Sellymin

Generic Name: sodium bicarbonate (Oral route, Intravenous route, Subcutaneous route)

SOE-dee-um bye-KAR-bo-nate

Commonly used brand name(s)

In the U.S.

• Brioschi


• Neut

In Canada

• Sellymin


• Sodium Bicarbonate

Available Dosage Forms:

• Tablet


• Solution


• Powder


• Granule


• Capsule

Therapeutic Class: Antacid, Sodium Bicarbonate Containing

Uses For Sellymin

Sodium bicarbonate , also known as baking soda, is used to relieve heartburn, sour stomach, or acid indigestion by neutralizing excess stomach acid. When used for this purpose, it is said to belong to the group of medicines called antacids. It may be used to treat the symptoms of stomach or duodenal ulcers. Sodium bicarbonate is also used to make the blood and urine more alkaline in certain conditions.

Antacids should not be given to young children (up to 6 years of age) unless prescribed by their doctor. Since children cannot usually describe their symptoms very well, a doctor should check the child before giving this medicine. The child may have a condition that needs other treatment. If so, antacids will not help and may even cause unwanted effects or make the condition worse.

Sodium bicarbonate for oral use is available without a prescription.

Before Using Sellymin

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

Antacids should not be given to young children (up to 6 years of age) unless prescribed by a physician. This medicine may not help and may even worsen some conditions, so make sure that your child's problem should be treated with this medicine before you use it.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of sodium bicarbonate in the elderly with use in other age groups.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 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 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.

• Dasatinib


• Itraconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Appendicitis or


• Intestinal or rectal bleeding—Oral forms of sodium bicarbonate may make these conditions worse

• Edema (swelling of feet or lower legs) or


• Heart disease or


• High blood pressure (hypertension) or


• Kidney disease or


• Liver disease or


• Problems with urination or


• Toxemia of pregnancy—Sodium bicarbonate may cause the body to retain (keep) water, which may make these conditions worse

Proper Use of sodium bicarbonate

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

For safe and effective use of sodium bicarbonate:

• Follow your doctor's instructions if this medicine was prescribed.


• Follow the manufacturer's package directions if you are treating yourself.

For patients taking this medicine for a stomach ulcer :

• Take it exactly as directed and for the full time of treatment as ordered by your doctor, to obtain maximum relief of your symptoms.


• Take it 1 and 3 hours after meals and at bedtime for best results, unless otherwise directed by your doctor.

Dosing

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

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

• For sodium bicarbonate effervescent powder:
  
  • To relieve heartburn or sour stomach:
    
    • Adults and teenagers—3.9 to 10 grams (1 to 2½ teaspoonfuls) in a glass of cold water after meals. However, the dose is usually not more than 19.5 grams (5 teaspoonfuls) a day.
    
    
    • Children up to 6 years of age—Dose must be determined by your doctor.
    
    
    • Children 6 to 12 years of age—1 to 1.9 grams (¼ to ½ teaspoonful) in a glass of cold water after meals.
    
    
  
  


• For sodium bicarbonate powder:
  
  • To relieve heartburn or sour stomach:
    
    • Adults and teenagers—One-half teaspoonful in a glass of water every two hours. Your doctor may change the dose if needed.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  
  • To make the urine more alkaline (less acidic):
    
    • Adults and teenagers—One teaspoonful in a glass of water every four hours. Your doctor may change the dose if needed. However, the dose is usually not more than 4 teaspoonfuls a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For sodium bicarbonate tablets:
  
  • To relieve heartburn or sour stomach:
    
    • Adults and teenagers—325 milligrams (mg) to 2 grams one to four times a day.
    
    
    • Children up to 6 years of age—Dose must be determined by your doctor.
    
    
    • Children 6 to 12 years of age—The dose is 520 mg. The dose may be repeated in thirty minutes.
    
    
  
  
  • To make the urine more alkaline (less acidic):
    
    • Adults and teenagers—At first, four grams, then 1 to 2 grams every four hours. However, the dose is usually not more than 16 grams a day.
    
    
    • Children—The dose is based on body weight and must be determined by your doctor. The usual dose is 23 to 230 mg per kilogram (kg) (10.5 to 105 mg per pound) of body weight a day. Your doctor may change the dose if needed.
    
    
  
  

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.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Sellymin

If this medicine has been ordered by your doctor and if you will be taking it regularly for a long time, your doctor should check your progress at regular visits. This is to make sure the medicine does not cause unwanted effects.

Do not take sodium bicarbonate:

• Within 1 to 2 hours of taking other medicine by mouth. To do so may keep the other medicine from working properly.


• For a long period of time. To do so may increase the chance of side effects.

For patients on a sodium-restricted diet:

• This medicine contains a large amount of sodium. If you have any questions about this, check with your health care professional.

For patients taking this medicine as an antacid:

• Do not take this medicine if you have any signs of appendicitis (such as stomach or lower abdominal pain, cramping, bloating, soreness, nausea, or vomiting). Instead, check with your doctor as soon as possible.


