Innohep 10,000 IU / ml and Innohep Syringe 10,000 IU / ml

1. Name Of The Medicinal Product

innohep^® 10,000 IU/ml and innohep^® Syringe 10,000 IU/ml

2. Qualitative And Quantitative Composition

Tinzaparin sodium 10,000 anti-Factor Xa IU/ml

3. Pharmaceutical Form

Solution for injection

4. Clinical Particulars

4.1 Therapeutic Indications

For the prevention of thromboembolic events, including deep vein thrombosis, in patients undergoing general and orthopaedic surgery.

For the prevention of clotting in the extracorporeal circuit during haemodialysis in patients with chronic renal insufficiency.

4.2 Posology And Method Of Administration

For prevention of thromboembolic events:

Administration is by subcutaneous injection.

Adults at low to moderate risk, e.g. patients undergoing general surgery:

3,500 anti-Factor Xa IU two hours before surgery and then once daily for 7 to 10 days post-operatively.

Adults at high risk, e.g. patients undergoing orthopaedic surgery:

In this high risk group the recommended dose is either a fixed dose of 4,500 anti-Factor Xa IU given 12 hours before surgery followed by a once daily dose, or 50 anti-Factor Xa IU/kilogram body weight 2 hours before surgery followed by a once daily dose for 7 to 10 days post-operatively.

For haemodialysis:

The dose of innohep^® should be given into the arterial side of the dialyser or intravenously. The dialyser can be primed by flushing with 500-1000 ml isotonic sodium chloride (9 mg/ml) containing 5,000 anti-Factor Xa IU innohep^® per litre.

Patients with chronic renal insufficiency:

a) Short-term haemodialysis (up to 4 hours)

A bolus dose of 2,000-2,500 anti-Factor Xa IU into the arterial side of the dialyser (or intravenously).

b) Long-term haemodialysis (more than 4 hours)

A bolus dose of 2,500 anti-Factor Xa IU into the arterial side of the dialyser (or intravenously) followed by 750 anti-Factor Xa IU/hour infused into the extracorporeal circuit.

Dosage adjustment

The bolus innohep^® dose may be adjusted (increased or decreased) by 250-500 anti-Factor Xa IU until a satisfactory response is obtained.

Additional innohep^® (500-1,000 anti-Factor Xa IU) may be given if concentrated red cells or blood transfusions (which may increase the likelihood of clotting in the dialyser) are given during dialysis or additional treatment beyond the normal dialysis duration is employed.

Dose monitoring

Determination of plasma anti-Factor Xa may be used to monitor the innohep^® dose during haemodialysis. Plasma anti-Factor Xa, one hour after dosing should be within the range 0.4 - 0.5 IU/ml.

Use in the elderly

No dose modifications are necessary.

Use in children

There is no experience of use in children.

4.3 Contraindications

• Known hypersensitivity to constituents.

• Current or history of heparin-induced thrombocytopenia.

• Generalised or local haemorrhagic tendency, including uncontrolled severe hypertension, severe liver insufficiency, active peptic ulcer, acute or subacute septic endocarditis, intracranial haemorrhage, or injuries and operations on the central nervous system, eyes and ears, and in women with abortus imminens.

• The innohep^® 10,000 IU/ml vial formulation contains 10 mg/ml of the preservative benzyl alcohol. This formulation must not be given to premature babies or neonates.

The innohep^® 10,000 IU/ml syringe formulation does not contain the preservative benzyl alcohol.

• An epidural anaesthesia during birth in pregnant women treated with low molecular weight heparin is contraindicated (see section 4.6).

• In patients receiving heparin for treatment rather than prophylaxis, locoregional anaesthesia in elective surgical procedures is contra-indicated because the use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis.

4.4 Special Warnings And Precautions For Use

Care should be taken when innohep^® is administered to patients with increased risk of bleeding complications.

In patients undergoing peridural or spinal anaesthesia or spinal puncture, the prophylactic use of heparin may be very rarely associated with epidural or spinal haematoma resulting in prolonged or permanent paralysis. The risk is increased by the use of a peridural or spinal catheter for anaesthesia, by the concomitant use of drugs affecting haemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors or anticoagulants, and by traumatic or repeated puncture.

In decision making on the interval between the last administration of heparin at prophylactic doses and the placement or removal of a peridural or spinal catheter, the product characteristics and the patient profile should be taken into account. Subsequent dose should not take place before at least four hours have elapsed. Re-administration should be delayed until the surgical procedure is completed.

Should a physician decide to administer anti-coagulation in the context of peridural or spinal anaesthesia, extreme vigilance and frequent monitoring must be exercised to detect any signs and symptoms of neurologic impairment, such as back pain, sensory and motor deficits and bowel or bladder dysfunction. Patients should be instructed to inform immediately a nurse or a clinician if they experience any of these.

innohep^® should not be administered by intramuscular injection due to the risk of haematoma.

Due to increased bleeding risk care should be taken when giving concomitant intramuscular injections, lumbar puncture and similar procedures.

innohep^® should be used with caution in patients with hypersensitivity to heparin or to other low molecular weight heparins.

