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Fioricet.biz sells the cheapest us liscensed tramadol online. No online tramadol pharmacy can bid it. 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:

Tramadol is a narcotic-like pain reliever. Tramadol is used to treat moderate to severe pain. Tramadol extended-release is used to treat moderate to severe chronic pain when treatment is needed around the clock.

Important information about tramadol

You should not take this medication if you are allergic to tramadol, 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, or medicine for depression, anxiety, or mental illness.

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.

Seek emergency medical attention if you think you have used too much of this medicine. A tramadol overdose can be fatal.

Tramadol may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

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.

WARNINGS

Seizure Risk

Seizures have been reported in patients receiving ULTRAM® (tramadol hcl) within the recommended dosage range. Spontaneous post-marketing reports indicate that seizure risk is increased with doses of ULTRAM® (tramadol hcl) above the recommended range.

Concomitant use of ULTRAM® (tramadol hcl) increases the seizure risk in patients taking:

Selective serotonin re-uptake inhibitors (SSRI antidepressants or anorectics),
Tricyclic antidepressants (TCAs), and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.), or
Other opioids.

Administration of ULTRAM® (tramadol hcl) may enhance the seizure risk in patients taking:

MAO inhibitors (see also WARNINGS, Use with MAO Inhibitors and Serotonin Re-Uptake Inhibitors),
Neuroleptics, or
Other drugs that reduce the seizure threshold.

Risk of convulsions may also increase in patients with epilepsy, those with a history of seizures, or in patients with a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, CNS infections) . In ULTRAM® (tramadol hcl) overdose, naloxone administration may increase the risk of seizure.

Suicide Risk

Do not prescribe ULTRAM® (tramadol hcl) for patients who are suicidal or addiction-prone.
Prescribe ULTRAM® (tramadol hcl) Tablets with caution for patients who are taking tranquilizers or antidepressant drug and patients who use alcohol in excess and who suffer from emotional disturbance or depression.

The judicious prescribing of tramadol is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics.

Tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs (see WARNINGS, Risk of Overdosage).

Serotonin Syndrome Risk

The development of a potentially life-threatening serotonin syndrome may occur with the use of tramadol products, including ULTRAM® (tramadol hcl) , particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs, and triptans, with drugs which impair metabolism of serotonin (including MAOIs), and with drugs which impair metabolism of tramadol (CYP2D6 and CYP3A4 inhibitors). This may occur within the recommended dose.

Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Anaphylactoid Reactions

Serious and rarely fatal anaphylactoid reactions have been reported in patients receiving therapy with ULTRAM® (tramadol hcl) . When these events do occur it is often following the first dose. Other reported allergic reactions include pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome. Patients with a history of anaphylactoid reactions to codeine and other opioids may be at increased risk and therefore should not receive ULTRAM®.

Respiratory Depression

Administer ULTRAM® (tramadol hcl) cautiously in patients at risk for respiratory depression. In these patients alternative non-opioid analgesics should be considered. When large doses of ULTRAM® (tramadol hcl) are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.

Interaction With Central Nervous System (CNS) Depressants

ULTRAM® (tramadol hcl) should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics. ULTRAM® (tramadol hcl) increases the risk of CNS and respiratory depression in these patients.

Interactions with Alcohol and Drugs of Abuse

Tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.

Increased Intracranial Pressure or Head Trauma

ULTRAM® (tramadol hcl) should be used with caution in patients with increased intracranial pressure or head injury. The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure, and may be markedly exaggerated in these patients. Additionally, pupillary changes (miosis) from tramadol may obscure the existence, extent, or course of intracranial pathology. Clinicians should also maintain a high index of suspicion for adverse drug reaction when evaluating altered mental status in these patients if they are receiving ULTRAM®.

Use in Ambulatory Patients

ULTRAM® (tramadol hcl) may impair the mental and or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.

Use With MAO Inhibitors and Serotonin Re-uptake Inhibitors

Use ULTRAM® (tramadol hcl) with great caution in patients taking monoamine oxidase inhibitors. Animal studies have shown increased deaths with combined administration. Concomitant use of ULTRAM® (tramadol hcl) with MAO inhibitors or SSRI’s increases the risk of adverse events, including seizure and serotonin syndrome.