• Do not take this medicine with large amounts of milk or milk products. To do so may increase the chance of side effects.


• Do not take sodium bicarbonate for more than 2 weeks or if the problem comes back often. Instead, check with your doctor. Antacids should be used only for occasional relief, unless otherwise directed by your doctor.

Sellymin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although the following side effects occur very rarely when this medicine is taken as recommended, they may be more likely to occur if it is taken: in large doses, for a long time, or by patients with kidney disease.

Check with your doctor as soon as possible if any of the following side effects occur:

• Frequent urge to urinate


• headache (continuing)


• loss of appetite (continuing)


• mood or mental changes


• muscle pain or twitching


• nausea or vomiting


• nervousness or restlessness


• slow breathing


• swelling of feet or lower legs


• unpleasant taste


• unusual tiredness or weakness

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

Less common

• Increased thirst


• stomach cramps

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: Sellymin side effects (in more detail)

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More Sellymin resources

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

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Bocouture

1. Name Of The Medicinal Product

Bocouture 4 units/0.1 ml powder for solution for injection

2. Qualitative And Quantitative Composition

One vial contains 50 LD₅₀ units* of Botulinum toxin type A (150 kD), free from complexing proteins.

0.1 ml solution contains 4 LD₅₀ units* of Botulinum toxin type A (150 kD), free from complexing proteins when reconstituted in 1.25 ml.

* One unit corresponds to the mean lethal dose (LD₅₀) when the reconstituted product is injected intraperitoneally into mice under defined conditions.

For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Powder for solution for injection

White powder

4. Clinical Particulars

4.1 Therapeutic Indications

Bocouture is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at frown (glabellar frown lines) in adults below 65 years when the severity of these lines has an important psychological impact for the patient.

4.2 Posology And Method Of Administration

Unit doses recommended for Bocouture are not interchangeable with those for other preparations of Botulinum toxin.

Comparative clinical study results suggest that Bocouture and the comparator product containing conventional Botulinum toxin type A complex (900 kD) are of equal potency.

Bocouture may only be administered by physicians with suitable qualifications and the requisite experience with this therapy, and who have the necessary equipment.

Posology

After reconstitution of Bocouture (50 units/1.25 ml) the recommended injection volume of 0.1 ml (4 units) is injected into each of the 5 injection sites: two injections in each corrugator muscle and one injection in the procerus muscle, which corresponds to a standard dose of 20 units. The dose may be increased by the physician to up to 30 units if required by the individual needs of the patients, with at least '3-months' interval between treatments.

An improvement in the vertical lines between the eyebrows (glabellar frown lines) generally takes place within 2 to 3 days with the maximum effect observed on day 30. The effect lasts up to 4 months after the injection. The intervals between treatments should not be shorter than 3 months. If the treatment fails, or the effect lessens with repeated injections, alternative treatment methods should be used.

Special populations

There are limited clinical data from phase 3 studies of Bocouture in patients over 65 years of age. Until further studies have been conducted in this age group, Bocouture is not recommended for use in patients over 65 years of age.

Paediatric population

The safety and efficacy of Bocouture for the treatment of vertical lines between the eyebrows has not been studied in individuals younger than 18 years old. Therefore, the use of Bocouture in individuals under the age of 18 is not recommended.

Method of administration

Reconstituted Bocouture is intended for intramuscular injection.

After reconstitution, Bocouture should be used immediately and may only be used for one treatment per patient.

For instructions on disposal of the vials, see Section 6.6.

Reconstituted Bocouture is injected using a thin sterile needle (e.g. 30 gauge needle).

Before and during the injection, the thumb and index finger should be used to apply firm pressure below the edge of the eye socket in order to prevent diffusion of the solution in this region. Superior and medial alignment of the needle should be maintained during the injection. To reduce the risk of blepharoptosis, injections near the levator palpebrae superioris and into the cranial portion of the orbicularis oculi should be avoided. Injections into the corrugator muscle should be done in the medial portion of the muscle, and in the central portion of the muscle belly at least 1 cm above the bony edge of the eye socket.

General information

If no treatment effect occurs within one month of the initial injection, the following measures should be taken:

- analysis of the reasons for non-response, e.g. injected into the wrong muscles, injection method, insufficient dosage, formation of neurotoxin-neutralising antibodies

- recheck Botulinum neurotoxin type A as an adequate therapy

- if no adverse reactions have occurred during the initial treatment, an additional treatment can be performed under the following conditions: 1.) dose adjustment with regard to the analysis of the most recent therapy failure, 2.) compliance with the minimum interval of 3 months between the initial and repeat treatment.

4.3 Contraindications

Hypersensitivity to the active substance Botulinum neurotoxin type A or to any of the excipients

Generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome)

Presence of infection or inflammation at the proposed injection site

4.4 Special Warnings And Precautions For Use

Bocouture may only be applied for its intended use to treat one patient for one session. Special care must be taken when preparing and administering the product, and when inactivating and disposing of unused solution (see Section 6.6).

