Go PLR Articles Directory Brunei: July 2012

Sunday 29 July 2012

fenofibrate

fen-oh-FYE-brate

Commonly used brand name(s)

In the U.S.

Antara

Fenoglide

Lipofen

Lofibra

Tricor

Triglide

Available Dosage Forms:

Tablet

Capsule

Therapeutic Class: Antihyperlipidemic

Chemical Class: Fibric Acid

Uses For fenofibrate

Fenofibrate is used together with a proper diet to treat high cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent the development of pancreatitis (inflammation of the pancreas) caused by high levels of triglycerides in the blood.

fenofibrate is available only with your doctor's prescription.

Before Using fenofibrate

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 fenofibrate, the following should be considered:

In addition to its helpful effects in treating your medical problem, this type of medicine may have some harmful effects. Results of large studies using other agents that are similar to fenofibrate seem to suggest that fenofibrate may increase the patient's risk of cancer, pancreatitis (inflammation of the pancreas), gallstones, and problems from gallbladder surgery. Studies with fenofibrate in rats found an increased risk of liver and pancreatic tumors when doses up to 6 times the human dose were given for a long time. Be sure you have discussed this with your doctor before taking fenofibrate.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fenofibrate 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 fenofibrate 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 fenofibrate in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving fenofibrate.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fenofibrate, 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 fenofibrate 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.

Acenocoumarol

Anisindione

Atorvastatin

Cerivastatin

Dicumarol

Fluvastatin

Lovastatin

Phenindione

Phenprocoumon

Pitavastatin

Pravastatin

Rosuvastatin

Simvastatin

Warfarin

Using fenofibrate 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.

Colchicine

Colestipol

Cyclosporine

Ezetimibe

Glimepiride

Rosiglitazone

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.

Proper Use of fenofibrate

Use fenofibrate only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered.

In addition to fenofibrate, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's order about any special diet.

fenofibrate is usually taken once a day. Take the medicine at the same time each day to maintain the medication's effect.

Fenoglide®, Lipofen®, and Lofibra™ should be taken with a meal. Antara™, Tricor®, and Triglide™ can be taken with or without a meal.

Swallow Tricor® tablet whole. Do not break, crush, or chew it.

Dosing

The dose of fenofibrate 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 fenofibrate. 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 oral dosage form (capsules):
- For high cholesterol:
  - Adults—
    - Antara™: 130 milligrams (mg) once a day with a meal.
    - Lipofen®: At first, 150 mg once a day with a meal. Your doctor may adjust your dose as needed.
    - Lofibra™: 200 mg once a day with a meal.
  - Children—Use and dose must be determined by your doctor.
- For high triglycerides or fats:
  - Adults—
    - Antara™: At first, 43 milligrams (mg) once a day with a meal. Your doctor may increase your dose as needed.
    - Lipofen®: At first, 50 to 150 mg once a day with a meal. Your doctor may increase your dose as needed. However, the dose is usually not more than 150 mg per day.
    - Lofibra™: At first, 67 mg once a day with a meal. Your doctor may increase your dose as needed.
  - Children—Use and dose must be determined by your doctor.

For oral dosage form (tablets):
- For high cholesterol:
  - Adults—
    - Fenoglide®: At first, 120 milligrams (mg) per day. Your doctor may adjust your dose as needed.
    - Tricor®: At first, 145 mg once a day. Your doctor may adjust your dose as needed.
    - Triglide®: 160 mg once a day.
  - Children—Use and dose must be determined by your doctor.
- For high triglycerides or fats:
  - Adults—
    - Fenoglide®: At first, 40 to 120 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 120 mg per day.
    - Tricor®: At first, 48 to 145 mg once a day. Your doctor may increase your dose as needed.
    - Triglide®: At first, 50 to 160 mg once a day. Your doctor may increase your dose as needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of fenofibrate, 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

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 fenofibrate

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride (fat) levels and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of a serious muscle problem called myopathy.

Stop using fenofibrate and check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Pancreatitis may occur while you are using fenofibrate. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

fenofibrate may increase your risk of having gallstones. Check with your doctor right away if you have severe stomach pain with nausea and vomiting.

Serious skin reactions can occur with fenofibrate. Check with your doctor right away if you have any of the following symptoms while using fenofibrate: blistering, peeling, or loosening of the skin; chills; diarrhea; itching; joint or muscle pain; rash; red skin lesions, often with a purple center; 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 signs of a fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cell counts, which may be caused by fenofibrate.

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.

fenofibrate 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:

Less common

Chills

fever

hives

itching

muscle aches and pains

nausea or vomiting

skin rash

Rare

Bloating or pain of the stomach

chronic indigestion

cough

dark urine

general ill feeling

loss of appetite

muscle cramps, pain, stiffness, swelling, or weakness

shortness of breath or troubled breathing

sore throat

unusual bleeding or bruising

unusual tiredness

yellow eyes or skin

Incidence not known

Bloody urine

constipation

decreased frequency or amount of urine

difficulty with moving

fast heartbeat

general tiredness and weakness

increased blood pressure

increased thirst

indigestion

light-colored stools

lower back or side pain

muscle cramps or spasms

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

pale skin

swelling of the face, fingers, or lower legs

swollen joints

troubled breathing

troubled breathing with exertion

upper right abdominal or stomach pain

vomiting

weight gain

yellow eyes or skin

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

Chest congestion

difficulty with breathing

runny nose

sneezing

sore throat

stuffy nose

Less common

Back pain

belching

decreased sexual drive

diarrhea

dizziness

eye irritation

headache

increased sensitivity of the skin to sunlight

lack or loss of strength

nausea

Incidence not known

Lack or loss of strength

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: fenofibrate side effects (in more detail)

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More fenofibrate resources

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

Fenofibrate Monograph (AHFS DI)

Fenofibrate Prescribing Information (FDA)

Fenofibrate MedFacts Consumer Leaflet (Wolters Kluwer)

Fenofibrate Professional Patient Advice (Wolters Kluwer)

Antara Prescribing Information (FDA)

Fenoglide Prescribing Information (FDA)

Lipofen Prescribing Information (FDA)

Lipofen MedFacts Consumer Leaflet (Wolters Kluwer)

Lofibra Prescribing Information (FDA)

Tricor Consumer Overview

Tricor Prescribing Information (FDA)

Triglide Prescribing Information (FDA)

Compare fenofibrate with other medications

Hyperlipoproteinemia
Hyperlipoproteinemia Type IIa, Elevated LDL
Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
Hyperlipoproteinemia Type IV, Elevated VLDL
Hyperlipoproteinemia Type V, Elevated Chylomicrons VLDL
Hypertriglyceridemia

NovoSeven 1 mg (50KIU) powder and solvent for solution for injection. NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection. NovoSeven 5 mg (250 KIU) powder and solvent for solution for injection.

1. Name Of The Medicinal Product

NovoSeven

2. Qualitative And Quantitative Composition

NovoSeven is presented as powder and solvent for solution for injection containing

1 mg eptacog alfa (activated) per vial (corresponds to 50 KIU/vial).

2 mg eptacog alfa (activated) per vial (corresponds to 100 KIU/vial).

5 mg eptacog alfa (activated) per vial (corresponds to 250 KIU/vial).

8 mg eptacog alfa (activated) per vial (corresponds to 400 KIU/vial).

