Robitussin Night Time Cough & Cold Pediatric

Generic Name: diphenhydramine and phenylephrine (DYE fen HYE dra meenand FEN il EFF rin)

Brand Names: Alahist LQ, Aldex-CT, Children's Triacting Night Time, D-Tann, Dimetapp Nighttime Cold & Congestion, Diphenmax D, Dytan-D, PediaCare Children's Allergy & Cold, Robitussin Night Time Cough & Cold, Robitussin Night Time Cough & Cold Children's, Robitussin Night Time Cough & Cold Pediatric, Triaminic Night Time Cold & Cough

What is Robitussin Night Time Cough & Cold Pediatric (diphenhydramine and phenylephrine)?

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

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

The combination of diphenhydramine and phenylephrine is used to treat runny or stuffy nose, sneezing, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Diphenhydramine and phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Robitussin Night Time Cough & Cold Pediatric (diphenhydramine and phenylephrine)?

Do not give this medication to a child younger than 2 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. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant. Avoid drinking alcohol while you are taking this medication. It can add to drowsiness caused by an antihistamine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by diphenhydramine.

What should I discuss with my healthcare provider before taking Robitussin Night Time Cough & Cold Pediatric (diphenhydramine and phenylephrine)?

You should not use this medication if you are allergic to diphenhydramine or phenylephrine.

Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have:

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  asthma;

  
  


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  heart disease or high blood pressure;

  
  


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  diabetes;

  
  


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  a thyroid disorder;

  
  


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  glaucoma;

  
  


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  kidney disease;

  
  


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  an enlarged prostate; or

  
  


• 
  

  problems with urination.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Robitussin Night Time Cough & Cold Pediatric (diphenhydramine and phenylephrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 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.

Measure the liquid form of this medicine 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.

Make sure you chew the chewable tablet before you swallow it.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Robitussin Night Time Cough & Cold Pediatric (diphenhydramine and phenylephrine)?

Avoid drinking alcohol while you are taking this medication. It can add to drowsiness caused by an antihistamine. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by diphenhydramine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. Antihistamines, decongestants, and cough suppressants are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant.

Robitussin Night Time Cough & Cold Pediatric (diphenhydramine and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

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  fast, pounding, or uneven heartbeat;

  
  


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  confusion, hallucinations, unusual thoughts or behavior;

  
  


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  urinating less than usual or not at all;

  
  


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  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


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  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


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  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or

  
  


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  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

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  blurred vision;

  
  


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  dry mouth;

  
  


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  nausea, stomach pain, constipation;

  
  


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  dizziness, drowsiness;

  
  


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  problems with memory or concentration;

  
  


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  ringing in your ears;

  
  


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  mild loss of appetite;

  
  


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  warmth, tingling, or redness under your skin;

  
  


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  feeling excited or restless;

  
  


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  sleep problems (insomnia); or

  
  


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  skin rash or itching.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Robitussin Night Time Cough & Cold Pediatric (diphenhydramine and phenylephrine)?

Tell your doctor about all other medications you use, especially:

• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others;

  
  


• 
  

  antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others; or

  
  


• 
  

  an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

  
  

This list is not complete and there may be other drugs that can interact with diphenhydramine and phenylephrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Robitussin Night Time Cough & Cold Pediatric resources

• Robitussin Night Time Cough & Cold Pediatric Side Effects (in more detail)
• Robitussin Night Time Cough & Cold Pediatric Use in Pregnancy & Breastfeeding
• Drug Images
• Robitussin Night Time Cough & Cold Pediatric Drug Interactions
• Robitussin Night Time Cough & Cold Pediatric Support Group
• 1 Review for Robitussin Night Time Cough & Cold Pediatric - Add your own review/rating

• Alahist LQ Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• D-Tann Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Robitussin Night Time Cough & Cold Pediatric with other medications

• Cold Symptoms
• Hay Fever
• Sinusitis

Where can I get more information?

• Your pharmacist can provide more information about diphenhydramine and phenylephrine.

See also: Robitussin Night Time Cough & Cold Pediatric side effects (in more detail)

Ambroxol Krewel Meuselbach

Ambroxol Krewel Meuselbach may be available in the countries listed below.

Ingredient matches for Ambroxol Krewel Meuselbach

Ambroxol

Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Ambroxol Krewel Meuselbach in the following countries:

• Germany

International Drug Name Search

Ryneze Liquid

chlorpheniramine maleate and methscopolamine nitrate

Dosage Form: liquid
Ryneze Liquid

DESCRIPTION:

Each teaspoonful (5 mL) for oral administration contains:

Chlorpheniramine Maleate ...................................... 4 mg

Scopolamine Methyl Nitrate .............................. 1.25 mg

INACTIVE INGREDIENTS: Citric Acid, Grape flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium

Saccharin, and Sorbitol.

RYNEZE® LIQUID contains ingredients from the following classes: antihistamine, and anticholinergic.

Chlorpheniramine Maleate is an antihistamine with the chemical name: 2-Pyridinepropanamine, γ-(4-chlorphenyl)-

N,N-dimethyl-, (Z)-2-butenedioate (1:1), and has the following chemical structure:

Chlorpheniramine Maleate structure:

Scopolamine Methyl Nitrate is an anticholinergic belldonna alkaloid derivative with the chemical name:

[7(s)-(α,2β,4β,5α,7β,)]–7–(3–hydroxy–1-oxo – 2- Phenylpropoxy)-9, 9-dimethyl–3-oxa– 9-azoniatricyclo

[3.3.1.0 2,4] nonane nitrate.It has the following chemical structure:

Scopolamine Methyl Nitrate:

CLINICAL PHARMACOLOGY:

Chlorpheniramine maleate competitively antagonizes most of the smooth muscle stimulating actions of histamine on the

H1 receptors of the GI tract, uterus, large blood vessels, and bronchial muscle. It also antagonizes the action of histamine

that results in increased capillary permeability and the formation of edema. Chlorpheniramine maleate is analkylamine-type antihistamine.

