AMITRIPTYLINE DRUG INFO

HOW TO USE: Take amitriptyline tablets by mouth. Follow the directions on the prescription label. Swallow the tablets with a drink of water. You can take the tablets with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your prescriber's advice.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

Adolescents, 12 to 18 years old, and elderly patients over 65 years old may have a stronger reaction to this medicine and need smaller doses.

SIDE EFFECTS: Side effects that you should report to your prescriber or health care professional as soon as possible: abnormal production of milk in females; blurred vision or eye pain; breast enlargement in both males and females; confusion, hallucinations (seeing or hearing things that are not really there); difficulty breathing; fainting spells; fever with increased sweating; irregular or fast, pounding heartbeat, palpitations; muscle stiffness, or spasms; pain or difficulty passing urine, loss of bladder control; seizures (convulsions); sexual difficulties (decreased sexual ability or desire, difficulty ejaculating); stomach pain; swelling of the testicles; tingling, pain, or numbness in the feet or hands; unusual weakness or tiredness; yellowing of the eyes or skin.

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): anxiety; constipation, or diarrhea; drowsiness or dizziness; dry mouth; increased sensitivity of the skin to sun or ultraviolet light; loss of appetite; nausea, vomiting; skin rash or itching; weight gain or loss.

PRECAUTIONS: Visit your prescriber or health care professional for regular checks on your progress. It can take several days before you feel the full effect of amitriptyline.

If you have been taking amitriptyline regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or you may get severe side effects. Ask your prescriber or health care professional for advice. Even after you stop taking amitriptyline it can still affect your body for several days.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how amitriptyline affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds or allergies without asking your prescriber or health care professional for advice. Some ingredients can increase possible side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.

Amitripyline may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your ophthalmologist if the problem does not go away or is severe.

Amitriptyline may make your skin more sensitive to the sun. Keep out of the sun, or wear protective clothing outdoors and use a sunscreen. Do not use sun lamps or sun tanning beds or booths.

If you are diabetic, check your blood sugar more often than usual, especially during the first few weeks of treatment with amitriptyline. Amitriptyline can affect blood glucose (sugar) levels. Call your prescriber or health care professional for advice if you notice a change in the results of blood or urine glucose tests.

If you are going to have surgery or will need an x-ray procedure that uses contrast agents, tell your prescriber or health care professional that you are taking this medicine.

DRUG INTERACTIONS: Amitriptyline can interact with many other medicines. Some interactions can be very important. Make sure your prescriber or health care professional knows about all other medicines you are taking. Many important interactions are listed below:

Do not take amitriptyline with any of the following medications: astemizole (Hismanal®); cisapride (Propulsid®); probucol; terfenadine (Seldane®); thioridazine (Mellaril®); medicines called MAO inhibitors-phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), selegiline (Eldepryl®); other medicines for mental depression (may be duplicate therapies or cause additive side effects).

Amitriptyline may also interact with any of the following medications: alcohol; antacids; atropine and related drugs like hyoscyamine, scopolamine, tolterodine and others; barbiturate medicines for inducing sleep or treating seizures (convulsions), such as phenobarbital; blood thinners, such as warfarin; bromocriptine; bupropion; cimetidine; clonidine; cocaine; delavirdine; diphenoxylate; disulfiram; donepezil; drugs for treating HIV infection; female hormones, including contraceptive or birth control pills and estrogen; galantamine; herbs and dietary supplements like ephedra (Ma huang), kava kava, SAM-e, St. John's wort, valerian, or others ; imatinib, STI-571; kaolin; pectin; labetalol; levodopa and other medicines for movement problems like Parkinson's disease; lithium; medicines for anxiety or sleeping problems; medicines for colds, flu and breathing difficulties, like pseudoephedrine; medicines for hay fever or allergies (antihistamines); medicines for weight loss or appetite control; medicines used to regulate abnormal heartbeat or to treat other heart conditions (examples: amiodarone, bepridil, disopyramide, dofetilide, encainide, flecainide, ibutilide, mibefradil, procainamide, propafenone, quinidine, and others); metoclopramide; muscle relaxants, like cyclobenzaprine; other medicines for mental or mood problems and psychotic disturbances; prescription pain medications like morphine, codeine, tramadol and others; procarbazine; seizure (convulsion) or epilepsy medicine such as carbamazepine or phenytoin; stimulants like dexmethylphenidate or methylphenidate; some antibiotics (examples: erythromycin, gatifloxacin, levofloxacin, linezolid, moxifloxacin, sotalol, sparfloxacin) ; tacrine; thyroid hormones such as levothyroxine.

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

NOTES: Prescriber needs to know if you have any of these conditions: an alcohol problem; asthma, difficulty breathing; blood disorders or disease; diabetes; difficulty passing urine, prostate trouble; glaucoma; having intramuscular injections; heart disease or previous heart attack; liver disease; over active thyroid; Parkinson's disease; schizophrenia; seizures (convulsions); stomach disease; an unusual or allergic reaction to amitriptyline, other medicines, foods, dyes, or preservatives; pregnant or trying to get pregnant; breast-feeding.

MISSED DOSE: If you miss a dose normally taken at bedtime to avoid daytime drowsiness, it may be better to miss that dose. If you take more than one dose a day and miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Follow your prescriber's advice on missed doses. Do not take double or extra doses.

STORAGE: Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.