As there is a risk of antibody-mediated heparin-induced thrombocytopenia, platelet counts should be measured in patients receiving heparin treatment for longer than 5 days and the treatment should be stopped immediately in those who develop thrombocytopenia.

As with other low molecular weight heparins, in some patients undergoing surgical procedures (especially orthopaedic) or presenting with a concomitant inflammatory process, the administration of innohep^® has coincided with an asymptomatic increase of platelet count, which in many cases subsided during continued administration. If an increase in platelet count occurs, evaluation of the benefit/risk of continuing therapy for that patient should be made.

Care should be taken when innohep^® is administered to patients with kidney insufficiency who are undergoing general or orthopaedic surgery. In such cases a dose reduction should be considered.

Heparin can suppress adrenal secretion of aldosterone leading to hyperkalaemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, a raised plasma potassium or taking potassium-sparing drugs. The risk of hyperkalaemia appears to increase with duration of therapy but is usually reversible. Plasma potassium should be measured in patients at risk before starting heparin therapy and monitored regularly thereafter particularly if treatment is prolonged beyond about 7 days.

The innohep^® 10,000 IU/ml vial formulation contains the preservative benzyl alcohol 10 mg/ml. This should be administered with caution to infants and children up to 3 years old, as there is a risk that benzyl alcohol may cause toxic reactions and allergic reactions (anaphylactoid) in this age group (see section 4.3 for premature babies and neonates).

Drugs affecting platelet function or the coagulation system should in general not be given concomitantly with innohep^® (see section 4.5).

Prosthetic heart valves:

There have been no adequate studies to assess the safe and effective use of tinzaparin sodium in preventing valve thrombosis in patients with prosthetic heart valves; therefore no dosage recommendations can be given. High doses of tinzaparin sodium (175 IU/kg) may not be sufficient prophylaxis to prevent valve thrombosis in patients with prosthetic heart valves. The use of tinzaparin sodium cannot be recommended for this purpose.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The anticoagulant effect of innohep^® may be enhanced by concomitant medication with other drugs affecting platelet function or the coagulation system, e.g. platelet aggregation inhibitors, thrombolytic agents, salicylates, non-steroidal anti-inflammatory drugs, vitamin K antagonists, dextrans, activated protein C.

innohep^® does not appear to interact with other drugs used widely in chronic renal failure, including vitamin B supplements, aluminium hydroxide, calcium supplements, alfacalcidol, ranitidine, vitamin C supplements, ferrous sulphate, folic acid, nifedipine, erythropoietin and azatadine.

4.6 Pregnancy And Lactation

Pregnancy

No transplacental passage of innohep^® was found (assessed by anti-Factor Xa and anti-Factor IIa activity) in patients given a dose of 35 to 40 anti-Factor Xa IU/kg in the second trimester of pregnancy. In rabbits, no transplacental passage of anti-Factor Xa or anti-Factor IIa activity was observed after doses of 1750 anti-Factor Xa IU/kg. Toxicological studies in rats have shown no embryotoxic or teratogenic effects, although a lower birthweight was found.

Although these animal studies show no hazard, as a precaution innohep^® should not be used in pregnancy unless no safer alternative is available.

As benzyl alcohol may cross the placenta, the use of innohep^® formulations containing benzyl alcohol should be avoided during pregnancy.

The use of innohep^® in women with abortus imminens is contraindicated (see section 4.3).

Prosthetic heart valves:

Therapeutic failures and maternal death have been reported in pregnant women with prosthetic heart valves on full anti-coagulant doses of low molecular weight heparins. In the absence of clear dosing, efficacy and safety information in this circumstance, tinzaparin sodium is not recommended for use in pregnant women with prosthetic heart valves.

Lactation

It is not known whether innohep^® is excreted in breast milk. However, patients are advised to stop breast-feeding while receiving innohep^®.

4.7 Effects On Ability To Drive And Use Machines

innohep^® has no or negligible influence on the ability to drive or use machines.

4.8 Undesirable Effects

Based on reports from clinical trials the frequency rate of all adverse reactions is 17.6%. The most frequently reported undesirable effects are bleeding events, injection site reactions, various skin reactions, reversible thrombocytopenia, allergic reactions, headache and reversible increase in liver enzymes.

Based on pooled study results, from a clinical trial programme where 3167 patients received innohep^®, local reactions following subcutaneous administration such as irritation, bruising, pain and ecchymosis were identified in approximately 3.7 % of patients. The overall bleeding risk was approximately 11 % while the risk of major bleeding was approximately 0.5%. Reversible thrombocytopenia was seen in approximately 0.6 % of patients.

A list of undesirable effects is given below. Where frequencies are given, these are based on the clinical trial data, using the stated frequency classification. Where the term 'Not known' is given, these effects are derived from spontaneous reports.

