LoHist-12D

Generic Name: brompheniramine and pseudoephedrine (BROM fen EER a meen and SOO doe ed FED rin)

Brand Names: Andehist NR Syrup, Bidhist-D, Bromaline, Bromhist Pediatric Drops, Bromhist-NR, BroveX PD, BroveX PSE, Brovex SR, Di-Bromm, Histex SR, J-TanD PD, Lodrane 12D, Lodrane 24D, Lodrane D, Lodrane Liquid, LoHist-12D, LoHist-PD, Q-Tapp, Sildec, Touro Allergy, Ultrabrom, Ultrabrom PD

What is LoHist-12D (brompheniramine and pseudoephedrine)?

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

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

The combination of brompheniramine and pseudoephedrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Brompheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about LoHist-12D (brompheniramine and pseudoephedrine)?

There are many brands and forms of this medicine available and not all brands are listed on this leaflet.

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 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 a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Brompheniramine and pseudoephedrine 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 drinking alcohol. It can increase some of the side effects of this medication.

What should I discuss with my healthcare provider before taking LoHist-12D (brompheniramine and pseudoephedrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take brompheniramine and pseudoephedrine if you have:

• kidney disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  an enlarged prostate; or

  
  


• 
  

  problems with urination.

  
  

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Brompheniramine and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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 LoHist-12D (brompheniramine and pseudoephedrine)?

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. Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

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.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

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 the medication at room temperature away from moisture and heat.

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 LoHist-12D (brompheniramine and pseudoephedrine)?

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 drinking alcohol. It can increase some of the side effects of this medication.

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.

Do not use any other over-the-counter 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 a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

LoHist-12D (brompheniramine and pseudoephedrine) 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:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

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

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

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

  
  


• 
  

  urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  blurred vision;

  
  


• 
  

  dry mouth;

  
  


• 
  

  nausea, stomach pain, constipation;

  
  


• 
  

  mild loss of appetite, stomach upset;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  restless or excitability (especially in children);

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration; or

  
  


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  ringing in your ears.

  
  

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 LoHist-12D (brompheniramine and pseudoephedrine)?

Sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by brompheniramine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications..

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

• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  
  


• 
  

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

  
  


• 
  

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

  
  

This list is not complete and there may be other drugs that can interact with brompheniramine and pseudoephedrine. 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 LoHist-12D resources

• LoHist-12D Side Effects (in more detail)
• LoHist-12D Use in Pregnancy & Breastfeeding
• LoHist-12D Drug Interactions
• LoHist-12D Support Group
• 0 Reviews for LoHist-12D - Add your own review/rating

• Bidhist-D Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Bromfenex Controlled-Release and Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Lodrane D MedFacts Consumer Leaflet (Wolters Kluwer)

Compare LoHist-12D with other medications

• Hay Fever
• Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about brompheniramine and pseudoephedrine.

See also: LoHist-12D side effects (in more detail)

Motrin IB

Pronunciation: EYE-bue-PROE-fen
Generic Name: Ibuprofen
Brand Name: Examples include Advil and Motrin IB

Motrin IB is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Motrin IB for a long time. Do not use Motrin IB right before or after bypass heart surgery.

Motrin IB may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Motrin IB is used for:

Treating minor aches and pains caused by the common cold, headaches, toothaches, back or muscle aches, menstrual cramps, or arthritis. It may be used to reduce fever. It may also be used for other conditions as determined by your doctor.

Motrin IB is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Do NOT use Motrin IB if:

• you are allergic to any ingredient in Motrin IB


• you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)


• you have recently had or will be having bypass heart surgery


• you are in the last 3 months of pregnancy

Contact your doctor or health care provider right away if any of these apply to you.

Before using Motrin IB:

Some medical conditions may interact with Motrin IB. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal product, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers, persistent or returning stomach pain or heartburn)


• if you have a history of swelling or fluid buildup, lupus, asthma, growths in the nose (nasal polyps), or mouth inflammation


• if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases


• if you are dehydrated or have low fluid volume (eg, caused by diarrhea, vomiting, not drinking fluids)


• if you have poor health or low blood sodium levels, you drink alcohol, or you have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Motrin IB. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased


• Probenecid because it may increase the risk of Motrin IB's side effects


• Cyclosporine, lithium, methotrexate, or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Motrin IB


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Motrin IB

This may not be a complete list of all interactions that may occur. Ask your health care provider if Motrin IB may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Motrin IB:

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

• Motrin IB comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Motrin IB refilled.


