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COLD + SINUS DAYTIME is a brand name for Ibuprofen, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE................................................................................................................3 CONTRAINDICATIONS .....................................................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Safety Studies of Ibuprofen and Pseudoephedrine Combination In patients with upper respiratory infections treated with either ibuprofen 200 mg plus pseudoephedrine 30 mg (n = 294), acetaminophen 500 mg (n = 296), or placebo (n = 146), the frequency of adverse events (mostly gastrointestinal and CNS symptoms) was similar among the three treatment groups [83].
In a placebo-controlled, double-blind clinical study of 58 subjects with rhinovirus infection, pseudoephedrine given alone or with ibuprofen was well tolerated [84]. Symptoms associated with sympathetic stimulation tended to be more frequent in subjects who were treated with pseudoephedrine (60 mg, either alone or with 200 mg ibuprofen) than in those who received placebo.
The three treatment groups were similar in mean pulse rate and mean blood pressure.
Safety Studies of Ibuprofen:
The results of a double-blind, placebo-controlled study in healthy subjects (N = 1246) representative of a non-prescription analgesic user population indicate that ibuprofen at a dosage of 1200 mg/day for 10 consecutive days is well tolerated [85].
The frequency of gastrointestinal adverse experiences was similar in the placebo and ibuprofen groups (16% with placebo vs. 19% with ibuprofen). The most frequent gastrointestinal adverse experiences (those reported by 1% of the subjects) were dyspepsia, abdominal pain, nausea, diarrhoea, flatulence, and constipation.
There was no difference between the two groups in the proportion discontinuing treatment because of gastrointestinal adverse events. 4%) had positive occult blood tests: the frequency was comparable for the two treatments. In two multitrial analyses [86,87], a meta analysis [88], and a literature review [89], ibuprofen had a low incidence of gastrointestinal drug reactions, comparable with that of acetaminophen and placebo.
Serious Warnings and Precautions Patients with glaucoma, or difficulty in urination due to enlargement of the prostate gland should not take this drug unless directed by a physician [64] (See WARNINGS AND PRECAUTIONS, General). Use with caution in patients with heart failure, hypertension or other conditions predisposing to fluid retention (See WARNINGS AND PRECAUTIONS, Cardiovascular and Fluid and Electrolyte Balance; and DRUG INTERACTIONS, Antihypertensives).
Caution in patients who might be prone to gastrointestinal tract irritation, particularly those with a history of diverticulosis, or other inflammatory disease of the gastrointestinal tract such as ulcerative colitis and Crohn’s disease (See WARNINGS AND PRECAUTIONS, Gastrointestinal and DRUG INTERACTIONS, Coumarin-type anticoagulants).
Caution in patients at greatest risk of renal toxicity, such as those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and the elderly (See WARNINGS AND PRECAUTIONS, Renal). If persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria and cystitis occur, the drug should be stopped immediately (See WARNINGS AND PRECAUTIONS, Genitourinary).
General As with other anti-inflammatory drugs, ibuprofen may mask the usual signs of infection. If nervousness, dizziness, or sleeplessness occur, use of Cold + Sinus Daytime should be discontinued and a physician should be consulted.
Cold + Sinus Daytime should not be used for more than 3 days for fever or 5 days for cold symptoms/pain. Carcinogenesis and Mutagenesis Not applicable. Cardiovascular Use of ibuprofen may precipitate congestive heart failure in patients with marginal cardiac function, elevated blood pressure and palpitations.
Cold + Sinus Daytime should be used with caution in hypertensive patients because of the possible pressor effect of pseudoephedrine. Pseudoephedrine has been shown to increase blood pressure in normotensive adults and in patients with hypertension.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In epidemiological studies, ibuprofen has consistently exhibited the lowest relative risk of severe gastrointestinal complications compared with other NSAIDs and acetylsalicylic acid [90,91,92]. No symptom or syndrome emerged in the trials that was not predicted from the drug’s pharmacology or could not have been anticipated based on ibuprofen’s extensive use as an analgesic/antipyretic in adults.
Garcia-Rodriguez reported on the frequency of acute liver injury among 625,307 people who received NSAIDs in England and Wales between 1987 and 1991, of whom 311,716 were prescribed ibuprofen [93]. 6/100,000. This was the lowest incidence among the eight NSAIDs studied and was significantly lower than the incidence among users of ketoprofen, piroxicam, fenbufen, or sulindac.
For NSAID users as a group, the only factors that had an independent effect on the occurrence of acute liver injury were simultaneous use of hepatotoxic medication and the presence of rheumatoid arthritis. Vita Health Products Inc. Page 12 of 49 Two large-scale safety studies of ibuprofen examined the potential risk in children of several rare events that are related to the pharmacological action of NSAIDs: GI bleeding, acute renal failure, and anaphylaxis.
The Children’s Analgesic Medicine Project (CAMP) was a multicenter, all-comers, open-label, nonrandomized, prospective study comparing the safety of ibuprofen suspension with acetaminophen suspension in children with fever and/or pain [94].