Frequency classification:

Very common	>1/10
Common	>1/100 and <1/10
Uncommon	>1/1,000 and <1/100
Rare	>1/10,000 and <1/1,000
Very rare	<1/10,000
• Blood and lymphatic system disorders
Uncommon:	Thrombocytopenia (type I).
Not known:	Heparin induced thrombocytopenia (HIT), probably of an immuno-allergic nature (see Section 4.4). In some cases, Heparin induced thrombocytopenia has been accompanied by venous or arterial thrombi.
	Increase in platelet count, asymptomatic and reversible (see section 4.4).
Class effect:	Valve thrombosis in patients with prosthetic heart valves has been reported rarely in patients receiving low molecular weight heparins, usually associated with inadequate dosing (see Section 4.4).
• Immune system disorders
Uncommon:	Allergic reactions (of all types and severities have been reported).
• Metabolism and nutrition disorders
Not known:	Hypoaldosteronism associated with hyperkalaemia and metabolic acidosis, especially in patients with renal impairment and diabetes mellitus (see Section 4.4).
• Nervous system disorders
Uncommon:	Headache.
• Vascular disorders
Very common:	Haemorrhage. Haemorrhagic complications may affect any organ, and may have different degrees of severity. In some cases haemorrhage has resulted in death or permanent disability. Haemorrhagic complications can occur in particular when high doses are administered. Anaemia can occur as a consequence of haemorrhage.
Not known:	Epidural and spinal haematoma (see Section 4.4).
• Hepatobiliary disorders
Uncommon:	Raised transaminases. These increases are reversible after drug withdrawal.
Not known:	Raised gamma-GT.
• Skin and subcutaneous tissue disorder
Uncommon:	Rash (such as erythematous or maculopapular), pruritus, urticaria.
Rare:	Skin necrosis.
Not known:	Angioedema, toxic epidermal necrolysis and Stevens-Johnson syndrome.
• Musculoskeletal and connective tissue disorders
Not known:	Osteoporosis has been reported in connection with long-term treatment with heparin.
• Reproductive system and breast disorders
Not known:	Priapism.
• General disorders and administration site conditions
Common:	Injection site reactions (local irritation, pain, bruising, ecchymosis).

4.9 Overdose

Overdose of innohep^® may be complicated by haemorrhage. With recommended dosages there should be no need for an antidote but in the event of accidental administration of an overdose, the effect of innohep^® can be reversed by intravenous administration of 1% protamine sulphate solution.

The dose of protamine sulphate required for neutralisation should be accurately determined by titrating with the patient's plasma.

Studies in healthy volunteers indicate that 65-80% of the anti-Xa activity is neutralised by protamine sulphate 1 mg/100 anti-Xa IU of innohep^®. A return of innohep^® anti-Xa, anti-IIa and APTT activities are seen 3 hours after its reversal probably due to continuous absorption of innohep^® from the s.c. depot. It may therefore be necessary to give protamine sulphate intermittently or as a continuous infusion to achieve and maintain neutralisation of s.c. innohep^® for at least 24 hours. Potential side-effects of protamine sulphate must be considered and patients carefully observed.

Transfusion of fresh plasma may be used, if necessary. Plasma anti-Factor Xa and anti-Factor IIa activity should be measured during the management of overdose situations.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

innohep^® is an antithrombotic agent. It potentiates the inhibition of several activated coagulation factors, especially Factor Xa, its activity being mediated via antithrombin III.

5.2 Pharmacokinetic Properties

The pharmacokinetics/pharmacodynamic activity of innohep^® is monitored by anti-Factor Xa activity.

innohep^® has a bioavailability of around 90% following a subcutaneous injection. The absorption half-life is 200 minutes, peak plasma activity being observed after 4 to 6 hours. The elimination half-life is about 90 minutes.

The half-life of innohep^® in patients with renal insufficiency given a bolus intravenous dose of 2,500 anti-Factor Xa IU is about 2.5 hours.

There is a linear dose response relationship between plasma activity and the dose administered.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

innohep^® 10,000 IU/ml:

Benzyl alcohol

Sodium acetate

Sodium hydroxide

Water for injections

innohep^® Syringe 10,000 IU/ml:

Sodium acetate

Water for injections

As pH adjuster: sodium hydroxide

6.2 Incompatibilities

innohep^® should not be mixed with any other injection.

6.3 Shelf Life

innohep^® 10,000 IU/ml:

2 years.

innohep^® Syringe 10,000 IU/ml:

3 years.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

innohep^® 10,000 IU/ml:

2 ml glass vial containing 10,000 anti-Factor Xa IU/ml in packs of 10 vials.

innohep^® Syringe 10,000 IU/ml:

A prefilled unit dose syringe with needle safety device containing:

2,500 anti-Factor Xa IU in 0.25 ml

3,500 anti-Factor Xa IU in 0.35 ml

4,500 anti-Factor Xa IU in 0.45 ml

in packs of 10 syringes.

6.6 Special Precautions For Disposal And Other Handling

innohep^® 10,000 IU/ml:

The vial should be discarded 14 days after first use.

innohep^® Syringe 10,000 IU/ml:

Contains no preservative, any portion of the contents not used at once should be discarded with the syringe.

