Analab

Analab

tramadol

Manufacturer:

Biolab

Distributor:

Biopharm
Concise Prescribing Info
Contents
Tramadol HCl
Indications/Uses
Dosage/Direction for Use
Cap Patient ≥17 yr w/ moderate to moderately severe chronic pain Not requiring rapid onset of analgesia: Dose titration: Initially 25 mg daily in the morning, increased by 25 mg increments every 3 days as separate doses up to 25 mg qid. Thereafter, increase dose by 50 mg every 3 days, up to 50 mg qid as tolerated. 50-100 mg every 4-6 hr as needed following titration. Requiring rapid onset of analgesia: 50-100 mg every 4-6 hr. Max: 400 mg daily. Renal impairment (CrCl <30 mL/min) 50-100 mg every 12 hr. Max: 200 mg daily. Hepatic cirrhosis 50 mg every 12 hr. Amp Adult & adolescent >14 yr 50-100 mg by slow IV, IM or SC. If required, may administer 50 mg 30 min to 1 hr after 1st dose. Max: 400 mg/day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Known intolerance to other opioids. Acute intoxication w/ alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs.
Special Precautions
Serious & rarely fatal anaphylactoid reactions. Do not give in patients w/ history of anaphylactoid reactions to codeine & other opioids. Seizure following 1st episode; w/ naloxone administration. Patients at risk for resp depression; w/ increased ICP or head injury; w/ acute abdominal conditions. W/drawal symptoms may occur if discontinued abruptly. Advanced hepatic cirrhosis. Renal impairment. Not to be used in pregnant women prior to or during labor. Not recommended for obstet pre-op medication or post-delivery analgesia in nursing women. Childn <17 yr.
Adverse Reactions
Dizziness, vertigo, headache, somnolence, nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability, hallucinations, asthenia, confusion, amnesia, depression, paresthesia, seizure, hypertonia; constipation, nausea, vomiting, dyspepsia, dry mouth, diarrhea, abdominal pain, anorexia, flatulence, wt loss; pruritus, rash, urticaria, SJS, TEN; vasodilation, orthostatic hypotension, syncope, tachycardia, hypotension; menopausal symptoms, urinary frequency, dysuria, menstrual disorder, increased serum creatinine conc, proteinuria; malaise, visual disturbance, dyspnea, dysgeusia, resp depression.
Drug Interactions
Increased conc w/ CYP2D6 inhibitors eg, fluoxetine, paroxetine, quinidine, amitriptyline. Decreased clearance w/ CYP3A4 inhibitors eg, macrolides, azole antifungals, PIs. Concomitant use w/ ritonavir, ketoconazole, clarithromycin. Increased clearance w/ CYP3A4 inducers eg, rifampin, carbamazepine, phenytoin. Increased metabolism w/ carbamazepine. Inhibited metabolism w/ SSRIs eg, nefazodone, venlafaxine, fluvoxamine. Increased anticoagulant effect of warfarin.
MIMS Class
Analgesics (Opioid)
ATC Classification
N02AX02 - tramadol ; Belongs to the class of other opioids. Used to relieve pain.
Presentation/Packing
Form
Analab cap 50 mg
Packing/Price
10 × 10's
Form
Analab inj 50 mg/mL
Packing/Price
10 × 1's
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