Cafetrate

Generic Name: caffeine and ergotamine (oral/rectal) (KAF een and er GOT a meen)

Brand Names: Cafergot, Migergot

What is caffeine and ergotamine?

Caffeine is a stimulant that causes narrowing of blood vessels (vasoconstriction).

Ergotamine is in a group of drugs called ergot alkaloids (ER-got AL-ka-loids). It works by narrowing the blood vessels around the brain. Ergotamine also affects blood flow patterns that are associated with certain types of headaches.

The combination of caffeine and ergotamine is used to treat or prevent a migraine type headache.

This medication will only treat a headache that has already begun. It will not prevent migraine headaches or reduce the number of attacks.

Caffeine and ergotamine should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches.

Caffeine and ergotamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about caffeine and ergotamine?

This medication can harm an unborn baby or a nursing baby. Do not use caffeine and ergotamine if you are pregnant or breast-feeding. Do not use this medication if you are allergic to caffeine and ergotamine or other ergot medicines, or if you have a history of heart disease, angina (chest pain), blood circulation problems, history of a heart attack or stroke, coronary artery disease, uncontrolled high blood pressure, severe liver or kidney disease, or a serious infection. Using certain medications together with caffeine and ergotamine can cause even greater decreases in blood flow than caffeine and ergotamine used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Tell your doctor about all other medications you are using, especially antibiotics, antidepressants, heart or blood pressure medications, or medicines to treat HIV or AIDS.

Also tell your doctor about all of your medical conditions, especially breathing problems, high blood pressure, liver or kidney disease, or risk factors for coronary artery disease (diabetes, high blood pressure or cholesterol, menopause or hysterectomy, smoking, taking birth control pills, being overweight, having a family history of coronary artery disease, or being a man older than 40).

This medication will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Never use more than your prescribed dose of caffeine and ergotamine. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. An overdose of caffeine and ergotamine can be fatal.

What should I discuss with my healthcare provider before using caffeine and ergotamine ?

Do not use this medication if you are allergic to caffeine or ergotamine, or other ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), methylergonovine (Methergine), or methysergide (Sansert).

Do not use caffeine and ergotamine if you are pregnant or breast-feeding, or if you have:

• 
  

  a history of heart disease, angina (chest pain), blood circulation problems, or history of a heart attack or stroke;

  
  


• 
  

  coronary artery disease or "hardening of the arteries";

  
  


• 
  

  uncontrolled high blood pressure;

  
  


• severe liver disease;


• severe kidney disease; or


• 
  

  a serious infection called sepsis.

  
  

Using certain medications together with caffeine and ergotamine can cause even greater decreases in blood flow than caffeine and ergotamine used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Do not use caffeine and ergotamine if you are also using any of the following medications:

• 
  

  conivaptan (Vaprisol);

  
  


• 
  

  diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), telithromycin (Ketek), or troleandomycin (Tao);

  
  


• 
  

  an antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

  
  


• 
  

  an antidepressant such as nefazodone;

  
  


• 
  

  heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quinaglute, Quinidex, Quin-Release), or verapamil (Calan, Covera, Isoptin, Verelan); or

  
  


• 
  

  HIV/AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir).

  
  

Caffeine and ergotamine can cause rare but serious side effects on the heart, including heart attack or stroke. If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using caffeine and ergotamine, tell your doctor if you have:

• 
  

  breathing problems;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  liver disease;

  
  


• 
  

  kidney disease; or

  
  


• 
  

  coronary artery disease (or risk factors that include diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

  
  

FDA pregnancy category X. This medication can cause birth defects. Do not use caffeine and ergotamine if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using caffeine and ergotamine. Caffeine and ergotamine passes into breast milk and may be harmful to a nursing infant. Do not use caffeine and ergotamine without telling your doctor if you are breast-feeding a baby.

How should I use caffeine and ergotamine?

Use this medication exactly as prescribed by your doctor. Never use more than your prescribed dose of caffeine and ergotamine. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. Caffeine and ergotamine is not for daily use.

To use caffeine and ergotamine tablets: Take 2 tablets of caffeine and ergotamine as soon as you notice headache symptoms, or after an attack has already begun.

If your headache does not completely go away, you may take 1 more tablet after at least 30 minutes have passed. If additional medication is needed, you may take 1 tablet every 30 minutes up to a total of 6 tablets for one migraine attack.

If you still have migraine symptoms after taking a total of 6 tablets, call your doctor. Do not take more than a total of 6 tablets in any 24-hour period. Do not take more than a total of 10 tablets over a period of 7 days.

To use caffeine and ergotamine rectal suppositories: Insert 1 suppository at the first sign of migraine headache symptoms, or after an attack has already begun. If your headache does not completely go away, use 1 more suppository after at least 1 hour has passed.

Do not take a rectal suppository by mouth. It is for use only in your rectum.

