Adamon SR 200: composition and dosage form
One prolonged-release capsule contains 50 mg, 100 mg, 150 mg or 200 mg of tramadol hydrochloride. The four strengths cover the whole working range, and the prolonged-release form sets the rhythm: the medicine is taken twice a day, independently of meals.
The capsule is swallowed whole with water. For those who find swallowing difficult there is a way round it: the capsule may be carefully opened and its contents — the granules — tipped onto a teaspoon, then the spoon is placed in the mouth and the granules swallowed with enough water. The granules must not be chewed or crushed.
How Adamon SR 200 works
Tramadol is a centrally acting opioid analgesic with opioid receptor agonist activity. The most interesting thing is that it works in two different ways at once, because it exists as two enantiomers. The (+) isomer shows predominantly opioid activity through its affinity for the μ receptor, while the (−) isomer enhances its analgesic action and at the same time works as an inhibitor of noradrenaline and serotonin reuptake, modifying the transmission of pain impulses.
Much of what follows flows from that duality — the interactions with antidepressants and the risk of serotonin toxicity. Tramadol also has an antitussive action. Its effect on the respiratory centre and the circulation at recommended doses appears clinically insignificant, and the strength of its action corresponds to between one tenth and one sixth of that of morphine.
Indications
The indication is put in a single sentence: the preparation is used in treating pain of moderate and severe intensity. Neither the cause of the pain nor its site is specified — the only criterion is severity.
From that wording follows the practical rule set out in the dosage section: the smallest dose that effectively relieves the pain should be given, and it should be matched to the severity of the pain and to the patient's individual response. The starting point is not the diagnosis but the result.
Method of administration and dosage
For adults and adolescents over 12 the usual starting dose is 50–100 mg twice a day, morning and evening. Depending on the severity of the pain it may be raised to 150–200 mg twice a day, but the maximum daily dose of 400 mg must not be exceeded. Beyond that the regimen is changed only by age and by the state of the kidneys and liver, and what changes is not the dose itself but the interval between doses: up to the age of 75, where there are no clinical signs of renal or hepatic impairment, nothing usually needs adjusting, while after 75 elimination of the medicine may be delayed and the interval is lengthened according to the patient's needs. The same is done in renal or hepatic impairment and on dialysis. In severe hepatic and renal impairment the medicine is not recommended, and children under 12 are not given it at all — there are no data on safety and efficacy for them.
Long-term treatment is dealt with separately. If it is necessary because of the nature and severity of the disease, the patient is monitored carefully and closely, with breaks in treatment where needed, so that possible changes in dosage are identified in good time. The breaks are not a formality here: they are precisely what shows whether the previous dose is still needed.
Contraindications
The first prohibition is the ordinary one: hypersensitivity to the active substance or to any excipient. The second concerns acute poisoning — with hypnotics, centrally acting analgesics, opioids, psychotropic medicines or alcohol. The third is tied to monoamine oxidase inhibitors: taking them at the same time, and the 2 weeks after they are stopped, close the door to tramadol completely.
The remaining three prohibitions are connected with one another and explain the limits of the medicine. Tramadol is contraindicated during concurrent treatment of opioid dependence. It should not be used to treat the withdrawal syndrome after stopping narcotics. And finally it is contraindicated in uncontrolled epilepsy — because it is itself capable of lowering the seizure threshold.
Special warnings and precautions
The product information opens with a cautious formulation: tramadol is a medicine with a low potential for dependence. With long-term use, however, tolerance and psychological and physical dependence may develop, and in rare cases withdrawal symptoms were observed even after therapeutic doses. In patients with a tendency to misuse medicines, treatment is given with breaks and under the doctor's strict supervision. And separately: the medicine is not suitable for people dependent on opioids — although it is an opioid receptor agonist, it does not relieve morphine withdrawal symptoms.
- seizures: in isolated cases they were reported after therapeutic doses, and the risk grows with the dose; patients with epilepsy or prone to seizures are given tramadol only where it is absolutely necessary, and the risk is higher when other medicines that lower the seizure threshold are taken at the same time;
- alcohol must not be drunk during treatment with tramadol;
- caution is needed in disorders of consciousness of unknown origin, severe hepatic or renal impairment, raised intracranial pressure from head injury and brain disease, disorders of the respiratory centre, and in shock;
- at the recommended therapeutic doses the medicine does not cause breathing disturbances, but in respiratory disease, with excess bronchial secretion and alongside medicines that depress the central nervous system, it can slow breathing;
- the composition includes sucrose, so in the rare hereditary disorders — fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency — it should not be taken.
On driving the wording is firmer than for most medicines: the product may have a considerable effect on the ability to drive and to operate machinery. It causes drowsiness, and that is intensified by alcohol, antihistamines and other medicines that depress the central nervous system. The rule is simple: if drowsiness appears, do not get behind the wheel.
