Setride COLD

Perennial Allergic Rhinitis: Cetirizine (Setride COLD) hydrochloride syrup is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing.

Chronic Urticaria: Cetirizine (Setride COLD) hydrochloride syrup is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.

For systemic use of Paracetamol (Setride COLD) Sante Naturelle: prevention and treatment of hypo- and avitaminosis of vitamin C; providing increased need for vitamin C during growth, pregnancy, lactation, with heavy loads, fatigue and during recovery after prolonged severe illness; in winter with an increased risk of infectious diseases.

For intravaginal use: chronic or recurrent vaginitis (bacterial vaginosis, nonspecific vaginitis) caused by the anaerobic flora (due to changes in pH of the vagina) in order to normalize disturbed vaginal microflora.

Oral

Nasal congestion

Adult: Per cap contains a combination w/ Phenylpropanolamine (Setride COLD) HCl 18 mg: ≥13 yr 2 cap 4 hrly. Max: 8 cap/day. Per tab contains a combination w/ Phenylpropanolamine (Setride COLD) HCl 25 mg: ≥13 yr 1 tab 4 hrly. Max: 4 tab/day.

Child: Per cap contains a combination w/ Phenylpropanolamine (Setride COLD) HCl 18 mg: 6-12 yr 1 cap 4 hrly. Max: 4 cap/day. As oral liquid containing Phenylpropanolamine (Setride COLD) 2.5 mg/5 mL: 6 mth-2 yr 2.5 mL tid, 3-5 yr 5 mL 3-4 times daily, 6-12 yr 5-10 mL 3-4 times daily.

Cetirizine (Setride COLD) 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.

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

Cetirizine (Setride COLD) is also used to treat itching and swelling caused by chronic urticaria (hives).

Cetirizine (Setride COLD) may also be used for purposes not listed in this medication guide.

Paracetamol (Setride COLD) (acetaminophen) is a pain reliever and a fever reducer. The exact mechanism of Paracetamol (Setride COLD) of is not known.

Paracetamol (Setride COLD) is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers. It relieves pain in mild arthritis but has no effect on the underlying inflammation and swelling of the joint.

Paracetamol (Setride COLD) may also be used for other purposes not listed in this medication guide.

Phenylpropanolamine (Setride COLD) is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in your body. Constriction of blood vessels in your sinuses, nose, and chest allows drainage of those areas, which decreases congestion.

Phenylpropanolamine (Setride COLD) is used to treat the congestion associated with allergies, hay fever, sinus irritation, and the common cold. Phenylpropanolamine (Setride COLD) also causes a decrease in appetite and is used in some over-the-counter diet aids.

Phenylpropanolamine (Setride COLD) has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain Phenylpropanolamine (Setride COLD).

Phenylpropanolamine (Setride COLD) may also be used for purposes other than those listed in this medication guide.

Usual Adult Dose for Allergic Rhinitis

5 to 10 mg orally or chewed once a day

Usual Adult Dose for Urticaria

5 to 10 mg orally or chewed once a day

Usual Pediatric Dose for Allergic Rhinitis

6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.

2 to 5 years: 2.5 mg orally once a day, may be increased to 5 mg/day in 1 to 2 divided doses.

6 years or older: 5 to 10 mg orally or chewed once a day.

Usual Pediatric Dose for Urticaria

6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.

2 to 5 years: 2.5 mg orally once a day, may be increased to 5 mg/day in 1 to 2 divided doses.

6 years or older: 5 to 10 mg orally or chewed once a day.

Renal Dose Adjustments

CrCl less than 30 mL/min: 5 mg orally or chewed once a day.

Use of Cetirizine (Setride COLD) is not recommended in children under 6 years of age with renal impairment due to the difficulty in reliably administering doses less than 2.5 mg (1/2 teaspoonful) and the lack of pharmacokinetic and safety information of Cetirizine (Setride COLD) in such patients.

