Triam-Forte

Generic Name: triamcinolone (Injection route)

trye-am-SIN-oh-lone

Commonly used brand name(s)

In the U.S.

• Aristocort


• Aristocort Forte


• Aristospan


• Clinacort


• Kenalog-10


• Kenalog-40


• Triamcot


• Triam-Forte


• Triesense

Available Dosage Forms:

• Suspension

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Triam-Forte

Triamcinolone injection is used to treat inflammation (swelling), allergic reactions, certain types of arthritis, gout, skin diseases, and many other medical problems. It is given to patients who are not able to take medicines by the mouth. This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

Before Using Triam-Forte

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of triamcinolone injection in the pediatric population. However, because of this medicine's toxicity, it should be used with caution especially in premature babies.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of triamcinolone injection in the elderly.

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 this medicine, 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 this medicine 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 this medicine 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.

• Aldesleukin


• Quetiapine

Using this medicine 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.

• Alatrofloxacin


• Alcuronium


• Aspirin


• Atracurium


• Balofloxacin


• Cinoxacin


• Ciprofloxacin


• Clinafloxacin


• Enoxacin


• Fleroxacin


• Flumequine


• Gallamine


• Gemifloxacin


• Grepafloxacin


• Hexafluorenium


• Itraconazole


• Levofloxacin


• Licorice


• Lomefloxacin


• Metocurine


• Moxifloxacin


• Norfloxacin


• Ofloxacin


• Pefloxacin


• Phenytoin


• Primidone


• Prulifloxacin


• Rosoxacin


• Rufloxacin


• Saiboku-To


• Sparfloxacin


• Temafloxacin


• Tosufloxacin


• Trovafloxacin Mesylate

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone problems (e.g., osteoporosis) or


• Cataracts or


• Cirrhosis (liver problem) or


• Congestive heart failure or


• Depression or


• Emotional problems or


• Glaucoma or


• Heart attack, recent or


• Heart disease or


• Hypertension (high blood pressure) or


• Intracranial hypertension (increased pressure in the head) or


• Kaposi's sarcoma or


• Kidney disease, severe or


• Mental illness or


• Myasthenia gravis (severe muscle weakness) or


• Stomach or bowel problems (e.g., diverticulitis, ulcers, ulcerative colitis) or


• Thyroid problems—Use with caution. May make these conditions worse.

• Brain injury, traumatic or


• Cerebral malaria or


• Herpes infection of the eye or


• Idiopathic thrombocytopenic purpura (low platelet count)—Should not be used in patients with this condition.

• Infection (bacteria, virus, fungus, parasite, or protozoa)—May decrease your body's ability to fight infection.

• Tuberculosis infection, inactive—Should be treated first before starting therapy with this medicine.

Proper Use of triamcinolone

This section provides information on the proper use of a number of products that contain triamcinolone. It may not be specific to Triam-Forte. Please read with care.

A nurse or other trained health professional will give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot into one of your muscles, a joint, or a spot on your skin called a lesion.

Precautions While Using Triam-Forte

Your doctor will check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine contains benzyl alcohol which may cause serious reactions (e.g., gasping syndrome, low blood pressure, and metabolic acidosis) to newborn or premature infants. Discuss this with your doctor if you are concerned.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after receiving this medicine.

Let your doctor know if you or your child have any events causing unusual stress or anxiety in your life. Your doctor may give you oral corticosteroids.

This medicine may cause fluid retention (edema) in some patients. Carefully follow your doctor's instructions about any special diet (especially on salt intake).

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and for patients who use large amounts for a long time. Talk to your doctor if you have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, pounding, or uneven heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

It may be easier for you to get an infection while you or your child are receiving triamcinolone. Avoid crowded places or being near people who are sick. If you are exposed to chicken pox or measles, tell your doctor right away.

Tell your doctor if you or your child have recently spent time in a tropical climate or have unexplained diarrhea before receiving this medicine.

Talk with your doctor before getting flu shots or other vaccines while you or your child are receiving this medicine because there are certain vaccines that you should not receive.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Before you have any skin tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not stop using this medicine without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.

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.

Triam-Forte 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

• Aggression


• agitation


• anxiety


• blurred vision


• decrease in the amount of urine


• dizziness


• fast, slow, pounding, or irregular heartbeat or pulse


• headache


• irritability


• mental depression


• mood changes


• nervousness


• noisy, rattling breathing


• numbness or tingling in the arms or legs


• pounding in the ears


• shortness of breath


• swelling of the fingers, hands, feet, or lower legs


• trouble thinking, speaking, or walking


• troubled breathing at rest


• weight gain

Incidence not known

• Abdominal cramping and/or burning (severe)


• abdominal pain


• backache


• bloody, black, or tarry stools


• cough or hoarseness


• darkening of skin


• decreased vision


• diarrhea


• dry mouth


• eye pain


• eye tearing


• facial hair growth in females


• fainting


• fatigue


• fever or chills


• flushed, dry skin


• fractures


• fruit-like breath odor


• full or round face, neck, or trunk


• heartburn and/or indigestion (severe and continuous)


• increased hunger


• increased thirst


• increased urination


• loss of appetite


• loss of sexual desire or ability


• lower back or side pain


• menstrual irregularities


• muscle pain or tenderness


• muscle wasting or weakness


• nausea


• pain in back, ribs, arms, or legs


• painful or difficult urination


• skin rash


• sleeplessness


• sweating


• trouble healing


• trouble sleeping


• unexplained weight loss


• unusual tiredness or weakness


• vision changes


• vomiting


• vomiting of material that looks like coffee grounds

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:

Incidence not known

• Blemishes on the skin


• bruising


• dry, scaly skin


• feeling of constant movement of self or surroundings


• full or bloated feeling


• increased appetite


• increased hair growth on the face, forehead, back, arms, and legs


• large, flat, blue, or purplish patches in the skin


• pimples


• pitting or depression of the skin at the injection site


• reddish purple lines on the arms, face, legs, trunk, or groin


• redness of the skin


• redness, swelling, tenderness, or pain at the injection site


• sensation of spinning


• small, red, or purple spots on the skin


• thin, fragile, or shiny skin


• thinning of the scalp hair

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.

