Twilite

Twilite is part of the drug classes:

• Aminoalkyl ethers

• Antihistamines for topical use

Diphenhydramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Diphenhydramine is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.

Diphenhydramine is also used to treat motion sickness, to induce sleep, and to treat certain symptoms of Parkinson's disease.

Diphenhydramine may also be used for purposes not listed in this medication guide.

You should not use diphenhydramine if you are allergic to it.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

• blockage in your digestive tract (stomach or intestines);

• bladder obstruction or other urination problems;

• a colostomy or ileostomy;

• liver or kidney disease;

• asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;

• cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

• heart disease, low blood pressure;

• glaucoma;

• a thyroid disorder; or

• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether diphenhydramine will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

Diphenhydramine can pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Ask a doctor before using this medicine if you are breast-feeding.

Older adults may be more likely to have side effects from this medicine.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

You should not use antihistamine medication to make a child sleepy.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

For motion sickness, take diphenhydramine 30 minutes before you will be in a situation that causes you motion sickness (such as a long car ride, airplane or boat travel, amusement park rides, etc). Continue taking diphenhydramine with meals and at bedtime for the rest of the time you will be in a motion-sickness situation.

As a sleep aid, take diphenhydramine within 30 minutes before bedtime.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can affect the results of allergy skin tests. Tell any doctor who treats you that you are using diphenhydramine.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using diphenhydramine and call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest;

• painful or difficult urination;

• little or no urinating;

• confusion, feeling like you might pass out; or

• tightness in your neck or jaw, uncontrollable movements of your tongue.

Common side effects may include:

• dizziness, drowsiness, loss of coordination;

• dry mouth, nose, or throat;

• constipation, upset stomach;

• dry eyes, blurred vision; or

• day-time drowsiness or "hangover" feeling after night-time use.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to diphenhydramine: compounding powder, injectable solution, oral capsule, oral disintegrating strip, oral liquid, oral tablet, oral tablet chewable, oral tablet disintegrating

General

The most commonly reported side effects included somnolence, dizziness, and incoordination.[Ref]

Nervous system

Common (1% to 10%): Sedation/somnolence/sleepiness, drowsiness, unsteadiness, dizziness, headache, attention disturbance
Rare (0.01% to 0.1%): Extrapyramidal effects, tremor, convulsions
Frequency not reported: Paresthesia, dyskinesia/muscle dyskinesia, vertigo, neuritis, incoordination, psychomotor impairment, activation of epileptogenic foci[Ref]

Drowsiness usually diminishes after a few days.[Ref]

Gastrointestinal

Common (1% to 10%): Dry mouth
Frequency not reported: Gastrointestinal disturbance, nausea, vomiting, constipation, diarrhea, dyspepsia, epigastric distress[Ref]

Other

Common (1% to 10%): Fatigue
Frequency not reported: Lassitude, tinnitus, acute labyrinthitis, asthenia, chills, impaired performance (including impaired driving, work, and/or information processing)[Ref]

Psychiatric

Rare (0.01% to 0.1%): Confusion, depression, sleep disturbances
Frequency not reported: Paradoxical excitation/excitation, agitation, increased energy, restlessness, nervousness, euphoria, anxiety, hallucinations, insomnia, irritability[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Palpitations, hypotension, arrhythmia
Frequency not reported: Tachycardia, chest tightness, extrasystoles[Ref]

Hematologic

Rare (0.01% to 0.1%): Blood disorders
Frequency not reported: Hemolytic anemia, thrombocytopenia, agranulocytosis[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity reactions
Frequency not reported: Angioedema, anaphylactic shock[Ref]

Hepatic

Rare (0.01% to 0.1%): Liver dysfunction[Ref]

Dermatologic

Frequency not reported: Rash, urticaria, skin rashes, erythema, photosensitivity, pruritus, drug rash, excessive perspiration[Ref]

Respiratory

Frequency not reported: Dyspnea, thickening of bronchial secretions, throat tightening, wheezing, nasal stuffiness, dry nose or throat[Ref]

Genitourinary

Frequency not reported: Urinary hesitancy/difficulty/retention, dysuria, early menses[Ref]

Ocular

Frequency not reported: Blurred vision, dry eyes, diplopia[Ref]

Metabolic

Frequency not reported: Increased appetite, anorexia[Ref]

Musculoskeletal

Frequency not reported: Muscle twitching/weakness[Ref]

Some side effects of Twilite may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.