Nizer-D

Nimesulide (Nizer-D) is a relatively COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. Its approved indications are the treatment of acute pain, the symptomatic treatment of osteoarthritis and primary dysmenorrhoea in adolescents and adults above 12 years old. Due to concerns about the risk of hepatotoxicity, Nimesulide (Nizer-D) has been withdrawn from market in many countries.

Pseudoephedrine (Nizer-D) has been withdrawn in Canada.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.

Tablet/Suspension: Adults: Treatment of a variety of painful inflammatory conditions including those associated with osteoarthritis, postoperative trauma, sports injuries, ear, nose and throat disorders, dental surgery, bursitis/tendinitis, thrombophlebitis, pharyngitis and gynaecological disorders.

Children: Suspension: Fever and inflammatory symptoms associated with upper respiratory tract infections (viral or bacterial origin) and in reducing pain of various origin in children eg, postoperative pain, pain due to musculoskeletal injury, pain due to minor soft tissue injury, etc.

Gel: For local application in the treatment of acute and chronic musculoskeletal disorders characterized by pain and inflammation including non-articular rheumatic disorders and soft-tissue injuries. These conditions include backache, tendonitis, tenosynovitis, sprains and strains.

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.

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

Pseudoephedrine (Nizer-D) 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 (Nizer-D) may also be used for purposes not listed in this medication guide.

Tablet/Suspension: Adults: Usual

Oral Dose: 100-mg tab twice daily.

Children: 1.5 mg/kg body weight, twice or thrice daily.

Gel: For external use only. Adults: Apply approximately 3 cm or 1¼ inches of Nimesulide (Nizer-D) gel lightly in a thin layer to the affected site and surrounding areas 3-4 times/day, or as directed by the physician. Clean and dry the affected areas thoroughly before treating with the gel. Patients should be advised to avoid occlusive dressing. Hands should be washed before and after using this medicine.

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 (Nizer-D) products where customers do not have direct access to such products before a sale is made. The FDA defines Pseudoephedrine (Nizer-D) 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.

Nimesulide (Nizer-D): Hypersensitivity to Nimesulide (Nizer-D) or any of the excipients of Nimesulide (Nizer-D). It should not be administered to patients in whom aspirin or other NSAIDs induced the symptoms of asthma, bronchospasm, rhinitis, angioedema, nasal polyps or urticaria by prostaglandin synthesis inhibition. It should not be used on injured or abraded skin or in the presence of local infection. It should not be used simultaneously with other topical products.

Use in Children: It should not be used in children <12 years.

Sulidin Thermo: Hypersensitivity to Nimesulide (Nizer-D), capsaicin or any of the excipients of Sulidin Thermo. In patients with hypersensitivity to aspirin and other NSAIDs that induce symptoms of asthma, rhinitis, angioedema, urticaria or nasal polyposis. In injured, damaged and sensitive skin, pruritic conditions eg, eczema and prurigo or open wounds.

Use in Pregnancy: Pregnancy Category C.

Sulidin Thermo is not recommended for use during pregnancy. Especially, it should not be used in 3rd trimester because of the risk of premature ductal constriction and uterine atony.

Use in Children: Dosage recommendations and indications for use in children have not been established. Thus, it should not be used in children.

See also:
What is the most important information I should know about Pseudoephedrine (Nizer-D)?

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 (Nizer-D) 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 (Nizer-D) or a decongestant.

Do not use Pseudoephedrine (Nizer-D) 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 Pseudoephedrine (Nizer-D) sustained-release tablets (24 hour) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Pseudoephedrine (Nizer-D) sustained-release tablets (24 hour) with food, water, or milk to minimize stomach irritation.
• Swallow Pseudoephedrine (Nizer-D) sustained-release tablets (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 (Nizer-D) sustained-release tablets (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 (Nizer-D) sustained-release tablets (24 hour).

Nimesulide (Nizer-D) is used to treat acute pain, osteoarthritis (pain and swelling of joints due to degeneration) and pain during periods.

Pseudoephedrine (Nizer-D) 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 (Nizer-D) 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 (Nizer-D) 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 (Nizer-D)

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 (Nizer-D) 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 (Nizer-D) may be different between products. Do not take more Pseudoephedrine (Nizer-D) 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.

Clinically important interactions involving interference with drug metabolism have not been described with Nimesulide (Nizer-D).

Gel: No clinically significant interactions involving interference with drug metabolism have been reported with topical application of Nimesulide (Nizer-D).

See also:
What other drugs will affect Pseudoephedrine (Nizer-D)?

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 (Nizer-D) 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.

Nimesulide (Nizer-D): Adverse effects possibly related to local treatment have been infrequently reported. In clinical trials, the majority of adverse effects are local reactions at the application site eg, mild or moderate local irritation, erythema, rash, desquamation, pruritus. Staining of clothing has been noted.

The frequency of adverse events listed as follows is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

Skin and Subcutaneous Tissue Disorders: Uncommon: Pruritus, erythema. Not Known: Desquamation, pruritus, rash, mild or moderate local irritation.

When Nimesulide (Nizer-D) is applied topically, the possibility of occurrence of systemic adverse effects is less in comparison to oral administration. However, when Nimesulide (Nizer-D) is applied long-term and in high doses, the occurrence of systemic adverse effects should not be neglected.

Sulidin Thermo: Adverse effects possibly related to local treatment have been infrequently reported. In clinical studies, the majority of adverse effects are local reactions at the application area eg, mild or moderate local irritation, erythema, rash, desquamation, pruritus.

The frequency classification of adverse effects are listed as following: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

İmmune System Disorders: Very Rare: Allergic reactions (anaphylactic shock may be seen in severe events).

Nervous System Disorders: Uncommon: Dyschezia, hypoesthesia. Very Rare: Nervousness, restlessness, euphoria, confusion, tinnitus, somnolence, blurred or double vision, chill, tremor, loss of consciousness.

Eye Disorders: Uncommon: Eye irritation.

Vascular Disorders: Uncommon: Hypertension.

Respiratory, Thoracic or Mediastinal Disorders: Uncommon: Cough, throat irritation, dyspnea, labored breathing and asthma exacerbation.

Gastrointestinal Disorders: Uncommon: Nausea.

Musculoskeletal Disorders, Connective Tissue and Bone Disorders: Uncommon: Pain in extremities, muscle spasms.

General Disorders and Administration Site Conditions: Very Common: Pain in the administration area, erythema. Common: Pruritus in the administration area, papule, vesicle, edema, swelling, dryness. Uncommon: Urticaria in the administration area, paresthesia, dermatitis, hyperesthesia, inflammation, irritation, cyanosis, peripheral edema.

When Nimesulide (Nizer-D) and capsaicin is applied topically, the possibility of occurrence systemic adverse effects is less in comparison to oral administration of Nimesulide (Nizer-D) and capsaicin. However, when Sulidin Thermo is applied long-term and in high doses, the occurrence of systemic adverse effects should not be neglected.

See also:
What are the possible side effects of Pseudoephedrine (Nizer-D)?

Applies to Pseudoephedrine (Nizer-D): 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 (Nizer-D) (the active ingredient contained in Pseudoephedrine (Nizer-D)) 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 (Nizer-D):

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 (Nizer-D) 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