7. Marketing Authorisation Holder

LEO Laboratories Limited

Longwick Road

Princes Risborough

Bucks HP27 9RR

8. Marketing Authorisation Number(S)

innohep^® 10,000 IU/ml: PL 00043/0205

innohep^® Syringe 10,000 IU/ml: PL 00043/0204

9. Date Of First Authorisation/Renewal Of The Authorisation

innohep® 10,000 IU/ml:	30 September 1998
innohep® Syringe 10,000 IU/ml:	20 November 1997

10. Date Of Revision Of The Text

1 September 2011

LEGAL CATEGORY

POM

Opioid Overdose Medications

Drugs associated with Opioid Overdose

The following drugs and medications are in some way related to, or used in the treatment of Opioid Overdose. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Narcan

Revex

KGS-PE Liquid

Pronunciation: fen-ill-EF-rin/poe-TASS-ee-uhm gwie-ah-kole-SULL-foe-nate
Generic Name: Phenylephrine/Potassium Guaiacolsulfonate
Brand Name: KGS-PE

KGS-PE Liquid is used for:

Relieving symptoms of congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

KGS-PE Liquid is a decongestant and expectorant combination. It works by constricting blood vessels and shrinking swollen and congested nasal tissues (mucous membranes) and by thinning and loosening mucus in the airway. This allows you to breathe more easily and makes coughs more productive.

Do NOT use KGS-PE Liquid if:

• you are allergic to any ingredient in KGS-PE Liquid


• you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems


• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using KGS-PE Liquid:

Some medical conditions may interact with KGS-PE Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


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


• if you have a fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, an enlarged prostate or other prostate problems, seizures, or an overactive thyroid


• if you have chronic cough

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because side effects of KGS-PE Liquid may be increased


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine because side effects may be increased by KGS-PE Liquid


• Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by KGS-PE Liquid

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

Use KGS-PE Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• KGS-PE Liquid may be taken with or without food.


• Take KGS-PE Liquid with a full glass of water unless your doctor directs otherwise.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of KGS-PE Liquid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use KGS-PE Liquid.

Important safety information:

• KGS-PE Liquid may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to KGS-PE Liquid. Using KGS-PE Liquid alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take diet or appetite control medicines while you are taking KGS-PE Liquid without checking with you doctor.


• Do NOT exceed the recommended dose or use/take KGS-PE Liquid for longer than prescribed without checking with your doctor.


• KGS-PE Liquid contains phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• KGS-PE Liquid may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking KGS-PE Liquid.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using KGS-PE Liquid.


• Use KGS-PE Liquid with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using KGS-PE Liquid in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking KGS-PE Liquid, discuss with your doctor the benefits and risks of using KGS-PE Liquid during pregnancy. It is unknown if KGS-PE Liquid is excreted in breast milk. Do not breast-feed while taking KGS-PE Liquid.

Possible side effects of KGS-PE Liquid:

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:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

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: KGS-PE side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of KGS-PE Liquid:

Store KGS-PE Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep KGS-PE Liquid out of the reach of children and away from pets.

General information:

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


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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More KGS-PE resources

• KGS-PE Side Effects (in more detail)
• KGS-PE Use in Pregnancy & Breastfeeding
• KGS-PE Drug Interactions
• KGS-PE Support Group
• 0 Reviews · Be the first to review/rate this drug

Temovate

Generic Name: clobetasol (Topical application route)

kloe-BAY-ta-sol PROE-pee-oh-nate

Commonly used brand name(s)

In the U.S.

• Clobevate


• Clobex


• Cormax


• Embeline


• Embeline E


• Embeline Scalp Application


• Olux


• Olux/Olux-E Complete Pack


• Olux-E


• Temovate


• Temovate E

In Canada

• Clobetasol Propionate


• Dermovate


• Dermovate Scalp Application


• Med Clobetasol Scalp Application


• Ratio-Clobetasol

Available Dosage Forms:

• Cream


• Ointment


• Gel/Jelly


• Spray


• Solution


• Foam


• Emollient Cream


• Lotion


• Shampoo

Therapeutic Class: Corticosteroid, Very Strong

Pharmacologic Class: Clobetasol

Uses For Temovate

Clobetasol topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. The solution and foam are used for scalp problems, the lotion and spray are used for moderate to severe plaque psoriasis, and the shampoo is used for moderate to severe scalp psoriasis. This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

Before Using Temovate

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clobetasol topical gel, foam, cream, ointment, or scalp solution in children 12 years of age and older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. Safety and efficacy have not been established in children younger than 12 years of age and the use of clobetasol topical gel, foam, cream, ointment, or scalp solution is not recommended. The safety and efficacy of clobetasol topical spray, lotion, or shampoo have not been established in children and use is not recommended.

Geriatric

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


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

• Infection of the skin at or near the place of application or


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

• Perioral dermatitis (skin problem) or


• Rosacea (skin problem)—Should not be used in patients with these conditions.

Proper Use of clobetasol

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

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

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

To use the cream, foam, gel, lotion, ointment, or spray:

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


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


• With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.


