Brufen Plus (Codeine Phosphate + Ibuprofen)

Brufen Plus (Codeine Phosphate + Ibuprofen)

Brufen Plus (Codeine Phosphate + Ibuprofen)

Brufen Plus (Codeine Phosphate + Ibuprofen)

PRODUCT DESCRIPTION:
Brufen Plus tablet is a combination non-steroidal anti-inflammatory/opioid analgesic pain medication.
Each tablet of ibuprofen with codeine contains the following:
Codeine phosphate, USP ... 20 mg
Ibuprofen, BP....................... 200 mg
Ibuprofen is practically insoluble in water and is very soluble in acetone and in methyl alcohol.
Codeine phosphate hemihydrate is freely soluble in water, slightly soluble in alcohol and practically insoluble in ether
CLINICAL PHARMACOLOGY 
Actions
Codeine, a phenanthrene derivative, is an opioid analgesic. It is much less potent as an analgesic than morphine and has relatively mild
sedative effects.
Brufen Plus is a combination of codeine with ibuprofen. Ibuprofen is a member of the propionic acid group of nonsteroidal anti-
inflammatory drugs (NSAIDs). Ibuprofen has shown anti-inflammatory, analgesic and antipyretic activity in both animal and human
studies. These properties provide symptomatic relief of inflammation and pain.
INDICATIONS
Ibuprofen Codeine is indicated in the symptomatic treatment of mild to moderate pain in adults.
Posology and method of administration
Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms
Adults
Ibuprofen- codeine 200mg/20mg tablets.
The recommended dose is one or two tablets one to four times daily. No more than eight tablets should be taken in 24 hours.
Pediatric population
Ibuprofen with codeine is not recommended in children and adolescents under 18 years.
Elderly population
No special dosage modifications are required for elderly patients, unless renal or hepatic function is impaired or there is the increased
possibility of sensitivity to the central effects of opioids or symptoms of prostatic hypertrophy. In such cases, the dosage should be
assessed individually.
Method of administration
Take ibuprofen with codeine tablets with a glass of water. Ibuprofen with codeine tablets should be swallowed whole and not chewed,
broken, crushed or sucked on to avoid oral discomfort and throat irritation.
CONTRAINDICATIONS ?Brufen Plus is contraindicated in: ?Known hypersensitivity to the active substance
Ibuprofen should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking ?acetylsalicylic acid/aspirin or other NSAIDs. ?Severe heart failure (NYHA IV). ?Severe liver failure. ?Severe renal failure (glomerular filtration below 30 mL/min). ?Conditions involving an increased tendency or active bleeding. ?History of gastrointestinal bleeding or perforation, related to previous NSAID therapy.
Active or history of ulcerative colitis, Crohn's disease, recurrent peptic ulceration or gastrointestinal hemorrhage (defined as two ?or more distinct episodes of proven ulceration or bleeding). ?During the third trimester of pregnancy.
 Patients of any age who are known to be CYP2D6 ultra-rapid metabolisers.

Brufen Plus (Codeine Phosphate + Ibuprofen)

Special warnings and precautions for use
General
Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms
(see DOSAGE AND ADMINISTRATION).
As with other NSAIDs, ibuprofen may mask the signs of infection. The concomitant use of alcohol should be avoided.
Elderly population
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation,
which may be fatal.
Gastrointestinal bleeding, ulceration and perforation
Ibuprofen with codeine should be used with caution in patients with a history of peptic ulceration and other gastrointestinal disease
since their conditions may be exacerbated.
Gastrointestinal bleeding, ulceration or perforation has been reported with all NSAIDs at any time during treatment. These adverse
events can be fatal and may occur with or without warning symptoms or a previous history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing ibuprofen doses in patients with a history of
ulcers, particularly if complicated with hemorrhage 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, as
well as patients requiring concomitant low dose aspirin, or for other drugs likely to increase gastrointestinal risk.
The concomitant administration of ibuprofen and other NSAIDs, including cyclooxygenase-2 (Cox-2) selective inhibitors, should be
avoided due to the increased risk of ulceration or bleeding.
Patients with a history of gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms
(especially gastrointestinal bleeding) in the initial stages of treatment. Caution should be exercised in patients receiving concomitant
medication which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin,
selective serotonin reuptake inhibitors or antiplatelet drugs such as aspirin.
If gastrointestinal bleeding or ulceration occurs in patients receiving ibuprofen with codeine, the treatment should be withdrawn.
Codeine should be used with caution in patients with biliary tract disease, including acute pancreatitis, as codeine may cause spasm of
the sphincter of Oddi and diminish biliary and pancreatic secretions.
Respiratory disorders
Caution is required if ibuprofen with codeine is administered to patients with a history of bronchial asthma, chronic rhinitis or allergic
diseases like bronchospasm, urticaria or angioedema.
Cardiac, renal and hepatic Impairment
Caution is required in patients with renal, hepatic or cardiac impairment since the use of NSAIDs may result in deterioration of renal
function.
The habitual concomitant intake of various painkillers further increases this risk. For patients with renal, hepatic or cardiac
impairment, use the lowest effective dose, for the shortest possible duration and monitor renal function especially in long-term
treated patients.
Cardiovascular and cerebrovascular Effects
Ibuprofen with codeine should be given with care to patients with a history of heart failure or hypertension since edema has been
reported in association with ibuprofen administration. Clinical Data suggest that use of ibuprofen, particularly at a high dose (2,400
mg/day) may be associated with a small increased risk of arterial thrombotic events, such as myocardial infarction or stroke. Overall
epistemological studies do not suggest that low dose ibuprofen (e.g. <1,200 mg/day) is associated with an increased risk of arterial
thrombotic events. Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral
arterial disease and/or cerebrovascular disease should only be treated with ibuprofen after careful Consideration and high doses
(2400 mg/day) should be avoided. Careful consideration should also be exercised before initiating long-term treatment of patients
with risk factors for cardiovascular event (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking), particularly if high doses
of ibuprofen (2400 mg/day) are required.
Dermatological effects
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal
necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these
reactions early in the course of therapy. In the majority of cases, the onset of the reaction occurs within the first month of treatment.
Ibuprofen with codeine should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of SOLID 1000306838 v4.0 17 Jul 2015 hypersensitivity.