Tramadex OD

/ Dexcel

The dosage should be adjusted according to the severity of pain and the response of the individual patient.
The tablets should be swallowed whole, with a sufficient quantity of liquid and not divided or chewed. The tablets can be taken with or without food.
Alternative tablet strengths of this drug are available. Where necessary, appropriate tablet strengths should be used to achieve the required dose.
This drug should be taken once every 24 hours as follows:
Adults and adolescents (14 years and over): The starting dose is one 100 mg prolonged-release tablet once daily. The usual dose is one 200 mg prolonged-release tablet once daily, to be taken preferably in the evening. If this does not provide sufficient pain relief, the dosage can be increased in 100 mg dose increments to 300 mg or to a maximum of 400 mg once daily.
In general, the lowest effective analgesic dose should be chosen. A daily dose of 400 mg of tramadol should not be exceeded except in special clinical cases.
this drug should not be used for a period longer than absolutely necessary. If continued pain treatment is necessary due to the nature and severity of the illness, careful regular surveillance should be carried out (including periods without treatment, if necessary) in order to determine the need for continued treatment.
Children (under 14): This drug is not recommended for the treatment of children (under 14 years of age).
Elderly patients: Dose adjustment in elderly patients (up to 75 years of age) without clinically relevant hepatic or renal impairment is normally not necessary. In patients over 75 years, the elimination half-life of tramadol may be prolonged. Use in these patients is not recommended.
Renal impairment, dialysis and hepatic impairment: 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 considered according to the patient’s requirements. This drug is not recommended for patients with severe hepatic impairment or with severe renal impairment (creatinine clearance <10 ml/min). Caution is advised in patients with moderate hepatic or moderate renal impairment (creatinine clearance <30 ml/min).
Method of administration: The tablets should be swallowed whole, with a sufficient quantity of liquid and not divided or chewed. The tablets can be taken with or without food.
For full details see prescribing information

Treatment of moderate to severe pain.

Known hypersensitivity to tramadol, any of the excipients or opioids.
Acute intoxication or overdose with CNS depressants (alcohol, hypnotics, other opioid analgesics, etc.).
Patients receiving concomitant treatment with MAO inhibitors or who have been treated with MAO inhibitors during the past 2 weeks.
Concomitant treatment with linezolid .
Severe hepatic or severe renal impairment (creatinine clearance < 10ml/min).
Epilepsy not adequately controlled by treatment.
Tramadol must not be administered during breastfeeding if long-term treatment, i.e. more than 2 to 3 days, is necessary.
This drug  is contraindicated in patients with significant respiratory depression in unmonitored settings or the absence of resuscitative equipment.
It is also contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment.
Do not prescribe this drug for patients who are suicidal or addiction-prone.
For full details see prescribing information.

Consumption of alcohol is not recommended during treatment with tramadol. Concomitant treatment with carbamazepine is not recommended.
With long-term use, tolerance and psychological and/or physical dependence may develop, even at therapeutic doses. Because of the potential for dependence or withdrawal to occur, the clinical need for continued analgesia should be reviewed regularly. In patients with a tendency to drug abuse or dependence, tramadol should only be used for short periods under strict medical surveillance.
Tramadol is an opioid agonist of the morphine type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.
Like other opioid agonists, legal or illicit, tramadol can be abused. This should be considered when prescribing or dispensing it in situations where the healthcare professional is concerned about a risk of misuse, abuse, or diversion.
This drug  could be abused by breaking, crushing, chewing, or dissolving the product which can result in the uncontrolled delivery of the opioid, and as a consequence poses a significant risk of overdose and death.
Concerns about abuse, addiction, and diversion should not prevent the proper management of pain.
Tramadol is not suitable as a substitute in opioid dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms. At therapeutic doses, withdrawal symptoms have been reported with a frequency of 1 in 8,000  while reports of dependence and abuse have been less frequent.
Withdrawal symptoms may occur if Tramadex OD is discontinued abruptly. Generally, tolerance and/or withdrawal are more likely to occur the longer a patient is on continuous opioid therapy. Clinical experience suggests that signs and symptoms of withdrawal may be avoided by tapering medication when discontinuing tramadol therapy.
Suicide Risk: Do not prescribe it  for patients who are suicidal or addiction-prone.
• Prescribe it with caution for patients who are taking tranquilizers or antidepressant drugs and patients who use alcohol in excess and who suffer from emotional disturbance Serious potential consequences of overdose with Tramadex OD are central nervous system depression, respiratory depression and death. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment.
Respiratory depression or patient taking CNS depressants: Caution is recommended with administration of tramadol in patients at risk for respiratory depression or receiving medicinal products likely to produce respiratory depression. In these patients, alternative non-opioid analgesics should be considered. When large doses of tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. Respiratory depression should be treated as an overdose. If naloxone is to be administered, use cautiously because it may precipitate seizures.
For full details see prescribing information.

