Tramadol Hcl ( * ) - @- Central analgesics- (FDC- List )- (1993)
Drug Name:Tramadol Hcl ( * ) - @- Central analgesics- (FDC- List )- (1993)
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Interaction with Food
Pregnancy and lactation
Drug Interaction:
Interacting drugs - summary
+ Tramodol
Carbamazepine +
significant increase in tramadol metabolism by carbamazepine
and reduced effect. Increased dose of tramadol required
MAO inhibitors +
tramadol inhibits serotonin reuptake
Quinidine +
concomittant use results in increased conc. of tramodol and
reduced inhbition of isoenzyme
Indication:
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Tramadol Analgesic January 1993
2.Tramadol Hcl IP 21-11-2011
(as immediate release Layer ) 50mg
+ Diclofenac Sodium IP (as sustained
release layer) 75mg tablets
For the Symptomatic Treatment of Moderate to Severe pain in adult
Patients
3.Tramadol Hcl 200mg 12-09-2013
Controlled release Tablet
Addl.Dosage Form
For use in in-patients under Hospital settings for Severe Acute Pain for
a period not exceeding 5 days
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Tramadol Hcl 37.5mg + 09-01-2003
Paracetamol 325mg tablet
For short term (five days or less ) management of
acute pain in adults
2.Tramadol Hcl (as immediate Release layer ) 50mg + 21-11-2011
Diclofenac sodium IP (S.R layer ) 75mg tablets
For the symptomatic treatment of moderate to severe
pain in adult patients
Adverse Reaction:
Body as a whole- malaise, allergic reaction, acidental injury, weight loss, sicidal tendency
Cardiovascular- vasodilation, syncope, orthostatic hypotension, tachycardia, abnormal ECG, hypertension, myocardial ischemia, palpitations
CNS- anxiety, confusion, coordination disturbance, euphoria, nervousness, sleep disturbances, seizure, paresthesia, congnitive dysfunction, hallucinations, tremor, amnesia, difficulty in concentratin, abnormal gait
GI- abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatistis
Dermatologic- rash, urticaria, vesicles
Special senses- visual disturbances, dysgeusia, cataracts, deafness, tinnitus
GU- urinary retention/frequency, menopausal symptoms, dysuria, menstrual disorder
Lab test abnormalities- creatinine increase, elevated liver enzymes, hemoglobin decrease, proteinuria
Miscellaneous- hypertonia, dyspnea
Contra-Indications:
Respiratory depression,acute attack of asthma,heart failure, secondary to pulmonary disease, acute alcoholism,head injury, raised intracranial pressure.
Special precautions:
Hypothyroidism,adrenocortical insufficiency,renal damage, inflmmatory/obstructive bowel
disease, myasthenia gravis, infants and during labour.Gradual withdrawal.
Respiratory depression- administer cautiously in patients at risk for respiratory depression
Increased intracranial pressure or head trauma- clinicians should maintain a high index of
suspicion for advese drug reactions when evaluating altered mental status in these pastients if they are receiving tramadol.
Acute abnormal conditions- tramadol may complicate the clinical assessment of patients with acute abdominal conditions.
Opoid dependence- although tramadol can produce drug dependence of the u-opid type
(like codeine or dextroprpoxyphene) and potentiallly may be abused, there has been little
evidence of abuse in clinical experience
Warnings-
Seizures- patients with epilepsy or otherwise are at increased risk for seizure.
Concomittant CNS depressants- use with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opoiods, anesthestice agents, phenothiazines, tranquilizers or sedative hynotics
Renal/hepatic function impairment- in patients with creatinine clearance < 30ml/min, dosing reduction is recommended
Elderly- daily doses > 300mg are not recommended in patients > 75 years of age.
Pregnancy- do not use in pregnant women prior to or during labor unless the potential benefit outweigh the risks.
Lactation- not recommended for obsteical preoperative medication or for the post-delivery
analgesia in nursing mothers because its safety in nursing mothers and newborns has
not been studied.
