Ambroxol/desloratadine/pseudoephedrine

Each retard capsule contains ambroxol hydrochloride 75 mg.

Each tablet contains ambroxol hydrochloride 30 mg.

Each 5 mL of syrup contains ambroxol hydrochloride 15 or 30 mg.

Each mL of syrup (infant drops) contains ambroxol hydrochloride 6 mg.

Ambroxol hydrochloride is trans-4-[(2-amino-3,5-dibromo-benzyl)amino] cyclohexanol hydrochloride.

It also contains the following excipients: Retard Capsules: Crospovidone collidon CL, carnauba wax, stearyl alcohol, magnesium stearate.

Tablets: Lactose, maize starch, colloidal silica, magnesium stearate.

Syrup: Purified water, sorbitol liquid, glycerol 85%, woodberry aroma (15 mg only), strawberry aroma (30 mg only), hydroxyethylcellulose, benzoic acid, acesulfame potassium, vanilla aroma.

Infant Drops: Hydroxyethylcellulose, sorbitol solution, glycerol 85%, sodium saccharin, pharma flavors, menthol, benzoic acid, propylene glycol.

Desloratadine Tab: Each tablet contains 5.0 mg of desloratadine.

Desloratadine Syr: Each mL of desloratadine (Desloratadine) syrup contains 500 mcg of desloratadine.

Excipients/Inactive Ingredients: Desloratadine Tab: Dibasic calcium phosphate dihydrate, microcrystalline cellulose, maize starch, talc, blue color film-coat material, clear film coat material, white wax and carnauba wax.

Pseudoephedrine has been withdrawn in Canada. In November 2000, the Food and Drug Administration (FDA) issued a public health advisory against the use of the drug.

For use Max Pidek Pharmaceuticals as monotherapy and in combination with clavulanic acid: an infectious-inflammatory diseases caused by susceptible microorganisms, including bronchitis, pneumonia, tonsillitis, pyelonephritis, urethritis, infections of the gastrointestinal tract, gynecological infections, infections of the skin and soft tissue, listeria, leptospirosis, gonorrhea.

For use Max Pidek Pharmaceuticals in combination with metronidazole: chronic gastritis in acute, peptic ulcer and duodenal ulcer in acute, associated with Helicobacter Pylori.

1.1 Seasonal Allergic Rhinitis

Desloratadine Tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older.

1.2 Perennial Allergic Rhinitis

Desloratadine Tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older.

1.3 Chronic Idiopathic Urticaria

Desloratadine Tablets are indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 12 years of age and older.

Temporary relief of symptoms of upper respiratory tract disorders such as sinusitis, vasomotor rhinitis, and hay fever; temporary relief of coughs associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma when tenacious mucus and/or mucus plugs and congestion complicate these conditions.

Relieving cough and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Ambroxol is a cough suppressant and expectorant combination. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough. The expectorant works by loosening mucus and lung secretions in the chest and making coughs more productive.

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

Desloratadine is used to treat the symptoms of allergies, such as sneezing, watery eyes, and runny nose. It is also used to treat skin hives and itching in people with chronic skin reactions.

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

Pseudoephedrine (pseudoephedrine) is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pseudoephedrine is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

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

Sustained-Release Capsule: Adults and Children >12 years: 1 cap once daily after meal with plenty of liquid (sufficient supply of liquid supports the expectorant effect of Ambroxol).

Ambroxol SR capsule is not suitable for children <12 years.

Tablet: Adults and Children >12 years: 1 tab thrice daily for the first 2-3 days and then 1 tab twice daily or ½ tab thrice daily. Children 6-12 years: ½ tab 2-3 times a day.

Syrup: Adults and Children >12 years: 10 mL thrice daily during the first 2-3 days, them 10 mL twice daily or 5 mL thrice daily. Children 6-12 years: 5 mL 2-3 times a day; 2-5 years: 2.5 mL 3 times a day; <2 years: 2.5 mL 2 times a day.

DS Syrup: Adults and Children >12 years: 5 mL thrice daily for 2-3 days then 5 mL twice daily for 2.5 mL thrice daily. Children 6-12 years: 2.5 mL 2-3 times a day.

Infant Drops: Children 13-24 months: 1.25 mL twice a day; 7-12 months: 1 mL twice a day; ≤6 months: 0.5 mL twice a day.

Desloratadine Tablets or

Oral Solution may be taken without regard to meals.

The age-appropriate dose of Desloratadine

Oral Solution should be administered with a commercially available measuring dropper or syringe that is calibrated to deliver 2 mL and 2.5 mL (½ teaspoon).

