Amoxil Vials for Injection 500mg

1. Name Of The Medicinal Product

Amoxil® Vials for Injection 500 Mg

2. Qualitative And Quantitative Composition

Amoxil Vials for Injection 500 mg contain 500 mg amoxicillin

The amoxicillin is present as the sodium salt in Amoxil injections (each 1 g vial contains approximately 3.3 mmol of sodium).

3. Pharmaceutical Form

Amoxil Vials: vials containing sterile powder for reconstitution.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of Infection: Amoxil is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as:

Upper respiratory tract infections

Otitis media

Acute and chronic bronchitis

Chronic bronchial sepsis

Lobar and bronchopneumonia

Cystitis, urethritis, pyelonephritis

Bacteriuria in pregnancy

Gynaecological infections including puerperal sepsis and septic abortion

Gonorrhoea

Peritonitis

Intra-abdominal sepsis

Septicaemia

Bacterial endocarditis

Typhoid and paratyphoid fever

Skin and soft tissue infections

In children with urinary tract infection the need for investigation should be considered.

Prophylaxis of endocarditis: Amoxil may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.

The wide range of organisms sensitive to the bactericidal action of Amoxil include:

Gram-positive	Gram-negative
Streptococcus faecalis	Haemophilus influenzae
Streptococcus pneumoniae	Escherichia coli
Streptococcus pyogenes	Proteus mirabilis
Streptococcus viridans	Salmonella species
Staphylococcus aureus	Shigella species
(penicillin-sensitive)	Bordetella pertussis
Clostridium species	Brucella species
Corynebacterium species	Neisseria gonorrhoeae
Bacillus anthracis	Neisseria meningitidis
Listeria monocytogenes	Vibrio cholerae
	Pasteurella septica

4.2 Posology And Method Of Administration

Treatment of infection:

Adult dosage (including elderly patients):

Injectable:

500 mg IM eight hourly (or more frequently if necessary) in moderate infections. (This dose may be given by slow IV injection if more convenient.)

1 g IV six hourly in severe infections.

Children's dosage (up to 10 years of age):

Injectable:

50-100 mg/kg body weight a day, in divided doses.

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

In renal impairment the excretion of the antibiotic will be delayed and, depending on the degree of impairment, it may be necessary to reduce the total daily dosage.

Prophylaxis of endocarditis: see table on next page.

Prophylaxis of endocarditis:

CONDITION		ADULTS' DOSAGE (INCLUDING ELDERLY)	CHILDREN'S DOSAGE	NOTES
Dental procedures: prophylaxis for patients undergoing extraction, scaling or surgery involving gingival tissues and who have not received a penicillin in the previous month. (N.B. Patients with prosthetic heart valves should be referred to hospital - see below).	Patient not having general anaesthetic.	3 g 'Amoxil' orally, 1 hour before procedure. A second dose may be given 6 hours later, if considered necessary.	Under 10: half adult dose. Under 5: quarter adult dose.	Note 1. If prophylaxis with 'Amoxil' is given twice within one month, emergence of resistant streptococci is unlikely to be a problem. Alternative antibiotics are recommended if more frequent prophylaxis is required, or if the patient has received a course of treatment with a penicillin during the previous month. Note 2 To minimise pain on injection, 'Amoxil' may be given as two injections of 500 mg dissolved in sterile 1% lidocaine solution (see Administration ).
Patient having general anaesthetic: if oral antibiotics considered to be appropriate.	Initially 3 g 'Amoxil' orally 4 hours prior to anaesthesia, followed by 3 g orally (or 1 g IV or IM if oral dose not tolerated) as soon as possible after the operation.
Patient having general anaesthetic: if oral antibiotics not appropriate.	1 g 'Amoxil' IV or IM immediately before induction; with 500 mg orally, 6 hours later.
Dental procedures: patients for whom referral to hospital is recommended: a) Patients to be given a general anaesthetic who have been given a penicillin in the previous month. b) Patients to be given a general anaesthetic who have a prosthetic heart valve. c) Patients who have had one or more attacks of endocarditis.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM immediately prior to anaesthesia (if given) or 15 minutes prior to dental procedure. Followed by (6 hours later): 500 mg 'Amoxil' orally.	Under 10: the doses of 'Amoxil' should be half the adult dose; the dose of gentamicin should be 2 mg/kg.   Under 5: the doses of 'Amoxil' should be quarter the adult dose; the dose of gentamicin should be 2 mg/kg.	See Note 2. Note 3. 'Amoxil' and gentamicin should not be mixed in the same syringe. Note 4. Please consult the appropriate data sheet for full prescribing information on gentamicin.
Genitourinary Surgery or Instrumentation: prophylaxis for patients who have no urinary tract infection and who are to have genito-urinary surgery or instrumentation under general anaesthesia.   In the case of Obstetric and Gynaecological Procedures and Gastrointestinal Procedures– routine prophylaxis is recommended only for patients with prosthetic heart valves.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM, immediately before induction. Followed by (6 hours later): 500 mg 'Amoxil' orally or IV or IM according to clinical condition.	See Notes 2, 3 and 4 above.
Surgery or Instrumentation of the Upper Respiratory Tract	Patients other than those with prosthetic heart valves.	1 g 'Amoxil' IV or IM immediately before induction; 500 mg 'Amoxil' IV or IM 6 hours later.	Under 10: half adult dose.   Under 5: quarter adult dose.	See Note 2 above. Note 5. The second dose of 'Amoxil' may be administered orally as 'Amoxil' Syrup SF/DF.
Patients with prosthetic heart valves.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM, immediately before induction; followed by (6 hours later) 500 mg 'Amoxil' IV or IM.	Under 10: the dose of 'Amoxil' should be half the adult dose; the gentamicin dose should be 2 mg/kg.   Under 5: the dose of 'Amoxil' should be quarter the adult dose; the dose of gentamicin should be 2 mg/kg.	See Notes 2, 3, 4 and 5 above.

