Aceclofenac And Paracetamol Tablet Uses

Name of the medicinal product

• Aceclofenac And Paracetamol Tablet Uses-ALGIC P

Qualitative and quantitative composition

acelofenac 100 mg and paracetmol mg film coated tablets,each film coated tablet contains,acelofene 100 and paracetmol 500 mg.

pharmaceutical form

It is a film-coated tablet, aceclofenac 100 mg and paracetamol 500 mg film film-coated tablets. white coloured caplet-shaped film-coated tablets with plain on both sides

Clinical particulars

Aceclofenac-aclefenac indicated for the relief of pain and inflammation in osteoarthritis,rheumatiod arthritis and ankylosing spondylitis.

paracetmol-for the treatment of mild to moderate pain including headache, migraine,neuralgia,toothache,sore throat,period pains,aches and pains,symptomic relief of rheumatic aches and pains and influenza,feverishness and feverish colds.

Posology and method of administration

1. Aceclofenac-aceclofenac film-coated tablets supplied for oral administration and should swallowed whole with a sufficient quantity of liquid
2. to  taken preferably with or after the food
3. When acelofenac  administered to fasting and fed healthy volunteers, only the rare and not the extent of acelofenac was affected.
4. Undesirable effects may  minimized by using the lowest effective dose for the shortest duration necessary to control symptoms

Adults

The recommended dose is 200 mg daily,taken as two as two separate 100 mg dose,one tablet in the morning and one in the evening.

Children

There are no clinical data on the use of acelofenac in children and therefore it is not recommended for use in chidren

Elderly

The elderly,who are more likely to be suffering from impaired renal,cardio vascular or hepatic function and receiving concomitant medication are at increased risk of the serious consequences of adverse reactions.if an NSAID is considerly necessary,the lowest effective dose should be used and for the shortest possible duration.hte patient should be monitored regularly for GI bleeding during said thearpy.the pharmacokinetics of aceclofenac are not altered in elderly patients,therefore it is not considered necessary to modify the dose or dose fequency.

Renal insufficiency

There is no evidence that the dosage of acelofenac needs to be modified in patients with mild renal impairment,but as with other NSAIDS caution should be exercised.

hepatic insufficiency

There is some evidence that the dose of acelofenac should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100 mg be used.

paracetmol

• adults,the elderly and young persons 16 years and over-2 tablets every 4 hours to a maximum of 8 tablets in 24 hours
• children 6-9 years-1/2 tablet every 4 hours to a maxximum of 4 doses in 24 hours
• children 10-11 years-1 tablet every 4 hours to a maxximum of 4 doses in 24 hours
• adolscents 12-15 years-1 to 1 1/2 tablets every 4 hours to a maximum of 4 doses in 24 hours.do not give to children aged under 6 years of age.

acelofenac contraindications

hypersensitivity to acetofenac or to any of the excipients listed. active, or history of recurrent peptic ulcer haemorrhage two or more distict episodes of proven ulceration or bledding. NSAIDS contractied in patients who have previously shown hypersensitivity reactions like asthma, rhinitis,aggiodema in response to ibuprofen, aspirin,or other non-steroidal anti-inflammatory drugs. hepatic failure and renal failure,patients with established conestive heart failure,istemic heart disease,perpheral arterial disease and or cerbrovascular disease. history of gastrointestional bleeding or performation,related to previous nsaids thearpy,active bleeding or bleeding disorders. Acetaminophen should not prescribed durong pregnancy,espically during the last trimerest of pregnancy,unless there are compelling reasons for doing so.The least effective dose should used.

Special warnings and precautions for use of accelofenac

Respiratory disoders,caution required if administered to patients suffering from,or with a previous history of,brochial astma since NSAIDS have reported to precipitate bronchaspam in such patients.The administration of an NSAID may cause a dose dependent reduction in prostagladin formation and precipitate renal failure. Patients at greatest risk of this reaction those with impaired renal fenction,cardiac impairment,liver dysfunction,those taking diuretis or recovering from major surgery,and the elderly. The importance of prostaglandins in maintaining renal blood flow should be taken into the in these patients. Renal function should monitered in these patients.

renal

Patients with mild to moderate renal impairment should kept under surveillance,since the use of nsaids may result in deterioration of renal function.the lowest effective dose should used and renal function monitored regularly.effects on renal function are usually reversible on withdrawal of acelofenac.

