Maxigesic Tablets / Film-coated

Paracetamol + Ibuprofen
"150mg , 500mg"
AFT Pharmaceuticals Limited
Pack size 16's (8's Blister x 2)
Dispensing mode P
Source NEW ZEALAND
AgentPHARMALINK
Retail Price 15.00 AED

Available as:

"150mg , 500mg" - Tablets / Film-coated 1000mg/300mg - Solution for Infusion

Indications

Maxigesic Tablets / Film-coated is used for: Mild to moderate pain, Fever, Inflammation

Adult Dose

Oral Fever, Inflammation, Mild to moderate pain Adult: Available preparations: Ibuprofen 150 mg and Paracetamol 500 mg tab 1-2 tab either 4 hourly, 6 hourly or 8 hourly, depending on the product being used. Max: 6-8 tab per 24 hours (ibuprofen 900-1,200 mg and paracetamol 3,000-4,000 mg). Max duration: 3 days (72 hours). Ibuprofen 200 mg and Paracetamol 500 mg tab 1-2 tab up to tid, with intervals of at least 6 hours. Max: 6 tabs per 24 hours (ibuprofen 1,200 mg and paracetamol 3,000 mg). Ibuprofen 200 mg and Paracetamol 325 mg tab or cap 1 tab or cap 6 hourly as needed. Max duration: 10 days. Intravenous Fever, Mild to moderate pain Adult: Each 100 mL vial contains: Ibuprofen (as Na dihydrate) 300 mg and Paracetamol 1,000 mg 100 mL infused over 15 minutes 6 hourly, as necessary. Max: Paracetamol 4,000 mg.

Child Dose

<12 years: Safety and efficacy not established

Renal Dose

Administration

Should be taken with food: Take immediately after meals.

Contra Indications

Hypersensitivity to ibuprofen, paracetamol or other NSAIDs. Active or history of peptic ulceration or haemorrhage (including history of gastrointestinal bleeding related to previous NSAID therapy); severe heart failure (NYHA Class IV), cerebrovascular or other active bleeding, coagulation disorders, history of ulcerative colitis or Crohn’s disease, bronchial asthma, urticaria or allergic-type reactions to aspirin or other NSAIDs, active alcoholism. Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery, spinal cord injury (IV). Children <18 years of age. Severe hepatic and renal failure. 3rd trimester of pregnancy (oral). Pregnancy and lactation (IV). Concomitant use with paracetamol- or NSAID-containing drugs (e.g. cyclo-oxygenase-2 inhibitors, aspirin (doses >75 mg daily).

Precautions

Patient with existing or history of bronchial asthma or allergic disease, history of hypertension, mild to moderate CHF, mixed connective tissue disorder, SLE, non-cirrhotic alcoholic liver disease. G6PD deficiency, chronic malnutrition, anorexia, bulimia, cachexia, dehydration, hypovolaemia (IV). Elderly. Renal and hepatic impairment. 1st and 2nd trimester of pregnancy. Lactation (PO).

Pregnancy-Lactation

Pregnancy Ibuprofen Avoid use in pregnant women starting at 30 weeks’ gestation; NSAID use during third trimester increases risk of premature closure of the fetal ductus arteriosus There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive Paracetamol Low risk of cryptorchidism in boys if used for several weeks or longer Lactation Ibuprofen Considered compatible with breastfeeding No lactation studies have been conducted; however, limited published literature reports that following oral administration, ibuprofen is present in human milk at relative infant doses of 0.06-0.6% of the maternal weight-adjusted daily dose Paracetamol Considered compatible with breastfeeding

Interactions

May enhance the effect of anticoagulants (e.g. warfarin). Paracetamol: May increase the plasma concentration of chloramphenicol. Increased absorption by domperidone and metoclopramide Decreased absorption by cholestyramine and other drugs that reduce gastric emptying time (e.g. narcotic analgesics, propantheline, antidepressants with anticholinergic properties). Altered plasma concentration with probenecid. Concomitant use with zidovudine, co-trimoxazole or isoniazid (alone or with other anti-TB drugs) may result in severe hepatotoxicity. Ibuprofen: May reduce the effects of ACE inhibitors, angiotensin II antagonists, diuretics and mifepristone. Increased risk of gastrointestinal bleeding with corticosteroids, antiplatelet agents and selective SSRIs. May increase the plasma levels of cardiac glycosides. May increase the risk of nephrotoxicity when given with ciclosporin and tacrolimus. May decrease the elimination of lithium and methotrexate. May increase the risk of convulsions associated with quinolone antibiotics. Increased risk of haematological toxicity with zidovudine. Potentially Fatal: Concomitant use with paracetamol- or NSAID-containing drugs (e.g. COX-2 inhibitors, aspirin) may result in serious adverse effects.

Adverse Effects

Side effects of Paracetamol + Ibuprofen : Significant: Fluid retention, impaired female fertility. Rarely, blood dyscrasias (e.g. anaemia). Ear and labyrinth disorders: Tinnitus. Gastrointestinal disorders: Nausea, vomiting, heartburn, abdominal pain or discomfort, diarrhoea, dyspepsia, constipation, flatulence. Investigations: Increased ALT, gamma-glutamyltransferase, blood creatinine and urea, abnormal LFT. Nervous system disorders: Dizziness, headache, nervousness. Psychiatric disorders: Insomnia. Surgical and medical procedures: Rash, pruritus. Vascular disorders: Hypertension. Potentially Fatal: Gastrointestinal bleeding, ulceration or perforation; Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, hepatotoxicity.

Mechanism of Action

Ibuprofen, an NSAID, has analgesic, anti-inflammatory and antipyretic properties. It inhibits cyclooxygenase-1 and 2 (COX-1 and -2) enzymes, thereby also inhibiting prostaglandin synthesis. Paracetamol is a para-aminophenol derivative with analgesic and antipyretic properties and weak anti-inflammatory activity. The mechanisms by which paracetamol exhibits its analgesic and antipyretic effects are not yet fully elucidated. Its analgesic effect may include inhibition of central prostaglandin synthesis and modulation of inhibitory descending serotonergic pathways while its antipyretic property may be due to reduced production of prostaglandin in the hypothalamus. It has a weak anti-inflammatory activity.

Note

Maxigesic "150mg , 500mg" Tablets / Film-coated manufactured by AFT Pharmaceuticals Limited. Its generic name is Paracetamol + Ibuprofen. Maxigesic is availble in United Arab Emirates. Farmaco UAE drug index information on Maxigesic Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Paracetamol + Ibuprofen :

Tablets / Film-coated
Nuromol "200mg , 500mg"
RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED
Tablets / Film-coated
Maxigesic "150mg , 500mg"
AFT Pharmaceuticals Limited
Capsules (Soft Gelatin)
Maxiflam "200mg, 500mg"
Pharmax Pharmaceuticals FZ LLC
Solution for Infusion
MAXIGESIC IV 1000mg/300mg
AFT Pharmaceuticals Limited