Liver Dose Adjustments

5 mg orally or chewed once a day

Use of Cetirizine (Setride COLD) is not recommended in children under 6 years of age with hepatic impairment due to the difficulty in reliably administering doses less than 2.5 mg (1/2 teaspoonful) and the lack of pharmacokinetic and safety information of Cetirizine (Setride COLD) in such patients.

Precautions

In clinical trials, the occurrence of somnolence has been reported. Due caution should therefore be exercised when driving a car or operating potential dangerous machinery. Concurrent use of alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

Dialysis

Cetirizine (Setride COLD) is not significantly removed by hemodialysis, thus supplementary dosing is not required following hemodialysis. The recommended dosage for patients on hemodialysis is 5 mg orally or chewed once a day.

Usual Adult Paracetamol (Setride COLD) Dose for Fever:

General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours orally or rectally.

Paracetamol (Setride COLD) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Adult Paracetamol (Setride COLD) Dose for Pain:

General Dosing Guidelines: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours orally or rectally.

Paracetamol (Setride COLD) 500mg tablets: Two 500 mg tablets orally every 4 to 6 hours

Usual Pediatric Dose for Fever:

Oral or Rectal:

<=1 month: 10 to 15 mg/kg/dose every 6 to 8 hours as needed.

>1 month to 12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Maximum: 5 doses in 24 hours)

Fever: 4 months to 9 years: Initial Dose: 30 mg/kg (Reported by one study (n=121) to be more effective in reducing fever than a 15 mg/kg maintenance dose with no difference regarding clinical tolerance.)

>=12 years: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours.

Usual Pediatric Dose for Pain:

Oral or Rectal:

<=1 month: 10 to 15 mg/kg/dose every 6 to 8 hours as needed.

>1 month to 12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Maximum: 5 doses in 24 hours)

Fever: 4 months to 9 years: Initial Dose: 30 mg/kg (Reported by one study (n=121) to be more effective in reducing fever than a 15 mg/kg maintenance dose with no difference regarding clinical tolerance.)

>=12 years: 325 to 650 mg every 4 to 6 hours or 1000 mg every 6 to 8 hours.

Applies to the following strengths: 75 mg; 25 mg; 37.5 mg; 50 mg; 180 mg-75 mg

Usual Adult Dose for:

• Nasal Congestion
• Weight Loss

Usual Pediatric Dose for:

• Nasal Congestion

Additional dosage information:

• Renal Dose Adjustments
• Other Comments

Usual Adult Dose for Nasal Congestion

25 mg orally every 4 hours.

-or-

75 mg orally extended release every 12 hours.

Not to exceed 150 mg/day.

Usual Adult Dose for Weight Loss

25 mg orally 3 times a day, one-half hour before meals.

-or-

75 mg orally extended release once a day in the morning.

The use of Phenylpropanolamine (Setride COLD) for weight loss should be limited to 12 weeks.

Usual Pediatric Dose for Nasal Congestion

2 to 6 years:

6.25 mg orally every 4 hours. Maximum daily dose is 37.5 mg.

6 to 12 years:

12.5 mg orally every 4 hours. Maximum daily dose is 75 mg.

> 12 years:

25 mg orally every 4 hours.

-or-

75 mg orally extended release every 12 hours.

Not to exceed 150 mg/day.

Renal Dose Adjustments

Because Phenylpropanolamine (Setride COLD) is eliminated primarily by the kidneys, one-half of the normally recommended dosage should be given. Patients with renal dysfunction should be monitored for signs and symptoms of toxicity when using Phenylpropanolamine (Setride COLD).

Other Comments

In November 2000, the Food and Drug Administration (FDA), in response to reports of increased risk of hemorrhagic stroke, requested that all drug companies discontinue marketing products containing Phenylpropanolamine (Setride COLD).

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

More about Phenylpropanolamine (Setride COLD)

• Phenylpropanolamine (Setride COLD) Side Effects
• During Pregnancy
• Drug Interactions
• Support Group
• 2 Reviews
• Drug class: decongestants

Related treatment guides

• Weight Loss
• Cold Symptoms
• Nasal Congestion

See also:
What is the most important information I should know about Cetirizine (Setride COLD)?