This group of antihistamines are among the most active histamine antagonists and are

generally effective in relatively low doses. They thereby prevent, but do not reverse, responses mediated by histamine

alone. The anticholinergic actions of most antihistamines provide a drying effect on the nasal mucosa. These drugs are

not so prone to produce drowsiness and are among the most suitable agents for daytime use, but a significant proportion

of patients do experience this effect.

Scopolamine methyl nitrate is one of the principal anticholinergic/antispasmodic components of belladonna

alkaloids that exhibits antisecretory activity. Scopolamine methyl nitrate inhibits the muscarinic actions of acetylcholine

on structures innervated by postganglionic cholinergic nerves: smooth muscle, cardiac muscle, sinoatrial and

atrioventricular nodes, and exocrine glands. In general, the smaller doses of anticholinergics inhibit salivary and

bronchial secretions, sweating, and accommodation; cause dilation of the pupil; and may affect the heart rate.

INDICATIONS AND USAGE:

This product is indicated for the temporary relief of symptoms associated with seasonal and

perennial allergic and non-allergic rhinitis, and sinusitis.Chlorpheniramine Maleate temporarily relieves runny nose

and reduces sneezing, itching of the nose or throat, and itchy,watery eyes due to hay fever or other upper respiratory

allergies. Scopolamine Methyl Nitrate further augments the anti-secretory activity of this product.

CONTRAINDICATIONS:

This product is contraindicated in patients with hypersensitivity or idiosyncrasy to any of its

ingredients. It is also contraindicated in women who are pregnant or nursing.

It is also contraindicated in newborn or premature infants, because this age group has an increased susceptibility to the

anticholinergic side effects of chlorpheniramine maleate. Geriatric patients may be more sensitive to the effects of this medication.

Risk-benefit should be considered when the following conditions exist: Acute asthma; Bladder neck obstruction;

Brain damage in children; Cardiac disease, especially cardiac arrhythmias, congestive heart failure, coronary artery disease,

and mitral stenosis; Cardiovascular disease; Diabetes mellitus; Down’s Syndrome; Esophagitis, reflux; Narrow angle

glaucoma; Acute hemorrhage with unstable cardiovascular status; Hepatic function impairment; Hernia; Hypertension;

Hyperthyroidism; Intestinal atony in the elderly or debilitated patient; Chronic lung disease; Myasthenia gravis; Autonomic

neuropathy; Paralytic ileus; Prostatic hypertrophy; Psychiatric disorders; Pyloric obstruction; Renal function impairment;

Spastic paralysis, in children; Tachycardia; Toxemia of pregnancy; Ulcerative colitis; Urinary retention, or

predisposition to; Uropathy; Xerostomia.

WARNINGS:

This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to

engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform

hazardous tasks while taking this drug.

Do not exceed recommended dosage.

Heat prostration can occur with the use of scopolamine methyl nitrate when the environmental temperature is high.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or

colostomy; in this instance, use of scopolamine methyl nitrate would be inappropriate and possibly harmful.

PRECAUTIONS:

General: Antihistamines have an atropine-like action and should be used with caution in

patients with a history of bronchial asthma, emphysema, increased intraocular pressure, hyperthyroidism,

cardiovascular disease and hypertension.

Use scopolamine methyl nitrate with caution in patients with hiatal hernia associated with reflux Esophagitis. Use

extreme caution and only when needed in patients with autonomic neuropathy, hyperthyroidism, coronary heart

disease, congestive heart failure, and cardiac arrhythmia.

Information for patients:

Patient consultation should include the following information regarding proper use of this medication:

• Do not take more medication than the amount recommended.

• This medication should be used with caution during exercise or hot weather, overheating may result in heat

stroke.

• Do not drive or operate machinery if drowsiness or dizziness occurs.

• Do not ingest alcoholic beverages, monoamine oxidase (MAO) inhibitors, or CNS depression producing

medications (hypnotics, sedatives, tranquilizers) while taking this medication.

• This medication possibly increases sensitivity of eyes to light.

• Scopolamine methyl nitrate may cause blurred vision.

• If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next

dose. Do not double dose.

Caution patients about the signs of potential side effects,

especially:

• Anticholinergic effects – clumsiness or unsteadiness;severe drowsiness; severe dryness of mouth, nose, or

throat; flushing or redness of face; shortness of breath or trouble breathing.

• Blood dyscrasias-sore throat and fever; unusual bleeding or bruising; unusual tiredness or weakness.

• Fast or irregular heartbeat.

• Psychotic episodes.

• Tightness in chest.

Note: When anticholinergics are given to patients, especially children, where the environmental temperature

is high there is a risk of a rapid increase in body temperature because of suppression of sweat gland

activity. Infants, patients with Down’s syndrome, and children with spastic paralysis or brain damage may show

an increased response to anticholinergics, thus increasing the potential for side effects.

Geriatric or debilitated patients may respond to usual doses of anticholinergics with excitement, agitation,

drowsiness, or confusion.

Laboratory Tests:

The following may be especially important in patient monitoring (other tests may be

warranted in some patients, depending on conditions): Blood pressure determination – recommended at

frequent intervals during therapy: Electrocardiogram (ECG) – monitoring may be required: Intraocular

pressure determination – recommended at periodic intervals, as these medications may increase the

intraocular pressure.

Drug Interactions:

Do not take this product if you are presently taking, or have taken within the preceding

two weeks, a prescription drug for high blood pressure or depression without first consulting your physician.

Absorption of other oral medications may be decreased during concurrent use with anticholinergics

due to decreased gastrointestinal motility and delayed gastric emptying.

Combinations containing any of the following medications, depending on the amount present, may

also interact with this product:

• Alkalizers, such as: calcium and/or magnesium-containing antacids; Carbonic inhibitors;

citrates; sodium bicarbonate-urinary excretion of anticholinergics may be delayed by alkalization of the

urine, thus potentiating scopolamine methyl nitrate therapeutic and/or side effects.

• Antacids or adsorbent antidiarrheals-simultaneous use of these medications may reduce absorption of

scopolamine methyl nitrate, resulting in decreased therapeutic effectiveness; doses of these should be

spaced 2 or 3 hours apart from doses of scopolamine methyl nitrate.

