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tramadol (Rx)Brand and Other Names:Ultram, Ultram ER, more...ConZip

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet: Schedule IV

  • 50mg

suspension reconstituted

  • 10 mg/mL

capsule, extended release: Schedule IV

  • 100mg (ConZip, Ultram ER)
  • 150mg (ConZip)
  • 200mg (ConZip, Ultram ER)
  • 300mg (ConZip, Ultram ER)
more...

Moderate-to-Severe Pain

Immediate release

  • Chronic: 25 mg PO every morning initially; increased by 25-50 mg/day every 3 days up to 50-100 mg PO q4-6hr PRN; not to exceed 400 mg/day
  • Acute: 50-100 mg PO q4-6hr PRN; not to exceed 400 mg/day

Extended release

  • 100 mg PO once daily initially; increased by 100 mg/day every 5 days; not to exceed 300 mg/day
  • Conversion from immediate release to extended release: Round total daily dose down to nearest 100 mg
  • Do not chew, crush, split, or dissolve

Dosing Considerations

Extended-release capsule/tablet must not be chewed, crushed, split, or dissolved

Also given in combination with acetaminophen

Dosing Modifications

Severe renal impairment (CrCl <30 mL/min): Immediate release, 50-100 mg PO q12hr; extended release not recommended

Severe hepatic impairment: Immediate release, 50 mg PO q12hr; extended release not recommended

HIV-Associated Neuropathy (Orphan)

Orphan indication sponsor

  • TheraQuest Biosciences, LLC, 146 Medinah Drive, Blue Bell, PA 19422-3212

Postherpetic Neuralgia (Orphan)

Orphan indication sponsor

  • TheraQuest Biosciences, LLC, 146 Medinah Drive, Blue Bell, PA 19422-3212

Dosage Forms & Strengths

tablet: Schedule IV

  • 50mg

suspension reconstituted

  • 10 mg/mL
more...

Moderate-to-Severe Pain

Immediate release

  • <17 years: Safety and efficacy not established
  • ≥17 years (acute): 50-100 mg PO q4-6hr PRN; not to exceed 400 mg/day
  • ≥17 years (chronic): 25 mg PO every morning initially; increased by 25-50 mg/day every 3 days as separate doses up to 50-100 mg PO q4-6hr PRN; not to exceed 400 mg/day

Extended release

  • <18 years: Safety and efficacy not established

>65 years: Initiate at lower end of dosing range; not to exceed 300 mg/day if >75 years

>75 years: Not to exceed 300 mg/day immediate release; use great caution with extended release

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Interactions

Interaction Checker

tramadol and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
             activity indicator 
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            Adverse Effects

            >10%

            Constipation (24-46%)

            Nausea (24-40%)

            Dizziness (10-33%)

            Vertigo (26-33%)

            Headache (18-32%)

            Somnolence (7-25%)

            Vomiting (9-17%)

            Agitation (7-14%)

            Anxiety (7-14%)

            Emotional lability (7-14%)

            Euphoria (7-14%)

            Hallucinations (7-14%)

            Nervousness (7-14%)

            Spasticity (7-14%)

            Dyspepsia (5-13%)

            Asthenia (6-12%)

            Pruritus (8-11%)

            1-10%

            Diarrhea (5-10%)

            Dry mouth (5-10%)

            Sweating (6-9%)

            Hypertonia (1-5%)

            Malaise (1-5%)

            Menopausal symptoms (1-5%)

            Rash (1-5%)

            Urinary frequency (1-5%)

            Urinary retention (1-5%)

            Vasodilation (1-5%)

            Visual disturbance (1-5%)

            <1%

            Abnormal gait

            Amnesia

            Cognitive dysfunction

            Depression

            Difficulty in concentration

            Dysphoria

            Dysuria

            Fatigue

            Hallucinations

            Menstrual disorder

            Motor system weakness

            Orthostatic hypotension

            Paresthesia

            Seizures

            Suicidal tendencies

            Syncope

            Tachycardia

            Tremor

            Frequency Not Defined

            Abnormal electrocardiogram (ECG)