Administration:

Intravenous Injection, Intravenous Infusion, Intramuscular:

Using vials for injection (See Section 6.6)

4.3 Contraindications

Amoxil is a penicillin and should not be given to penicillin-hypersensitive patients. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics, e.g. cephalosporins.

4.4 Special Warnings And Precautions For Use

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to beta-lactam antibiotics (see Section 4.3).

Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin.

Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.

In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see Section 4.9 Overdose). Amoxicillin has been reported to precipitate in bladder catheters after intravenous administration of large doses. A regular check of patency should be maintained.

Dosage should be adjusted in patients with renal impairment (see Section 4.2).

Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see sections 4.5 and 4.8).

When prepared for intramuscular or direct intravenous injection, Amoxil should be administered immediately after reconstitution. The stability of Amoxil in various infusion fluids is given in the Package Enclosure Leaflet.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Amoxil may result in increased and prolonged blood levels of amoxicillin.

In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin (see sections 4.4 and 4.8).

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

4.6 Pregnancy And Lactation

Use in pregnancy

Animal studies with Amoxil have shown no teratogenic effects. The product has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, Amoxil may be considered appropriate when the potential benefits outweigh the potential risks associated with treatment.

Use in lactation:

Amoxicillin may be given during lactation. With the exception of the risk of sensitisation associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breast-fed infant.

4.7 Effects On Ability To Drive And Use Machines

Adverse effects on the ability to drive or operate machinery have not been observed.

4.8 Undesirable Effects

The following convention has been utilised for the classification of undesirable effects:-

Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000,<1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000)

The majority of side effects listed below are not unique to amoxicillin and may occur when using other penicillins.

Unless otherwise stated, the frequency of adverse events has been derived from more than 30 years of post-marketing reports.

Infections and infestations

Very Rare: Mucocutaneous candidiasis

Blood and lymphatic system disorders

Very rare:

Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia. Prolongation of bleeding time and prothrombin time (see section 4.4 – Special Warnings and Precautions for Use.

Immune system disorders

Very rare:

As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (see Section 4.4 - Special Warnings and Precautions for Use), serum sickness and hypersensitivity vasculitis.

If a hypersensitivity reaction is reported, the treatment must be discontinued. (See also Skin and subcutaneous tissue disorders).

Nervous system disorders

Very rare:

Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Gastrointestinal disorders

Clinical Trial Data

Common :	Diarrhoea and nausea.
Uncommon :	Vomiting.

Post-marketing Data

Very rare:

Antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis).

Hepato-biliary disorders

Very rare:

Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT.

The significance of a rise in AST and/or ALT is unclear.

Skin and subcutaneous tissue disorders

Clinical Trial Data

Common :	Skin rash
Uncommon :	Urticaria and pruritus

Post-marketing Data

Very rare :

Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalised exanthematous pustulosis (AGEP)

(See also Immune system disorders).

Renal and urinary tract disorders

Very rare :

Interstitial nephritis, crystalluria (See Section 4.9 Overdose).

The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.

4.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically with attention to the water/electrolyte balance. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special warnings and special precautions for use).

Amoxicillin may be removed from the circulation by haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Amoxil is a broad spectrum antibiotic.

It is rapidly bactericidal and possesses the safety profile of a penicillin.

5.2 Pharmacokinetic Properties

Amoxil is well absorbed by the oral and parenteral routes. Amoxil gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Amoxil Injection:

None

6.2 Incompatibilities

Amoxil should not be mixed with blood products, other proteinaceous fluids such as protein hydrolysates, or with intravenous lipid emulsions.

If Amoxil is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can occur under these conditions.

6.3 Shelf Life

Injection Vials

24 months

6.4 Special Precautions For Storage

Amoxil Vials for Injection should be stored in a cool, dry place.

When prepared for intramuscular or direct intravenous injection, Amoxil should be administered immediately after reconstitution. The stability of Amoxil in various infusion fluids is dependent upon the concentration and temperature: stability times are given in the Package Enclosure Leaflet.

6.5 Nature And Contents Of Container

Amoxil Vials for Injection: Clear Type I glass vials fitted with a chlorobutyl rubber bung and an aluminium overseal. 500 mg: packs of 5 or 10. Each pack carries instructions for use.

6.6 Special Precautions For Disposal And Other Handling

Intravenous Injection:

Dissolve 500 mg in 10 ml Water for Injections BP (Final volume=10.4 ml).

Amoxil injection, suitably diluted, may be injected directly into a vein or the infusion line over a period of three to four minutes.

Intravenous Infusion:

Solutions may be prepared as described for intravenous injections and then added to an intravenous solution in a minibag or in-line burette and administered over a period of half to one hour. Alternatively, using a suitable reconstitution device, the appropriate volume of intravenous fluid may be transferred from the infusion bag into the vial and then drawn back into the bag after dissolution.

Intramuscular:

500 mg: Add 2.5 ml Water for Injections BP ^† and shake vigorously (Final volume=2.9 ml).

