Cerazette 75 microgram film-coated tablet

1. Name Of The Medicinal Product

Cerazette^® 75 microgram film-coated tablet.

2. Qualitative And Quantitative Composition

Each tablet contains 75 microgram desogestrel.

Excipient: lactose <65mg.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Film-coated tablet.

The tablet is white, round, biconvex and 5 mm in diameter. On one side it is coded KV above 2 and on the reverse side Organon _*.

4. Clinical Particulars

4.1 Therapeutic Indications

Contraception.

4.2 Posology And Method Of Administration

4.2.1 How to take Cerazette

Tablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual bleeding. Thereafter one tablet each day is to be taken continuously, without taking any notice on possible bleeding. A new blister is started directly the day after the previous one.

4.2.2 How to start Cerazette

No preceding hormonal contraceptive use [in the past month]

Tablet-taking has to start on day 1 of the woman's natural cycle (day 1 is the first day of her menstrual bleeding). Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended for the first 7 days of tablet-taking.

Following first-trimester abortion

After first-trimester abortion it is recommended to start immediately. In that case there is no need to use an additional method of contraception.

Following delivery or second-trimester abortion

Contraceptive treatment with Cerazette after delivery can be initiated before the menstruations have returned. If more than 21 days have elapsed pregnancy ought to be ruled out and an additional method of contraception should be used for the first week.

For additional information for breastfeeding women see Section 4.6.

How to start Cerazette when changing from other contraceptive methods

Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch).

The woman should start Cerazette preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC or on the day of removal of her vaginal ring or transdermal patch. In these cases, the use of an additional contraceptive is not necessary. Not all contraceptive methods may be available in all EU countries.

The woman may also start at the latest on the day following the usual tablet-free, patch-free, ring-free, or placebo tablet interval of her previous combined hormonal contraceptive, but during the first 7 days of tablet-taking an additional barrier method is recommended.

Changing from a progestogen-only-method (minipill, injection, implant or from a progestogen-releasing intrauterine system [IUS]).

The woman may switch any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due).

4.2.3 Management of missed tablets

Contraceptive protection may be reduced if more than 36 hours have elapsed between two tablets. If the user is less than 12 hours late in taking any tablet, the missed tablet should be taken as soon as it is remembered and the next tablet should be taken at the usual time. If she is more than 12 hours late, she should use an additional method of contraception for the next 7 days. If tablets were missed in the first week and intercourse took place in the week before the tablets were missed, the possibility of a pregnancy should be considered.

4.2.4 Advice in case of gastrointestinal disturbances

In case of severe gastro-intestinal disturbance, absorption may not be complete and additional contraceptive measures should be taken.

If vomiting occurs within 3-4 hours after tablet-taking, absorption may not be complete. In such an event, the advice concerning missed tablets, as given in Section 4.2.3 is applicable.

4.2.5 Treatment surveillance

Before prescription, a thorough case history should be taken and a thorough gynaecological examination is recommended to exclude pregnancy. Bleeding disturbances, such as oligomenorrhoea and amenorrhoea should be investigated before prescription. The interval between check-ups depends on the circumstances in each individual case. If the prescribed product may conceivably influence latent or manifest disease (see Section 4.4), the control examinations should be timed accordingly.

Despite the fact that Cerazette is taken regularly, bleeding disturbances may occur. If bleeding is very frequent and irregular, another contraceptive method should be considered. If the symptoms persist, an organic cause should be ruled out.

Management of amenorrhoea during treatment depends on whether or not the tablets have been taken in accordance with the instructions and may include a pregnancy test.

The treatment should be stopped if a pregnancy occurs.

Women should be advised that Cerazette does not protect against HIV (AIDS) and other sexually transmitted diseases.

4.3 Contraindications

• Known or suspected pregnancy.

• Active venous thromboembolic disorder.

• Presence or history of severe hepatic disease as long as liver function values have not returned to normal.

• Known or suspected sex-steroid sensitive malignancies.

• Undiagnosed vaginal bleeding.

• Hypersensitivity to the active substance or to any of the excipients.

4.4 Special Warnings And Precautions For Use

If any of the conditions/risk factors mentioned below is present, the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start with Cerazette. In the event of aggravation, exacerbation, or first appearance of any of these conditions, the woman should contact her physician. The physician should then decide on whether the use of Cerazette should be discontinued.

The risk for breast cancer increases in general with increasing age. During use of combined oral contraceptives (COCs) the risk of having breast cancer diagnosed is slightly increased. This increased risk disappears gradually within 10 years after discontinuation of OC use and is not related to the duration of use, but to the age of the woman when using the COC. The expected number of cases diagnosed per 10 000 women who use COCs (up to 10 years after stopping) relative to never users over the same period has been calculated for the respective age groups and is presented in the table below.

age group	expected cases COC-users	expected cases non-users
16-19 years	4.5	4
20-24 years	17.5	16
25-29 years	48.7	44
30-34 years	110	100
35-39 years	180	160
40-44 years	260	230

The risk in users of progestogen-only contraceptives (POCs), such as Cerazette, is possibly of similar magnitude as that associated with COCs. However, for POCs the evidence is less conclusive. Compared to the risk of getting breast cancer ever in life, the increased risk associated with COCs is low. The cases of breast cancer diagnosed in COC users tend to be less advanced than in those who have not used COCs. The increased risk in COC users may be due to an earlier diagnosis, biological effects of the pill or a combination of both.

Since a biological effect of progestogens on liver cancer cannot be excluded an individual benefit/risk assessment should be made in women with liver cancer.

When acute or chronic disturbances of liver function occur the woman should be referred to a specialist for examination and advice.