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

To use the foam, scalp solution, or shampoo:

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


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


• Do not cover the scalp (e.g., shower cap, bathing cap) while it is being treated.


• Do not use the shampoo for more than 4 weeks, the foam and scalp solution for more than 2 weeks unless your doctor has told you to.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

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 redness, itching, and swelling of the skin:
  
  • For topical dosage forms (cream, gel, or ointment):
    
    • Adults—Apply to the affected area of the skin two times per day.
    
    
    • Children 12 to 17 years of age—Apply to the affected area of the skin two times per day.
    
    
    • Children younger than 12 years of age—Use is not recommended.
    
    
  
  
  • For topical dosage form (lotion):
    
    • Adults—Apply to the affected area of the skin two times per day.
    
    
    • Children—Use is not recommended.
    
    
  
  


• For plaque psoriasis:
  
  • For topical dosage form (foam):
    
    • Adults—Apply to the affected area of the skin two times per day, once in the morning and once at night.
    
    
    • Children 12 to 17 years of age—Apply to the affected area of the skin two times per day, once in the morning and once at night.
    
    
    • Children younger than 12 years of age—Use is not recommended.
    
    
  
  
  • For topical dosage form (spray):
    
    • Adults—Spray to the affected area of the skin two times per day.
    
    
    • Children—Use is not recommended.
    
    
  
  


• For scalp problems:
  
  • For topical dosage form (foam or scalp solution):
    
    • Adults—Apply to the affected area of the scalp two times per day, once in the morning and once at night.
    
    
    • Children 12 to 17 years of age—Apply to the affected area of the scalp two times per day, once in the morning and once at night.
    
    
    • Children younger than 12 years of age—Use is not recommended.
    
    
  
  
  • For topical dosage form (shampoo):
    
    • Adults—Apply to the affected area of the scalp once a day.
    
    
    • Children—Use is not recommended.
    
    
  
  

Missed Dose

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

Storage

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.

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

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

Precautions While Using Temovate

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

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

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

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

Make sure your doctor knows that you are using clobetasol gel. You may need to stop using this medicine several days before having surgery.

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

Temovate 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

• Burning or stinging at the application site

Less common

• Burning sensation of the skin


• dry skin


• flushing or redness of the skin


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


• skin irritation


• skin rash, encrusted, scaly and oozing


• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)

Incidence not known

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


• hair loss


• redness and scaling around the mouth


• thinning of the hair


• thinning, weakness, or wasting away of the 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

• Cough


• sore throat

Less common

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


• changes in skin coloring


• body aches or pain


• congestion


• cough


• dryness or soreness of the throat


• fever


• headache


• hoarseness


• raised, dark red, wart-like spots on the skin, especially when used on the face


• skin discomfort


• stuffy or runny nose


• tender, swollen glands in the neck


• trouble with swallowing


• unusual tiredness or weakness


• voice changes

Incidence not known

• Acne or pimples


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


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


• lightening of normal skin color


• lightening of treated areas of dark skin


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


• softening of the skin

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

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

See also: Temovate side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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

More Temovate resources

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

• Temovate Prescribing Information (FDA)


• Temovate Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Temovate Concise Consumer Information (Cerner Multum)


• Clobex Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Clobex Prescribing Information (FDA)


• Cormax Prescribing Information (FDA)


• Olux Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Olux Prescribing Information (FDA)


• Olux-E Emollient Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Olux-E Prescribing Information (FDA)

Compare Temovate with other medications

• Atopic Dermatitis
• Dermatitis
• Lichen Planus
• Lichen Sclerosus
• Psoriasis

Salofalk Rectal

Generic Name: mesalamine (Rectal route)

me-SAL-a-meen

Commonly used brand name(s)

In the U.S.

• Canasa


• Rowasa


• sfRowasa

In Canada

• Mesasal


• Pentasa


• Salofalk

Available Dosage Forms:

• Suppository


• Enema

Therapeutic Class: Gastrointestinal Agent

Chemical Class: Salicylate, Non-Aspirin

Uses For Salofalk

Mesalamine is used to treat inflammatory bowel disease, such as ulcerative colitis. This medicine works inside the bowel by helping to reduce inflammation and other symptoms.

Mesalamine 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 this use is not included in product labeling, mesalamine is used in certain patients with the following medical condition:

• Ulcerative colitis, history of—prevent it from occurring again

Before Using Salofalk

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of mesalamine in children with use in other age groups.

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 mesalamine in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 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.

• Varicella Virus Vaccine

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.

• Ardeparin


• Certoparin


• Dalteparin


• Danaparoid


• Enoxaparin


• Nadroparin


• Parnaparin


• Reviparin


• Tamarind


• Tinzaparin


• Warfarin

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:

• Kidney disease—The use of mesalamine may make this condition worse.

Proper Use of mesalamine

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

For best results, empty your bowel just before using the rectal enema or suppository.

Keep using this medicine for the full time of treatment even if you begin to feel better after a few days. Do not miss any doses.

