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warnings
WARNINGS On very rare occasions, the first dose of Carisoprodol has been followed by idiosyncratic reactions with symptoms appearing within minutes or hours. These may include extreme weakness, transient quadriplegia, dizziness, ataxia temporary loss of vision, diplopia, mydriasis, dysarthria, agitation, euphoria, confusion and disorientation. Although symptoms usually subside over the course of the next several hours, discontinue Carisoprodol, Aspirin and Codeine Phosphate Tablets and initiate appropriate supportive and symptomatic therapy, which may include epinephrine and/or antihistamines. In severe cases, corticosteroids may be necessary. Severe reactions have been manifested by asthmatic episodes, fever, weakness, dizziness, angioneurotic edema, smarting eyes, hypotension, and anaphylactoid shock. The effects of carisoprodol with agents such as alcohol, other CNS depressants or psychotropic drugs may be additive. Appropriate caution should be exercised with patients who take one or more of these agents simultaneously with Carisoprodol, Aspirin and Codeine Phosphate tablets.
ADVERSE REACTIONS If severe reactions occur, discontinue Carisoprodol, Aspirin and Codeine Phosphate Tablets and initiate appropriate symptomatic and supportive therapy. The following side effects which have occurred with the administration of the individual ingredients alone may also occur with the combination. Carisoprodol: Central Nervous System-Drowsiness is the most frequent complaint and along with other CNS effects may require dosage reduction. Observed less frequently are dizziness, vertigo and ataxia. Tremor, agitation, irritability, headache, depressive reactions, syncope, and insomnia have been infrequent or rare. Idiosyncratic - Idiosyncratic reactions are very rare. They are usually seen within the period of the first to fourth dose in patients having had no previous contact with the drug (see WARNINGS ). Allergic - Skin rash, erythema multiforme, pruritis, eosinophilia, and fixed drug eruptions with cross-reaction to meprobamate have been reported. If allergic reactions occur, discontinue Carisoprodol, Aspirin and Codeine Phosphate Tablets and treat symptomatically. In evaluating possible allergic reactions, also consider allergy to excipients (information on excipients is available to physicians on request). Cardiovascular - Tachycardia, postural hypotension, and facial flushing. Gastrointestinal - Nausea, vomiting, epigastric distress, and hiccup. Hematologic - No serious blood dyscrasias have been attributed to carisoprodol alone. Leukopenia and pancytopenia have been reported, very rarely, in situations in which other drugs or viral infections may have been responsible. Aspirin: The most common adverse reactions associated with the use of aspirin have been gastrointestinal, including nausea, vomiting, gastritis, occult bleeding, constipation, and diarrhea. Gastric erosion, angioedema, asthma, rash, pruritus and urticaria have been reported less commonly. Tinnitus is a sign of high serum salicylate levels (see OVERDOSAGE ). Aspirin Intolerance - Allergic type reactions in aspirin–sensitive individuals may involve the respiratory tract or the skin. Symptoms of the former, range from rhinorrhea and shortness of breath to severe asthma and the latter may consist of urticaria, edema, rash, or angioedema (giant hives). These may occur independently or in combination. Codeine Phosphate: Nausea, vomiting, constipation, miosis, sedation, and dizziness have been reported.