Epidemiological investigations have associated the use of COCs with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). Although the clinical relevance of this finding for desogestrel used as a contraceptive in the absence of an oestrogenic component is unknown, Cerazette should be discontinued in the event of a thrombosis. Discontinuation of Cerazette should also be considered in case of long-term immobilisation due to surgery or illness. Women with a history of thrombo-embolic disorders should be made aware of the possibility of a recurrence.

Although progestogens may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using progestogen-only pills. However, diabetic patients should be carefully observed during the first months of use.

If a sustained hypertension develops during the use of Cerazette, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, the discontinuation of Cerazette should be considered.

Treatment with Cerazette leads to decreased estradiol serum levels, to a level corresponding with the early follicular phase. It is as yet unknown whether the decrease has any clinically relevant effect on bone mineral density.

The protection with traditional progestogen-only pills against ectopic pregnancies is not as good as with combined oral contraceptives, which has been associated with the frequent occurrence of ovulations during the use of progestogen-only pills. Despite the fact that Cerazette consistently inhibits ovulation, ectopic pregnancy should be taken into account in the differential diagnosis if the woman gets amenorrhoea or abdominal pain.

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking Cerazette.

The following conditions have been reported both during pregnancy and during sex steroid use, but an association with the use of progestogens has not been established: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss; (hereditary) angioedema.

Cerazette contains less than 65 mg lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.5.1 Interactions

Interactions between hormonal contraceptives and other medicinal products may lead to breakthrough bleeding and/or contraceptive failure. The following interactions have been reported in the literature (mainly with combined contraceptives but occasionally also with progestogen-only contraceptives).

Hepatic metabolism: Interactions can occur with medicinal products that induce microsomal enzymes, which can result in increased clearance of sex hormones (such as, hydantoins (e.g. phenytoin), barbiturates (e.g. phenobarbital), primidone, carbamazepine, rifampicin, and possibly also for oxcarbazepine, topiramate, rifabutin, felbamate, ritonavir, nelfinavir, griseofulvin and products containing St. John's wort (Hypericum perforatum)).

Maximal enzyme induction is not seen for 2-3 weeks, but may then be sustained for at least 4 weeks after the cessation of drug therapy. Women on treatment with any of these medicinal products should temporarily use a barrier method in addition to Cerazette. With microsomal enzyme-inducing drugs, the barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation. For women on long-term therapy with hepatic enzyme inducers a non-hormonal method of contraception should be considered.

During treatment with medical charcoal, the absorption of the steroid in the tablet may be reduced and thereby the contraceptive efficacy. Under these circumstances, the advice as given for missed tablets in Section 4.2 is applicable.

Hormonal contraceptives may interfere with the metabolism of other drugs. Accordingly, plasma and tissue concentrations may either increase (e.g. cyclosporine) or decrease.

Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.

4.5.2 Laboratory tests

Data obtained with COCs have shown that contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, serum levels of (carrier) proteins, e.g. corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. The changes generally remain within the normal range. To what extent this also applies to progestogen-only contraceptives is not known.

4.6 Pregnancy And Lactation

Animal studies have shown that very high doses of progestogenic substances may cause masculinisation of female foetuses.

Extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used COCs prior to pregnancy, nor a teratogenic effect when COCs were taken inadvertently during early pregnancy. Pharmacovigilance data collected with various desogestrel-containing COCs also do not indicate an increased risk.

Cerazette does not influence the production or the quality (protein, lactose, or fat concentrations) of breast milk. However, small amounts of etonogestrel are excreted in the breast milk. As a result, 0.01 - 0.05 microgram etonogestrel per kg body weight per day may be ingested by the child (based on an estimated milk ingestion of 150 ml/kg/day).

Limited long-term follow-up data are available on children, whose mothers started using Cerazette during the 4^th to 8^th week post-partum. They were breast-fed for 7 months and followed up to 1.5 years (n=32) or to 2.5 years (n= 14) of age. Evaluation of growth and physical and psychomotor development did not indicate any differences in comparison to nursing infants, whose mother used a copper-IUD. Based on the available data Cerazette may be used during lactation. The development and growth of a nursing infant, whose mother uses Cerazette, should, however, be carefully observed.

4.7 Effects On Ability To Drive And Use Machines

Cerazette has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable Effects

The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity has been reported in up to 50% of women using Cerazette. Since Cerazette causes ovulation inhibition close to 100%, in contrast to other progestogen-only pills, irregular bleeding is more common than with other progestogen-only pills. In 20 - 30% of the women, bleeding may become more frequent, whereas in another 20% bleeding may become less frequent or totally absent. Vaginal bleeding may also be of longer duration. After a couple of months of treatment, bleedings tend to become less frequent. Information, counselling, and a bleeding diary can improve the woman's acceptance of the bleeding pattern.

The most commonly reported other undesirable effects in the clinical trials with Cerazette (> 2.5%) were acne, mood changes, breast pain, nausea and weight increase. The undesirable effects mentioned in the table below have been judged, by the investigators, as having an established, probable, or possible link to the treatment.

System Organ Class (MedDRA)*	Frequency of adverse reactions
Common	Uncommon < 1/100,	Rare (<1/1000)
Infections and infestations		Vaginal infection
Psychiatric disorders	Mood altered, Libido decreased
Nervous system disorders	Headache
Eye disorders		Contact lens intolerance
Gastrointestin-al disorders	Nausea	Vomiting
Skin and subcutaneous tissue disorders	Acne	Alopecia	Rash, Urticaria, Erythema nodosum
Reproductive system and breast disorders	Breast pain, Menstruation irregular, Amenorrhoea	Dysmenorrhoea, Ovarian cyst
General disorders and administration site condition		Fatigue
Investigations	Weight increased

* MedDRA version 9.0

Breast discharge may occur during use of Cerazette. On rare occasions, ectopic pregnancies have been reported (See Section 4.4).