Tablet: Cetirizine (Setride COLD) should not be used except under special circumstances for patients with hepatic and renal function impairment.

The risk-benefit should be considered when medical problems eg, bladder neck obstruction, prostatic hypertrophy, urinary retention and glaucoma exists.

Syrup: Hypersensitivity to Cetirizine (Setride COLD) dihydrochloride, hydroxyzine, any piperazine derivatives or to any of the excipients of Cetirizine (Setride COLD). Patients with severe renal impairment CrCl <10 mL/min. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Cetirizine (Setride COLD).

See also:
What is the most important information I should know about Paracetamol (Setride COLD)?

Paracetamol (Setride COLD) should not be used in patients who have previously exhibited hypersensitivity to aspirin and/or nonsteroidal antiinflammatory agents. Paracetamol (Setride COLD) should not be given to patients with a recent history of gastrointestinal bleeding or in patients with bleeding disorders (e.g., hemophilia).

See also:
What is the most important information I should know about Phenylpropanolamine (Setride COLD)?

Decreased kidney function.

Decreased liver function.

Children under 10 years of age, unless on the advice of a doctor.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Use Cetirizine (Setride COLD) orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Do not remove the blister unit from the carton until you are ready to take Cetirizine (Setride COLD) orally disintegrating tablets. Make sure that your hands are dry when you open the blister unit. Do not push the tablet through the foil. Peel back the foil on the blister unit and place the tablet on your tongue. The tablet dissolves quickly and can be swallowed with saliva. Cetirizine (Setride COLD) orally disintegrating tablets may be taken with or without water. Take the tablet immediately after opening the blister unit. Do not store the removed tablet for future use.
• If you miss a dose of Cetirizine (Setride COLD) orally disintegrating tablets 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 Cetirizine (Setride COLD) orally disintegrating tablets.

Use Paracetamol (Setride COLD) exactly as directed on the label, or as prescribed by your doctor.

Do not use more of this medication than is recommended. An overdose of Paracetamol (Setride COLD) can cause serious harm. The maximum amount for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Using more Paracetamol (Setride COLD) could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking Paracetamol (Setride COLD) and never use more than 2 grams (2000 mg) per day. If you are treating a child, use a pediatric form of Paracetamol (Setride COLD). Carefully follow the dosing directions on the medicine label. Do not give the medication to a child younger than 2 years old without the advice of a doctor.

Measure the liquid form of Paracetamol (Setride COLD) 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. You may need to shake the liquid before each use. Follow the directions on the medicine label.

The Paracetamol (Setride COLD) chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the Paracetamol (Setride COLD) disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the Paracetamol (Setride COLD) effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Do not take a Paracetamol (Setride COLD) rectal suppository by mouth. It is for use only in your rectum. Wash your hands before and after inserting the suppository.

Try to empty your bowel and bladder just before using the Paracetamol (Setride COLD) suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

For best results from the suppository, lie down and insert the suppository pointed tip first into the rectum. Hold in the suppository for a few minutes. It will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after inserting the suppository.

Stop using Paracetamol (Setride COLD) and call your doctor if:

• you still have a fever after 3 days of use;

• you still have pain after 7 days of use (or 5 days if treating a child);

• you have a skin rash, ongoing headache, or any redness or swelling; or

• if your symptoms get worse, or if you have any new symptoms.

Urine glucose tests may produce false results while you are taking Paracetamol (Setride COLD). Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

Store Paracetamol (Setride COLD) at room temperature away from heat and moisture. The rectal suppositories can be stored at room temperature or in the refrigerator.

This combination medication is used to treat tension headaches. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

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.

This medication may also be used to treat migraine headaches.

How to use Cetirizine (Setride COLD)

Take this medication by mouth with or without food as directed by your doctor, usually every 4 hours as needed.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition, age, and response to treatment. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Report any withdrawal reactions right away.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Do not take more than recommended. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

How to use Paracetamol (Setride COLD)

Take this product by mouth as directed. Follow all directions on the product package. If you are uncertain about any of the information, consult your doctor or pharmacist.