Children- not recommended in children because safety and efficacy in patients
< 16 years of age have not been established
Dosages/ Overdosage Etc:
Date of Approval 1993
Indication -
Management of pain
Dosage-
Recommende dose - 50 to 100mg can be adminiostered for relief every 4 to 6 hours., not to exceed 400mg/day.
Elderly- > 75 years < 300mg /day in divided doses
Overdosage-
Symptoms
Few cases of overdose with tramadol have been reported.
Ingested doses of foreign fatalities have been in the region of 3 to 5g.
Serious potential consequences of overdosage are respiratory depression and seizures.
Treatment
1. Naloxone will reverse some but not symptoms of overdosage with tramadol, so that general supportive treatment is recommended.
2. Give primary atention to the assurance of adequate respiratory exchange.
3. Hemodialysis is not expected to be helpful because it removes only a small percentage of the administered dose.
Missed dose-
1. If you miss a dose of this medicine, take it as soon as possible.
2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.
3. Do not double doses.
Patient Information:
Tramadol may impair mental or physical abilities or coordination required for
the performance of potentially hazardous tasks such as driving a car
or operating machinery.
Ref - USP PDI Vol II 17th Edition (1997)
TRAMADOL- SYSTEMIC
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
Tramadol or narcotic analgesics. Also tell your healthcare care professional
if you are allergic to any other substances such as foods. preservatives or dyes.
2.Pregnancy-
Although sudies on birth defects have not been done in pregnant women,
tramadol has not been reported to cause birth defects.
In animal studies there were drug-related birth defects observed.
Studies done in animals given very high (toxic) doses resulted in lower
than normal weights and some death in the fetuses and birth defects
in some of the newborns.
3. Breast-feeding-
Tramadol passes into breast milk and cause unwanted side effects in
nursing babies. Be sure you discuss the risks and benefits with your
doctor.
4.Children-
There is no specific information on the relationship of age to the effects
of tramadol in patients less than 16 years of age.
5.Older adults-
Studies in older adults show that tramadol stays in the body a little longer
than it does in younger adults. Your doctor will consider this when deciding
the doses
6. Other medicines-
When you are taking Tramadol it is especially important that your doctor
knows if you are taking-
Carbamazepine - may decrease the effect of tramadol by decreasing the
amount of medicine in the body.
Central nervous system depressants- using these medicine with tramadol
may increase the chance of serious side effects or increase the risk of
convulsion(seizures).
MAO inhibitors- the chance of convulsion may be increased
7. Other medical problems-
The presence of other medical problems may affect the use of tramadol.
Make sure you tell your doctor if you have any other medical problems
especially-
Abdominal or stomach conditions - tramadol may hide the signs of
other medical conditions.
Alcohol or drug abuse- may increase serious side effects of tramadol
Head injury- tramadol can hide the signs of other medical conditions.
Kidney disease or
Liver disease - the chance of side effects may be increased
Seizures- the chance of convulsions may be increased
Pharmacology/ Pharmacokinetics:
Pharmacology:
Tramadol is a centrally acting synthetic analgesic compound that is not derived from natural sources nor is it chemically related to opiates. The mode of action is not clearly understood.
Pharmacokinetics:
Tramadol is rapidly and almost completely absorbed after oral administration. The mean absolute bioavailabilty of a 100mg oral dose is about 75%. Administration with food does not significantly affect its rate of absorption. Metabolism: Tamadol is extensively metabolised after oral administration. Approximately 30% of the dose is excreted in the urine as unchanged drug,whereas 60% is excreted as metabolites.
Interaction with Food:
Not significant.
Pregnancy and lactation:
Do not use in pregnant women prior to or during labour. Safe use in pregnancy has not been established.
Lactation:
Tramadol is not recommended for use in nursing mothers.
Children:
Not recommended in children because safety and efficacy in patients below 16 years of age have not been established.
