Ultram Warnings & Precautions

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Ultram - Warnings & Precautions [Tramadol]

Interaction With Central Nervous System (CNS) Depressants

ULTRAM 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 increases the risk of CNS and respiratory depression in these patients.

Increased Intracranial Pressure or Head Trauma

ULTRAM 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. (See Respiratory Depression.)

Time (h)
Conc.
(ng/ mL)

0 12 24 36 48

1000
100
10

Tramadol
(Multiple Dose)

Tramadol
(Single Dose)

M1
(Multiple Dose)

M1
(Single Dose)

600
400

200

60
40

20

Population/ Parent Drug/ Peak Conc. Time to Clearance/ F b t1/ 2 (hrs) Dosage Regimen a Metabolite (ng/ mL) Peak (hrs) (mL/ min/ Kg)
Healthy Adults, Tramadol 592 (30) 2.3 (61) 5.90 (25) 6.7 (15) 100 mg qid,
MD p. o. M1 110 (29) 2.4 (46) c 7.0 (14)
Healthy Adults, Tramadol 308 (25) 1.6 (63) 8.50 (31) 5.6 (20) 100 mg

SD p. o. M1 55.0 (36) 3.0 (51) c 6.7 (16)
Geriatric, Tramadol 208 (31) 2.1 (19) 6.89 (25) 7.0 (23) (> 75 yrs)

50 mg SD p. o. M1 d d c d
Hepatic Impaired, Tramadol 217 (11) 1.9 (16) 4.23 (56) 13.3 (11) 50 mg

SD p. o. M1 19.4 (12) 9.8 (20) c 18.5 (15)
Renal Impaired, Tramadol c c 4.23 (54) 10.6 (31) CLcr 10-30 mL/ min

100 mg SD i. v. M1 c c c 11.5 (40)
Renal Impaired, Tramadol c c 3.73 (17) 11.0 (29) CLcr <5 mL/ min