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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Triam-Forte resources

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

• Triamcinolone Prescribing Information (FDA)


• Triamcinolone Professional Patient Advice (Wolters Kluwer)


• Triamcinolone Monograph (AHFS DI)


• Aristocort MedFacts Consumer Leaflet (Wolters Kluwer)


• Aristocort Prescribing Information (FDA)


• Azmacort Consumer Overview


• Azmacort Prescribing Information (FDA)


• Azmacort Aerosol MedFacts Consumer Leaflet (Wolters Kluwer)


• Kenalog-10 Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Kenalog-10 Prescribing Information (FDA)


• Kenalog-40 Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Kenalog-40 Prescribing Information (FDA)

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Nurofen Extra Strength 400mg Tablets

1. Name Of The Medicinal Product

Nurofen Extra Strength 400 mg Tablets

2. Qualitative And Quantitative Composition

Ibuprofen 400 mg. For excipients, see 6.1

3. Pharmaceutical Form

Coated Tablet

A white to off-white, biconvex, round, sugar coated tablet printed with an identifying logo in red on one face.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of migraine-headaches, backache, dental pain, neuralgia and period pains as well as rheumatic and muscular pains, and pain of non-serious arthritic conditions.

Nurofen relieves pain and reduces inflammation and temperature as well as relieving headaches and other types of pain. It also relieves cold and flu symptoms.

4.2 Posology And Method Of Administration

For oral administration and short-term use only.

Adults and children over 12 years: Initial dose one tablet taken with water, then if necessary, one tablet every four hours. Do not exceed three tablets in any 24 hours. Not for use by children under 12 years of age without medical advice.

Elderly: No special dosage modifications are required.

The minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days or if symptoms persist or worsen, the patient should consult a doctor.

Leave at least four hours between doses and do not take more than 1200 mg in any 24 hour period.

4.3 Contraindications

Hypersensitivity to ibuprofen or any of the constituents in the product.

Patients who have previously shown hypersensitivity reactions (eg asthma, rhinitis, angioedema or urticaria) in response to aspirin or other NSAIDs. Active or previous peptic ulcer. History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.

Use with concomitant NSAIDS including cycloxygenase-2 specific inhibitors (see section 4.5 Interactions). Severe hepatic failure, renal failure or heart failure (see section 4.4, Special Warnings and Precautions for Use). Last trimester of pregnancy (see section 4.6 Pregnancy and Lactation).

4.4 Special Warnings And Precautions For Use

Bronchospasm may be precipitated in patients suffering from, or with a previous history of, bronchial asthma or allergic disease.

Undesirable effects may be minimised by using the minimum effective dose for the shortest possible duration.

The elderly are at increased risk of serious consequences of adverse reactions.

Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8 Undesirable Effects).

Chronic inflammatory intestinal disease (ulcerative colitis, Crohn's disease)- as these conditions may be exacerbated (see section 4.8 Undesirable effects).

Hypertension and/or cardiac impairment since renal function may deteriorate and/or fluid retention occur.

Renal impairment as renal function may further deteriorate (see section 4.3 Contraindications and section 4.8 Undesirable effects).

Hepatic dysfunction (see section 4.3 Contraindications and section 4.8 Undesirable effects).

There is limited evidence that drugs which inhibit cyclo-oxygenase/prostaglandins synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.

Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAID's at anytime during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.

Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of gastrotoxicity or bleeding, such as corticosteroids, or anticoagulants such as warfarin or anti-platelet agents such as aspirin (see section 4.5 Interactions).

Where gastrointestinal bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

The label will include:

Read the enclosed leaflet before taking this product Do not take if you have or have ever had a stomach ulcer, perforation or bleeding or are allergic to ibuprofen or any of the ingredients of the product, aspirin or other related painkillers are taking other NSAID painkillers, or aspirin with a daily dose above 75 mg are in the last 3 months of pregnancy

Speak to your doctor or pharmacist before taking this product if you have asthma, liver, heart, kidney or bowel problems are in the first 6 months of pregnancy

If symptoms persist or worsen consult your doctor.

Do not exceed the stated dose. Keep out of the reach and sight of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Ibuprofen (like other NSAIDs) should not be used in combination with:

aspirin unless low-dose aspirin (not above 75 mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (see section 4.3 Contraindications).

Other NSAIDs. This may result in an increased incidence of adverse reactions (see section 4.3 Contraindications). Ibuprofen should be used with caution in combination with:

Antihypertensives and diuretics: NSAIDs may diminish the effects of these drugs. Anti-coagulants. NSAIDs may enhance the effects of anticoagulants such as warfarin (see section 4.4 Special warnings).

Corticosteriods may increase the risk of adverse reactions in the gastrointestinal tract (see section 4.4 Special warnings). Lithium: there is evidence for potential increases in plasma levels of lithium.

Methotrexate. There is a potential for an increase in plasma levels methotrexate. Zidovudine: There is evidence of an increased risk of haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

4.6 Pregnancy And Lactation

Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Nurofen during pregnancy should, if possible, be avoided during the first 6 months of pregnancy.

During the 3^rd trimester, ibuprofen is contraindicated as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and duration of labour increased with an increased bleeding tendency in both mother and child (see section 4.3 Contraindications).

In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.

See section 4.4 regarding female fertility.

4.7 Effects On Ability To Drive And Use Machines

None expected at recommended doses and duration of therapy.

4.8 Undesirable Effects

Hypersensitivity reactions have been reported and these may consist of non-specific allergic reactions and anaphylaxis respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm, dyspnoea various skin reactions e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme)

The list of the following adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.

Hypersensitivity Uncommon: Hypersensitivity reactions with Reactions urticaria and pruritus.

Very rare: Severe hypersensitivity reactions. Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock).

Exacerbation of asthma and bronchospasm.