If pain is experienced on intramuscular injection, a sterile 1% solution of lidocaine hydrochloride or 0.5% solution of procaine hydrochloride may be used in place of Water for Injections.

A transient pink colouration or slight opalescence may appear during reconstitution. Reconstituted solutions are normally a pale straw colour.

ADMINISTRATIVE DATA

7. Marketing Authorisation Holder

Beecham Group plc

Great West Road, Brentford, Middlesex TW8 9GS

Trading as GlaxoSmithKline UK Stockley Park West, Uxbridge, Middlesex UB11 1BT

And/or

Bencard or SmithKline Beecham Pharmaceuticals at Mundells Welwyn Garden City, Hertfordshire AL7 1 EY

8. Marketing Authorisation Number(S)

Amoxil Vials for Injection 500 mg

0038/0222

9. Date Of First Authorisation/Renewal Of The Authorisation

Amoxil Vials for Injection 500 mg

13.10.98

10. Date Of Revision Of The Text

1^st March 2010

11. Legal Status

POM

Fungizone 50mg Powder for Sterile Concentrate

1. Name Of The Medicinal Product

Fungizone 50mg Powder for Sterile Concentrate

2. Qualitative And Quantitative Composition

Each vial contains as a yellow, fluffy powder: amphotericin 50,000 units (50mg).

3. Pharmaceutical Form

Powder for Concentrate for Solution for Infusion. (Powder for Sterile Concentrate)

4. Clinical Particulars

4.1 Therapeutic Indications

Fungizone should be administered primarily to patients with progressive, potentially fatal infections. This potent drug should not be used to treat the common forms of fungal disease which show only positive skin or serological tests.

Fungizone is specifically intended to treat cryptococcosis (torulosis); North American blastomycosis; the disseminated forms of candidosis, coccidioidomycosis and histoplasmosis; mucormycosis (phycomycosis) caused by species of the genera Mucor, Rhizopus, Absidia, Entomophthora, and Basidiobolus sporotrichosis (Sporotrichum schenckii), aspergillosis (Aspergillus fumigatus).

Amphotericin may be helpful in the treatment of American mucocutaneous leishmaniasis but is not the drug of choice in primary therapy.

4.2 Posology And Method Of Administration

Adults and children:

Fungizone should be administered by intravenous infusion over a period of 2-4 hours. Reduction of the infusion rate may reduce the incidence of side-effects. In rare instances infusion times of up to 6 hours may be necessary. Initial daily dose should be 0.25mg/kg of body weight gradually increasing to a level of 1.0mg/kg of body weight depending on individual response and tolerance. Within the range of 0.25-1.0mg/kg the daily dose should be maintained at the highest level which is not accompanied by unacceptable toxicity.

In seriously ill patients the daily dose may be gradually increased up to a total of 1.5mg/kg. Since amphotericin is excreted slowly, therapy may be given on alternate days in patients on the higher dosage schedule. Several months of therapy are usually necessary; a shorter period of therapy may produce an inadequate response and lead to relapse.

When commencing all new courses of treatment, it is advisable to administer a test dose immediately preceding the first dose. A volume of the infusion containing 1mg (i.e. 10ml) should be infused over 20-30 minutes and the patient carefully observed for at least a further 30 minutes. It should be noted that patient responses to the test dose may not be predictive of subsequent severe side effects.

Whenever medication is interrupted for a period longer than seven days, therapy should be resumed by starting with the lowest dosage level, i.e. 0.25mg/kg of body weight and increased gradually.

CAUTION:

Under no circumstances should a total daily dose of 1.5mg/kg be exceeded. Amphotericin B overdoses can result in potentially fatal cardiac or cardiorespiratory arrest (see section 4.4 & 4.9). The recommended concentration for intravenous infusion is 10mg/100ml.

Elderly:

No specific dosage recommendations or precautions.

Preparation of solutions:

Reconstitute as follows: An initial concentrate of 5mg amphotericin per ml is first prepared by rapidly expressing 10ml sterile water for injection, without a bacteriostatic agent, directly into the lyophilised cake, using a sterile needle (minimum diameter: 20 gauge) and syringe. Shake the vial immediately until the colloidal solution is clear. The infusion solution, providing 10mg/100ml is obtained by further dilution (1:50) with 5% Glucose Injection of pH above 4.2. The pH of each container of Glucose Injection should be ascertained before use. Commercial Glucose Injection usually has a pH above 4.2; however, if it is below 4.2 then 1 or 2 ml of buffer should be added to the Glucose Injection before it is used to dilute a concentrated solution of amphotericin. The recommended buffer has the following composition:

Dibasic sodium phosphate (anhydrous)	1.59g
Monobasic sodium phosphate (anhydrous)	0.96g
Water for Injections BP	q.s. to 100ml

The buffer should be sterilised before it is added to the Glucose Injection, either by filtration through a bacterial filter, or by autoclaving for 30 mins at 15lb pressure (121°C).

CAUTION:

Aseptic technique must be strictly observed in all handling, since no preservative or bacteriostatic agent is present. Do not reconstitute with saline solutions. The use of any diluent other than the ones recommended or the presence of a bacteriostatic agent in the diluent may cause precipitation of the amphotericin. Do not use the initial concentrate or the infusion solution if there is any evidence of precipitation of foreign matter.

An in-line membrane filter may be used for intravenous infusion of amphotericin; however the mean pore diameter of the filter should not be less than 1.0 micron in order to assure passage of the amphotericin dispersion.

Other preparations for injection should not be added to the infusion solution or administered via the cannula being used to administer Fungizone.

The use of Fungizone by other routes has been documented in the published literature:

Bladder irrigation/instillation (e.g. candiduria): Continuous irrigation with 50mg Fungizone in 1 litre sterile water each day until urinary cultures are negative. Intermittent use of volumes of 100-400ml (concentrations of 37.5-200mcg/ml) has also been reported. The urine should be alkalinised (with potassium citrate) and antifungal ointment applied to the perineal area.

Lung inhalation (e.g. pulmonary aspergillosis): 8-40mg amphotericin (nebulised in sterile water or 5% Glucose) has been given daily in divided doses. Concurrent eradication of oral and intestinal yeast reservoirs is recommended.

Intrathecal (e.g. coccidiodal meningitis): Current published dosage recommendations are for maintenance 0.25-1.0mg amphotericin 2-4 times weekly following initiation with a low dose (0.025mg) and cautious increases. Amphotericin is irritating when injected into the CSF.

Other: Other uses of solutions prepared using Fungizone include local instillations for the treatment of fungal infections of the ear, eye, peritoneum, lung cavities and joint spaces.

4.3 Contraindications

Those patients who are hypersensitive to amphotericin, unless, in the opinion of the physician, the condition requiring treatment is life-threatening and amenable only to such therapy.

4.4 Special Warnings And Precautions For Use

Prolonged therapy with amphotericin is usually necessary. Unpleasant reactions are quite common when the drug is given parenterally at therapeutic dosage levels. Some of these reactions are potentially dangerous. Hence amphotericin should be used parenterally only in hospitalised patients, or those under close clinical observation. If serum creatinine exceeds 260 micromol/l the drug should be discontinued or the dosage markedly reduced until renal function is improved. Weekly blood counts and serum potassium determinations are also advisable. Low serum magnesium levels have also been noted during treatment with amphotericin. Therapy should be discontinued if liver function test results (elevated bromsulphalein, alkaline phosphatase and bilirubin) are abnormal.

Leucoencephalopathy has been reported very occasionally following the use of amphotericin injection in patients who received total body irradiation. Most of these patients received high cumulative doses of amphotericin.

Rapid intravenous infusion, over less than one hour, particularly in patients with renal insufficiency, has been associated with hyperkalaemia and arrhythmias and should therefore be avoided.

Corticosteroids should not be administered concomitantly unless they are necessary to control drug reactions. Other nephrotoxic antibiotics and antineoplastic agents should not be given concomitantly except with great caution.

Care must be taken when administering Fungizone to prevent overdose, which can result in potentially fatal cardiac or cardiorespiratory arrest. Verify the product name and dosage pre-administration, especially if the dose prescribed exceeds 1.5mg/kg (see section 4.2 Posology and Method of Administration and section 4.9 Overdose Symptoms, Emergency Procedures, Antidotes).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant administration of nephrotoxic drugs or antineoplastics should be avoided if at all possible.

The hypokalaemia following amphotericin therapy may potentiate the toxicity of digitalis glycosides or enhance the curariform actions of skeletal muscle relaxants.

Corticosteroids may increase the potassium loss due to amphotericin.

Flucytosine toxicity may be enhanced during concomitant administration, possibly due to an increase in its cellular uptake and/or impairment of its renal excretion.

Acute pulmonary reactions have occasionally been observed in patients given amphotericin during or shortly after leukocyte transfusions. It is advisable to separate these infusions as far as possible and to monitor pulmonary function.

4.6 Pregnancy And Lactation

Safety for use in pregnancy has not been established; therefore it should be used during pregnancy only if the possible benefits to be derived outweigh the potential risks involved.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

While some patients may tolerate full intravenous doses of amphotericin without difficulty, most will exhibit some intolerance. In patients experiencing adverse reactions these may be made less severe by giving aspirin, antihistamines or anti-emetics. Febrile reactions may be decreased by the intravenous administration of small doses of adrenal corticosteroids, e.g. 25mg hydrocortisone. This may be administered just prior to or during amphotericin infusion. The dosage and duration of such corticosteroid therapy should be kept to a minimum. Administration of the drug on alternate days may decrease anorexia and phlebitis. Adding a small amount of heparin to the infusion may lessen the incidence of thrombophlebitis and coagulation problems. Extravasation may cause chemical irritation. The adverse reactions that are most commonly observed are: fever (sometimes with shaking chills), headache, anorexia, weight loss, nausea and vomiting, malaise, muscle and joint pains, dyspepsia, cramping epigastric pain, diarrhoea, local venous pain at the injection site with phlebitis and thrombophlebitis, normochromic normocytic anaemia and hypokalaemia. Abnormal renal function (including renal impairment, renal insufficiency, acute renal failure and nephrogenic diabetes insipidus) including hypokalaemia, azotaemia, hyposthenuria, renal tubular acidosis or nephrocalcinosis, is also commonly observed and usually improves upon interruption of therapy; however, some permanent impairment often occurs, especially in those patients receiving large amounts (over 5g) of amphotericin.