A total of 424 pediatricians enrolled children at 69 US clinics; 14,281 were <2 years of age and 15,863 were 2 to <12 years of age. Among children <2 years of age, fever, vomiting, diarrhoea, rhinitis, rash, and otitis media were the only adverse events with frequency >1% in either treatment group (ibuprofen or acetaminophen).
Among children 2 years of age, the only adverse events with frequency >1% in either treatment group were rhinitis, pharyngitis, and otitis media. Adverse events were generally mild to moderate for both treatments within the two age groups.
There were no serious adverse events, (no anaphylaxis, Reye syndrome, renal failure, or GI bleeding/perforation). 6% vs. 9% vs. 7%). The difference may have been due to the preference of physicians to treat the sicker children with ibuprofen.
Overall, ibuprofen exhibited an adverse event profile similar to that of acetaminophen. The Boston Fever Study was a randomized, double-blind study that assessed the risk of rare but serious adverse events after the use of ibuprofen suspension in febrile children between 6 months and 12 years of age [95,96,97].
The study evaluated a total of 83,915 children enrolled by 1735 pediatricians, family physicians, and general practitioners in the United States. Children were randomly assigned to receive ibuprofen suspension 5 mg/kg (N = 27,948), ibuprofen suspension 10 mg/kg (N = 27,837), or acetaminophen suspension 12 mg/kg (N = 28,130).
Medications were given every 4 to 6 hours, as needed, for a total of up to five doses per day. The study recorded hospitalisations for acute GI bleeding, acute renal failure, and anaphylaxis and monitored for the occurrence of Reye syndrome.
In the entire population, the authors found no significant difference between ibuprofen and acetaminophen-treated children in the observed risk of GI bleeding, acute renal failure, or anaphylaxis. No cases of Reye syndrome were seen.
Adverse Events with Doses of Ibuprofen ≥ 1200 mg/day […]
Pseudoephedrine treatment may increase heart rate and can cause arrhythmia. Asymptomatic, multifocal premature ventricular contractions (PVCs) were reported with the use of Actifed® (a combination of pseudoephedrine with an antihistamine, triprolidine), two tablets every 4 hours around the clock, for Vita Health Products Inc.
Page 6 of 49 several days to treat nasal congestion [67]. The PVCs disappeared within a few days after discontinuation of the medication. Dependence/Tolerance Pseudoephedrine has the potential to cause drug dependency and withdrawal effects.
Reportedly, a woman with a history of depression experienced a stimulatory effect from the use of 50 to 300 mL of Actifed® (pseudoephedrine and triprolidine) daily (the recommended dose is 30 mL per day) [75]. A 37-year-old woman admitted to taking 100 to 150 30-mg pseudoephedrine tablets daily [76].
She had gradually increased the daily dose over the previous 5 years to counteract chronic fatigue, apathy, and depression. A previous attempt to discontinue use of the drug had produced visual hallucinations, severe fatigue, and depression.
Slow withdrawal by 200 to 300 mg/day resulted in a return of depressive symptoms; thereafter, the dose was decreased more slowly, by 90 mg/day. The patient was later diagnosed as having a mixed character disorder and reactive depression.
Ear/Nose/Throat See Contraindications. Endocrine and Metabolism Patients with thyroid disease should not take this drug. See Contraindications. Fluid and Electrolyte Balance Fluid retention and oedema have been observed in patients treated with ibuprofen.
Therefore, as with many other nonsteroidal anti-inflammatory drugs, the possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should be borne in mind. Cold + Sinus Daytime should be used with caution in patients with heart failure, hypertension or other conditions predisposing to fluid retention.
With nonsteroidal anti-inflammatory treatment there is a potential risk of hyperkalemia, particularly in patients with conditions such as diabetes mellitus or renal failure; elderly patients; or in patients receiving concomitant therapy with B-adrenergic blockers, angiotensin converting enzyme inhibitors or some diuretics.
Serum electrolytes should be monitored periodically during long-term therapy, especially in those patients who are at risk. Gastrointestinal See Contraindications. Serious GI toxicity, such as peptic ulceration, perforation and gastrointestinal bleeding, sometimes severe and occasionally fatal, can occur at any time, with or without symptoms in patients treated with NSAIDs including ibuprofen.
Minor upper GI problems, such as dyspepsia, are common, usually developing early in therapy. Physicians should remain alert for ulceration and bleeding in patients treated with non-steroidal anti- inflammatory drugs, even in the absence of previous GI tract symptoms.
In patients observed in clinical trials of such agents, symptomatic upper GI ulcers, gross bleeding, or perforation appear to occur in approximately 1% of patients treated for 3-6 months and in about 2-4% of patients treated for one year.
The risk continues beyond one year and possibly increases. The Vita Health Products Inc. Page 7 of 49 incidence of these complications increases with increasing dose. Cold + Sinus Daytime should be given under close medical supervision to patients prone to gastrointestinal tract irritation, particularly those with a history of peptic ulcer, diverticulosis or other inflammatory disease of the gastrointestinal tract such as ulcerative colitis and Crohn's disease.
In these cases the physician must weigh the benefits of treatment against the possible hazards. Physicians should inform patients about the signs and/or symptoms of serious GI toxicity and instruct them to contact a physician immediately if they experience persistent dyspepsia or other symptoms or signs suggestive of […]