Utramal Capsule 50mg10 capsules
Utramal capsule: Green cap and yellow body capsule, imprinted with and ‘UTRAMAL’; each capsule contains Tramadol Hydrochloride BP
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
– 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
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,
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.
Store in a cool and dry place, protected from light.
Utramal capsule: Cartons containing 30 capsules in blister.