Brand Information

Strength	Rate	Packing Style
100mg	206.75	10s c.r tablets

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.

TRD-CONTIN

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Interaction with Food

Pregnancy and lactation