Dexigesic P
Dexigesic P Uses, Dosage, Side Effects, Food Interaction and all others data.
Dexibuprofen possesses analgesic and anti-inflammatory properties. Its mode of action, like that of other nonsteroidal anti-inflammatory agents, is not completely understood, but may be related to prostaglandin synthesis inhibition.
Like common NSAIDs, dexibuprofen is an active enantiomer of ibuprofen that suppresses the prostanoid synthesis in the inflammatory cells via inhibition of the COX-2 isoform of the arachidonic acid COX. Attenuating the synthesis of prostaglandins and thromboxanes gives the drug three major therapeutic actions. Anti-inflammatory action comes from decreased prostaglandin E2 and prostacyclin leading to decreased vasodilation and oedema that enhances vascular permeability and activity of inflammatory mediators. Decreased prostaglandin levels in the hypothalamus confers the antipyretic effect of the drug. Analgesic effect stems from decreased prostaglandin levels that sensitize the nociceptors to inflammatory mediators at sites of pain and enhance transmission from afferent pain fibers at the spinal cord
For more information, refer to ibuprofen.
Paracetamol exhibits analgesic action by peripheral blockage of pain impulse generation. It produces antipyresis by inhibiting the hypothalamic heat-regulating centre. Its weak anti-inflammatory activity is related to inhibition of prostaglandin synthesis in the CNS.
Paracetamol (Acetaminophen) is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Unlike NSAIDs, acetaminophen does not inhibit cyclooxygenase in peripheral tissues and, thus, has no peripheral anti-inflammatory affects. While aspirin acts as an irreversible inhibitor of COX and directly blocks the enzyme's active site, studies have found that acetaminophen indirectly blocks COX, and that this blockade is ineffective in the presence of peroxides. This might explain why acetaminophen is effective in the central nervous system and in endothelial cells but not in platelets and immune cells which have high levels of peroxides. Studies also report data suggesting that acetaminophen selectively blocks a variant of the COX enzyme that is different from the known variants COX-1 and COX-2. This enzyme is now referred to as COX-3. Its exact mechanism of action is still poorly understood, but future research may provide further insight into how it works. The antipyretic properties of acetaminophen are likely due to direct effects on the heat-regulating centres of the hypothalamus resulting in peripheral vasodilation, sweating and hence heat dissipation.
| Trade Name | Dexigesic P |
| Generic | Dexibuprofen + Paracetamol |
| Type | Tablet |
| Therapeutic Class | |
| Manufacturer | Invision Medi Sciences Pvt Ltd |
| Available Country | India |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Dexibuprofen is used for:
- Pain and inflammation associated with osteoarthritis, rheumatoid arthritis & other musculoskeletal disorders
- Mild to moderate pain and inflammation including dysmenorrhoea, dental pain
- Pyrexia of unknown origin
- Headache
Paracetamol IV is used for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, the reduction of fever.
Paracetamol is a non-salicylate antipyretic and non-opioid analgesic agent. Paracetamol IV injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of Paracetamol intended for intravenous infusion.
Dexigesic P is also used to associated treatment for these conditions: Fever, Inflammation, Pain, Spasms, AnalgesiaAcute Gouty Arthritis, Acute Musculoskeletal Pain, Allergies, Ankylosing Spondylitis (AS), Arthritis, Chills, Cold, Cold Symptoms, Common Cold, Common Cold/Flu, Cough, Cough caused by Common Cold, Coughing caused by Flu caused by Influenza, Dyskinesia of the Biliary Tract, Dyskinesia of the Urinary Tract, Febrile Convulsions, Febrile Illness Acute, Fever, Fibromyalgia Syndrome, Flu caused by Influenza, Headache, Joint dislocations, Menstrual Distress (Dysmenorrhea), Mild pain, Muscle Inflammation, Muscle Injuries, Muscle Spasms, Musculoskeletal Pain, Nasal Congestion, Neuralgia, Osteoarthritis (OA), Pain, Pollen Allergy, Postoperative pain, Premenstrual cramps, Rheumatoid Arthritis, Rhinopharyngitis, Rhinorrhoea, Severe Pain, Sinusitis, Soreness, Muscle, Spasms, Spastic Pain of the Gastrointestinal Tract, Sprains, Tension Headache, Toothache, Upper Respiratory Tract Infection, Whiplash Syndrome, Acute Torticollis, Mild to moderate pain, Minor aches and pains, Minor pain, Moderate Pain, Airway secretion clearance therapy, Antispasmodic, Bronchodilation
How Dexigesic P works
Like common NSAIDs, dexibuprofen is an active enantiomer of ibuprofen that suppresses the prostanoid synthesis in the inflammatory cells via inhibition of the COX-2 isoform of the arachidonic acid COX. For more information, refer to ibuprofen.
Dosage
Dexigesic P dosage
The recommended dosage of dexibuprofen is 600 to 900 mg/day, at 2-3 divided doses. Maximum single dose is 400 mg. The dosage can be raised temporarily up to 1200 mg/day in patients with acute disorders or exacerbations.
Adults and adolescents weighing 50 kg and over: the recommended dosage of Paracetamol IV is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Paracetamol IV of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 4000 mg per day.
Adults and adolescents weighing under 50 kg: the recommended dosage of Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg/kg per day.
Children >2 to 12 years of age: the recommended dosage of Paracetamol IV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of Paracetamol IV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg/kg per day.
Side Effects
The most common side effects are nausea, vomiting and abdominal pain. Besides these fatigue, drowsiness, headache, dizziness, vertigo, rash, peripheral odema may also occur. Bleeding time may be prolonged.