1 KIU equals 1000 IU (International Units).

eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) with a molecular mass of approximately 50,000 Dalton produced in baby hamster kidney cells (BHK Cells) by recombinant DNA technology.

After reconstitution, the product contains 1 mg/ml eptacog alfa (activated) and 10 mg/ml sucrose when reconstituted with solvent.

For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Powder and solvent for solution for injection.

White lyophilized powder. Solvent: clear colourless solution. The reconstituted solution has a pH of approximately 6.0.

4. Clinical Particulars

4.1 Therapeutic Indications

NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:

• in patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX > 5 Bethesda Units (BU)

• in patients with congenital haemophilia who are expected to have a high anamnestic response to factor VIII or factor IX administration

• in patients with acquired haemophilia

• in patients with congenital FVII deficiency

• in patients with Glanzmann's thrombasthenia with antibodies to GP IIb - IIIa and/or HLA, and with past or present refractoriness to platelet transfusions.

4.2 Posology And Method Of Administration

Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders.

Posology

Haemophilia A or B with inhibitors or expected to have a high anamnestic response

Dose

NovoSeven should be given as early as possible after the start of a bleeding episode. The recommended initial dose, administered by intravenous bolus injection, is 90 μg per kg body weight.

Following the initial dose of NovoSeven further injections may be repeated. The duration of treatment and the interval between injections will vary with the severity of the haemorrhage, the invasive procedures or surgery being performed.

Dosing in children

Current clinical experience does not warrant a general differentiation in dosing between children and adults, although children have faster clearance than adults. Therefore, higher doses of rFVIIa may be needed in paediatric patients to achieve similar plasma concentrations as in adult patients (see Section 5.2).

Dose interval

Initially 2 - 3 hours to obtain haemostasis.

If continued therapy is needed, the dose interval can be increased successively once effective haemostasis is achieved to every 4, 6, 8 or 12 hours for as long as treatment is judged as being indicated.

Mild to moderate bleeding episodes (including home therapy)

Early intervention has been shown to be efficacious in the treatment of mild to moderate joint, muscle and mucocutaneous bleeds. Two dosing regimens can be recommended:

1) Two to three injections of 90 µg per kg body weight administered at three-hour intervals

If further treatment is required, one additional dose of 90 µg per kg body weight can be administered

2) One single injection of 270 µg per kg body weight

The duration of the home therapy should not exceed 24 hours.

There is no clinical experience with administration of a single dose of 270 µg per kg body weight in elderly patients.

Serious bleeding episodes

An initial dose of 90 µg per kg body weight is recommended and could be administered on the way to the hospital where the patient is usually treated. The following dose varies according to the type and severity of the haemorrhage. Dosing frequency should initially be every second hour until clinical improvement is observed. If continued therapy is indicated, the dose interval can then be increased to 3 hours for 1 - 2 days. Thereafter, the dose interval can be increased successively to every 4, 6, 8 or 12 hours for as long as treatment is judged as being indicated. A major bleeding episode may be treated for 2 - 3 weeks but can be extended beyond this if clinically warranted.

Invasive procedure/surgery

An initial dose of 90 µg per kg body weight should be given immediately before the intervention. The dose should be repeated after 2 hours and then at 2 - 3 hour intervals for the first 24 - 48 hours depending on the intervention performed and the clinical status of the patient. In major surgery, the dose should be continued at 2 - 4 hour intervals for 6 - 7 days. The dose interval may then be increased to 6 - 8 hours for another 2 weeks of treatment. Patients undergoing major surgery may be treated for up to 2 - 3 weeks until healing has occurred.

Acquired Haemophilia

Dose and dose interval

NovoSeven should be given as early as possible after the start of a bleeding episode. The recommended initial dose, administered by intravenous bolus injection, is 90 µg per kg body weight. Following the initial dose of NovoSeven further injections may be given if required. The duration of treatment and the interval between injections will vary with the severity of the haemorrhage, the invasive procedures or the surgery being performed.

The initial dose interval should be 2 - 3 hours. Once haemostasis has been achieved, the dose interval can be increased successively to every 4, 6, 8 or 12 hours for as long as treatment is judged to be indicated.

Factor VII deficiency

Dose, dose range and dose interval

The recommended dose range for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 15 - 30 μg per kg body weight every 4 - 6 hours until haemostasis is achieved. Dose and frequency of injections should be adapted to each individual.

Glanzmann's thrombasthenia

Dose, dose range and dose interval

The recommended dose for treatment of bleeding episodes and for the prevention of bleeding in patients undergoing surgery or invasive procedures is 90 µg (range 80 - 120 µg) per kg body weight at intervals of two hours (1.5 - 2.5 hours). At least three doses should be administered to secure effective haemostasis. The recommended route of administration is bolus injection as lack of efficacy may appear in connection with continuous infusion.

For those patients who are not refractory, platelets are the first line treatment for Glanzmann's thrombasthenia.

Method of administration

Reconstitute the solution as described under section 6.6 and administer as an intravenous bolus injection over 2 - 5 minutes.

Monitoring of treatment – laboratory tests

There is no requirement for monitoring of NovoSeven therapy. Severity of bleeding condition and clinical response to NovoSeven administration must guide dosing requirements.

After administration of rFVIIa, prothrombin time (PT) and activated partial thromboplastin time (aPTT) have been shown to shorten, however no correlation has been demonstrated between PT and aPTT and clinical efficacy of rFVIIa.

4.3 Contraindications

Hypersensitivity to the active substance, or to any of the excipients, or to mouse, hamster or bovine protein.

4.4 Special Warnings And Precautions For Use

In pathological conditions in which tissue factor may be expressed more extensively than considered normal, there may be a potential risk of development of thrombotic events or induction of Disseminated Intravascular Coagulation (DIC) in association with NovoSeven treatment.

Such situations may include patients with advanced atherosclerotic disease, crush injury, septicaemia or DIC. Because of the risk of thromboembolic complications, caution should be excercised when administering NovoSeven to patients with a history of coronary heart disease, to patients with liver disease, to patients post-operatively, to neonates, or to patients at risk of thromboembolic phenomena or disseminated intravascular coagulation. In each of these situations, the potential benefit of treatment with NovoSeven should be weighed against the risk of these complications.

As recombinant coagulation factor VIIa NovoSeven may contain trace amounts of mouse IgG, bovine IgG and other residual culture proteins (hamster and bovine serum proteins), the remote possibility exists that patients treated with the product may develop hypersensitivity to these proteins. In such cases treatment with antihistamines i.v. should be considered.

If allergic or anaphylactic-type reactions occur, the administration should be discontinued immediately. In case of shock, standard medical treatment for shock should be implemented. Patients should be informed of the early signs of hypersensitivity reactions. If such symptoms occur, the patient should be advised to discontinue use of the product immediately and contact their physician.

In case of severe bleeds the product should be administered in hospitals preferably specialized in treatment of haemophilia patients with coagulation factor VIII or IX inhibitors, or if not possible in close collaboration with a physician specialized in haemophilia treatment.

If bleeding is not kept under control hospital care is mandatory. Patients/carers should inform the physician/supervising hospital at the earliest possible opportunity about all usages of NovoSeven.

Factor VII deficient patients should be monitored for prothrombin time and factor VII coagulant activity before and after administration of NovoSeven. In case the factor VIIa activity fails to reach the expected level or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed. The risk of thrombosis in factor VII deficient patients treated with NovoSeven is unknown.