• Anticholinergics – Concurrent use with anticholinergic effects; patients should be advised to report

occurrence of gastrointestinal problems promptly since paralytic ileus may occur with concurrent therapy.

• CNS Depressants – Concurrent use of alcohol, antihistamines with alcohol, tricyclic antidepressants,

barbiturates and other CNS depressants may have an additive effect.

• Ketoconazole – Anticholinergics may increase gastrointestinal pH, possibly resulting in a marked

reduction in ketoconazole absorption during concurrent use with anticholinergics; patients should be advised

to take these medications at least 2 hours after ketoconazole.

• MAO inhibitors – Concurrent use may prolong and intensify cardiac stimulate and vasopressor effects of

chlorpheniramine, resulting in headache, cardiac arrhythmias, vomiting or sudden and severe

hypertensive and/or hyperpyretic crisis. These medications should not be administered during

or within 14 days following the administration of MAO inhibitor therapy.

• Metoclopramide – Concurrent use of metoclopramide with anticholinergics may antagonize

metoclopramide’s effects on gastrointestinal motility.

• Potassium chloride – Concurrent use with anticholinergics may increase the severity of

potassium chloride-induced gastrointestinal lesions.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data is available on the long-term potential of the components of this product for Carcinogenesis, Mutagenesis or Impairment of Fertility in animals or humans.

Pregnancy:

Category C: It is not known whether Ryneze® Liquid can cause fetal harm when administered

to a pregnant woman or can affect reproduction capacity. Ryneze® Liquid should be given to a pregnant

woman only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted

in human milk, caution should be exercised when Ryneze Liquid is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness of Ryneze® Liquid in children below the age of 6 have not been established.

Use is not recommended for children under six years of age. A paradoxical reaction characterized by

hyperexcitability may occur in children taking large doses of anticholinergics.

Geriatric Use:

Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation,

drowsiness, or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects,

such as constipation, dryness of the mouth, and urinary retention (especially in males). If these side effects occur

and continue or are severe, medication should probably be discontinued.

Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of

precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, with the

continued use of anticholinergics, since these drugs block the action of acetylcholine, which is responsible for

many functions of the brain, including memory function.

ADVERSE REACTIONS:

The following adverse reactions have been observed with the use of chlorpheniramine and

scopolamine methyl nitrate; Arrhytmias, blood dyscrasias, CNS depression, CNS stimulation, dizziness, drowsiness,

dryness of mouth, hallucinations, hypotension, hypertension, increased sweating, loss of appetite,

paradoxical reaction, restlessness, skin rash, stomach upset or pain, thickening of mucus, tingling in hands or

feet, trembling, troubled breathing, unusual tiredness or weakness, vomiting.

Note: Agitation; confusion; difficult or painful urination; drowsiness; dizziness; and dryness of mouth, nose and

throat are more likely to occur in the elderly. Nightmares, unusual excitement, nervousness,

restlessness, or irritability are more likely to occur in children and the elderly. When anticholinergics are given

to patients, especially children, where the environmental temperature is high, there is risk of a rapid increase in

body temperature.

OVERDOSAGE:

In all cases of suspected overdose, immediately call your regional poison center and/or

contact a physician immediately. The stomach should be emptied promptly by lavage or induction of emesis with

syrup of ipecac. The installation of activated charcoal into he stomach also should be considered. The treatment of

overdose is essentially sypmptomatic and supportive. If respiratory depression is present treat promptly with oxygen and/or

mechanical support of ventilation. If convulsions or marked CNS excitement occurs, only short-acting benzodiazepine-type

drugs should be used.

DOSAGE AND ADMINISTRATION:

Adults and children 12 years of age and older:

1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours.

Children 6 to under 12 years of age:

½ teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours.

RYNEZE® LIQUID is not recommended for children under 6 years of age.

Note:Geriatric patients may be more sensitive to the effects of the usual adult dose. Adjust adult dose accordingly.

HOW SUPPLIED:

RYNEZE® LIQUID is supplied as a clear, grape-flavored liquid, dye free, sugar free, alcohol

free, and gluten free in 16 fl oz (473 mL) bottles, NDC 24839-346-16, and 10 mL sample,

NDC 24839-346-10

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL

OVERDOSE, CALL A DOCTOR OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Pharmacist: Store at controlled room temperature, 15°-30°C (59°-86°F). Avoid exposure to heat. Dispense

in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Manufactured For:

SJ pharmaceuticals

4200 Northside Pkwy NW,

Building 12

Atlanta, GA 30327


Manufactured By:

Great Southern Laboratories

Houston, TX 77099


Rev. 06/09

PRODUCT PACKAGING:

The packaging below represents the labeling currently used.

Ryneze® Liquid

Antihistamine/Anticholinergic

Each 5 mL (one teaspoonful) for oral

administration contains:

Chlorpheniramine Maleate ...... 4 mg

Scopolamine Methyl Nitrate .... 1.25 mg

Rx Only

Dye Free/Sugar Free

Alcohol Free/Gluten Free

Grape Flavor

16 fl oz (473 mL)

DOSAGE AND ADMINISTRATION:

Adults and children 12 years of age and older:1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours.

Children 6 to under 12 years of age:

1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours.

RYNEZE® LIQUID is not recommended for children under 6 years of age.


THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.


Note: Geriatric patients may be more sensitive to the effects of the usual adult dose. Adjust adult dose accordingly.


KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE,

CALL A DOCTOR OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.


Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.


Pharmacist:Store at controlled room temperature, 15o-30oC (59o-86oF). Avoid exposure to heat. Dispense in a

tight, light-resistant container as defined in the USP/NF with a child-resistant closure.


