Utramal Capsule 50mg

Product Information

UTRAMAL

Utramal®(Tramadol Hydrochloride)

Presentation

Utramal capsule: Green cap and yellow body capsule, imprinted with and ‘UTRAMAL’; each capsule contains Tramadol Hydrochloride BP

50 mg.

Indications

Treatment of moderate to severe pain.

Dosage and administration

GThe dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. Unless otherwise

prescribed, Utramal (Tramadol Hydrochloride) capsule should be administered as follows:

Adults and adolescents above the age of 12 years: Tramadol Hydrochloride 50-100 mg (1-2 Utramal capsule/s) 4-6 hourly. The

capsules are to be taken whole, not divided or chewed, with sufficient liquid, independent of meals. The lowest analgesically

effective dose should generally be selected. Daily doses of Tramadol Hydrochloride 400 mg (8 Utramal capsules) should not

be exceeded, except in special clinical circumstances. Utramal (Tramadol Hydrochloride) should under no circumstances be

administered for longer than absolutely necessary. If long-term pain treatment with Utramal (Tramadol Hydrochloride) is necessary

in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with

breaks in treatment) to establish whether and to what extent further treatment is necessary.

Children: Utramal (Tramadol Hydrochloride) capsule is not suitable for children below the age of 12 years.

Geriatric patients: A dose adjustment is not usually necessary in elderly patients (up to 75 years) without clinically manifest

hepatic or renal insufficiency. In elderly patients (over 75 years) elimination may be prolonged. Therefore, if necessary, the

dosage interval is to be extended according to the patients requirements. Renal insufficiency/dialysis and hepatic insufficiency:

In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. In these patients prolongation of the

dosage intervals should be carefully con sidered according to the patients requirements. In cases of severe renal and/or severe

hepatic insufficiency Tramadol Hydrochloride is not recommended.

Contra-indications, warnings, etc.

Contra-indications: Tramadol Hydrochloride is contraindicated

– in hypersensitivity to tramadol,

– in acute intoxication with alcohol, hypnotics, analgesics, opioids or other psychotropic medicinal

products,

– in patients who are receiving MAO inhibitors or who have taken them within the last 14 days,

– in patients with epilepsy not adequately controlled by treatment,

– for use in narcotic withdrawal treatment.

Warnings and precautions: Tramadol may only be used with particular caution in opioid dependent patients, patients with head

injury, shock, a reduced level of consciousness of uncertain origin, disorders of the respiratory centre or function, increased

intracranial pressure. In patients sensitive to opiates Tramadol should only be used with caution. Care should be taken when

treating patients with respiratory depression, or if concomitant CNS depressant drugs are being administered, or if the

recommended dosage is significantly exceeded as the possibility of respiratory depression cannot be excluded in these situations.

Convulsions have been reported in patients receiving Tramadol at the recommended dose levels. The risk may be increased when doses

of Tramadol Hydrochloride exceed the recommended upper daily dose limit (400 mg). In addition, Tramadol may increase the seizure

risk in patients taking other medicinal products that lowers the seizure threshold. Patients with epilepsy or those susceptible to

seizures should only be treated with Tramadol if there are compelling circumstances. Tramadol has a low dependence potential. On

long-term use tolerance, psychic and physical dependence may develop. In patients with a tendency to drug abuse or dependence,

treatment with Tramadol should only be carried out for short periods under strict medical supervision. Tramadol is not suitable as

a substitute in opioid-dependent patients. Although it is an opioid agonist, Tramadol cannot suppress morphine

withdrawal symptoms.

Use in pregnancy and lactation: Animal studies with Tramadol revealed at very high doses effects on organ development,

ossification and neonatal mortality. Tramadol crosses the placenta. There is inadequate evidence available on the safety of

Tramadol in human pregnancy. Therefore Tramadol should not be used in pregnant women. Tramadol administered before or during

birth does not affect uterine contractility. In neonates it may induce changes in the respiratory rate which are usually not

clinically relevant. Chronic use during pregnancy may lead to neonatal withdrawal symptoms. During lactation about 0.1% of the

maternal dose is secreted into the milk. Tramadol is not recommended during breast-feeding. After a single administration

of Tramadol it is not usually necessary to interrupt breast-feeding.

Side effect: The most commonly reported adverse reactions are nausea and dizziness, both occurring in more than 10 % of patients.

Cardiovascular disorders: uncommon- cardiovascular regulation(palpitation, tachycardia, postural hypotension or cardiovascular

collapse). These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed,

rare- bradycardia, increase in blood pressure. Nervous system disorders: very common- dizziness, common- headache, somnolence,

rare- changes in appetite, paraesthesia, tremor, respiratory depression, epileptiform convulsions, involuntary muscle

contractions, abnormal coordination, syncope. If the recommended doses are considerably exceeded and other centrally depressant

substances are administered concomitantly, respiratory depression may occur. Epileptiform convulsions occurred mainly after

administration of high doses of Tramadol or after concomitant treatment with medicinal products which can lower the

seizure threshold, not known: speech disorders. Psychiatric disorders: rare- hallucinations, confusion, sleep disturbance, anxiety

and nightmares. Psychic adverse reactions may occur following administration of Tramadol which vary individually in intensity and

nature (depending on personality and duration of treatment). These include changes in mood (usually elation, occasionally

dysphoria), changes in activity (usually suppression, occasionally increase) and changes in cognitive and sensorial capacity (e.g.

decision behaviour, perception disorders). Dependence may occur. Eye disorders: rare- blurred vision, not known- mydriasis.