Care should be taken to ensure that Bocouture is not injected into a blood vessel.

There have been very rare reports of undesirable effects that might be related to the spread of the toxin to sites far from the injection site (see Section 4.8). Patients treated with therapeutic doses may experience exaggerated muscle weakness. The injection of Bocouture is not recommended for patients with a history of dysphagia and aspiration.

Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders arise.

Rarely, an anaphylactic reaction may occur after injection of Botulinum neurotoxin type A (see Section 4.8). Adrenaline and other medical aids for treating anaphylaxis should be available.

Prior to administering Bocouture, the physician must familiarise himself/herself with the patient's anatomy and any alterations to the anatomy due to prior surgical procedures.

There is limited experience with the long-term application of Bocouture for this indication.

Bocouture should be used with caution:

• if bleeding disorders of any type occur

• in patients receiving anticoagulant therapy or taking other substances in anticoagulant doses

• in patients suffering from amyotrophic lateral sclerosis or other diseases which result in peripheral neuromuscular dysfunction

• in targeted muscles which display pronounced weakness or atrophy.

Too frequent or too high doses may increase the risk of antibody formation, which can result in treatment failure even if the product is being used to treat other indications (see Section 4.2).

Bocouture contains albumin, a derivative of human blood. Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include careful selection of donors, screening of individual donations and plasma pools for specific markers of infection and the implementation of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

There are no reports of viral transmissions with albumin manufactured according to the specifications of the European Pharmacopoeia using established procedures.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed.

Theoretically, the effect of Botulinum neurotoxin may be potentiated by aminoglycoside antibiotics or other medicinal products that interfere with neuromuscular transmission e.g. tubocurarine-type muscle relaxants.

Therefore, the concomitant use of Bocouture with aminoglycosides or spectinomycin requires special care. Peripheral muscle relaxants should be used with caution, if necessary reducing the starting dose of relaxant, or using an intermediate-acting substance such as vecuronium or atracurium rather than substances with longer lasting effects.

4-aminoquinolines may reduce the effect of Bocouture.

4.6 Pregnancy And Lactation

There are no adequate data from the use of Botulinum neurotoxin type A in pregnant women. Studies in animals have shown reproductive toxicity (see Section 5.3). The potential risk for humans is unknown.

Therefore, Bocouture should not be used during pregnancy unless clearly necessary.

It is not known whether Botulinum neurotoxin type A is excreted into the breast milk. Therefore, the use of Bocouture during lactation cannot be recommended.

4.7 Effects On Ability To Drive And Use Machines

Bocouture has a minor or moderate influence on the ability to drive and use machines. There is a potential risk of localised muscle weakness or visual disturbances linked with the use of this medicinal product which may temporarily impair the ability to drive or operate machinery.

Individuals who drive vehicles and operate machines should be informed of the possible risks of asthenia, muscle weakness, dizziness and vision disorders, which could be caused by this medicinal product and could make it dangerous to drive vehicles or operate machinery.

4.8 Undesirable Effects

Usually, undesirable effects are observed within the first week after treatment and are temporary in nature. Undesirable effects may be related to the active substance, the injection procedure or both.

Localised muscle weakness is one expected pharmacological effect of Botulinum toxin. Blepharoptosis, which can be caused by injection technique, is associated with the pharmacological effect of Bocouture.

Localised pain, tenderness, itching, swelling and/or haematoma can occur in conjunction with the injection. Temporary vasovagal reactions associated with pre-injection anxiety, such as syncope, circulatory problems, nausea or tinnitus, may occur.

Frequency of occurrence

Based on clinical experience, information on the frequency of undesirable effects is given below. The frequency categories are defined as follows: very common (

The following table lists adverse reactions as reported with Bocouture. In addition, adverse reactions are presented which were reported with the comparator product containing conventional Botulinum toxin type A complex used in some clinical studies of Bocouture. These adverse reactions are highlighted with an asterisk. It is possible that these adverse reactions can also occur with Bocouture:

Infections and infestations

Uncommon:

bronchitis, nasopharyngitis, influenza, infection*

Psychiatric disorders

Uncommon:

depression, insomnia

Nervous system disorders

Common:	headache
Uncommon:	facial paresis (brow ptosis), vasovagal syncope, paraesthesia*, dizziness*

Eye disorders

Uncommon:

eyelid oedema, eyelid ptosis, blurred vision, blepharitis*, eye pain*

Ear and labyrinth disorder

Uncommon:

tinnitus

Gastrointestinal disorders

Uncommon:

nausea, dry mouth*

Skin and subcutaneous tissue disorders

Uncommon:

pruritus, skin nodule, photosensitivity*, dry skin*

Musculoskeletal and connective tissue disorders

Common:	muscle disorders (elevation of eyebrow), sensation of heaviness
Uncommon:	muscle twitching, muscle cramps

General disorders and administration site conditions

Uncommon:

Injection site reactions (bruising, pruritus), tenderness, Influenza like illness, fatigue (tiredness)

General

In rare cases, localised allergic reactions, such as swelling, oedema, erythema, pruritus or rash, have been reported after treating vertical lines between the eyebrows (glabellar frown lines) and other indications.