Try to empty your bladder just before using the suppository. Remove the outer wrapper from the suppository and insert it gently into the rectum, pointed tip first. Avoid handling the suppository too long or it will melt in your hands.

For best results, lie down after inserting the suppository and hold it in for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after you have inserted the suppository.

If you still have migraine symptoms after using a total of 2 rectal suppositories, call your doctor. Do not use more than a total of 2 suppositories per headache. Do not use more than a total of 5 suppositories over a period of 7 days. Do not give this medication to anyone else, even if they have the same headache symptoms you have. Caffeine and ergotamine can be dangerous if it is used to treat headache in a person who has not been diagnosed by a doctor as having true migraine headaches. Store caffeine and ergotamine at room temperature away from moisture, heat, and light. Do not use any stored caffeine and ergotamine if the expiration date on the label has passed.

What happens if I miss a dose?

Since caffeine and ergotamine is used only when needed, you are not likely to miss a dose.

Do not take more than 6 caffeine and ergotamine tablets per day or more than 10 tablets per week. Do not use more than 2 suppositories per headache or 5 suppositories per week.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of caffeine and ergotamine can be fatal.

Overdose can cause vomiting, confusion, drowsiness, weak pulses in your arms and legs, numbness and tingling or pain in your hands or feet, blue-colored fingers or toes, fainting, and seizure (convulsions).

What should I avoid while using caffeine and ergotamine?

Do not use caffeine and ergotamine within 24 hours before or after using another migraine headache medicine, including:

• 
  

  dihydroergotamine (D.H.E. 45, Migranal), caffeine and ergotamine (Cafergot, Ercaf, Wigraine), ergonovine (Ergotrate), methylergonovine (Methergine), methysergide (Sansert); or

  
  


• 
  

  almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), sumatriptan (Imitrex), rizatriptan (Maxalt, Maxalt-MLT), or zolmitriptan (Zomig).

  
  

Grapefruit and grapefruit juice may interact with caffeine and ergotamine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Caffeine and ergotamine 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 caffeine and ergotamine and call your doctor at once if you have a serious side effect such as:

• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  fast or slow heart rate;

  
  


• 
  

  muscle pain in your arms or legs;

  
  


• 
  

  leg weakness;

  
  


• 
  

  numbness or tingling and a pale or blue-colored appearance in your fingers or toes;

  
  


• 
  

  severe pain in your stomach or lower back;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  painful sores on your rectum after using the rectal suppositories;

  
  


• 
  

  swelling or itching in any part of your body;

  
  


• 
  

  cough with stabbing chest pain and trouble breathing; or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness, spinning sensation;

  
  


• 
  

  weakness;

  
  


• 
  

  nausea, vomiting; or

  
  


• 
  

  mild itching.

  
  

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

What other drugs will affect caffeine and ergotamine?

Many drugs can interact with caffeine and ergotamine. Below is just a partial list. Talk with your doctor before using caffeine and ergotamine if you are also taking:

• 
  

  birth control pills;

  
  


• 
  

  zileuton (Zyflo);

  
  


• 
  

  cold or allergy medications;

  
  


• 
  

  nicotine (Nicoderm, Nicorette);

  
  


• 
  

  diet pills, stimulants, or medication to treat ADHD (such as Ritalin or Adderall);

  
  


• 
  

  an antidepressant such fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), nefazodone (Serzone), paroxetine (Paxil), sertraline (Zoloft), and others;

  
  


• 
  

  nitroglycerin or other nitrate medicines such as isosorbide (Isordil, Dilatrate, Imdur, Monoket); or

  
  


• 
  

  heart or blood pressure medication such as atenolol (Tenormin), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

  
  

This list is not complete and there may be other drugs that can interact with caffeine and ergotamine. 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 Cafetrate resources

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

• Cafergot Advanced Consumer (Micromedex) - Includes Dosage Information


• Cafergot MedFacts Consumer Leaflet (Wolters Kluwer)


• Cafergot Prescribing Information (FDA)


• Migergot Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Cafetrate with other medications

• Cluster Headaches
• Migraine

Where can I get more information?

• Your pharmacist can provide more information about caffeine and ergotamine.

See also: Cafetrate side effects (in more detail)

Amoxicillin 250 mg Capsules

1. Name Of The Medicinal Product

Amoxicillin 250 mg capsules

2. Qualitative And Quantitative Composition

1 capsule contains 250 mg amoxicillin (as trihydrate)

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Capsule, hard

Yellow, opaque capsules with black imprints “Amx” and “250” alternatively axially

4. Clinical Particulars

4.1 Therapeutic Indications

Amoxicillin 250mg capsules are indicated for the oral treatment of the following bacterial infections caused by amoxicillin-sensitive gram-positive and gram-negative pathogens (see section 5.1):

• Infections of the upper respiratory tract, including infections of the ears, nose and throat: Acute otitis media, acute sinusitis and bacterial pharyngitis

• Infections of the lower respiratory tract: Acute exacerbation of chronic bronchitis, community-acquired pneumonia

• Infections of the lower urinary tract: Cystitis

• Endocarditis: Prophylaxis of endocarditis in patients at risk i.e. surgery in the oral cavity or upper airways

Consideration should be given to official local guidance (e.g. national recommendations) on the appropriate use of antibacterial agents.