In women using (combined) oral contraceptives a number of (serious) undesirable effects have been reported. These include venous thromboembolic disorders, arterial thromboembolic disorders, hormone-dependent tumours (e.g. liver tumours, breast cancer), and chloasma, some of which are discussed in more detail in Section 4.4.

4.9 Overdose

There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are nausea, vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and further treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: hormonal contraceptives for systemic use, ATC code: G03AC09.

Cerazette is a progestogen-only pill, which contains the progestogen desogestrel. Like other progestogen-only pills, Cerazette is best suited for use during breast feeding and for women who may not or do not want to use oestrogens. In contrast to traditional progestogen-only pills, the contraceptive effect of Cerazette is achieved primarily by inhibition of ovulation. Other effects include increased viscosity of the cervical mucus.

When studied for 2 cycles, using a definition of ovulation as a progesterone level greater than 16 nmol/L for 5 consecutive days, the ovulation incidence was found to be 1% (1/103) with a 95% confidence interval of 0.02% - 5.29% in the ITT group (user and method failures). Ovulation inhibition was achieved from the first cycle of use. In this study, when Cerazette was discontinued after 2 cycles (56 continuous days), ovulation occurred on average after 17 days (range 7-30 days).

In a comparative efficacy trial (which allowed a maximum time of 3 hours for missed pills) the overall ITT Pearl-Index found for Cerazette was 0.4 (95% confidence interval 0.09 - 1.20), compared to 1.6 (95% confidence interval 0.42 - 3.96) for 30 μg levonorgestrel.

The Pearl-Index for Cerazette is comparable to the one historically found for COCs in the general COC-using population.

Treatment with Cerazette leads to decreased estradiol levels, to a level corresponding to the early follicular phase. No clinically relevant effects on carbohydrate metabolism, lipid metabolism, and haemostasis have been observed.

5.2 Pharmacokinetic Properties

ABSORPTION

After oral dosing of Cerazette desogestrel (DSG) is rapidly absorbed and converted into etonogestrel (ENG). Under steady-state conditions, peak serum levels are reached 1.8 hours after tablet-intake and the absolute bioavailability of ENG is approximately 70%.

DISTRIBUTION

ENG is 95.5-99% bound to serum proteins, predominantly to albumin and to a lesser extent to SHBG.

METABOLISM

DSG is metabolised via hydroxylation and dehydrogenation to the active metabolite ENG. ENG is metabolised via sulphate and glucuronide conjugation.

ELIMINATION

ENG is eliminated with a mean half-life of approximately 30 hours, with no difference between single and multiple dosing. Steady-state levels in plasma are reached after 4-5 days. The serum clearance after i.v. administration of ENG is approximately 10 l per hour. Excretion of ENG and its metabolites either as free steroid or as conjugates, is with urine and faeces (ratio 1.5:1). In lactating women, ENG is excreted in breast milk with a milk/serum ratio of 0.37-0.55. Based on these data and an estimated milk intake of 150 ml/kg/day, 0.01 - 0.05 microgram etonogestrel maybe ingested by the infant.

5.3 Preclinical Safety Data

Toxicological studies did not reveal any effects other than those, which can be explained from the hormonal properties of desogestrel.

6. Pharmaceutical Particulars

6.1 List Of Excipients

TABLET CORE

Silica, colloidal anhydrous

All-rac-α-tocopherol

Lactose monohydrate

Maize starch

Povidone

Stearic acid.

FILM COATING

Hypromellose

Macrogol 400

Talc

Titanium dioxide (E 171).

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 Years.

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

PVC/Aluminium blister.

Each blister contains 28 tablets. Each carton contains 1, 3 or 6 blisters packed separately in an aluminium laminated sachet.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Organon Laboratories Ltd, Cambridge Science Park, Milton Road, Cambridge, CB4 0FL, UK

8. Marketing Authorisation Number(S)

PL0065/0159

9. Date Of First Authorisation/Renewal Of The Authorisation

09 November 1998/12 December 2007

10. Date Of Revision Of The Text

12 December 2007

Konsyl-Orange

Generic Name: psyllium (SIL ee um)

Brand Names: Fiberall, Hydrocil, Konsyl, Konsyl Orange Sugar-free, Konsyl-D, Konsyl-Orange, Laxmar, Laxmar Orange, Laxmar Sugar Free, Metamucil, Metamucil Berry Burst Smooth Texture Sugar Free, Metamucil Orange Coarse Milled Original Texture, Metamucil Orange Smooth Texture, Metamucil Orange Smooth Texture Sugar Free, Metamucil Original Texture Regular, Metamucil Pink Lemonade Smooth Texture Sugar-Free, Metamucil Unflavored Coarse Milled Original Texture, Metamucil Unflavored Smooth Texture Sugar Free, Natural Fiber Therapy, Perdiem Fiber Powder, Reguloid

What is Konsyl-Orange (psyllium)?

Psyllium is a bulk-forming fiber laxative. Psyllium works by absorbing liquid in the intestines and swelling to create a softer, bulky stool that is easier to pass.

Psyllium is used to treat occasional constipation or bowel irregularity. Psyllium may also be used to treat diarrhea and may help lower cholesterol when used together with a diet low in cholesterol and saturated fat.

Psyllium may also be used for purposes not listed in this product guide.