Manufactured for:

SJ Pharmaceuticals

4200 Northside Parkway, NW

Building 12

Atlanta, GA 30327


Manufactured by:

Great Southern Laboratories

Houston, TX 77099


Rev. 06/09

Ryneze Liquid  chlorpheniramine maleate, scopolamine methyl nitrate  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24839-346 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 4 mg  in 5 mL Methscopolamine Nitrate (Methscopolamine) Methscopolamine Nitrate 1.25 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24839-346-10 6 BOTTLE In 1 CARTON contains a BOTTLE (24839-346-10) 1 24839-346-10 10 mL In 1 BOTTLE This package is contained within the CARTON (24839-346-10) 2 24839-346-16 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		07/09/2009

Labeler - SJ Pharmaceuticals, LLC (845662720)

Registrant - Great Southern Laboratories (056139553)

Establishment
Name	Address	ID/FEI	Operations
Great Southern Laboratories		056139553	manufacture

Revised: 07/2009SJ Pharmaceuticals, LLC

More Ryneze Liquid resources

• Ryneze Liquid Side Effects (in more detail)
• Ryneze Liquid Dosage
• Ryneze Liquid Use in Pregnancy & Breastfeeding
• Drug Images
• Ryneze Liquid Drug Interactions
• Ryneze Liquid Support Group
• 0 Reviews for Ryneze - Add your own review/rating

Compare Ryneze Liquid with other medications

• Rhinitis

Rimantadine

Dosage Form: tablet, film coated
Rimantadine Hydrochloride Tablets USP

100 mg

Rx only

DESCRIPTION: Rimantadine hydrochloride is a synthetic antiviral drug available as a 100 mg film-coated tablet for oral administration. Each Rimantadine hydrochloride tablet USP contains 100 mg of Rimantadine hydrochloride USP. In addition, it also contains the following inactive ingredients:

corn starch, FD&C Yellow No. 6 Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol and sodium starch glycolate.

Rimantadine hydrochloride is a white to off-white crystalline powder which is freely soluble in water (50 mg/mL at 20°C). Chemically, Rimantadine hydrochloride is alpha-methyltricyclo-(3.3.1.1/3.7)decane-1-methanamine hydrochloride, with an empirical formula of C12H21N•HCl, a molecular weight of 215.77 and the following structural formula:

CLINICAL PHARMACOLOGY: MECHANISM OF ACTION: The mechanism of action of Rimantadine is not fully understood. Rimantadine appears to exert its inhibitory effect early in the viral replicative cycle, possibly inhibiting the uncoating of the virus. Genetic studies suggest that a virus protein specified by the virion M2 gene plays an important role in the susceptibility of influenza A virus to inhibition by Rimantadine.

MICROBIOLOGY: Rimantadine is inhibitory to the in vitro replication of influenza A virus isolates from each of the three antigenic subtypes, i.e., H1N1, H2N2 and H3N2, that have been isolated from man. Rimantadine has little or no activity against influenza B virus (Ref. 1,2). Rimantadine does not appear to interfere with the immunogenicity of inactivated influenza A vaccine.

A quantitative relationship between the in vitro susceptibility of influenza A virus to Rimantadine and clinical response to therapy has not been established.

Susceptibility test results, expressed as the concentration of the drug required to inhibit virus replication by 50% or more in a cell culture system, vary greatly (from 4 ng/mL to 20 mcg/mL) depending upon the assay protocol used, size of the virus inoculum, isolates of the influenza A virus strains tested, and the cell types used (Ref. 2).

Rimantadine-resistant strains of influenza A virus have emerged among freshly isolated epidemic strains in closed settings where Rimantadine has been used. Resistant viruses have been shown to be transmissible and to cause typical influenza illness. (Ref. 3).

PHARMACOKINETICS: Although the pharmacokinetic profile of Rimantadine hydrochloride has been described, no pharmacodynamic data establishing a correlation between plasma concentration and its antiviral effect are available.

The tablet and syrup formulations of Rimantadine hydrochloride are equally absorbed after oral administration. The mean ± SD peak plasma concentration after a single 100 mg dose of Rimantadine hydrochloride was 74 ± 22 ng/mL (range: 45 to 138 ng/mL). The time to peak concentration was 6 ± 1 hours in healthy adults (age 20 to 44 years). The single dose elimination half-life in this population was 25.4 ± 6.3 hours (range: 13 to 65 hours). The single dose elimination half-life in a group of healthy 71 to 79 year-old subjects was 32 ± 16 hours (range: 20 to 65 hours).

After the administration of Rimantadine 100 mg twice daily to healthy volunteers (age 18 to 70 years) for 10 days, area under the curve (AUC) values were approximately 30% greater than predicted from a single dose. Plasma trough levels at steady state ranged between 118 and 468 ng/mL. In these patients no age-related differences in pharmacokinetics were detected. However, in a comparison of three groups of healthy older subjects (age 50 to 60, 61 to 70 and 71 to 79 years), the 71 to 79 year-old group had average AUC values, peak concentrations and elimination half-life values at steady state that were 20 to 30% higher than the other two groups. Steady-state concentrations in elderly nursing home patients (age 68 to 102 years) were 2- to 4-fold higher than those seen in healthy young and elderly adults.

The pharmacokinetic profile of Rimantadine in children has not been established. In a group (n=10) of children 4 to 8 years old who were given a single dose (6.6 mg/kg) of Rimantadine hydrochloride syrup, plasma concentrations of Rimantadine ranged from 446 to 988 ng/mL at 5 to 6 hours and from 170 to 424 ng/mL at 24 hours. In some children drug was detected in plasma 72 hours after the last dose.

Following oral administration, Rimantadine is extensively metabolized in the liver with less than 25% of the dose excreted in the urine as unchanged drug. Three hydroxylated metabolites have been found in plasma. These metabolites, an additional conjugated metabolite and parent drug account for 74 ± 10% (n=4) of a single 200 mg dose of Rimantadine excreted in urine over 72 hours.

In a group (n=14) of patients with chronic liver disease, the majority of whom were stabilized cirrhotics, the pharmacokinetics of Rimantadine were not appreciably altered following a single 200 mg oral dose compared to 6 healthy subjects who were sex, age and weight matched to 6 of the patients with liver disease. After administration of a single 200 mg dose to patients (n=10) with severe hepatic dysfunction, AUC was approximately 3-fold larger, elimination half-life was approximately 2-fold longer and apparent clearance was about 50% lower when compared to historic data from healthy subjects.

