BRANDS / TRADE NAMES OF TRAMADOL IN KENYA
Anadol ,Square Pharmaceuticals Ltd.
Cipadol, Cipla Ltd
Dolafree, Galaxy Pharmaceutical Limited
Dolonil , The ACME Laboratories Ltd
Domadol , Unichem Laboratories Ltd.
E-Dol, Sakar Healthcare Ltd.
Essmadol, Essar K Ltd
Kridol, Krishna Chemists Ltd
Metadol , National Pharmacy Ltd
Ramgic , MSN Laboratories Private Limited
Sacmol, ESSAAR Ltd
Strom, Lincoln Pharmaceuticals Ltd
Takol ,Raptakos Brett & Co. Ltd
Tenadol, Shambhuprasad and Sons
Trabilin ,Acino Pharma AG
Tradmin , Unosource Pharma Limited
Tramadex ,Laborate Pharmaceuticals India Limited
Tramadol ,Kilitch Drugs (India) Ltd.
Tramadol Denk , Denk Pharma Gmbh & Co. KG
Tramadol-Hameln, Hameln pharma plus
Tramafred , Crown healthcare
Tramal , Janssen Pharmaceutica pty Ltd
Tramamed , Medisel Kenya Ltd
Tramavent , Sai Pharmaceuticals Limited
Tramaz , Zawadi Healthcare Ltd
Tramsun , Zawadi Healthcare Ltd
Trasic ,kopran Limited
TRD Contin , Modi Mundipharma Private Limited
Unitram , Medisel Kenya Ltd
Upmadol , Harleys Limited
Urgendol, Win Medicare Private Limited
Utram , Umedica Laboratories Pvt Ltd
Zimadol, Zim Laboratories Ltd
MODE OF ACTION
Tramadol is a centrally acting analgesic with a multimode of action. It acts on serotonergic and noradrenergic nociception, while its metabolite O-desmethyltramadol acts on the µ-opioid receptor. Its analgesic potency is claimed to be about one tenth that of morphine.
Treatment of moderate to severe pain.
DOSAGE AND ADMINISTRATION
The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected.
Unless otherwise prescribed, Tramadol should be administered as follows:
Adults and children aged 12 years and over
Acute pain: An initial dose is 50-100 mg depending on the intensity of pain. This can be followed by doses of 50 or 100 mg 4-6 hours later, and the duration of therapy should be matched to clinical needs. A total daily dose of 400 mg should not be exceeded except in special clinical circumstances.
Pain associated with chronic conditions: Use an initial dose of 50 mg and then titrate dose according to pain severity. The initial dose may be followed if necessary by 50-100 mg every 4-6 hours. The recommended doses are intended as a guideline. Patients should always receive the lowest dose that provides effective pain control. A total daily dose of 400 mg should not be exceeded except in special clinical circumstances. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported
Tramadol capsules are not suitable for children below the age of 12 years.
A dose adjustment is not usually necessary in 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 patient’s requirements.
Renal insufficiency/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. In cases of severe renal and/or severe hepatic insufficiency tramadol are not recommended.
Tramadol is contraindicated:
– in hypersensitivity to tramadol hydrochloride or any of the excipients.
– in acute intoxication with alcohol, hypnotics, analgesics, opioids, or 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.
Tramadol should not be combined with MAO inhibitors
In patients treated with MAO inhibitors in the 14 days before 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 are not advisable, because of the analgesic effect of a pure agonist may be theoretically reduced in such circumstances.
Tramadol can induce convulsions and increase the potential for selective serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic anti-depressants, anti-psychotics and other seizure threshold lowering medicinal products (such as bupropion, mirtazapine, tetrahydrocannabinol) to cause convulsions.
Concomitant therapeutic use of tramadol and serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), MAO inhibitors, tricyclic antidepressants, and mirtazapine may cause serotonin toxicity. Serotonin syndrome is likely when one of the following is observed: Spontaneous clonus
- Inducible or ocular clonus with agitation or diaphoresis
- Tremor and hyperreflexia
- Hypertonia and body temperature; 38°C and inducible or ocular clonus.
Withdrawal of the serotonergic drugs usually brings about a rapid improvement. Treatment depends on the type 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 medicinal products known to inhibit CYP3A4, such as ketoconazole, ritonavir, and erythromycin, might inhibit the metabolism of tramadol (N-demethylation) and 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.
