Description and Brand NamesBefore UsingProper UsePrecautionsSide Effects Brand Name : Descriptions 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 . This product is available in the following dosage forms: Tablet, Extended Release 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. Pediatric 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. 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 . Geriatric 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. Pregnancy Information about this cetirizine-and-pseudoephedrine-oral-route Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breastfeeding 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. Drug Interactions 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. • Clorgyline • Dihydroergotamine • Furazolidone • Iproniazid • Isocarboxazid • Linezolid • Moclobemide • Nialamide • Pargyline • Phenelzine • Procarbazine • Rasagiline • Selegiline • Toloxatone • 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. • Guanethidine • Iobenguane I 123 • Methyldopa • Midodrine 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. 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 For cetirizine • Liver disease—May be worsened by cetirizine For pseudoephedrine • 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 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. 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. 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.