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ULTRAM (GENERIC TRAMADOL 50MG)

DRUG DESCRIPTION

ULTRAM® (tramadol hydrochloride) tablets is a centrally acting analgesic. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:

 

 

 

The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. ULTRAM® tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are pregelatinized corn starch, modified starch (corn), hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and carnauba wax.

 

What are the possible side effects of tramadol (ConZip, Rybix ODT, Ryzolt, Ultram, Ultram ER)?

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:

  • agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
  • seizure (convulsions);
  • a red, blistering, peeling skin rash; or
  • shallow breathing, weak pulse.

Less serious side...

What are the precautions when taking tramadol hcl (Ultram)?

Before taking tramadol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression, suicidal thoughts), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus),...

What should I discuss with my healthcare provider before taking tramadol (Ultram)?

 

You should not take tramadol if you are allergic to it, if you have ever been addicted to drugs or alcohol, or if you have ever attempted suicide.

Do not take tramadol while you are intoxicated (drunk) or taking any of the following:

  • alcohol or street drugs;
  • narcotic pain medicine;
  • sedatives or tranquilizers (such as Valium);
  • medicine for depression or anxiety; or
  • medicine for mental illness (such as bipolar disorder, schizophrenia).

Seizures have occurred in some people taking tramadol. Talk with your doctor about your seizure risk, which may be higher if you have:

  • a history of drug or alcohol addiction;
  • a history of epilepsy or other seizure disorder;
  • a history of head injury;
  • a metabolic disorder; or
  • if you are also taking an antidepressant, muscle relaxer, narcotic, antipsychotic, or medicine for nausea and vomiting.

To make sure you can safely take tramadol, tell your doctor if you have any of these other conditions:

  • kidney disease (or if you are on dialysis);
  • cirrhosis or other liver disease;
  • a stomach disorder; or
  • a history of depression, mental illness, or thoughts of suicide.

Tramadol may be habit forming and should be used only by the person it was prescribed for. Never share tramadol with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether tramadol will harm an unborn baby. Tramadol may cause serious or fatal side effects in a newborn if the mother uses the medication during pregnancy or labor. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Tramadol can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking tramadol.

Do not give this medication to anyone younger than 16 years old without the advice of a doctor.

Rybix ODT may contain phenylalanine. Talk to your doctor before using this form of tramadol if you have phenylketonuria (PKU).

 

How should I take tramadol (Ultram)?

 

Take exactly as prescribed. Never take tramadol in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Tramadol can be taken with or without food, but take it the same way each time.

Do not crush, chew, or break a tramadol tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhalation or injection can cause life-threatening side effects, overdose, or death.

To take tramadol orally disintegrating tablets (Rybix ODT):

  • Keep the tablet in its blister pack until you are ready to take it.
  • Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.
  • Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
  • Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.

If you use the tramadol extended-release tablet, the tablet shell may pass into your stools (bowel movements). This is normal and does not mean that you are not receiving enough of the medicine.

Do not stop using tramadol suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Tramadol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

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