Interaction with other medicines
The two main mechanisms of tramadol's interactions follow from its dual nature: it lowers the seizure threshold and it interferes with serotonin metabolism. Hence two groups of risk — seizures and serotonin toxicity — and both involve the same psychotropic medicines.
| With what | What happens |
| Medicines that lower the seizure threshold | tramadol itself provokes seizures and increases the risk of seizures caused by them; this covers antidepressants of both groups, antipsychotics, bupropion, mirtazapine and tetrahydrocannabinol |
| Serotonergic medicines, including MAO inhibitors | serotonin toxicity is possible; the diagnosis is likely with spontaneous, inducible or ocular clonus together with agitation or profuse sweating, tremor and hyperreflexia, increased muscle tone and a temperature above 38 °C |
| MAO inhibitors and the 2 weeks after they are stopped | with opioids, life-threatening interactions affecting the central nervous system, the respiratory centre and the circulation have been described; the same cannot be ruled out for tramadol |
| Medicines acting on the central nervous system, and alcohol | mutual enhancement of effect |
| Carbamazepine | markedly lowers the serum concentration of tramadol, weakening the analgesia and shortening it |
| Ritonavir | raises the serum concentration of tramadol to the point of a toxic effect |
| Coumarin derivatives, warfarin for example | cases of a rise in INR with major bleeding and bruising have been described — caution is needed |
| Agonist-antagonists: buprenorphine, nalbuphine, pentazocine | the combination is not recommended — the analgesic action of a pure agonist may weaken |
Three interactions turned out weaker than might have been expected. With digoxin, its own unwanted effects were observed rarely; the changes in tramadol concentration with cimetidine proved clinically insignificant and did not call for a dose change; and no interaction with food was observed at all. One observation from surgery stands apart: in patients with postoperative pain who were given ondansetron as an antiemetic, the need for tramadol increased.
Pregnancy and breastfeeding
There are no sufficient data on the use of tramadol in pregnant women, and the potential risk to humans is not known. Hence the cautious formulation: the product must not be used during pregnancy unless it is absolutely necessary.
About labour and the first days more is said. Giving tramadol before or during labour does not affect uterine contractility. In newborns the product may cause changes in the breathing rate that are usually of no clinical significance. During breastfeeding it should not be used: tramadol and its metabolites are detected in breast milk, into which about 0.1% of the administered dose passes.
Adverse effects
Two reactions occur more often than all the others and both very commonly, that is in more than 10% of patients: nausea and dizziness; vomiting also belongs to the very common ones. Commonly recorded are headache, drowsiness, constipation, dry mouth, sweating and fatigue.
- uncommon: cardiac rhythm disturbances and tachycardia, which may appear particularly after physical exertion; circulatory collapse and orthostatic hypotension; retching, gastrointestinal complaints, a feeling of pressure in the stomach area and of fullness; skin reactions — itching, rash, urticaria;
- rare: change in appetite; bradycardia and a rise in blood pressure; blurred vision; motor weakness; disturbances of micturition up to urinary retention; psychiatric disturbances of varying severity, depending on the patient's personality and the length of treatment — mood changes, changes in activity, changes in cognitive and sensory function, hallucinations, confusion, sleep disturbance and nightmares;
- very rare: allergic and anaphylactic reactions — breathlessness, bronchospasm, wheezing, angioedema; epileptic seizures after high doses or with medicines that lower the seizure threshold; tremor; a spinning sensation; sudden flushing of the face;
- unknown frequency: hypoglycaemia; in isolated cases a rise in liver enzyme activity was recorded, as were cases of asthma exacerbation whose causal link with the medicine has not been established.
Long-term use may lead to dependence, and then withdrawal symptoms resembling opioid ones are possible: agitation, anxiety, nervousness, insomnia, hyperkinesia, muscle tremors and stomach and bowel disturbances. Respiratory depression was observed when the recommended dose was considerably exceeded and when medicines depressing the central nervous system were taken at the same time.
Overdose
The symptoms of tramadol overdose are typical of opioid analgesics: vomiting, pinpoint pupils, sedation, generalised epileptic seizures, breathing disturbances up to respiratory arrest, a fall in blood pressure with circulatory failure, and coma.
Treatment consists in maintaining respiration and the working of the circulatory system. For respiratory depression naloxone is given, and for seizures diazepam is considered — and there is a subtlety here worth remembering: the use of naloxone may increase the risk of seizures occurring. Haemodialysis and haemofiltration are not suitable for treating acute overdose: by those methods tramadol is removed from the serum too slowly.
How to get a prescription for Adamon SR 200 online
Tramadol holds an unusual place among analgesics: in strength it corresponds to roughly one tenth to one sixth of morphine, yet at the same time it lowers the seizure threshold and interferes with serotonin metabolism. That is why the main question when prescribing is not "how badly does it hurt" but what else you are taking: the list of psychotropic medicines incompatible with tramadol is longer than for most analgesics. On e-zdrowie.com you fill in a medical questionnaire, the doctor reviews the answers and, if the medicine is suitable, issues an electronic prescription: the code arrives by message, and any Polish pharmacy will dispense the capsules against it.
Begin the questionnaire with antidepressants and other psychotropic medicines: name them all — SSRIs, serotonin and noradrenaline reuptake inhibitors, tricyclics, antipsychotics, bupropion, mirtazapine — and also MAO inhibitors, including any you stopped less than two weeks ago: that is a direct contraindication. Report epilepsy and any past seizures separately. Describe the pain: what causes it, how long it has lasted and what you have already tried against it. Give your creatinine and liver tests if you have them: in severe impairment the medicine is not recommended, and in moderate impairment the interval between doses is lengthened. State your age — after 75 the regimen is different. And list your other medicines: carbamazepine weakens the analgesia, ritonavir increases toxicity, and warfarin calls for INR monitoring.