When treating other indications with Botulinum toxins, undesirable effects related to spread of the toxin far from the site of administration have been reported very rarely (excessive muscle weakness, dysphagia, aspiration pneumonia with a fatal outcome in some cases) (see Section 4.4). Undesirable effects such as these cannot be completely ruled out with the use of Bocouture.

4.9 Overdose

Symptoms of overdose:

Increased doses of Botulinum neurotoxin type A may result in pronounced neuromuscular paralysis distant from the injection site. Symptoms of overdose are not immediately apparent post-injection and may include general weakness, ptosis, diplopia, speech difficulties, paralysis of the respiratory muscles and swallowing difficulties which may result in an aspiration pneumonia.

Measures in cases of overdose:

In case of an overdose, the patient must be monitored medically for several days. If signs of intoxication appear, hospitalisation with general supportive measures is necessary. Intubation and assisted ventilation will become necessary until improvement if paralysis of the respiratory muscles occurs.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: other muscle relaxants, peripherally acting agents

ATC code: M03AX01

Botulinum neurotoxin type A blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine. The nerve terminals of the neuromuscular junction no longer respond to nerve impulses, and secretion of the neurotransmitter at the motor endplates is prevented (chemical denervation). Recovery of impulse transmission is re-established by the formation of new nerve terminals and reconnection with the motor endplates.

The mechanism of action by which Botulinum neurotoxin type A exerts its effects on cholinergic nerve terminals can be described by a four-step sequential process which includes the following steps:

• Binding: The heavy chain of Botulinum neurotoxin type A binds with exceptionally high selectivity and affinity to receptors only found on cholinergic terminals.

• Internalisation: Constriction of the nerve terminal's membrane and absorption of the toxin into the nerve terminal (endocytosis).

• Translocation: The amino-terminal segment of the neurotoxin's heavy chain forms a pore in the vesicle membrane, the disulphide bond is cleaved and the neurotoxin's light chain passes through the pore into the cytosol.

• Effect: After the light chain is released, it very specifically cleaves a target protein (SNAP 25) that is essential for the release of acetylcholine.

Complete recovery of endplate function/impulse transmission after injection normally occurs within 3-4 months as nerve terminals sprout and reconnect with the endplate.

Results of the clinical studies

A total of 447 subjects with moderate to severe glabellar frown lines at maximum frown participated in studies relevant to the efficacy of Bocouture in the indication glabellar frown lines. Of these, 169 subjects (

Subgroup analysis showed that efficacy in patients older than 50 years is lower compared to younger patients. Of those, 113 subjects were in the age of 50 years or younger and 56 subjects were older than 50 years of age. Efficacy in men is lower compared to women. Of those, 33 subjects were male and 136 subjects were female.

5.2 Pharmacokinetic Properties

General characteristics of the active substance

Classic kinetic and distribution studies cannot be conducted with Botulinum neurotoxin type A because the active substance is applied in such small quantities (picograms per injection) and binds rapidly and irreversibly to the cholinergic nerve terminals.

Native Botulinum toxin is a high molecular weight complex which, in addition to the neurotoxin (150 kD), contains other non-toxic proteins, like haemagglutinins and non-haemagglutinins. In contrast to conventional preparations containing the Botulinum toxin type A complex, Bocouture contains pure (150 kD) neurotoxin because it is free from complexing proteins.

Like many other proteins, Botulinum neurotoxin type A has been shown to undergo retrograde axonal transport after intramuscular injection. However, retrograde transsynaptic passage of active Botulinum neurotoxin type A into the central nervous system has not been found.

Receptor-bound Botulinum neurotoxin type A is endocytosed into the nerve terminal prior to reaching its target (SNAP 25) and is then degraded intracellularly. Freely circulating Botulinum neurotoxin type A molecules, which have not bound to presynaptic cholinergic nerve terminal receptors, are phagocytosed or pinocytosed and degraded like any other freely circulating protein.

Distribution of the active substance in patients

Human pharmacokinetic studies with Bocouture have not been performed for the reasons detailed above.

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard based on studies of cardiovascular safety pharmacology.

The findings from repeated-dose toxicity studies on the systemic toxicity of Bocouture in animals were mainly related to its pharmacodynamic properties, i.e. signs of local muscle atony, such as reduced motility and decreased muscle tone.