The following adverse reactions occur less frequently or rarely; anuria (oliguria); cardiovascular toxicity including arrhythmias, ventricular fibrillation, cardiac arrest, hypotension, hypertension; coagulation defects; thrombocytopenia; leucopenia; agranulocytosis; eosinophilia; leucocytosis; melaena or haemorrhagic gastroenteritis; maculopapular rash and pruritus; hearing loss, tinnitus; transient vertigo; blurred vision, or diplopia; encephalopathy (see precautions); peripheral neuropathy, convulsions and other neurologic symptoms; anaphylactoid reactions, acute liver failure and flushing.

4.9 Overdose

Amphotericin overdoses can result in potentially fatal cardiac or cardio-respiratory arrest. If an overdose is suspected, discontinue therapy and monitor the patient's clinical status (e.g., cardio-respiratory, renal, and liver function, haematologic status serum electrolytes) and administer supportive therapy as required. Amphotericin is not haemodialysable. Prior to reinstituting therapy, the patient's condition should be stabilised (including correction of electrolyte deficiencies, etc.)

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Amphotericin is a polyene antifungal antibiotic active against a wide range of yeasts and yeast-like fungi including Candida albicans. Crystalline amphotericin is insoluble in water; therefore, the antibiotic is solubilised by the addition of sodium desoxycholate to form a mixture which provides a colloidal dispersion for parenteral administration. Amphotericin is fungistatic rather than fungicidal in concentrations obtainable in body fluids. It probably acts by binding to sterols in the fungal cell membrane with a resultant change in membrane permeability which allows leakage of intracellular components. Mammalian cell membranes also contain sterols and it has been suggested that the damage to human and fungal cells may share common mechanisms. No strains of Candida resistant to amphotericin have been reported in clinical use, and although in vitro testing does produce a small number of resistant isolates this occurs only following repeated subcultures.

5.2 Pharmacokinetic Properties

An initial intravenous infusion of 1 to 5mg of amphotericin per day, gradually increased to 0.65mg/kg daily, produces peak plasma concentrations of approximately 2 to 4mg/l which can persist between doses since the plasma half-life of amphotericin is about 24 hours. It has been reported that amphotericin is highly bound (more than 90%) to plasma proteins and is poorly dialysable.

Amphotericin is excreted very slowly by the kidneys with 2 to 5% of a given dose being excreted in biologically active form. After treatment is discontinued the drug can be detected in the urine for at least seven weeks. The cumulative urinary output over a seven day period amounts to approximately 40% of the amount of drug infused.

Details of tissue distribution and possible metabolic pathways are not known.

5.3 Preclinical Safety Data

No further relevant data.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Other ingredients: desoxycholic acid, concentrated phosphoric acid, sodium hydroxide, disodium phosphate dodecahydrate, monosodium phosphate dehydrate, water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months

6.4 Special Precautions For Storage

Vials of powder for reconstitution should be stored in a refrigerator. The concentrate (5mg per ml after reconstitution with 10ml sterile Water for Injections) should be stored protected from light. The absence of any microbial preservative and the risk of contamination during reconstitution mean that the product should be stored for no more than 8 hours at room temperature (25°C) or 24 hours in a refrigerator (2-8°C). Should the need arise and a validated aseptic reconstitution technique is applied, the product is chemically stable when stored for 24 hours at room temperature or one week in a refrigerator. It is not intended as a multidose vial. Any unused material should be discarded. Solutions prepared for intravenous infusion (i.e. 10mg or less amphotericin per 100ml) should be used promptly after preparation.

6.5 Nature And Contents Of Container

Type I flint glass vials closed with a grey chlorobutyl rubber stopper.

Vials of 50mg

6.6 Special Precautions For Disposal And Other Handling

See Section 4.2. Aseptic technique must be strictly observed during the preparation of the concentrate, the buffer and the infusion.

7. Marketing Authorisation Holder

E. R. Squibb & Sons Limited

Uxbridge Business Park

Sanderson Road

Uxbridge

Middlesex UB8 1DH

8. Marketing Authorisation Number(S)

PL 0034/5041R

9. Date Of First Authorisation/Renewal Of The Authorisation

18 September 1996

10. Date Of Revision Of The Text

27 February 2010

Isoflurane Vet

Isoflurane Vet may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Isoflurane Vet

Isoflurane

Isoflurane is reported as an ingredient of Isoflurane Vet in the following countries:

• New Zealand

International Drug Name Search

Sodium Tetradecyl Sulfate

Pronunciation: SO-dee-uhm tet-ra-deck-el
Generic Name: Sodium Tetradecyl Sulfate
Brand Name: Sotradecol

Sodium Tetradecyl Sulfate is used for:

Treating varicose veins.

Sodium Tetradecyl Sulfate is sclerosing agent. It works by closing the varicose vein through scarring.

Do NOT use Sodium Tetradecyl Sulfate if:

• you are allergic to any ingredient in Sodium Tetradecyl Sulfate


• you have redness or tenderness in the vein


• you have pain, swelling, or redness near the vein


• you are bedridden


• you have varicose veins caused by a stomach or pelvic tumor that has not been removed


• you have uncontrolled diabetes, an overactive thyroid, tuberculosis (TB), asthma, an abnormal growth or tumor, an infection, blood disease, lung disease, or skin disease

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

Before using Sodium Tetradecyl Sulfate:

Some medical conditions may interact with Sodium Tetradecyl Sulfate. 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 Buerger disease, hardening of the arteries or other heart problems, blood clots, or a nerve injury

Some MEDICINES MAY INTERACT with Sodium Tetradecyl Sulfate. However, no specific interactions with Sodium Tetradecyl Sulfate are known at this time.