Adults And Adolescents 12 Years Of Age And Over

The recommended dose of Desloratadine Tablets is one 5-mg tablet once daily. The recommended dose of Desloratadine

Oral Solution is 2 teaspoonfuls (5 mg in 10 mL) once daily.

Children 6 To 11 Years Of Age

The recommended dose of Desloratadine

Oral Solution is 1 teaspoonful (2.5 mg in 5 mL) once daily.

Children 12 Months To 5 Years Of Age

The recommended dose of Desloratadine

Oral Solution is ½ teaspoonful (1.25 mg in 2.5 mL) once daily.

Children 6 To 11 Months Of Age

The recommended dose of Desloratadine

Oral Solution is 2 mL (1 mg) once daily.

Adults With Hepatic Or Renal Impairment

In adult patients with liver or renal impairment, a starting dose of one 5-mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data.

How supplied

Dosage Forms And Strengths

Desloratadine Tablets are light blue, film-coated tablets embossed with “C5” containing 5 mg desloratadine.

Desloratadine

Oral Solution is a clear orange-colored liquid containing 0.5 mg desloratadine/1 mL.

Storage And Handling

Desloratadine Tablets: Embossed “C5”, light blue, film-coated tablets that are packaged in high-density polyethylene plastic bottles of 100 (NDC 0085-1264-01) and 500 (NDC 0085-1264-02).

Desloratadine

Oral Solution:

Storage

• Desloratadine Tablets: Protect Unit-of-Use packaging and Unit-Dose Hospital Pack from excessive moisture. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Heat Sensitive. Avoid exposure at or above 30°C (86°F).
• Desloratadine

  Oral Solution:

  Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light.

Manufactured by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manufactured by: Schering-Plough Canada, Inc., Pointe Claire, Quebec, Canada. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Revised: Nov 2013

Usual Adult Dose for Nasal Congestion

Immediate release: 30 to 60 mg orally every 4 to 6 hours as needed

12-hour extended- release: 120 mg orally every 12 hours as needed

24-hour extended-release: 240 mg orally every 24 hours as needed

Maximum dose: 240 mg per day

Comment: Recommended doses should not be exceeded.

Uses:

-Temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies.

-Temporarily relieve sinus congestion and pressure.

Usual Pediatric Dose for Nasal Congestion

4 to 5 years:

Immediate release: 15 mg orally every 4 to 6 hours as needed

Maximum dose: 60 mg in 24 hours

6 to 12 years:

Immediate release: 30 mg orally every 4 to 6 hours as needed

Maximum dose: 120 mg in 24 hours

12 years or older:

Immediate release: 30 to 60 mg orally every 4 to 6 hours as needed

12-hour extended- release: 120 mg orally every 12 hours as needed

24-hour extended-release: 240 mg orally every 24 hours as needed

Maximum dose: 240 mg in 24 hours

Comments:

-Recommended doses should not be exceeded.

-Giving more than 1 cough and cold medicine to a child could result in overdose; there are many products that have similar names and it is critical to identify the active ingredients in the product to ensure the correct dosage is being used.

Uses:

-Temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies.

-Temporarily relieve sinus congestion and pressure.

Renal Dose Adjustments

Severe renal impairment: Use caution, especially in patients with concurrent cardiovascular disease.

Liver Dose Adjustments

Severe hepatic impairment: Use caution, especially in patients with concurrent cardiovascular disease.

Precautions

On March 9, 2006, The Combat Methamphetamine Epidemic Act of 2005 was enacted which requires sellers of this drug ensure that: employees have been trained; records of the training are being maintained; sales limits are being enforced; products are being stored appropriately; and a written or electronic logbook is being maintained. The law requires that retailers place pseudoephedrine products where customers do not have direct access to such products before a sale is made. The FDA defines pseudoephedrine as an OTC drug in accordance with the monograph and FDA regulations.

The US FDA strongly recommends that over- the- counter (OTC) cough and cold products not be used in children younger than 2 years of age because serious and potentially life-threatening side effects can occur including death, convulsions, rapid heart rates, and decreased levels of consciousness. OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives.

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Oral Liquid:

-Use only with enclosed measuring device or measuring devices specifically designed for measuring drugs.

Extended-release tablets:

-Swallow whole; do not divide crush, chew, or dissolve

Storage requirements:

-Protect from light

General:

-Over the counter cough and cold products can be harmful if more than the recommended amount is consumed; this may happen if more than 1 product containing the same active ingredient is used.