There are many brands and forms of acetaminophen available. Read the dosing instructions carefully for each product because the amount of acetaminophen may be different between products. Do not take more acetaminophen than recommended.

If you are giving acetaminophen to a child, be sure you use a product that is meant for children. Use your child's weight to find the right dose on the product package. If you don't know your child's weight, you can use their age.

For suspensions, shake the medication well before each dose. Some liquids do not need to be shaken before use. Follow all directions on the product package. Measure the liquid medication with the provided dose-measuring spoon/dropper/syringe to make sure you have the correct dose. Do not use a household spoon.

For rapidly-dissolving tablets, chew or allow to dissolve on the tongue, then swallow with or without water. For chewable tablets, chew thoroughly before swallowing.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

For effervescent tablets, dissolve the dose in the recommended amount of water, then drink.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.

Do not take this medication for fever for more than 3 days unless directed by your doctor. For adults, do not take this product for pain for more than 10 days (5 days in children) unless directed by your doctor. If the child has a sore throat (especially with high fever, headache, or nausea/vomiting), consult the doctor promptly.

Tell your doctor if your condition persists or worsens or if you develop new symptoms. If you think you may have a serious medical problem, get medical help right away.

Phenylpropanolamine (Setride COLD) is used to relieve blocked nose or sinuses caused by common cold and seasonal nasal allergies (hay fever). It is also used to decrease appetite for weight control.

See also:
What other drugs will affect Cetirizine (Setride COLD)?

Tablet: Concurrent use with alcohol may potentiate the CNS depressant effects of Cetirizine (Setride COLD); maprotiline or tricyclic antidepressants may potentiate the anticholinergic effects of either these medications or Cetirizine (Setride COLD).

Monoamine oxidase (MAO) inhibitors are not recommended because the use may prolong and intensify the anticholinergic and CNS depressant effects of Cetirizine (Setride COLD).

Concurrent use with ototoxic medications may mask the symptoms of ototoxicity eg, tinnitus, dizziness or vertigo; photosensitizing medications may cause additive photosensitizing effects.

Syrup: No interaction is observed for Cetirizine (Setride COLD) with pseudoephedrine, cimetidine, ketoconazole, erythromycin and azithromycin. Small decrease in Cetirizine (Setride COLD) clearance is observed when theophylline (400 mg once daily) is taken with Cetirizine (Setride COLD). However, disposition of theophylline was not altered by concomitant Cetirizine (Setride COLD) administration. Concomitant administration of Cetirizine (Setride COLD) and macrolides or ketoconazole has never resulted clinically relevant EGG changes. Extent of exposure to Cetirizine (Setride COLD) was increased by 40% when ritonavir is taken with Cetirizine (Setride COLD). Disposition of ritonavir was slightly altered further to concomitant Cetirizine (Setride COLD) administration.

See also:
What other drugs will affect Paracetamol (Setride COLD)?

With the simultaneous use with inducers of microsomal liver enzymes, means having hepatotoxic effect, increasing the risk of hepatotoxic Paracetamol (Setride COLD) of Paracetamol (Setride COLD).

With the simultaneous use of anticoagulants may be slight to moderate increase in prothrombin time.

With the simultaneous use of anticholinergics may decrease absorption of Paracetamol (Setride COLD).

With the simultaneous use of oral contraceptives accelerated excretion of Paracetamol (Setride COLD) from the body and may reduce its analgesic Paracetamol (Setride COLD).

With the simultaneous use with urological means reduced their effectiveness.

With the simultaneous use of activated charcoal reduced bioavailability of Paracetamol (Setride COLD).

When Paracetamol (Setride COLD) Guardian applied simultaneously with diazepam may decrease excretion of diazepam.

There have been reports about the possibility of enhancing mielodepression effect of zidovudine while applying with Paracetamol (Setride COLD). A case of severe toxic liver injury.