Susceptibility of the causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available.

4.2 Posology And Method Of Administration

Posology

The dosage of amoxicillin is dependent on age, bodyweight and renal function of the patient, on the seriousness and localisation of the infection and on the expected or proved causative agent.

Standard dosage:

Adults and adolescents (> 40 kg body weight):

The usual dosage covers a range from 750 mg to 3g amoxicillin daily in three divided doses. In some areas 1500 mg amoxicillin daily in three divided doses are recommended as the upper usual dose.

Special dosage recommendation

Acute exacerbation of chronic bronchitis in adults: 2 x 1 g per day

Children (under 12 years):

For infants and children oral suspensions containing amoxicillin are recommended.

Dosage for the prevention of endocarditis

For the prevention of endocarditis, in patients not having general anaesthetic, 3 g amoxicillin are given in the hour preceding the surgical procedure, followed by (6 hours later) a further 3 g dose, if considered necessary.

For further details and description of risk patients local official guidelines for the prevention of endocarditis should be consulted.

Dosage in impaired renal function:

The dose should be reduced in patients with severe renal function impairment. In patients with a renal clearance of less than 30 ml/min an increase in the dosage interval or a reduction in the subsequent doses is recommended (see section 4.4). Short course treatments with a single dose of 3 g cannot be given in case of renal failure.

Adults (including elderly patients):
Creatinine clearance ml/min	Dose	Interval between administration
>30	No adjustment necessary
10 – 30	500 mg	12 h
<10	500 mg	24 h
In case of haemodialysis: 500 mg should be administered at the end of the procedure.

Dosage in impaired hepatic function:

No dose reduction is necessary as long as the renal function is not impaired.

Duration of therapy

In general the therapy should be continued for 2 to 3 days following the disappearance of symptoms. In β-haemolytic streptococcal infections the duration of therapy should be at least 10 days in order to achieve eradication of the organism.

Parenteral therapy is indicated if the oral route is considered impracticable or unsuitable, and particularly for the urgent treatment of severe infection.

Method of administration

The preparations are administered orally.

Amoxicillin capsules should be taken, unchewed, with liquid (e.g. a glass of water).

The absorption of amoxicillin is not reduced by food intake.

4.3 Contraindications

Amoxicillin is contraindicated in patients with:

• Hypersensitivity to penicillin; a cross-allergy to other beta-lactams such as cephalosporins should be taken into account.

• Hypersensitivity to any of the other ingredients in the product

4.4 Special Warnings And Precautions For Use

Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins and cephalosporins. The possibility of cross-hypersensitivity (10 % - 15 %) with cephalosporins should be taken into account.

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to beta-lactam antibiotics.

Patients suffering from severe gastrointestinal disturbances with diarrhoea and vomiting should not be treated with Amoxicillin , due to the risk of reduced absorption. In these cases a parenteral treatment with amoxicillin is advisable.

Amoxicillin should be used with caution in patients with allergic diathesis and asthma.

In patients with renal function impairment the excretion of amoxicillin will be delayed and, depending on the degree of the impairment, it may be necessary to reduce the total daily dosage (see section 4.2.).

The prolonged use of amoxicillin may occasionally result in an overgrowth of non-susceptible organisms or yeasts. Patients should therefore carefully be watched for superinfections.

The occurrence of anaphylactic shock and other severe allergic reactions is rare following the oral administration of amoxicillin. However, if such reactions occur, appropriate emergency treatment measures must be taken: I.V. administration of epinephrine, followed by antihistaminic drugs, volume substitution and administration of glucocorticoids. Patients should be kept under close observation, and further therapeutic measures (artificial respiration, oxygen) should be administered as required.

The presence of high urinary concentrations of amoxicillin can cause precipitation of the product in urinary catheters. Therefore, catheters should be visually inspected at intervals.

At high doses, adequate fluid intake and urinary output must be maintained to minimise the possibility of amoxicillin crystalluria.

Amoxicillin should be used with caution in patients with viral infections, acute lymphatic leukaemia, or infectious mononucleosis (due to an increased risk of erythematous skin rashes).

Pseudomembranous colitis should be borne in mind if severe persistent diarrhoea occurs (in most cases caused by Clostridium difficile). In this case Amoxicillin should be discontinued and an adequate therapy has to be started. The use of antiperistaltics is contraindicated.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use not recommended with:

Allopurinol

Concomitant administration of allopurinol may promote the occurrence of allergic cutaneous reactions and is therefore not advised.

