.

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Ultram.

Side effects may include:

Agitation, anxiety, bloating and gas, constipation, convulsive movements, diarrhea, dizziness, drowsiness, dry mouth, feeling of elation, hallucinations, headache, indigestion, itching, nausea, nervousness, sweating, tremor, vomiting, weakness.

 
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using tramadol and call your doctor at once if you have any of these serious side effects:

  • seizure (convulsions);
  • a red, blistering, peeling skin rash; or
  • shallow breathing, weak pulse.

Less serious side effects may include:

  • dizziness, drowsiness, weakness;
  • nausea, vomiting, constipation, loss of appetite;
  • blurred vision;
  • flushing (redness, warmth, or tingly feeling); or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Avoid Tramadol Ultram if it has ever given you an allergic reaction. Also avoid Tramadol Ultram after taking large doses of sleeping pills such as Halcion, Dalmane, and Restoril; narcotic pain relievers such as Demerol, morphine, Darvon, and Percocet; or psychotherapeutic drugs such as antidepressants and tranquilizers. And do not take Tramadol Ultram after drinking excessive amounts of alcohol.

If you have stomach problems such as an ulcer, make sure your doctor is aware of them. Tramadol Ultram may hide the symptoms, making them difficult to diagnose and treat.

Tramadol Ultram can cause mental and physical addiction. If you’ve ever had a problem with narcotic painkillers such as Percocet, Demerol, or morphine, you should avoid Tramadol Ultram. Withdrawal symptoms may occur if you stop taking Tramadol Ultram abruptly. Such symptoms include anxiety, sweating, insomnia, pain, nausea, tremor, diarrhea, and respiratory problems. A gradual decrease in dosage will help prevent these symptoms.

Do not take more than the recommended dose of Tramadol Ultram, since larger doses have been known to cause seizures, especially if you have epilepsy or are taking medications that also increase the risk of seizures. Among such medications are almost all antidepressant drugs, plus narcotics and major tranquilizers such as Loxitane and Stelazine.

If you have liver or kidney disease, be sure your doctor knows about it. Your dosage may have to be reduced.

Before you have any kind of surgery, make sure the doctor knows you are taking Tramadol Ultram.

If you have any kind of breathing problem, use Tramadol Ultram with caution or take a different kind of painkiller. Tramadol Ultram can impair respiration, especially if taken with alcohol.

If you have experienced a head injury, consult your doctor before taking Tramadol Ultram. The medication’s effects may be stronger and could hide warning signs of serious trouble.

Tramadol Ultram may increase the drowsiness caused by alcohol. Do not drink alcohol while taking Tramadol Ultram.

There have been reports of serious harm to developing babies when Tramadol Ultram was used during pregnancy. If you are pregnant or plan to become pregnant, tell your doctor immediately.

Tramadol Ultram appears in breast milk and may affect a nursing infant. If Tramadol Ultram is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment is finished.

Avoid Tramadol Ultram, too, if you are taking the seizure medication Tegretol.

Symptoms of Ultram overdose include:

Difficult or slowed breathing, drowsiness, coma, seizures, cardiac arrest. Tramadol can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

***** Gelonida *****

Gelonida - generic name is parecoxib sodium. It is used to treat or prevent moderate to severe pain.

* Side effects

That may go away during treatment, include drowsiness, dizziness, constipation, or nausea. If they continue or are bothersome, check with your doctor.

Check with your doctor if you experience vomiting, skin rash, itching, slowed or difficult breathing, difficulty urinating, or fainting.

Don’t take this drug if you are also taking Quinidine. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding.

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include cold and clammy skin, slowed breathing, slowed heartbeat, drowsiness, dizziness, lightheadedness, deep sleep, and loss of consciousness.

Avoid alcohol while you are using this drug. This drug will add to the effects of alcohol and other depressants.

Don’t drive, don’t operate machinery until you know how you react to this medicine? Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.

Don’t take this drug if you have had a severe allrgic reaction to Codeine, Hydrocodone, Dihydrocodeine, or Oxycodone (such as Tylox, Tylenol with Codeine, Vicodin).

A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness.

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Ultram: Prescription Drug Abuse & Testing


Ultram is the trade name for Tramadol which is an atypical opioid. It is a synthetic agent, as a 4-phenyl-piperidine analogue of codeine, and appears to have actions on the GABAergic, noradrenergic and serotonergic systems & is thus used as a centrally acting analgesic for treating moderate to severe pain.

Tramadol is usually marketed as the hydrochloride salt (tramadol hydrochloride) and is available in both injectable (intravenous and/or intramuscular) and oral preparations. It is also available in conjunction with paracetamol.