Patient advice:

-Patients should be instructed to pay close attention to drugs labels, particularly to the active ingredients section to ensure they are not receiving duplicate therapy.

-Adult cough and cold products should not be used for children; appropriate measuring devices should be used with liquid products.

-Patients should check with their health care provider if they are receiving concomitant medications.

-Patients should understand that over the counter cough and cold medications do not cure or shorten the duration of the common cold, these products are for the management of symptoms.

See also:
What is the most important information I should know about Ambroxol?

Hypersensitivity to ambroxol hydrochloride or to any other excipients of Ambroxol.

In case of rare hereditary conditions that may be incompatible with an excipient of Ambroxol, the use of Ambroxol is contraindicated.

See also:
What is the most important information I should know about Desloratadine?

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

Before taking desloratadine, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.

Do not give this medication to a child younger than 2 years old without the advice of a doctor.

Desloratadine disintegrating tablets (Desloratadine) may contain phenylalanine. Talk to your doctor before using this form of desloratadine if you have phenylketonuria (PKU).

See also:
What is the most important information I should know about Pseudoephedrine?

Do not give this medication to a child younger than 4 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.

Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants 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 pseudoephedrine or a decongestant.

Do not use pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Use Ambroxol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Ambroxol by mouth with or without food.
• Drink plenty of water while taking Ambroxol.
• If you miss a dose of Ambroxol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ambroxol.

Use Desloratadine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Desloratadine. Talk to your pharmacist if you have questions about this information.
• Take Desloratadine by mouth with or without food.
• Do not remove the blister from the outer pouch until you are ready to take Desloratadine. Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister pack and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Desloratadine may be taken with or without water. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use.
• If you miss a dose of Desloratadine and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Desloratadine.

Use Pseudoephedrine (24 hour) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine (24 hour) with food, water, or milk to minimize stomach irritation.
• Swallow Pseudoephedrine (24 hour) whole. Do not break, crush, or chew before swallowing.
• Do not take more than 1 tablet in 24 hours.
• If you miss a dose of Pseudoephedrine (24 hour) and are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pseudoephedrine (24 hour).

Ambroxol is used to treat certain diseases of the respiratory tract and to relieve cough associated with thickened mucous.

Use: Labeled Indications

Allergic rhinitis: Relief of nasal and non-nasal symptoms of seasonal (SAR) and perennial (PAR) allergic rhinitis

Urticaria: Symptomatic relief of pruritus, reduction in number of hives, and reduction in size of hives associated with chronic idiopathic urticaria (CIU)

Off Label Uses

NSAID-associated urticaria (prophylaxis)

Data from a retrospective study with a limited number of patients suggest that desloratadine may be beneficial for prophylactic therapy in patients with NSAID-associated urticaria prior to receiving a strong COX-1 inhibitor. Additional trials may be needed to further define the role of desloratadine in this setting.

Pseudoephedrine is used for the temporary relief of stuffy nose and sinus pain/pressure caused by infection (such as the common cold, flu) or other breathing illnesses (such as hay fever, allergies, bronchitis). Pseudoephedrine is a decongestant (sympathomimetic). It works by narrowing the blood vessels to decrease swelling and congestion.

If you are self-treating with this medication, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product in children younger than 6 years unless specifically directed by the doctor. Long-acting tablets/capsules are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar decongestants. Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Your doctor may direct you to use pseudoephedrine to decrease pain and swelling in the ear or to help "open up" the ear canal when there is a change in air pressure (such as during air travel, underwater diving). Follow your doctor's directions carefully.

How to use Pseudoephedrine

If you are taking the over-the-counter product to self-treat, read all directions on the product package before taking this medication. If you have any questions, ask your doctor or pharmacist. If your doctor has prescribed this medication, take it as directed.

Take this medication by mouth with or without food, usually every 4-6 hours, as directed by the product package or by your doctor. Do not take more than 4 doses in a day. Dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or take this drug more often than directed. Do not take more of this medication than recommended for your age.

If you are using the chewable tablets, chew each tablet well and swallow. If you are using the liquid form of this medication, measure the dose carefully using a special measuring device/cup. Do not use a household spoon because you may not get the correct dose.

There are many brands and forms of pseudoephedrine available. Some tablets should be swallowed with plenty of water. Check your product package for specific directions. Read the dosing instructions carefully for each product because the amount of pseudoephedrine may be different between products. Do not take more pseudoephedrine than recommended.