Gastrointestinal Disorders	Uncommon:	Abdominal pain, dyspepsia and nausea.
	Rare:	Diarrhoea, flatulence, constipation and vomiting.
	Very rare:	Peptic ulcer, perforation or gastrointestinal haemorrhage, sometimes fatal, particularly in the elderly (see section 4.4 Special warnings). Exacerbation of ulcerative colitis and Crohn's disease (see section 4.4 Special warnings).
Nervous System	Uncommon:	Headache.
Renal	Very rare:	Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea concentrations and oedema.
Hepatic	Very rare:	Liver disorders.
Haematological	Very rare:	Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
Skin	Uncommon:	Various skin rashes.
	Very rare:	Severe forms of skin reactions such as erythema multiforme and epidermal necrolysis can occur.
Immune System		In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see section 4.4 Special warnings).

4.9 Overdose

In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5 - 3 hours.

Symptoms – Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or, more rarely, diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning, metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management – Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans, ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.

ATC Code: M01A E01

5.2 Pharmacokinetic Properties

Ibuprofen is well absorbed from the gastrointestinal tract. Ibuprofen is extensively bound to plasma proteins.

Peak serum concentration occurs approximately 1-2 hours after administration.

Ibuprofen is metabolised in the liver to two major metabolites with primary excretion via the kidneys, either as such or as major conjugates, together with a negligible amount of unchanged ibuprofen. Excretion by the kidney is both rapid and complete.

Elimination half-life is approximately 2 hours.

No significant differences in pharmacokinetic profile are observed in the elderly.

5.3 Preclinical Safety Data

There are no preclinical safety data of relevance to the consumer.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet Core Croscarmellose Sodium Sodium Laurilsulfate Sodium Citrate Stearic Acid Colloidal Anhydrous Silica Sugar Coat Ingredients Carmellose Sodium Calcium Sulphate Dihydrate Acacia Spray Dried Sucrose Titanium Dioxide Carnauba Wax Powder Purified Water Tablet Printing Ink Opacode S-1-9460 HV Brown (solids)¹ Industrial Methylated Spirit ¹ Opacode S-1-8152 HV Brown contains the following residual materials after application:

Shellac USNF 28.877%

Iron oxide red (E172) 25.000%

Soya lecithin 1.000%

Simethicone 0.005%

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

PVC blister pack only – Do not store above 30°C.

Store in the original pack. PVC/PVDC Blister:

Store in the original pack. HDPE bottle: Store in the original pack.

6.5 Nature And Contents Of Container

The tablets will be packed in blisters consisting of:

Push through laminate consisting of opaque, white 250 micron PVC heat-sealed to 20 micron aluminium foil

Or

Push through laminate consisting of opaque, white 250 micron PVC with 40 gsm PVdC, heat-sealed to 20 micron aluminium foil.

The blisters are contained in a cardboard carton.

2, 3, 4, 5, 8, 10, 12, 15, 16, 18, 20, 24, 28, 32 or 48 tablets. Not all packs will be marketed.

Or

High density polyethylene bottle with a child resistant cap that is internally wadded with expanded polyethylene. 96 tablets. Not all packs will be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Crookes Healthcare Limited

1 Thane Road

West Nottingham

NG2 3AA

8. Marketing Authorisation Number(S)

PL 00327/0184

9. Date Of First Authorisation/Renewal Of The Authorisation

20/02/2007

10. Date Of Revision Of The Text

20/02/2007

Cedax

Generic Name: Ceftibuten
Class: Third Generation Cephalosporins
Molecular Formula: C₁₅H₁₄N₄O₆S₂
CAS Number: 97519-39-6

Introduction

Antibacterial; β-lactam antibiotic; third generation cephalosporin.^{1 3}

Uses for Cedax

Otitis Media

Treatment of acute otitis media (AOM) caused by H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes (group A β-hemolytic streptococci).^{1 2 3 5 7 8 42} (See Acute Otitis Media under Cautions.)

Management of otitis media with effusion†.³⁶ Use of anti-infectives controversial; they provide only limited benefit in enhancing resolution of effusion and may promote resistance.^{36 49 50 51 52 67 68}

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci).^{1 2 16} Generally effective in eradicating S. pyogenes from the nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not been established to date.¹

CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;^{12 13 25 53} oral cephalosporins and oral macrolides considered alternatives.^{12 13 25 53} Amoxicillin sometimes used instead of penicillin V, especially for young children.^{13 53}

Respiratory Tract Infections

Treatment of acute bacterial exacerbations of chronic bronchitis caused by Streptococcus pneumoniae (penicillin-susceptible strains only), Haemophilus influenzae (including β-lactamase-producing strains), or Moraxella catarrhalis (including β-lactamase-producing strains).^{1 2 9 26 37}

Treatment of acute maxillary sinusitis† caused by susceptible S. pneumoniae, H. influenzae, or M. catarrhalis.^{3 45}

Treatment of acute bronchitis†,^{3 26 27 46} bronchiectasis†,⁴⁷ or pneumonia†^{3 46 47} caused by susceptible bacteria.

Urinary Tract Infections (UTIs)

Treatment of uncomplicated UTIs† caused by susceptible Escherichia coli, Klebsiella, Proteus mirabilis, Enterobacter, or staphylococci.^{3 63 64}

Treatment of complicated or recurrent UTIs† caused by susceptible E. coli, Klebsiella, P. mirabilis, Enterobacter, or staphylococci.^{3 63 64}

Cedax Dosage and Administration

Administration

Oral Administration

Administer capsules orally without regard to meals.^{1 17}

Administer oral suspension at least 2 hours before or 1 hour after meals.^{1 2}

Reconstitution

Reconstitute oral suspension at time of dispensing by adding the amount of water specified on the container in 2 portions; invert bottle and shake after each addition.¹

Dosage

Available as ceftibuten dihydrate; dosage expressed in terms of anhydrous ceftibuten.¹

Pediatric Patients

Otitis Media

Acute Otitis Media (AOM)

Oral

Children 6 months through 11 years of age: 9 mg/kg (up to 400 mg) once daily for 10 days.¹

