Tramadol HCl is a centrally acting synthetic analgesic compound. Although its mode of action is not completely understood, at least two complementary mechanisms appear applicable; binding to m-opioid receptors and inhibition of reuptake of norepinephrine and serotonin.

Tramadol HCl causes significantly less respiratory depression than morphine. In contrast to morphine, Tramadol HCl has not been shown to cause histamine release.

 

TRAMADOL ELSaad injection is indicated for the management of moderate to moderately severe pains.

 

Tramadol HCl should not be administered to patients who have previously demonstrated hypersensitivity to Tramadol HCl or in cases of acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.

 

- Administration of Tramadol HCl may enhance the seizure risk in patients taking MAO inhibitors,  neuroleptics, naloxone and other drugs that reduce the seizure threshold in patients with epilepsy.

- Tramadol HCl should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics.

- Tramadol HCl should be administered cautiously in patients at risk for respiratory depression.

- Tramadol HCl should be used with caution in patients with increased intracranial pressure or head injury.

- The administration of Tramadol HCl may complicate the clinical assessment of patients with acute abdominal conditions.

- Tramadol HCl is not recommended for patients who are dependent on opioids (withdrawal symptoms).

- In patients with creatinine clearance of less than 30 mL/min or in cirrhotic patients, dosing reduction is recommended.   

- Tramadol HCl may impair mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.

- Pregnancy & Lactation: Category C. It should not be taken during pregnancy and breast-feeding unless treatment is necessary and according to the physician decision.

 -Children & Elderly Patients: Tramadol HCl Injection is not intended for use in children below the age of 1 year. In elderly people the intervals between doses may be prolonged.

 

Depending on the administered amount, Tramadol HCl may slow down breathing and cause various degree of sedation (soothing, depressant effect, ranging from slight tiredness to muzziness).

Occasionally nausea, sweating, dry mouth, dizziness and muzziness may occur. In rare cases there may be effects on the heart and blood circulation (pounding of the heart, fast heart-beat, feeling faint or collapse), especially when the patients is in an upright position or under physical strain.

Moreover, in rare cases headache, retching, vomiting, constipation, stomach troubles (e.g. feeling of pressure in the stomach, bloating) and skin reactions (e.g. itching or rash) may occur.

In very rare cases motorial weakness (weak muscles), changes in appetite and difficulties in passing water have been observed.

Also in very rare cases various psychic side effects may occur after the administration of Tramadol HCl which vary individually in intensity and nature, depending on personality and duration of treatment. These include changes in mood (usually high spirits, occasionally irritated mood), changes in activity (usually suppression, occasionally increase) and decreased sensory perception (changes in senses and recognition, which may lead to errors in judgment).

Allergic reactions (hypersensitivity) up to shock (sudden heart and blood circulation failure) cannot definitely be ruled out.

Epileptic fits have been observed on very rare occasions, usually after administration of high Tramadol HCl dosages or when drugs which may also provoke fits or reduce the seizure threshold (e.g. antidepressants/neuroleptics) are taken at the same time.

 

- If alcohol or drugs which also depress the brain are taken together with Tramadol HCl, the side-effects of Tramadol HCl affecting the brain may be intensified; in particular breathing may slow down.

- If drugs which may provoke fits or reduce the seizure threshold (e.g. drugs for the treatment of certain psychological diseases) are taken at the same time, epileptic fits have been observed on very rare occasions.

- Drugs containing carbamazepine may reduce the pain-relieving effect of Tramadol HCl and the length of time it acts.

- When MAO inhibitors were taken 14 days before the administration of the opioid pethidine, life threatening interactions affecting the central nervous system, breathing and circulation were observed. The same interactions with MAO inhibitors cannot be ruled out during treatment with Tramadol HCl. Please note that these remarks may also apply if these medicines have been taken recently.

- Tramadol HCl solution for injection has proved to be incompatible with solutions for injection of diclofenac, indomethacin, phenylbutazone, diazepam, flunitrazepam, glyceryl trinitrate.

 

Moderate pain: For adults and adolescents above 14 years of age receive 50 mg of Tramadol injection as a single dose. If there is no pain-relieving effect after 30-60 minutes, a further 50 mg can be administered.

In severe pain a higher dose is necessary, 100 mg Tramadol injection are administered as a single dose.

For the treatment of severe pain: After operations, on demand pain relief may require even higher doses in the first few hours. In general, over 24 hours more than the normal daily doses of Tramadol injection are not necessary.

Depending on the pain, the effect lasts for 4 to 8 hours. In general, 400 mg of Tramadol injection per day need not to be exceeded.

However, for the treatment of cancer pain much higher doses may be necessary.

Children aged 1 to 13 years receive 1-2 mg Tramadol injection per kg body weight as a single dose. In this case Tramadol injection is diluted in water for injection. As in the following table:

 

When kidney or liver function is impaired, it is not necessary to adjust the dose of Tramadol injection in acute pain conditions, because the preparation is only given once or occasionally. In chronic (long–lasting) pain, however, the intervals between doses should be extended on account of the risk of accumulation due to delayed excretion.

Even if there is no recognizable restriction of liver or kidney function, excretion may be delayed in elderly patients (over 75 years of age), and therefore the intervals between doses may have to be extended.

Tramadol injection is administered intravenously, intramuscularly or subcutaneously.

(on intravenous injection Tramadol injection is mostly injected into a surface blood vessel of the arm, on intramuscular injection into the buttocks and on subcutaneous injection under the skin).

Intravenous injection is carried out slowly by injecting 50 mg Tramadol injection per minute.

Tramadol injection must not be administered for longer than absolutely necessary. If long-term treatment is necessary, your doctor should check at regular short intervals as to whether and with what dose Tramadol injection should be continued if necessary, with breaks in treatment.

 

Tolerance development has been reported to be relatively mild and withdrawal, when present, is not considered to be as severe as that produced by other opioids. Prolonged use of the product should be avoided because of dependency.

 

Serious potential consequences of overdosage are respiratory depression and seizure. Naloxone will reverse some, but not all, symptoms caused by overdosage with Tramadol HCl so that general supportive treatment is recommended. Primary attention should be given to the assurance of adequate respiratory exchange. Hemodialysis is not expected to be helpful because it removes only a small percentage of the administered dose. Convulsions occurring following the administration of toxic doses of Tramadol HCl could be suppressed with barbiturates or benzodiazepines, but were increased with naloxone.

 

TRAMADOL ELSaad – Injection: A pack of  5 or 100 ampoules of 2 mL. Each ampoule (2mL) contains Tramadol  Hydrochloride 100 mg.

 

Store TRAMADOL ELSaad – Injection at temperature below 30°C.