Drug ID: 1d00000014
Drug Name: Acetaminophen / Paracetamol
Generic Names: Kemol | Febrimol | T -98 Suspension | P -500 | Cofamol | Pacimol XP | Cemol KT | MOL inj | PCM Susp | T -98 (500mg) | P 125 | Parix | P -125 DT (500mg) | Redimol | Paracetamol | Panacet | Paracetamol Kid 125 | Tyfy (300 mg) | Centanil | Oropyrin Susp. | Paracip (650 mg) | P -250 | Ultramol (650 mg) | Temfix (500mg) | Pyritec Susp | Indamol | Activate (125 mg) | Dispirin | Crocin (500mg) | Medomol (650 mg) | Tylenol | Tylophen | Anacin Asprin free | Apra | Feverall | Genapap | Panodil | Efferalgan | Doliprane | Dafalgan | Alvedon | Panadol | Valadol | More
Legal Status: Non Opioid Prescription only drug
Indication for Mother: Category A
Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Recommended Dose: The oral dose for adults is 325 to 650 mg every 4 to 6 hours. The maximum daily dose is 4 grams.
Child- the recommended dose is 10 to 15 mg/kg every 4 to 6 hours.
Recommended In: This medication is a non-opiate, analgesic and antipyretic, prescribed for headache, pain (muscle ache, backache) and fever either alone or combined with other medications.
Directions For Use: It comes as a tablet and capsule to take by mouth, with or without food.
Storage: Store tablets and solution at room temperature 15°- 30°C. Keep this medication out of the reach of children.
Dosage Forms: Tablet | Syrup
Side Effects: Nausea, stomach pain, loss of appetite, upper stomach pain, dark urine, clay colored stool, Hepatic damage, allergic reactions, skin rash and kidney impairment.
In Case of Overdose: Mild poisoning may not cause symptoms, and when present, symptoms are usually minor until ? 48 h after ingestion. Symptoms, which occur in 4 stages, include anorexia, nausea, vomiting, and right upper quadrant abdominal pain. Renal failure and pancreatitis may occur, occasionally without liver failure. After > 5 days, hepatotoxicity resolves or progresses to multiple organ failure, which can be fatal.
Stage I (0–24 h)
Anorexia, nausea, vomiting
Stage II (24–72 h)
Right upper quadrant abdominal pain (common)
AST, ALT, and, if poisoning is severe, bilirubin and PT (usually reported as the INR) sometimes elevated
Stage III (72–96 h)
Vomiting and symptoms of liver failure
Peaking of AST, ALT, bilirubin, and INR
Sometimes renal failure and pancreatitis
Stage IV (> 5 days)
Resolution of hepatotoxicity or progression to multiple organ failure (sometimes fatal)
Activated charcoal may be given if acetaminophen is likely to still remain in the GI tract.
N-Acetylcysteine is an antidote for acetaminophen poisoning. This drug is a glutathione precursor that decreases acetaminophen toxicity by increasing hepatic glutathione stores and possibly via other mechanisms. It helps prevent hepatic toxicity by inactivating the toxic acetaminophen metabolite NAPQI before it can injure liver cells. However, it does not reverse damage to liver cells that has already occurred.
Avoid If: Caution should be exercised in patients with history of alcohol dependency, kidney or liver impairment, G6PD deficiency, elderly, children, during pregnancy and breastfeeding.
It may cause liver damage; avoid long-term use of this medication.
Avoid excess dosage.
Do not crush or chew extended-release tablets, because it can release the entire drug at once, increasing the risk of side effects.
Also, do not split the tablets unless they have a score line. Swallow the whole or split tablet without crushing or chewing.
Drug Interaction: Alcohol
The package label for adult TYLENOL® acetaminophen products contains an alcohol warning that states, "If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage."
Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports of this event are rare. Healthcare professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen.
Some reports have suggested that patients taking long-term anticonvulsants, who overdose on acetaminophen, may be at increased risk of hepatotoxicity because of accelerated metabolism of acetaminophen.
At usual oral therapeutic doses of acetaminophen and carbamazepine, no special dosage adjustment is generally required. Carbamazepine is primarily metabolized by CYP3A4, whereas acetaminophen is metabolized primarily via CYP2E1.141 It is not known whether there is increased risk from an acetaminophen overdose in patients on chronic carbamazepine therapy.
Professional literature from the manufacturer of diflunisal cautions that concomitant administration with acetaminophen produces an approximate 50% increase in plasma levels of acetaminophen in normal volunteers.
Some reports suggest that patients on chronic isoniazid therapy may be at risk for developing hepatotoxicity from an acetaminophen overdose at doses that would not have been expected to produce toxicity. Since patients on isoniazid therapy may develop hepatic effects from isoniazid alone, data from individual case reports are unclear as to whether chronic administration of isoniazid may increase the risk of acetaminophen toxicity.
There have been several reports that suggest that acetaminophen may produce hypoprothrombinemia (elevated international normalized ratio [INR] or prothrombin time) when administered with coumarin derivatives. In the period immediately following discharge from the hospital or whenever other medications are initiated, discontinued, or taken regularly, it is important to monitor patient response to anticoagulation therapy with additional prothrombin time or INR determinations.