• Take Motrin IB by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.


• Take Motrin IB with a full glass of water (8 oz/240 mL) as directed by your doctor.


• If you miss a dose of Motrin IB and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. 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 the proper use of Motrin IB.

Important safety information:

• Motrin IB may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Motrin IB with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Serious stomach ulcers or bleeding can occur with the use of Motrin IB. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Motrin IB with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.


• Talk to your doctor before you take Motrin IB if you drink more than 3 drinks with alcohol per day.


• Do NOT take more than the recommended dose or use for longer than 10 days for pain or 2 days for sore throat without checking with your doctor.


• If you have pain that does not get better within 10 days or fever that does not get better within 3 days, check with your doctor. If your symptoms get worse or if you have new symptoms, check with your doctor.


• Check with your doctor if you have a severe or persistent sore throat. Check with your doctor if you have a sore throat with fever, headache, nausea, and vomiting.


• Motrin IB has ibuprofen in it. Before you start any new medicine, check the label to see if it has ibuprofen in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not take aspirin while you are using Motrin IB unless your doctor tells you to.


• Use Motrin IB with caution in the ELDERLY; they may be more sensitive to its effects, including stomach bleeding and kidney problems.


• Different brands of Motrin IB may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: Motrin IB may cause harm to the fetus. Do not take it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Motrin IB while you are pregnant. It is not known if Motrin IB is found in breast milk. Do not breast-feed while taking Motrin IB.

Possible side effects of Motrin IB:

All medicines can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach pain or upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; stiff neck; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Motrin IB side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.

Proper storage of Motrin IB:

Store Motrin IB at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Avoid temperatures above 104 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Motrin IB out of the reach of children and away from pets.

General information:

• If you have any questions about Motrin IB, please talk with your doctor, pharmacist, or other health care provider.


• Motrin IB is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Motrin IB. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Motrin IB resources

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

• Motrin IB Prescribing Information (FDA)


• Ibuprofen Prescribing Information (FDA)


• Ibuprofen Monograph (AHFS DI)


• Ibuprofen Professional Patient Advice (Wolters Kluwer)


• Advil Prescribing Information (FDA)


• Advil Advanced Consumer (Micromedex) - Includes Dosage Information


• Advil Consumer Overview


• Advil Childrens Prescribing Information (FDA)


• Advil Migraine Prescribing Information (FDA)


• Caldolor Consumer Overview


• Caldolor Prescribing Information (FDA)


• Caldolor Advanced Consumer (Micromedex) - Includes Dosage Information


• Ibutilide Fumarate Monograph (AHFS DI)


• Motrin Prescribing Information (FDA)


• Motrin Consumer Overview


• NeoProfen Prescribing Information (FDA)

Compare Motrin IB with other medications

• Aseptic Necrosis
• Back Pain
• Costochondritis
• Cystic Fibrosis
• Diffuse Idiopathic Skeletal Hyperostosis
• Dysautonomia
• Fever
• Frozen Shoulder
• Gout, Acute
• Headache
• Muscle Pain
• Osteoarthritis
• Pain
• Patent Ductus Arteriosus
• Period Pain
• Rheumatoid Arthritis
• Sciatica
• Spondylolisthesis
• Temporomandibular Joint Disorder

Probiotics

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Probiotics are live microorganisms (called

See also

Medical conditions associated with probiotics:

• Clostridial Infection
• Diarrhea
• Dietary Supplementation
• Irritable Bowel Syndrome
• Oral Thrush
• Traveler's Diarrhea
• Urinary Tract Infection
• Vaginal Yeast Infection

Drug List:

Acidophilus-Extra-Strength

Florastor

Acidophilus

Bacid

Culturelle-Ds

Culturelle-Hs

Flora-Q

Flora-Q-2

Florastor-Kids

Novaflor

Risaquad

Risaquad-2

Superdophilus

Care Decongestant Nasal Spray

1. Name Of The Medicinal Product

Oxymetazoline 0.05% w/v Nasal Spray

Care Decongestant Nasal Spray

2. Qualitative And Quantitative Composition

The nasal solution contains Oxymetazoline (as hydrochloride) 0.05% w/v.