For patients using the enema form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Remove the bottles from the protective foil pouch, being careful not to squeeze or puncture them. The enema is an off-white to tan color. Contents of the enemas removed from the foil pouch may darken with time. Slight darkening will not affect the potency of the contents. However, enemas with dark brown contents should be discarded.


• Shake the bottle well to make sure that the medication is thoroughly mixed. Remove the protective cover from the applicator tip. Hold bottle at the neck so that no medicine spills out.


• Lie on your left side with your left leg straight and your right knee bent in front of you for balance. You can also lie in the knee-chest position, on your knees with your chest touching the bed.


• Gently insert the rectal tip of the enema applicator pointed slightly toward your naval to prevent damage to the rectal wall. Tilt the nozzle slightly toward the back and squeeze slowly to cause the enema to flow into your rectum. Steady pressure will discharge most of the medicine. After administering, withdraw and discard the bottle.


• Remain in position for at least 30 minutes to allow the medicine to distribute thoroughly. Retain the medicine all night if possible.

For patients using the suppository form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Detach one suppository from strip of suppositories. Hold suppository upright and carefully remove the foil wrapper.


• Avoid excessive handling of the suppository, which is designed to melt at body temperature.


• Insert suppository (pointed end first) completely into rectum with gentle pressure. Retain the suppository for 3 hours or longer, if possible, to achieve the best result.

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 inflammatory bowel disease:
  
  • For enema dosage form:
    
    • Adults and teenagers—4 grams (1 unit), used as directed, every night for three to six weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For suppository dosage form:
    
    • Adults and teenagers—500 milligrams (mg), inserted into your rectum, two or three times a day for three to six weeks or 1000 mg, inserted into your rectum, one time a day at bedtime for three to six weeks.
    
    
    • Children—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.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Salofalk

It is important that your doctor check your progress at regular visits.

Contact your doctor if you develop cramping, acute abdominal pain, bloody diarrhea, fever, headache or rash. These may be symptoms of a serious condition.

Tell your doctor right away if you experience chest pain or shortness of breath.

Check with your doctor if you notice rectal bleeding, blistering, pain, burning, itching, or other sign of irritation not present before you started using this medicine.

Mesalamine rectal enema may stain clothing, fabrics, painted surfaces, marble, granite, vinyl, or other surfaces it touches.

Salofalk 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 as soon as possible if any of the following side effects occur:

Less common or rare

• Abdominal or stomach cramps or pain (severe)


• anxiety


• back pain (severe)


• bloody, black, or tarry stools


• blue or pale skin


• bright red blood in the stool


• chest pain, possibly moving to the left arm, neck, or shoulder


• chills


• diarrhea (severe)


• fast heartbeat


• fever


• headache (severe)


• nausea or vomiting


• shortness of breath


• skin rash


• stomach cramps, tenderness, pain


• swelling of the stomach


• unusual tiredness or weakness


• watery or bloody diarrhea


• yellow eyes or skin

Incidence not known

• Blood in urine


• change in frequency of urination or amount of urine


• cough


• difficulty in breathing


• drowsiness


• high fever


• increased thirst


• loss of appetite


• lower back or side pain


• painful or difficult urination


• pale skin


• sore throat


• sores, ulcers, or white spots on lips or in mouth


• swelling of feet or lower legs


• swollen glands


• troubled breathing


• unexplained or unusual bleeding or bruising


• 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

• Abdominal or stomach cramps or pain (mild)


• gas or flatulence


• headache (mild)


• nausea

Less common or rare

• Acne


• diarrhea


• dizziness


• leg or joint pain


• loss of hair


• rectal pain or irritation

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: Salofalk Rectal side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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

More Salofalk Rectal resources

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

Compare Salofalk Rectal with other medications

• Crohn's Disease
• Crohn's Disease, Maintenance
• Inflammatory Bowel Disease
• Ulcerative Colitis
• Ulcerative Colitis, Active
• Ulcerative Colitis, Maintenance
• Ulcerative Proctitis

Lufyllin-400

Generic Name: dyphylline (Oral route)

DYE-fi-lin

Commonly used brand name(s)

In the U.S.

• Dilor-200


• Dilor-400


• Dylix


• Lufyllin


• Lufyllin-400

In Canada

• Protophylline Alcohol And Sugar Free

Available Dosage Forms:

• Tablet


• Elixir

Therapeutic Class: Bronchodilator

Chemical Class: Methylxanthine

Uses For Lufyllin-400

Dyphylline is used to treat and/or prevent the symptoms of bronchial asthma, chronic bronchitis, and emphysema. It works by opening up the bronchial tubes (air passages of the lungs) and increasing the flow of air through them.

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

Before Using Lufyllin-400

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

Use of other bronchodilator medicines is preferred.

Geriatric

As in younger patients, use of other bronchodilator medicines is preferred. Also, older patients with kidney disease may require a lower dose of dyphylline than do older adults without kidney disease.

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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Heart or blood vessel disease or


• Stomach ulcer (or history of) or other stomach problems—May make these conditions worse.