Digoxin

An increase in the absorption of digoxin is possible on concurrent administration with amoxicillin. A dose adjustment of digoxin may be necessary.

Disulfiram

Simultaneous administration of disulfiram is not recommended.

Anticoagulants

Concomitant administration of amoxicillin and anticoagulants from the coumarin class, may prolong the bleeding time. A dose adjustment of anticoagulants may be necessary.

Probenecid

By inhibiting the renal elimination of amoxicillin the concomitant administration of probenecid leads to an increase in the concentrations of amoxicillin in serum and bile.

Other antibiotics

In general amoxicillin should not be combined with bacteriostatic chemotherapeutics/antibiotics (like tetracyclines, macrolids, sulfonamids or chloramphenicol), because in vitro antagonism is observed. When used simultaneously with aminoglycosides a synergistic effect may occur.

Methotrexate

Interaction between amoxicillin and methotrexate leading to methotrexate toxicity has been reported. Serum methotrexate levels should be closely monitored in patients who receive amoxicillin and methotrexate simultaneously. Amoxicillin decreases the renal clearance of methotrexate, probably by competition at the common tubular secretion system.

Caution is recommended when amoxicillin is given concomitantly with:

Oral hormonal contraceptives

Administration of amoxicillin can transiently decrease the plasma level of estrogens and progesterone, and may reduce the efficacy of oral contraceptives. It is therefore recommended to take supplemental non-hormonal contraceptive measures.

Other forms of interactions:

− Forced diuresis leads to a reduction in blood concentrations by increased elimination of amoxicillin.

− The occurrence of diarrhoea may impair the absorption of other medicaments and consequently adversely affect the efficacy.

− It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.

− Amoxicillin may decrease the amount of urinary estriol in pregnant women.

− At high concentrations, amoxicillin may diminish the results of serum glycemia levels

− Amoxicillin may interfere with protein testing when colormetric methods are used.

4.6 Pregnancy And Lactation

Amoxicillin passes the placenta and foetal plasma concentrations are approximately 25-30% of the maternal plasma concentrations.

Data on a limited number of exposed pregnancies indicate no adverse effects of amoxicillin on pregnancy or on the health of the foetus/new-born child. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy,embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.

Amoxicillin diffuses into the breast milk (approx. 10% of the corresponding serum concentration) and in rare cases this can lead to diarrhoea and/or fungal colonisation of the mucosa in the infant. The possibility of sensitisation of the infant to beta-lactam drugs should also be considered.

4.7 Effects On Ability To Drive And Use Machines

No effects on the ability to drive and use machines have been observed.

4.8 Undesirable Effects

In this section undesirable effects are defined as follows:

Very common
Common
Uncommon
Rare
Very rare	<1/10,000, not known (cannot be estimated from the available data)

Infections and infestations

Uncommon

Superinfections and colonization with resistant organisms or yeasts such as oral and vaginal candidiasis after prolonged and repeated use of amoxicillin.

Blood and the lymphatic system disorders

Rare

Eosinophilia and haemolytic anaemia.

Very rare

Leucopenia, granulocytopenia, thrombocytopenia, pancytopenia, anaemia, myelosuppression, agranulocytosis, prolongation of bleeding time, and prolongation of prothrombin time. All were reversible on discontinuation of therapy.

Immune system disorders

Rare

Laryngeal oedema, serum sickness, allergic vasculitis, anaphylaxis and anaphylactic.

Nervous system disorders

Rare

CNS effects including hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Gastrointestinal disorders:

Common

Gastric complaints, nausea, loss of appetite, vomiting, flatulence, soft stools, diarrhoea, enanthemas (particularly in the region of the mouth), dry mouth, taste disturbances. These effects on the gastrointestinal system are mostly mild and frequently disappear either during the treatment or very soon after completion of therapy. The occurrence of these side effects can generally be reduced by taking amoxicillin during meals.

Rare

Superficial discoloration of the teeth (especially with the suspension). Usually the discoloration can be removed by teeth brushing.

Very rare

If severe and persistent diarrhoea occurs, the very rare possibility of pseudomembranous colitis should be considered. The administration of anti-peristaltic drug is contraindicated.

Development of a black tongue.

Hepato-biliary disorders:

Uncommon

Moderate and transient increase of liver enzymes.

Rare

Hepatitis and cholestatic jaundice.

Skin and subcutaneous tissue disorders:

Common

Cutaneous reactions such as exanthema, pruritus, urticaria; the typical morbilliform exanthema occurs 5 - 11 days after start of therapy. Immediate appearance of urticaria indicates an allergic reaction to amoxicillin and therapy should therefore be discontinued.

Rare (see also section 4.4)

Angioneurotic oedema (Quincke's oedema),erythema multiforme exsudativum, acute generalized pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis.

Renal disorders

Rare

Acute interstitial nephritis.

General disorders and administration site conditions

Rare

Drug fever.