Studies of the effects of renal insufficiency on the pharmacokinetics of Rimantadine have given inconsistent results. Following administration of a single 200 mg oral dose of Rimantadine to 8 patients with a creatinine clearance (CLcr) of 31 to 50 mL/min and 6 patients with a CLcr of 11 to 30 mL/min, the apparent clearance was 37% and 16% lower, respectively, and plasma metabolite concentrations were higher when compared to weight-, age-, and sex-matched healthy subjects (n=9, CLcr > 50 mL/min). After a single 200 mg oral dose of Rimantadine was given to 8 hemodialysis patients (CLcr 0 to 10 mL/min), there was a 1.6-fold increase in the elimination half-life and a 40% decrease in apparent clearance compared to age-matched healthy subjects. Hemodialysis did not contribute to the clearance of Rimantadine.

The in vitro human plasma protein binding of Rimantadine is about 40% over typical plasma concentrations. Albumin is the major binding protein.

INDICATIONS AND USAGE: Rimantadine hydrochloride tablet is indicated for the prophylaxis and treatment of illness caused by various strains of influenza A virus in adults.

Rimantadine hydrochloride tablet is indicated for prophylaxis against influenza A virus in children.

PROPHYLAXIS: In controlled studies of children over the age of 1 year, healthy adults and elderly patients, Rimantadine hydrochloride has been shown to be safe and effective in preventing signs and symptoms of infection caused by various strains of influenza A virus. Early vaccination on an annual basis as recommended by the Centers for Disease Control's Immunization Practices Advisory Committee is the method of choice in the prophylaxis of influenza unless vaccination is contraindicated, not available or not feasible. Since Rimantadine hydrochloride does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically-related viruses. Following vaccination during an influenza outbreak, Rimantadine hydrochloride prophylaxis should be considered for the 2 to 4 week time period required to develop an antibody response. However, the safety and effectiveness of Rimantadine hydrochloride prophylaxis have not been demonstrated for longer than 6 weeks.

TREATMENT: Rimantadine hydrochloride therapy should be considered for adults who develop an influenza-like illness during known or suspected influenza A infection in the community. When administered within 48 hours after onset of signs and symptoms of infection caused by influenza A virus strains, Rimantadine hydrochloride has been shown to reduce the duration of fever and systemic symptoms.

CONTRAINDICATIONS: Rimantadine hydrochloride is contraindicated in patients with known hypersensitivity to drugs of the adamantane class, including Rimantadine and amantadine.

PRECAUTIONS: GENERAL: An increased incidence of seizures has been reported in patients with a history of epilepsy who received the related drug amantadine. In clinical trials of Rimantadine hydrochloride, the occurrence of seizure-like activity was observed in a small number of patients with a history of seizures who were not receiving anticonvulsant medication while taking Rimantadine hydrochloride. If seizures develop, Rimantadine hydrochloride should be discontinued.

The safety and pharmacokinetics of Rimantadine in renal and hepatic insufficiency have only been evaluated after single dose administration. In a single dose study of patients with anuric renal failure, the apparent clearance of Rimantadine was approximately 40% lower and the elimination half-life was 1.6-fold greater than that in healthy age-matched controls. In a study of 14 persons with chronic liver disease (mostly stabilized cirrhotics), no alterations in the pharmacokinetics were observed after the administration of a single dose of Rimantadine. However, the apparent clearance of Rimantadine following a single dose to 10 patients with severe liver dysfunction was 50% lower than reported for healthy subjects. Because of the potential for accumulation of Rimantadine and its metabolites in plasma, caution should be exercised when patients with renal or hepatic insufficiency are treated with Rimantadine.

Transmission of Rimantadine resistant virus should be considered when treating patients whose contacts are at high risk for influenza A illness. Influenza A virus strains resistant to Rimantadine can emerge during treatment and such resistant strains have been shown to be transmissible and to cause typical influenza illness (Ref. 3). Although the frequency, rapidity, and clinical significance of the emergence of drug-resistant virus are not yet established, several small studies have demonstrated that 10% to 30% of patients with initially sensitive virus, upon treatment with Rimantadine, shed Rimantadine resistant virus. (Ref. 3,4,5,6)

Clinical response to Rimantadine, although slower in those patients who subsequently shed resistant virus, was not significantly different from those who did not shed resistant virus. (Ref. 3) No data are available in humans that address the activity or effectiveness of Rimantadine therapy in subjects infected with resistant virus.

DRUG INTERACTIONS: Cimetidine: The effects of chronic cimetidine use on the metabolism of Rimantadine are not known. When a single 100 mg dose of Rimantadine hydrochloride was administered one hour after the initiation of cimetidine (300 mg four times a day), the apparent total Rimantadine clearance of this single dose in normal healthy adults was reduced by 18% (compared to the apparent total Rimantadine clearance in the same subjects in the absence of cimetidine).

Acetaminophen: Rimantadine hydrochloride 100 mg, was given twice daily for 13 days to 12 healthy volunteers. On day 11, acetaminophen (650 mg four times daily) was started and continued for 8 days. The pharmacokinetics of Rimantadine were assessed on days 11 and 13. Coadministration with acetaminophen reduced the peak concentration and AUC values for Rimantadine by approximately 11%.

Aspirin: Rimantadine hydrochloride 100 mg, was given twice daily for 13 days to 12 healthy volunteers. On day 11, aspirin (650 mg, four times daily) was started and continued for 8 days. The pharmacokinetics of Rimantadine were assessed on days 11 and 13. Peak plasma concentrations and AUC of Rimantadine were reduced approximately 10% in the presence of aspirin.

CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY: Carcinogenesis: Carcinogenicity studies in animals have not been performed.

Mutagenesis: No mutagenic effects were seen when Rimantadine was evaluated in several standard assays for mutagenicity.

Impairment of Fertility: A reproduction study in male and female rats did not show detectable impairment of fertility at dosages up to 60 mg/kg/day (3 times the maximum human dose based on body surface area comparisons).