For excipients, see 6.1

3. Pharmaceutical Form

Nasal spray, solution

4. Clinical Particulars

4.1 Therapeutic Indications

Oxymetazoline Nasal Spray or Care Decongestant Nasal Spray is recommended for the relief of nasal congestion in such conditions as the common cold, catarrh and hayfever.

4.2 Posology And Method Of Administration

Adults and Elderly

While holding upright the spray nozzle should be inserted into each nostril in turn and squeezed firmly twice while breathing in. The application may be repeated up to 2 times a day, or used at bedtime to give relief through the night.

Children

Not recommended for children under 12 years of age.

4.3 Contraindications

Hypersensitivity to any component of the medicinal product.

Patients who are receiving monoamine oxidase inhibitors or within 14 days of stopping such treatment; patients suffering from porphyria, glaucoma, coronary artery disease, hypertension, hyperthyroidism or diabetes.

4.4 Special Warnings And Precautions For Use

If symptoms persist, consult your doctor. Prolonged use may result in rhinitis medicamentosa and should therefore be avoided. Treatment should be limited to a maximum of seven days. Keep all medicines safely away from children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

If you are taking other medicines, you should see your doctor for advice before taking this medicine.

4.6 Pregnancy And Lactation

The safety to use in pregnancy has not been established and administration of oxymetazoline during pregnancy should be avoided.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that it may cause local skin reactions (e.g. contact dermatitis) and discolouration.

Benzalkonium chloride may cause local skin irritation.

4.9 Overdose

No statement.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group (ATC code): S01G A04 Sympathomimetics used as decongestants.

Oxymetazoline is an alpha-adrenoceptor agonist which causes local vasoconstriction when applied to nasal membrane.

5.2 Pharmacokinetic Properties

When applied locally to nasal mucosa, oxymetazoline acts within a few minutes and its effects last for up to 12 hours.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzalkonium chloride

Thiomersal

Sodium chloride

Levomenthol

Cineole

Camphor

Methyl salicylate

Poloxamer 188

Sodium citrate (dihydrate) (E331)

Citric acid (anhydrous) (E330)

Purified water

6.2 Incompatibilities

None

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

White, low density polyethylene/polyethylene copolymer 15ml bottle.

White, high density polyethylene 15ml and 20ml bottle.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Thornton & Ross Ltd

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0343

9. Date Of First Authorisation/Renewal Of The Authorisation

24/01/2007

10. Date Of Revision Of The Text

20/12/2010

11 DOSIMETRY (IF APPLICABLE)

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Not Applicable

Ganite

Generic Name: gallium nitrate (GAL ee um NYE trate)

Brand Names: Ganite

What is Ganite (gallium nitrate)?

Gallium nitrate is a form of nitrate salt.

Gallium nitrate is used to lower blood levels of calcium when they have become dangerously high in cancer patients.

Gallium nitrate may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Ganite (gallium nitrate)?

Before receiving gallium nitrate, tell your doctor if you are allergic to any drugs, if you have heart disease, or if you take diuretics (water pills). If you have any of these conditions, you may need dosage adjustments or special tests during treatment.

Many other drugs can damage the kidneys and should not be used together with gallium nitrate. Tell your doctor if you are receiving chemotherapy, taking an NSAID (non-steroidal anti-inflammatory drug) pain medicine, or using medicines used to treat a bowel disorder, medications to prevent organ transplant rejection, antiviral medications, or any injected antibiotics.

Gallium nitrate must be given as an IV infusion around the clock for up to 5 days, or until blood calcium levels are lowered to a safe level.

During your treatment with gallium nitrate, you may also need to be put on IV fluids to keep you from getting dehydrated.