No evidence of local intolerability was noted. Reproductive toxicity studies with Bocouture performed in rabbits did not show adverse effects on male or female fertility nor direct effects on embryonic development. However, the administration of Bocouture at dose levels exhibiting maternal toxicity at weekly to biweekly intervals increased the number of abortions in a prenatal study in rabbits. Continuous systemic exposure of the dams during the (unknown) sensitive phase of organogenesis as a pre-requisite for the induction of teratogenic effects cannot necessarily be assumed.

No genotoxicity, carcinogenicity or pre- and postnatal development studies have been conducted with Bocouture.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Human albumin

Sucrose

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in Section 6.6.

6.3 Shelf Life

Unopened vial:

3 years

Reconstituted solution:

Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C. From a microbiological point of view, the product should be used immediately.

6.4 Special Precautions For Storage

Unopened vial: Do not store above 25°C.

Storage conditions for the reconstituted solution: See Section 6.3.

6.5 Nature And Contents Of Container

Vial (type 1 glass) with a stopper (bromobutyl rubber) and tamper-proof seal (aluminium). Pack sizes of 1, 2, 3 or 6 vials.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

50 units of Bocouture are reconstituted prior to use in 1.25 ml unpreserved sodium chloride 9 mg/ml (0.9%) solution for injection. This corresponds to a concentration of 40 units/ml. Reconstitution and dilution should be performed in accordance with good clinical practice guidelines, particularly with respect to asepsis.

It is good practice to reconstitute the vial contents and prepare the syringe over plastic-lined paper towels to catch any spillage. An appropriate amount of sodium chloride solution is drawn up into a syringe. The sodium chloride solution must be injected gently into the vial. The vial must be discarded if the vacuum does not pull the solvent into the vial. Reconstituted Bocouture is a clear, colourless solution free of particulate matter.

Bocouture must not be used if the reconstituted solution (prepared as above) has a cloudy appearance or contains floccular or particulate matter.

Any solution for injection that has been stored for more than 24 hours as well as any unused solution for injection must be discarded.

PROCEDURE TO FOLLOW FOR A SAFE DISPOSAL OF VIALS, SYRINGES AND MATERIALS USED

For safe disposal, unreconstituted Bocouture should be reconstituted in the vial with a small amount of water and then autoclaved. Any empty vials, vials containing residual solution, syringes or spillage should be autoclaved. Alternatively, the remaining Bocouture can be inactivated with diluted sodium hydroxide solution (0.1 N NaOH) or with diluted sodium hypochlorite solution (0.5% or 1% NaOCl).

After inactivation used vials, syringes and materials should not be emptied and must be discarded into appropriate containers and disposed of in accordance with local requirements.

RECOMMENDATIONS SHOULD ANY INCIDENT OCCUR DURING THE HANDLING OF BOTULINUM TOXIN

• Any spills of the product must be wiped up: either using absorbent material impregnated with a solution of sodium hydroxide or sodium hypochlorite (bleach) in case of the powder, or with dry, absorbent material in case of reconstituted product.

• The contaminated surfaces should be cleaned using absorbent material impregnated with a solution of sodium hydroxide or sodium hypochlorite (bleach), then dried.

• If a vial is broken, proceed as mentioned above by carefully collecting the pieces of broken glass and wiping up the product, avoiding any cuts to the skin.

• If the product comes into contact with the skin, wash the affected area with a solution of sodium hydroxide or sodium hypochlorite (bleach) then rinse abundantly with water.

• If product enters into contact with the eyes, rinse thoroughly with plenty of water or with an ophthalmic eyewash solution.

• If product enters into contact with a wound, cut or broken skin, rinse thoroughly with plenty of water and take the appropriate medical steps according to the dose injected.

These instructions for use handling and disposal should be strictly followed.

7. Marketing Authorisation Holder

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100

60318 Frankfurt/Main

Germany

8. Marketing Authorisation Number(S)

PL 29978/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

29/06/2010

10. Date Of Revision Of The Text

29/06/2010

Lofepramine 70mg tablets

1. Name Of The Medicinal Product

Lofepramine 70mg tablets

2. Qualitative And Quantitative Composition

Lofepramine hydrochloride 76.10mg/tablet equivalent to lofepramine base 70mg/tablet

3. Pharmaceutical Form

Oral tablet

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of symptoms of depressive illness

4.2 Posology And Method Of Administration

Route of administration:

Oral

Recommended dosage:

The usual dose is 70mg twice daily (140mg) or three times daily (210mg) depending upon patient response.

Children: Not recommended

Elderly: May respond to lower doses in some cases

4.3 Contraindications

Lofepramine must not be used in patients hypersensitive to lofepramine, dibenzazepines, or any of the excipients.

Lofepramine must not be used in patients

• with mania,

• with severe liver impairment,

• with severe renal impairment,

• with heart block,

• with cardiac arrhythmias,

• in the recovery phase following a myocardial infarction,

• with untreated narrow angle glaucoma

• with prostatic hypertrophy with urinary retention.

• at risk for paralytic ileus

Lofepramine must not be administered with or within 2 weeks of cessation of therapy with monoamine oxidase inhibitors.