What is the most important information I should know about Konsyl-Orange (psyllium)?

Laxatives may be habit-forming if they are used too often or for too long. This can lead to damage of intestinal nerves or muscle tissues. Do not take psyllium for longer than directed on the label or prescribed by your doctor. You should not take this product if you are allergic to psyllium, or if you have trouble swallowing, a sudden change in bowel habits that lasts longer than 2 weeks, severe nausea, vomiting, or stomach pain, or if you have ever had a skin rash while taking psyllium.

Also talk with your doctor before using psyllium if you have a colostomy or ileostomy, rectal bleeding, or a blockage in your intestines.

Stop using psyllium and call your doctor at once if you have choking or trouble swallowing, severe stomach pain or cramping, nausea or vomiting, constipation that lasts longer than 7 days, rectal bleeding, or itchy skin rash. Do not take psyllium for longer than 7 days in a row unless your doctor has told you to.

What should I discuss with my healthcare provider before taking Konsyl-Orange (psyllium)?

Laxatives may be habit-forming if they are used too often or for too long. This can lead to damage of intestinal nerves or muscle tissues. Do not take psyllium for longer than directed on the label or prescribed by your doctor. You should not take this product if you are allergic to psyllium, or if you have:

• 
  

  trouble swallowing;

  
  


• 
  

  a sudden change in bowel habits that lasts longer than 2 weeks;

  
  


• 
  

  severe nausea, vomiting, or stomach pain; or

  
  


• 
  

  if you have ever had a skin rash while taking psyllium.

  
  

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  a colostomy or ileostomy;

  
  


• 
  

  rectal bleeding; or

  
  


• 
  

  a blockage in your intestines.

  
  

Psyllium products may contain sugar, sodium, or artificial sweeteners. This may be of concern to you if you have diabetes, high blood pressure, or phenylketonuria (PKU). Check the product label if you have any of these conditions.

Psyllium 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 psyllium 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 Konsyl-Orange (psyllium)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take psyllium with a full glass (at least 8 ounces) of water or another liquid. Taking psyllium without enough liquid may cause it to swell in your throat and cause choking. Drinking plenty of fluids each day while you are taking psyllium will also help improve bowel regularity.

The psyllium wafer must be chewed before you swallow it.

Do not swallow psyllium powder dry. It must be mixed with liquid. Place the psyllium powder into an empty glass and add at least 8 ounces of water or other liquid such as fruit juice. Stir this mixture and drink all of it right away.

If the powder and liquid mixture is too thick, add more liquid. After drinking the entire mixture, add a little more liquid to the same glass, swirl gently and drink right away to make sure you get the entire dose of psyllium.

Psyllium may be only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

It may take up to 3 days of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 2 or 3 days of treatment.

Do not take psyllium for longer than 7 days in a row unless your doctor has told you to. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since psyllium is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using psyllium.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, and stomach pain. Using a laxative too often or for too long may cause severe medical problems involving your intestines.

What should I avoid while taking Konsyl-Orange (psyllium)?

Avoid taking other oral (by mouth) medications within 2 hours before or after you take psyllium. Bulk-forming laxatives can make it harder for your body to absorb other medications, possibly making them less effective.

Avoid breathing in the dust from psyllium powder when mixing. Inhaling psyllium dust may cause an allergic reaction.

If you take psyllium as part of a cholesterol-lowering treatment plan, avoid eating foods that are high in fat or cholesterol. Your treatment will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Konsyl-Orange (psyllium) 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 psyllium and call your doctor at once if you have a serious side effect such as:

• 
  

  choking or trouble swallowing;

  
  


• 
  

  severe stomach pain, cramping, nausea or vomiting;

  
  


• 
  

  constipation that lasts longer than 7 days;

  
  


• 
  

  rectal bleeding; or

  
  


• 
  

  itchy skin rash.

  
  

Less serious side effects may include:

• 
  

  bloating; or

  
  


• 
  

  minor change in your bowel habits.

  
  

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 Konsyl-Orange (psyllium)?

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

• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven); or

  
  


• 
  

  demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and other drugs may interact with psyllium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Konsyl-Orange resources

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

• Konsyl Powder MedFacts Consumer Leaflet (Wolters Kluwer)


• Metamucil MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Konsyl-Orange with other medications

• Constipation
• Dietary Fiber Supplementation
• Irritable Bowel Syndrome

Where can I get more information?

• Your pharmacist can provide more information about psyllium.

See also: Konsyl-Orange side effects (in more detail)

Pediaderm TA

Generic Name: triamcinolone topical (trye am SIN oh lone)

Brand Names: Cinolar, Kenalog, Oralone, Pediaderm TA, Triamcinolone Acetonide in Absorbase, Trianex, Triderm

What is Pediaderm TA (triamcinolone topical)?

Triamcinolone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Triamcinolone topical is used to treat the inflammation caused by a number of conditions such as allergic reactions, eczema, and psoriasis. The dental paste form of triamcinolone is used to treat mouth ulcers.

Triamcinolone topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Pediaderm TA (triamcinolone topical)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with triamcinolone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Avoid using this medication on your face, near your eyes, or on body areas where you have skin folds or thin skin.

Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of triamcinolone topical.

Triamcinolone topical will not treat a bacterial, fungal, or viral skin infection.

Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days.

What should I discuss with my healthcare provider before using Pediaderm TA (triamcinolone topical)?

Do not use this medication if you are allergic to triamcinolone.

