Claritin 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.

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

Claritin is also used to treat skin hives and itching in people with chronic skin reactions

Warnings

You should not take Claritin if you are allergic to loratadine or to desloratadine (Clarinex).

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Some chewable dosage forms of Claritin may contain phenylalanine. Talk to your doctor before using these forms of loratadine if you have phenylketonuria (PKU).

Ask a doctor or pharmacist before taking Claritin if you have liver or kidney disease.

Before taking this medicine

Ask a doctor or pharmacist if Claritin is safe to use if you have ever had:

• kidney disease; or
• liver disease.

The chewable Claritin tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU).

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Do not give this medicine to a child younger than 2 years old without medical advice.

How should I take Claritin?

Use Claritin 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 Claritin 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.

Claritin is usually taken once per day. Follow your doctor’s instructions.

Do not crush, chew, or break the regular tablet. Swallow the tablet whole.

A child’s dose is based on age and some forms of loratadine are not for use in children younger than 6 years old. Carefully follow the dosing instructions provided with this medicine.

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.

The Claritin chewable tablet must be chewed before you swallow it.

To take the orally disintegrating tablet (Claritin RediTab):

• Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.
• Use dry hands to remove the tablet and place it in your mouth.
• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

Call your doctor if your symptoms do not improve, or if they get worse.

Store at room temperature away from moisture and heat.

Claritin side effects

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

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

• fast or uneven heart rate;
• severe headache; or
• a light-headed feeling, like you might pass out;

Common Claritin side effects may include:

• headache;
• feeling tired or drowsy;
• stomach pain, vomiting;
• dry mouth; or
• feeling nervous or hyperactive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Dosing information

Usual Adult Dose for Allergic Rhinitis:

10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Adult Dose for Urticaria:

10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Pediatric Dose for Allergic Rhinitis:

2 to 5 years: 5 mg orally once a day
-Maximum dose: 5 mg/day

6 years and older: 10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Pediatric Dose for Urticaria:

2 to 5 years: 5 mg orally once a day
-Maximum dose: 5 mg/day

6 years and older: 10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

What other drugs will affect Claritin?

Other drugs may interact with loratadine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What happens if I miss a dose?

Claritin is used when needed. Do not use Claritin more than once in a 24-hour period. Do not use two doses at one time.

What happens if I overdose?

Overdose symptoms may include headache, drowsiness, and fast or pounding heartbeat.

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Claritin?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Cetirizine is a second generation antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Cetirizine is used to treat cold or allergy symptoms such as sneezing, itching, watery eyes, or runny nose.

Cetirizine is also used to treat an allergic reaction, itching and swelling caused by chronic urticaria (hives) and minimizes or eliminates the symptoms of perennial allergic rhinitis, seasonal allergic rhinitis, chronic idiopathic urticaria, allergic asthma, physical urticaria, and atopic dermatitis.

Warnings

Cetirizine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of cetirizine.

Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by cetirizine.

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

Rarely, some people have reported severe itching when stopping cetirizine after daily, long-term use of at least a few months or several years. If you experience widespread, severe itching on stopping this medication, contact your healthcare provider.

Before taking this medicine

You should not use this medication if you are allergic to or had an adverse reaction to cetirizine.

Before taking cetirizine, tell your doctor about all of your medical conditions or if you have ever had kidney or liver disease.

Cetirizine is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Cetirizine can pass into breast milk and may harm a nursing baby. Do not use cetirizine without telling your doctor if you are breast-feeding a baby.

Cetirizine is indicated for chronic idiopathic urticaria in adults and children 6 months of age and older.

Older adults may need to take a lower than normal dose. Follow your doctor’s instructions.

How should I take cetirizine?

Take cetirizine exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

You may take cetirizine with or without food.

The chewable tablet must be chewed before you swallow it.

Oral doses: measure liquid medicine (oral solution) with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever. Store cetirizine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine or add extra doses to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, and then feeling drowsy.

What should I avoid?

Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by cetirizine.

Cetirizine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of cetirizine.