• Heart failure or


• Kidney disease—The effects of the medicine may be increased.

Proper Use of dyphylline

This section provides information on the proper use of a number of products that contain dyphylline. It may not be specific to Lufyllin-400. Please read with care.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, dyphylline must be taken at regularly spaced times, as ordered by your doctor. Do not miss any doses.

This medicine also works best when taken with a glass of water on an empty stomach (either 30 minutes to 1 hour before meals or 2 hours after meals). However, in some cases your doctor may want you to take this medicine with meals or right after meals to lessen stomach upset.

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 oral dosage forms (elixir or tablets):
  
  • For asthma, bronchitis, or emphysema:
    
    • Adults—Dose is based on body weight. The usual dose is 15 milligrams (mg) per kilogram (kg) of body weight up to four times per day.
    
    
    • Children—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. Do not refrigerate. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Lufyllin-400

Your doctor will check your progress at regular visits, especially during the first few weeks of your treatment with this medicine.

Before you have any kind of surgery that requires general anesthesia, tell the medical doctor in charge that you are using this medicine.

Lufyllin-400 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 as soon as possible if any of the following side effects occur:

Less common

• Heartburn


• vomiting

Symptoms of overdose

• Abdominal pain (continuing or severe)


• confusion or change in behavior


• convulsions (seizures)


• dark or bloody vomit


• diarrhea


• fast or irregular heartbeat


• nervousness or restlessness (continuing)


• trembling (continuing)

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

• Fast heartbeat


• headache


• increased urination


• nausea


• nervousness


• trembling


• trouble with sleeping

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

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

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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

More Lufyllin-400 resources

• Lufyllin-400 Use in Pregnancy & Breastfeeding
• Lufyllin-400 Drug Interactions
• Lufyllin-400 Support Group
• 0 Reviews for Lufyllin-400 - Add your own review/rating

• Dyphylline Professional Patient Advice (Wolters Kluwer)


• Dilor MedFacts Consumer Leaflet (Wolters Kluwer)


• Dilor Concise Consumer Information (Cerner Multum)


• Dylix Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Lufyllin Prescribing Information (FDA)

Compare Lufyllin-400 with other medications

• Asthma
• Bronchitis
• COPD

Besavar XL 10mg Tablets

BESAVAR XL 10MG TABLETS

alfuzosin hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

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


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


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


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

In this leaflet:

• 1. What Besavar XL is and what it is used for


• 2. Before you take Besavar XL


• 3. How to take Besavar XL


• 4. Possible side effects


• 5. How to store Besavar XL


• 6. Further information

What Besavar XL is and what it is used for

The name of your medicine is Besavar XL 10mg Tablets (called Besavar XL throughout this leaflet). Besavar XL contains a medicine called alfuzosin hydrochloride. This belongs to a group of medicines called alpha-blockers.

Besavar XL can be used to treat the symptoms of Benign Prostatic Hypertrophy. This is when the prostate gland enlarges (hyperplasia), but the growth is not cancerous (it is benign).

It can cause problems in passing water (urine). This happens mainly in older men.

• The prostate gland lies underneath the bladder. It surrounds the urethra. This is the tube that takes your water to the outside of the body.


• If the prostate gets bigger, it presses on the urethra making it smaller. This makes it difficult to pass water.


• Your tablets work by relaxing the prostate gland muscle. This allows the urethra to get bigger and so makes it easier to pass water.

In a few patients with benign prostatic hyperplasia, the prostate gland gets so big that it stops the flow of urine completely. This is called Acute Urinary Retention. This is very painful and you may need a short stay in hospital.

• A thin, flexible tube (catheter) is passed into the bladder. This drains the water and relieves the pain.


• During this time, Besavar XL may be used to help the water to flow again. This has only been shown to help in men aged over 65.

Before you take Besavar XL

Do not take Besavar XL and tell your doctor if:

• You are allergic (hypersensitive) to alfuzosin hydrochloride or any of the other ingredients of this medicine (listed in Section 6 below)
  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue


• You are taking other alpha-blockers to treat Benign Prostatic Hypertrophy or possibly to lower your blood pressure. See section below on 'Taking other medicines'.


• You have, or have ever had, something called orthostatic hypotension. This is a drop in blood pressure which usually happens when you stand up. It can make you feel dizzy, light-headed or faint when you stand or sit up quickly


• You have liver problems

Take special care and check with your doctor before taking Besavar XL if:

• You have chest pain (angina)


• You have a condition where your kidneys are hardly working at all


• You have kidney problems


• If you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used Besavar XL. This is because Besavar XL may cause complicatiosns during the surgery which can be managed if your specialist is prepared in advance


• You are allergic (hypersensitive) to other alpha blockers such as doxazosin, tamsulosin


• You are taking medicines for high blood pressure. Your doctor should monitor your blood pressure regularly while you are taking this medicine. This is particularly important at the start of your treatment.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Besavar XL.

Taking Besavar XL with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Besavar XL and some other medicines can affect the way each other work.