The most commonly reported undesirable effects, nausea and dizziness, have been observed in more than 10% of
patients.
Cardiac disorders: Uncommon (≥1/1,000, <1/100): effects on cardiovascular regulation (palpitations, tachycardia, orthostatic hypotension or cardiovascular collapse). These undesirable effects occur in particular after intravenous administration and in patients undergoing physical exertion. Rare (≥1/10,000, <1/1,000): bradycardia, increase in blood pressure.
Not known (cannot be estimated from the available data): hypotension.
Nervous system disorders: Very common (≥1/10): dizziness.
Common (≥1/100, <1/10): headaches, confusion, tremor, Somnolence, vertigo.
Rare (≥1/10,000, <1/1,000): changes in appetite, paraesthesia, respiratory depression, epileptiform seizures.
Respiratory depression may occur if the quantities administered greatly exceed the recommended doses and in the case of concomitant administration of other CNS depressant medicinal products.
Epileptiform seizures primarily occurred following administration of high doses of tramadol or following concomitant treatment with medicinal products that lower the seizure threshold or trigger seizures.
Not known (cannot be estimated from the available data): loss of consciousness, ataxia, disturbance in attention, dysarthria, gait abnormal, headache aggravated, mental impairment, sedation, sleep apnea syndrome, syncope.
Psychiatric disorders: Common (≥1/100, <1/10): anxiety, insomnia
Rare (≥1/10,000, <1/1,000): hallucinations, confusion, sleep disturbance, nightmares.
After the administration of tramadol, in rare cases, various psychiatric adverse events may occur, the nature and severity of which vary between patients (depending on the individual reactivity and the duration of treatment). Mood disorders (usually euphoria, occasionally dysphoria), changes in activity (usually reduced activity, occasionally an increase) and, altered cognitive and sensory capacities (for example the ability to make decisions, perception problems) may be observed. Dependence and drug abuse may occur.
Not known (cannot be estimated from the available data): abnormal behavior, agitation, depression, emotional disturbance, euphoric mood, indifference, irritability, libido decreased, nervousness.
Eye disorders:  Rare (≥1/10,000, <1/1,000): blurred vision.
Not known (cannot be estimated from the available data): visual disturbance.
Respiratory, thoracic and mediastinal disorders: An aggravation of asthma has been reported although a causal relationship was not confirmed.
Not known (cannot be estimated from the available data): dyspnea.
Gastrointestinal disorders: Very common (≥1/10): nausea, constipation.
Common (≥1/100, <1/10): vomiting, dry mouth, diarrhea, dyspepsia, abdominal pain. Uncommon (≥1/1,000, <1/100): gastro-intestinal irritation (a feeling of gastric heaviness, flatulence). Not known (cannot be estimated from the available data): abdominal discomfort, abdominal distension, abdominal tenderness, change in bowel habit, constipation aggravated, diverticulitis, diverticulum, dyspepsia aggravated, dysphagia, fecal impaction, gastric irritation, gastritis, gastrointestinal hemorrhage, gastro-esophageal reflux disease, lower abdominal pain, pancreatitis aggravated, rectal hemorrhage, rectal prolapse, retching, blood in stool.
Skin and subcutaneous tissue disorders: Common (≥1/100, <1/10): sweating, pruritus. Uncommon (≥1/1,000, <1/100): dermal reactions (for example, rash, urticaria). Not known (cannot be estimated from the available data): allergic dermatitis, cold sweat, dermatitis, night sweats, pallor, generalized pruritus.
Musculoskeletal and connective tissue disorders: Common (≥1/100, <1/10): arthralgia. Rare (≥1/10,000, <1/1,000): muscular weakness.
For full details see prescribing information

