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Since 2009, the Food and Drug Administratio"...
Zonalon Consumer (continued)
To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: severe constipation, loss of coordination, ringing in the ears, persistent heartburn, mental/mood changes (e.g., agitation, confusion, depression), muscle weakness/spasms, numbness/tingling of the hands/feet, restlessness, decreased sexual ability/interest, trouble urinating, swelling of the hands/feet, weight gain.
Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, persistent nausea/vomiting, signs of infection (e.g., fever, persistent sore throat), pain/redness/swelling of arms or legs, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.
Seek immediate medical attention if any of these rare but very serious side effects occur: slurred speech, fast/irregular heartbeat, vision changes, fainting, weakness on one side of the body, seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Zonalon (doxepin) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using doxepin, tell your doctor or pharmacist if you are allergic to it, or to other tricyclic antidepressants (e.g., amitriptyline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain eye problem (narrow-angle glaucoma), problems urinating (e.g., due to enlarged prostate).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., bronchitis, emphysema), long-term constipation, long-term heartburn, diabetes, eating disorders (e.g., bulimia), certain eye problem (open-angle glaucoma), heart problems (e.g., irregular heartbeat), kidney problems, liver problems, overactive thyroid (hyperthyroidism), personal or family history of mental/mood conditions (e.g., bipolar disorder, psychosis, suicide), seizures, conditions that may increase your risk of seizures (e.g., other brain disease, alcohol withdrawal).
Doxepin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using doxepin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using doxepin safely.
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.
To reduce dizziness and lower the risk of fainting, get up slowly when rising from a sitting or lying position.
Before having surgery, tell your doctor or dentist that you are using this medication.
If you have diabetes, this drug may make your blood sugar levels harder to control. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high or low blood sugar such as fast heartbeat, increased thirst/urination, shakiness, unusual sweating, or hunger. Your anti-diabetic medication or diet may need to be adjusted.
Older adults may be more sensitive to the side effects of this drug, especially dizziness, drowsiness, confusion, difficulty urinating, and QT prolongation (see above).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
Additional Zonalon Information
- Zonalon Drug Interactions Center: doxepin top
- Zonalon Side Effects Center
- Zonalon Overview including Precautions
- Zonalon FDA Approved Prescribing Information including Dosage
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