PREGNANCY: Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Rimantadine is reported to cross the placenta in mice. Rimantadine has been shown to be embryotoxic in rats when given at a dose of 200 mg/kg/day (11 times the recommended human dose based on body surface area comparisons). At this dose the embryotoxic effect consisted of increased fetal resorption in rats; this dose also produced a variety of maternal effects including ataxia, tremors, convulsions and significantly reduced weight gain. No embryotoxicity was observed when rabbits were given doses up to 50 mg/kg/day (5 times the recommended human dose based on body surface area comparisons). However, there was evidence of a developmental abnormality in the form of a change in the ratio of fetuses with 12 or 13 ribs. This ratio is normally about 50:50 in a litter but was 80:20 after Rimantadine treatment.

Nonteratogenic Effects: Rimantadine was administered to pregnant rats in a peri- and postnatal reproduction toxicity study at doses of 30, 60, and 120 mg/kg/day (1.7, 3.4 and 6.8 times the recommended human dose based on body surface area comparisons). Maternal toxicity during gestation was noted at the two higher doses of Rimantadine, and at the highest dose, 120 mg/kg/day, there was an increase in pup mortality during the first 2 to 4 days postpartum. Decreased fertility of the F1 generation was also noted for the two higher doses.

For these reasons, Rimantadine hydrochloride should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

NURSING MOTHERS: Rimantadine hydrochloride should not be administered to nursing mothers because of the adverse effects noted in offspring of rats treated with Rimantadine during the nursing period. Rimantadine is concentrated in rat milk in a dose-related manner; 2 to 3 hours following administration of Rimantadine, rat breast milk levels were approximately twice those observed in the serum.

PEDIATRIC USE: In children, Rimantadine hydrochloride is recommended for the prophylaxis of influenza A. The safety and effectiveness of Rimantadine hydrochloride in the treatment of symptomatic influenza infection in children have not been established. Prophylaxis studies with Rimantadine hydrochloride have not been performed in children below the age of 1 year.

ADVERSE REACTIONS: In 1,027 patients treated with Rimantadine hydrochloride in controlled clinical trials at the recommended dose of 200 mg daily, the most frequently reported adverse events involved the gastrointestinal and nervous systems.

Incidence >1%: Adverse events reported most frequently (1 to 3%) at the recommended dose in controlled clinical trials are shown in the table below.

	Rimantadine (n=1027)	Control (n=986)
Nervous System
Insomnia	2.1%	0.9%
Dizziness	1.9%	1.1%
Headache	1.4%	1.3%
Nervousness	1.3%	0.6%
Fatigue	1.0%	0.9%
Gastrointestinal System
Nausea	2.8%	1.6%
Vomiting	1.7%	0.6%
Anorexia	1.6%	0.8%
Dry Mouth	1.5%	0.6%
Abdominal pain	1.4%	0.8%
Body as a Whole
Asthenia	1.4%	0.5%

Less frequent adverse events (0.3 to 1%) at the recommended dose in controlled clinical trials were: Gastrointestinal System: diarrhea, dyspepsia; Nervous System: impairment of concentration, ataxia, somnolence, agitation, depression; Skin and Appendages: rash; Hearing and Vestibular: tinnitus; Respiratory: dyspnea.

Additional adverse events (less than 0.3%) reported at recommended doses in controlled clinical trials were: Nervous System: gait abnormality, euphoria, hyperkinesia, tremor, hallucination, confusion, convulsions; Respiratory: bronchospasm, cough; Cardiovascular: pallor, palpitation, hypertension, cerebrovascular disorder, cardiac failure, pedal edema, heart block, tachycardia, syncope; Reproduction: non-puerperal lactation; Special Senses: taste loss/change, parosmia.

Rates of adverse events, particularly those involving the gastrointestinal and nervous systems, increased significantly in controlled studies using higher than recommended doses of Rimantadine hydrochloride. In most cases, symptoms resolved rapidly with discontinuation of treatment. In addition to the adverse events reported above, the following were also reported at higher than recommended doses: increased lacrimation, increased micturition frequency, fever, rigors, agitation, constipation, diaphoresis, dysphagia, stomatitis, hypesthesia and eye pain.

Adverse Reactions in Trials of Rimantadine and Amantadine: In a six-week prophylaxis study of 436 healthy adults comparing Rimantadine with amantadine and placebo, the following adverse reactions were reported with an incidence >1%.

	Rimantadine 200 mg/day (n=145)	Placebo (n=143)	Amantadine 200 mg/day (n=148)
Nervous System
Insomnia	3.4%	0.7%	7.0%
Nervousness	2.1%	0.7%	2.8%
Impaired Concentration	2.1%	1.4%	2.1%
Dizziness	0.7%	0.0%	2.1%
Depression	0.7%	0.7%	3.5%
Total % of subjects with adverse reactions	6.9%	4.1%	14.7%
Total % of subjects withdrawn due to adverse reactions	6.9%	3.4%	14.0%

Geriatric Use: Approximately 200 patients over the age of 64 were evaluated for safety in controlled clinical trials with Rimantadine hydrochloride. Geriatric subjects who received either 200 mg or 400 mg of Rimantadine daily for 1 to 50 days experienced considerably more central nervous system and gastrointestinal adverse events than comparable geriatric subjects receiving placebo. Central nervous system events including dizziness, headache, anxiety, asthenia, and fatigue, occurred up to two times more often in subjects treated with Rimantadine than in those treated with placebo. Gastrointestinal symptoms, particularly nausea, vomiting, and abdominal pain occurred at least twice as frequently in subjects receiving Rimantadine than in those receiving placebo. The gastrointestinal symptoms appeared to be dose related. In patients over 64, the recommended dose is 100 mg, daily (see Clinical Pharmacology and Dosage and Administration).

OVERDOSAGE: As with any overdose, supportive therapy should be administered as indicated. Overdoses of a related drug, amantadine, have been reported with adverse reactions consisting of agitation, hallucinations, cardiac arrhythmia and death. The administration of intravenous physostigmine (a cholinergic agent) at doses of 1 to 2 mg in adults (Ref. 7) and 0.5 mg in children (Ref. 8) repeated as needed as long as the dose did not exceed 2 mg/hour has been reported anecdotally to be beneficial in patients with central nervous system effects from overdoses of amantadine.