Lofepramine must not be administered in patients with acute alcoholic, hypnotic, analgesic and psychotropic drug poisoning and acute deliria.

4.4 Special Warnings And Precautions For Use

Suicide/suicidal thoughts or clinical worsening.

Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.

Other psychiatric conditions for which lofepramine are prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.

Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

It should be remembered that severely depressed patients are at risk of suicide. An improvement in depression may not occur immediately upon initiation of treatment; therefore the patient should be closely monitored until symptoms improve.

Lofepramine may lower the convulsion threshold; therefore it should be used with extreme caution in patients with a history of epilepsy or recent convulsions or other predisposing factors, or during withdrawal from alcohol or other drugs with anticonvulsant properties.

Concurrent electroconvulsive therapy should only be undertaken with careful supervision.

Caution is needed in patients with hyperthyroidism, or during concomitant treatment with thyroid preparations, since aggravation of unwanted cardiac effects may occur.

Lofepramine should be used with caution in patients with cardiovascular disease, because it is associated with a risk of cardiovascular adverse reactions in all age groups.

Lofepramine should be used with caution in patients with impaired liver function, impaired renal function, blood dyscrasias or porphyria.

Caution is called for where there is a history of prostatic hypertrophy, narrow angle glaucoma or increased intra-ocular pressure, because of lofepramine's anticholinergic properties.

In patients with narrow angle glaucoma. Lofepramine may only be used if adequate glaucoma treatment is given.

In chronic constipation, tricyclic antidepressants may cause paralytic ileus, particularly in elderly and bedridden patients.

Care should be exercised in patients with tumours of the adrenal medulla (e.g. phaeochromocytoma, neuroblastoma) in whom tricyclic antidepressants may provoke antihypertensive crises.

Blood pressure should be checked before initiating treatment because individuals with hypertension, or an unstable circulation, may react to lofepramine with a fall in blood pressure.

Anaesthetics may increase the risks of arrhythmias and hypotension (see Interactions), therefore before local or general anaesthesia, the anaesthetist should be informed that the patient has been taking lofeprmaine.

Lofepramine should be used with caution where there is a history of mania. Psychotic symptoms may be aggravated. There have also been reports of hypomanic or manic episodes during a depressive phase in patients with cyclic affective disorders receiving antidepressants.

It is recommended that abrupt withdrawal of Lofepramine be avoided unless essential, because withdrawal symptoms may occur on abrupt cessation of therapy. Withdrawal symptoms may include insomnia, irritability and excessive perspiration..

Lofepramine can prolong the QT-interval in The ECG and may lead to Torsades de Pointes. Lofepramine may only be used with particular caution when other risk factors for Torsades de Pointes are present, such as:

• congenital long QT syndrome

• other clinically significant cardiac disorders

• parallel treatment with medicinal products,

which also prolong the QT interval in the ECG or can cause hypokalaemia. If Torsades de Pointes occur the treatment with Lofepramine has to be stopped.

There are isolated reports of agranulocytosis, pancytopenia and thrombocytopenia reported in association with lofepramine (see section 4.8). Monitoring of full blood count should be considered before start of treatment and periodically during treatment, particularly in patients with a history of blood dyscrasias.

Lofepramine contains lactose; therefore its use is not recommended in patients with rare hereditary problems of galactose- intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

Paediatric patients

Lofepramine is not recommended for the treatment of children and adolescents under the age of 18 years.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

MAO Inhibitors: Lofepramine must not be administered with or within 2 weeks of cessation of therapy with monoamine oxidase inhibitors. Thereafter, cautious initiation of therapy is recommended using a low initial dose and the effects monitored.

SSRI Inhibitors: co-medication may lead to additive effects on the serotonergic system. Fluvoxamine and fluoxetine may also increase plasma concentrations of Lofepramine resulting in a lowered convulsion threshold and seizures.

Antiarrhythmic agents: There is an increased risk of ventricular arrhythmias, which may lead to Torsades de Pointes if Lofepramine is given with anti-arrhythmic agents which prolong the QT interval e.g. disopyramide, procainamide, propafenone, quinidine, sotalol and amiodarone. Particular caution is advised if Lofepramine is used in combination with such agents.

Sympathomimetic drugs: Lofepramine should not be given with sympathomimetic agents (e.g. adrenalin, ephedrine, isoprenaline, noradrenaline, phenylephedrine, phenylpropanoloamine) since their cardiovascular effects may be potentiated.

CNS depressants: Lofepramine's effects may be potentiated when administered with CNS depressant substances e.g. barbiturates, general anaesthetics and alcohol. If surgery is necessary, the anaesthetist should be informed that a patient is being so treated because of the increased risk of arrhythmias and hypotension.

Neuroleptic agents: In addition to an increased risk of arrythmias, there may be an increased plasma level of the tricyclic antidepressant, a lowered convulsion threshold and seizures.

