Tramadol + Paracetamol + Domperidone Pharmacology
Tramadol + Paracetamol + Domperidone
Distribution:
Tramadol: Widely distributed, crosses the placenta and distributes into the breast milk; protein binding: 20%.
Paracetamol: Widely distributed; crosses placenta and distributes into breast milk; negligible protein binding.
Metabolism:
Tramadol: Undergoes metabolism by the cytochrome P450 isoenzymes CYP3A4 and CYP2D6; one of the metabolites, O-desmethyltramadol is pharmacologically active.
Paracetamol: Metabolised in liver.
Excretion: Tramadol: Excreted via urine as metabolites (60%) and unchanged drug (30%); elimination half-life of O-desmethyltramadol: 7 hr. Paracetamol: Excreted mainly in urine as metabolites and unchanged drugs (<5%);
2.Vomiting
3.Constipation
4.Diarrhea
5.Abdominal pain
6.Dry mouth
7.Dyspepsia
8.Flatulence
9.Dizziness
10.Somnolence
11.Headache
12.Confusion
13.Mood changes
14.Nightmares
15.Amnesia
16.Sweating
17.Pruritus
18.Potentially Fatal: Severe anaphylactic reactions.
2.Situations where opioid use may be contra-indicated (e.g. acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs).
3.Severe hepatic impairment,
4.Uncontrolled epilepsy
5.Concurrent use or within 2 wk of discontinuation from MAOIs
2.Severe respiratory insufficiency
3.Liver disease or opioid dependent patients
4.Increased intracranial pressure or head injury, patients at risk of seizures or on drugs that may lower the seizure threshold (e.g. SSRI, TCA, antipsychotics, centrally acting analgesics or local anaesthesia)
5.Biliary tract disorders
6.In a state of shock or unconsciousness
7.May impair ability to drive or operate machinery
8.Avoid abrupt withdrawal. May cause withdrawal symptoms, dependence and abuse
2.Increased risk of seizures of SSRI, TCA, antipsychotics, centrally acting analgesics or local anaesthesia.
3.Decreased tramadol levels with carbamazepine.
4..Decreased analgesic efficacy of tramadol with ondansetron.
5..Increased INR with warfarin.
Potentially Fatal:
1.Increased risk of serotonin syndrome with MAOIs, avoid concurrent use or within 2 wk of discontinuation from MAOIs.
2.Increased risk of CNS and respiratory depression with CNS depressants (e.g. alcohol, opioids, anaesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics).
Child: 2 tablets at least every 6 hrly. Max: 8 tablets daily.
Tramadol
Distribution-Widely distributed in the body, about 20% bound to the plasma protein. It may cross the placenta.
Metabolism-It is metabolized in the liver by O-demethylation; N-demethylation, glucoronidation or sulfation to its metabolites. Mono-O-desmethylate is its active metabolite.
Excretion - Excreted 30% as unchanged form and 60% as its metabolites via urine.
2. Weakness
3. Headache
4. Anxiety
5. Agitation
6. Drowsiness
7. Blurred vision
8. Stomach upset
9. Vomiting
10. Diarrhea
11. Constipation
12. Itching
13. Sweating
14. Flushing
15. Dry mouth
2. Acute alcoholic intoxification
3. Hypnotics
4. With centrally acting analgesics
5. With psychotropic drug
6. With Opioid drug
2. Acute abdominal conditions
3. Seizures
4. Respiratory depression
5. Renal failure
6. Hepatic failure
7. Physical dependence on Opioids
2. Arthralgia
3. Musculoskeletal pain
4. Low back pain
5. Pain associated with other reasons
Hypnotics, Tranquilizers and other CNS depressants: Sedative effects potentiated.
MAOIs: Fatal interaction occurs.
Opioid analgesics like Buprenorphine, Butorphanol and Pentazocine: May precipitate withdrawl symptoms.
Tranquilizers: Analgesia potentiated.
Adults - 50 to 100mg every 4 to 6 hrs or twice daily.
Intravenous-
50 to 100 mg given every 4 to 6 hrs.
Rectal-
100 mg suppository 4 times daily.
Paracetamol
It is more active on cyclo-oxygenase enzyme in brain. Peripherally it is a poor inhibitor of prostaglandin synthesis.
Analgesic action: Paracetamol raises the pain threshold and produces analgesic effect.
Antipyretic action: Paracetamol lowers fever by direct action on the thermoregulatory centre in the Hypothalamus and block the effects of endogenous pyrogen.
Distribution: It is distributed mostly in the body in unbound form.
Metabolism: It is extensively metabolised in the liver.
Excretion: Excreted in the urine.
2. Abdominal distress
3. Allergic reactions
4. Rash
2. Renal impairment
3. Hypertension
NEONATES : Contraindicated
2. Acute gout
3. Migraine
Charcoal: Activated, administered immediately reduces absorption of paracetamol.
Domperidone and metochlopramide: Enhance absorption of paracetamol.
Alcohol: Chronic excessive ingestion of alcohol potentiates hepatotoxicity of paracetamol.
Zidovudine: Effects zidovudine may be decreased.
500 - 1000 mg in 3 times daily
Maximum dose: 4 g / day
For migraine: 500 mg to be taken at the first sign of migraine attack and repeated 4 - 6 hourly until suppress mild attacks.
Children:
60 mg / kg body weight /day in 4 divided doses.
Maintenance dose: 75 mg / kg orally every 4 - 6 hours for 2 - 3 days. Haemodialysis can be done in emergency conditions.
Domperidone
Domperidone acts peripherally in the gastrointestinal system and increases oesophageal peristalsis, oesophageal sphincter pressure and gastric motility. These all facilitates gastric emptying. Domperidone is used in migraine to relieve nausea and vomiting.
Anaesthetic adjuncts: It is used preoperatively in order to reduce the post operative vomiting.
2.Dry mouth
3.Galactorrhoea
4.Gynaecomastia
5.Skin rash
6.Abdominal discomfort
7.Dystonic reactions
2.Prolactin releasing pituitary tumour(prolactinoma)
3.Gastrointestinal obstruction
2.Renal impairment
NEONATES: contraindicated
2.Delayed gastric emptying of functional origin
3.As an Antiemetic in patient receiving cytotoxic drugs
4.Preanaesthetic medication
Aspirin, Paracetamol & Oral Diazepam: Increases absorption of these agents.
Anticholinergic agents: Antagonize the effects of domperidone.
Phenothiazines: CNS depression enhanced by domperidone.
Antimuscarinic agents and opioids: Antagonize GI effects of domperidone.
Suxamethonium: Neuromuscular blockade enhanced by domperidone.
Migraine: 20 mg by mouth may be taken up to every 4 hours with Paracetamol, as required up to a maximum of 4 doses in 24 hours.
Children: 300 mcg / kg body weight 3 - 4 times daily 30 minutes before meals and at bed time if required
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