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

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

• Sodium Tetradecyl Sulfate is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Sodium Tetradecyl Sulfate at home, carefully follow the injection procedures taught to you by your health care provider.


• If Sodium Tetradecyl Sulfate contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Sodium Tetradecyl Sulfate, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Sodium Tetradecyl Sulfate.

Important safety information:

• Follow-up visits to your doctor will be required. Be sure to keep all doctor appointments.


• Use Sodium Tetradecyl Sulfate with extreme caution in NEWBORNS. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Sodium Tetradecyl Sulfate during pregnancy. It is unknown if Sodium Tetradecyl Sulfate is excreted in breast milk. If you are or will be breast-feeding while you are using Sodium Tetradecyl Sulfate, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Sodium Tetradecyl Sulfate:

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:

Pain, itching, or lesions at the injection site; sloughing skin at the injection site.

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); burning at the injection site; discoloration or redness around the vein; headache; itchy eyes or nose; nausea; pain or tenderness in the leg; runny nose; sneezing; swelling of the leg; vomiting; warm feeling in the leg; wheezing.

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: Sodium Tetradecyl Sulfate 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.

Proper storage of Sodium Tetradecyl Sulfate:

Store Sodium Tetradecyl Sulfate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sodium Tetradecyl Sulfate out of the reach of children and away from pets.

General information:

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


• Sodium Tetradecyl Sulfate 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 Sodium Tetradecyl Sulfate. 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 Sodium Tetradecyl Sulfate resources

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

• Sodium Tetradecyl Sulfate Professional Patient Advice (Wolters Kluwer)


• sodium tetradecyl sulfate Concise Consumer Information (Cerner Multum)


• sodium tetradecyl sulfate Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Sotradecol Prescribing Information (FDA)

Compare Sodium Tetradecyl Sulfate with other medications

• Varicose Veins

Pediazole

Generic Name: erythromycin and sulfisoxazole (Oral route)

e-rith-roe-MYE-sin eth-il-SUX-i-nate, sul-fi-SOX-a-zole A-se-teel

Commonly used brand name(s)

In the U.S.

• E.S.P.


• Eryzole


• Pediazole

Available Dosage Forms:

• Powder for Suspension

Therapeutic Class: Antibiotic Combination

Chemical Class: Erythromycin

Uses For Pediazole

Erythromycin and sulfisoxazole is a combination antibiotic used to treat ear infections in children. It also may be used for other problems as determined by your doctor. It will not work for colds, flu, or other virus infections.

Erythromycin and sulfisoxazole combination 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 specifically included in product labeling, erythromycin and sulfisoxazole combination is used in certain patients with the following medical condition:

• Sinusitis (sinus infection)

Before Using Pediazole

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

This medicine has been tested in children over the age of 2 months and has not been shown to cause different side effects or problems than it does in adults. This medicine should not be given to infants under 2 months of age unless directed by the child's doctor, because it may cause unwanted effects.

Geriatric

This medicine is intended for use in children and is not generally used in adult patients.

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 is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Astemizole


• Bepridil


• Cisapride


• Dihydroergotamine


• Dronedarone


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Grepafloxacin


• Levomethadyl


• Mesoridazine


• Methylergonovine


• Methysergide


• Pimozide


• Posaconazole


• Simvastatin


• Sparfloxacin


• Terfenadine


• Thioridazine


• Ziprasidone

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.

• Acecainide


• Ajmaline


• Amiodarone


• Amisulpride


• Amitriptyline


• Amoxapine


• Apomorphine


• Aprindine


• Arsenic Trioxide


• Asenapine


• Atorvastatin


• Azimilide


• Azithromycin


• Bretylium


• Cerivastatin


• Chloral Hydrate


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clindamycin


• Clomipramine


• Colchicine


• Crizotinib


• Dasatinib


• Desipramine


• Dibenzepin


• Digoxin


• Diltiazem


• Disopyramide


• Dofetilide


• Dolasetron


• Doxepin


• Droperidol


• Encainide


• Enflurane


• Eplerenone


• Everolimus


• Fentanyl


• Flecainide


• Fluconazole


• Fluoxetine


• Foscarnet


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Halothane


• Hydroquinidine


• Ibutilide


• Iloperidone


• Imipramine


• Isoflurane


• Isradipine


• Itraconazole


• Ketoconazole


• Lapatinib


• Levofloxacin


• Lidoflazine


• Lopinavir


• Lorcainide


• Lovastatin


• Lumefantrine


• Mefloquine


• Methotrexate


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Oxycodone


• Paliperidone


• Pazopanib


• Pentamidine


• Perflutren Lipid Microsphere


• Pirmenol


• Pitavastatin


• Prajmaline


• Probucol


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Risperidone


• Saquinavir


• Sematilide


• Sertindole


• Sertraline


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Spiramycin


• Sulfamethoxazole


• Sultopride


• Sunitinib


• Tadalafil


• Tedisamil


• Telavancin


• Telithromycin


• Tetrabenazine


• Theophylline


• Tolvaptan


• Toremifene


• Trazodone


• Trifluoperazine


• Trimethoprim


• Trimipramine


• Troleandomycin


• Vandetanib


• Vasopressin


• Vemurafenib


• Verapamil


• Voriconazole


• Warfarin


• Zolmitriptan


• Zotepine

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.