Children ≥12 years of age: 400 mg once daily for 10 days.^{1 3}

Pediatric Dosage of Ceftibuten Oral Suspension for AOM1

Weight (kg)	Daily Dosage
10	90 mg once daily1
20	180 mg once daily1
40	360 mg once daily1
>45	400 mg once daily1

Otitis Media with Effusion†

Oral

Children 7 months to 12 years of age: 9 mg/kg (up to 400 mg) once daily for 14 days.³⁶

Pharyngitis and Tonsillitis

Oral

Children 6 months through 11 years of age: 9 mg/kg (up to 400 mg) once daily for 10 days.¹

Children ≥12 years of age: 400 mg once daily for 10 days.¹

Pediatric Dosage of Ceftibuten Oral Suspension for Pharyngitis and Tonsillitis1

Weight (kg)	Daily Dosage
10	90 mg once daily1
20	180 mg once daily1
40	360 mg once daily1
>45	400 mg once daily1

Respiratory Tract Infections

Acute Exacerbations of Chronic Bronchitis

Oral

Children ≥12 years of age: 400 mg once daily for 10 days.^{1 3}

Adults

Acute Otitis Media (AOM)

Oral

400 mg once daily for 10 days.^{1 3}

Pharyngitis and Tonsillitis

Oral

400 mg once daily for 10 days.^{1 3}

Respiratory Tract Infections

Acute Exacerbations of Chronic Bronchitis

Oral

400 mg once daily for 10 days.^{1 3}

Uncomplicated UTIs†

Oral

400 mg once daily for 7 days.⁶⁴

Prescribing Limits

Pediatric Patients

Oral

Maximum 400 mg once daily for children 6 months through 11 years of age.¹

Adults

Oral

Maximum 400 mg once daily.¹

Special Populations

Hepatic Impairment

No dosage adjustments required.¹

Renal Impairment

Dosage for Renal Impairment1

Clcr (mL/min)	Daily Dosage
>50	9 mg/kg or 400 mg once every 24 hours1
30–49	4.5 mg/kg or 200 mg once every 24 hours1 4
5–29	2.25 mg/kg or 100 mg once every 24 hours1 4

For patients undergoing hemodialysis 2 or 3 times weekly, a single 400-mg dose (given as a capsule) or 9 mg/kg (up to 400 mg; given as the oral suspension) may be given at the end of each dialysis period.^{1 5}

Geriatric Patients

No dosage adjustments required other than those related to renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Cautions for Cedax

Contraindications

• 
  

  Known hypersensitivity to ceftibuten or other cephalosporins.¹

  
  

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible organisms (e.g., Enterobacter, Pseudomonas, enterococci, Candida) with prolonged use.^a Careful observation of the patient is essential.¹ Institute appropriate therapy if superinfection occurs.^{1 a}

Treatment with anti-infectives may permit overgrowth of Clostridium difficile.¹ C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including ceftibuten, and may range in severity from mild diarrhea to fatal colitis.¹

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.¹ Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.

If CDAD is suspected or confirmed, the anti-infective may need to be discontinued. Some mild cases may respond to discontinuance alone.¹ Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.¹

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity reactions such as urticaria, pruritus, rash (maculopapular, erythematous, morbilliform), fever and chills, eosinophilia, joint pain or inflammation, edema, erythema, genital and anal pruritus, angioedema, shock, hypotension, vasodilatation, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis, and anaphylaxis.^a

If hypersensitivity reaction occurs, discontinue ceftibuten and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).¹

Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.^{1 43}

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to any cephalosporins or penicillins.¹ Cautious use recommended in individuals hypersensitive to penicillins:^a avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction^{1 43 44} and administer with caution to those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.^a

General Precautions

Diabetes Mellitus

Reconstituted oral suspension contains 1 g of sucrose per 5 mL.¹

Acute Otitis Media

Possibly less effective than some other β-lactam antibiotics for the treatment of AOM caused by S. pneumoniae.^{1 2 7} Use for empiric therapy only when adequate antimicrobial coverage against S. pneumoniae has been previously administered.^{1 2}

History of GI Disease

Use with caution in patients with a history of GI disease, particularly colitis.¹ (See Superinfection/Clostridium difficile-associated Colitis under Cautions.)

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether distributed into milk;¹ use with caution.¹

Pediatric Use

Safety and efficacy not established in children <6 months of age.¹

Increased incidence of diarrhea in pediatric patients ≤2 years of age compared with older pediatric patients.¹

Geriatric Use

Increased peak plasma concentrations and half-life may be due to age-related changes in renal function.^{1 3 5 17} Adjust dosage based on the degree of renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Hepatic Impairment

Pharmacokinetics not altered; dosage adjustments not required.^{1 3}

Renal Impairment

Increased plasma half-life and decreased total body clearance.^{1 4}

Use with caution and reduce dosage.^a (See Renal Impairment under Dosage and Administration.)

Careful clinical observation and renal function tests recommended prior to and during cephalosporin therapy.^a

Common Adverse Effects

GI effects (e.g., nausea, diarrhea, dyspepsia, vomiting, abdominal pain), headache, dizziness, increased BUN concentrations, eosinophilia.^{1 3 5 34}

Interactions for Cedax

Specific Drugs

Drug	Interaction
Antacids	No known pharmacokinetic interaction1
Histamine H2-receptor antagonists (ranitidine)	Potential for increased ceftibuten concentrations1
Theophylline	No evidence of pharmacokinetic interaction with IV theophylline;1 effects of concomitant oral theophylline unknown

Cedax Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed following oral administration.^{1 5 28 29 31} Oral bioavailability is 75–90%.⁵

In adults, a 400-mg ceftibuten dose given as the oral suspension is bioequivalent to a 400-mg dose given as 400-mg capsules.⁴⁰

Food

Food decreases rate and extent of absorption of ceftibuten; this effect is more pronounced with the oral suspension than with capsules.^{1 2 31}