Sedative medicines such as benzodiazepines or related drugs:
The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma, and death because of the additive CNS depressant effect. The dose and duration of concomitant use should be limited
Rare: Hallucinations, confusion, sleep disturbance, anxiety, and nightmares. Psychic side-effects may occur following the administration of tramadol, which varies individually in intensity and nature (depending on personality and duration of medication). These include changes in mood (usually elation, occasionally dysphoria), changes in activity (mostly reduced, occasionally increased), and changes in cognitive and sensorial ability (e.g. decision behavior, perception disorders). Dependence may occur.
Nervous system disorders
Very common: Dizziness.
Common: Headache, somnolence.
Rare: Changes in appetite, paraesthesia, tremor, respiratory depression, epileptiform convulsions, abnormal coordination, involuntary muscle contractions, 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
Rare: Blurred vision.
Uncommon:Cardiovascular regulation (palpitations, tachycardia, postural hypotension or cardiovascular collapse). These adverse effects may occur especially in connection with intravenous administration and if the patient is experiencing physical stress.
Rare: Bradycardia, increased blood pressure.
Metabolism and nutrition disorders
Not known: hypoglycemia
Respiratory, thoracic and mediastinal disorders
Frequency not known: Worsening of asthma has been reported, though a causal relationship has not been established.
Very common: Nausea.
Common: Vomiting, constipation, dry mouth.
Uncommon: Retching; gastrointestinal irritation (a feeling of pressure in the stomach, bloating), diarrhea.
Frequency not known: In a few isolated cases an increase in liver enzyme values has been reported in a temporal connection with the therapeutic use of tramadol.
Skin and subcutaneous tissue disorders
Uncommon: Dermal reactions (e.g. pruritus, rash, urticaria).
Musculoskeletal and connective tissue disorders
Rare: Motorial weakness.
Renal and urinary disorders
Rare: Micturition disorders (difficulty in passing urine and urinary retention).
Rare: Allergic reactions (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic edema) 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).
Reporting a Suspected Drug Reaction:
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Forms , firstname.lastname@example.org or clicking below button:
Tramadol hydrochloride may induce psychic and physical dependence of the morphine-type (μ-opioid).
Dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug are not limited to those patients with prior history of opioid dependence. The risk in patients with substance abuse has been observed to be higher. Tramadol hydrochloride is associated with craving and tolerance development. Withdrawal symptoms may occur if tramadol hydrochloride is discontinued abruptly. These symptoms may include anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely hallucinations. Other symptoms that have been seen less frequently with tramadol hydrochloride discontinuation include panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be relieved by reinstitution of opioid therapy followed by a gradual, tapered dose reduction of the medication combined with symptomatic support.
Clinical | Pharmacokinetic data
Pregnancy Category: C
Routes of Administration: By mouth , I.V , I.M , Rectal
Bioavailability: 70–75% (by mouth), 77% (rectal), 100% (IM)
Protein Binding: 20%
Metabolosim: Liver-mediated demethylation and glucuronidation via CYP2D6 & CYP3A4
Onset of Action: Less than 1 hour (by mouth)
Elimination Half life: 6.3 ± 1.4 h
Excretion: Urine (95%)
Legal Status | Dosage forms & Strengths
Prescription only Medicine (POM) , ℞-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
Schedule 1 ,Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:
|CompTox Dashboard (EPA)|
- Bamigbade, T. A., and R. M. Langford. “The clinical use of tramadol hydrochloride.” Pain reviews 5 (1998): 155-182.
- Tiwari, Sandip B., et al. “Controlled release formulation of tramadol hydrochloride using hydrophilic and hydrophobic matrix system.” aaps Pharmscitech 4.3 (2003): 18-23.
- Cicero, Theodore J., et al. “A postmarketing surveillance program to monitor Ultram®(tramadol hydrochloride) abuse in the United States.” Drug and alcohol dependence 57.1 (1999): 7-22.
- Sunshine, Abraham, et al. “Analgesic oral efficacy of tramadol hydrochloride in postoperative pain.” Clinical Pharmacology & Therapeutics 51.6 (1992): 740-746.
- Bamigbade, T. A., and R. M. Langford. “Tramadol hydrochloride: an overview of current use.” Hospital medicine (London, England: 1998) 59.5 (1998): 373-376.