• Acetohexamide


• Alfentanil


• Alprazolam


• Anisindione


• Bexarotene


• Budesonide


• Buspirone


• Carbamazepine


• Cilostazol


• Clozapine


• Cyclosporine


• Diazepam


• Dicumarol


• Fesoterodine


• Methylprednisolone


• Midazolam


• Phenprocoumon


• Roflumilast


• Salmeterol


• Sildenafil


• Sirolimus


• Tacrolimus


• Tolterodine


• Triazolam


• Trimetrexate


• Valproic Acid


• Zafirlukast

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Anemia or other blood problems or


• Glucose-6-phosphate dehydrogenase (G6PD) deficiency—Erythromycin and sulfisoxazole may increase the chance of blood problems

• Heart disease—High doses of erythromycin and sulfisoxazole may increase the chance of side effects in patients with a history of an irregular heartbeat

• Kidney disease or


• Liver disease—Patients with liver or kidney disease may have an increased chance of side effects

• Loss of hearing—High doses of erythromycin and sulfisoxazole may increase the chance for hearing loss in some patients

• Porphyria—Erythromycin and sulfisoxazole may increase the chance of a porphyria attack

Proper Use of erythromycin and sulfisoxazole

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

Erythromycin and sulfisoxazole combination is best taken with extra amounts of water and may be taken with food. Additional amounts of water should be taken several times every day, unless otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects (e.g., kidney stones) of sulfa medicines.

Do not give this medicine to infants under 2 months of age, unless otherwise directed by your doctor. Sulfa medicines may cause liver problems in these infants.

Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Do not use after the expiration date on the label. The medicine may not work properly after that date. Check with your pharmacist if you have any questions about this.

To help clear up your infection completely, keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take 4 doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

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 form (suspension):
  
  • For infections caused by bacteria:
    
    • Adults and teenagers—This medicine is used only in children.
    
    
    • Children up to 2 months of age—Use is not recommended.
    
    
    • Children 2 months of age and older—Dose is based on body weight:
      
      • For the four-times-a-day dosing schedule
      
      
      • Children weighing less than 8 kilograms (kg) (under 18 pounds): Dose must be determined by your doctor.
      
      
      • Children weighing 8 to 16 kg (18 to 35 pounds): 1/2 teaspoonful (2.5 milliliters [mL]) every six hours for ten days.
      
      
      • Children weighing 16 to 24 kg (35 to 53 pounds): 1 teaspoonful (5 mL) every six hours for ten days.
      
      
      • Children weighing 24 to 32 kg (53 to 70 pounds): 1 1/2 teaspoonfuls (7.5 mL) every six hours for ten days.
      
      
      • Children weighing more than 32 kg (over 70 pounds): 2 teaspoonfuls (10 mL) every six hours for ten days.
      
      
      • For the three-times-a-day dosing schedule
      
      
      • Children weighing less than 6 kg (under 13 pounds): Dose must be determined by your doctor.
      
      
      • Children weighing 6 to 12 kg (13 to 26 pounds): 1/2 teaspoonful (2.5 mL) every eight hours for ten days.
      
      
      • Children weighing 12 to 18 kg (26 to 40 pounds): 1 teaspoonful (5 mL) every eight hours for ten days.
      
      
      • Children weighing 18 to 24 kg (40 to 53 pounds): 1 1/2 teaspoonfuls (7.5 mL) every eight hours for ten days.
      
      
      • Children weighing 24 to 30 kg (53 to 66 pounds): 2 teaspoonfuls (10 mL) every eight hours for ten days.
      
      
      • Children weighing more than 30 kg (over 66 pounds): 2 1/2 teaspoonfuls (12.5 mL) every eight hours for ten days.
      
      
    
    
  
  

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 in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Pediazole

It is very important that your doctor check you at regular visits for any blood problems that may be caused by this medicine, especially if you will be taking this medicine for a long time.

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

Erythromycin and sulfisoxazole may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.


• Wear protective clothing, including a hat. Also, wear sunglasses.


• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.


• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.


• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Erythromycin and sulfisoxazole combination may cause blood problems. These problems may result in a greater chance of infection, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.

Pediazole 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

• Itching


• skin rash

Less common

• Aching of joints and muscles


• difficulty in swallowing


• nausea or vomiting


• pale skin


• redness, blistering, peeling, or loosening of skin


• skin rash


• sore throat and fever


• stomach pain, severe


• unusual bleeding or bruising


• unusual tiredness or weakness


• yellow eyes or skin

Rare

• Blood in urine


• dark or amber urine


• irregular or slow heartbeat


• temporary loss of hearing (with kidney disease and high doses)


• lower back pain


• pain or burning while urinating


• pale stools


• recurrent fainting


• severe stomach pain


• swelling of front part of neck

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

More common

• Increased sensitivity to sunlight

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 cramping and discomfort


• diarrhea


• headache


• loss of appetite


• nausea or vomiting

Less common

• Sore mouth or tongue

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: Pediazole 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 Pediazole resources

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

• Pediazole MedFacts Consumer Leaflet (Wolters Kluwer)


• Pediazole Concise Consumer Information (Cerner Multum)


• Eryzole Concise Consumer Information (Cerner Multum)

Compare Pediazole with other medications

• Otitis Media

Isoptin SR

Generic Name: verapamil (oral) (ver AP a mil)

Brand Names: Calan, Calan SR, Covera-HS, Isoptin SR, Verelan, Verelan PM

What is verapamil?

Verapamil is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.

Verapamil is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders.

Verapamil may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about verapamil?