To be sure this medication is helping your condition, your blood and urine will need to be tested often. This will help your doctor determine how long to treat you with gallium nitrate.

What should I discuss with my health care provider before receiving Ganite (gallium nitrate)?

You should not use this medication if you are allergic to gallium nitrate, or if you have severe kidney disease.

Before receiving gallium nitrate, tell your doctor if you are allergic to any drugs, if you have heart disease, or if you take diuretics (water pills). If you have any of these conditions, you may need dosage adjustments or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant before you receive gallium nitrate. It is not known whether gallium nitrate passes into breast milk or if it could harm a nursing baby. Do not receive this medication before telling your doctor if you are breast-feeding a baby.

How is gallium nitrate given?

Gallium nitrate is given as an injection through a needle placed into a vein. You will receive this injection in a hospital or emergency setting.

Gallium nitrate must be given as an IV infusion around the clock for up to 5 days, or until blood calcium levels are lowered to a safe level.

During your treatment with gallium nitrate, you may also need to be put on IV fluids to keep you from getting dehydrated.

To be sure this medication is helping your condition, your blood and urine will need to be tested often. This will help your doctor determine how long to treat you with gallium nitrate.

What happens if I miss a dose?

Since gallium nitrate is given by a healthcare provider, it is not likely that you will miss a dose.

What happens if I overdose?

Tell your caregivers right away if you think you have received too much of this medicine.

Overdose symptoms may include nausea and vomiting, or urinating less than usual.

What should I avoid while receiving Ganite (gallium nitrate)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you receive gallium nitrate.

Ganite (gallium nitrate) 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. Tell your caregivers right away if you have any of these serious side effects:

• 
  

  increased thirst, swelling in your lower legs;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  pale skin, easy bruising or bleeding;

  
  


• 
  

  blurred vision, headache or pain behind your eyes;

  
  


• 
  

  confusion, hallucinations;

  
  


• 
  

  noisy breathing, feeling short of breath;

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, diarrhea, constipation;

  
  


• 
  

  tired feeling;

  
  


• 
  

  feeling hot or cold;

  
  


• 
  

  numbness or tingling; or

  
  


• 
  

  fast heart rate.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ganite (gallium nitrate)?

Before receiving gallium nitrate, tell your doctor if you are using any of the following drugs:

• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  a steroid such as prednisone;

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


• 
  

  methotrexate (Rheumatrex, Trexal);

  
  


• 
  

  pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;

  
  


• 
  

  medicines used to treat a ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

  
  


• 
  

  medicines used to prevent organ transplant rejection, such as tacrolimus (Prograf);

  
  


• 
  

  IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

  
  


• 
  

  antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

  
  


• 
  

  cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

  
  

Many of these other drugs can damage the kidneys If you are using any of these drugs, you may not be able to receive gallium nitrate, or you may need dosage adjustments or special tests during treatment.

This list is not complete and there may be other drugs that can interact with gallium nitrate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors.

More Ganite resources

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

• Ganite Prescribing Information (FDA)


• Ganite MedFacts Consumer Leaflet (Wolters Kluwer)


• Ganite Monograph (AHFS DI)


• Ganite Advanced Consumer (Micromedex) - Includes Dosage Information


• Gallium Nitrate Professional Patient Advice (Wolters Kluwer)

Compare Ganite with other medications

• Hypercalcemia
• Hypercalcemia of Malignancy

Where can I get more information?

• Your doctor or pharmacist can provide more information about gallium nitrate.

See also: Ganite side effects (in more detail)

Methadose Diluent

1. Name Of The Medicinal Product

Methadose Diluent

Methadone Diluent

2. Qualitative And Quantitative Composition

There is no active ingredient in the product

3. Pharmaceutical Form

Blue solvent for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

For use as a diluent with Methadone Oral Concentrate 10mg/1ml and 20mg/1ml

4.2 Posology And Method Of Administration

For oral administration only.

Dosage recommendations

As required.