Patients with rare hereditary problems of fructose intolerance, glucose malabsorption or sucrose-isomaltase insufficiency should not take this medicine

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The risk of a potential interaction between NovoSeven and coagulation factor concentrates is unknown. Simultaneous use of prothrombin complex concentrates, activated or not, should be avoided.

Anti-fibrinolytics have been reported to reduce blood loss in association with surgery in haemophilia patients, especially in orthopaedic surgery and surgery in regions rich in fibrinolytic activity, such as the oral cavity. Experience with concomitant administration of anti-fibrinolytics and rFVIIa treatment is however limited.

4.6 Pregnancy And Lactation

Pregnancy

As a precautionary measure, it is preferable to avoid use of NovoSeven during pregnancy. Data on a limited number of exposed pregnancies within approved indications indicate no adverse effects of rFVIIa 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 (see Section 5.3).

Lactation

It is unknown whether rFVIIa is excreted in human breast milk. The excretion of rFVIIa in milk has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with NovoSeven should be made taking into account the benefit of breast-feeding to the child and the benefit of NovoSeven therapy to the woman.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable Effects

The frequencies of both serious and non-serious adverse drug reactions are listed by system organ classes in the table below.

Blood and the lymphatic system disorders
Rare (> 1/10,000, < 1/1,000)	– Disseminated intravascular coagulation and related laboratory findings including elevated levels of D-dimer and decreased levels of AT (see Section 4.4) – Coagulopathy.
Immune system disorders
Rare (> 1/10,000, < 1/1,000)	– Hypersensitivity, (see Sections 4.3 and 4.4)
Not known	– Anaphylactic reaction.
Nervous system disorders
Rare (> 1/10,000, < 1/1,000)	– Headache.
Vascular disorders
Rare (> 1/10,000, < 1/1,000)	– Arterial thromboembolic events (myocardial infarction, cerebral infarction, cerebral ischaemia, cerebral artery occlusion, cerebrovascular accident, renal artery thrombosis, peripheral ischaemia, peripheral arterial thrombosis and intestinal ischaemia) – Angina pectoris
Uncommon (> 1/1,000, < 1/100)	– Venous thromboembolic events (deep vein thrombosis, thrombosis at i.v. site, pulmonary embolism, thromboembolic events of the liver including portal vein thrombosis, renal vein thrombosis, thrombophlebitis, superficial thrombophlebitis and intestinal ischaemia)
Not known	– Intracardiac thrombus
Gastrointestinal disorders
Rare (> 1/10,000, < 1/1,000)	– Nausea.
Skin and subcutaneous disorders
Uncommon (> 1/1,000, < 1/100)	– Rash (including allergic dermatitis and rash erythematous) – Pruritus and urticaria
Not known	– Flushing – Angioedema.
General disorders and administration site conditions
Uncommon (> 1/1,000, < 1/100)	– Therapeutic response decreased* – Pyrexia
Rare (> 1/10,000, < 1/1,000)	– Injection site reaction including injection site pain.
Investigations
Rare (> 1/10,000, < 1/1,000)	– Increased fibrin degradation products – Increase in alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase and prothrombin.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adverse drug reaction reported post-marketing only (i.e. not in clinical trials) are presented with a frequency of not known.

* Lack of efficacy (therapeutic response decreased) has been reported. It is important that the dosage regimen of NovoSeven is compliant with the recommended dosage as stated in Section 4.2.

Patients with acquired haemophilia

Clinical trials conducted in 61 patients with acquired haemophilia with a total of 100 treatment episodes, showed that certain adverse drug reactions were reported more frequent (1% based on treatment episodes): Arterial thromboembolic events (cerebral artery occlusion, cerebrovascular accident), venous thromboembolic events (pulmonary embolism and deep vein thrombosis), angina pectoris, nausea, pyrexia, erythematous rash and investigation of increased levels of fibrin degradation products.

Inhibitory antibody formation

In post-marketing experience, there have been no reports of antibodies against NovoSeven or FVII in patients with haemophilia A or B.

In clinical trials of patients with factor VII deficiency, formation of antibodies against NovoSeven and FVII is the only adverse drug reaction reported (frequency: common (in vitro. Risk factors that may have contributed to antibody development including previous treatment with human plasma and/or plasma-derived factor VII, severe mutation of FVII gene, and overdose of NovoSeven, were present. Patients with factor VII deficiency treated with NovoSeven should be monitored for factor VII antibodies, (see Section 4.4).

Thromboembolic events

When NovoSeven is administered to patients outside approved indications, arterial thromboembolic events are common (

Safety and efficacy of NovoSeven have not been established outside the approved indications and therefore NovoSeven should not be used.

Thromboembolic events may lead to cardiac arrest.

4.9 Overdose

Dose limiting toxicities of NovoSeven have not been investigated in clinical trials.

Three cases of overdose have been reported in patients with haemophilia in 13 years. The only complication reported in connection with an overdose was a slight transient increase in blood pressure in a 16 year-old patient receiving 24 mg rFVIIa instead of 5.5 mg.

No cases of overdose have been reported in patients with acquired haemophilia or Glanzmann's thrombasthenia.

In patients with factor VII deficiency, where the recommended dose is 15 – 30 µg/kg rFVIIa, one episode of overdose has been associated with a thrombotic event (occipital stroke) in an elderly (> 80 year) male patient treated with 10 – 20 times the recommended dose. In addition, the development of antibodies against NovoSeven and FVII has been associated with overdose in one patient with factor VII deficiency.

The dose schedule should not be intentionally increased above the recommended doses due to the absence of information on the additional risk that may be incurred.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Blood coagulation factors, ATC code: B02BD08

NovoSeven contains activated recombinant coagulation factor VII. The mechanism of action includes the binding of factor VIIa to exposed tissue factor. This complex activates factor IX into factor IXa and factor X into factor Xa, leading to the initial conversion of small amounts of prothrombin into thrombin. Thrombin leads to the activation of platelets and factors V and VIII at the site of injury and to the formation of the haemostatic plug by converting fibrinogen into fibrin. Pharmacological doses of NovoSeven activate factor X directly on the surface of activated platelets, localized to the site of injury, independently of tissue factor. This results in the conversion of prothrombin into large amounts of thrombin independently of tissue factor. Accordingly, the pharmacodynamic effect of factor VIIa gives rise to an increased local formation of factor Xa, thrombin and fibrin.

A theoretical risk for the development of systemic activation of the coagulation system in patients suffering from underlying diseases predisposing them to DIC cannot be totally excluded.

5.2 Pharmacokinetic Properties

Healthy subjects

Using the FVII clotting assay, the pharmacokinetics of rFVIIa were investigated in 35 healthy Caucasian and Japanese subjects in a dose-escalation study. Subjects were stratified according to sex and ethnic group and dosed with 40, 80 and 160 µg rFVIIa per kg body weight and/or placebo (3 doses each). The pharmacokinetic profiles indicated dose proportionality. The pharmacokinetics were similar across sex and ethnic groups. The mean steady state volume of distribution ranged from 130 to 165 ml/kg, the mean values of clearance ranged from 33.3 to 37.2 ml/h×kg, and the mean terminal half-life ranged from 3.9 to 6.0 hours.