Cetirizine acute and common side effects

Get emergency medical help if you have any serious adverse effects or any of these signs of an allergic reaction: chronic idiopathic urticaria (hives); difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using cetirizine and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;
• weakness, tremors (uncontrolled shaking), or sleep problems (insomnia);
• severe restless feeling, hyperactivity;
• confusion;
• problems with vision; or
• urinating less than usual or not at all.

Less serious cetirizine side effects may include:

• dizziness, drowsiness;
• tired feeling;
• dry mouth;
• sore throat, cough;
• nausea, constipation; or
• headache.

Chlorpheniramine 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.

Chlorpheniramine is used to treat runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.

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

Chlorpheniramine side effects

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

Chlorpheniramine may cause serious side effects. Stop using chlorpheniramine and call your doctor at once if you have:

• fast or uneven heart rate;
• mood changes;
• tremor, seizure (convulsions);
• easy bruising or bleeding, unusual weakness;
• feeling short of breath; or
• little or no urinating.

Common side effects of chlorpheniramine may include:

• dizziness, drowsiness;
• dry mouth, nose, or throat;
• constipation;
• blurred vision; or
• feeling nervous or restless.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

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 chlorpheniramine if you have narrow-angle glaucoma, a blockage in your stomach or intestines, an enlarged prostate, if you are unable to urinate, or if you are having an asthma attack.

Before taking this medicine

You should not use chlorpheniramine if you are allergic to it, or if you have:

• narrow-angle glaucoma;
• a blockage in your stomach or intestines;
• an enlarged prostate;
• if you are unable to urinate; or
• if you are having an asthma attack.

Ask a doctor or pharmacist if it is safe for you to take chlorpheniramine if you have:

• a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;
• liver or kidney disease;
• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
• high blood pressure, heart disease, coronary artery disease, or recent heart attack;
• epilepsy or other seizure disorder;
• urination problems;
• pheochromocytoma (an adrenal gland tumor); or
• overactive thyroid.

FDA pregnancy category B. Chlorpheniramine is not expected to harm an unborn baby. Do not use this medicine without your doctor’s advice if you are pregnant.

Chlorpheniramine may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without your doctor’s advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take chlorpheniramine?

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. chlorpheniramine is usually taken only for a short time until your symptoms clear up.

Do not take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

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

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.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat. Do not allow the liquid form of this medicine to freeze.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking chlorpheniramine?

chlorpheniramine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of chlorpheniramine.

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlorpheniramine can decrease sweating and you may be more prone to heat stroke.

What other drugs will affect chlorpheniramine?

Taking chlorpheniramine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking chlorpheniramine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Benadryl 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.

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

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

Warnings

You should not use Benadryl to make a child sleepy.

When taking Benadryl, use caution driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking Benadryl.

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.

Before taking this medicine

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

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 Benadryl 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.

How should I take Benadryl?

Use Benadryl 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 Benadryl 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 Benadryl 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 Benadryl with meals and at bedtime for the rest of the time you will be in a motion-sickness situation.

As a sleep aid, take Benadryl 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 Benadryl.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since Benadryl is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Benadryl may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of diphenhydramine.

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines are contained in many combination medicines. Taking certain products together can cause you to get too much of this type of medicine. Check the label to see if a medicine contains an antihistamine.

Benadryl side effects

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

Stop using Benadryl 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 Benadryl 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.

What is hydroxyzine?

Hydroxyzine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of itching, or hives on the skin. Hydroxyzine may be used to treat allergic skin reactions such as hives or contact dermatitis.

Since hydroxyzine also reduces activity in the central nervous system, it can be used as a sedative to treat anxiety and tension. It is also used together with other medications given during and after general anesthesia.

Hydroxyzine is also used to treat allergic skin reactions such as hives or contact dermatitis.

Warnings

Hydroxyzine may cause birth defects. Talk to you doctor before using hydroxyzine if pregnant or breastfeeding.

Hydroxyzine can cause a serious heart problem, especially if you use certain medicines at the same time. Tell your doctor about all your current medicines and any you start or stop using.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Stop using this medicine and call your doctor at once if you have a serious side effect such as tremors, confusion, seizures, or restless muscle movements in your eyes, tongue, jaw, or neck.