4.3 Contraindications

None known

4.4 Special Warnings And Precautions For Use

None given

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

Not applicable

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

None known

4.9 Overdose

Not applicable

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Not applicable

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Propylene Glycol BP, Propyl Hydroxybenzoate BP, Methyl Hydroxybenzoate BP, Patent Blue V (E131), Purified Water BP

6.2 Incompatibilities

None known

6.3 Shelf Life

Shelf life- 2 years

Shelf life after first opening container - 3 months

6.4 Special Precautions For Storage

Store below 25°C but not in a refrigerator

6.5 Nature And Contents Of Container

Amber glass bottle with Aluminium, EPE wadded, roll-on pilfer proof closures or HDPE, EPE wadded, tamper evident child resistant closures or HDPE, EPE wadded, tamper evident closures to contain 200ml, 500ml or 1000ml of product.

6.6 Special Precautions For Disposal And Other Handling

This product is intended for use as a diluent with Methadone Oral Concentrate 10mg/1ml and 20mg/1ml

7. Marketing Authorisation Holder

Rosemont Pharmaceuticals Ltd

Rosemont House

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

8. Marketing Authorisation Number(S)

PL 00427/0099

9. Date Of First Authorisation/Renewal Of The Authorisation

31 January 1996

10. Date Of Revision Of The Text

July 1997

Sulfimycin

Generic Name: erythromycin and sulfisoxazole (ee RITH roe MYE sin and SUL fa SOX i zole)

Brand Names: Pediazole

What is Sulfimycin (erythromycin and sulfisoxazole)?

Erythromycin is in a group of drugs called macrolide antibiotics. Erythromycin fights bacteria in the body.

Sulfisoxazole is a sulfa drug that also fights bacteria in the body.

The combination of erythromycin and sulfisoxazole is used to ear infections in children.

Erythromycin and sulfisoxazole may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Sulfimycin (erythromycin and sulfisoxazole)?

Do not take this medication if you are allergic to erythromycin or sulfisoxazole, if you are in your 9th month of pregnancy, or if you are breast-feeding a baby younger than 2 months old.

Before taking erythromycin and sulfisoxazole, tell your doctor if you have liver or kidney disease, diabetes, myasthenia gravis, a history of "Long QT Syndrome," or if you are allergic to sulfa drugs or other antibiotics such as azithromycin (Zithromax) or clarithromycin (Biaxin).

Take this medication for the full prescribed length of time. Your symptoms may get better before the infection is completely cleared. Erythromycin and sulfisoxazole will not treat a viral infection such as the common cold or flu.

What should I discuss with my healthcare provider before taking Sulfimycin (erythromycin and sulfisoxazole)?

Do not take this medication if you are allergic to erythromycin or sulfisoxazole, or if::

• 
  

  you are in your 9th month of pregnancy; or

  
  


• 
  

  you are breast-feeding a baby younger than 2 months old.

  
  

Erythromycin may interact with these medicines and could cause dangerous or life-threatening heart rhythm disorders.

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

• kidney disease;


• 
  

  liver disease;

  
  


• 
  

  diabetes;

  
  


• 
  

  myasthenia gravis;

  
  


• 
  

  a history of "Long QT Syndrome"; or

  
  


• 
  

  if you are allergic to sulfa drugs or other antibiotics such as azithromycin (Zithromax) or clarithromycin (Biaxin).

  
  

FDA pregnancy category C. It is not known whether erythromycin and sulfisoxazole is harmful to an unborn baby when taken in early pregnancy. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Do not take erythromycin and sulfisoxazole during late pregnancy. Erythromycin and sulfisoxazole can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not take erythromycin and sulfisoxazole if you are breast-feeding a baby younger than 2 months old. Older adults may be more likely to have side effects from this medication. Do not give this medication to a child younger than 2 months old.

How should I take Sulfimycin (erythromycin and sulfisoxazole)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take erythromycin and sulfisoxazole with a full glass (8 ounces) of water. Drink plenty of fluids every day while taking this medication.

Take this medication with food or milk if it upsets your stomach.

Shake the liquid medicine well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Erythromycin and sulfisoxazole is usually given 3 or 4 times daily. Try to take the medicine at evenly spaced intervals throughout the day.