hepatic

if abnormal liver function tests perist or wosen,clinical signs or symptoms consist with liver disease develop or if other manifestations occur, acelofenac should be discontinued.close medical surveillance is necessary in patients suffering from mild to moderate impairment of hepatic function. Hepatitis may occur  without prodromal symptoms.useof acelofenac in patients with hepatic porphyria may triggger an attack.

cardiovascular and cerebrovascular effects

Appropriate monitoring and adice required for patients with a history of hypertension and wild to moderate congestive heart failure as fluid retention and oedema have reported in association with NSAID thearphy. Patients with congestive heart failure and patients with significant risk factors for cardiovascular events should treated with acelofenac after careful consideration.as the cardiovascular risks of acelofenac may increase with dose and duration exposure,the shortest duration possible and the lowest effective daily dose should be used.the patients need for symptomic relief and response to theaphy should be revaluated periodically. Acetaminophen should also be administered with caution and under close medical surveillance to patients with a histiory of cerebrovascular bleeding.

gastro intenstinal bleeding, ulceration and performation

GI bleeding, ulceration or performation , which can fatel ,has reported with all NSAIDS at any time during treatment,with or without warning symtoms or a pevious histiory of serious GI events,close medical surveillance impertive in patients with symptoms indicative if gastrointestinal disorders involving either the upper or lower gastrointestional tract. with a history suggestive of gastrointestinal ulceration,bleeding or performation, with ulcerative colitis or with Crohn’s disease or haematological abnormalities,as these conditions may  exacerbated.The risk of go bleeding or ulceration or performation is higher with increasing NSAID doses on patients with a history of ulcer,particularly if complicated with haemorrhage or performance and in the elderly.

These patients should commence treatment on the lowest dose available. Combination thearphy with protective agents should considered for these patients, and also for patients requiring concomitant low dose aspirin,or other drugs likely to increase gastointestinal risk. Patients with a history of GI toxicity,particularly when elderly,should report any unusual abdominal symtoms. Caution should advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding,such as systemic corticosteriods,anticougulants such as wararin selectives serotonin reuptake inhibitions or antiplatent agents such as aspiran. When GI bleeding or ulceration occurs in patients receiving acelofenac,he treatment should withdrawn.

dermatological

serious skin reactions,some of them fatal,including exfolitative dermarisis,steve johnson syndrome and toxic epidermal necrolysis,have reported very rarely in association eith the use of nsaids.patients appear to be at higher risk for these reactions early in the course of thearpy,the onset of the reaction occuring in the majority of cases within the first month of treatment. Acetaminophen should discontinued at the first appearance of skin rash, mucosal lesions,or any other sign of hypersensitivity. Exceptionally,varicella can trigger serious cutaneous and soft tissues infections complications. To date,the contributiong role of nsaids in the worsening of these infections cannot ruled out. This,it is adivisable to avoid use of aceclofenac in cause of varicella.

paracetamol

• care advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment.The hazards  of overdose are greater in those with noncirrhotic alcoholic liver disease.
• do not take more medicine than the label tells you to.if you do not get better,talk to your doctor.contain paracetmol.
• do not take anything else containing paracetamol while taking the medicine.
• talk to your doctor at once ifyou take too much of this medicine,even if you feel well.this is beause too much paracetamol can cause delayed,serous liver damae
• patients should advied that paracetamol may cause severe skin reactions.If a skin reaction such as skin redding,blisters,or rash occurs,they should stop use and seek medical assistance right away.

interaction with other medicinal products

other analgesics, including cyclooxygenase-2 selective inhibitors. Avoid concomitant use of two or more NSAIDS as this may increase the risk of adverse effects, including GI bleeding. amti hypertensives,nsaids may reduce the effect of anti hypertensive. The risk of renal insufficiency, which usually reversible,may  increased in some patients with comprised renal function. When ACE inhibitors or angiotensin 2 recetor antagonists  combined with NSAIDS.Therefore,the combination should be administered with caution,espicially in the elderly.patients should adequently hydrated and consireration should given to monitering of renal function after initiation of concomitant therapy,and periodically.

diuretics

aceclfenac,like other nsaids,may inhibit the activity of diuretucs. Diuretics can increase the risk of nephrotoxcity of nsaids. Although it not shown to affect blood pressure control when coadministered with bendrofluazide,interactions with other diuretics cannot ruled out. When concomitant administration with potassium-sparing diuretics employed,serum potassium should monitered.

digoxin

NSAIDS may exacerbate cardiac failure,reduce GFR and inhibit the renal clerance of glycosides,resulting in increases plasma glycoside levels.The combination should aoided unless frequent monitering of glycoside levels can be performend.

