Aseptic Meningitis
N891
BRUFEN COLD
Film-coated tablets
For the relief of Cold, Flu and Sinusitis
DESCRIPTION
Active ingredients
Each tablet contains:
Ibuprofen 400 mg
Pseudoephedrine Hydrochloride 60 mg
Clinical Pharmacology:
anti-pyretic activity).
Ibuprofen is a propionic acid derivative with
anti-pyretic activity.
The drug’s therapeutic effects are thought to result from its inhibitory effect
on the enzyme cyclo-oxygenase, which results in a marked reduction in
prostaglandin synthesis.
These properties provide symptomatic relief of
Pseudoephedrine Hydrochloride (decongestant action). Pseudoephedrine
Hydrochloride is an orally effective sympathomimetic amine that decongests
swollen mucous membranes of the respiratory tract by vasoconstriction.
While its vasoconstrictor action is similar to that of ephedrine,
pseudoephedrine has been shown to have less pressor effect than ephedrine
in normotensive adults.
INDICATIONS
Brufen Cold ® is indicated for the relief of the
including
1. - Sore throat.
2. - Runny or blocked nose and sinuses.
3. - Aches and pain.
4. - Headache.
5. - Fever.
DOSAGE AND ADMINISTRATION
Adults:
The recommended dose is one tablet 3 times a day.
CONTRAINDICATIONS
Brufen Cold ® is contraindicated in patients with known hypersensitivity to any
of its ingredients.
Sympathomimetic amines are contraindicated in nursing mothers.
Ibuprofen is contraindicated in patients with active peptic ulceration and
those with a history of hypersensitivity reactions, including asthma, rhinitis or
urticaria, in response to Ibuprofen, aspirin or other NSAIDs.
WARNINGS
Do not exceed the recommended dosage.
If nervousness, restlessness or sleeplessness occurs, reduce dosage.
Sympathomimetic amines should be used with caution in patients with
cardiovascular disease such as ischemic heart disease, arrhythmia
or tachycardia, occlusive vascular disorders including arteriosclerosis
hypertension, or aneurysms.
Anginal pain may be precipitated in patients with angina pectoris.
Care is required when sympathomimetic agents are given to patients with
diabetes mellitus or closed-angle glaucoma.
May cause excitability, especially in children.
Elderly persons (approximately 60 years of age and older) are more likely to
have adverse reactions to sympathomimetic amines.
Persistent and severe pain or for fever for more than 3 days, could be signs
of a serious condition that needs investigation and additional treatment.
Do not take this product for persistent or chronic cough such as occurs with
smoking, asthma, emphysema, or if cough is accompanied by excessive
phlegm (mucus).
Alcohol Warning:
There is an increased overall relative risk for upper gastrointestinal
bleeding with regular use of Ibuprofen among varying amounts of alcohol
consumption.
PRECAUTION:
General Precautions:
Ibuprofen should be given with care to patients with a history of
gastrointestinal disease.
Caution is required if Ibuprofen is administered to patients suffering from
or with a previous history of bronchial asthma since Ibuprofen has been
reported to cause bronchospasm in such patients.
Caution is required in patients with renal, hepatic or cardiac impairment since
the use of NSAIDs may result in deterioration of renal function.
The dose should be kept as low as possible and renal function should be
monitored in these patients.
Ibuprofen 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.
As with other NSAIDs, Ibuprofen may mask the signs of infection.
Renal Effects:
Caution should be used when initiating treatment with Ibuprofen in patients
with considerable dehydration.
As with other NSAIDs, long-term administration of Ibuprofen has resulted in
renal papillary necrosis and other renal pathologic changes.
Renal toxicity has also been seen in patients in whom renal prostaglandins
have a compensatory role in the maintenance of renal perfusion. In these
patients, administration of a nonsteroidal
a dose-dependent reduction in prostaglandin formation and, secondarily, in
Patients at greatest risk of this reaction are those with impaired renal
function, heart failure, liver dysfunction, those taking diuretics and ACE
inhibitors and the elderly.
Discontinuation of nonsteroidal drug therapy is usually
followed by recovery to the pretreatment state.
Hematological Effects:
Ibuprofen, like other NSAIDs, can inhibit platelet aggregation and has been
shown to prolong bleeding time in normal subjects.