Distribution

Extent

Distributed into blister fluid,³¹ bronchial secretions,^{1 31 33} nasal secretions,³¹ sputum,¹ middle ear fluid,^{1 31 32} tracheal secretions,³¹ and tonsillar tissue.⁴¹

Not known whether the drug crosses the placenta or is distributed into milk.^{1 66}

Plasma Protein Binding

Approximately 65%.¹

Elimination

Metabolism

Ceftibuten is present in plasma and urine principally as cis-ceftibuten; about 10% of a dose is converted in vivo to trans-ceftibuten.^{1 29} The trans-isomer has only about 12% of the antibacterial activity of the cis-isomer.^{1 30}

Elimination Route

The cis- and trans-isomers of ceftibuten eliminated principally in urine.^{1 29 30} Approximately 56% of a dose eliminated in urine and 39% excreted in feces within 24 hours.¹

Half-life

Adults with normal renal function: 2–2.6 hours.^{1 29 30 31}

Children 6 months to 16 years of age: 1.9–2.5 hours.^{31 35}

Special Populations

In renal impairment, plasma half-life averages 7.1–22.3 hours depending on creatinine clearance.¹

Stability

Storage

Oral

Capsules

Tight container at 2–25°C.¹

For Suspension

2–25°C.¹ Following reconstitution, store suspension at 2–8°C for up to 14 days.¹

Actions and SpectrumActions

• 
  

  Third generation cephalosporin with an expanded spectrum of activity against aerobic gram-negative bacteria compared with first and second generation cephalosporins.^{3 5}

  
  


• 
  

  Usually bactericidal.^a

  
  


• 
  

  Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.^a

  
  


• 
  

  In vitro spectrum of activity includes some gram-positive aerobic bacteria and some gram-negative aerobic bacteria; inactive against most anaerobes; inactive against fungi and viruses.^{3 19 a}

  
  


• 
  

  Gram-positive aerobes: active in vitro and in clinical infections against Streptococcus pneumoniae (penicillin-susceptible strains only) and S. pyogenes (group A β-hemolytic streptococci).¹ Inactive against other streptococci, staphylococci, and enterococci (e.g., Enterococcus faecalis).^{3 19 a}

  
  


• 
  

  Gram-negative aerobes: active in vitro and in clinical infections against Haemophilus influenzae (including β-lactamase-producing strains) and Moraxella catarrhalis (including β-lactamase-producing strains).¹ Inactive against Pseudomonas aeruginosa.^{1 3 5 19 22 23}

  
  


• 
  

  Stable in the presence of a variety of plasmid-mediated β-lactamases produced by gram-positive and gram-negative bacteria;^{1 2 3 5 7 8 19 20 21 22 23} more active in vitro than other currently available oral third generation cephalosporins against Enterobacteriaceae that produce plasmid-mediated β-lactamases.^{3 5 7 19 20 21 22 23} Unstable in the presence of chromosomally-mediated cephalosporinases.¹

  
  


• 
  

  Strains of staphylococci resistant to penicillinase-resistant penicillins (oxacillin-resistant [methicillin-resistant] staphylococci) should be considered resistant to ceftibuten, although results of in vitro susceptibility tests may indicate that the organisms are susceptible to the drug.²⁴

  
  

Advice to Patients

• 
  

  Importance of administering oral suspension at least 2 hours before or 1 hour after meals.^{1 2} Capsules may be administered without regard to meals.^{1 17}

  
  


• 
  

  Importance of completing full course of therapy.¹

  
  


• 
  

  Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.

  
  


• 
  

  Importance of discontinuing ceftibuten and informing clinician if an allergic reaction occurs.¹

  
  


• 
  

  For patients with diabetes, importance of being informed of sucrose content of oral suspension.¹

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Ceftibuten Dihydrate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	400 mg (of anhydrous ceftibuten)	Cedax	Shionogi
	For suspension	90 mg (of anhydrous ceftibuten) per 5 mL	Cedax	Shionogi

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Cedax 400MG Capsules (PERNIX THERAPEUTICS): 20/$299.99 or 60/$859.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Shionogi USA. Cedax (ceftibuten) capsules and oral suspension prescribing information. Florham Park, NJ; 2004 Aug.

2. Schering Corporation. Cedax profile. Kenilworth, NJ.

3. Wiseman LR, Balfour JA. Ceftibuten: a review of its antibacterial activity, pharmacokinetic properties and clinical efficacy. Drugs. 1994; 47:784-808. [PubMed 7520858]

4. Kelloway JS, Awni WM, Lin CC et al. Pharmacokinetics of ceftibuten-cis and its trans metabolite in healthy volunteers and in patients with chronic renal insufficiency. Antimicrob Agents Chemother. 1991; 35:2267-74. [IDIS 295994] [PubMed 1803999]

5. Spector S. Review of the properties and features of ceftibuten: a new orally active antibiotic. Infect Dis Clinical Pract. 1995; 4(Suppl 2): S113-23.

6. Klein JO. Selection of oral antimicrobial agents for otitis media and pharyngitis. Infect Dis Clin Pract. 1995; 4(Suppl 2):S88-94.

7. Blumer JL, McLinn SE, Deabate CA et al. Multinational multicenter controlled trial comparing ceftibuten with cefaclor for the treatment of acute otitis media. Pediatr Infect Dis J. 1995; 14(Suppl):S115-20. [IDIS 349762] [PubMed 7567311]

8. McLinn SE, McCarty JM, Perrotta R et al. Multicenter controlled trial comparing ceftibuten with amoxicillin/clavulanate in the empiric treatment of acute otitis media. Pediatr Infect Dis J. 1995; 14(Suppl):S108-14.

9. Bensch GW, Klaustermeyer WB, McCarty J et al. Efficacy and safety of once-daily ceftibuten vs. twice-daily ciprofloxacin in the treatment of acute exacerbation of chronic bronchitis. Infect Dis Clin Pract. 1995; 4(Suppl 2): S80-7.

10. Chin NX, Huang HB, Neu HC. Postantibiotic effect of ceftibuten on respiratory pathogens. Pediatr Infect Dis J. 1995; 14(Suppl):S84-7.

