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Deconamine Warnings, Precautions, Pregnancy, Nursing, Abuse - Guaifenesin; Hydrocodone; Pseudoephedrine

Deconamine Warnings, Precautions, Pregnancy, Nursing, Abuse - Guaifenesin; Hydrocodone; Pseudoephedrine

WARNINGS

Hydrocodone should be prescribed and administered with the same degree of caution as all oral medications containing a narcotic analgesic. Extreme caution should be exercised in the use of hydrocodone in patients with severe respiratory impairment or patients with impaired respiratory drive.

If sympathomimetic amines are used in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure or prostatic hypertrophy, judicious caution should be exercised (see CONTRAINDICATIONS.)

Use in Elderly: The elderly (60 years and older) are more likely to have adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression and death.

PRECAUTIONS

General

Caution should be exercised if used in patients with diabetes, hypertension, cardiovascular diseases, hyperreactivity to ephedrine, or decreased respiratory drive (see CONTRAINDICATIONS.)

Information for the Patient

Hydrocodone may produce drowsiness. Persons who perform hazardous tasks requiring mental alertness or physical coordination should be cautioned accordingly. Concomitant use of hydrocodone with tranquilizers, alcohol or other depressants may produce additive depressant effects. Do not exceed the prescribed dosage.

IF YOU HAVE HAD A SEVERE ALLERGIC REACTION to codeine, hydrocodone, dihydrocodeine, or oxycodone (such as Tylox, Tylenol with Codeine, Vicodin), contact your doctor or pharmacist BEFORE TAKING THIS MEDICINE. A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. If you have a question about whether you are allergic to this medicine or if a certain medicine contains codeine, hydrocodone, dihydrocodeine, or oxycodone, contact your doctor or pharmacist. IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more doses of this medicine unless your doctor tells you to do so. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. THIS MEDICINE MAY CAUSE DIZZINESS OR DROWSINESS. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. THIS MEDICINE WILL ADD TO THE EFFECTS of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants. AVOID ALCOHOLIC beverages while you are taking this medicine. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. DO NOT TAKE DIET OR APPETITE CONTROL MEDICINES while you are taking this medicine without checking with your doctor. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine.

Laboratory Test Interactions

Guaifenesin interferes with the colorimetric determination of 5-hydroxyindoleacetic acid (5-HIAA) and Vanillylmandelic acid (VMA).

Pregnancy Category C

Animal reproduction studies have not been conducted with pseudoephedrine, guaifenesin, or hydrocodone. It is also not known whether pseudoephedrine, guaifenesin or hydrocodone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pseudoephedrine, guaifenesin or hydrocodone may be given to a pregnant woman only if clearly needed.

Nursing Mothers

Because of the potential for serious adverse reactions in nursing infants from sympathomimetic amines, pseudoephedrine is contraindicated in nursing mothers.

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