Drinking alcohol can increase certain side effects of hydroxyzine.

Before taking this medicine

You should not use hydroxyzine if you are allergic to it, or if:

• you have long QT syndrome;
• you are allergic to cetirizine (Zyrtec) or levocetirizine (Xyzal); or

Hydroxyzine could harm the unborn baby or cause birth defects. Talk to you doctor before using hydroxyzine if pregnant.

To make sure this medicine is safe for you, tell your doctor if you have:

• blockage in your digestive tract (stomach or intestines);
• bladder obstruction or other urination problems;
• glaucoma;
• heart disease, slow heartbeats;
• personal or family history of long QT syndrome;
• an electrolyte imbalance (such as high or low levels of potassium in your blood);
• if you have recently had a heart attack.

It is not known whether hydroxyzine passes into breast milk or if it could harm a nursing baby. Talk to your doctor before breastfeeding while using this medicine.

Do not give this medicine to a child without medical advice.

How should I take hydroxyzine?

Take hydroxyzine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Shake the oral suspension (liquid) well just before you measure a dose. 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.

Hydroxyzine is for short-term use only.

You should not take this medicine for longer than 4 months. Call your doctor if your anxiety symptoms do not improve, or if they get worse.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include severe drowsiness, nausea, vomiting, uncontrolled muscle movements, or seizure (convulsions).

What to avoid

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol with this medicine can cause side effects.

Hydroxyzine side effects

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

In rare cases, hydroxyzine may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have sudden skin redness or a rash that spreads and causes white or yellow pustules, blistering, or peeling.

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

• fast or pounding heartbeats;
• headache with chest pain;
• severe dizziness, fainting; or
• a seizure (convulsions).

Side effects such as drowsiness and confusion may be more likely in older adults.

Common hydroxyzine side effects may include:

• drowsiness;
• headache;
• dry mouth; or
• skin rash.

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 .

What other drugs will affect hydroxyzine?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking hydroxyzine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Hydroxyzine can cause a serious heart problem, especially if you use certain medicines at the same time, including antibiotics, antidepressants, heart rhythm medicine, antipsychotic medicines, and medicines to treat cancer, malaria, HIV or AIDS. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with this medicine.

Other drugs may interact with hydroxyzine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Hydroxyzine Pamoate Description

Hydroxyzine pamoate is designated chemically as 1-(p-chlorobenzhydryl) 4- [2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis (2 hydroxy- 3-naphthalene carboxylic acid).

Inert ingredients for the capsule formulations are: hard gelatin capsules (which may contain Yellow 10, Green 3, Yellow 6, Red 33, and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose.

Hydroxyzine Pamoate – Clinical Pharmacology

Hydroxyzine pamoate is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines.

Hydroxyzine pamoate is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally. Bronchodilator activity, and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity. Hydroxyzine is rapidly absorbed from the gastrointestinal tract and Hydroxyzine pamoate’s clinical effects are usually noted within 15 to 30 minutes after oral administration.

Indications and Usage for Hydroxyzine Pamoate

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.

As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.

The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

Contraindications

Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.

Hydroxyzine is contraindicated in patients with a prolonged QT interval.

Hydroxyzine pamoate is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.

Hydroxyzine is contraindicated in patients with known hypersensitivity to hydroxyzine products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride.

Warnings

Nursing Mothers

It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.

Precautions

THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NON-NARCOTIC ANALGESICS AND BARBITURATES. Therefore, when central nervous system depressants are administered concomitantly with hydroxyzine, their dosage should be reduced. Since drowsiness may occur with use of the drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking Hydroxyzine pamoate. Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased.

QT Prolongation/Torsade de Pointes (TdP)

Cases of QT prolongation and Torsade de Pointes have been reported during postmarketing use of hydroxyzine. The majority of reports occurred in patients with other risk factors for QT prolongation/TdP (pre-existing heart disease, electrolyte imbalances or concomitant arrhythmogenic drug use). Therefore, hydroxyzine should be used with caution in patients with risk factors for QT prolongation, congenital long QT syndrome, a family history of long QT syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia, as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias.