DOSAGE AND ADMINISTRATION: FOR PROPHYLAXIS IN ADULTS AND CHILDREN: Adults: The recommended adult dose of Rimantadine hydrochloride is 100 mg twice a day. In patients with severe hepatic dysfunction, renal failure (CrCl ≤10 mL/min.) and elderly nursing home patients, a dose reduction to 100 mg, daily is recommended. There are currently no data available regarding the safety of Rimantadine during multiple dosing in subjects with renal or hepatic impairment. Because of the potential for accumulation of Rimantadine metabolites during multiple dosing, patients with any degree of renal insufficiency should be monitored for adverse effects, with dosage adjustments being made as necessary.

Children: In children less than 10 years of age, Rimantadine hydrochloride should be administered once a day, at a dose of 5 mg/kg but not exceeding 150 mg. For children 10 years of age or older, use the adult dose.

FOR TREATMENT IN ADULTS: The recommended adult dose of Rimantadine hydrochloride is 100 mg twice a day. In patients with severe hepatic dysfunction, renal failure (CrCl ≤10 mL/min.) and elderly nursing home patients, a dose reduction to 100 mg daily is recommended. There are currently no data available regarding the safety of Rimantadine during multiple dosing in subjects with renal or hepatic impairment. Because of the potential for accumulation of Rimantadine metabolites during multiple dosing, patients with any degree of renal insufficiency should be monitored for adverse effects, with dosage adjustments being made as necessary. Rimantadine hydrochloride therapy should be initiated as soon as possible, preferably within 48 hours after onset of signs and symptoms of influenza A infection. Therapy should be continued for approximately seven days from the initial onset of symptoms.

HOW SUPPLIED: Rimantadine hydrochloride tablets USP 100 mg are supplied as orange, round film coated tablets in bottles of 100 (NDC 0781-5029-01) and 1000 (NDC 0781-5029-10). Debossed “cor” on one side and “111” on other side.

Store at controlled room temperature 15° - 30°C (59° - 86°F). (see USP).

Dispense in a tight container as defined in the USP.

REFERENCES:

1. Belshe, R.B., Burk, B., Newman, F., Cerruti, R.L. and Sim, I.S. (1989) J. Infect. Dis. 159, 430-435.


2. Sim, I.S., Cerruti, R.L. and Connell, E.V., (1989) J. Resp. Dis. (Suppl.), S46-S51.


3. Hayden, F.G., Belshe, R.B., Clover, R.D. et al (1989) N. Engl. J. Med, 321 (25), 1696-1702.


4. Hall, C.B., Dolin, R., Gala, C.L., et al (1987) Pediatrics 80, 275-282.


5. Thompson, J., Fleet, W., Lawrence, E. et al (1987) J. Med. Vir. 21, 249-255.


6. Belshe, R.B., Smith, M.H., Hall, C.B., et al (1988) J. Virol, 62, 1508-1512.


7. Casey, D.F., N. Engl. J. Med. 1978:298; 516.


8. Berkowitz, C.D. J. Pediatrics 1979:95;144.

Rev. July 2007

MF #183-04

Manufactured by

Corepharma LLC

Middlesex, NJ 08846 for

Sandoz Inc.

Princeton, NJ 08540

Rimantadine HYDROCHLORIDE  Rimantadine hydrochloride   tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0781-5029 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Rimantadine HYDROCHLORIDE (Rimantadine) Rimantadine HYDROCHLORIDE 100 mg

Inactive Ingredients Ingredient Name Strength STARCH, CORN   FD&C YELLOW NO. 6   HYPROMELLOSE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   PROPYLENE GLYCOL   SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color ORANGE (Orange) Score no score Shape ROUND (round) Size 9mm Flavor Imprint Code cor;111 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0781-5029-01 100 TABLET In 1 BOTTLE, PLASTIC None 2 0781-5029-10 1000 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075916	11/02/2001

Labeler - Sandoz Inc (110342024)

Establishment
Name	Address	ID/FEI	Operations
Corepharma LLC		031192276	manufacture

Revised: 03/2010Sandoz Inc

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• Rimantadine MedFacts Consumer Leaflet (Wolters Kluwer)


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Acute or chronic inflammation of the gallbladder.

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rituximab Intravenous

ri-TUX-i-mab

Intravenous route(Solution)

Fatal infusion reactions may occur within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue rituximab infusion for severe reactions. Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of tumor lysis syndrome following treatment with rituximab monotherapy in patients with non-Hodgkin's lymphoma. Severe and potentially fatal mucocutaneous reactions can occur. JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death can also occur .

Commonly used brand name(s)

In the U.S.

• Rituxan

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Uses For rituximab

Rituximab injection is a monoclonal antibody. It is used to treat a type of cancer called non-Hodgkin's lymphoma (NHL). It can be used alone or with other cancer medicines (chemotherapy). It is also used as a "maintenance" treatment for patients with advanced follicular lymphoma who responded to initial treatment with rituximab plus chemotherapy (induction treatment).

Rituximab is also used in combination with fludarabine and cyclophosphamide (FC) for the treatment of chronic lymphocytic leukemia (CLL).

Rituximab may also be used in combination with methotrexate to reduce the signs and symptoms of rheumatoid arthritis and help keep joint damage from getting worse after at least one other medicine (e.g., adalimumab, etanercept, infliximab) has been used and did not work well.

Rituximab is also used in combination with glucocorticoids to treat Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA).

rituximab is to be administered only by or under the immediate supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, rituximab is used in certain patients with the following medical conditions:

• Immune or idiopathic thrombocytopenic purpura (ITP) (a blood disease).


• Waldenstrom's macroglobulinemia (cancer of the blood).