Misuse, Abuse and Diversion

Tramadol has mu-opioid agonist activity. ULTRAM® (tramadol hcl) can be sought by drug abusers and people with addiction disorders and may be subject to criminal diversion. The possibility of illegal or illicit use should be considered when prescribing or dispensing ULTRAM® (tramadol hcl) in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Misuse or abuse poses a significant risk to the abuser that could result in overdose and death.

Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. The development of addiction to opioid analgesics in properly managed patients with pain has been reported to be rare. However, data are not available to establish the true incidence of addiction in chronic pain patients.

Risk of Overdosage

Patients taking tramadol should be warned not to exceed the dose recommended by their physician. Tramadol products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a cause of drug-related deaths. Patients should be cautioned about the concomitant use of tramadol products and alcohol because of potentially serious CNS additive effects of these agents. Because of its added depressant effects, tramadol should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS depressant drugs. Patients should be advised of the additive depressant effects of these combinations.

Serious potential consequences of overdosage with ULTRAM® (tramadol hydrochloride) tablets are central nervous system depression, respiratory depression and death. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of tramadol alone or in combination with other drugs. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment.

Withdrawal

Withdrawal symptoms may occur if ULTRAM® (tramadol hcl) is discontinued abruptly. Reported symptoms have included anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been reported less frequently with ULTRAM® (tramadol hcl) discontinuation include panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be avoided by tapering ULTRAM® (tramadol hcl) at the time of discontinuation.

Before taking tramadol

You should not take this medication if you are allergic to tramadol, 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 this 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.

Acute Abdominal Conditions

The administration of ULTRAM® (tramadol hcl) may complicate the clinical assessment of patients with acute abdominal conditions.

Use in Renal and Hepatic Disease

Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1. In patients with creatinine clearances of less than 30 mL/min, dosing reduction is recommended. Metabolism of tramadol and M1 is reduced in patients with advanced cirrhosis of the liver. In cirrhotic patients, dosing reduction is recommended.

With the prolonged half-life in these conditions, achievement of steady-state is delayed, so that it may take several days for elevated plasma concentrations to develop.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A slight, but statistically significant, increase in two common murine tumors,pulmonary and hepatic, was observed in a mouse carcinogenicity study, particularly in aged mice. Mice were dosed orally up to 30 mg/kg (90 mg/m² or 0.36 times the maximum daily human dosage of 246 mg/m²) for approximately two years, although the study was not done with the Maximum Tolerated Dose. This finding is not believed to suggest risk in humans. No such finding occurred in a rat carcinogenicity study (dosing orally up to 30 mg/kg, 180 mg/m², or 0.73 times the maximum daily human dosage).

Tramadol was not mutagenic in the following assays: Ames Salmonella microsomal activation test, CHO/HPRT mammalian cell assay, mouse lymphoma assay (in the absence of metabolic activation), dominant lethal mutation tests in mice, chromosome aberration test in Chinese hamsters, and bone marrow micronucleus tests in mice and Chinese hamsters. Weakly mutagenic results occurred in the presence of metabolic activation in the mouse lymphoma assay and micronucleus test in rats. Overall, the weight of evidence from these tests indicates that tramadol does not pose a genotoxic risk to humans.

No effects on fertility were observed for tramadol at oral dose levels up to 50 mg/kg (300 mg/m²) in male rats and 75 mg/kg (450 mg/m²) in female rats. These dosages are 1.2 and 1.8 times the maximum daily human dosage of 246 mg/m², respectively.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Tramadol has been shown to be embryotoxic and fetotoxic in mice, (120 mg/kg or 360 mg/m²), rats ( ≥ 25 mg/kg or 150 mg/m²) and rabbits ( ≥ 75 mg/kg or 900 mg/m²) at maternally toxic dosages, but was not teratogenic at these dose levels. These dosages on a mg/m² basis are 1.4, ≥ 0.6, and ≥ 3.6 times the maximum daily human dosage (246 mg/m²) for mouse, rat and rabbit, respectively.