Caffeine can increase the side effects of this medication. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas), eating large amounts of chocolate, or taking nonprescription products that contain caffeine.

If your symptoms do not improve after 7 days, if they worsen or return, if you develop fever, rash, or a persistent headache, or if you think you may have a serious medical problem, seek immediate medical attention.

See also:
What other drugs will affect Ambroxol?

Amoxicillin may decrease the effectiveness of contraceptives for oral administration.

With the simultaneous use of Max Pidek Pharmaceuticals with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) appears synergies; with bacteriostatic antibiotic (including macrolides, chloramphenicol, lincosamides, tetracyclines, sulphonamide) - antagonism.

Amoxicillin increases the effects of indirect anticoagulants inhibiting intestinal microflora, reduces the synthesis of vitamin K and prothrombin index.

Amoxicillin reduces the effect of drugs, in the process of metabolism that produce PABA.

Probenecid, diuretics, allopurinol, phenylbutazone, NSAIDs decrease the tubular secretion of amoxicillin, which can be accompanied by an increase in its concentration in blood plasma.

Antacids, glucosamine, laxatives, aminoglycosides, slow down and reduce, and ascorbic acid increases the absorption of amoxicillin.

With the combined use of amoxicillin and clavulanic acid pharmacokinetics of both components unchanged.

See also:
What other drugs will affect Desloratadine?

Inhibitors Of Cytochrome P450 3A4

In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine.

Fluoxetine

In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine.

Cimetidine

In controlled clinical studies co-administration of desloratadine with cimetidine, a histamine H2-receptor antagonist, resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine.

Drug Abuse And Dependence

There is no information to indicate that abuse or dependency occurs with Desloratadine Tablets.

See also:
What other drugs will affect Pseudoephedrine?

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: stimulants (such as caffeine, dextroamphetamine, methamphetamine, herbal products like ephedra/ma huang), terbutaline.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Pseudoephedrine may decrease the effectiveness of blood pressure medications (such as beta blockers, calcium channel blockers, reserpine, guanethidine, methyldopa).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain similar ingredients (decongestants such as phenylephrine). Ask your pharmacist about using those products safely.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

See also:
What are the possible side effects of Ambroxol?

Applies to albuterol: oral syrup, oral tablet, oral tablet extended release

Other dosage forms:

• inhalation aerosol powder, inhalation capsule, inhalation powder, inhalation solution

As well as its needed effects, albuterol (the active ingredient contained in Ambroxol) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking albuterol, check with your doctor immediately:

More common:

• Shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet

• Fast, irregular, pounding, or racing heartbeat or pulse

• Cough
• difficulty breathing
• difficulty with swallowing
• hives or welts
• hoarseness
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• redness of the skin
• shortness of breath
• skin rash
• slow or irregular breathing
• swelling of the mouth or throat
• tightness in the chest
• wheezing

• Agitation
• anxiety
• arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• confusion
• convulsions
• extra heartbeats
• fainting
• hallucinations
• headache
• irritability
• lightheadedness
• mood or mental changes
• muscle pain or cramps
• muscle spasm or jerking of all extremities
• nervousness
• nightmares
• pounding in the ears
• restlessness
• sudden loss of consciousness
• sweating
• total body jerking
• unusual feeling of excitement
• vomiting

Minor Side Effects

Some albuterol side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common:

• Dizziness
• feeling of warmth
• irritability
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• sleeplessness
• trouble with holding or releasing urine
• trouble sleeping
• unable to sleep

• Sleepiness
• unusual drowsiness

• Bad, unusual, or unpleasant (after) taste
• change in taste
• feeling of constant movement of self or surroundings
• gagging
• rough, scratchy sound to voice
• sensation of spinning
• tightness in the throat

See also:
What are the possible side effects of Desloratadine?

The following adverse reactions are discussed in greater detail in other sections of the label:

• Hypersensitivity reactions.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adults and Adolescents

Allergic Rhinitis: In multiple-dose placebo-controlled trials, 2834 patients ages 12 years or older received desloratadine tablets at doses of 2.5 mg to 20 mg daily, of whom 1655 patients received the recommended daily dose of 5 mg. In patients receiving 5 mg daily, the rate of adverse events was similar between desloratadine and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the desloratadine group and 2.6% in the placebo group. There were no serious adverse events in these trials in patients receiving desloratadine. All adverse events that were reported by greater than or equal to 2% of patients who received the recommended daily dose of desloratadine tablets (5 mg once daily), and that were more common with desloratadine tablets than placebo, are listed in Table 1.

The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in desloratadine and placebo-treated patients.

