Takol-CR

Takol-CR

tramadol

Manufacturer:

Raptakos Brett

Distributor:

Raptakos Brett
Concise Prescribing Info
Contents
Tramadol HCl
Indications/Uses
Management of moderate to severe chronic pain.
Dosage/Direction for Use
Adult 1 cap once daily or bid. Max: 400 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to tramadol HCl or opioids. Acute intoxication w/ alcohol, hypnotics, analgesics or psychotropics. Patients receiving MAOIs or w/in 2 wk of w/drawal. Not for narcotic w/drawal treatment. Resp depression especially in the presence of cyanosis & excessive bronchial secretions; increased intracranial pressure or CNS depression due to head injury or cerebral disease. Pregnancy & lactation.
Special Precautions
Patients w/ severe hepatic & renal impairment or those prone to convulsive disorders or shock. Concurrent intake w/ CNS depressants. Risk of seizures in patients exceeding the recommended dose, taking TCAs or other tricyclic compounds (eg, promethazine, SSRI, MAOIs & neuroleptics); w/ epilepsy, history of seizures or w/ recognized risk of seizures eg, drug & alcohol w/drawal & intracranial infections, head trauma, metabolic disorders & naloxone administration w/ tramadol overdose; cerebral convulsions. Opioid-dependent patients, previously dependent on or chronically using other opioids; patients w/ a tendency to drug abuse. Not for the treatment of minor pain. May affect ability to drive or operate machinery.
Adverse Reactions
Nausea, vomiting, dry mouth, heartburn, constipation, abdominal discomfort, diarrhea; fatigue, sedation, drowsiness, dizziness, confusion, hallucinations, seizures; sweating, skin rashes, bradycardia, tachycardia, flushing, bronchospasm, angioedema, syncope, paraesthesia, anaphylaxis & anaphylactic reactions; postural hypotension or CV collapse; toxic epidermal necrolysis & Stevens-Johnson syndrome (potential).
Drug Interactions
Increased potential to cause convulsions for SSRIs, TCAs, anti-psychotics & other seizure threshold lowering drugs. May potentiate CNS depressant effects w/ other centrally acting drugs, including alcohol, centrally acting analgesics, opioids & psychotropic drugs. Significantly reduced analgesic effect w/ carbamazepine. Increased conc w/ quinidine. May reduce metabolic clearance w/ CYP2D6 &/or CYP3A4 inhibitors eg, quinidine, fluoxetine, paroxetine, amitriptyline (CYP2D6 inhibitors), ketoconazole & erythromycin (CYP3A4 inhibitors).
MIMS Class
ATC Classification
N02AX02 - tramadol ; Belongs to the class of other opioids. Used to relieve pain.
Presentation/Packing
Form
Takol-CR cap 100 mg
Packing/Price
100's;30's
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