4.9 Overdose

Symptoms of overdose:

Amoxicillin is not generally associated with acute toxic effects, even when accidentally consumed in high doses. Overdosage can lead to symptoms such as gastrointestinal disturbances and fluid and electrolyte imbalance. In patients with severely impaired renal function, large overdoses can result in signs of renal toxicity; crystalluria is possible.

Management of overdose:

There is no specific antidote for an overdose of amoxicillin.

Treatment consists primarily of administration of activated charcoal (a gastric lavage is usually not necessary) or symptomatic measures. Particular attention should be paid to the water and electrolyte balance of the patients.

Amoxicillin can be eliminated via haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

General Properties

ATC-Code: J01CA04

Pharmacotherapeutic group: Beta-lactam antibacterials

Mode of action

Amoxicillin is an aminobenzyl penicillin that has a bactericidal action due to its inhibition of the synthesis of the bacterial cell wall.

Mechanism of resistance

Bacteria may be resistant to amoxicillin (and, thus, ampicillin) due to production of beta-lactamases which hydrolyse aminopenicillins (hydrolysis which can be inhibited by clavulanic acid), due to alteration in penicillin-binding proteins, due to impermeability to the drug, or due to drug efflux pumps. One or more of these mechanisms may co-exist in the same organism, leading to a variable and unpredictable cross-resistance to other beta-lactams and to antibacterial drugs of other classes.

Breakpoints (CLSI)

Enterobacteriaceae:	S
Staphylococcus spp.:	S
Haemophilus spp.:	S
Str. pneumoniae:	S

Susceptibility:

The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

Commonly susceptible species

Aerobic Gram-positive Bacillus anthracis Listeria monocytogenes Staphylococcus aureus (beta-lactamase negative, methicillin susceptible) Streptococcus agalactiae Streptococcus bovis Streptococcus pyogenes * Aerobic Gram-negative Neisseria meningitidis Anaerobes Peptostreptococci

Species for which acquired resistance may be a problem

Aerobic Gram-positive Corynebacterium spp Enterococcus faecalis Streptococcus pneumoniae * + Streptococcus viridans Aerobic Gram-negative Haemophilus influenzae * Haemophilus para-influenzae * Neisseria gonorrhoea Proteus mirabilis Anaerobes Bacteroides melaninogenicus Fusobacterium spp

Inherently resistant organisms

Aerobic Gram-positive Staphylococcus (β-lactamase producing strains) Aerobic Gram-negative Acinetobacter spp Citrobacter spp Enterobacter spp Escherichia coli Klebsiella spp Moraxella catarrhalis * Proteus spp (indol positive) Proteus vulgaris Providencia spp Pseudomonas spp Serratia spp Anaerobes Bacteroides fragilis Others Chlamydia Mycoplasma Rickettsia

* Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications

+ Rates of resistance vary within Europe

5.2 Pharmacokinetic Properties

Absorption:

The absolute bioavailability of amoxicillin depends on the dose and ranges between 75 and 90%. In the dose range between 250 mg and 750 mg the bioavailability (parameters: AUC and/or recovery in urine) is linearly proportional to the dose. At higher doses the extent of absorption decreases. The absorption is not affected by concomitant food intake. Oral administration of a single dose of 500 mg amoxicillin results in plasma concentrations of 6 - 11 mg/l. After administration of a single dose of 3 g amoxicillin, the plasmaconcentrations reach 27 mg/l. Peak plasma concentrations are present about 1-2 hours after administration.

Distribution:

Protein binding for amoxicillin is approximately 17%. Therapeutic drug levels are rapidly achieved in serum, lung tissue, bronchial secretions, middle ear fluid, bile and urine. In healthy meninges amoxicillin diffuses badly in liquor cerebrospinalisis. In inflamed meninges the concentration can reach approximately 20% of the concentration in blood. Amoxicillin crosses the placenta and a small percentage is excreted into the breast milk.

Biotransformation and elimination:

The main route of excretion of amoxicillin is the kidney. About 60-80% of an oral dose of amoxicillin are excreted in unchanged active form in the urine within 6 hours of administration, and a small fraction is excreted in the bile. Approximately 7 - 25% of the administered dose is metabolised to inactive penicilloic acid. The serum half-life in patients with normal renal function is approximately 1 – 1,5 hour. In patients with end-stage renal failure the half-life ranges between 5 to 20 hours. The substance is haemodialysable.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Content:	Magnesium stearate Cellulose, microcrystalline
Shell:	Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin
Black printing ink:	Propylene Glycol Shellac Black iron oxide (E172)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

4 years

6.4 Special Precautions For Storage

Do not store above 25 °C.

6.5 Nature And Contents Of Container

Nature:

Blister consisting of a clear polyvinyl chloride foil with a coating of polyvinylidene chloride (PVC/PVDC) 236 µm and aluminium foil 20 µm.

