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Brand Name :
Duraxin, Ed-Flex
Synonyms :
acetaminophen/salicylamide/phenyltoloxamine
Class :
Analgesic combinations
Brand Name :
Duraxin, Ed-Flex
Synonyms :
acetaminophen/salicylamide/phenyltoloxamine
Class :
Analgesic combinations
Dosage Forms & Strengths
Tablets or Capsules
300mg-20mg-200mg (acetaminophen/salicylamide/phenyltoloxamine)
Pain
1 or 2 capsules or tablets orally, every 4 hours
Maximum dose: 8 capsules or tablets in a day
1 or 2 capsules or tablets for each 4 hours
Maximum dose: 8 capsules or tablets in a day
Dosage Forms & Strengths
Tablets or capsules
6 years: Safety and efficacy have not been shown.
between 6 and 12 years old:
Pain
Half tablet or full tablet,orally, every 4 hours
Four pills or capsules maximum per day.
>=12 years:
1 or 2 capsules or tablets,every 4hours
8 pills or capsules maximum in a 24-hour period.
Refer to adult dosing
Actions and spectrum:
The two main uses of acetaminophen are as an analgesic and as an antipyretic. It is believed to function by preventing the brain’s generation of prostaglandins, which are essential for controlling body temperature and the experience of pain.
In order to treat mild to moderate pain, such as headaches, tooth discomfort, and musculoskeletal pain, acetaminophen is frequently utilized.
Similar to aspirin, salicylic acid works by preventing the formation of prostaglandins.
Comparatively less people take salicylamide than acetaminophen or aspirin. Although it can be used to treat minor pain and lower fever, it is not as widely prescribed or accessible as these other drugs.
phenyltoloxamine
Antihistamine phenyltoloxamine also has sedative qualities. It primarily helps to reduce allergy and allergic reaction symptoms. Drowsiness can also be produced by its sedative effect.
To treat allergic problems, phenyltoloxamine is used to treat symptoms including runny or stuffy nose, sneezing, itching, and watery eyes.
Frequency not defined
Mouth dryness
Drowsiness
Headache
Loss of appetite
Cramps in stomach
Anxiety
Muscle weakness
Black Box Warning
Do not take this combination drugs for more duration than prescribed by your doctor
Contraindication/Caution:
Contraindication:
Blurred vision
Irregular heartbeat
Seizures
tachycardia
Caution:
rashes, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, chest tightness, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat are all indications of an allergic response.
It’s possible to experience a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis). It may result in death occasionally and very serious health issues that may not get better.
Pregnancy consideration:
US FDA Pregnancy category C
Lactation:
No sufficient data
Pregnancy category:
Category A: Studies that were well-controlled and met expectations revealed no risk to the foetus `in either the first or second trimester.
<b>Category B: There were a lack of studies on pregnant women and no evidence of risk to the foetus in animal experiments.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology:
Pharmacodynamics:
acetaminophen functions primarily as an antipyretic and analgesic with a central action. Although the precise mechanism of action is not entirely understood, it is believed to prevent the central nervous system from producing prostaglandins.
salicylamide works as both an analgesic and an antipyretic. Although chemically like salicylic acid, which is the aspirin’s active ingredient, it has a less potent anti-inflammatory action.
A first-generation antihistamine with sedative effects is phenyltoloxamine. It does this by obstructing histamine receptors, especially H1 receptors in the central nervous system, to produce its pharmacological effects.
Pharmacokinetics:
Absorption
Absorption of acetaminophen is carried in the g.i.tract especially in the small intestine
Salicylamide is absorbed well in the gastrointestinal system
Absorption of phenyltoloxamine is carried in the g.i.tract
Distribution
acetaminophen is easily distributed in the body tissues and blood. It also has the ability to cross the blood-brain-barrier
salicylamide is easily distributed into blood and it can cross BB barrier
phenyltoloxamine could cross blood brain barrier due to which it causes sedation and antihistaminic properties
Metabolism
Metabolism of acetaminophen is mostly carried in the liver through glucuronide conjugation
Salicylic acid, a metabolite of acetylsalicylic acid is formed when salicylamide undergoes metabolism in liver
Through the process of oxidation, phenyltoloxamine undergoes hepatic metabolism
Elimination and excretion
Primarily acetaminophen is excreted in urine however, small fractions of it is eliminated through faeces.
salicylamide along with its metabolite sare excreted through urine
through urination, phenyltoloxamine is eliminated from the body
Half life:
acetaminophen: 2-3 hours
salicylamide: 3-4 hours
phenyltoloxamine: 4-8 hours
Administration:
This combination drug is administered orally as tablets or capsules
Patient information leaflet
Generic Name: acetaminophen/salicylamide/phenyltoloxamine
Pronounced: a set a MEE noe fen; sal i SILL a mide; fen ill toe LOX a meen;
Why do we use acetaminophen/salicylamide/phenyltoloxamine?
acetaminophen and salicylamide are used as an antipyretic and as analgesic in the treatment of mild to moderate pains like headache, toothache etc. phenyltoloxamine is used in the treatment of allergies due to its antihistaminic properties. It is also known to produce sedative effects.
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