lithium

Several NSAIDS drugs inhibit the renal clearance of lithium,resulting in increases serum concentrations of lithium. The combination should avoided unless frequent monitering of lithium can be performed.

methotrexate

The possible interaction between NSAIDS and methotrexate should borne in mind also when low doses of methotrexate used,espicially in patients with decreased renal function. When combination theraphy to used,the renal function to  moniterd. Caution should exercised if both NSAIDS and methotrexate  administered within 24 hours of each other,since NSAIDS may increase plasma levels of methotrexate,resulting in increased toxicity.

mifepristone

NSAIDS should not used for 812 days after mifepristone adminstration as nsaids can reduce the effect of mifepristione.corticosteroids,increaed risk of gastro intestinal ulceration or bleeding.

anticoagulants

NSAIDS may enhance the effects of anticoagulants,such as warfarin. Close monitering of patients on combined anticoagulants and aceclfenac thearpy should undertaken.

quinolone antibiotics

animal data indicate that nsaids can increase the risk of convulsions associated with quinolone antibiotcs.Patients taking nsaids and quinolenes may have an increases risk of developing convulsions.

paracetmol

• Cholestyramine speed of absorption of paracetamol reduced by cholestyramine. Therefore,the che cholestyramine should not taken within one hour if maximal analgesia required.
• Metaclopramide and domperidone absorption of paracetamol increased by metoclopramide and domperidone however, concurrent use need not avoided
• The anticoagulant effect of warfarin and other coumarins may  enhanced by prolonged regular use of paracetamol with increased risk of bleeding,occasional doses have no significant effect.

fertility pregnancy and lactatoin acelofene

there is no information on the use of acelofenac during pregnancy.inhibition,of prostaglandin synthesis may adversely affect the pregnant and the embryo development. Aceclofenac and Paracetamol Tablet Uses Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation or gastroschisis after use of prostaglandin synthesis inhibitor in early pregnancy. Thee absolute risk for cardiovascular malformation increased from less than 1 % up to approximately 1.5%.The risk believed to increase with dose and duration of therapy.in animals, administration of a prostaglandin synthesis inhibitor has shown to result in increased preimplantation loss and embryo foetal lethality.

In addition,increased incidences of various malformations,including cardiovascular,have reported in animals given a prostaglandin synthesis inhibitor during the organogetic period. During the first and second trimster of pregnancy, aceclofenac should not given unless clearly. Suppose Aceclfenac used by a women attempting to conceive or during the first and second trimster of pregnancy. In that case, the dose should kept as low and duration of treatment as short as Aceclofenac And Paracetamol Tablet Uses possoble. During the third trimester of pregnancy,all prostaglandin synthesis inhibitors may exposure the foetus.

acelofenac overdose

• symtoms

Symptoms include headache, nausea,vomtin,epigastric pain,gastro intestional irritation, gastrointestinal bleeding,rarely diarrhoea,disorientation,exxiation,coma,drosiness,diziness, tinnitus,hypotension,respiratory depression,faintin,ocassionally convulsions.in the cases significant poisoning acute renal failure and liver damage.

• therapeutic measure

patients should treated symptomatically as required. Within one hour of ingetion of a potentionally toxic amount,activated charcoal should cosidered. alternatively,in adults,gastric lavage should  considered within one hour of ingestion of a potentially life-threatening overdose.Specific therapic such as dialysis or haemoperfusion, are probable of no help on eliminationg NSAIDS due to their high rate of protein binding and extensive metabolism.

paracetmol overdose

• symptoms

Symptoms of paracetamol overdose om the first 24 hours ae pallor, nausea,anorexia and abdominal pain.liver damge may become aparent 12 to 48 hours after ingestion. Abnormalities of glucose metablosim and acidosis may occur. Aceclofenac And Paracetamol Tablet Uses In severe poisoning,hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema,and death.acute renal failure with acute tubular necrosis,strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage.

• management

Immediate treatment is essential in e essential in te mangement of paracetamol overdose. Despite a lack of significant early symptoms, patients referred to hospital urgently for immediate medical attention. Symptoms  limited to nausea or vomting and not reflect the severity of overdose or the risk of organ damage. managemet  in accordance with established treatment guidelines see BNF overdose section. Aceclofenac And Paracetamol Tablet Uses Treatment with activated charcoal should  considered if the overdose taken within 1 hour,plasma paracetamol concentration  measured at 4 hours or later after ingestion.