11. Neu HC. Ceftibuten: minimal inhibitory concentration, postantibiotic effect and beta-lactamase stability—a rationale for dosing programs. Pediatr Infect Dis J. 1995; 14:S88-92.

12. Dajani A, Taubert K, Ferrieri P et al and the American Heart Association Committee on Rheumatic Fever et al. Treatment of acute streptococcal pharyngitis and prevention of rheumatic fever: a statement for health professionals. Pediatrics. 1995; 96:758-64. [IDIS 355409] [PubMed 7567345]

13. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006:755.

14. Bisno AL. Streptococcus pyogenes. In: Mandell GL, Bennett JE, Dolin R, eds. Principles and practice of infectious diseases. 4th ed. New York: Churchill Livingstone; 1995:1786-99.

15. Anon. Choice of antibacterial drugs. Med Lett Treat Guid. 2004; 2:15-16.

16. Pichichero ME, McLinn SE, Gocch WM III et al. Ceftibuten vs. penicillin V in group A beta-hemolytic streptococcal pharyngitis. Pediatr Infect Dis J. 1995; 14(Suppl):S102-7.

17. Schering Corporation, Kenilworth, NJ: Personal communication.

19. Bauernfeind A, Jungwirth R. Antibacterial activity of cefpodoxime in comparison with cefixime, cefdinir, cefetamet, ceftibuten, loracarbef, cefprozil, BAY 3522, cefuroxime, cefaclor, and cefadroxil. Infection. 1991; 19:353-62. [PubMed 1800377]

20. Bauernfeind A. Ceftibuten and bactericidal kinetics: comparative in vitro activity against Enterobacteriaceae producing extended spectrum beta-lactamases. Diagn Microbiol Infect Dis. 1991; 14:89-92. [PubMed 2013215]

21. Bauernfeind A. Comparative antimicrobial spectrum and activity of ceftibuten against clinical isolates from West Germany. Diagn Microbiol Infect Dis. 1991; 14:63-74. [PubMed 2013211]

22. Jones RN. Ceftibuten: a review of antimicrobial activity, spectrum and other microbiologic features. Pediatr Infect Dis J. 1995; 14:S77-83. [IDIS 349756] [PubMed 7567314]

23. Jones RN, Barry AL. Antimicrobial activity, spectrum, and recommendations for disk diffusion susceptibility testing of ceftibuten (7432-S; SCH 39720), a new orally administered cephalosporin. Antimicrob Agents Chemother. 1988; 32:1576-82. [IDIS 246913] [PubMed 3190185]

24. Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing; sixteenth informational supplement. CLSI document M100-S16. Wayne, PA; 2006.

25. Cooper RJ, Hoffman JR, Bartlett JG et al. Principles of appropriate antibiotic use for acute pharyngitis in adults: background. Ann Intern Med. 2001; 134:509-17. [IDIS 460578] [PubMed 11255530]

26. Perotta R, McCabe R, Rumans L et al. Comparison of the efficacy and safety of ceftibuten and cefaclor in the treatment of acute bacterial bronchitis. Infect Dis Clin Pract. 1994; 3:270-6.

27. Chirurgi VA, Edelstein H, Oster SE et al. Ceftibuten versus cefaclor for the treatment of bronchitis. J Antimicrob Chemother. 1991; 28:577-80. [PubMed 1761452]

28. Bressolle F, Galtier M, Kinowski JM et al. Multiple-dose pharmacokinetics of ceftibuten after oral administration to healthy volunteers. J Pharm Sci. 1994; 83:1236-40. [IDIS 334891] [PubMed 7830237]

29. Lin C, Lim J, Radwanski E et al. Pharmacokinetics and dose proportionality of ceftibuten in men. Antimicrob Agents Chemother. 1995; 39:359-61. [IDIS 341970] [PubMed 7726498]

30. Lin C, Radwanski E, Affrime M et al. Multiple-dose pharmacokinetics of ceftibuten in healthy volunteers. Antimicrob Agents Chemother. 1995; 39:356-8. [IDIS 341969] [PubMed 7726497]

31. Barr WH, Affrime M, Lin CC et al. Pharmacokinetics of ceftibuten in children. Pediatr Infect Dis J. 1995; 14(Suppl):S93-101. [IDIS 349759] [PubMed 7567317]

32. Lin C, Kumari P, Perrotta RJ et al. Penetration of ceftibuten into middle ear fluid. Antimicrob Agents Chemother. 1996; 40:1394-6. [IDIS 368420] [PubMed 8726007]

33. Scaglione F, Triscari F, Demartini G et al. Concentrations of ceftibuten in bronchial secretions. Chemotherapy. 1995; 41:229-33. [IDIS 352360] [PubMed 7555201]

34. Reidenberg BE. Worldwide safety experience with ceftibuten pediatric suspension. Pediatr Infect Dis J. 1995; 14(Suppl):S130-3.

35. Kearns GL, Reed MD, Jacobs RF et al. Single-dose pharmacokinetics of ceftibuten (SCH 39720) in infants and children. Antimicrob Agents Chemother. 1991; 35:2078-84. [IDIS 288658] [PubMed 1759830]

36. Mandel EM, Casselbrant ML, Kurs-Lasky M et al. Efficacy of ceftibuten compared with amoxicillin for otitis media with effusion in infants and children. Pediatr Infect Dis J. 1996; 15:409-14. [IDIS 366219] [PubMed 8724062]

37. McAdoo MA, Rice K, Gordon GR et al. Comparison of ceftibuten once daily and amoxicillin-clavulanate three times daily in the treatment of acute exacerbations of chronic bronchitis. Clin Ther. 1998; 20:88-100. [IDIS 402073] [PubMed 9522107]

38. Ziering W, McElvaine P. Randomized comparison of once-daily ceftibuten and twice-daily clarithromycin in the treatment of acute exacerbation of chronic bronchitis. Infection. 1998; 26:68-75. [PubMed 9505188]