Haemophilia A and B with inhibitors

Using the FVIIa assay, the pharmacokinetic properties of rFVIIa were studied in 12 paediatric (2 - 12 years) and 5 adult patients in non bleeding state. Dose proportionality was established in children for the investigated doses of 90 and 180 µg per kg body weight, which is in accordance with previous findings at lower doses (17.5 - 70 µg/kg rFVIIa). Mean clearance was approximately 50% higher in paediatric patients relative to adults (78 versus 53 ml/h×kg), whereas the mean terminal half life was determined to 2.3 hours in both groups. Mean volume of distribution at steady state was 196 ml/kg in paediatric patients versus 159 ml/kg in adults. Clearance appears related with age, therefore in younger patients clearance may be increased by more than 50%.

Factor VII deficiency

Single dose pharmacokinetics of rFVIIa, 15 and 30 μg per kg body weight, showed no significant difference between the two doses used with regard to dose-independent parameters: total body clearance (70.8 - 79.1 ml/h×kg), volume of distribution at steady state (280 - 290 ml/kg), mean residence time (3.75 - 3.80 h), and half-life (2.82 - 3.11 h). The mean in vivo plasma recovery was approximately 20%.

Glanzmann's thrombasthenia

Pharmacokinetics of NovoSeven in patients with Glanzmann's thrombasthenia have not been investigated, but are expected to be similar to the pharmacokinetics in haemophilia A and B patients.

5.3 Preclinical Safety Data

All findings in the preclinical safety programme were related to the pharmacological effect of rFVIIa.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Powder

Sodium chloride

Calcium chloride dihydrate

Glycylglycine

Polysorbate 80

Mannitol

Sucrose

Methionine

Hydrochloric acid (for pH-adjustment)

Sodium hydroxide (for pH-adjustment)

Solvent

Histidine

Hydrochloric acid (for pH-adjustment)

Sodium hydroxide (for pH-adjustment)

Water for injections

6.2 Incompatibilities

NovoSeven must not be mixed with infusion solutions or be given in a drip.

6.3 Shelf Life

The shelf life for the product packed for sale is:

3 years when the product is stored below 25°C

After reconstitution, chemical and physical stability have been demonstrated for 6 hours at 25°C and 24 hours at 5°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, storage time and storage conditions prior to use are the responsibility of the user, and should not be longer than 24 hours at 2°C - 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

6.4 Special Precautions For Storage

– Store powder and solvent below 25°C.

– Store powder and solvent protected from light.

– Do not freeze to prevent damage to the solvent vial.

– For storage conditions of the reconstituted medicinal product, see Section 6.3.

6.5 Nature And Contents Of Container

The NovoSeven package contains Type I glass vials closed with a chlorobutyl rubber stopper, covered with an aluminium cap.The closed vials are equipped with a tamper-evident snap-off cap which is made of polypropylene.

Each NovoSeven package contains:

1 mg & 2 mg

– 1 vial (2 ml) with white powder for solution for injection

– 1 vial (2 ml) with solvent for reconstitution

5 mg & 8 mg

– 1 vial (12 ml) with white powder for solution for injection

– 1 vial (12 ml) with solvent for reconstitution

6.6 Special Precautions For Disposal And Other Handling

Always use an aseptic technique

Reconstitution

• NovoSeven powder and solvent vials should be at room temperature at reconstitution. Remove the plastic caps from the two vials. If the caps are loose or missing, do not use the vials. Clean the rubber stoppers on the vials with alcohol swabs and allow them to dry before use. Use a disposable syringe of an appropriate size and a vial adapter, transfer needle (20 - 26G) or other suitable device.

• Attach the vial adapter to the solvent vial. If using a transfer needle, screw the transfer needle tightly onto the syringe.

• Pull the plunger to draw in a volume of air that is equal to the amount of solvent in the solvent vial (ml equals cc on the syringe).

• Screw the syringe tightly onto the vial adapter on the solvent vial. If using a transfer needle, insert the transfer needle into the rubber stopper of the solvent vial. Inject air into the vial by pushing the plunger until you feel a clear resistance.

• Hold the syringe with the solvent vial upside down. If using a transfer needle, make sure the transfer needle tip is in the solvent. Pull the plunger to draw the solvent into the syringe.

• Remove the empty solvent vial. If using a vial adapter, tip the syringe to remove it from the vial.

• Attach the syringe with the vial adapter or transfer needle to the powder vial. If using a transfer needle, make sure to penetrate the centre of the rubber stopper. Hold the syringe slightly tilted with the vial facing downwards. Push the plunger slowly to inject the solvent into the powder vial. Make sure not to aim the stream of solvent directly at the NovoSeven powder as this will cause foaming.

• Gently swirl the vial until all the powder is dissolved. Do not shake the vial as this will cause foaming.

NovoSeven reconstituted solution is colourless and should be inspected visually for particulate matter and discolouration prior to administration.

Do not store reconstituted NovoSeven in plastic syringes.

It is recommended to use NovoSeven immediately after reconstitution.

Administration

• Ensure that the plunger is pushed all the way in before turning the syringe upside down (it may have been pushed out by the pressure in the syringe). If using a transfer needle, make sure the transfer needle tip is in the solution. Hold the syringe with the vial upside down and pull the plunger to draw all the solution into the syringe.

• If using a vial adapter, unscrew the vial adapter with the empty vial. If using a transfer needle, remove the transfer needle from the vial, replace the transfer needle cap, and twist the transfer needle off the syringe.

• NovoSeven is now ready for injection. Locate a suitable site, and slowly inject NovoSeven into a vein over a period of 2 - 5 minutes without removing the needle from the injection site.

Safely dispose of the syringe, vials and any unused product. Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

8. Marketing Authorisation Number(S)


NovoSeven® 1 mg	EU/1/96/006/004
NovoSeven® 2 mg	EU/1/96/006/005
NovoSeven® 5 mg	EU/1/96/006/006
NovoSeven® 8 mg	EU/1/96/006/007

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 23 February 1996

Date of latest renewal: 23 February 2006

10. Date Of Revision Of The Text

01/2012

Detailed information on this product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/

Flovent Diskus

Generic Name: fluticasone (Inhalation route)

floo-TIK-a-sone

Commonly used brand name(s)

In the U.S.

Flovent

Flovent Diskus

Flovent HFA

Flovent Rotadisk

Available Dosage Forms:

Powder

Disk

Aerosol Powder

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Flovent Diskus

Fluticasone belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It is used to help prevent the symptoms of asthma. When used regularly every day, inhaled fluticasone decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Inhaled fluticasone works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

This medicine may be used with other asthma medicines, such as bronchodilators (medicines that open up narrowed breathing passages) or other corticosteroids taken by mouth.

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

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

Pulmonary disease, chronic obstructive

Before Using Flovent Diskus

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

Corticosteroids taken by mouth or injection have been shown to slow or stop growth in children and cause reduced adrenal gland function. If enough fluticasone is absorbed following inhalation, it is possible it also could cause these effects. Your doctor will want you to use the lowest possible dose of fluticasone that controls asthma. This will lessen the chance of an effect on growth or adrenal gland function. It is also important that children taking fluticasone visit their doctors regularly so that their growth rates may be monitored. Children who are taking this medicine may be more susceptible to infections, such as chickenpox or measles. Care should be taken to avoid exposure to chickenpox or measles. If the child is exposed or the disease develops, the doctor should be contacted and his or her directions should be followed carefully. Before this medicine is given to a child, you and your child's doctor should talk about the good this medicine will do as well as the risks of using it.

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of inhaled fluticasone in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, which may require caution in patients receiving inhaled fluticasone.

Pregnancy

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

Breast Feeding

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is 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.