Concomitant medication contraindicated during treatment with tramadol: Tramadol must not be used in combination with selective or nonselective MAO inhibitors. Serotonin Syndrome (diarrhoea, tachycardia, sweating, tremor, confusion and coma) may develop.
Linezolid: Treatment experience with non-selective MAOI indicates a risk of development of Serotonin Syndrome: diarrhoea, tachycardia, sweating, tremor, confusion and coma.
Concomitant medication not recommended during treatment with tramadol: Mixed agonist-antagonists (buprenorphine, nalbuphine and pentazocine): Concomitant treatment with tramadol is not recommended because theoretically, this could reduce the analgesic effects of the pure agonist due to competitive blocking of receptors, resulting in the risk of occurrence of withdrawal symptoms.
Alcohol: Alcohol increases the sedative effect of opioid analgesics. The resulting drowsiness can be dangerous while driving or operating machinery. Alcoholic beverages and medicinal products containing alcohol should not be consumed during treatment with tramadol. dangerous while driving or operating machinery. Alcoholic beverages and medicinal products containing alcohol should not be consumed during treatment with tramadol.
For full details see prescribing information.

Fertility: No fertility studies have been conducted with this drug.
Pregnancy: Tramadol should not be used during pregnancy unless clearly necessary. In humans, there is insufficient data available to appropriately assess the safety of tramadol use in pregnant women.
As with other opioid analgesics: Tramadol crosses the placental barrier, At the end of pregnancy, high dosages, even for short-term treatment, may induce respiratory depression in the newborn.
Neonatal seizures, neonatal withdrawal syndrome, fetal death and stillbirth have been reported during post-marketing surveillance of tramadol immediate-release products. The effect of Tramadex OD, if any, on the later growth, development and functional maturation of the child is unknown.
Animal studies have not shown any teratogenic effects, but at high doses, foetotoxicity due to maternotoxicity appeared.
Lactation: Tramadex OD is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.
Tramadol and its metabolites have been detected in human breast milk in small amounts. An infant could ingest 0.1% of the single dose given to the mother. A single administration of tramadol does not usually require breastfeeding to be interrupted. If repeated administration is needed for several days, i.e. more than 2 to 3 days, breastfeeding should be suspended. If long-term treatment after birth is necessary, breastfeeding is contraindicated.

Symptoms: In tramadol intoxication, in principle, the same symptoms occur as for all other central acting analgesics (opioids). In particular, these include miosis, vomiting, cardiovascular collapse, loss of consciousness leading to coma, convulsions, respiratory depression leading to respiratory failure, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, bradycardia, hypotension, central nervous system depression, and death.
Unexpected effect of overdose: serotonin syndrome has been reported in a context of overdose or abuse with tramadol.
Death due to overdose have been reported with abuse and misuse of tramadol, by ingesting, inhaling, or injecting the crushed tablets. The risk of fatal overdose is further increased when tramadol is abused concurrently with alcohol and other CNS depressants, including other opioids.
Treatment: In the treatment of tramadol overdose, primary attention should be given to the re-establishment of a patient airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.
Emptying of the stomach by means of vomiting (patient to be conscious) or by means of pumping the stomach. Gastric lavage can be considered if the ingestion of overdose is very recent. This must not delay the (repeated) administration of activated charcoal to prevent the absorption of tramadol.
While naloxone will reverse some (but not all) symptoms caused by overdose with tramadol, the risk of seizures is also increased with naloxone administration. In animals, convulsions following the administration of toxic doses of tramadol could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice.
Tramadol is only minimally removed from plasma using haemodialysis or haemofiltration. Therefore treatment of acute overdose of tramadol using haemodialysis or haemofiltration alone is not a suitable way of detoxification.

Shelf-life: 3 years
Storage: Store below 25°C.