There were no differences in adverse events for subgroups of patients as defined by gender, age, or race.

Chronic Idiopathic Urticaria: In multiple-dose, placebo-controlled trials of chronic idiopathic urticaria, 211 patients ages 12 years or older received desloratadine tablets and 205 received placebo. Adverse events that were reported by greater than or equal to 2% of patients who received desloratadine tablets and that were more common with desloratadine than placebo were (rates for desloratadine and placebo, respectively): headache (14%, 13%), nausea (5%, 2%), fatigue (5%, 1%), dizziness (4%, 3%), pharyngitis (3%, 2%), dyspepsia (3%, 1%), and myalgia (3%, 1%).

Pediatrics

Two hundred and forty-six pediatric subjects 6 months to 11 years of age received Desloratadine

Oral Solution for 15 days in three placebo-controlled clinical trials. Pediatric subjects aged 6 to 11 years received 2.5 mg once a day, subjects aged 1 to 5 years received 1.25 mg once a day, and subjects 6 to 11 months of age received 1.0 mg once a day.

In subjects 6 to 11 years of age, no individual adverse event was reported by 2 percent or more of the subjects.

In subjects 2 to 5 years of age, adverse events reported for desloratadine and placebo in at least 2 percent of subjects receiving Desloratadine

Oral Solution and at a frequency greater than placebo were fever (5.5%, 5.4%), urinary tract infection (3.6%, 0%) and varicella (3.6%, 0%).

In subjects 12 months to 23 months of age, adverse events reported for the desloratadine product and placebo in at least 2 percent of subjects receiving Desloratadine

Oral Solution and at a frequency greater than placebo were fever (16.9%, 12.9%), diarrhea (15.4%, 11.3%), upper respiratory tract infections (10.8%, 9.7%), coughing (10.8%, 6.5%), appetite increased (3.1%, 1.6%), emotional lability (3.1%, 0%), epistaxis (3.1%, 0%), parasitic infection (3.1%, 0%), pharyngitis (3.1%, 0%), rash maculopapular (3.1%, 0%).

In subjects 6 months to 11 months of age, adverse events reported for desloratadine and placebo in at least 2 percent of subjects receiving Desloratadine

Oral Solution and at a frequency greater than placebo were upper respiratory tract infections (21.2%, 12.9%), diarrhea (19.7%, 8.1%), fever (12.1%, 1.6%), irritability (12.1%, 11.3%), coughing (10.6%, 9.7%), somnolence (9.1%, 8.1%), bronchitis (6.1%, 0%), otitis media (6.1%, 1.6%), vomiting (6.1%, 3.2%), anorexia (4.5%, 1.6%), pharyngitis (4.5%, 1.6%), insomnia (4.5%, 0%), rhinorrhea (4.5%, 3.2%), erythema (3.0%, 1.6%), and nausea (3.0%, 0%).

There were no clinically meaningful changes in any electrocardiographic parameter, including the QTc interval. Only one of the 246 pediatric subjects receiving Desloratadine

Oral Solution in the clinical trials discontinued treatment because of an adverse event.

Post-Marketing Experience

Because adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following spontaneous adverse events have been reported during the marketing of desloratadine: tachycardia, palpitations, rare cases of hypersensitivity reactions (such as rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis), psychomotor hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures, and elevated liver enzymes including bilirubin, and very rarely, hepatitis.

See also:
What are the possible side effects of Pseudoephedrine?

Applies to pseudoephedrine: oral capsule, oral capsule extended release, oral capsule liquid filled, oral liquid, oral solution, oral suspension, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release

Along with its needed effects, pseudoephedrine (the active ingredient contained in Pseudoephedrine) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Rare

• Convulsions (seizures)
• hallucinations (seeing, hearing, or feeling things that are not there)
• irregular or slow heartbeat
• shortness of breath or troubled breathing

Symptoms of Overdose

• Convulsions (seizures)
• fast breathing
• hallucinations (seeing, hearing, or feeling things that are not there)
• increase in blood pressure
• irregular heartbeat (continuing)
• shortness of breath or troubled breathing (severe or continuing)
• slow or fast heartbeat (severe or continuing)
• unusual nervousness, restlessness, or excitement

Some side effects of pseudoephedrine 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

• Nervousness
• restlessness
• trouble in sleeping

Less Common

• Difficult or painful urination
• dizziness or light-headedness
• fast or pounding heartbeat
• headache
• increased sweating
• nausea or vomiting
• trembling
• unusual paleness
• weakness