Described cases of toxic effects of Paracetamol (Setride COLD), while the use of isoniazid.

When applied simultaneously with carbamazepine, phenytoin, phenobarbital, primidonom decreases the effectiveness of Paracetamol (Setride COLD), which is caused by an increase in its metabolism and excretion from the body. Cases of hepatotoxicity, while the use of Paracetamol (Setride COLD) and phenobarbital.

In applying cholestyramine a period of less than 1 h after administration of Paracetamol (Setride COLD) may decrease of its absorption.

At simultaneous application with lamotrigine moderately increased excretion of lamotrigine from the body.

With the simultaneous use of metoclopramide may increase absorption of Paracetamol (Setride COLD) and its increased concentration in blood plasma.

When applied simultaneously with probenecid may decrease clearance of Paracetamol (Setride COLD), with rifampicin, sulfinpyrazone - may increase clearance of Paracetamol (Setride COLD) due to increasing its metabolism in the liver.

At simultaneous application of Paracetamol (Setride COLD) Guardian with ethinylestradiol increases absorption of Paracetamol (Setride COLD) from the gut.

Enhances the effect of indirect anticoagulants (coumarin derivatives and indandione). Antipyretic and analgesic activity of caffeine increases, reduce - rifampicin, phenobarbital and alcohol (accelerated biotransformation, inducing microsomal liver enzymes).

See also:
What other drugs will affect Phenylpropanolamine (Setride COLD)?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you take this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

You should not take other medicines that contain Phenylpropanolamine (Setride COLD) in combination with this medicine, as this can easily result in exceeding the maximum recommended daily dose of Phenylpropanolamine (Setride COLD). Many cold and flu remedies and over-the-counter painkillers contain Phenylpropanolamine (Setride COLD), so be sure to check the ingredients of any other medicines before taking them with this one. Migraleve yellow can be taken four hours after taking Migraleve pink if you still have a migraine, but make sure you do not exceed the maximum dose recommended in the information leaflet.

This medicine should be used with caution in people taking a monoamine oxidase inhibitor (MAOI), for example the antidepressants phenelzine, tranylcypromine or isocarboxacid. Ask your doctor or pharmacist for advice before taking this medicine if you have taken an MAOI in the last 14 days.

Cholestyramine reduces the absorption of Phenylpropanolamine (Setride COLD) from the gut. It should not be taken within an hour of taking Phenylpropanolamine (Setride COLD) or the effect of the Phenylpropanolamine (Setride COLD) will be reduced.

Metoclopramide and domperidone may increase the absorption of Phenylpropanolamine (Setride COLD) from the gut.

Long-term or regular use of Phenylpropanolamine (Setride COLD) may increase the anti-blood-clotting effect of warfarin and other anticoagulant medicines, leading to an increased risk of bleeding. This effect does not occur with occasional painkilling doses. If you are taking an anticoagulant medicine and you are also taking co-codamol regularly, your blood clotting time (INR) should be regularly monitored.

In the unlikely event that this medicine makes you feel drowsy, this may be enhanced by other medicines that can cause drowsiness, such as the following:

antipsychotics, eg haloperidol

barbiturates, eg phenobarbital, amobarbital

benzodiazepines, eg diazepam, temazepam

other opioids, eg morphine, dihydrocodeine

sedating antihistamines, eg chlorphenamine, hydroxyzine

sleeping tablets, eg zopiclone

tricyclic antidepressants, eg amitriptyline.

See also:
What are the possible side effects of Cetirizine (Setride COLD)?

Pediatric studies were conducted with Cetirizine (Setride COLD) hydrochloride. More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with Cetirizine (Setride COLD) hydrochloride at doses of 1.25 to 10 mg per day were included in controlled and uncontrolled clinical trials conducted in the United States. The duration of treatment ranged from 2 to 12 weeks. Placebo-controlled trials up to 4 weeks duration included 168 pediatric patients aged 2 to 5 years who received Cetirizine (Setride COLD), the majority of whom received single daily doses of 5 mg. A placebo-controlled trial 18 months in duration included 399 patients aged 12 to 24 months treated with Cetirizine (Setride COLD) (0.25 mg/kg bid), and another placebo-controlled trial of 7 days duration included 42 patients aged 6 to 11 months who were treated with Cetirizine (Setride COLD) (0.25 mg/kg bid).