To make sure you can safely use triamcinolone topical, tell your doctor if you have any of these other conditions:

• 
  

  any skin infection, especially tuberculosis infection of the skin;

  
  


• 
  

  chicken pox or herpes infection (including cold sores);

  
  


• 
  

  diabetes; or

  
  


• 
  

  a stomach ulcer.

  
  

FDA pregnancy category C. It is not known whether triamcinolone topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether triamcinolone topical 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. Do not use this medication on a child without a doctor's advice. Children are more sensitive to the effects of triamcinolone topical.

How should I use Pediaderm TA (triamcinolone topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Triamcinolone topical will not treat a bacterial, fungal, or viral skin infection.

Wash your hands before and after each application, unless you are using triamcinolone topical to treat a hand condition.

Apply a small amount to the affected area and rub it gently into the skin.

Avoid using this medication on your face, near your eyes or mouth, or on body areas where you have skin folds or thin skin.

If you are using the dental paste, apply the medication in a thin layer, just enough to cover the mouth ulcer. The paste may stick better if you dry the mouth ulcer before applying the medication.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with triamcinolone topical can increase the amount of the drug your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Contact your doctor if your condition does not improve or if it gets worse after using this medication for several days. It is important to use triamcinolone topical regularly to get the most benefit. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222, especially if anyone has accidentally swallowed this medicine. An overdose of triamcinolone topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using Pediaderm TA (triamcinolone topical)?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use triamcinolone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or skin cleansers, or skin products with alcohol, spices, astringents, or lime. Avoid using other medications on the areas you treat with triamcinolone topical unless you doctor tells you to.

Pediaderm TA (triamcinolone topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these signs that you may be absorbing triamcinolone topical through your skin or gums:

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  uneven heartbeats;

  
  


• 
  

  mood changes;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face; or

  
  


• 
  

  feeling tired.

  
  

Less serious side effects may include:

• 
  

  skin redness, burning, itching, or peeling;

  
  


• 
  

  thinning of your skin; or

  
  


• 
  

  blistering skin; or

  
  


• 
  

  stretch marks.

  
  

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 Pediaderm TA (triamcinolone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied triamcinolone topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Pediaderm TA resources

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

• Pediaderm TA Advanced Consumer (Micromedex) - Includes Dosage Information


• Pediaderm TA Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Aristocort A Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Kenalog Consumer Overview


• Kenalog Aerosol Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Oralone Prescribing Information (FDA)


• Triderm Prescribing Information (FDA)

Compare Pediaderm TA with other medications

• Aphthous Ulcer
• Atopic Dermatitis
• Dermatitis
• Lichen Planus
• Psoriasis

Where can I get more information?

• Your pharmacist can provide more information about triamcinolone topical.

See also: Pediaderm TA side effects (in more detail)

Forteo

Pronunciation: TER-i-PAR-a-tide
Generic Name: Teriparatide
Brand Name: Forteo

Forteo has been shown to increase the rate of bone tumors in lab animals. It is not known if there is a higher risk of bone tumors in humans. Forteo should not be used in patients who are at risk for bone tumors, including patients with Paget disease, children and young adults with open epiphyses, prior radiation involving the skeleton, or unexplained high levels of alkaline phosphatase in their blood.

Forteo is used for:

Treating bone weakening (osteoporosis) in men and postmenopausal women who are at high risk for having fractures, have had fractures, or cannot use other osteoporosis treatments. It is also used to treat patients with osteoporosis due to prolonged use of glucocorticoid medicines (eg, prednisone).

Forteo is a man-made (synthetic) form of parathyroid hormone. It works by increasing bone mass and bone strength, which helps decrease your chance of getting a fracture.

Do NOT use Forteo if:

• you are allergic to any ingredient in Forteo


• you have high levels of alkaline phosphatase, calcium, or parathyroid hormone in your blood


• you have deformed bones, softening of the bones (osteomalacia), Paget disease, pseudohypoparathyroidism, or rickets


• you have a history of bone tumors, bone cancer, or other cancers that have spread to your bones


• you have had radiation therapy involving the bones


• you have a bone disease other than osteoporosis


• the patient is a child or young adult whose bones may still be growing


• you are pregnant or breast-feeding

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

Before using Forteo:

Some medical conditions may interact with Forteo. 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 kidney stones


• if you smoke, drink alcohol, or have a history of alcohol abuse or dependence

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

• Digoxin because the risk of its side effects may be increased by Forteo

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

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

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


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


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


• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.


• Using Forteo at the same time each day will help you remember to use it.


• Use Forteo on a regular schedule to get the most benefit from it.


• Use of Forteo for more than 2 years is not recommended.


• 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 Forteo, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

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


• Forteo may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Some patients experience dizziness or a fast heartbeat after the first few doses of Forteo. For the first few doses, inject Forteo where you can sit or lie down right away if you get dizzy or have a fast heartbeat.


• Learn about other means of preventing bone loss, including taking regular calcium or vitamin D supplements, doing weight-bearing exercise, quitting smoking, and limiting alcohol intake.


• Lab tests, including blood calcium levels, uric acid levels, and bone density tests, may be performed while you use Forteo. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Forteo should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Forteo may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Forteo while you are pregnant. It is not known if Forteo is found in breast milk. Do not breast-feed while using Forteo.

Possible side effects of Forteo:

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:

Constipation; diarrhea; headache; increased cough; indigestion; joint pain; leg or back cramps; mild dizziness or fast heartbeat; minor bruising, itching, pain, redness, and swelling at the injection site; nausea; runny nose; sore throat; weakness.

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; unusual hoarseness); blurred vision; chest pain; depression; fainting; persistent fast heartbeat; persistent trouble sleeping; severe or persistent dizziness or lightheadedness when sitting or standing; severe or persistent nausea, vomiting, constipation, muscle weakness, or tiredness; shortness of breath; sudden, severe headache; tooth problems.