Do not take this medicine, and tell your doctor, if you are taking:

• Other alpha-blockers such as doxazosin, indoramin, prazosin, terazosin, tamsulosin, or phenoxybenzamine.

Tell your doctor if you are taking any of the following:

• You are taking a medicine for high blood pressure, as you may get dizzy, weak or start sweating within a few hours of taking this medicine. If this happens, lie down until the symptoms have completely gone. Tell your doctor as he or she may decide to change the dose of your medicine.


• Medicines such as glyceryl trinitrate for chest pain (angina)


• Medicines for fungal infections (such as ketoconazole and itraconazole) and HIV (ritonavir).

Operations and tests while taking Besavar XL

• If you are being treated for high blood pressure, your doctor should measure your blood pressure regularly, especially at the start of treatment.


• If you are going to have an operation that needs a general anaesthetic, tell your doctor you are taking Besavar XL before the operation. Your doctor may decide to stop you having Besavar XL 24 hours before the operation.

This is because it can be dangerous as it can lower your blood pressure.

Taking Besavar XL with food and drink

• Take Besavar XL after a meal.


• You may feel dizzy and weak while taking Besavar XL. If this happens do not drink any alcohol.

Driving and using machines

You may feel dizzy and weak while taking Besavar XL. If this happens do not drive or operate any tools or machines.

Important information about some of the ingredients of Besavar XL

• 
  Hydrogenated castor oil: This can cause stomach upset and diarrhoea.

How to take Besavar XL

Always take Besavar XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Swallow the tablets whole with plenty of water


• Do not break, crush or chew your tablets. This can affect the release of your medicine into the body.


• Take this medicine after a meal.

How much to take

Benign Prostatic Hyperplasia

• The usual dose is one Besavar XL tablet once a day.

Acute Urinary Retention

• Besavar XL will be given to you by your doctor on the day you have the catheter inserted.


• You should continue taking Besavar XL once a day.


• You should stop taking Besavar XL the day after the catheter is removed (3-4 days in total).

If you take more Besavar XL than you should

Contact your local hospital Accident and Emergency department straight away. Tell the doctor or nurse how many tablets you have taken. Lie down as much as possible to help stop the side effects. Do not try to drive to the hospital yourself.

If you forget to take Besavar XL

Do not take a double dose to make up for a forgotten tablet. Miss it out and then go on as before.

If you stop taking Besavar XL

Keep taking your tablets, even if your symptoms improve. Only stop if your doctor tells you to. The symptoms are better controlled if you continue taking the same dose of this medicine.

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

Possible side effects

Like all medicines, Besavar XL can cause side effects, although not everybody gets them.

Stop taking Besavar XL and see a doctor or go to a hospital straight away if:

• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to Besavar XL tablets.


• You have chest pain (angina). This usually only happens if you have had angina before. This side effect is very rare


• You have a painful erection of the penis, not related to sexual activity, which will not go away. This side effect has only been reported in a very small number of people taking Besavar XL.

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet

Common side effects (affects less than 1 in 10 people)

• Feeling dizzy or faint


• Headache


• Feeling sick (nausea)


• Stomach pain


• Weakness or tiredness

Uncommon side effects (affects less than 1 in 100 people)

• Feeling dizzy light-headed or faint when you stand or sit up quickly (postural hypotension)


• A fast heart beat (tachycardia) and pounding in the chest and uneven heartbeat (palpitations)


• Chest pain


• Drowsiness


• Diarrhoea


• Dry mouth


• Rash and itching


• Flushes


• Water retention (may cause swollen arms or legs)


• General feeling of being unwell

Additional side effects (frequency not known) which may occur are:

• Abnormal liver function (liver problem). Signs may include yellowing of your skin or the whites of your eyes


• Occasionally problems have arisen during cataract surgery in patients taking alfuzosin. If you are due to have eye surgery because of cataract it is important that you tell the specialist before the operation that you are using, or have used, Besavar XL.

How to store Besavar XL

• Keep this medicine in a safe place where children cannot see or reach it.


• Store in the original packaging.


• Do not use Besavar XL after the expiry date which is stated on the carton.


• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Besavar XL 10mg Tablets contain

Each tablet contains 10mg of alfuzosin hydrochloride as the active substance.

The other ingredients are, ethyl cellulose, hydrogenated castor oil, hypromellose, yellow ferric oxide (E172), magnesium stearate, microcrystalline cellulose, povidone, colloidal hydrated silica and mannitol.

What Besavar XL looks like and contents of the pack

Besavar XL 10mg Tablets are round, biconvex, three layer tablets: one white layer between two yellow layers. They are supplied in blister packs of 30 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder is:

Winthrop Pharmaceuticals

PO Box 611

Guildford

Surrey

GU1 4YS

UK

Manufacturer is:

Fawdon Manufacturing Centre

Edgefield Avenue

Fawdon

Newcastle-upon-Tyne

Tyne and Wear

United Kingdom

This leaflet was last revised in:

September 2008

'Winthrop' is a registered trademark

© 2008 Winthrop Pharmaceuticals.