TRADE NAMES OF TRAMADOL / PARACETAMOLÂ IN KENYA
Dolafree-P®, Galaxy Pharmaceutical Ltd
Febrex TM®, Indoco Remedies Limited
Strom P®, Lincoln Pharmaceuticals Ltd
Tramacet®, Janssen Pharmaceutica pty Ltd
Tramacetal®, Catchet Pharmaceuticals Pvt Ltd
Trap®, Cadila Healthcare Limited
Ultramol®, Pharmaken Ltd
Zamadol P®, Macleods Pharmaceuticals Limited
MODE OF ACTION
The mechanism of action for Tramadol is not exactly known. But it is known to act on the mu-opioid receptors to produce pain relief.
Paracetamol has a central analgesic effect that is mediated through the activation of descending serotonergic pathways. Debate exists about its primary site of action, which may be inhibition of prostaglandin (PG) synthesis or through an active metabolite influencing cannabinoid receptors.
INDICATIONS
Tramadol hydrochloride/Paracetamol tablets are indicated for the symptomatic treatment of moderate to severe pain.
The use of Tramadol hydrochloride/Paracetamol should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol
DOSAGE AND ADMINISTRATION
The use of Tramadol Hydrochloride/Paracetamol should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol.
The dose should be adjusted to the intensity of pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total dose of 300 mg tramadol hydrochloride and 2600 mg paracetamol per day should not be exceeded. The dosing interval should not be less than six hours.
CONTRAINDICATIONS
– Hypersensitivity to the active substance or to any of the excipients.
– acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs,
– Tramadol hydrochloride/Paracetamol should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal,
– severe hepatic impairment,
– epilepsy not controlled by treatment
DRUG INTERACTIONS
Concomitant use is contraindicated with:
• Non-selective MAO Inhibitors
Risk of the serotonergic syndrome: diarrhea, tachycardia, hyperhidrosis, trembling, confusional state, even coma.
• Selective-A MAO Inhibitors
Extrapolation from non-selective MAO inhibitors
Risk of the serotonergic syndrome: diarrhea, tachycardia, hyperhidrosis, trembling, confusional state, even coma.
• Selective-B MAO Inhibitors
Central excitation symptoms are evocative of a serotonergic syndrome: diarrhea, tachycardia, hyperhidrosis, trembling, confusional state, even coma.
In the case of recent treatment with MAO inhibitors, a delay of two weeks should occur before treatment with tramadol
Concomitant use is not recommended with:
• Alcohol
Alcohol increases the sedative effect of opioid analgesics.
The effect on alertness can make driving of vehicles and the use of machines dangerous.
Avoid the intake of alcoholic drinks and of medicinal products containing alcohol.
• Carbamazepine and other enzyme inducers
Risk of reduced efficacy and shorter duration due to decreased plasma concentrations of tramadol.
• Opioid agonists-antagonists (buprenorphine, nalbuphine, pentazocine)
Decrease of the analgesic effect by competitive blocking effect at the receptors, with the risk of occurrence of withdrawal syndrome.
Concomitant use which needs to be taken into consideration:
• Tramadol can induce convulsions and increase the potential for selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, antipsychotics, and 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:
o Spontaneous clonus
o Inducible or ocular clonus with agitation or diaphoresis,
o Tremor and hyperreflexia
o 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.
• Other opioid derivatives (including antitussive drugs and substitutive treatments)
Increased risk of respiratory depression which can be fatal in cases of overdose.
• Other central nervous system depressants, such as other opioid derivatives (including antitussive drugs and substitutive treatments), other anxiolytics, hypnotics, sedative antidepressants, sedative antihistamines, neuroleptics, centrally-acting antihypertensive drugs, thalidomide, and baclofen.
These drugs can cause increased central depression. The effect on alertness can make driving of vehicles and the use of machines dangerous.
• Sedating medicinal products such as benzodiazepines or related substances:
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 additive CNS depressant effects. The dose and duration of the concomitant use should be limited.
• As medically appropriate, periodic evaluation of prothrombin time should be performed when Tramadol hydrochloride/Paracetamol and warfarin like compounds are administered concurrently due to reports of increased INR.
• 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.
ADVERSE EFFECTS
Cardiac disorders:
• Uncommon: palpitations, tachycardia, arrhythmia.
Eye disorders:
• Rare: vision blurred, miosis, mydriasis
Ear and labyrinth disorders:
• Uncommon: tinnitus
Gastrointestinal disorders:
• Very common: nausea
• Common: vomiting, constipation, dry mouth, diarrhea abdominal pain, dyspepsia, flatulence
• Uncommon: dysphagia, melaena
General disorders and administration site conditions:
• Uncommon: chills, chest pain
Investigations:
• Uncommon: transaminases increased
Metabolism and nutrition disorders:
• Unknown: hypoglycemia
Nervous system disorders:
• Very common: dizziness, somnolence
• Common: headache trembling
• Uncommon: involuntary muscular contractions, paraesthesia, amnesia
• Rare: ataxia, convulsions, syncope, speech disorders.
Psychiatric disorders:
• Common: confusional state, mood altered, anxiety, nervousness, euphoric mood), sleep disorders
• Uncommon: depression, hallucinations, nightmares
• Rare: delirium, drug dependence.
Reporting of suspected adverse reactions:
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 authorization of the medicinal product are 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 Yellow Form, pv@pharmacyboardkenya.org or clicking below button:
Tramadol / Paracetamol In Kenya
Tramadol / Paracetamol In Kenya
Tramadol / Paracetamol In Kenya
Tramadol / Paracetamol In Kenya
Tramadol / Paracetamol In Kenya
Clinical | Pharmacokinetic data
Pregnancy Category: C
Routes of Administration: Oral
Bioavailability: Not available
Protein Binding: Not available
Metabolosim: Not available
Onset of Action: Not available
Elimination Half life: Not available
Excretion: Not Available
Legal Status | Dosage forms & Strengths
Prescription Category:
Prescription only Medicine (POM) , â„ž-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This is a controlled Schedule 1 Drug ,Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:
Tablets
Drug Indentifiers:
Drug Images