Caution is recommended during the concomitant use of drugs known to prolong the QT interval. These include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics, certain antipsychotics (e.g., ziprasidone, iloperidone, clozapine, quetiapine, chlorpromazine), certain antidepressants (e.g., citalopram, fluoxetine), certain antibiotics (e.g., azithromycin, erythromycin, clarithromycin, gatifloxacin, moxifloxacin); and others (e.g., pentamidine, methadone, ondansetron, droperidol).

Acute Generalized Exanthematous Pustulosis (AGEP)

Hydroxyzine may rarely cause acute generalized exanthematous pustulosis (AGEP), a serious skin reaction characterized by fever and numerous small, superficial, non-follicular, sterile pustules, arising within large areas of edematous erythema. Inform patients about the signs of AGEP, and discontinue hydroxyzine at the first appearance of a skin rash, worsening of pre-existing skin reactions which hydroxyzine may be used to treat, or any other sign of hypersensitivity. If signs or symptoms suggest AGEP, use of hydroxyzine should not be resumed and alternative therapy should be considered. Avoid cetirizine or levocetirizine in patients who have experienced AGEP or other hypersensitivity reactions with hydroxyzine, due to the risk of cross-sensitivity.

Geriatric Use

A determination has not been made whether controlled clinical studies of Hydroxyzine pamoate included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.

The extent of renal excretion of Hydroxyzine pamoate has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.

Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of Hydroxyzine pamoate and observed closely.

Adverse Reactions/Side Effects

Side effects reported with the administration of Hydroxyzine pamoate are usually mild and transitory in nature.

Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports.

Anticholinergic: Dry mouth.

Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses.

Cardiac System: QT prolongation, Torsade de Pointes.

In postmarketing experience, the following additional undesirable effects have been reported: Body as a Whole: allergic reaction, Nervous System: headache, Psychiatric: hallucination, Skin and Appendages: pruritus, rash, urticaria.

Overdosage

The most common manifestation of overdosage of Hydroxyzine pamoate is hypersedation. Other reported signs and symptoms were convulsions, stupor, nausea and vomiting. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and vasopressors (do not use epinephrine as hydroxyzine counteracts its pressor action.) Caffeine and Sodium Benzoate Injection, USP, may be used to counteract central nervous system depressant effects.

Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes. ECG monitoring is recommended in cases of hydroxyzine overdose.

There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.

Hydroxyzine Pamoate Dosage and Administration

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 to 100 mg 4 times daily; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 to 100 mg daily in divided doses.

For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg 3 times daily or 4 times daily; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50 to 100 mg daily in divided doses.

As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg in adults, and 0.6 mg/kg in children.

When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.

As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

How is Hydroxyzine Pamoate supplied

Hydroxyzine pamoate capsules (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride)

Store below 30°C (86°F). Dispense in tight, light-resistant containers (USP).

This product’s label may have been updated. For full prescribing information, please visit www.greenstonellc.com.

LAB-1402-1.0
Revised: February 2020

PRINCIPAL DISPLAY PANEL – 100 Capsule Bottle Label (50mg)

NDC 59762-5420-1
100 Capsules

GREENSTONE® BRAND

hydroxyzine
pamoate
Capsules

50 mg*

Rx only

PRINCIPAL DISPLAY PANEL – 100 Capsule Bottle Label (25mg)

NDC 59762-5410-1
100 Capsules

GREENSTONE® BRAND

hydroxyzine
pamoate
Capsules

25 mg*

Rx only

What is levocetirizine?

Levocetirizine is an antihistamine that may be used to reduce allergy symptoms such as red, itchy, or watery eyes; a runny nose; sneezing; rashes; or reactions to insect bites or stings.

Levocetirizine works by reducing the effects of a natural chemical in the body called histamine. Histamine can produce symptoms such as a runny nose or hives.

Levocetirizine is used to treat symptoms of year-round (also called perennial) allergies in adults and children who are at least 6 months old.

Levocetirizine is also used to treat itching and swelling caused by chronic (long-lasting) urticaria (hives) in adults and children who are at least 6 months old.