Respiratory disorders: rare- dyspnoea, worsening of asthma has been reported, though a causal relationship has not been

established. Gastrointestinal disorders: very common- nausea, commonconstipation, dry mouth, vomiting, uncommon- retching,

gastrointestinal irritation (a feeling of pressure in the stomach, bloating), diarrhea. Skin and subcutaneous tissue disorders:

commonsweating, uncommon- dermal reactions (e.g. pruritus, rash, urticaria). Musculo-skeletal disorders: rare- motorial weakness.

Hepatobiliary disorders: In a few isolated cases an increase in liver enzyme values has been reported in a temporal connection

with the therapeutic use of Tramadol. Renal and urinary disorders: rare- micturation disorders (difficulty in passing urine,

dysuria and urinary retention). General disorders: common- fatigue, rare- allergic reactions (e.g. dyspnoea, bronchospasm,

wheezing, angioneurotic oedema) and anaphylaxis; symptoms of withdrawal reactions, similar to those occurring during opiate

withdrawal, may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms.

Other symptoms that have very rarely been seen with Tramadol discontinuation include: panic attacks, severe anxiety,

hallucinations, paraesthesias, tinnitus and unusual CNS symptoms (i.e. confusion, delusions, depersonalization, derealization,

paranoia).

Drug interactions: Tramadol should not be combined with MAO inhibitors. In patients treated with MAO inhibitors in the 14 days

prior to the use of the opioid pethidine, life threatening interactions on the central nervous system, respiratory and

cardiovascular function have been observed. The same interactions with MAO inhibitors cannot be ruled out during treatment

with Tramadol. Concomitant administration of Tramadol with other centrally depressant medicinal products including alcohol may

potentiate the CNS effects. The results of pharmacokinetic studies have so far shown that on the concomitant or previous

administration of cimetidine (enzyme inhibitor) clinically relevant interactions are unlikely to occur. Simultaneous or

previous administration of carbamazepine (enzyme inducer) may reduce the analgesic effect and shorten the duration of action. The

combination with mixed agonist/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) and Tramadol is not advisable, because

the analgesic effect of a pure agonist like Tramadol may be theoretically reduced in such circumstances. Tramadol can

induce convulsions and increase the potential for selective serotonin re-uptake inhibitors, tricyclic antidepressants,

anti-psychotics and other seizure threshold-lowering medicinal products to cause convulsions. In isolated cases there have been

reports of serotonin syndrome in a temporal connection with the therapeutic use of Tramadol in combination with other

serotoninergic medicinal products such as selective serotonin re-uptake inhibitors (SSRIs) or with MAO inhibitors. Signs of

serotonin syndrome may be for example confusion, agitation, fever, sweating, ataxia, hyperreflexia, myoclonus and diarrhoea.

Withdrawal of the serotoninergic medicinal products usually brings about a rapid improvement. Treatment depends on the nature

and severity of the symptoms. Caution should be exercised during concomitant treatment with Tramadol and coumarin derivatives

(e.g. warfarin) due to reports of increased INR with major bleeding and ecchymoses in some patients. Other active substances known

to inhibit CYP3A4, such as ketoconazole and erythromycin, might inhibit the metabolism of Tramadol (Ndemethylation) probably also

the metabolism of the active O-demethylated metabolite. The clinical importance of such an interaction has not been studied. In a

limited number of studies the pre- or postoperative application of the antiemetic 5-HT3 antagonist ondansetron increased the

requirement of Tramadol in patients with postoperative pain.

Overdose: Symptoms: In principle, on intoxication with Tramadol symptoms similar to those of other centrally acting analgesics

(opioids) are to be expected. These include in particular miosis, vomiting, cardiovascular collapse, consciousness disorders up to

coma, convulsions and respiratory depression up to respiratory arrest. Treatment: The general emergency measures apply. Keep open

the respiratory tract (aspiration), maintain respiration and circulation depending on the symptoms. The antidote for respiratory

depression is naloxone. In animal experiments naloxone had no effect on convulsions. In such cases diazepam should be

given intravenously. In case of intoxication with oral formulations, gastrointestinal decontamination with activated charcoal or

by gastric lavage is only recommended within 2 hours after Tramadol intake. Gastrointestinal decontamination at a later time point

may be useful in case of intoxication with exceptionally large quantities or prolonged-release formulations. Tramadol is minimally

eliminated from the serum by haemodialysis or haemofiltration. Therefore treatment of acute intoxication with Tramadol with

haemodialysis or haemofiltration alone is not suitable for detoxification.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Utramal capsule: Cartons containing 30 capsules in blister.

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