The majority of adverse reactions reported in pediatric patients aged 2 to 11 years with Cetirizine (Setride COLD) hydrochloride were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in pediatric patients receiving up to 10 mg of Cetirizine (Setride COLD) hydrochloride was uncommon (0.4% on Cetirizine (Setride COLD) hydrochloride vs. 1.0% on placebo).

Table 1 lists adverse experiences which were reported for Cetirizine (Setride COLD) hydrochloride 5 and 10 mg in pediatric patients aged 6 to 11 years in placebo-controlled clinical trials in the United States and were more common with Cetirizine (Setride COLD) hydrochloride than placebo. Of these, abdominal pain was considered treatment-related and somnolence appeared to be dose-related, 1.3% in placebo, 1.9% at 5 mg and 4.2% at 10 mg. The adverse experiences reported in pediatric patients aged 2 to 5 years in placebo-controlled trials were qualitatively similar in nature and generally similar in frequency to those reported in trials with children aged 6 to 11 years.

In the placebo-controlled trials of pediatric patients 6 to 24 months of age, the incidences of adverse experiences, were similar in the Cetirizine (Setride COLD) and placebo treatment groups in each study. Somnolence occurred with essentially the same frequency in patients who received Cetirizine (Setride COLD) hydrochloride and patients who received placebo. In a study of 1 week duration in children 6 to 11 months of age, patients who received Cetirizine (Setride COLD) exhibited greater irritability/fussiness than patients on placebo. In a study of 18 months duration in patients 12 months and older, insomnia occurred more frequently in patients who received Cetirizine (Setride COLD) compared to patients who received placebo (9.0% v. 5.3%). In those patients who received 5 mg or more per day of Cetirizine (Setride COLD) as compared to patients who received placebo, fatigue (3.6% v. 1.3%) and malaise (3.6% v. 1.8%) occurred more frequently.

Table 1.

Adverse Experiences Reported in Pediatric Patients Aged 6 to 11 Years in Placebo-Controlled United States Cetirizine (Setride COLD) Hydrochloride Trials (5 or 10 mg Dose) Which Occurred at a Frequency of ≥2% in Either the 5-mg or the 10-mg Cetirizine (Setride COLD) Hydrochloride Group, and More Frequently Than in the Placebo Group

The following events were observed infrequently (less than 2%), in either 3982 adults and children 12 years and older or in 659 pediatric patients aged 6 to 11 years who received Cetirizine (Setride COLD) hydrochloride in U.S. trials, including an open adult study of six months duration. A causal relationship of these infrequent events with Cetirizine (Setride COLD) hydrochloride administration has not been established.

Autonomic Nervous System: anorexia, flushing, increased salivation, urinary retention.

Cardiovascular: cardiac failure, hypertension, palpitation, tachycardia.

Central and Peripheral Nervous Systems: abnormal coordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine,

myelitis, paralysis, paresthesia, ptosis, syncope, tremor, twitching, vertigo, visual field defect.

Gastrointestinal: abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia, eructation, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal hemorrhage, stomatitis including ulcerative stomatitis, tongue discoloration, tongue edema.

Genitourinary: cystitis, dysuria, hematuria, micturition frequency, polyuria, urinary incontinence, urinary tract infection.

Hearing and Vestibular: deafness, earache, ototoxicity, tinnitus.

Metabolic/Nutritional: dehydration, diabetes mellitus, thirst.

Musculoskeletal: arthralgia, arthritis, arthrosis, muscle weakness, myalgia.

Psychiatric: abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness, paroniria, sleep disorder.