Non-antiarrhythmic agents which may prolong the QT interval: There is an increased risk of ventricular arrhythmias which may lead to Torsades de Pointes if Lofepramine is given with non- anti-arrhythmic agents which prolong the QT interval e.g. certain antibiotics (e.g. macrolides), malaria agents, antihistamines, neuroleptic agents. Particular caution is advised if Lofepramine is used in combination with such agents.

Medicinal products that may cause hypokalaemia: Combination with medicinal products that may cause hypokalaemia may increase the risk for ventricular arrhythmias including Torsades de Pointes. Particular caution is advised if Lofepramine is used in combination with such agents.

Adrenergic neurone blockers: Lofepramine may decrease or abolish the antihypertensive effects of some adrenergic neurone blocking drugs e.g. guanethidine, betanidine, resperine, clonidine and a-methyl-dopa. Antihypertensives of a different type e.g. diuretics, vasodilators or β-blockers should be given therefore where patients require co-medication for hypertension.

Anticoagulants: Lofepramine may inhibit hepatic metabolism leading to an enhancement of anticoagulant effect. Careful monitoring of plasma prothrombin is advised.

Anti-cholinergic agents: Lofepramine may potentiate the effects of these drugs (e.g. phenothiazine, antiparkinson agents, antihistamines, atropine, beperiden) on the central nervous system, eye, bowel and bladder.

Analgesics: There is an increased risk of ventricular arrhythmias.

Anti-epileptics: Antagonism can lead to a lowering of the convulsive threshold. Plasma levels of some tricyclic antidepressants, and therefore the therapeutic effect, may be reduced.

Calcium channel blockers: Diltiazem and verapamil may increase the plasma concentration of Lofepramine.

Diuretics: There is an increased risk of postural hypotension.

Rifampicin: The metabolism of Lofepramine is accelerated by rifampicin leading to a reduced plasma concentration.

Digitalis glycosides: With digitalis glycosides there is a higher risk of arrhythmias.

Cimetidine: Cimetidine can increase the plasma concentration of Lofepramine.

Disulfiram and alprazolam: Co- medication with either disulfiram or alprazolam may require a reduction in the dose of Lofepramine.

Nitrates: The effectiveness of sublingual nitrates may be reduced where the tricyclic antidepressant's anticholinergic effect has lead to dryness of the mouth.

Ritonavir: There may be an increased plasma concentration of Lofepramine.

Thyroid hormone therapy: During concomitant treatment, there may be aggravation of unwanted cardiac effects.

Oral contraceptives: Oestrogens and progestogens may antagonize the therapeutic effect of tricyclic antidepressants. Adverse reactions of tricyclic antidepressants may be exacerbated due to an increased plasma concentration.

4.6 Pregnancy And Lactation

Pregnancy

The safety of Lofepramine for use during pregnancy has not been established and there is evidence of harmful effects in pregnancy in animals when high doses are given. Lofepramine has been shown to cross the placenta. The administration of Lofepramine in pregnancy therefore is not advised unless there are compelling medical reasons.

Adverse effects such as withdrawal symptoms, respiratory depression and agitation have been reported in neonates whose mothers have taken tricyclic antidepressants during the last trimester of pregnancy.

Lactation

Lofepramine is excreted in breast milk. The administration of Lofepramine during breast-feeding is not advised unless there are compelling medical reasons.

4.7 Effects On Ability To Drive And Use Machines

As with other antidepressants, ability to drive a car and operate machinery may be affected, especially in conjunction with alcohol.

Therefore caution should be exercised initially until the individual reaction to treatment is known.

4.8 Undesirable Effects

The following side effects have been reported with Lofepramine:

Investigations:

Changes of blood sugar level

Cardiac disorders:

Tachycardia, cardiac conduction disorders, increase in cardiac insufficiency, QT-prolongation, arrhythmias

(including ventricular arrhythmias or Torsades de Pointes.)

Nervous system disorders:

Dizziness, headache, paraesthesia, tremor; rarely, drowsiness, convulsions, impairment of the sense of taste; very rarely, uncoordinated movement.

Reproductive system and breast disorders:

Interference with sexual function, testicular disorders (e,g testicular pain), gynaecomastia, galactorrhoea.

Skin and subcutaneous tissue disorders

Skin rash, allergic skin reactions, “photosensitivity reactions”; rarely, cutaneous bleeding, sweating.

Gastrointestinal disorders:

Gastrointestinal disturbances including nausea, vomiting, diarrhoea; constipation and dryness of mouth.

Endocrine disorders:

Rarely, inappropriate secretion of antidiuretic hormone leading to hyponatraemia.

Blood and lymphatic system disorders:

Rarely, bone marrow depression including isolated reports of: agranulocytosis, eosinophilia, granulocytopenia, leucopenia, pancytopenia, thrombocytopenia.

Eye disorders:

Visual disturbances including blurred vision, mydriasis, disturbances of accommodation; induction of glaucoma.