Levocetirizine was FDA approved in 2007.

Warnings

Follow all the directions on your levocetirizine label and package. Tell all your healthcare providers that you take levocetirizine.

Before taking this medicine

You should not use levocetirizine if you are allergic to levocetirizine or cetirizine (Zyrtec).

You should not take levocetirizine if you have end-stage kidney disease or if you are on dialysis. Any child younger than 12 years old with kidney disease should not take levocetirizine.

Tell your doctor if you have ever had:

• kidney disease;
• liver disease;
• urination problems (caused by conditions such as enlarged prostate or spinal cord lesion); or
• gallbladder problems.

Levocetirizine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or intending to become pregnant.

You should not breast-feed while taking levocetirizine.

Levocetirizine is not approved for use by anyone younger than 6 months old.

How should I take levocetirizine?

Take levocetirizine exactly as directed on the label and read all medication guides or instruction sheets about levocetirizine.

A child’s dose of levocetirizine is based on the age of the child. Follow your doctor’s dosing instructions very carefully.

Do not give a child more than the prescribed dose of levocetirizine. A child’s body absorbs twice as much of the same dose of levocetirizine as an adult’s body.

Taking more levocetirizine than instructed will not make it more effective, and may cause severe drowsiness.

Levocetirizine is usually taken in the evening, with or without food.

Measure liquid levocetirizine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

Store levocetirizine at room temperature away from moisture and heat.

What happens if I miss a dose?

If you miss a dose of levocetirizine, take the missed dose as soon as you can. Skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line ..

What should I avoid while taking levocetirizine?

Avoid driving or hazardous activity until you know how levocetirizine will affect you. Your reactions could be impaired.

Drinking alcohol with levocetirizine can cause side effects such as drowsiness.

Levocetirizine side effects

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

Levocetirizine may cause serious side effects. Stop using levocetirizine and call your doctor at once if you have:

• worsening allergy or urticaria symptoms;
• painful or difficult urination;
• little or no urination;
• a light-headed feeling, like you might pass out;
• fever; or
• signs of an ear infection–ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child.

Common side effects of levocetirizine may include:

• drowsiness, tiredness;
• sinus pain;
• ear infection;
• cough;
• fever;
• nosebleed;
• vomiting, diarrhea, constipation;
• dry mouth; or
• weight gain.

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.

Levocetirizine dosing information

Usual Adult Dose for Urticaria:

5 mg orally once a day in the evening

Comments: Some patients may be adequately controlled on 2.5 mg orally once a day in the evening.

Usual Adult Dose for Allergic Rhinitis:

Seasonal Allergic Rhinitis (OTC): 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day

Usual Pediatric Dose for Allergic Rhinitis:

Perennial Allergic Rhinitis:
6 months to 2 years: 1.25 mg orally once a day in the evening

Comments: The recommended dose in pediatric patients 6 months to 2 years should not be exceeded.
Seasonal Allergic Rhinitis (OTC):
6 to 11 years: 2.5 mg orally once a day in the evening
12 years or older: 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day

Comments: Avoid use in patients less than 6 years.

Usual Pediatric Dose for Urticaria:

6 months to 5 years: 1.25 mg orally once a day in the evening
6 to 11 years: 2.5 mg orally once a day in the evening
12 years or older: 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day

What is loratadine?

Loratadine 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.

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

Loratadine is also used to treat skin hives and itching in people with chronic skin reactions

Warnings

You should not take this medication if you are allergic to loratadine or to desloratadine (Clarinex).

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Some chewable dosage forms of loratadine may contain phenylalanine. Talk to your doctor before using these forms of loratadine if you have phenylketonuria (PKU).

Ask a doctor or pharmacist before taking this medicine if you have liver or kidney disease.

Before taking this medicine

Ask a doctor or pharmacist if loratadine is safe to use if you have ever had:

• kidney disease; or
• liver disease.

The disintegrating tablet may contain phenylalanine and could be harmful if you have phenylketonuria (PKU).

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Do not give this medicine to a child younger than 2 years old without medical advice.

How should I take loratadine?

Use loratadine 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 medicine 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.

Loratadine is usually taken once per day. Follow your doctor’s instructions.

Do not crush, chew, or break the regular tablet. Swallow the pill whole.

A child’s dose is based on age and some forms of loratadine are not for use in children younger than 6 years old. Carefully follow the dosing instructions provided with this medicine.

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.

The chewable tablet must be chewed before you swallow it.

To take the orally disintegrating tablet (Claritin RediTab, Alavert):

• Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.
• Use dry hands to remove the tablet and place it in your mouth.
• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

Call your doctor if your symptoms do not improve, or if they get worse.

Store at room temperature away from moisture and heat.

Loratadine side effects

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

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

• fast or uneven heart rate;
• severe headache; or
• a light-headed feeling, like you might pass out;

Common loratadine side effects may include:

• headache;
• feeling tired or drowsy;
• stomach pain, vomiting;
• dry mouth; or
• feeling nervous or hyperactive.

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

Dosing information

Usual Adult Dose for Allergic Rhinitis:

10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Adult Dose for Urticaria:

10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Pediatric Dose for Allergic Rhinitis:

2 to 5 years: 5 mg orally once a day
-Maximum dose: 5 mg/day

6 years and older: 10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

Usual Pediatric Dose for Urticaria:

2 to 5 years: 5 mg orally once a day
-Maximum dose: 5 mg/day

6 years and older: 10 mg orally once a day
-Maximum dose: 10 mg/day

Use: Temporary relief of symptoms associated with hay fever or other upper respiratory allergies (e.g., runny nose, itchy, watery eyes, sneezing, itching of the nose/throat)

What other drugs will affect loratadine?

Other drugs may interact with loratadine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What happens if I miss a dose?

Loratadine is used when needed. Do not use loratadine more than once in a 24-hour period. Do not use two doses at one time.

What happens if I overdose?

Overdose symptoms may include headache, drowsiness, and fast or pounding heartbeat.

Seek emergency medical attention or call the Poison Help line

What should I avoid while taking loratadine?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

What is Phenergan?

Phenergan belongs to a group of drugs called phenothiazines. It works by changing the actions of chemicals in your brain. Promethazine also acts as an antihistamine. It blocks the effects of the naturally occurring chemical histamine in your body.

Phenergan is used to treat allergy symptoms such as itching, runny nose, sneezing, itchy or watery eyes, hives, and itchy skin rashes.

Phenergan also prevents motion sickness, and treats nausea and vomiting or pain after surgery. It is also used as a sedative or sleep aid.

Phenergan is not for use in treating symptoms of asthma, pneumonia, or other lower respiratory tract infections.

Warnings

Stop using Phenergan and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects. Phenergan should not be given to a child younger than 2 years old. Phenergan can cause severe breathing problems or death in very young children. Carefully follow your doctor’s instructions when giving this medicine to a child of any age.

Phenergan can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which can increase some of the side effects of Phenergan. There are many other medicines that can interact with promethazine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Before taking this medicine

Phenergan should not be given to a child younger than 2 years old. Phenergan can cause severe breathing problems or death in very young children. Carefully follow your doctor’s instructions when giving this medicine to a child of any age.

You should not take Phenergan if you are allergic to promethazine or to similar medicines such as chlorpromazine, fluphenazine, mesoridazine, perphenazine, prochlorperazine, thioridazine, or trifluperazine.

You should not take Phenergan if you have asthma or another lower respiratory tract disorder.

To make sure Phenergan is safe for you, tell your doctor if you have:

• asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
• a sulfite allergy;
• a history of seizures;
• a weak immune system (bone marrow depression);
• glaucoma;
• enlarged prostate or problems with urination;
• stomach ulcer or obstruction;
• heart disease or high blood pressure;
• liver disease;
• adrenal gland tumor (pheochromocytoma);
• low levels of calcium in your blood (hypocalcemia); or
• if you have ever had a serious side effect while using promethazine or any other phenothiazine.

It is not known whether Phenergan will affect an unborn baby. Animal studies have not shown any effects. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether promethazine passes into breast milk or if it could affect a nursing baby. Tell your doctor if you are nursing prior to using Phenergan.