Ultram Prescription:

Ultram is used to relieve moderate to moderately severe pain. Ultram extended-release tablets are only used by people who are expected to need medication to relieve pain around-the-clock for a long time. Ultram belongs to the class of drugs called opiate agonists. It works by changing the way the body senses pain.

Tramadol comes as a tablet and an extended-release (long-acting) tablet to take by mouth. The regular tablet is usually taken with or without food every 4-6 hours as needed. The extended-release tablet should be taken once a day. Oral doses range from 50–400 mg daily, with up to 600 mg daily when given IV/IM. The formulation containing APAP contains 37.5 mg of Tramadol and 325 mg of paracetamol, intended for oral administration with a common dosing recommendation of one or two tabs every four to six hours although final dosage is decided by physician and is highly case specific.

Ultram Abuse:

MedWatch is a FDA database of adverse events of case reports voluntarily submitted to the FDA. From 1999 through September 2004, the FDA received 766 case reports of Tramadol abuse. It is most commonly abused by narcotic addicts, chronic pain patients, and health professionals.

Tramadol is approximately 10% as potent as morphine, when given by the IV/IM route. It is a potent habit-forming substance. Tramadol is not currently scheduled by the U.S. DEA, unlike other opioid analgesics. Nevertheless, the prescribing information for Ultram warns that Tramadol may induce psychological and physical dependence of the morphine-type. In addition, there are widespread reports by consumers of extremely difficult withdrawal experiences. A controlled study that compared different medications found that the percent of subjects who scored positive for abuse at least once during the 12-month follow-up were 2.5% for NSAIDs, 2.7% for Tramadol, and 4.9% for hydrocodone. Taking more Tramadol / Ultram than what is prescribed by your doctor may cause serious side effects or death.

Effects of Ultram Abuse:

The most commonly reported adverse drug reactions are nausea, vomiting and sweating. Drowsiness is reported, although it is less of an issue than with other opioids. Respiratory depression, a common side effect of opioids, is not clinically significant in normal doses. Serious potential consequences of over dosage are respiratory depression, lethargy, coma, seizure, cardiac arrest and death. Fatalities have been reported in post marketing in association with both intentional and unintentional overdose with Ultram.

Ultram may induce psychic and physical dependence of the morphine-type opioids. Dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug are not limited to those patients with prior history of opioid dependence. The risk in patients with substance abuse has been observed to be higher. Ultram is associated with craving and tolerance development. Withdrawal symptoms may occur if Ultram is discontinued abruptly. These symptoms may be relieved by reinstitution of opioid therapy followed by a gradual, tapered dose reduction of the medication combined with symptomatic support.



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Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery

The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during the first 6 hours postoperatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side effects. The first unit dose will be administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3 is reached. The second and third unit dose will be administered after 1 and 2 hours, respectively, when a VAS of more than 3 is observed.

 

Condition Intervention Phase
Pain Drug: Tramadol per os (Tradonal Odis® orodispersible tablets)
Drug: Tramadol IV (Tradonal® IV)
Phase IV

 

Drug Information available for:   Tramadol hydrochloride    Tramadol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
 
Official Title:   Comparison of the Therapeutic Efficacy and Side Effects of Tramadol Per os (Tradonal Odis® Orodispersible Tablets) Versus an Optimised Dosis of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery.

 

Further study details as provided by University Hospital, Ghent:

 

Primary Outcome Measures:

  • Difference in pain score between groups [ Time Frame: In the first hours after anaesthesia and surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Difference in side-effects between the groups [ Time Frame: In the first hours after anaesthesia and surgery ] [ Designated as safety issue: Yes ]
Estimated Enrollment:   200
Study Start Date:   March 2008
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental

Tramadol per os (Tradonal Odis® orodispersible tablets)
Drug: Tramadol per os (Tradonal Odis® orodispersible tablets)

Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages
2: Active Comparator

Tramadol IV (Tradonal® IV)
Drug: Tramadol IV (Tradonal® IV)

Administration of tramadol IV given in 3 unit dosage of 35 mg

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Tramadol and Pain Sensitization (TRAMADOL)

Purpose

Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered.

Condition Intervention Phase
Pain Drug: Tramadol Phase I

Drug Information available for:   Tramadol hydrochloride    Tramadol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
 
Official Title:   Tramadol and Pain Sensitization

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

  • Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area [ Time Frame: with an induced hyperalgic area ] [ Designated as safety issue: Yes ]
Estimated Enrollment:   12
Study Start Date:   September 2007
Estimated Study Completion Date:   December 2007
Estimated Primary Completion Date:   December 2007 (Final data collection date for primary outcome measure)
Intervention Details:

    Drug: Tramadol

    to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials

Detailed Description:

The study is a comparison of the analgesic of tramadol versus placebo in a pain model using evoked potentials. Evaluation criteria will be the amplitude of the evoked potential obtained defore and after treatment

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