Atazanavir

Boceprevir

Bupropion

Clarithromycin

Darunavir

Indinavir

Itraconazole

Ketoconazole

Nefazodone

Nelfinavir

Ritonavir

Saquinavir

Telaprevir

Telithromycin

Tipranavir

Interactions with Food/Tobacco/Alcohol

Proper Use of fluticasone

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

Inhaled fluticasone is used to prevent asthma attacks. It is not used to relieve an attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your health care professional.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects. The full benefit of this medicine may take 1 to 2 weeks or longer to achieve.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

Gargling and rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. However, do not swallow the water after rinsing.

Inhaled fluticasone is used with a special inhaler and usually comes with patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your health care professional to show you what to do. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.

For patients using the inhalation aerosol:

When you use the inhaler for the first time, or if you have not used it for 4 weeks or longer, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine into the air four times. (Spray the inhaler once into the air if it has not been used in 1 to 3 weeks.) The inhaler will now be ready to give the right amount of medicine when you use it.

To use the inhaler:
- Shake the inhaler well for 15 seconds immediately before each use.
- Take the cap off the mouthpiece (the strap will stay attached to the actuator). Check the mouthpiece and remove any foreign objects. Make sure the canister is fully and firmly inserted into the actuator.
- Hold the mouthpiece away from your mouth and breathe out slowly and completely.
- Use the inhalation method recommended by your doctor.
  - Open-mouth method—Place the mouthpiece about 1 or 2 inches (two fingerwidths) in front of your widely opened mouth. Make sure the inhaler is aimed into your mouth so that the spray does not hit the roof of your mouth or your tongue.
  - Closed-mouth method—Place the mouthpiece in your mouth between your teeth and over your tongue, with your lips closed tightly around it. Do not block the mouthpiece with your teeth or tongue.
- Tilt your head back a little. Start to breathe in slowly and deeply through your mouth and, at the same time, press the top of the canister one time to get one puff of the medicine. Continue to breathe in slowly for 5 to 10 seconds. Count the seconds while inhaling. It is important to press the top of the canister and breathe in slowly at the same time so the medicine is pulled into your lungs. This step may be difficult at first. If you are using the closed-mouth method and you see a fine mist coming from your mouth or nose, the inhaler is not being used correctly.
- Hold your breath as long as you can up to 10 seconds. This gives the medicine time to settle in your airways and lungs. Take the mouthpiece away from your mouth and breathe out slowly.
- If your doctor has told you to inhale more than one puff of medicine at each dose, wait about 30 seconds and then gently shake the inhaler again, and take the second puff following exactly the same steps you used for the first puff.
- When you are finished, wipe off the mouthpiece and replace the cover to keep the mouthpiece clean and free of foreign objects.

The inhaler has a dose counter that keeps track of how many more times you can use it before you need to open a new one. When the dose counter reaches "020", call your doctor or pharmacist if refill is needed .

If the dose counter is not working correctly, do not use the inhaler and return it to your pharmacy or doctor. Do not change the numbers or remove the counter from the canister .

Clean the inhaler and mouthpiece at least once a day to prevent buildup of medicine and blockage of the mouthpiece.
- To clean the inhaler:
  - Remove the metal canister from the inhaler and set it aside.
  - Rinse the mouthpiece and cover and plastic case in warm, running water.
  - Shake off the excess water and let the inhaler parts air dry completely before replacing the metal canister and cover.

For patients using the powder for inhalation:

To load the inhaler:
- Make sure your hands are clean and dry.
- Do not insert the disk until just before you are ready to use the medicine.
- Take off the mouthpiece cover and make sure that the mouthpiece is clean.
- Hold the corners of the white tray and pull out gently until you can see all of the plastic ridges on the sides of the tray.
- Put your finger and thumb on the ridges, squeeze inward, and gently pull the tray out of the body of the inhaler.
- Place a disk on the wheel with the numbers facing up, and then slide the tray back into the inhaler.
- Hold the corners of the tray and slide the tray out and in. This will rotate the disk.
- Continue to turn the disk in this way until the number 4 appears in the small window. Each disk has four blisters containing the medicine. The window will display how many inhalations you have left after you use it each time. For example, when you see the number 1, you have one inhalation left.
- To replace the empty disk with a full disk, follow the same steps you used to load the inhaler. Do not throw away the wheel when you discard the empty disk.

To use the inhaler:
- Hold the inhaler flat in your hand. Lift the rear edge of the lid until it is fully upright.
- The plastic needle on the front of the lid will break the blister containing one inhalation of medicine. When the lid is raised as far as it will go, both the upper and the lower surfaces of the blister will be pierced. Do not lift the lid if the cartridge is not in the inhaler. Doing this will break the needle and you will need a new inhaler.
- After the blister is broken open, close the lid. Keeping the inhaler flat and well away from your mouth, breathe out to the end of a normal breath.
- Raise the inhaler to your mouth, and place the mouthpiece in your mouth.
- Close your lips around the mouthpiece and tilt your head slightly back. Do not bite down on the mouthpiece. Do not block the mouthpiece with your teeth or tongue. Do not cover the air holes on the side of the mouthpiece.
- Breathe in through your mouth as steadily and as deeply as you can until you have taken a full deep breath.
- Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out. This gives the medicine time to settle in your airways and lungs.
- Hold the inhaler well away from your mouth and breathe out to the end of a normal breath.
- Prepare the cartridge for your next inhalation. Pull the cartridge out once and push it in once. The disk will turn to the next numbered dose as seen in the indicator window. Do not pierce the blister until just before the inhalation.
- If your doctor has told you to inhale more than one puff of medicine at each dose, take the second puff following exactly the same steps you used for the first puff.
- When you are finished, wipe off the mouthpiece and replace the cover to keep the mouthpiece clean and free of foreign objects.

To clean the inhaler:
- Remove the tray from the body of the inhaler.
- Hold the wheel between your forefinger and thumb and pull upward to separate it from the tray.
- Use the brush that is stored in the rear of the body of the inhaler to brush away any powder left behind on the parts of the inhaler.
- Replace the wheel and push it down firmly until it snaps back into place.
- Replace the tray and mouthpiece cover.
- Separate the parts of the inhaler using the steps outlined above.
- Rinse the parts of the inhaler with warm water and let them air dry before reassembling them as described above.
The inhaler should be cleaned once a week.

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.

For bronchial asthma
- For inhalation aerosol:
  - Adults and children 12 years of age and older—88 to 880 micrograms (mcg) two times a day, morning and evening.
  - Canadian labeling recommends—For adults and children 16 and older: 100 to 1000 mcg two times a day.
  - Children 4 to 11 years of age—88 mcg two times a day.
  - Canadian labeling recommends—For children 4 to 16 years of age: 50 to 100 mcg two times a day; For children up to 4 years of age: Use and dose must be determined by your doctor.
  - Children younger than 4 years of age—Use and dose must be determined by your doctor .
- For powder for inhalation:
  - Adults and children older than 11 years of age—100 to 1000 mcg two times a day.
  - Children 4 to 11 years of age—50 to 100 mcg two times a day.
  - Canadian labeling recommends—For children 4 to 16 years of age: 50 to 100 mcg two times a day.
  - Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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

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

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Flovent Diskus

Check with your doctor if:

You go through a period of unusual stress to your body, such as surgery, injury, or infection.

You have an asthma attack that does not improve after you take a bronchodilator medicine.