Respiratory System: bronchitis, dyspnea, hyperventilation, increased sputum, pneumonia, respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection.

Reproductive: dysmenorrhea, female breast pain, intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis.

Reticuloendothelial: lymphadenopathy.

Skin: acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash, photosensitivity reaction, photosensitivity toxic reaction, pruritus, purpura, rash, seborrhea, skin disorder, skin nodule, urticaria.

Special Senses: parosmia, taste loss, taste perversion.

Vision: blindness, conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular hemorrhage, xerophthalmia.

Body as a Whole: accidental injury, asthenia, back pain, chest pain, enlarged abdomen, face edema, fever, generalized edema, hot flashes, increased weight, leg edema, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigors.

Occasional instances of transient, reversible hepatic transaminase elevations have occurred during Cetirizine (Setride COLD) therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of Cetirizine (Setride COLD) hydrochloride has been reported.

Post-Marketing Experience

In the post-marketing experience period, the following additional rare, but potentially severe adverse events have been reported: aggressive reaction, anaphylaxis, cholestasis, convulsions, glomerulonephritis, hallucinations, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, suicidal ideation, suicide and thrombocytopenia.

See also:
What are the possible side effects of Paracetamol (Setride COLD)?

Effects due to the presence of acetylsalicylic acid.

Accidents awareness with respiratory or skin reactions (angioedema, urticaria, asthma, anaphylactic shock);

Cross hypersensitivity reactions with NSAIDs and with tartrazine;

At low doses recommended for the use of Paracetamol (Setride COLD), side effects of aspirin are generally limited to some irritation of the gastro-intestinal tract.

At higher doses, side effects include gastrointestinal mucosal erosions, gastric ulcer or duodenal ulcer, occult blood loss, melena.

Acetylsalicylic acid may also increase the tendency to bleeding and bleeding time (the lengthening of bleeding continues 4-6 days after stopping the drug).

It may also worsen renal function including cases of pre-existing condition (the long-term use can cause chronic kidney disease).

The signs of salicylic overdose described under.

Effects due to the presence of Paracetamol (Setride COLD).

At the doses and duration of recommended treatment, side effects are usually negligible, but the prolonged use of Paracetamol (Setride COLD) in therapeutic doses large (2-4 g per day, or 10-20 tablets Paracetamol (Setride COLD)) may cause the appearance chronic hepatitis. This justifies the recommendations of caution especially in patients with liver disease prior.

Very rarely, it can produce thrombocytopenia.

The acute liver toxicity in overdose massive (doses greater than 8 g of Paracetamol (Setride COLD)) is described in paragraph overdose.

See also:
What are the possible side effects of Phenylpropanolamine (Setride COLD)?

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Constipation.

Skin rash.

Codeine can cause drowsiness, although at the dose contained in this medicine this is very unlikely. However, if you do find this medicine makes you feel sleepy or dizzy you should not drive or operate machinery and avoid alcoholic drink.

The side effects listed above may not include all of the side effects reported by the medicines’s manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

Cetirizine (Setride COLD) HCl is a piperazine derivative and a metabolite of hydroxyzine. It competes reversibly with histamine to block the histamine (H₁) receptor sites. Cetirizine (Setride COLD) HCl is considered a long-acting nonsedating antihistamine and has some mast-cell stabilizing activity.

Paracetamol (Setride COLD) is an organic compound that consists of a six-membered ring containing two opposing nitrogen atoms. Paracetamol (Setride COLD) exists as small alkaline deliquescent crystals with a saline tasteacinol was introduced to medicine as a solvent for uric acid. When taken into the body the drug is partly oxidized and partly eliminated unchanged. Outside the body, piperazine has a remarkable power to dissolve uric acid and producing a soluble urate, but in clinical experience it has not proved equally successfulacinol was first introduced as an anthelmintic in 1953. A large number of piperazine compounds have anthelmintic Paracetamol (Setride COLD). Their mode of Paracetamol (Setride COLD) is generally by paralysing parasites, which allows the host body to easily remove or expel the invading organism.

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