39. Aubier MA. Comparison of ceftibuten versus amoxicillin/clavulanate in the treatment of acute exacerbations of chronic bronchitis. Chemotherapy. 1997; 43:297-302. [IDIS 389325] [PubMed 9209787]

40. Lin CC, Affrime M, Radwanski E et al. Comparative bioavailability of ceftibuten in capsule and suspension forms. Clin Ther. 1996; 18:1139-49. [IDIS 380772] [PubMed 9001830]

41. Scaglione F, Pintucci JP, Demartini G et al. Ceftibuten concentrations in human tonsillar tissue. Eur J Clin Microbiol Infect Dis. 1996; 15:940-3. [PubMed 9031878]

42. Blumer JL, Forti WP, Summerhouse TL. Comparison of the efficacy and tolerability of once-daily ceftibuten and twice-daily cefprozil in the treatment of children with acute otitis media. Clin Ther. 1996; 18:811-20. [IDIS 376625] [PubMed 8930425]

43. Kishiyam JL, Adelman DC. The cross-reactivity and immunology of β-lactam antibiotics. Drug Saf. 1994; 10:318-27. [PubMed 8018304]

44. Thompson JW, Jacobs RF. Adverse effects of newer cephalosporins: an update. Drug Saf. 1993; 9:132-42. [PubMed 8397890]

45. De Abate CA, Perrotta RJ, Dennington ML et al. The efficacy and safety of once-daily ceftibuten compared with co-amoxiclav in the treatment of acute sinusitis. J Chemother. 1992; 4:358-63. [PubMed 1287138]

46. Kammer RB, Ress R. Randomized comparative study of ceftibuten versus cefaclor in the treatment of acute lower respiratory tract infections. Diagn Microbiol Infect Dis. 1991; 14:101-5. [PubMed 2013204]

47. McCabe R, Rumans L, Perrotta R et al. Comparison and efficacy and safety of ceftibuten and cefaclor in the treatment of pneumonia and bronchiectasis. J Chemother. 1993; 5:124-32. [PubMed 8515295]

48. Stool SE, Gerg AO, Berman S et al. Otitis media with effusion in young children. Clinical practice guideline No 12. AHCPR publication No. 94-0622. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Services; 1994 Jul.

49. Williams RL, Chalmers TC, Stange KC et al. Use of antibiotics in preventing recurrent acute otitis media and in treating otitis media with effusion: a meta-analytic attempt to resolve the brouhaha. JAMA. 1993; 270:1344-51. [IDIS 319598] [PubMed 8141875]

50. Paradise JL. Treatment guidelines for otitis media: the need for breadth and flexibility. Pediatr Infect Dis J. 1995; 14:429-35. [IDIS 348106] [PubMed 7638033]

51. Berman S. Otitis media in children. N Engl J Med. 1995; 332:1560-5. [IDIS 348227] [PubMed 7739711]

52. The Otitis Media Guideline Panel. Managing otitis media with effusion in young children. Pediatrics. 1994; 94:766-73. [IDIS 337882] [PubMed 7936917]

53. Bisno AL, Gerber MA, Gwaltney JM. Practice guidelines for the diagnosis and management of group A streptococcal pharyngitis. Clin Infect Dis. 2002; 35:113-25. [IDIS 484228] [PubMed 12087516]

54. Klein JO. Management of streptococcal pharyngitis. Pediatr Infect Dis J. 1994; 13:572-5. [IDIS 331902] [PubMed 8078757]

55. Pichichero ME, Cohen R. Shortened course of antibiotic therapy for acute otitis media, sinusitis and tonsillopharyngitis. Pediatr Infect Dis J. 1997; 16:680-95. [IDIS 390075] [PubMed 9239773]

56. Tack KJ, Henry DC, Gooch WM et al et al. Five-day cefdinir treatment for streptococcal pharyngitis. Antimicrob Agents Chemother. 1998; 42:1073-5. [IDIS 404900] [PubMed 9593129]

57. Milatovic D, Adam D, Hamilton H et al. Cefprozil versus penicillin V in treatment of streptococcal tonsillopharyngitis. Antimicrob Agents Chemother. 1993; 37:1620-3. [IDIS 318765] [PubMed 8215273]

58. Aujard Y, Boucot I, Brahimi N et al. Comparative efficacy and safety of four-day cefuroxime axetil and ten-day penicillin treatment of group A beta-hemolytic streptococcal pharyngitis in children. Pediatr Infect Dis J. 1995; 14:295-300. [IDIS 345876] [PubMed 7603811]

59. Mehra S, Van Moerkerke M, Welck J et al. Short course therapy with cefuroxime axetil for group A streptococcal tonsillopharyngitis in children. Pediatr Infect Dis J. 1998; 17:452-7. [IDIS 408830] [PubMed 9655533]

60. Dajani AS, Kessler SL, Mendelson R et al. Cefpodoxime proxetil vs. penicillin V in pediatric streptococcal pharyngitis/tonsillitis. Pediatr Infect Dis J. 1993; 12:275-9. [PubMed 8483620]

61. Pichichero ME. Cephalosporins are superior to penicillin for treatment of streptococcal tonsillopharyngitis: is the difference worth it? Pediatr Infect Dis. 1993; 12:268-74.

62. Milatovic D. Evaluation of cefadroxil, penicillin and erythromycin in the treatment of streptococcal tonsillopharyngitis. Pediatr Infect Dis J. 1991; 10:S61-3. [PubMed 1945599]

63. Banfi A, Gabriele G, Hill-Juarez MJ et al. Multinational comparative trial of ceftibuten and trimethoprim-sulfamethoxazole in the treatment of children with complicated or recurrent urinary tract infections. Pediatr Infect Dis J. 1993; 12:S84-91.

64. Stein GE, Christensen S, Mummaw N. Treatment of acute uncomplicated urinary tract infection with ceftibuten. Infection. 1991; 19:125-7.