            Angioedema

            Bronchospasm

            Flushing

            Hypertension

            Hypotension

            Myocardial ischemia

            Palpitation

            Urticaria

            Withdrawal syndrome

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            Warnings

            Contraindications

            Hypersensitivity to tramadol or opioids

            ER tablet formulation

            • Acute intoxication with alcohol
            • Concomitatn use with centrally acting analgesics, psychotropic drugs, opioids, hypnotics
            • Severe renal or hepatic impairment

            ER capsule formulation

            • Severe/acute bronchial asthma, significant respiratory depression, hypercapnia
            • Severe renal or hepatic impairment

            Cautions

            Renal impairment (reduce dose)

            Anaphylactoid/fatal reactions including pruritus, hives, angioedema, epidermal necrolysis, and Stevens-Johnson syndrome reported with use; risk higher in patients with previous anaphylactoid reactions to opioids

            Use caution when administering with other respiratory depressants and monoamine oxidase inhibitors (MAOIs); risk of respiratory depression or increased ICP

            Increased risk of respiratory depression in patients with respiratory disorders including COPD, hypercapnia, cor pulmonale, or hypoxia

            Seizure risk even at recommended dosage, epilepsy patients, or recognized risks (head trauma, metabolic disorders, alcohol and drug withdrawal, central nervous system [CNS] infections), concomitant administraiton with other opioids, SSRIs, tricyclic antidepressants, cyclobenzaprine, promethazine, neuroleptics, MAO inhibitors, or drugs that impair metabolism of tramadol (CYP2D6, 3A4)

            Not recommended for obstetric preoperative medication or for postdelivery analgesia in nursing mothers

            May impair ability to perform skilled or hazardous tasks

            Serotonin syndrome (potentially life-threatening) may develop

            Increased risk of serotonin syndrome if oadministered with serotonergic drugs (eg, selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], tricyclic antidepressants [TCAs], MAOIs, triptans) or drugs that may impair tramadol metabolism (CYP2D6 and CYP3A4 inhibitors) may increase risk for serotonin syndrome

            May impair ability to diagnose or determine clinical course of patients with acute abdominal conditions

            Use caution in patients with history of chemical dependency

            Avoid use in patients who are suicidal; use caution in patients taking tranquilizers and/or antidepressants

            Off-label use in children

            • Severe respiratory depression reported with off-label use in children
            • Tramadol undergoes extensive hepatic metabolism; it is metabolized by CYP2D6 to the active metabolite O-desmethyltramadol (M1), which has a 200-fold greater affinity for opioid receptors than does tramadol
            • CYP2D6 poor metabolizers have shown a 20% increase in tramadol levels and a 40% decrease in O-desmethyltramadol (M1)
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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Drug excreted at high concentration in breast milk; not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Non-opioid-derived synthetic opioid; centrally acting analgesic, but may act at least partially by binding to opioid mu receptors, causing inhibition of ascending pain pathways

            Absorption

            Bioavailability: Immediate release, 75%; extended release, 85-90%

            Onset: ~1 hr

            Duration: 9 hr

            Peak plasma time: Immediate release, 1.5 hr; extended release, 12 hr

            Distribution

            Protein bound: 20%

            Vd: 2.5-3 L/kg

            Metabolism

            Metabolized in liver by CYP2D6 and CYP3A4 via N- and O-demethylation and glucuronidation/sulfation

            Metabolites: M1 (O-desmethyltramadol; active); M1 metabolite has 200-fold greater affinity for opioid receptors than parent drug

            In CYP2D6 poor metabolizers, tramadol levels may increase by 20% and M1 levels decrease by 40%

            Elimination

            Half-life: 6-8 hr

            Excretion: Urine (90%)

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Select a class to view formulary status for similar drugs

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