Your asthma symptoms do not improve or your condition worsens.

You are exposed to the chickenpox or measles.

Your doctor may want you to carry a medical identification card stating that you are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.

Before you have any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine.

Flovent Diskus 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

White patches in mouth and throat

Less common

Diarrhea

ear ache

fever

lower abdominal pain

nausea

pain on passing urine

redness or discharge of the eye, eyelid, or lining of the eye

shortness of breath

sore throat

trouble in swallowing

vaginal discharge (creamy white) and itching

vomiting

Rare

Blindness, blurred vision, eye pain

large hives

bone fractures

diabetes mellitus [increased hunger, thirst, or urination]

excess facial hair in women

fullness or roundness of face, neck, and trunk

growth reduction in children or adolescents

heart problems

high blood pressure

hives and skin rash

impotence in males

lack of menstrual periods

muscle wasting

numbness and weakness of hands and feet

weakness

swelling of face, lips, or eyelids

tightness in chest, troubled breathing, or wheezing

Incidence not known

Difficulty breathing

difficulty swallowing

dizziness

fast heartbeat

growth rate decreased in children and teenagers

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

noisy breathing

swelling of the mouth or throat

Symptoms of overdose

Darkening of skin

fainting

loss of appetite

mental depression

unusual tiredness or weakness

More common

Cough

general aches and pains or general feeling of illness

greenish-yellow mucus in nose

headache

hoarseness or other voice changes

runny, sore, or stuffy nose

Less common

Bloody mucus or unexplained nosebleeds

dizziness

eye irritation

feeling 'faint'

giddiness

irregular or painful menstrual periods

irritation due to inhalant

joint pain

migraines

mouth irritation

muscle soreness, sprain, or strain

sneezing

stomach pain or burning

Rare

Aggression

agitation

bruising

itching

restlessness

weight gain

Incidence not known

Abdominal pain

blurred vision

decrease in height

dry mouth

fatigue

flushed, dry skin

fruit-like breath odor

increased hunger

increased thirst

increased urination

loss of voice

pain in back, ribs, arms or legs

sweating

trouble sitting still

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.

See also: Flovent Diskus side effects (in more detail)

More Flovent Diskus resources

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

Flovent Diskus Powder MedFacts Consumer Leaflet (Wolters Kluwer)

Fluticasone Prescribing Information (FDA)

Fluticasone Professional Patient Advice (Wolters Kluwer)

Flovent Prescribing Information (FDA)

Flovent Monograph (AHFS DI)

Flovent Consumer Overview

Flovent Aerosol Inhaler MedFacts Consumer Leaflet (Wolters Kluwer)

Flovent HFA Aerosol Inhaler MedFacts Consumer Leaflet (Wolters Kluwer)

Flovent Rotadisk Prescribing Information (FDA)

Compare Flovent Diskus with other medications

Asthma, Maintenance
Bronchopulmonary Dysplasia
Eosinophilic Esophagitis

Friday 27 July 2012

Capsaicin Cream

Pronunciation: kap-SAY-sin
Generic Name: Capsaicin
Brand Name: Examples include Capzasin-P and Zostrix

Capsaicin Cream is used for:

Temporary relief of muscle and joint pain associated with arthritis, simple backaches, sprains, strains, and bruises. It may also be used for other conditions as determined by your doctor.

Capsaicin Cream is a topical analgesic. Exactly how it works is unknown, but it is thought to decrease the amount of a certain substance (substance P) that transmits pain in the body.

Do NOT use Capsaicin Cream if:

you are allergic to any ingredient in Capsaicin Cream

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

Before using Capsaicin Cream:

Some medical conditions may interact with Capsaicin Cream. 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 an open wound or damaged, broken, or irritated skin

Some MEDICINES MAY INTERACT with Capsaicin Cream. Because little, if any, of Capsaicin Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Capsaicin Cream 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 Capsaicin Cream:

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

An extra patient leaflet is available with Capsaicin Cream. Talk to your pharmacist if you have questions about this information.

Apply just enough medicine to cover the affected area. Gently massage the medicine into skin until it disappears.

Wash your hands with soap and water immediately after using Capsaicin Cream unless your hands are part of the treated area.

If you are using Capsaicin Cream on your hands, allow 30 minutes for the medicine to absorb before washing. During this time, avoid touching damaged or irritated skin, contact lenses, or your eyes, nose, mouth, or other mucous membranes. Wash hands after 30 minutes.

Do not apply to wounds or damaged, broken (open), or irritated skin.

Do not bandage or wrap the affected area.

Do not use Capsaicin Cream with a heating pad.

Do not expose the treated area to heat or direct sunlight. Warm or hot water or sunlight may increase the likelihood of burning or itching. Do not use Capsaicin Cream immediately after bathing, swimming, using a hot tub, sunbathing, or exposure to heat.

If you miss a dose of Capsaicin Cream, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

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

Important safety information:

For external use only. Avoid contact with the eyes, nose, and mouth. If Capsaicin Cream gets into your eyes, rinse immediately with cool water.

Do not use more than the recommended dose, use for longer than prescribed, or use large amounts of Capsaicin Cream without checking with your doctor.

Do not inhale any residue from Capsaicin Cream after it has dried. Coughing, sneezing, or throat or respiratory irritation may occur.

Capsaicin Cream may be harmful if swallowed. If you may have taken Capsaicin Cream by mouth, contact your local poison control center or emergency room immediately.

If condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days, stop use of this product and contact your health care provider.

If redness is present or if irritation develops, check with your doctor before using any more of Capsaicin Cream.

If severe burning or itching occurs, remove product by thoroughly washing the area with soap and cold water.

Capsaicin Cream should not be used in CHILDREN younger than 18 years old without checking with the child's doctor; safety and effectiveness in these 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 Capsaicin Cream while you are pregnant. It is not known if Capsaicin Cream is found in breast milk. If you are or will be breast-feeding while you use Capsaicin Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Capsaicin Cream:

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:

Temporary burning or stinging at the application site that usually disappears in a few days.

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); difficulty breathing or swallowing; irritation, redness, blistering, or severe or persistent burning at the application site.

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: Capsaicin 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. Capsaicin Cream may be harmful if swallowed.

Proper storage of Capsaicin Cream:

Store Capsaicin Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Close cap tightly after use. Do not store in the bathroom. Keep Capsaicin Cream out of the reach of children and away from pets.

General information:

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

Capsaicin Cream 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 Capsaicin Cream. 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

More Capsaicin resources

Capsaicin Side Effects (in more detail)
Capsaicin Dosage
Capsaicin Use in Pregnancy & Breastfeeding
Capsaicin Drug Interactions
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Tuesday 24 July 2012

Securon I.V.

1. Name Of The Medicinal Product

Securon IV

2. Qualitative And Quantitative Composition

Verapamil Hydrochloride BP 2.5 mg/ml

3. Pharmaceutical Form

Aqueous solution for intravenous injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Securon IV is indicated for the treatment of paroxysmal supraventricular tachycardia and the reduction of ventricular rate in atrial flutter/fibrillation.

4.2 Posology And Method Of Administration

For slow intravenous injection.

Adults: 5-10 mg by slow intravenous injection over a period of 2 minutes. The patient should be observed continuously, preferably under ECG and blood pressure control. If necessary, e.g. in paroxysmal tachycardia, a further 5 mg may be given after 5 to 10 minutes.

Children: Securon IV must always be administered under ECG monitoring in young patients.

0-1 year: 0.1-0.2 mg/kg bodyweight (usual single dose range: 0.75-2 mg).

1-15 years: 0.1-0.3 mg/kg bodyweight (usual single dose range: 2-5 mg).

The dose may be repeated after 30 minutes if necessary. Many cases are controlled by doses at the lower end of the range. The injection should be stopped at the onset of the desired effect.

Elderly: The dosage should be administered over 3 minutes to minimise the risk of adverse effects.

Dosage in impaired liver and renal function: Significant hepatic and renal impairment should not increase the effects of a single intravenous dose but may prolong its duration of action.

For use with beta-blocker therapy, see 'Contra-indications' and 'Special Warnings and Precautions for Use'.

4.3 Contraindications

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

Cardiogenic shock; acute myocardial infarction complicated by bradycardia, marked hypotension or left ventricular failure; second or third degree AV block (except in patients with a functioning artificial ventricular pacemaker); sino-atrial block; sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker); uncompensated heart failure; bradycardia of less than 50 beats/minute; hypotension of less than 90 mmHg systolic; simultaneous administration of intravenous beta-blockers.

Patients with atrial flutter/fibrillation in the presence of an accessory pathway (e.g. WPW syndrome) may develop increased conduction across the anomalous pathway and ventricular tachycardia may be precipitated.

4.4 Special Warnings And Precautions For Use

Verapamil may affect impulse conduction. For this reason, Securon IV should be used with caution in patients with bradycardia or first degree AV block. Verapamil may affect left ventricular contractility; this effect is small and normally not important but cardiac failure may be precipitated or aggravated. In patients with poor ventricular function, therefore, Securon IV should only be given after cardiac failure has been controlled with appropriate therapy, e.g. digitalis.

Although the pharmacokinetics of verapamil in patients with renal impairment are not affected, caution should be exercised and careful patient monitoring is recommended. Verapamil is not removed during dialysis.

Caution should be exercised in treatment with HMG CoA reductase inhibitors (e.g., simvastatin, atorvastatin or lovastatin) for patients taking verapamil. These patients should be started at the lowest possible dose of verapamil and titrated upwards. If verapamil treatment is to be added to patients already taking an HMG CoA reductase inhibitor (e.g., simvastatin, atorvastatin or lovastatin), refer to advice in the respective statin product information.

Use with caution in the presence of diseases in which neuromuscular transmission is affected (myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy)

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In rare instances, including when patients with severe cardiomyopathy, congestive heart failure or recent myocardial infarction were given intravenous beta-adrenergic blocking agents or disopyramide concomitantly with intravenous verapamil hydrochloride, serious adverse effects have occurred. Concomitant use of verapamil hydrochloride with agents that decrease adrenergic function may result in an exaggerated hypotensive response.

In vitro metabolic studies indicate that verapamil hydrochloride is metabolized by cytochrome P450 CYP3A4, CYP1A2, CYP2C8, CYP2C9 and CYP2C18. Verapamil has been shown to be an inhibitor of CYP3A4 enzymes and P-glycoprotein (P-gp). Clinically significant interactions have been reported with inhibitors of CYP3A4 causing elevation of plasma levels of verapamil hydrochloride while inducers of CYP3A4 have caused a lowering of plasma levels of verapamil hydrochloride, therefore, patients should be monitored for drug interactions.

The following are potential drug interactions associated with verapamil:

Acetylsalicylic acid

Concomitant use of verapamil with aspirin may increase the risk of bleeding

Alpha blockers

Verapamil may increase the plasma concentrations of prazosin and terazosin which may have an additive hypotensive effect.

Antiarrhythmics

Verapamil may slightly decrease the plasma clearance of flecainide whereas flecainide has no effect on the verapamil plasma clearance.

Verapamil may increase the plasma concentrations of quinidine.

The combination of verapamil and antiarrhythmic agents may lead to additive cardiovascular effects (e.g. AV block, bradycardia, hypotension, heart failure). Care must be exercised if Securon IV is combined with anti-arrhythmic agents by any route.

Anticonvulsants

Verapamil may increase the plasma concentrations of carbamazepine. This may produce side effects such as diplopia, headache, ataxia or dizziness. Verapamil may also increase the plasma concentrations of phenytoin.

Antidepressants

Verapamil may increase the plasma concentrations of imipramine.

Antidiabetics

Verapamil may increase the plasma concentrations of glibenclamide (glyburide).

Anti-infectives

Rifampicin may reduce the plasma concentrations of verapamil which may produce a reduced blood pressure lowering effect. Erythromycin, clarithromycin and telithromycin may increase the plasma concentrations of verapamil.

Antineoplastics

There is no significant difference between the pharmacokinetic parameters of doxorubicin with intravenous verapamil administration.

Barbiturates

Phenobarbital may reduce the plasma concentrations of verapamil.

Benzodiazepines and other anxiolytics

Verapamil may increase the plasma concentrations of buspirone and midazolam.

Beta blockers

Verapamil may increase the plasma concentrations of metoprolol and propranolol which may lead to additive cardiovascular effects (e.g. AV block, bradycardia, hypotension, heart failure).

Securon IV should not be given in combination with intravenous beta-blocker therapy and care must be exercised if Securon IV is combined with oral beta-blocker therapy.

Cardiac glycosides

Verapamil may increase the plasma concentrations of digitoxin and digoxin. Verapamil has been shown to increase the serum concentration of digoxin and caution should be exercised with regard to digitalis toxicity. The digitalis level should be determined and the glycoside dose reduced, if required.

Colchicine

Colchicine is a substrate for both CYP3A and the efflux transporter, P-glycoprotein (P-gp). Verapamil is known to inhibit CYP3A and P-gp. When verapamil and colchicine are administered together, inhibition of P-gp and/or CYP3A by verapamil may lead to increased exposure to colchicine. Combined use is not recommended.

H₂ Receptor antagonists

Cimetidine may increase the plasma concentrations of verapamil following intravenous verapamil administration.

HIV antiviral agents

Due to the metabolic inhibitory potential of some of the HIV antiviral agents, such as ritonavir, plasma concentrations of verapamil may increase. Caution should be used or dose of verapamil may be decreased.

Immunosuppressants

Verapamil may increase the plasma concentrations of ciclosporin, everolimus, sirolimus and tacrolimus.

Inhaled anaesthetics

When used concomitantly, inhalation anaesthetics and calcium antagonists, such as verapamil hydrochloride, should each be titrated carefully to avoid additive cardiovascular effects (e.g. AV block, bradycardia, hypotension, heart failure).

Lipid lowering agents

Verapamil may increase the plasma concentrations atorvastatin, lovastatin and simvastatin.

Treatment with HMG CoA reductase inhibitors (e.g., simvastatin, atorvastatin or lovastatin) in a patient taking verapamil should be started at the lowest possible dose and titrated upwards. If verapamil treatment is to be added to patients already taking an HMG CoA reductase inhibitor (e.g., simvastatin, atorvastatin or lovastatin), consider a reduction in the statin dose and retitrate against serum cholesterol concentrations.

Atorvastatin has been shown to increase verapamil levels. Although there is no direct in vivo clinical evidence, there is strong potential for verapamil to significantly affect atorvastatin pharmacokinetics in a similar manner to simvastatin or lovastatin. Consider using caution when atorvastatin and verapamil are concomitantly administered.

Fluvastatin, pravastatin and rosuvastatin are not metabolized by CYP3A4 and are less likely to interact with verapamil.