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

See also: Forteo side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness or weakness, especially when standing; headache; nausea; vomiting.

Proper storage of Forteo:

Store Forteo in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Do not use Forteo if it has been frozen. Recap the pen after each use. Discard Forteo after 28 days of use, even if it is not completely empty. Keep Forteo out of the reach of children and away from pets.

General information:

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


• Forteo 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 Forteo. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Forteo resources

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

• Forteo Prescribing Information (FDA)


• Forteo Consumer Overview


• Forteo Monograph (AHFS DI)


• Forteo Advanced Consumer (Micromedex) - Includes Dosage Information


• Teriparatide Professional Patient Advice (Wolters Kluwer)

Compare Forteo with other medications

• Osteoporosis

ketorolac Nasal

kee-toe-ROLE-ak

Nasal route(Spray)

For short term use only (up to 5 days in adults). Not for use in pediatric patients and not indicated for minor or chronic pain. Contraindicated in patients with peptic ulcer disease, history of gastrointestinal (GI) bleeding or perforation, peri-operative pain in the setting of CABG surgery, advanced renal impairment, risk of renal failure due to volume depletion, cerebrovascular bleeding, hemorrhagic diathesis, incomplete homeostasis, and high risk of bleeding. Use caution with elderly patients due to high risk of GI adverse events and in patients with cardiovascular disease or risk factors for cardiovascular disease .

Commonly used brand name(s)

In the U.S.

• Sprix

Available Dosage Forms:

• Spray

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Uses For ketorolac

Ketorolac nasal spray is used to relieve moderate to moderately severe pain, such as pain that occurs after an operation or other painful procedure. It is a nonsteroidal anti-inflammatory drug (NSAID) that will reduce pain and inflammation.

Ketorolac has side effects that can be very dangerous. The risk of having a serious side effect increases with the amount that is used and the length of time it is used. Ketorolac should not be used for more than 5 days in a row. Before using ketorolac, you should discuss with your doctor the good that ketorolac can do as well as the risks of using it.

ketorolac is available only with your doctor's prescription.

Before Using ketorolac

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 ketorolac, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ketorolac 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 ketorolac nasal spray in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ketorolac nasal spray in the elderly. However, because of ketorolac's toxicity, it should be used with caution in the elderly, after less toxic alternatives have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during treatment. In addition, elderly patients are more likely to have age-related heart, kidney, liver, stomach, or bowel problems, which may require caution and an adjustment in the dose for patients receiving ketorolac nasal spray.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	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.
2nd Trimester	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.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 taking ketorolac, 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 ketorolac 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.

• Aceclofenac


• Acemetacin


• Alclofenac


• Apazone


• Aspirin


• Benoxaprofen


• Bufexamac


• Carprofen


• Clometacin


• Clonixin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Ibuprofen


• Indomethacin


• Indoprofen


• Isoxicam


• Ketoprofen


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Nabumetone


• Naproxen


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Pentoxifylline


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Probenecid


• Propyphenazone


• Proquazone


• Sulindac


• Suprofen


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Tolmetin


• Zomepirac

Using ketorolac 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.

• Abciximab


• Ardeparin


• Argatroban


• Beclamide


• Beta Glucan


• Bivalirudin


• Caramiphen


• Carbamazepine


• Certoparin


• Chlormethiazole


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Diazepam


• Dipyridamole


• Enoxaparin


• Escitalopram


• Ethotoin


• Felbamate


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Fosphenytoin


• Gabapentin


• Ginkgo


• Heparin


• Lacosamide


• Lepirudin


• Levetiracetam


• Mephenytoin


• Mephobarbital


• Methotrexate


• Nadroparin


• Nefazodone


• Oxcarbazepine


• Paraldehyde


• Paramethadione


• Parnaparin


• Paroxetine


• Pemetrexed


• Phenacemide


• Phenobarbital


• Phenytoin


• Piracetam


• Pregabalin


• Protein C


• Reviparin


• Rivaroxaban


• Rufinamide


• Sertraline


• Sibutramine


• Stiripentol


• Tacrolimus


• Tiagabine


• Ticlopidine


• Tinzaparin


• Tirofiban


• Topiramate


• Trimethadione


• Valproic Acid


• Vigabatrin


• Vilazodone


• Zimeldine


• Zonisamide

Using ketorolac 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.

• Acebutolol


• Acetohexamide


• Alacepril


• Alprenolol


• Amiloride


• Arotinolol


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desvenlafaxine


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Xipamide


• Zofenopril

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

• Anemia or


• Congestive heart failure or


• Crohn's disease, history of or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease or


• Hypertension (high blood pressure) or


• Kidney disease, or history of or


• Liver disease, or history of or


• Stroke, history of or


• Ulcerative colitis, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma, history of or


• Aspirin sensitivity, history of or


• Bleeding problems or


• Kidney disease, severe or


• Major surgery, prior to or


• Stomach ulcers or bleeding, or history of—Should not be used in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

Proper Use of ketorolac

Take ketorolac only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not use it for more than 5 days in a row. The total number of days also includes any doses of ketorolac that may be given in a hospital or clinic setting. Using too much of ketorolac increases the chance of side effects, especially in elderly patients.

ketorolac should come with a medication guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

ketorolac is only used in the nose. Do not get any of it in your eyes. If it does get in the eyes, rinse them with water right away and call your doctor.

Drink extra fluids while you are using ketorolac. This will keep your kidneys working well and help prevent kidney problems.

