TRAMADOL Hcl

Indications & Dose:

Moderate to moderately severe pain management

Adult.

• BY MOUTH:

50-100 mg every 4-6 hours; usual max. 400 mg daily.

BY INTRAMUSCULAR INJECTION OR BY INTRAVENOUS INJECTION

(over 2-3 minutes) or infusion, 50-100 mg every 4-6 hours.

Postoperative pain:

100 mg initially then 50 mg every 10-20 minutes if necessary during first hour to total max. 250 mg (including initial dose) in first hour, then 50-100/ hours; max. 600 mg daily.

• RENAL IMPAIRMENT: CrCl <30 ml/min, extend dosing interval q 12h.

 Hepatic impairment: (cirrhosis) 50 m ql2h

Children

Not recommended. 

Contraindications:

Acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs 

Side Effects:

Cautions:

Precautions:

Respiratory depression, increased intracranial pressure or head trauma, acute abdominal conditions, drug abuse and dependence, seizure disorder 

Interaction:

DRUGS

alpha blockers, CYP2D6 and CYP3A4 inhibitors (amitriptyline, erythromycin, fluoxetine, paroxetine, quinidine), linezolid, lithium, MAO inhibitors, St. John’s wort, selective serotonin and norepinephrine reuptake inhibitors, tricydic antidepressants, triptans: Increased risk of serotonin syndrome amiodarone, cimetidine, domipramine, desipramine, fluphenazine, haloperidol, propa-fenone, quinidine, ritonavir, thioridazine: Decreased analgesia, increased adverse effects of tramadol amitriptyline, amphetamines, antipsychotics, bupropion, cydobenzaprine, dextroamphetamine, erythromydn, fluoxetine, ketoconazole, paroxetine, quinidine, MAO inhibitors, naloxone, tricydic antidepressants: Increased risk of seizures carbamazepine: Increased tramadol metabolism CNS depressants such as barbiturates, benzodiazepines, opioid analgesics, phenothiazines, sedative-hypnotics, tranquilizers: Additive

CNS depression general anesthetics: Increased CNS and respiratory depression phenothiazines, rifampin: Additive CNS depression, increased risk of seizures warfarin: Possibly increased INR

Warnings:

Adverse Effects:

Lactations:

pregnancy category C; small amounts excreted into breast milk

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

CNS: Anxiety, asthenia, CNS stimulation, confusion, coordination disturbance, dizziness, euphoria, headache, nervousness, seizures, sleep disorder, somnolence, vertigo

CV: Vasodilation

EENT: Visual disturbance

GI: Abdominal pain, anorexia, contipation, diarrhea, dry mouth, dyspepsia, flatulence, nausea, vomiting

GU: Menopausal symptoms, urinary retention and frequency

SKIN: Pruritus, rash

ADVERSE REACTIONS 

CNS: Agitation, anxiety, asthenia, depression, dizziness, emotional lability, euphoria, fatigue, fever, hallucinations, headache, hypertonia, hypoesthesia, insomnia, lethargy, nervousness, paresthesia, restlessness, rigors, seizures, serotonin syndrome, somnolence, suicidal ideation, tremor, vertigo, weakness

CV: Chest pain, orthostatic hypotension, vasodilation

EENT: Blurred vision, dry mouth, nasal or sinus congestion, sore throat, vision changes

ENDO: Hot flashes

GI: Abdominal pain, anorexia, constipation, diarrhea, indigestion, nausea, vomiting

GU: Urinary frequency, urine retention

MS: Arthralgia; back, limb, or neck pain

RESP: Cough, dyspnea

SKIN: Diaphoresis, dermatitis, flushing, pruritus, rash

Other: Flulike illness, physical and psycho-logical dependence

Patient And Carer Advice: