Cetirizine and pseudoephedrine (Oral route)

Pronunciation:

se-TIR-i-zeen hye-droe-KLOR-ide, soo-doe-e-FED-rin hye-droe-KLOR-ide

Brand Names:

ZyrTEC-D

Dosage Forms:

Tablet, Extended Release

Classifications:

Therapeutic—

Antihistamine/Decongestant Combination

Pharmacologic—

Cetirizine

Chemical—

Cetirizine

Uses of This Medicine:

Cetirizine and pseudoephedrine is a combination of an antihistamine and a decongestant used to treat the symptoms of seasonal or yearly allergies. Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. Decongestants produce a narrowing of blood vessels. This leads to clearing of nasal congestion, but it may also cause an increase in blood pressure in patients who have high blood pressure.

This medicine is available without a prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Use is not recommended in infants and children up to 12 years of age. In children 12 years of age and older, this medicine is not expected to cause different side effects or problems than it does in adults.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of cetirizine and pseudoephedrine in the elderly with use in other age groups.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Dihydroergotamine
Furazolidone
Iproniazid
Isocarboxazid
Linezolid
Methylene Blue
Moclobemide
Nialamide
Phenelzine
Procarbazine
Rasagiline
Safinamide
Selegiline
Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acepromazine
Alfentanil
Alprazolam
Amobarbital
Anileridine
Aripiprazole
Asenapine
Baclofen
Benperidol
Benzhydrocodone
Bromazepam
Buprenorphine
Buspirone
Butabarbital
Butorphanol
Calcium Oxybate
Cannabidiol
Cannabis
Carbinoxamine
Carisoprodol
Carphenazine
Chloral Hydrate
Chlordiazepoxide
Chlorpromazine
Chlorzoxazone
Clobazam
Clonazepam
Clorazepate
Clozapine
Codeine
Cyclobenzaprine
Daridorexant
Dexmedetomidine
Diacetylmorphine
Diazepam
Dichloralphenazone
Difenoxin
Dihydrocodeine
Diphenhydramine
Diphenoxylate
Doxylamine
Droperidol
Enflurane
Esketamine
Estazolam
Eszopiclone
Ethchlorvynol
Ethopropazine
Ethylmorphine
Fentanyl
Flibanserin
Fluphenazine
Flurazepam
Fluspirilene
Fospropofol
Guanethidine
Halazepam
Haloperidol
Halothane
Hexobarbital
Hydrocodone
Hydromorphone
Hydroxyzine
Iobenguane I 123
Iobenguane I 131
Isoflurane
Ketamine
Ketazolam
Ketobemidone
Lacosamide
Levorphanol
Lorazepam
Loxapine
Magnesium Oxybate
Meclizine
Melperone
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaxalone
Methadone
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Methyldopa
Methylene Blue
Midazolam
Midodrine
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Nalbuphine
Nicomorphine
Nitrazepam
Nitrous Oxide
Olanzapine
Opium
Opium Alkaloids
Orphenadrine
Oxazepam
Oxycodone
Oxymorphone
Papaveretum
Paregoric
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenobarbital
Pimozide
Piperacetazine
Pipotiazine
Piritramide
Pitolisant
Potassium Oxybate
Prazepam
Primidone
Prochlorperazine
Promazine
Promethazine
Propofol
Quazepam
Quetiapine
Ramelteon
Remifentanil
Remoxipride
Ropeginterferon Alfa-2b-njft
Secobarbital
Sertindole
Sodium Oxybate
Sufentanil
Sulpiride
Suvorexant
Tapentadol
Temazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Tilidine
Tizanidine
Tolonium Chloride
Topiramate
Tramadol
Triazolam
Trifluoperazine
Trifluperidol
Triflupromazine
Trimeprazine
Zaleplon
Zavegepant
Zolpidem
Zopiclone
Zotepine
Zuranolone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Kidney disease—Removal of cetirizine and pseudoephedrine from the body may be reduced

Liver disease—May be worsened by cetirizine

Diabetes or
Heart disease or
High blood pressure or
Inner eye pressure or
Narrow-angle glaucoma or
Urination difficulties or
Prostate, enlarged or
Thyroid problems—May be worsened by pseudoephedrine

Proper Use of This Medicine:

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Swallow the extended-release tablet whole. Do not crush, break, or chew before swallowing.

For oral dosage form (extended release tablets):
- For relief of symptoms from seasonal or yearly allergies:
  - Adults and children 12 years of age and older—Take one tablet two times a day with or without food.
  - Children 4 to 12 years of age—Use and dose must be determined by your doctor.
  - Children and infants up to 4 years of age—Use is not recommended .

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

The antihistamine in this medicine will add to the effects of alcohol and other CNS depressants including tricyclic antidepressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are other antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Examples of Tricyclic antidepressants are amitriptyline [e.g. Elavil], amoxapine [e.g. Asendin], clomipramine [e.g. Anafranil], desipramine [e.g. Pertofrane], doxepine [e.g. Sinequan], imipramine [e.g. Tofranil], nortriptyline [e.g. Aventyl], protriptyline [Vivactil], trimipramine [e.g. Surmontil]. Check with your doctor before taking any of the above while you are taking this medicine.

The antihistamine in this medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Antihistamines may cause dryness of the mouth, nose, and throat. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

The decongestant in this medicine may cause some people to be nervous or restless or to have trouble in sleeping. If you have trouble in sleeping, take the last dose of this medicine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of Overdose: Changes in mood, irrational behavior, depersonalization hallucinations; convulsions (seizures); extreme sleepiness or unusual drowsiness; fast, slow, pounding, or irregular heartbeat or pulse; feeling anxious; giddiness; headache; irritability; muscle weakness or tenderness; nausea; restlessness; shallow, irregular, fast, or slow breathing; sleeplessness or trouble in sleeping; abdominal and/or chest pain; thirst

Check with your doctor as soon as possible if any of the following side effects occur:

Rare: Breathing, troubled; back, leg, or stomach pain; blurred vision; bloody, cloudy, or dark urine, sudden decrease in amount of urine; black, tarry stools, diarrhea, light-colored stools; confusion; dizziness, feeling faint, or lightheaded; fever or chills; increased blood pressure; rapid weight gain; skin rash or hives; swelling of face, mouth, throat, fingers, glands, feet, and/or lower legs; stillbirth; twitching, twisting, or uncontrolled repetitive movements of the face; sudden sweating; vomiting blood, bleeding gums, nosebleeds, unusual bleeding or bruising; pale or yellow eyes or skin; unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common: Sleepiness or unusual drowsiness, extreme tiredness

Less common: Dry mouth; weakness

Rare: Dizziness; sore throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Last Updated: 11/16/2023

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