Medicase - Fapdol - Tablet - 325mg+37.5mg - Paracetamol + Tramadol Hydrochloride

Fapdol325mg+37.5mg

Type:Tablet

Generic Name:Paracetamol + Tramadol Hydrochloride

Manufacturer:Beacon Pharmaceuticals Ltd.

Price:৳8.00

Indication

Moderate to severe pain

Administration

May with or without food.

Adult Dose

Oral Moderate to severe pain Adult: 1-2 tab 6 hrly. Max: 8 tab/day. Max duration: 5 days. Hepatic impairment: Moderate: Increase dosing interval. Severe: Contraindicated.

Child Dose

Not recommended in child under 18 years of age.

Renal Dose

Renal impairment: CrCl (ml/min) Dosage Recommendation 10-30 Increase dosing interva to 12 hr.ly <10 Not recommended.

Contraindication

Hypersensitivity to tramadol, paracetamol or opioids. Situations where opioid use may be contra-indicated (e.g. acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs). Severe hepatic impairment, uncontrolled epilepsy. Concurrent use or within 2 wk of discontinuation from MAOIs.

Mode of Action

Tramadol is a centrally acting opioid analgesic which binds to mu-opioid receptors and weakly inhibits the reuptake of norepinephrine and serotonin. Paracetamol, a para-aminophenol derivative, has analgesic, antipyretic and weak anti-inflammatory activity. Together, tramadol and paracetamol has faster onset of action compared to tramadol alone and longer duration of action compared to paracetamol alone.

Precaution

Patient w/ epilepsy controlled by treatment, risk of seizure, cranial trauma, biliary tract disorder, altered state of consciousness for unknown reasons, problems affecting the resp centre or resp function, increased intracranial pressure, suicidal tendency or patients in a state of shock. Not a suitable substitute in opioid-dependent patients. May cause withdrawal symptoms, dependence and abuse. Severe renal impairment. Elderly. Pregnancy and lactation. Patient Counselling May impair ability to drive or operate machinery. Monitoring Parameters Monitor pain relief, resp rate, BP, and pulse rate; signs of tolerance, abuse, or suicidal ideation.

Side Effect

Postural hypotension, resp depression, hepatotoxicity, Stevens-Johnson syndrome, toxic epidermal necrolysis, bradycardia, collapse, allergic reactions w/ resp symptoms (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema), changes in appetite, motor weakness, changes in mood, activity, cognitive and sensorial capacity; exacerbation of asthma, withdrawal symptoms (e.g. agitation, anxiety), skin rash, blood dyscrasias, hypoprothrombinemia. Potentially Fatal: Severe anaphylactic reactions.

Interaction

Increased risk of seizures and serotonin syndrome w/ SSRIs, SNRIs, TCAs, and 5-HT agonists (e.g. sumatriptan). Increased CNS depression w/ barbiturates, benzodiazepines, other anxiolytics, hypnotics, sedative antidepressants, sedative antihistamines, neuroleptics, centrally-acting antihypertensive drugs, thalidomide and baclofen. Decreased analgesic efficacy w/ ondansetron. Increased INR w/ warfarin. Potentially Fatal: Increased risk of seizure and serotonin sydrome w/ MAOIs.