65. Reviewers’s comments (personal observations).

66. Schering, Kenilworth, NJ: Personal communication.

67. Dowell SF, Marcy SM, Phillips WR et al. Otitis media—principles of judicious use of antimicrobial agents. Pediatrics. 1998; 101:165-71.

68. Stool SE, Berg AO, Berman S et al for the Otitis Media Guideline Panel. Otitis media with effusion in young children. Clinical practice guideline. Number 12. AHCPR Publication No. 94-0622. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Resources. July 1994.

69. American Academy of Pediatrics and American Academy of Family Physicians Subcommittee on Management of Acute Otitis Media. Diagnosis and management of acute otitis media. Pediatrics. 2004: 113:1451-65.

70. American Academy of Pediatrics, American Academy of Family Physicians, American Academy of Otolaryngology-Head and Neck Surgery, and American Academy of Pediatrics Subcommittee on Otitis Media with Effusion. Otitis media with effusion. Pediatrics. 2004: 113:1412-29.

a. AHFS Drug Information 2003. McEvoy GK, ed. Cephalosporins General Statement. American Society of Health-System Pharmacists; 2003:125-39.

More Cedax resources

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

• Cedax Prescribing Information (FDA)


• Cedax MedFacts Consumer Leaflet (Wolters Kluwer)


• Cedax Concise Consumer Information (Cerner Multum)


• Cedax Advanced Consumer (Micromedex) - Includes Dosage Information


• Ceftibuten Professional Patient Advice (Wolters Kluwer)

Compare Cedax with other medications

• Bladder Infection
• Bronchitis
• Otitis Media
• Pneumonia
• Sinusitis
• Strep Throat
• Tonsillitis/Pharyngitis

lactulose

Generic Name: lactulose (LAK too lose)

Brand names: Enulose, Generlac, Kristalose, ...show all 11 brand names.Chronulac, Cephulac, Constilac, Cholac, Duphalac, Constulose, Evalose, Heptalac

What is lactulose?

Lactulose is a type of sugar. It is broken down in the large intestine into mild acids that draw water into the colon, which helps soften the stools.

Lactulose is used to treat chronic constipation.

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

What is the most important information I should know about lactulose?

You should not use this medication if you are on a special diet low in galactose (milk sugar).

Before taking lactulose, tell your doctor if you have diabetes or if you need to have any type of intestinal test using a scope (such as a colonoscopy).

It may take up to 48 hours before you have a bowel movement after taking lactulose.

Stop using lactulose and call your doctor at once if you have severe or ongoing diarrhea.

The liquid form of lactulose may become slightly darken in color, but this is a harmless effect. However, do not use the medicine if it becomes very dark, or if it gets thicker or thinner in texture.

If you use lactulose over a long period of time, your doctor may want you to have occasional blood tests. Do not miss any scheduled appointments.

What should I discuss with my healthcare provider before taking lactulose?

You should not use this medication if you are on a special diet low in galactose (milk sugar).

Before taking lactulose, tell your doctor if you have:

• 
  

  diabetes; or

  
  


• 
  

  if you need to have any type of intestinal test using a scope (such as a colonoscopy).

  
  

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

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether lactulose passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take lactulose?

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.

Measure liquid 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.

The liquid form of lactulose may become slightly darken in color, but this is a harmless effect. However, do not use the medicine if it becomes very dark, or if it gets thicker or thinner in texture.

Lactulose powder should be mixed with at least 4 ounces of water. You may also use fruit juice or milk to make the medication better.

It may take up to 48 hours before you have a bowel movement after taking lactulose.

If you use lactulose over a long period of time, your doctor may want you to have occasional blood tests. Do not miss any scheduled appointments.

Store lactulose at room temperature away from moisture and heat.

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 diarrhea, stomach pain, hot and dry skin, confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, and muscle weakness or limp feeling.

What should I avoid while taking lactulose?

Avoid using antacids without your doctor's advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb lactulose.

Lactulose 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 lactulose and call your doctor at once if you have severe or ongoing diarrhea.

Less serious side effects may include:

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  bloating, gas;

  
  


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  stomach pain;

  
  


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  diarrhea; or

  
  


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  nausea, vomiting.

  
  

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.

Lactulose Dosing Information

Usual Adult Dose for Constipation -- Chronic:

15 mL orally once a day.

Usual Adult Dose for Constipation -- Acute:

Initial dose: 15 mL orally once a day. Therapy should be continued until normal bowel function resumes.

Usual Adult Dose for Hepatic Encephalopathy:

Initial dose: 30 mL orally 3 times a day or
300 mL in 700 mL water or normal saline as an enema retained for 30 to 60 minutes every 4 to 6 hours.
Maintenance dose: 30 to 45 mL orally 3 times a day.

Usual Pediatric Dose for Hepatic Encephalopathy:

Infants: 1.7 to 6.7 g/day (2.5 to 10 mL) orally daily divided in 3 to 4 doses. Adjust dosage to produce 2 to 3 soft stools per day.

Children: 26.7 to 60 g/day (40 to 90 mL) orally daily divided in 3 to 4 doses. Adjust dosage to produce 2 to 3 soft stools per day.

Usual Pediatric Dose for Constipation -- Chronic:

Children: 0.7 to 2 g/kg/day (1 to 3 mL/kg/day) orally in divided doses daily; generally recommended not to exceed the adult maximum of 40 g/day (60 mL/day).

What other drugs will affect lactulose?

There may be other drugs that can interact with lactulose. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More lactulose resources

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

• Lactulose Prescribing Information (FDA)


• Lactulose Monograph (AHFS DI)


• Lactulose Professional Patient Advice (Wolters Kluwer)


• Lactulose Crystals MedFacts Consumer Leaflet (Wolters Kluwer)


• Constulose Prescribing Information (FDA)


• Constulose Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Enulose Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Enulose Prescribing Information (FDA)


• Generlac Prescribing Information (FDA)

Compare lactulose with other medications

• Constipation, Acute
• Constipation, Chronic
• Hepatic Encephalopathy

Where can I get more information?

• Your pharmacist can provide more information about lactulose.

See also: lactulose side effects (in more detail)