Take this medication for the full prescribed length of time. Your symptoms may get better before the infection is completely cleared. Erythromycin and sulfisoxazole will not treat a viral infection such as the common cold or flu. If you need to have any type of surgery, tell the surgeon ahead of time that you are using erythromycin and sulfisoxazole. You may need to stop using the medicine for a short time.

Erythromycin and sulfisoxazole can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using erythromycin.

Store this medication in the refrigerator. Do not freeze. Throw away any unused medicine that is older than 14 days

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. 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 dizziness, drowsiness, loss of appetite, nausea, vomiting, diarrhea, ringing in your ears, headache, stomach pain, fever, and fainting.

What should I avoid while taking Sulfimycin (erythromycin and sulfisoxazole)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, stop taking this medication and call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Avoid exposure to sunlight, sunlamps, or tanning beds. Erythromycin and sulfisoxazole can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors.

Sulfimycin (erythromycin and sulfisoxazole) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  dizziness, fainting, fast or pounding heartbeat;

  
  


• 
  

  diarrhea that is watery or bloody;

  
  


• 
  

  confusion, hallucinations;

  
  


• 
  

  muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;

  
  


• 
  

  white patches or sores inside your mouth or on your lips;

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  
  


• 
  

  the first sign of any skin rash, no matter how mild;

  
  


• 
  

  pale skin, easy bruising or bleeding;

  
  


• 
  

  ringing in your ears, or problems with hearing;

  
  


• 
  

  numbness or tingly feeling in your hands or feet;

  
  


• 
  

  sore throat, swelling or lump in your throat or neck;

  
  


• 
  

  cough, feeling short of breath;

  
  


• 
  

  blood in your urine, pain in your side or lower back, pain when you urinate;

  
  


• 
  

  urinating less than usual or not at all; or

  
  


• 
  

  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:

• 
  

  mild nausea, vomiting, diarrhea, or stomach pain;

  
  


• 
  

  headache, mild dizziness, spinning sensation; or

  
  


• 
  

  vaginal itching or discharge.

  
  

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 Sulfimycin (erythromycin and sulfisoxazole)?

Many drugs can interact with erythromycin. Below is just a partial list. Tell your doctor if you are using:

• 
  

  bromocriptine (Parlodel);

  
  


• 
  

  colchicine (Colcrys);

  
  


• 
  

  alprazolam (Xanax), midazolam (Versed), or triazolam (Halcion);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  digoxin (Lanoxin);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  antifungal medication such as itraconazole (Sporanox), fluconazole (Diflucan), ketoconazole (Nizoral), or voriconazole (Vfend);

  
  


• 
  

  any other antibiotic, especially clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), levofloxacin (Levaquin), moxifloxacin (Avelox), or rifabutin (Mycobutin);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  diabetes medication you take by mouth;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  a cholesterol-lowering medication such as lovastatin (Mevacor) or simvastatin (Zocor);

  
  


• 
  

  heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), dofetilide (Tikosyn), felodipine (Plendil), nifedipine (Nifedical, Procardia), sotalol (Betapace), or verapamil (Calan, Covera, Isoptin, Verelan);

  
  


• 
  

  heart rhythm medicine such as disopyramide (Norpace), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quinidex, Quin-Release Quin-G);

  
  


• 
  

  migraine headache medicine such as eletriptan (Relpax), ergotamine (Ercaf, Cafergot, Ergostat, Ergomar) or dihydroergotamine (D.H.E. 45, Migranal); or

  
  


• 
  

  seizure medication such as carbamazepine (Tegretol), phenytoin (Dilantin), or valproic acid (Depakote, Depakene).

  
  

This list is not complete and there are many other drugs that can interact with erythromycin and sulfisoxazole. 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. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Sulfimycin resources

• Sulfimycin Use in Pregnancy & Breastfeeding
• Sulfimycin Drug Interactions
• Sulfimycin Support Group
• 0 Reviews for Sulfimycin - Add your own review/rating

• Eryzole Advanced Consumer (Micromedex) - Includes Dosage Information


• Pediazole MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Sulfimycin with other medications

• Otitis Media

Where can I get more information?

• Your pharmacist can provide more information about erythromycin and sulfisoxazole.