You should not use verapamil if you are allergic to it, or if you have certain serious heart conditions such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker), low blood pressure, or if you have recently had a heart attack.

Before taking verapamil, tell your doctor if you are allergic to any drugs, or if you have kidney disease, liver disease, congestive heart failure, or a nerve-muscle disorder such as myasthenia gravis or muscular dystrophy.

There are many other drugs that can interact with verapamil. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you. Verapamil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not stop taking this medication without first talking to your doctor. If you stop taking verapamil suddenly, your condition may become worse.

Verapamil may be only part of a complete program of treatment that also includes diet, exercise, and other medications. Follow your diet, medication, and exercise routines very closely.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

What should I discuss with my healthcare provider before taking verapamil?

You should not use verapamil if you are allergic to it, or if you have:

• 
  

  certain serious heart conditions, especially "sick sinus syndrome" or "AV block" (unless you have a pacemaker);

  
  


• 
  

  low blood pressure; or

  
  


• 
  

  if you have recently had a heart attack.

  
  

To make sure you can safely take verapamil, tell your doctor if you have any of these other conditions:

• kidney disease;


• liver disease;


• 
  

  congestive heart failure; or

  
  


• 
  

  a nerve-muscle disorder such as myasthenia gravis or muscular dystrophy.

  
  

FDA pregnancy category C. It is not known whether verapamil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Verapamil can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take verapamil?

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

Your doctor may occasionally change your dose to make sure you get the best results.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

If you have trouble swallowing a verapamil capsule whole, ask your doctor or pharmacist if it is safe for you to open the capsule and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Use verapamil regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not stop taking this medication without first talking to your doctor. If you stop taking verapamil suddenly, your condition may become worse.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

Verapamil may be only part of a complete program of treatment that also includes diet, exercise, and other medications. Follow your diet, medication, and exercise routines very closely.

Your blood pressure will need to be checked often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using verapamil. You may need to stop using the medicine for a short time. Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of verapamil can be fatal.

Overdose symptoms may include slow heartbeat and fainting.

What should I avoid while taking verapamil?

Verapamil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of verapamil.

Grapefruit and grapefruit juice may interact with verapamil and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Verapamil side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  fast or slow heartbeats;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  
  


• 
  

  restless muscle movements in your eyes, tongue, jaw, or neck;

  
  


• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling, rapid weight gain; or

  
  


• 
  

  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  constipation, nausea;

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  dizziness, headache, tired feeling; or

  
  


• 
  

  warmth, itching, redness, or tingly feeling under your skin.

  
  

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

What other drugs will affect verapamil?

Many drugs can interact with verapamil. Below is just a partial list. Tell your doctor if you are using:

• 
  

  buspirone (BuSpar);

  
  


• 
  

  cimetidine (Tagamet);

  
  


• 
  

  clonidine (Catapres, Clorpres, Kapvay, Nexiclon) or any other blood pressure medications;

  
  


• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  digoxin (digitalis, Lanoxin, Lanoxicaps);

  
  


• 
  

  lithium (Eskalith, LithoBid);

  
  


• 
  

  lovastatin (Mevacor, Advicor) or simvastatin (Zocor, Simcor, Vytorin);

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifampin (Rifadin, Rimactane, Rifater), or telithromycin (Ketek);

  
  


• 
  

  an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta, Ziac), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), timolol (Blocadren), and others;

  
  


• 
  

  cancer medicine such as cisplatin (Platinol), cyclophosphamide (Cytoxan, Neosar), doxorubicin (Adriamycin), paclitaxel (Taxol), procarbazine (Matulane), vincristine (Oncovin), or vinorelbine (Navelbine);

  
  


• 
  

  cholesterol-lowering drugs such as atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor), or simvastatin (Zocor, Simcor, Vytorin, Juvisync);

  
  


• 
  

  a heart rhythm medication such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), flecainide (Tambocor), or quinidine (Quin-G);

  
  


• 
  

  HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), or ritonavir (Norvir, Kaletra);

  
  


• 
  

  a sedative such as midazolam (Versed) or triazolam (Halcion); or

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol) or phenobarbital (Solfoton).

  
  

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

More Isoptin SR resources

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

• Isoptin SR Advanced Consumer (Micromedex) - Includes Dosage Information


• Isoptin SR Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Isoptin SR Prescribing Information (FDA)


• Verapamil Prescribing Information (FDA)


• Calan Prescribing Information (FDA)


• Calan MedFacts Consumer Leaflet (Wolters Kluwer)


• Calan SR Prescribing Information (FDA)


• Covera-HS Sustained-Release Tablets (Controlled Onset) MedFacts Consumer Leaflet (Wolters Kluwer)


• Covera-HS Prescribing Information (FDA)


• Verapamil Hydrochloride Monograph (AHFS DI)


• Verelan Prescribing Information (FDA)


• Verelan Sustained-Release Pellet-Filled Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Verelan PM Prescribing Information (FDA)


• Verelan PM Sustained-Release Capsules Controlled Onset MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Isoptin SR with other medications

• Angina
• Arrhythmia
• Bipolar Disorder
• Cluster Headaches
• High Blood Pressure
• Idiopathic Hypertrophic Subaortic Stenosis
• Migraine Prevention
• Nocturnal Leg Cramps
• Supraventricular Tachycardia

Where can I get more information?

• Your pharmacist can provide more information about verapamil.

See also: Isoptin SR side effects (in more detail)