Zulu MR

Class: Anti-inflamatory, analgesic and muscle relaxant

Manufacturer: Atoz Pharmaceutical Pvt Ltd Block A, Balaji Nagar, Ambattur, Chennai-600 053, India.

Dosage Form: Tablet

Similar Brands:

Uses:

For the temporary relief of mild to moderate pain associated with migraine, headache, backache, period pain, dental pain, rheumatic and muscular pain, pain of non-serious arthritis, cold and flu symptoms, sore throat and fever. This product is especially suitable for pain which requires stronger analgesia than ibuprofen or paracetamol alone. Treatment of apnoea of prematurity. It is indicated for the relief of pain and inflammation in osteoarthritis and anklylosing spondylitis. For the relief of discomfort associated with acute painful musculoskeletal conditions.

Dosage:

Studies performed with aceclofenac, chlorzoxazone and with paracetamol, individually, have not demonstrated pediatric-specific problems that would limit the usefulness of either medication in children. However, use of this combination medication required that care be taken to ensure that the dosage of each agent is appropriate for the child’s age and weight.

Usual pediatric dosage

Administration of this combination medication to a child depends upon whether the appropriate dose of each ingredient, which must be individualized according to the child’s age and weight, can be provided. Dosage of chlorzoxazone ranges between 125 and 500mg, administered three or four times daily. The quantity of paracetamol in one tablet of the chlorzoxazone and paracetamol combination (500mg) may be administered to children six years of age and older, but the quantity present in tho tablets (600mg) is higher than the maximum dose recommended for children younger than twelve years of age.

Side Effects:

Elderly

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. Caution is required in patients with certain conditions.

Respiratory disorders

In patients suffering from, or with a history of, bronchial asthma or allergic disease NSAIDs have been reported to precipitate bronchospasm.

Cardiovascular and renal impairment

The administration of NSAIDs may cause a dose dependant reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients.

Cardiovascular and cerebrovascular effects appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Clinical trial data suggest that use of ibuprofen, particularly at high doses (2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (e.g myocardial infarction or stroke).

Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. less than 1200mg daily) is associated with an increased risk of myocardial infarction. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration. Similar consideration should be made before initiating long-term treatment for patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking)

Gastrointestinal bleeding ulceration and perforation

Gastrointestinal (GI) bleeding, ulceration and perforation, which can be fatal has been reported with all NSAIDs and anytime during treatment, with or without warning symptoms or a previous history of serious GI events. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose acetylsalicylic acid, or other drugs likely to increase gastrointestinal risk.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants, such as warfarin selective serotonin-reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid. Which GI bleeding or ulceration occurs in patients receiving ibuprofen containing products, the treatment should be withdrawn. NSAIDs should be given with care to patients with a history of GI disease (ulcerative colitis, crohn’s disease) as these conditions may be exacerbated.

Warnings & Precautions:

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

The use of aceclofenac with concomitant NSAIDs including cyclooxygnase-2 selective inhibitors should be avoided. The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients. The administration of an NSAID may cause a dose dependant reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics or recovering from major surgery, and the elderly. The importance of prostaglandins in maintaining renal blood flow should be taken into account in these patients. Renal function should be monitored in these patients. Patients with mild to moderate renal impairment should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function monitored regularly. Effects on renal function are usually reversible on withdrawal of aceclofenac.

Pregnancy & Lactation:

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation or gastroschisis after use of prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1% up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy.

Lactation

There is no information on the secretion of aceclofenac to breast milk; there was however no notable transfer or radio labeled (14C) aceclofenac to the milk of lactating rats. The use of aceclofenac should therefore be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the potential risks to the foetus.

Drug Interactions:

Aceclofenac

Other analgesics including cyclooxygenase-2 selective inhibitors: avoid concomitant use of the two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects, including GI bleeding. NSAIDs may reduce the effect of antihypertensives. The risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients or elderly patients) when ACE-inhibitors or angiotensin II receptor antagonists are combined with NSAIDs. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.

Paracetamol

The speed of absorption of paracetamol may be increased by metoclopromide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding, occasional doses have no significant effect.

Chlorzoxazone

Using chlorzoxazone with any of the following medicines is usually not recommended but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Adinazolam, Alfentanil, Alprazolam, Amobarbital, Bromazepam, Butalbital, Clonazepam, Codein, Diazepam, Fentanyl, Flunitrazepam, Morphine, Nitrazepam, Oxazepam, Pentobarbital, Phenobarbital, Quazepam, Remifentanil, Secobarbital, Sufentanil, Thiopental, Triazolam.

 

Contraindications:

Hypersensitivity to aceclofenac history of recurrent peptic ulcers/haemorrhage(two or more distinct episodes of proven ulceration or bleeding). NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs. Severe heart failure, hepatic failure and renal failure. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active bleedings or bleeding disorders. Aceclofenac should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so.

Price: Ksh 900

Notes:

Pack Size: 20s

Overdose

Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, gastrointestinal bleeding, rarely diarrhea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage possible.

Date of publication of insert: 20^th February 2021