Contents:

Amoxicillin 250 mg Capsules: single packs for 12, 21 and 100 capsules hospital packs for 500 and 1000 capsules

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Sandoz Ltd

Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR.

United Kingdom

8. Marketing Authorisation Number(S)

PL 04416/0576

9. Date Of First Authorisation/Renewal Of The Authorisation

18.02.1998 / 14.09.2005

10. Date Of Revision Of The Text

November 2010

Sodium Phosphate P 32

Rx Only.

Sodium Phosphate P 32 Description

Sterile, non-pyrogenic Sodium Phosphate P 32 is available for therapeutic application as an intravenous solution dosage form with a concentration of 24.8 megabecquerels (0.67 millicurie) per milliliter. The intravenous solution contains 1.6 milligrams per milliliter of sodium acetate as a buffer, 0.9% sodium chloride for isotonicity and may contain sodium hydroxide or hydrochloric acid for pH adjustment. The pH of the solution is between 5.0 and 6.0.

PHYSICAL CHARACTERISTICS

Phosphorus P 32 decays by beta emission with a physical half-life of 14.3 days.1 The mean energy of the phosphorus P 32 beta particle is 694.9 keV.

Table 1. Principal Radiation Emission Data

Radiation	Mean Percent Per Disintegration	Mean Energy (keV)
Beta-1	100.0	694.9

1

Kocher, David C., “Radioactive Decay Data Tables,” DOE/TIC 11026, page 70 (1981).

EXTERNAL RADIATION

The range of the phosphorus P 32 beta particle, which has a maximum energy of 1.71 MeV, is 2.8 mm of aluminum.

To correct for physical decay of this radionuclide, the fractions remaining at selected time intervals before and after the day of calibration are shown in Table 2.

Table 2. Physical Decay Chart; Phosphorus P 32, Half-Life 14.3 days

*Calibration Day
Days	Fraction Remaining		Days	Fraction Remaining
0*	1.000		30	0.233
1	0.953		35	0.183
2	0.908		40	0.144
5	0.785		45	0.113
10	0.616		50	0.089
15	0.483		55	0.070
20	0.379		60	0.055
25	0.297

Sodium Phosphate P 32 - Clinical Pharmacology

Phosphorus is necessary to metabolic and proliferative activity of cells. Radioactive phosphorus concentrates to a very high degree in rapidly proliferating tissue.

Indications and Usage for Sodium Phosphate P 32

The principal use of Sodium Phosphate P 32 is for the treatment of polycythemia vera, and it is effective for the treatment of chronic myelocytic leukemia and chronic lymphocytic leukemia. Sodium Phosphate P 32 is also used in palliative treatment of selected patients with multiple areas of skeletal metastases.

Contraindications

Sodium Phosphate P 32 should not be used as a part of sequential treatment with a chemotherapeutic agent.

In polycythemia vera, Sodium Phosphate P 32 should not be administered when the leukocyte count is below 5,000/cu mm, or a platelet count is below 150,000/cu mm.

In chronic myelocytic leukemia, Sodium Phosphate P 32 should not be administered when the leukocyte count is below 20,000/cu mm.

For treatment of bone metastases it is usually not administered when the leukocyte count is below 5,000/cu mm, and platelet count is below 100,000/cu mm.

Warnings

This radiopharmaceutical should administered for intracavitary use.

Overdose of Sodium Phosphate P 32 may produce serious effects on the hemopoietic system. The blood and bone marrow should be carefully monitored at regular intervals.

Sodium Phosphate P 32 ordinarily does not localize in retinoblastomas.

PRECAUTIONS.

General

As in the use of any other radioactive material, care should be taken to insure minimum radiation exposure to the patient, consistent with proper patient management, and to insure minimum radiation exposure to occupational workers.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether Sodium Phosphate P 32 affects fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with Sodium Phosphate P 32. It is also not known whether Sodium Phosphate P 32 can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Sodium Phosphate P 32 should be given to a pregnant woman only if clearly needed.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

Nursing Mothers

It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken when a patient is being given Sodium Phosphate P 32.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

None known.

Sodium Phosphate P 32 Dosage and Administration

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Oral administration of high-specific-activity Sodium Phosphate P 32 in the fasting state may equal intravenous administration.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Waterproof gloves should be used during the entire handling and administration procedure.

Maintain adequate shielding during the life of the product and use a sterile, shielded syringe for withdrawing and injecting the drug.

For polycythemia vera, intravenous dosages from 37 to 296 megabecquerels (1 to 8 millicuries) are given depending upon the stage of disease and size of the patient. Repeat doses must be adjusted to individual needs.

For chronic leukemia, the individual dose is 222 to 555 megabecquerels (6 to 15 millicuries), usually administered with concomitant hormone manipulation.

RADIATION DOSIMETRY

The estimated absorbed radiation doses2 to an average patient (70 kg) following intravenous administration of 555 megabequerels (15 millicuries) of Sodium Phosphate P 32 are shown in Table 3.

