Generic
Paracetamol + Tramadol Hydrochloride
38 brands available in the market
At a glance
Paracetamol + Tramadol Hydrochloride is a combination pain reliever used for the short-term (5 days or less) management of moderate to moderately severe pain including muscle ache, back pain, joint pain, menstrual cramps, and toothache.
Description
Paracetamol is a para-aminophenol derivative with analgesic and antipyretic properties and weak anti-inflammatory activity. Tramadol is a synthetic opioid analgesic that acts centrally. It binds to μ-opioid receptors and weakly inhibits the reuptake of norepinephrine and serotonin. This combination provides faster onset than tramadol alone and longer duration than paracetamol alone.
Indications
- Moderate to moderately severe pain
- Muscle ache
- Back pain
- Joint pain
- Menstrual cramps
- Toothache
Therapeutic class
Opioid Analgesics
Pharmacological class
Analgesic Combination
Pharmacology
Tramadol binds to μ-opioid receptors and weakly inhibits norepinephrine and serotonin reuptake, blocking pain signal transmission to the brain. Paracetamol increases pain threshold by inhibiting prostaglandin synthesis in the CNS. Together they provide faster and longer-lasting pain relief.
Mechanism of action
Tramadol acts as a μ-opioid receptor agonist and paracetamol inhibits prostaglandin synthesis in the CNS for pain relief.
Dosage
Adult Dose (Oral):
- Moderate to moderately severe pain: 1-2 tablets every 6 hours; max 8 tablets/day
- Short-term (5 days or less) management of acute pain: 2 tablets every 4-6 hours; max 8 tablets/day
- CrCl 10-30 mL/min: Increase dosing interval to 12 hours
- CrCl <10 mL/min: Not recommended
- Hepatic impairment: Moderate: Increase dosing interval; Severe: Contraindicated
Administration
- Can be taken with or without food, but better at a fixed time
- Swallow tablet whole; do not chew, crush or break
- Follow dose and duration as advised by your doctor
Missed dose
If you miss a dose, take it as soon as you remember; skip if it's almost time for next dose; do not double the dose.
Side effects
Common Side Effects:
- Nausea
- Vomiting
- Constipation
- Weakness
- Dizziness
- Dry mouth
- Drowsiness
- Hyperhidrosis
- Skin rash
- Anorexia
- Anxiety
- Insomnia
Precautions & warnings
- May impair ability to drive or operate machinery; do not drive if drowsy or blurred vision occurs
- Use only for severe acute pain for not more than 5 days; prolonged use may cause dependence
- Avoid alcohol
- Do not use with other tramadol or paracetamol-containing products
- Caution with tranquilizers, hypnotics, or other opioid analgesics
- Caution in epilepsy
Contraindications
- Hypersensitivity to tramadol, paracetamol, or opioids
- Severe hepatic impairment
- Uncontrolled epilepsy
- Concurrent use or within 2 weeks of MAOI discontinuation
- Acute intoxication with alcohol, hypnotics, centrally-acting analgesics, or psychotropic drugs
Drug interactions
- Increased risk of seizures and serotonin syndrome with SSRIs, SNRIs, TCAs, and 5-HT agonists
- Increased CNS depression with barbiturates, benzodiazepines, anxiolytics, hypnotics, sedative antidepressants, antihistamines, neuroleptics, centrally-acting antihypertensives, thalidomide, and baclofen
- Decreased analgesic efficacy with ondansetron
- Increased INR with warfarin
- Potentially fatal: Increased risk of seizure and serotonin syndrome with MAOIs
Food interactions
Alcohol consumption with Paracetamol + Tramadol Hydrochloride is unsafe.
Use in pregnancy
Use in Pregnancy: May be unsafe during pregnancy; limited human studies and animal studies show harmful effects. Doctor will weigh benefits and risks before prescribing.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Probably safe; limited human data suggests no significant risk. Consult doctor if baby shows increased sleepiness, difficulty breastfeeding, or limpness.
Pediatric use
Safety and efficacy not established in children under 18 years.
Geriatric use
Caution required in elderly patients; higher frequency of decreased hepatic, renal, or cardiac function.
Renal / hepatic impairment
Renal Impairment: Caution in kidney disease; CrCl <30 mL/min: increase dosing interval to 12 hours; CrCl <10 mL/min: not recommended.
Hepatic Impairment: Caution in liver disease; moderate impairment: increase dosing interval; severe impairment: contraindicated.
Overdose effects
Overdose may cause nausea, vomiting, abdominal pain, drowsiness, convulsions, respiratory depression, hepatic or renal damage. In case of overdose, tell your doctor immediately.
Storage conditions
Store in a cool and dry place; do not freeze; keep out of reach of children.
Chemical structure
Paracetamol + Tramadol Hydrochloride