Before Using rituximab

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rituximab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rituximab injection in the elderly. However, elderly patients are more likely to have infections and age-related heart and lung problems, which may require caution in patients receiving rituximab injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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

Interactions with Medicines

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

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

• Rotavirus Vaccine, Live

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

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Cisplatin


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Using rituximab with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Pneumococcal Vaccine Polyvalent

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Angina (chest pain), history of or


• Heart disease or


• Heart rhythm problems (e.g., arrhythmia), history of or


• Hepatitis B or


• Kidney disease or


• Lung problems (e.g., asthma, bronchitis), history of or


• Stomach or bowel problems (e.g., intestinal blockage, perforation, ulcers)—Use with caution. May make these conditions worse.

• Infection—May decrease your body's ability to fight infection.

Proper Use of rituximab

Before receiving rituximab, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

You will receive rituximab while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you rituximab. rituximab is given through a needle placed in one of your veins.

Rituximab must be given slowly, so the needle will remain in place for a few hours. You may also receive medicines to help prevent possible allergic reactions to the injection.

rituximab should come with a Medication Guide. It is very important that you read and understand this information. ask your doctor about anything you do not understand.

Precautions While Using rituximab

It is very important that your doctor check your progress at regular visits to make sure that rituximab is working properly. Blood tests may be needed to check for unwanted effects.

rituximab may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using rituximab. Wash your hands often. Tell your doctor if you have lupus or if you have any kind of infection before you start using rituximab. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

rituximab may cause a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML). The risk for getting this infection is higher if you have rheumatoid arthritis. Talk to your doctor about the benefits of taking rituximab and the risk of this infection. Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.

Call your doctor right away if you start to have a cough that won't go away, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.

While you are being treated with rituximab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. If you have rheumatoid arthritis, non-live virus vaccines should be given at least 4 weeks before receiving rituximab. Rituximab may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not get live vaccines (e.g., nasal flu virus vaccine). Try to avoid persons who have taken live vaccines. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should wear a protective face mask that covers the nose and mouth.

Rituximab may cause chest pain, fever, chills, itching, hives, flushing of the face, rash, troubled breathing, or swelling of the face, tongue, and throat within a few hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.

rituximab may cause a serious type of reaction called tumor lysis syndrome (TLS). Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

Serious skin reactions can occur during treatment with rituximab. Stop using rituximab and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using rituximab.

Stop using rituximab and check with your doctor immediately if you have any symptoms of liver problems including skin and eyes turning yellow, dark brown-colored urine, right-sided abdominal or stomach pain, fever, or severe tiredness.

rituximab may cause serious stomach and bowel problems, especially when used with other cancer medicines. Check with your doctor right away if you start having stomach pain while being treated with rituximab.

Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are using rituximab and for 12 months after stopping it. Talk to your doctor about effective birth control.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

rituximab Side Effects

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

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• back pain


• black, tarry stools


• bleeding gums


• bloating or swelling of the face, arms, hands, lower legs, or feet


• blood in the urine or stools


• blurred vision


• body aches or pain


• chest pain


• confusion


• convulsions


• cough or hoarseness


• difficulty with breathing


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• drowsiness


• dry mouth


• ear congestion


• fever and chills


• flushed, dry skin


• flushing of the face


• fruit-like breath odor


• headache


• hives or welts


• increased hunger


• increased thirst


• increased urination


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lower back or side pain


• nasal congestion


• nausea


• nervousness


• noisy breathing


• pain or tenderness around the eyes and cheekbones


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


• pounding in the ears


• rapid weight gain


• runny nose


• shortness of breath


• skin rash


• slow or fast heartbeat


• sneezing


• sore throat


• sores, ulcers, or white spots in the mouth or on the lips


• stuffy or runny nose


• sweating


• swelling of the tongue or throat


• swollen glands


• tightness of the chest


• tingling of the hands or feet


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• vomiting


• wheezing

Less common

• Blistering, peeling, or loosening of the skin


• blisters in the mouth


• blisters on the trunk, scalp, or other areas


• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling


• burning, tingling, numbness or pain in the hands, arms, feet, or legs


• decreased frequency and amount of urination


• diarrhea


• difficulty with moving


• discouragement


• feeling of warmth


• feeling sad or empty


• increased thirst


• irregular heartbeat


• irritability


• joint or muscle pain


• loss of appetite


• loss of interest or pleasure


• muscle cramps


• muscle pain or stiffness


• nervousness


• numbness or tingling in the hands, feet, or lips


• pain at the place of injection


• pain, swelling, or redness in the joints


• red skin lesions, often with a purple center


• red, itchy lining of the eye


• redness of the face, neck, arms, and occasionally, upper chest


• stabbing pain


• swelling of the face or fingers


• swelling of the feet or lower legs


• trouble concentrating


• trouble sleeping

Incidence not known

• Abdominal or stomach cramps or pain


• blindness


• blue-yellow color blindness


• blurred vision or other change in vision


• burning or stinging of the skin


• decreased vision


• dilated neck veins


• dry cough


• extreme fatigue


• eye pain, tearing


• general feeling of discomfort, illness, or weakness


• irregular breathing


• nosebleed


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• redness of the eye


• redness, soreness, or itching of the skin


• sensitivity of the eye to light


• severe abdominal or stomach pain


• severe vomiting, sometimes with blood


• sores, welting, or blisters


• swelling, stiffness, redness, or warmth around many joints


• swollen and inflamed joints


• swollen lymph glands


• vision loss

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

More common

• Fear


• increased cough


• lack or loss of strength


• muscle aching or cramping


• night sweats


• swollen joints


• throat irritation

Less common

• Agitation or anxiety


• change in taste


• dry eyes


• excessive muscle tone


• feeling of constant movement of self or surroundings


• heartburn


• increase in body movements


• lightheadedness


• muscle tension


• pain or redness at the injection site


• sensation of spinning


• sleepiness


• swelling of the stomach

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

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

See also: rituximab Intravenous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More rituximab Intravenous resources

• Rituximab Intravenous Side Effects (in more detail)
• Rituximab Intravenous Use in Pregnancy & Breastfeeding
• Rituximab Intravenous Drug Interactions
• Rituximab Intravenous Support Group
• 14 Reviews for Rituximab Intravenous - Add your own review/rating

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