Table 3. Absorbed Radiation Doses

	Absorbed radiation doses for 555 megabecquerels (15 millicuries)
Tissue	grays	rads
Skeleton	9.45	945
Liver	0.93	93
Spleen	1.10	110
Brain	0.45	45
Testes	0.15	15
Ovaries	0.12	12
Total Body	1.50	150

2

Method of Calculation: “S”, Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet #11 (1975).

How is Sodium Phosphate P 32 Supplied

Catalog Number 461

Sodium Phosphate P 32 is supplied as a sterile, non-pyrogenic solution in single dose vials containing 185 megabequerels (5 millicuries) of phosphorus P 32. Each milliliter contains 24.8 megabecquerels (0.67 millicuries) Sodium Phosphate P 32 at the time of calibration, 1.6 milligrams sodium acetate and 9 milligrams sodium chloride. The solution may contain sodium hydroxide or hydrochloric acid for pH adjustment.

STORAGE AND HANDLING

Store at controlled room temperature 20-25°C (68-77°F).

Storage and disposal of Sodium Phosphate P 32 Solution should be controlled in a manner that is in compliance with the appropriate regulations of the government agency authorized to license the use of this radionuclide.

The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in Section 35.300, and to persons who hold an equivalent license issued by an Agreement State.

Revised 11/2000

Mallinckrodt Inc.

St. Louis, MO 63134

A461I0

Sodium Phosphate P 32  sodium phosphate, p-32  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0019-N461 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Sodium Phosphate, P-32 (Sodium Phosphate, P-32) Active 0.67 MILLICURIE  In 1 MILLILITER sodium acetate Inactive 1.6 MILLIGRAM  In 1 MILLILITER sodium chloride Inactive 0.9 MILLIGRAM  In 1 MILLILITER sodium hydroxide Inactive   hydrochloric acid Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0019-N461-F0 1 VIAL In 1 CAN contains a VIAL 1 7.5 mL (MILLILITER) In 1 VIAL This package is contained within the CAN (0019-N461-F0)

Revised: 03/2007Mallinckrodt Inc.

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Atropine

Pronunciation: AT-row-peen
Generic Name: Atropine
Brand Name: Generic only. No brand available.

Atropine is used for:

Decreasing the production of saliva and secretions of the airway prior to surgery. It is also used to treat spasms in the stomach, intestines, and other organs. It may also be used to counteract the effects of certain other medicines or for other conditions as determined by your doctor.

Atropine is an anticholinergic. It works by blocking the effects of a chemical in the body (acetylcholine) in the nervous system, stomach, intestines, certain glands (eg, salivary gland), urinary tract, and other tissues.

Do NOT use Atropine if:

• you are allergic to any ingredient in Atropine


• you have adhesions between the iris and lens of the eyes, asthma, blocking of the stomach or bowel, ulcerative colitis, bleeding, angle-closure glaucoma, myasthenia gravis, difficulty urinating due to a blockage, excess acid in the stomach or throat, esophagus problems (difficulty swallowing), or bowel muscle weakness

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

Before using Atropine:

Some medical conditions may interact with Atropine. 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 preparation, or dietary supplement


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


• if you have a history of megacolon or a predisposition to angle-closure glaucoma


• if you have numbness due to nerve damage, prostate problems (enlarged prostate), blockage of the bladder, trouble urinating, heart problems (congestive heart failure), hiatal hernia, or open-angle glaucoma

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

• Antihistamines (eg, diphenhydramine), medicine for Parkinson disease (eg, benztropine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Atropine's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Atropine 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 Atropine:

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

• Atropine is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Atropine at home, a health care provider will teach you how to use it. Be sure you understand how to use Atropine. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Atropine if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Atropine, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Atropine.

Important safety information:

• If your symptoms do not get better within a few days or if they get worse, check with your doctor.


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


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Atropine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Report any symptoms of fluid or electrolyte loss to your doctor: dry mouth; thirst; weakness; lethargy; drowsiness; restlessness; muscle pain or cramps; muscle weakness; low blood pressure; infrequent urination; rapid heartbeat; stomach disorders such as nausea and vomiting.


• Atropine may make your eyes more sensitive to sunlight. It may help to wear sunglasses.


• Tell your doctor or dentist that you take Atropine before you receive any medical or dental care, emergency care, or surgery.


• Use Atropine with caution in the ELDERLY; they may be more sensitive to its effects.


• Atropine should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Atropine while you are pregnant. It is not known if Atropine is found in breast milk. If you are or will be breast-feeding while you use Atropine, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Atropine:

All medicines may 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:

Blurred vision; constipation; decreased salivation; decreased sweating; difficulty sleeping; difficulty swallowing; dilation of the pupils; dizziness; drowsiness; excitement; fever; headache; hot, flushed, dry skin; loss of taste; mild to severe dryness of the nose and mouth; nausea; nervousness; thirst.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in heartbeat; confusion; delirium; diarrhea; difficulty focusing your eyes; difficulty urinating; fast/irregular heartbeat; hallucinations; rash; restlessness with weakness; speech disturbance; unusual weakness; vomiting.

