Tramal Capsule (Tramadol 50 mg.) For Pain reliever 50 caps

Active substance : Tramadol hydrochloride 50mg.

Indication : Treatment of moderate to severe pain.

Tramal is a two-coloured(green/pale-yellow), shiny oblong capsules imprinted with the manufacturer’s logo.

Adults and adolescents above the age of 12 years

The usual initial dose is 50-100 mg. tramadol hydrochloride twice daily, morning and evening. If pain relief is insufficient, the dose may be titrated upwards to 150 or 200 mg. tramadol hydrochloride twice daily.

The lowest analgesically effective dose should generally be selected. Daily dose of 400 mg. active substance should not be exceeded, except in special clinical circumstances.

Children

Children aged 1-11 years receive 1-2 mg. tramadol hydrochloride per kg. body weight as a single dose (suitable presentations : solution for injection, oral drops). The lowest analgesically effective dose should generally be selected. Daily dose of 8 mg. active substance per kg. body weight  or 400 mg. active substance , whichever is lower, should not be exceeded.

On account of their high dosage strengths, capsules, prolonged release tablets, suppositories and tablets are not intended for children below the age of 12 years.

HOW DO I USE Tramadol?

For the treatment of painful conditions Tramadol 50 mg to 100 mg can be administered as needed for relief every four to six hours, not to exceed 400 mg per day. For moderate pain Tramadol 50 mg may be adequate as the initial dose, and for more severe pain, Tramadol 100 mg is usually more effective as the initial dose.

Individualization of Dose:

Patients 65 to 75 years of age: No dose adjustment is necessary.

Patients over 75 years old: No more then 300 mg/day in divided doses

Patients with kidney impairment: The dosing interval of Tramadol should be increased to 12 hours with a maximum daily dose of 200 mg.

Dialysis patients: These patients can receive their regular dose on the day of dialysis.

Patients with cirrhosis: Recommended dosage is 50 mg every 12 hours.

Patients receiving chronic carbamazepine: Doses up to 800 mg daily may be required, this is up to twice the recommended dose of Tramadol.

ADVERSE REACTIONS:

Tramadol was administered to 550 patients during the double-blind or open-label extension periods in U.S. studies of chronic nonmalignant pain. Of these patients, 375 were 65 years old or older. TABLE 2 reports the cumulative incidence rate of adverse reactions by 7, 30 and 90 days for the most frequent reactions (5% or more by 7 days). The most frequently reported events were in the central nervous system and gastrointestinal system. Although the reactions listed in the table are felt to be probably related to Tramadol administration, the reported rates also include some events that may have been due to underlying disease or concomitant medication. The overall incidence rates of adverse experiences in these trials were similar for Tramadol and the active control groups, acetaminophen 300 mg with codeine phosphate 30 mg, and aspirin 325 mg with codeine phosphate 30 mg. (TABLE 2)

TABLE 2 Cumulative Incidence of Adverse Reactions for Tramadol HCl In Chronic Trials of Nonmalignant Pain (N = 427)
	Up to 7 Days	Up to 30 Days	Up to 90 Days
Dizziness/Vertigo	26%	31%	33%
Nausea	24%	34%	40%
Constipation	24%	38%	46%
Headache	18%	26%	32%
Somnolence (Sleepiness)	16%	23%	25%
Vomiting	9%	13%	17%
Pruritus	8%	10%	11%
"CNS Stimulation"1	7%	11%	14%
Asthenia (Weakness)	6%	11%	12%
Sweating	6%	7%	9%
Dyspepsia (Acid Indigestion)	5%	9%	13%
Dry Mouth	5%	9%	10%
Diarrhea	5%	6%	10%
1 "CNS Stimulation" is a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability and hallucinations.

 

DRUG ABUSE AND DEPENDENCE:

Tramadol has a potential to cause psychic and physical dependence of the morphone-type. The drug has been associated with craving, drug-seeking behavior and tolerance development. Cases of abuse and dependence on Tramadol have been reported.

Tramadol should not be used in opioid-dependent patients. Tramadol can reinitiate physical dependence in patients that have been previously dependent or chronically using other opioids. In patients with a tendency to drug abuse, a history of drug dependence, or are chronically using opioids, treatment with Tramadol is not recommended.

Tramadol AND SEIZURES:

Seizure Risk:Seizures have been reported in patients receiving Tramadol within the recommended dosage range. Concomitant use of Tramadol increases the seizure risk in patients taking:

Selective serotonin reuptake inhibitors (SSRI antidepressants or anoretics -phentermine),

Tricyclic antidepressants and other tricyclic compounds (e.g., cyclobenzaprine, promethazine, etc.)

Opioids.

MAO inhibitors

Neuroleptics

Any drugs that reduce the seizure threshold

Epilepsy

Tramadol AND DROWZINESS:

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

Tramadol should not be taken with alcohol containing beverages.

Tramadol should be used with caution when taking medications such as tranquilizers, hypnotics or other opiate containing analgesics.

Tramadol AND PREGNANCY:

 

Tramadol should not be used in pregnant women or nursing mothers, safe use in pregnancy has not been established.

Chronic use during pregnancy may lead to physical dependence and post-pregnancy withdrawal symptoms in the newborn.

Tramadol has been shown to cross the placenta. Nonetheless, the effect of Tramadol, if any, on the later growth, development, and functional maturation of the child is unknown.

OVERDOSAGE:

Serious potential consequences of over dosage are respiratory depression and seizure.