As all paracetamol products, adverse drug reactions are rare (>1/10000, <1/1000) or very rare (<1/10000). Frequent adverse reactions at injection site have been reported during clinical trials (pain and burning sensation). Very rare cases of hypersensitivity reactions ranging from simple skin rash or urticaria to anaphylactic shock have been reported and require discontinuation of treatment. Cases of erythema, flushing, pruritus and tachycardia have been reported.
Toxicity
Oral LD50 value in rats is 636 mg/kg. For more information, refer to ibuprofen.
Precaution
Dexibuprofen should be used with caution in patients with active and suspected gastrointestinal bleeding and bronchial asthma. In heart failure, hypertension, renal or hepatic disease, especially during concomitant diuretic treatment, the risk of fluid retention and deterioration in renal function should be taken into account. In case of elderly patient dexibuprofen should be started with lower dose. In case of hepatic and renal dysfunction it should be started with lower dose. It should not be used in patient with severe hepatic and renal dysfunction.
Administration of Paracetamol in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. Do not exceed the maximum recommended daily dose of Paracetamol. Use caution when administering Paracetamol in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance < 30 ml/min). There were infrequent reports of life-threatening anaphylaxis requiring emergent medical attention. Discontinue Paracetamol IV immediately if symptoms associated with allergy or hypersensitivity occurs. Do not use Paracetamol IV in patients with Paracetamol allergy.
Interaction
Drug interactions is noticed with concomitant use of anticoagulant, methotrexate, lithium, corticosteroids, phenytoin, thiazides and thiazide related substances, other NSAIDs and salicylates, digoxin, ciclosporin, tacrolimus, beta blockers and ACE inhibitors.
Volume of Distribution
For more information, refer to ibuprofen.
Volume of distribution is about 0.9L/kg. 10 to 20% of the drug is bound to red blood cells. Acetaminophen appears to be widely distributed throughout most body tissues except in fat.
Elimination Route
The time it take to reach peak plasma concentration is 2.25-5 hours post-administration of oral tablets containing 300mg of dexibuprofen. For more information, refer to ibuprofen.
Half Life
Oral tablets containing 300mg of dexibuprofen results in 2.2-4.7 hours . For more information, refer to ibuprofen.
The half-life for adults is 2.5 h after an intravenous dose of 15 mg/kg. After an overdose, the half-life can range from 4 to 8 hours depending on the severity of injury to the liver, as it heavily metabolizes acetaminophen.
Clearance
For more information, refer to ibuprofen.
Adults: 0.27 L/h/kg following a 15 mg/kg intravenous (IV) dose. Children: 0.34 L/h/kg following a 15 mg/kg intravenous (IV dose).
Elimination Route
Mainly renal excretion. For more information, refer to ibuprofen.
Pregnancy & Breastfeeding use
Pregnancy: no clinical data on exposed pregnancies are available.
Lactation: Ibuprofen is slightly excreted in human milk. Breast-feeding is possible with dexibuprofen if dosage is low and the treatment period is short.
Pregnancy Category C. There are no studies of intravenous Paracetamol in pregnant women; however, epidemiological data on oral Paracetamol use in pregnant women show no increased risk of major congenital malformations. Animal reproduction studies have not been conducted with IV Paracetamol and it is not known whether Paracetamol IV can cause fetal harm when administered to a pregnant woman. Paracetamol IV should be given to a pregnant woman only if clearly needed. There are no adequate and well-controlled studies with Paracetamol IV during labor and delivery; therefore, it should be used in such settings only after a careful benefit-risk assessment. While studies with Paracetamol IV have not been conducted, Paracetamol is secreted in human milk in small quantities after oral administration.
Contraindication
Dexibuprofen is contraindicated in patients with known hypersensitivity to any ingredient of Dexibuprofen or individuals with acute rhinitis, nasal polyps, urticaria or angioneurotic oedema, gastrointestinal ulcer or bleeding.
Paracetamol is contraindicated in patients with known hypersensitivity to its active ingredient or to any of the excipients in the intravenous formulation. Also contraindicated in patients with severe hepatic impairment or severe active liver disease
Special Warning
Children: As the molecule's safety and efficacy has not been established in patients under 18 years of age, it cannot be recommended in this age group.
Elderly patient: Lowest effective dose is recommended. The dosage can be raised to adult dosage if well tolerated.
Hepatic impairment patient: Patients with mild to moderate liver function impairments must start with low amounts, and must closely be monitored. Dexibuprofen should not be used in patients with serious liver function impairment.
Renal impairment patient: The starting amount must be reduced to patients with mild to moderate kidney function impairments. Dexibuprofen should not be used patients with serious kidney function impairments.
Pediatric Use: The safety and effectiveness of Paracetamol IV for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Paracetamol IV in adults.
Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Patients with Hepatic Impairment: Paracetamol is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease. A reduced total daily dose of Paracetamol may be warranted.
Patients with Renal Impairment: In cases of severe renal impairment (creatinine clearance < 30 ml/min), longer dosing intervals and a reduced total daily dose of Paracetamol may be warranted.
Acute Overdose
Dexibuprofen has a low acute toxicity and patients have survived after single dose as high as 54 g of racemic ibuprofen. Mild symptoms are most common including abdominal pain, nausea, vomiting, lethargy, drowsiness, headache, titinus, nystagmus and ataxia. The onset of symptoms usually occurs within 4 hours. Treatment is symptomatic and there is no specific antidote.
Storage Condition
Store in a cool & dry place protected from light and moisture. Keep out of reach of children.
Store in a cool & dry place & away from children. For single use only. The product should be used within 6 hours after opening. Do not refrigerate or freeze.
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