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.

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 anxiety; coma; difficulty breathing; dilated pupils; disorientation; hallucinations; high blood pressure; high body temperature; hyperactivity; muscle weakness; restlessness; seizures; severe dizziness; urinary retention; vomiting.

Proper storage of Atropine:

Store Atropine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Atropine out of the reach of children and away from pets.

General information:

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


• Atropine 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 Atropine. 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.

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• Atropine Advanced Consumer (Micromedex) - Includes Dosage Information


• Atropine Monograph (AHFS DI)


• Atropine Prescribing Information (FDA)


• atropine Concise Consumer Information (Cerner Multum)


• AtroPen Prescribing Information (FDA)

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Drug List:

Westcort Topical application

Generic Name: hydrocortisone valerate (Topical application route)

hye-droe-KOR-ti-sone VAL-er-ate

Commonly used brand name(s)

In the U.S.

• Westcort

In Canada

• Hydroval


• Tarocort

Available Dosage Forms:

• Ointment


• Cream

Therapeutic Class: Corticosteroid, Intermediate

Pharmacologic Class: Hydrocortisone

Uses For Westcort

Hydrocortisone valerate topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor's prescription.

Before Using Westcort

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 have not been performed on the relationship of age to the effects of hydrocortisone valerate topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children and teenagers who must use this medicine should be checked often by their doctor since hydrocortisone valerate topical may be absorbed through the skin and can affect growth or cause other unwanted effects. Safety and effectiveness have not been established.

Geriatric

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

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection at or near the place of application or


• Large sores, broken skin, or severe injury at the area of application—The chance of side effects may be increased.

Proper Use of hydrocortisone valerate

This section provides information on the proper use of a number of products that contain hydrocortisone valerate. It may not be specific to Westcort. Please read with care.

Use this medicine exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. This medicine may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.

Wash your hands with soap and water before and after using this medicine.

Be very careful not to get this medicine in your eyes. Wash your hands after using your finger to apply the medicine. If you accidentally get this medicine in your eyes, flush them with water.

Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.

Unless otherwise directed by your doctor, do not apply this medicine to open wounds, burns, or broken or inflamed skin.

This medicine should only be used for problems being treated by your doctor. Check with your doctor before using it for other problems, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap or a special patch) to be applied over this medicine, make sure you know how to apply it. Since occlusive dressings increase the amount of medicine absorbed through your skin and the possibility of side effects, use them only as directed. If you have any questions about this, check with your doctor.

Do not use this medicine on the face, groin, or underarms unless directed to do so by your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage forms (cream and ointment):
  
  • For redness, itching, and swelling of the skin:
    
    • Adults—Apply to the affected area of the skin two or three times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Westcort

It is very important that your doctor check your or your child's progress at regular visits for any problems or unwanted effects that may be caused by this medicine.

If your symptoms do not improve within 2 weeks, or if it become worse, check with your doctor.

After applying this medicine to the skin of your child, watch the child carefully to make sure that he or she does not get any of the medicine in the eyes or mouth. This medicine can cause serious side effects, especially in children, if it gets into the mouth and is swallowed.

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 or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Avoid using tight-fitting diapers or plastic pants on a child if this medicine is being used on the child's diaper area. Plastic pants and tight-fitting diapers may increase the chance of absorption of the medicine through the skin and the chance of side effects.

Do not use cosmetics or other skin care products on the treated skin areas.

Westcort 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 immediately if any of the following side effects occur:

More common

• Skin rash, encrusted, scaly, and oozing


• stinging

Less common

• Burning, itching, redness, skin rash, swelling, or soreness at the application site


• cough or hoarseness


• dry skin


• fever or chills


• itching in the genital or other skin areas


• lower back or side pain


• painful or difficult urination


• rash


• rash with flat lesions or small raised lesions on the skin


• skin irritation

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• itching, scaling, severe redness, soreness, or swelling of the skin


• redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on facial or intertriginous areas

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:

Less common

• Diarrhea


• indigestion


• loss of appetite


• nausea or vomiting


• passing of gas


• stomach pain, fullness, or discomfort

Incidence not known

• Acne or pimples


• burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


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


• lightening of normal skin color


• lightening of treated areas of dark skin


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


• softening of the skin

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

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

See also: Westcort Topical application side effects (in more detail)

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• Westcort Topical application Side Effects (in more detail)
• Westcort Topical application Use in Pregnancy & Breastfeeding
• Westcort Topical application Drug Interactions
• Westcort Topical application Support Group
• 1 Review for Westcort Topical application - Add your own review/rating

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