Tramadol Hydrochloride 100 mg Injection

You should not take tramadol if you have used alcohol, sedatives, tranquilizers, or narcotic medications within the past few hours.

Tramadol can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take tramadol in larger amounts, or for longer than prescribed. Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

Seizures (convulsions) have occurred in some people taking this medicine. Tramadol may be more likely to cause a seizure if you have a history of seizures or head injury, a metabolic disorder, or if you are taking certain medicines such as antidepressants, muscle relaxers, narcotic, or medicine for nausea and vomiting.

Tramadol may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Taking tramadol during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use tramadol with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Tramadol can interact with many other drugs and cause dangerous side effects or death. Tell your doctor about all your current medicines and any you start or stop using.

Do not crush the tramadol tablet. 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.

Get emergency medical help if you have any signs of an allergic reaction to tramadol: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tramadol is not for use in children. Seek emergency medical attention if a child has taken this medicine and has: noisy breathing, sighing, slow breathing with long pauses between breaths; being unusually sleepy or hard to wake up; blue colored lips.

Call your doctor at once if you have:

• seizure (convulsions);

• weak or shallow breathing;

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex; or

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are ill or debilitated.

Common tramadol side effects may include:

• headache, dizziness, drowsiness, tired feeling;

• constipation, diarrhea, nausea, vomiting, stomach pain;r

• feeling nervous or anxious; or

• itching, sweating, flushing (warmth, redness, or tingly feeling).

Patients Not Currently on Tramadol Immediate-Release Products

Initiate treatment with Tramadol Hydrochloride Extended-Release at a dose of 100 mg once daily and titrated up as necessary by 100 mg increments every five days to achieve a balance between relief of pain and tolerability.

Patients 65 Years of Age and Older

Initiate dosing of an elderly patient (over 65 years of age) should be initiated cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. Tramadol Hydrochloride Extended-Release should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.

Patients with Renal Impairment

The limited availability of dose strengths and once daily dosing of Tramadol Hydrochloride Extended-Release Capsules do not permit the dosing flexibility required for safe use in patients with severe renal impairment. Do not use Tramadol Hydrochloride Extended-Release in patients with creatinine clearance less than 30 mL/min

Patients with Hepatic Impairment

The limited availability of dose strengths and once daily dosing of Tramadol Hydrochloride Extended-Release Capsules do not permit the dosing flexibility required for safe use in patients with severe hepatic impairment. Do not use Tramadol Hydrochloride Extended-Release in patients with severe hepatic impairment

You should not take tramadol if you are allergic to it, or if you have:

• severe asthma or breathing problems;

• a blockage in your stomach or intestines;

• if you have recently used alcohol, sedatives, tranquilizers, or narcotic medications; or

• if you have used an MAO inhibitor in the past 14 days (such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine).

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 head injury, epilepsy or other seizure disorder;

• a history of drug or alcohol addiction;

• a metabolic disorder; or

• if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS.

Some medicines can interact with tramadol and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson‚s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure tramadol is safe for you, tell your doctor if you have:

• liver or kidney disease;

• a stomach disorder; or

• a history of drug abuse, alcohol addiction, mental illness, or suicide attempt.

Tramadol is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Tramadol may be habit forming and should be used only by the person it was prescribed for. Never share this medicine 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. Selling or giving away tramadol to any other person is against the law.

It is not known whether tramadol will harm an unborn baby. If you use this medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

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

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