To use:

• If you are using the nasal spray for the first time, you will need to prime the spray. To do this, pump the bottle five times until some of the medicine sprays out. Now it is ready to use.


• Gently blow your nose to clear the nostrils.


• Sit or stand up straight and tilt your head slightly forward.


• Insert the tip of the bottle into your right nostril. Point the bottle away from the center of your nose.


• Spray once into your right nostril. If your dose is 2 sprays, spray once into your left nostril the same way.


• After using the spray, wipe the tip of the bottle with a clean tissue and put the clear plastic cover back on.


• Do not use the bottle for more than 24 hours after your first dose. Throw the bottle away after 24 hours even if it still has liquid in it.

Dosing

The dose of ketorolac 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 ketorolac. 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 nasal dosage form (spray):
  
  • For pain:
    
    • Adults weighing 50 kilograms (kg) or more—31.5 milligrams (mg) or 1 spray in each nostril every 6 to 8 hours. Your doctor may adjust your dose if needed. However, the dose is usually not more than 126 mg (a total of 8 sprays) per day.
    
    
    • Older adults and adults weighing less than 50 kg—15.75 mg or 1 spray in only one nostril every 6 to 8 hours. However, the dose is usually not more than 63 mg (a total of 4 sprays) per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of ketorolac, take 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. Do not double doses.

Storage

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.

Keep the unopened bottle in the refrigerator. Protect it from light and freezing. Once opened, store the bottle at room temperature, away from heat and direct sunlight. Throw away any unused medicine 24 hours after you opened the bottle and used your first dose.

Precautions While Using ketorolac

It is very important that your doctor check your progress while you are using ketorolac. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

Do not use any other form of ketorolac (such as injection or tablets) or other NSAIDs unless your doctor says it is okay. Some examples of NSAIDs are aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Ecotrin®, Motrin®, or Voltaren®. Also, you should not use ketorolac together with pentoxifylline (Trental®) or probenecid (Benemid®).

Ketorolac may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner). Stop using ketorolac and call your doctor right away if you have bloody or black, tarry stools; severe stomach pain or heartburn; or vomiting of blood or material that looks like coffee grounds.

ketorolac 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 have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using ketorolac.

Ketorolac may increase your risk of having a heart attack. This is more likely in people who already have heart disease. Stop using ketorolac and call your doctor right away if you have chest pain or discomfort; an irregular or fast heart beat; severe indigestion or heartburn; nausea; sweating; or troubled breathing with exertion.

Serious skin reactions can occur during treatment with ketorolac. Stop using ketorolac and check with your doctor right away if you have any of the following symptoms while you are using ketorolac: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

Check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

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.

ketorolac 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

• Abdominal or stomach pain, cramping, or burning


• bloody or black, tarry stools


• blurred vision


• constipation


• diarrhea


• dizziness


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


• headache


• heartburn


• indigestion


• nausea


• nervousness


• pale skin


• pounding in the ears


• severe stomach pain


• sweating


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds

Less common

• Burning feeling in the chest or stomach


• chest pain or discomfort


• decrease in amount or frequency of urine


• difficult or labored breathing


• frequent urge to urinate


• frequent urination


• increased amount of pale, dilute urine


• lightheadedness, dizziness, or fainting


• rapid, shallow breathing


• shortness of breath


• troubled breathing with exertion

Rare

• Bleeding gums


• bloody or cloudy urine


• blue lips and fingernails


• chills


• clay-colored stools


• confusion


• cough or hoarseness


• coughing that sometimes produces a pink frothy sputum


• dark urine


• difficult, burning, or painful urination


• difficulty with swallowing


• dilated neck veins


• extreme fatigue


• general tiredness and weakness


• increased blood pressure


• increased sweating


• increased thirst


• itching or hives


• light-colored stools


• lower back or side pain


• nosebleeds


• pain or burning in the throat


• pinpoint red spots on the skin


• rash


• rectal bleeding


• sores, ulcers, or white spots on the lips or tongue or inside the mouth


• stomach upset


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


• swollen glands


• tenderness in the stomach area


• tightness in the chest


• unpleasant breath odor


• upper right abdominal pain


• vomiting


• weight gain or loss


• wheezing


• yellow eyes or skin

Incidence not known

• Blistering, peeling, or loosening of the skin


• bloating


• change in consciousness


• convulsions


• difficulty with moving


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


• feeling of warmth


• feeling that others are watching you or controlling your behavior


• feeling, seeing, or hearing things that are not there


• fever with or without chills


• general body swelling


• joint or muscle pain


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


• loss of consciousness


• muscle aching or cramping


• muscle pains or stiffness


• pain or discomfort in the arms, jaw, back, or neck


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale or blue lips, fingernails, or skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• red skin lesions, often with a purple center


• red, irritated eyes


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


• redness, soreness, or itching skin


• severe mood or mental changes


• sneezing


• sores, welting, or blisters


• swollen joints


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• weakness or heaviness of the legs

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

More common

• Acid or sour stomach


• belching


• continuing ringing or buzzing or other unexplained noise in the ears


• drowsiness


• excess air or gas in the stomach or intestines


• full feeling


• hearing loss


• nasal discomfort


• passing gas


• swelling or inflammation of the mouth

Less common

• Runny nose


• stuffy nose


• watering of the eyes

Rare

• Abnormal dreams


• abnormal taste


• appetite changes


• bloody nose


• bruising


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• decreased awareness or responsiveness