How should I take Phenergan?

Take Phenergan exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Phenergan is often taken at bedtime or before meals. For motion sickness, Phenergan is usually started within 1 hour before traveling. When used for surgery, Phenergan is usually taken the night before the surgery.

How often you take Phenergan and the timing of your dose will depend on the condition being treated.

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.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Phenergan doses are based on weight in children, and any changes may affect your child’s dose.

Call your doctor if your symptoms do not improve, or if they get worse while using Phenergan.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Phenergan.

Store Phenergan at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include overactive reflexes, loss of coordination, severe drowsiness or weakness, fainting, dilated pupils, weak or shallow breathing, or seizure (convulsions).

What to avoid

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of Phenergan. Do not drink alcohol while taking this medication.

Avoid exposure to sunlight or tanning beds. Phenergan can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Phenergan side effects

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

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

• severe drowsiness, weak or shallow breathing;
• a light-headed feeling, like you might pass out;
• confusion, agitation, hallucinations, nightmares;
• seizure (convulsions);
• fast or slow heartbeats;
• jaundice (yellowing of the skin or eyes);
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• easy bruising or bleeding (nosebleeds, bleeding gums);
• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing; or
• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Side effects such as confusion and severe drowsiness may be more likely in older adults.

Common Phenergan side effects may include:

• drowsiness, dizziness;
• ringing in your ears;
• double vision;
• feeling nervous;
• dry mouth; or
• tired feeling, sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Phenergan?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can interact with Phenergan and cause medical problems or increase side effects. Tell your doctor if you regularly use any of these medicines.

Also tell your doctor if you are using any of the following medicines:

• lithium (Eskalith, Lithobid);
• atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
• blood pressure medication such as guanadrel (Hylorel), guanethidine (Ismelin), propranolol (Inderal), and others;
• a blood thinner such as warfarin (Coumadin);
• bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
• bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), and others;
• a MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam) or methylene blue injection; or
• medicines to treat Parkinson’s disease, restless leg syndrome, or pituitary gland tumor (prolactinoma); or
• medicine to treat stomach ulcer or irritable bowel syndrome, such as dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), mepenzolate (Cantil), or propantheline (Pro-Banthine).

What is promethazine?

Promethazine is in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain. Promethazine also acts as an antihistamine. It blocks the effects of the naturally occurring chemical histamine in your body.

Promethazine is used to treat allergy symptoms such as itching, runny nose, sneezing, itchy or watery eyes, hives, and itchy skin rashes. It also prevents motion sickness, and treats nausea and vomiting or pain after surgery. It is also used as a sedative or sleep aid.

Promethazine is not for use in treating symptoms of asthma, pneumonia, or other lower respiratory tract infections.

Warnings

Stop using promethazine and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects. Promethazine should not be given to a child younger than 2 years old. Promethazine can cause severe breathing problems or death in a child in very young children. Carefully follow your doctor’s instructions when giving this medicine to a child of any age.

Promethazine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which can increase some of the side effects of promethazine. There are many other medicines that can interact with promethazine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Before taking this medicine

Promethazine should not be given to a child younger than 2 years old. Promethazine can cause severe breathing problems or death in very young children. Carefully follow your doctor’s instructions when giving this medicine to a child of any age.

You should not take this medicine if you are allergic to promethazine or to similar medicines such as chlorpromazine, fluphenazine, mesoridazine, perphenazine, prochlorperazine, thioridazine, or trifluperazine.

To make sure promethazine is safe for you, tell your doctor if you have:

• asthma, chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
• a sulfite allergy;
• a history of seizures;
• a weak immune system (bone marrow depression);
• glaucoma;
• enlarged prostate or problems with urination;
• stomach ulcer or obstruction;
• heart disease or high blood pressure;
• liver disease;
• adrenal gland tumor (pheochromocytoma);
• low levels of calcium in your blood (hypocalcemia); or
• if you have ever had a serious side effect while using promethazine or any other phenothiazine.

It is not known whether promethazine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether promethazine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take promethazine?