Ear and labyrinth disorders:

Very rarely, tinnitus

Renal and urinary disorders

Urinary hesitancy, urinary retention

Vascular disorders

Hypotension

General disorders and administration site conditions

Malaise, facial oedema; rarely, inflammation of mucosal membranes.

Hepatobiliary disorders:

Increases in liver enzymes, sometimes progressing to clinical hepatitis and jaundice, have been reported in some patients, usually occurring within the first 3 months of starting therapy.

Psychiatric disorders:

Sleep disturbances, agitation, confusion, nightmares, hallucinations, hypomania, mania, psychoses, delirium.

Cases of suicidal ideation and suicidal behaviours have been reported during lofepramine therapy or early after discontinuation (see section 4.4)

It should be remembered that severely depressed patients are at risk of suicide until there is a complete remission of symptomatology.

Epidemiological studies, mainly in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRls and TCAs. The mechanism leading to this risk is unknown.

4.9 Overdose

The treatment of overdosage is symptomatic and supportive. It should include immediate gastric lavage and routine close monitoring of cardiac function.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Lofepramine is a tricyclic antidepressant. It exerts its therapeutic effect by blocking the uptake of noradrenaline by the nerve cell thus increasing the amine in the synaptic cleft and hence the effect on the receptors. There is evidence to suggest that serotonin may also be involved. Other pharmacological effects are due to anti-cholinergic activity, but less sedation is observed than with other tricyclics.

5.2 Pharmacokinetic Properties

Lofepramine is a tertiary amine, similar in structure to imipramine but with improved lipophilicity and lower base strength. It is readily absorbed when given orally. From the plasma it is distributed throughout the body notably to the brain, lungs, liver and kidney. It is metabolised in the liver by cleavage of the p-chlorophenacyl group from the lofepramine molecule leaving desmethylimipramine (DMI).

The latter is pharmacologically active. The p-chlorobenzoyl portion is mainly metabolised to p-chlorobenzoic acid which is then conjugated with glycine. The conjugate is excreted mostly in the urine. DMI has been found excreted in the faeces. In a study of protein binding capability it has been found that lofepramine is up to 99% protein bound.

5.3 Preclinical Safety Data

Preclinical studies investigating effects of lofepramine and desipramine its major active metabolite on cardiac repolarisation are limited. Both compounds are able to block various ion channels participating in cardiac depolarisation and repolarisation with effects only at concentrations above the free plasma level at the recommended human dose. Decrease in heart rate and QTc-prolongation were seen in dogs at dose levels of 25 mg/kg and higher, approximately 6 times above the therapeutic dosage of 140 mg lofepramine per day calculated on a mg/m2 basis (60 kg patient).

6. Pharmaceutical Particulars

6.1 List Of Excipients

Excipients

Lactose

Corn starch

L(+) ascorbic acid

Talcum

Glycerol

Glycerol monostearate

Ethylene dinitriletetra acetic acid disodium salt (dihydrate) [titriplex III]

Dimethicone

Silicone dioxide

Hydroxypropyl methyl cellulose

Coating

1,2-Propanediol

Hydroxypropyl methyl cellulose

Ponceau 4R aluminium lake E124

Talc

Titanium dioxide

Indigotine lake E132

6.2 Incompatibilities

None

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Protect from light and moisture. Store in the original package.

6.5 Nature And Contents Of Container

Containers

1. PVDC/Al foil blister calendar packs containing 28, 56, 1008 or 2016 tablets

2. Polypropylene containers containing 56, 250, 500 or 1000 tablets

3. Amber glass bottles containing 56 tablets

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Merck Serono Ltd

Bedfont Cross

Stanwell Road

Feltham

Middlesex

TW14 8NX,

United Kingdom

8. Marketing Authorisation Number(S)

PL 11648/0011

9. Date Of First Authorisation/Renewal Of The Authorisation

30 July 1982/ 1 December 1998

10. Date Of Revision Of The Text

16 November 2010

fluticasone Inhalation, oral/nebulization

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 fluticasone

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.

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

fluticasone 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 fluticasone

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 fluticasone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fluticasone 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 fluticasone 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 fluticasone is given to a child, you and your child's doctor should talk about the good fluticasone 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 fluticasone 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

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 fluticasone, 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 fluticasone 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

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

• Herpes simplex (virus) infection of the eye or


• Infections (virus, bacteria, or fungus)—Inhaled fluticasone may make these infections worse.

• Tuberculosis (active or history of)—Inhaled fluticasone may cause this infection to start up again.

Proper Use of fluticasone

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 fluticasone 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 fluticasone may take 1 to 2 weeks or longer to achieve.

In order for fluticasone 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 fluticasone. 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 fluticasone 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 fluticasone. 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 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 fluticasone, 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 fluticasone 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 fluticasone

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 fluticasone 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 fluticasone.

fluticasone 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

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

• 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.

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