• delusions


• dementia


• difficulty with speaking


• drooling


• excessive thirst


• false or unusual sense of well-being


• feeling of constant movement of self or surroundings


• feeling sad or empty


• general feeling of discomfort or illness


• inability to concentrate


• increase in body movements


• irritability


• lack or loss of strength


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


• loss of balance control


• loss of interest or pleasure


• muscle trembling, jerking, or stiffness


• redness, swelling, or soreness of the tongue


• restlessness


• seeing, hearing, or feeling things that are not there


• sensation of spinning


• shakiness in the legs, arms, hands, or feet


• shuffling walk


• sleepiness or unusual drowsiness


• sleeplessness


• tiredness


• trouble concentrating


• trouble sleeping


• uncontrolled movements, especially of the face, neck, and back


• weight loss

Incidence not known

• Burning, dry, or itching eyes


• eye discharge or excessive tearing


• flushed, dry skin


• fruit-like breath odor


• increased hunger


• increased urination


• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid


• stiff neck or back


• unexplained weight loss

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.

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Fucidin Cream

Fucidin Cream

fusidic acid

Please read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects become serious, or you notice any side effects not listed in this
  leaflet please tell your doctor or pharmacist.

In this leaflet:

• 1. What Fucidin Cream is and what it is used for


• 2. Before you use Fucidin Cream


• 3. How to use Fucidin Cream


• 4. Possible side effects


• 5. How to store Fucidin Cream


• 6. Further information

What Fucidin Cream Is And What It Is Used For

Fucidin Cream contains fusidic acid. It is a type of antibiotic.

Fucidin Cream works by killing germs (bacteria) that cause infections.

Fucidin Cream is used to treat conditions where the skin is infected by germs (bacteria), such as:

• Impetigo (a weeping, crusty and swollen patch of skin)


• Infected dermatitis (inflammation of the skin) and spots


• Infected cuts and grazes.

Before You Use Fucidin Cream

Do not use Fucidin Cream

• If you are allergic (hypersensitive) to fusidic acid.


• If you are allergic (hypersensitive) to any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.

Take special care with Fucidin Cream

• Take special care if you are going to use this medicine near your eyes or the eyes of a child.


• If you use the cream over a long time or in large amounts it may make the chance of getting any side effects higher. Also your skin may get more sensitive to this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

Pregnancy and breast-feeding

Please ask your doctor or pharmacist for advice before using Fucidin Cream:

• If you are pregnant, or think you are pregnant. You must not use your medicine for a long time or in large amounts. You must ask your doctor for advice.


• If you are breast-feeding.

Tell your doctor if you become pregnant while using this medicine.

Driving and using machines

Usually your medicine will have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.

Important information about some of the ingredients of Fucidin Cream

Fucidin Cream contains:

• Butylhydroxyanisole (E320). This may give you an itchy rash and inflammation on your skin where your medicine is used. This may also cause irritation to the eyes and mucous membranes (such as lips or genital area).


• Cetyl alcohol. This may give you an itchy rash and inflammation on your skin where your medicine is used.


• Potassium sorbate. This may give you an itchy rash and inflammation on your skin where your medicine is used.

Please ask your doctor if you are worried about any of the ingredients in this medicine.

How To Use Fucidin Cream

Always use Fucidin Cream exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How to put on Fucidin Cream

This medicine is only for using on your skin or the skin of a child. Do not swallow it. Do not put it inside your body.

Remove the cap. Check the seal is not broken before you first use the cream. Then push the spike in the cap through the seal on the tube.

Always wash your hands before using Fucidin Cream. Rub the medicine gently on the skin. If you use it on your face be careful to avoid your eyes.

Unless you are using the cream to treat your hands, always wash your hands after using Fucidin Cream.

If you accidentally get any medicine in your eye, wash it out with cold water straight away. Then bathe your eye with eyewash if possible. Your eye may sting. If you start to have any problems with your sight or your eye is sore, contact your doctor immediately.

How much Fucidin Cream to use

Your doctor will tell you how much Fucidin Cream to use.

Usually, you should use this medicine three or four times each day.

If you have been told to cover the skin with any dressings or bandages you may not need to use the medicine so often. A nappy on a baby may act as a dressing. Follow the advice of your doctor.

If you forget to use Fucidin Cream

If you forget to use this medicine, use it as soon as you remember. Then next use this medicine at the usual time.

If you have any further questions about using this medicine, please ask your doctor or pharmacist.

Fucidin Cream Side Effects

Like all medicines, Fucidin Cream can cause side effects, although not everybody gets them.

Important side effects to look out for:

You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:

• You have difficulty breathing


• Your face or throat swell


• Your skin develops a severe rash.

Other possible side effects:

Skin problems

• Rash


• Stinging and irritation


• Itchy rash and skin inflammation in the area where the medicine is used.

If any of the side effects become serious or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

How To Store Fucidin Cream

• Keep out of the reach and the sight of children.


• Do not use Fucidin Cream after the expiry date on the carton. The expiry date is the last day of that month.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need any more. If you do this you will help protect the environment.

Further Information

What Fucidin Cream contains

• The active ingredient is fusidic acid 2%.


• The other ingredients are butylhydroxyanisole (E320), cetyl alcohol, glycerol, liquid paraffin, polysorbate 60, potassium sorbate, purified water and white soft paraffin.

You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet.

What Fucidin Cream looks like and contents of the pack

Fucidin Cream is a white to off-white cream.

Fucidin Cream comes in tubes of 15 g and 30 g.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

LEO Laboratories Limited

Princes Risborough

Bucks.

HP27 9RR

UK

Manufacturer:

LEO Laboratories Limited

Dublin 12

Ireland

This leaflet was last revised in March 2008.

Registered Trade Mark

LEO

014158-01