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NIGHTTIME COLD, COUGH & FLU is a brand name for Ibuprofen, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ................................................................................................ 3 CONTRAINDICATIONS................................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Ibuprofen is contraindicated for patients with active peptic ulcer, a history of recurrent ulceration or active inflammatory disease of the gastrointestinal system. Both ibuprofen and diphenhydramine have been associated with hypersensitivity.
Patients who are hypersensitive to these drugs or to any ingredient in the formulation or component of the container should not use this product. For a complete listing, see Dosage Forms, Composition and Packaging Section of the product monograph.
The potential for cross-reactivity between different NSAIDs must be kept in mind. Ibuprofen containing products should not be used in patients with the complete or partial syndrome of nasal polyps, or in whom asthma, anaphylaxis, urticaria, rhinitis or other allergic manifestations are precipitated by ASA or other nonsteroidal anti- inflammatory agents.
Fatal anaphylactoid reactions have occurred in such individuals. As well, individuals with the above medical problems are at risk of a severe reaction even if they have taken NSAIDs in the past without any adverse effects. Significant hepatic impairment or active liver disease.
Severely impaired or deteriorating renal function (creatinine clearance <30 mL/min). Individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored.
Ibuprofen is not recommended for use with other NSAIDs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive side effects. Children with kidney disease and children who have suffered significant fluid loss due to vomiting, diarrhea or lack of fluid intake, should not be given ibuprofen.
Ibuprofen should not be used during pregnancy or by nursing mothers. Ibuprofen is contraindicated in patients with systemic lupus erythematosus, as an anaphylaxis-like reaction with fever may occur, particularly when ibuprofen has been administered previously.
Known hyperkalemia (see Warnings and Precautions – Renal – Fluid and Electrolyte Balance) Ibuprofen should not be used right before or after heart surgery. WARNINGS AND PRECAUTIONS Serious Warnings and Precautions 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).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Page 5 of 45 Caution in patients prone to gastrointestinal tract irritation, including those with a history of peptic ulcer (See Warnings and Precautions, Gastrointestinal; and Drug Interactions, Coumarin-type anticoagulants). Patients at greatest risk of renal toxicity are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and the elderly (See Warnings and Precautions, Renal).
If urinary symptoms, hematuria and cystitis occur, the drug should be stopped immediately (See Warnings and Precautions, Genitourinary). Ibuprofen use during pregnancy/nursing should be avoided (See Warnings and Precautions, Special Populations: Pregnant Women and Nursing Women).
Causes sedation or sleepiness. Not for daytime use. General As with other anti-inflammatory drugs, ibuprofen may mask the usual signs of infection. Ibuprofen is NOT recommended for use with other NSAIDs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions.
(See Drug Interactions - Drug/Drug Interactions - Acetylsalicylic acid (ASA) or other NSAIDs). Patients with glaucoma, chronic lung disease (emphysema or chronic bronchitis), or difficulty in urination due to prostate enlargement or bladder neck problems should not take this product unless directed by a physician [126].
If symptoms of fever and pain associated with cold or flu symptoms do not improve within 5 days, a physician should be consulted. Carcinogenesis and Mutagenesis Not applicable.
Cardiovascular Ibuprofen:
Congestive heart failure in patients with marginal cardiac function, elevated blood pressure and palpitations. Long term continuous use may increase the risk of heart attack or stroke [139].
Diphenhydramine:
Vasconstrictive effects have been noted [17]. Dependence/Tolerance A combination of butorphanol and diphenhydramine is being increasingly used as a drug of abuse. Diphenhydramine dependence has been documented in case reports involving mentally ill patients [17].
Ear/Nose/Throat Patients with complete or partial syndrome of nasal polyps should not use Nighttime Cold, Cough & Flu (See Contraindications). Page 6 of 45 Endocrine and Metabolism Patients with thyroid disease should not take this drug unless directed by a physician.
Fluid and Electrolyte Balance Fluid retention and oedema have been observed in patients treated with ibuprofen. Therefore, as with many other NSAIDs, the possibility of precipitating congestive heart failure in elderly patients or those with compromised cardiac function should be borne in mind.
Nighttime Cold, Cough & Flu 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 Serious gastrointestinal (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 […]