No drug-related teratogenic effects were observed in progeny of mice (up to 140 mg/kg or 420 mg/m²), rats (up to 80 mg/kg or 480 mg/m²) or rabbits (up to 300 mg/kg or 3600 mg/m²) treated with tramadol by various routes. Embryo and fetal toxicity consisted primarily of decreased fetal weights, skeletal ossification and increased supernumerary ribs at maternally toxic dose levels. Transient delays in developmental or behavioral parameters were also seen in pups from rat dams allowed to deliver. Embryo and fetal lethality were reported only in one rabbit study at 300 mg/kg (3600 mg/m²), a dose that would cause extreme maternal toxicity in the rabbit. The dosages listed for mouse, rat and rabbit are 1.7, 1.9 and 14.6 times the maximum daily human dosage (246 mg/m²), respectively.

Non-teratogenic Effects

Tramadol was evaluated in peri- and post-natal studies in rats. Progeny of dams receiving oral (gavage) dose levels of 50 mg/kg (300 mg/m² or 1.2 times the maximum daily human tramadol dosage) or greater had decreased weights, and pup survival was decreased early in lactation at 80 mg/kg (480 mg/m² or 1.9 and higher the maximum daily human dose).

There are no adequate and well-controlled studies in pregnant women. ULTRAM® (tramadol hcl) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and still birth have been reported during post-marketing.

Labor and Delivery

ULTRAM® (tramadol hcl) should not be used in pregnant women prior to or during labor unless the potential benefits outweigh the risks. Safe use in pregnancy has not been established. Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn. Tramadol has been shown to cross the placenta. The mean ratio of serum tramadol in the umbilical veins compared to maternal veins was 0.83 for 40 women given tramadol during labor.

The effect of ULTRAM® (tramadol hcl) , if any, on the later growth, development, and functional maturation of the child is unknown.

Nursing Mothers

ULTRAM® (tramadol hcl) is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hours postdose was 100 μg of tramadol (0.1% of the maternal dose) and 27 μg of M1.

Pediatric Use

The safety and efficacy of ULTRAM® (tramadol hcl) in patients under 16 years of age have not been established. The use of ULTRAM® (tramadol hcl) in the pediatric population is not recommended.

Geriatric Use

In general, dose selection for an elderly patient should be cautious, 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. In patients over 75 years of age, daily doses in excess of 300 mg are not recommended.

A total of 455 elderly (65 years of age or older) subjects were exposed to ULTRAM® (tramadol hcl) in controlled clinical trials. Of those, 145 subjects were 75 years of age and older.

In studies including geriatric patients, treatment-limiting adverse events were higher in subjects over 75 years of age compared to those under 65 years of age. Specifically, 30% of those over 75 years of age had gastrointestinal treatment-limiting adverse events compared to 17% of those under 65 years of age. Constipationresulted in discontinuation of treatment in 10% of those over 75.

Tramadol side effects

Get emergency medical help if you have any of these signs of an allergic reaction to tramadol: 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 tramadol side effects may include:

dizziness, spinning sensation;
constipation, upset stomach;
headache;
drowsiness; or
feeling nervous or anxious.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tramadol?

You may be more likely to have a seizure (convulsions) if you take tramadol while you are using certain other medicines. Do not take tramadol without telling your doctor if you also use any of the following medications:

an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or
an antidepressant such as amitriptyline (Elavil, Vanatrip), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), or sertraline (Zoloft).

Cold or allergy medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety can add to sleepiness caused by tramadol. Tell your doctor if you regularly use any of these medicines, or any other pain medication.

Tell your doctor about all other medicines you use, especially:

carbamazepine (Carbatrol, Equetro, Tegretol);
lithium (Eskalith, LithoBid);
ADHD medications (Adderall, Ritalin, Strattera);
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), linezolid (Zyvox), rifampin (Rifadin, Rimactane, Rifater); or telithromycin (Ketek);
antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);
cancer medications such as gefitinib (Iressa), imatinib (Gleevec), or nilotinib (Tasigna);
a heart rhythm medication such as amiodarone (Cordarone, Pacerone), flecainide (Tambocor), propafenone (Rythmol), or quinidine (Quin-G);
heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;
HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or
migraine headache medicine such as sumatriptan (Imitrex, Treximet).

This list is not complete and there are many other drugs that can interact with tramadol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

HOW Fioricet SUPPLIED

ULTRAM® (tramadol hydrochloride) Tablets – 50 mg are white, capsule-shaped, coated tablet imprinted “ULTRAM (tramadol hcl) ” on one side and “06 59” on the scored side.