Take promethazine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Promethazine is often taken at bedtime or before meals. For motion sickness, promethazine is usually started within 1 hour before traveling. When used for surgery, promethazine is usually taken the night before the surgery.

How often you take this medicine and the timing of your dose will depend on the condition being treated.

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.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Promethazine doses are based on weight in children, and any changes may affect your child’s dose.

Call your doctor if your symptoms do not improve, or if they get worse while using promethazine.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using promethazine.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include overactive reflexes, loss of coordination, severe drowsiness or weakness, fainting, dilated pupils, weak or shallow breathing, or seizure (convulsions).

What to avoid

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of promethazine.

Avoid exposure to sunlight or tanning beds. Promethazine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Promethazine side effects

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

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

• severe drowsiness, weak or shallow breathing;
• a light-headed feeling, like you might pass out;
• confusion, agitation, hallucinations, nightmares;
• seizure (convulsions);
• fast or slow heartbeats;
• jaundice (yellowing of the skin or eyes);
• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• easy bruising or bleeding (nosebleeds, bleeding gums);
• sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing; or
• severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Side effects such as confusion and severe drowsiness may be more likely in older adults.

Common promethazine side effects may include:

• drowsiness, dizziness;
• ringing in your ears;
• double vision;
• feeling nervous;
• dry mouth; or
• tired feeling, sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect promethazine?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can interact with promethazine and cause medical problems or increase side effects. Tell your doctor if you regularly use any of these medicines.

Also tell your doctor if you are using any of the following medicines:

• lithium (Eskalith, Lithobid);
• atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
• blood pressure medication such as guanadrel (Hylorel), guanethidine (Ismelin), propranolol (Inderal), and others;
• a blood thinner such as warfarin (Coumadin);
• bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
• bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), and others;
• an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or
• medicines to treat Parkinson’s disease, restless leg syndrome, or pituitary gland tumor (prolactinoma); or
• medicine to treat stomach ulcer or irritable bowel syndrome, such as dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), mepenzolate (Cantil), or propantheline (Pro-Banthine).

This list is not complete and there are many other medicines that can interact with promethazine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What is Atarax?

Atarax reduces activity in the central nervous system. It also acts as an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing and runny nose, or hives on the skin.

Atarax is used as a sedative to treat anxiety and tension. It is also used together with other medications given for anesthesia.

Atarax is also used to treat allergic skin reactions such as hives or contact dermatitis.

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

Warnings

You should not use Atarax if you are allergic to hydroxyzine, or if you are pregnant.

Before you take Atarax, tell your doctor if you have a seizure disorder, liver disease, or kidney disease.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Stop using Atarax and call your doctor at once if you have a serious side effect such as tremors, confusion, seizures, or restless muscle movements in your eyes, tongue, jaw, or neck.

Drinking alcohol can increase certain side effects of hydroxyzine.

Before taking this medicine

You should not use Atarax if you are allergic to hydroxyzine, or if you are pregnant.

To make sure you can safely take Atarax, tell your doctor if you have any of these other conditions:

• epilepsy or other seizure disorder;
• asthma, emphysema, or other breathing problem;
• glaucoma;
• heart disease or high blood pressure;
• stomach ulcer, blockage in your stomach or intestines;
• thyroid disorder;
• enlarged prostate or problems with urination;
• liver disease; or
• kidney disease.

Do not use Atarax without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether hydroxyzine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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

How should I take Atarax?

Take Atarax exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Measure Atarax syrup with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include extreme drowsiness, nausea, vomiting, feeling like you might pass out.

What should I avoid?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of Atarax.

Atarax side effects

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

Stop using Atarax and call your doctor at once if you have a serious side effect such as:

• restless muscle movements in your eyes, tongue, jaw, or neck;
• tremor (uncontrolled shaking);
• confusion; or
• seizure (convulsions).

Less serious Atarax side effects may include:

• dizziness, drowsiness;
• blurred vision, dry mouth; or
• headache.

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 .

What other drugs will affect Atarax?

Before using Atarax, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Atarax.

This list is not complete and other drugs may interact with hydroxyzine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.