Aseptic meningitis has been observed on rare occasions in patients on
Ibuprofen therapy.
Although it is probably more likely to occur in patients with systemic lupus
erythematosus and related connective tissue diseases, it has been reported
in patients who do not have an underlying chronic disease.
Drug-drug interactions
Care should be taken in patients treated with any of the following drugs as
interactions have been reported in some patients:
- Anti-hypertensives, such as ACE inhibitors,and diuretics ( reduced effect):
- Lithium salts and methotrexate ( decreased elimination).
- Anticoagulants ( enhanced anticoagulant effect).
- Aspirin As with other products containing NSAIDs, concomitant
administration of Ibuprofen and aspirin is not generally recommended
because of the potential of increased adverse effects.
Cardiac Glycosides - NSAIDs may exacerbate cardiac failure, reduce
and increase plasma cardiac glycoside levels.
- Cyclosporine - Increased risk of nephrotoxicity with NSAIDs.
- Corticosteroids- Increased risk of gastrointestinal bleeding with NSAIDs.
The effects of sympathomimetics are increased with MAO inhibitors and
beta-adrenergic blockers.
- Sympathomimetics amines may reduce the antihypertensive effects
of reserpine, veratrum alkaloids, methyldopa and mecamylamine.
Sympathomimetics agents should be avoided or used with caution in patients
undergoing anesthesia with cyclopropane, halothane, or other halogenated
anesthetics, as they
An increased risk of arrhythmias may occur if sympathomimetic agents
are given to patients receiving cardiac glycosides, quinidine, or tricyclic
antidepressants.
Pregnancy
Safety for use during pregnancy has not been established.
While no teratogenic effects have been demonstrated in animal toxicology
studies, the use of Ibuprofen during pregnancy should, if possible, be
avoided.
Congenital abnormalities have been reported in association with Ibuprofen
administration in man; however these are low in frequency and do not appear
to follow any discernible pattern.
In view of the known effects of NSAIDs on the fetal cardiovascular system
(closure of ductus arteriosus) use in late pregnancy should be avoided.
Labor and Delivery
Administration of Ibuprofen is not recommended during labor and delivery.
Nursing Mothers
In the limited studies so far available, Ibuprofen appears in the breast milk in
very low concentrations.
Ibuprofen is not recommended for use in nursing mothers.
Ability to Drive and to Use Machines
No adverse effects known.
ADVERSE EVENTS:
Adverse Reactions to Ibuprofen
The pattern of adverse events reported for Ibuprofen is similar to that for
other NSAIDs.
- Gastrointestinal
The most commonly observed adverse events are gastrointestinal in nature.
Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, melena,
hematemesis, ulcerative stomatitis and gastrointestinal hemorrhage have
been reported following Ibuprofen administration.
Less frequently, gastritis, duodenal ulcer and gastric ulcer have been observed.
Epidemiological data indicate that of the seven most widely used oral, non-
aspirin NSAIDs, Ibuprofen presents the lowest risk of upper gastrointestinal
toxicity.
- Hypersensitivity
Hypersensitivity reactions have been reported following treatment with
Ibuprofen. These may consist of (a)
anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated
asthma, bronchospasm or dyspnea, or (c) assorted skin disorders including
rashes of various types, pruritus, urticaria, purpura, angioedema and less
commonly, bullous dermatoses (including epidermal necrolysis and erythema
multiform).
- Cardiovascular
Edema has been reported in association with Ibuprofen treatment.
Other adverse events reported less commonly and for which causality has
not necessarily been established include:
- Dermatological
Photosensitivity, “ may cause Steven – Johnson Syndrome”
- Hematological
Thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia and
hemolytic anemia.
- Hepatic
Hepatitis, jaundice
- Neurological
Disturbances of vision, optic neuritis, headaches, paresthesia, vertigo,
dizziness, drowsiness
- Psychiatric
Depression, confusion
- Renal
Renal nephrotoxicity in various forms, including interstitial nephritis, nephrotic
syndrome and renal failure
- Special Senses
Tinnitus
Storage
Store at room temperature below 30° C, protect from heat, light and moisture.
Keep out of reach of children.
How SUPPLIED
coated tablets.
Manufactured by:
Kahira Pharm. & Chem. Ind. Co.,
ABBOTT Under licence of
Abbott Laboratories P.53