Lithium

Serum levels of lithium may be reduced. However there may be increased sensitivity to lithium causing enhanced neurotoxicity.

Neuromuscular blocking agents employed in anaesthesia

The effects may be potentiated.

Protein-bound drugs

As verapamil hydrochloride is highly bound to plasma proteins, it should be administered with caution to patients receiving other highly protein-bound drugs.

Serotonin receptor agonists

Verapamil may increase the plasma concentrations of almotriptan.

Theophylline

Verapamil may increase the plasma concentrations of theophylline.

Uricosurics

Sulfinpyrazone may reduce the plasma concentrations of verapamil which may produce a reduced blood pressure lowering effect.

Other

St. John's Wort may reduce the plasma concentrations of verapamil, whereas grapefruit juice may increase the plasma concentrations of verapamil.

4.6 Pregnancy And Lactation

Although animal studies have not shown any teratogenic effects, verapamil should not be given during the first trimester of pregnancy unless, in the clinician's judgement, it is essential for the welfare of the patient. Verapamil crosses the placental barrier and can be detected in umbilical vein blood at delivery. Also, verapamil is excreted in human breast milk. Limited human data from oral administration has shown that the infant relative dose of verapamil is low (0.1-1% of the mother's oral dose) and that verapamil use may be compatible with breastfeeding. However, there are currently no reports of verapamil injection or infusion use during breastfeeding. Due to the potential for serious adverse reactions in nursing infants, verapamil should only be used during lactation if it is essential for the welfare of the mother.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Adverse events observed in clinical trials are depicted in the following table. Within each system organ class, the adverse drug reactions are ranked under headings of frequency, using the following convention: common (>1/100, <1/10), uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000), very rare (<1/10,000), including isolated reports.

System Organ Class	Frequency	Undesirable Effects
Nervous system disorders
	common	- dizziness - headache
Cardiac disorders/vascular disorders
	common	- bradycardia - hypotension
	uncommon	- tachycardia
Gastrointestinal disorders
	uncommon	- nausea - abdominal pain

Cases of seizures during verapamil hydrochloride injection have been reported.

In rare cases of hypersensitivity, bronchospasm accompanied by pruritis and urticaria has been reported.

Other Reactions from Postmarketing Surveillance or Phase IV Clinical Trials

Other adverse events reported with verapamil are listed below by system organ class:

Psychiatric disorders: on rare occasions, nervousness has been reported.

Nervous system disorders: somnolence and extrapyramidal syndrome.

Ear and labyrinth disorders: vertigo.

Cardiac disorders/vascular disorders: decreased myocardial contractility has been reported. On rare occasions, 2^nd and 3^rd block may occur and in extreme cases, this may lead to asystole. The asystole is usually of short duration and cardiac action returns spontaneously after a few seconds, usually in the form of sinus rhythm. If necessary, the procedures for the treatment of overdosage should be followed as described below. On rare occasions, flushing has been reported.

Gastrointestinal disorders: gingival hyperplasia may occur very rarely when the drug is administered over prolonged periods, and is fully reversible when the drug is discontinued. On rare occasions, vomiting has also been reported.

Skin and subcutaneous tissue disorders: Steven-Johnson syndrome, erythema and hyperhidrosis.

Reproductive system and breast disorders: On very rare occasions, gynaecomastia has been observed in elderly male patients under long-term verapamil treatment; this was fully reversible in all cases when the drug was discontinued.

Investigations: A reversible impairment of liver function characterized by an increase of transaminase and/or alkaline phosphatase may occur on very rare occasions during verapamil treatment and is most probably a hypersensitivity reaction.

4.9 Overdose

The symptoms of overdosage include hypotension, shock, loss of consciousness, first and second degree AV block (frequently as Wenckebach's phenomenon with or without escape rhythms), total AV block with total AV dissociation, escape rhythm, asystole, bradycardia up to high degree AV block and, sinus arrest, hyperglycaemia, stupor and metabolic acidosis. Fatalities have occurred as a result of overdose.

Treatment of overdosage depends on the type and severity of symptoms. The specific antidote is calcium, e.g. 10-20 ml of 10% calcium gluconate solution i.v. (2.25-4.5 mmol) if necessary by repeated injection or continuous infusion (e.g. 5 mmol/hour). The usual emergency measures for acute cardiovascular collapse should be applied and followed by intensive care. Verapamil hydrochloride cannot be removed by haemodialysis. Similarly, in the case of second or third degree AV block, atropine, orciprenaline, isoprenaline and if required, pacemaker therapy should be considered. If there are signs of myocardial insufficiency, dopamine, dobutamine, cardiac glycosides or calcium gluconate (10-20 ml of a 10% solution) can be administered.

In the case of hypotension, after appropriately positioning the patient, dopamine, dobutamine or noradrenaline may be given.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Verapamil is a calcium antagonist which blocks the inward movement of calcium ions in cardiac muscle cells, in smooth muscle cells of the coronary and systemic arteries and in cells of the intracardiac conduction system. Because of its effect on the movement of calcium in the intracardiac conduction system, verapamil reduces automaticity, decreases conduction velocity and increases the refractory period.

5.2 Pharmacokinetic Properties

Following intravenous infusion in man, verapamil is eliminated bi-exponentially with a rapid distribution phase (half-life about 4 minutes) and a slower terminal elimination phase (half-life 2-5 hours). Plasma protein binding of verapamil is about 90%. Renal insufficiency does not affect the kinetics of verapamil. In patients with liver cirrhosis, elimination half

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Water for injections, sodium chloride (8.5 mg/ml), hydrochloric acid as pH adjuster.

6.2 Incompatibilities

Securon IV is incompatible with alkaline solutions.

6.3 Shelf Life

Ampoule: 60 months.

Syringe: 36 months.

6.4 Special Precautions For Storage

Store at room temperature. Protect from light.

6.5 Nature And Contents Of Container

2 ml glass ampoule (hydrolytic type 1) containing 5 mg verapamil. Pack size: 5 × 2 ml ampoules.

2 ml pre-filled glass syringe (borosilicate type 1) with tip cap and butyl rubber stopper and polystyrene plunger. Pack size: 5 × 2 ml syringes.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Abbott Laboratories Ltd

Abbott House,

Vanwall Business Park,

Vanwall Road,

Maidenhead,

Berkshire,

SL6 4XE ,

United Kingdom.

8. Marketing Authorisation Number(S)

PL 00037/0367

9. Date Of First Authorisation/Renewal Of The Authorisation

17 June 2003

10. Date Of Revision Of The Text

02^nd August 2010

Sunday 29 July 2012

fenofibrate

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NovoSeven 1 mg (50KIU) powder and solvent for solution for injection. NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection. NovoSeven 5 mg (250 KIU) powder and solvent for solution for injection.

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

8. Marketing Authorisation Number(S)

9. Date Of First Authorisation/Renewal Of The Authorisation

10. Date Of Revision Of The Text

Flovent Diskus

Commonly used brand name(s)

Uses For Flovent Diskus

Before Using Flovent Diskus

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of fluticasone

Dosing

Missed Dose

Storage

Precautions While Using Flovent Diskus

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Friday 27 July 2012

Capsaicin Cream

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Before using Capsaicin Cream:

How to use Capsaicin Cream:

Important safety information:

Possible side effects of Capsaicin Cream:

If OVERDOSE is suspected:

General information: