Go PLR Content Directory Sierra Leone: June 2012

Thursday 28 June 2012

Puri-Nethol Tablets

1. Name Of The Medicinal Product

Puri-Nethol 50 mg tablets

2. Qualitative And Quantitative Composition

Each tablet contains 50 mg of 6

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablets

Pale yellow, round tablets, biconvex, scored on one side, engraved GX above the score and EX2 below the score and plain on the other side

4. Clinical Particulars

4.1 Therapeutic Indications

Cytotoxic agent.

Puri-Nethol is indicated for the treatment of acute leukaemia. It may be utilised in remission induction and it is particularly indicated for maintenance therapy in: acute lymphoblastic leukaemia; acute myelogenous leukaemia. Puri-Nethol may be used in the treatment of chronic granulocytic leukaemia.

4.2 Posology And Method Of Administration

For oral administration

Dosage in adults and children:

For adults and children the usual starting dose is 2.5 mg/kg bodyweight per day, or 50-75 mg/m² body surface area per day, but the dose and duration of administration depend on the nature and dosage of other cytotoxic agents given in conjunction with Puri-Nethol.

The dosage should be carefully adjusted to suit the individual patient.

Puri-Nethol has been used in various combination therapy schedules for acute leukaemia and the literature should be consulted for details.

Dosage in the elderly:

No specific studies have been carried out in the elderly. However, it is advisable to monitor renal and hepatic function in these patients, and if there is any impairment, consideration should be given to reducing the Puri-Nethol dosage.

Dosage in renal impairment:

Consideration should be given to reducing the dosage in patients with impaired renal function.

Dosage in hepatic function:

Consideration should be given to reducing the dosage in patients with impaired hepatic function.

In general:

When Zyloric (allopurinol) and 6-mercaptopurine are administered concomitantly it is essential that only a quarter of the usual dose of 6-mercaptopurine is given since Zyloric (allopurinol) decreases the rate of catabolism of 6-mercaptopurine.

4.3 Contraindications

Hypersensitivity to any component of the preparation.

In view of the seriousness of the indications there are no other absolute contra-indications.

4.4 Special Warnings And Precautions For Use

Puri-Nethol is an active cytotoxic agent for use only under the direction of physicians experienced in the administration of such agents.

Immunisation using a live organism vaccine has the potential to cause infection in immunocompromised hosts. Therefore, immunisations with live organism vaccines are not recommended.

Safe handling of Puri-Nethol Tablets:

See section 6.6 Instructions for Use/Handling

Monitoring:

Treatment with Puri-Nethol causes bone marrow suppression leading to leucopenia and thrombocytopenia and, less frequently, to anaemia. Full blood counts must be taken daily during remission induction and careful monitoring of haematological parameters should be conducted during maintenance therapy.

The leucocyte and platelet counts continue to fall after treatment is stopped, so at the first sign of an abnormally large fall in the counts, treatment should be interrupted immediately.

Bone marrow suppression is reversible if Puri-Nethol is withdrawn early enough.

During remission induction in acute myelogenous leukaemia the patient may frequently have to survive a period of relative bone marrow aplasia and it is important that adequate supportive facilities are available.

There are individuals with an inherited deficiency of the enzyme thiopurine methyltransferase (TPMT) who may be unusually sensitive to the myelosuppresive effect of 6-mercaptopurine and prone to developing rapid bone marrow depression following the initiation of treatment with Puri-Nethol. This problem could be exacerbated by coadministration with drugs that inhibit TPMT, such as olsalazine, mesalazine or sulfazalazine. Also a possible association between decreased TPMT activity and secondary leukaemias and myelodysplasia has been reported in individuals receiving 6–mercaptopurine in combination with other cytotoxics (see Section 4.8 Undesirable Effects). Some laboratories offer testing for TPMT deficiency, although these tests have not been shown to identify all patients at risk of severe toxicity. Therefore close monitoring of blood counts is still necessary.

Puri-Nethol is hepatotoxic and liver function tests should be monitored weekly during treatment. More frequent monitoring may be advisable in those with pre-existing liver disease or receiving other potentially hepatotoxic therapy. The patient should be instructed to discontinue Puri-Nethol immediately if jaundice becomes apparent.

During remission induction when rapid cell lysis is occurring, uric acid levels in blood and urine should be monitored as hyperuricaemia and/or hyperuricosuria may develop, with the risk of uric acid nephropathy.

Cross resistance usually exists between 6-mercaptopurine and 6-tioguanine.

The dosage of 6-mercaptopurine may need to be reduced when this agent is combined with other drugs whose primary or secondary toxicity is myelosuppression.

Mutagenicity and carcinogenicity:

Increases in chromosomal aberrations were observed in the peripheral lymphocytes of leukaemic patients, in a hypernephroma patient who received an unstated dose of 6-mercaptopurine and in patients with chronic renal disease treated at doses of 0.4 – 1.0 mg/kg/day.

In view of its action on cellular deoxyribonucleic acid (DNA) 6-mercaptopurine is potentially carcinogenic and consideration should be given to the theoretical risk of carcinogenisis with this treatment.

Two cases have been documented of the occurrence of acute nonlymphatic leukaemia in patients who received 6-mercaptopurine, in combination with other drugs, for non-neoplastic disorders. A single case has been reported where a patient was treated for pyoderma gangrenosum with 6-mercaptopurine and later developed acute nonlymphatic leukaemia, but it is not clear whether this was part of the natural history of the disease or if the 6-mercaptopurine played a causative role.

A patient with Hodgkins Disease treated with 6-mercaptopurine and multiple additional cytotoxic agents developed acute myelogenous leukaemia.

Twelve and a half years after 6-mercaptopurine treatment for myasthenia gravis a female patient developed chronic myeloid leukaemia.

Reports of hepatosplenic T

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Vaccinations with live organism vaccines are not recommended in immunocompromised individuals (see Section 4.4 Special Warnings and Precautions for Use).

When Zyloric (allopurinol) and Puri-Nethol are administered concomitantly it is essential that only a quarter of the usual dose of Puri-Nethol is given since Zyloric decreases the rate of catabolism of Puri-Nethol.

Inhibition of the anticoagulant effect of warfarin, when given with Puri-Nethol, has been reported.

As there is in vitro evidence that aminosalicylate derivatives (eg. olsalazine, mesalazine or sulfazalazine) inhibit the TPMT enzyme, they should be administered with caution to patients receiving concurrent Puri-Nethol therapy (see Section 4.4 Special Warnings and Precautions for Use).

4.6 Pregnancy And Lactation

Pregnancy:

6-mercaptopurine is potentially teratogenic. The use of Puri-Nethol should be avoided whenever possible during pregnancy. In any individual case the potential hazard to the foetus must be balanced against the expected benefit to the mother.

As with all cytotoxic chemotherapy, adequate contraceptive precautions should be advised if either partner is receiving Puri-Nethol tablets.

Maternal Exposure:

Studies of 6-mercaptopurine in animals have shown reproductive toxicity (see Section 5.3 Preclinical Safety Data). The potential risk for humans is unclear.

Normal offspring have been born after mercaptopurine therapy administered as a single chemotherapy agent during human pregnancy. Abortions and prematurity have been reported after maternal exposure. Multiple congenital abnormalities have been reported following maternal 6-mercatopurine treatment in combination with other chemotherapy agents.

Paternal Exposure:

Congenital abnormalities and spontaneous abortion have been reported after paternal exposure to 6-mercaptopurine.

Effects on fertility:

The effect of Puri-Nethol therapy on human fertility is largely unknown but there are reports of successful fatherhood/motherhood after receiving treatment during childhood or adolescence.Transient profound oligospermia was observed in a young man who received 6-mercaptopurine 150 mg/day plus prednisone 80 mg/day for acute leukaemia. Two years after cessation of the chemotherapy, he had a normal sperm count and he fathered a normal child.

Lactation:

6-Mercaptopurine has been detected in the breast milk of renal transplant patients receiving immunosuppressive therapy with azathioprine, a pro-drug of 6-mercaptopurine and thus mothers receiving Puri-Nethol should not breast-feed.

4.7 Effects On Ability To Drive And Use Machines

There are no data on the effect of 6-mercaptopurine on driving performance or the ability to operate machinery. A detrimental effect on these activities cannot be predicted from the pharmacology of the drug.

4.8 Undesirable Effects

For mercaptopurine there is a lack of modern clinical documentation which can serve as support for accurately determining the frequency of undesirable effects.

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

Neoplasms benign, malignant and unspecified (including cysts and polyps)

Very Rare: secondary leukaemia and myelodysplasia (see Section 4.4 Special Warnings and Precautions for Use); hepatosplenic T-cell lymphoma in patients with IBD (an unlicensed indication) when used in combination with anti

Blood and lymphatic system disorders

Very common Bone marrow suppression; leucopenia and thrombocytopenia.

The main side effect of treatment with 6-mercaptopurine is bone marrow suppression leading to leucopenia and thrombocytopenia.

Uncommon anaemia

Immune system disorders

Hypersensitivity reactions with the following manifestations have been reported:

Rare: Arthralgia; skin rash; drug fever

Very Rare: Facial oedema

Metabolism and nutrition disorders

Uncommon Anorexia

Gastrointestinal disorders

Common Nausea; vomiting; pancreatitis in the IBD population* (an unlicensed indication)

Rare Oral ulceration; pancreatitis (in the licensed indications)

Very rare Intestinal ulceration

Hepato-biliary disorders

Common Biliary stasis; hepatotoxicity

Rare Hepatic necrosis

6-mercaptopurine is hepatotoxic in animals and man. The histological findings in man have shown hepatic necrosis and biliary stasis

The incidence of hepatotoxicity varies considerably and can occur with any dose but more frequently when the recommended dose of 2.5 mg/kg bodyweight daily or 75 mg/m² body surface area per day is exceeded.

Monitoring of liver function tests may allow early detection of hepatotoxicity. This is usually reversible if 6-mercaptopurine therapy is stopped soon enough but fatal liver damage has occurred.

Skin and subcutaneous tissue disorders

Rare alopecia

Reproductive system and breast disorders

Very Rare Transient oligospermia

4.9 Overdose

Symptoms and signs:

Gastrointestinal effects, including nausea, vomiting and diarrhoea and anorexia may be early symptoms of overdosage having occurred.The principal toxic effect is on the bone marrow, resulting in myelosuppression. Haematological toxicity is likely to be more profound with chronic overdosage than with a single ingestion of Puri-Nethol. Liver dysfunction and gastroenteritis may also occur.

The risk of overdosage is also increased when Zyloric is being given concomitantly with Puri-Nethol (see Section 4.5 Interactions with other Medicaments and other forms of Interaction).

Management:

As there is no known antidote the blood picture should be closely monitored and general supportive measures, together with appropriate blood transfusion, instituted if necessary. Active measures (such as the use of activated charcoal) may not be effective in the event of 6-mercaptopurine overdose unless the procedure can be undertaken within 60 minutes of ingestion.

Further management should be as clinically indicated or as recommended by the national poisons centre.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: L01BB02

Pharmacotherapeutic group:

6-Mercaptopurine is sulphydryl analogue of the purine base hypoxanthine and acts as a cytotoxic antimetabolite.

Mode of Action:

6-Mercaptopurine is an inactive pro-drug which acts as a purine antagonist but requires cellular uptake and intracellular anabolism to tioguanine nucleotides for cytotoxicity. The 6-mercaptopurine metabolites inhibit de novo purine synthesis and purine nucleotide interconversions. The tioguanine nucleotides are also incorporated into nucleic acids and this contributes to the cytotoxic effects of the drug.

5.2 Pharmacokinetic Properties

The bioavailability of oral 6-mercaptopurine shows considerable inter-individual variability, which probably results from its first-pass metabolism (when administered orally at a dosage of 75 mg/m² to 7 paediatric patients, the bioavailability averaged 16% of the administered dose, with a range of 5 to 37%).

The elimination half-life of 6-mercaptopurine is 90 ± 30 minutes, but the active metabolites have a longer half-life (approximately 5 hours) than the parent drug. The apparent body clearance is 4832 ± 2562 ml/min/m². There is low entry of 6-mercaptopurine into the cerebrospinal fluid.

The main method of elimination for 6-mercaptopurine is by metabolic alteration. The kidneys eliminate approximately 7% of 6-mercaptopurine unaltered within 12 hours of the drug being administered. Xanthine oxidase is the main catabolic enzyme of 6-mercaptopurine and it converts the drug into the inactive metabolite, 6-thiouric acid. This is excreted in the urine.

5.3 Preclinical Safety Data

6-Mercaptopurine, in common with other antimetabolites, is potentially mutagenic in man and chromosome damage has been reported in mice, rats and man.

Teratogenicity

6-Mercaptopurine causes embryolethality and severe teratogenic effects in the mouse, rat, hamster and rabbit at doses that are non-toxic to the mother. In all species, the degree of embryotoxicity and the type of malformations are dependent on the dose and stage of the gestation at the time of administration.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose

Maize Starch

Hydrolysed Starch

Stearic Acid

Magnesium Stearate

Purified Water

6.2 Incompatibilities

None known

6.3 Shelf Life

60 months

6.4 Special Precautions For Storage

Store below 25ºC. Keep the bottle tightly closed.

6.5 Nature And Contents Of Container

Amber glass bottles with child resistant high density polyethylene closures with induction heat seal liners.

Pack size: 25 tablets

6.6 Special Precautions For Disposal And Other Handling

Safe handling and disposal:

It is recommended that 6

Administrative Data

7. Marketing Authorisation Holder

The Wellcome Foundation Ltd

Glaxo Wellcome House Berkeley Avenue

Greenford

Middlesex UB6 0NN

trading as

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex UB11 1BT

8. Marketing Authorisation Number(S)

PL 00003/5227R

9. Date Of First Authorisation/Renewal Of The Authorisation

27 April 1998

10. Date Of Revision Of The Text

13 Oct 2009

11. Legal Status

POM

Wednesday 27 June 2012

Calpol Six Plus Sugar Free Suspension

1. Name Of The Medicinal Product

Calpol Six Plus Sugar Free Suspension

2. Qualitative And Quantitative Composition

Calpol Six Plus Sugar Free Suspension contains 250 mg Paracetamol Ph Eur in each 5 ml.

3. Pharmaceutical Form

Suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

Calpol Six Plus Sugar Free Suspension is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, sore throat, colds and influenza, aches and pains and post-immunisation fever.

4.2 Posology And Method Of Administration

4.2.1 Posology

Children aged 6 to 12 years:

Child's Age	How Much	How often (in 24 hours)*
Under 6 years	Not recommended	N/A
6 – 8 years	One 5 ml spoonful (large end)	4 times
8 – 10 years	One 5 ml spoonful (large end) and one 2.5 ml spoonful (small end)	4 times
10 – 12 years	Two 5 ml spoonfuls (large end)	4 times
• Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

Children aged 12-16 years: Two - three 5ml spoonfuls (large end) up to 4 times a day

Adults and children over 16 years: Two - four 5ml spoonfuls (large end) up to 4 times a day.

It is important to shake the bottle for at least 10 seconds before use. <Bottle only>

It is important to massage the sachet before use.<Sachet only>

The Elderly:

In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.

4.3 Contraindications

Calpol Six Plus Sugar Free Suspension is contra-indicated in patients with known hypersensitivity to paracetamol, or any of the other components.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal impairment or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Sorbitol and maltitol may have a mild laxative effect. Each 5 ml spoonful of this product contains 1.935 g sorbitol and 2.04g of maltitol.

Calorific values: 2.6 kcal/g sorbitol and 2.3 kcal/g maltitol.

The label contains the following statements:

Contains paracetamol.

Do not give this medicine with any other paracetamol containing products.

For oral use only

Never give more medicine than shown in the table.

Do not overfill the spoon.

Always use the spoon supplied with the pack.

Do not give more than 4 doses in any 24 hour period.

Leave at least 4 hours between doses.

Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

As with all medicines, if your child is currently taking any other medicine consult your doctor or pharmacist before using this product.

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package (Bottle only).

Keep sachets in the original container (Sachet only).

Shake the bottle for at least 10 seconds before use. (Bottle only)

Massage contents of sachet before opening. (Sachet only)

Do not exceed the stated dose.

If symptoms persist consult your doctor.

Immediate medical advice should be sought in the event of an overdose, even if the child seems well. (label)

Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage. (leaflet)

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Acute alcohol intake may diminish an individual's ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.

The use of drugs that induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptives, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of the doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare. Very rarely hypersensitivity and anaphylactic reactions including skin rash may occur.

There have been reports of blood dyscrasias including thrombocytopenia and agranulocystosis but these were not necessarily casually related to paracetamol.

Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of the disease improved after paracetamol withdrawal.

Nephrotoxicity following therapeutic doses of paracetamol is uncommon. Papillary necrosis has been reported after prolonged administration.

4.9 Overdose

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient

• Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

• Regularly consumes ethanol in excess of recommended amounts.

• Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain. It has weak anti-inflammatory effects.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma half-life is in the range of 1 to 3 hours after therapeutic doses. Drug is widely distributed throughout most body fluids. Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours almost entirely following hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected. Children have less capacity for glucuronidation of the drug than do adults. In overdosage there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.

5.3 Preclinical Safety Data

The active constituent of this product is a well known constituent of medicinal products and its safety profile is well documented.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maltitol Liquid (E965)

Sorbitol Liquid (70% non crystallising) (E420)

Glycerol

Dispersible cellulose

Xanthan gum

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Acesulfame potassium

Polysorbate 80

Saccharin Sodium

Strawberry flavour 500286E

Strawberry Cream 11407-33

Purified water

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months for the bottles.

36 months for the sachets.

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

12 x 5 ml aluminium foil/polyethylene laminate sachets.

70 ml, 100 ml, 140 ml, 200 ml, 500 ml and 1000 ml amber glassbottle closed with a two-piece plastic child resistant, tamper evident closure fitted with a polyethylene or polvinylidine chloride (PVDC) laminate faced wad

Amber glass bottle closed with a three piece plastic child resistant, tamper evident closure fitted with a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad

Amber glass bottle closed with a plastic screw closure or metal roll-on pilfer proof closure fitted with a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.

A spoon with a 2.5 ml and 5ml measure is supplied with all packs of this product.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

8. Marketing Authorisation Number(S)

PL 15513/0003

9. Date Of First Authorisation/Renewal Of The Authorisation

28.04.97 / 05/March/2009

10. Date Of Revision Of The Text

6^th June 2011

Sunday 24 June 2012

Nexium Delayed-Release Capsules

Pronunciation: ES-oh-MEP-ra-zole
Generic Name: Esomeprazole
Brand Name: Nexium

Nexium Delayed-Release Capsules are used for:

Treating heartburn or irritation of the esophagus caused by gastroesophageal reflux disease (GERD). It may also be used to prevent stomach ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). It may also be used with certain antibiotics to treat ulcers of the small intestines and to prevent them from coming back. It may also be used to treat conditions that cause your body to make too much stomach acid (eg, Zollinger-Ellison syndrome). It may also be used for other conditions as determined by your doctor.

Nexium Delayed-Release Capsules are a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced in the stomach.

Do NOT use Nexium Delayed-Release Capsules if:

you are allergic to any ingredient in Nexium Delayed-Release Capsules or to any similar medicine (eg, omeprazole)

you are taking dasatinib, certain HIV protease inhibitors (eg, atazanavir, nelfinavir), rifampin, or St. John's wort.

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

Before using Nexium Delayed-Release Capsules:

Some medical conditions may interact with Nexium Delayed-Release Capsules. 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 low blood potassium or magnesium levels, liver problems or stomach or bowel cancer

if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)

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

Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood magnesium levels may be increased

Voriconazole because it may increase the risk of Nexium Delayed-Release Capsules's side effects

Ginkgo biloba, rifampin, or St. John's wort because they may decrease Nexium Delayed-Release Capsules's effectiveness

Anticoagulants (eg, warfarin), cilostazol, diazepam, digoxin, or saquinavir because the risk of their side effects may be increased by Nexium Delayed-Release Capsules

Azole antifungals (eg, ketoconazole), clopidogrel, HIV protease inhibitors (eg, atazanavir, nelfinavir), iron, mycophenolate, or tyrosine kinase inhibitors (eg, dasatinib, erlotinib) because their effectiveness may be decreased by Nexium Delayed-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nexium Delayed-Release Capsules 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 Nexium Delayed-Release Capsules:

Use Nexium Delayed-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Nexium Delayed-Release Capsules. Talk to your pharmacist if you have questions about this information.

Take Nexium Delayed-Release Capsules by mouth on an empty stomach at least 1 hour before eating.

Swallow Nexium Delayed-Release Capsules whole. Do not break, crush, or chew before swallowing.

If you have difficulty swallowing the capsule, you may add 1 tablespoon of applesauce to an empty bowl. Open the capsule and empty the pellets onto the applesauce. Mix the pellets with the applesauce and swallow the mixture right away. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. Do not chew or crush the pellets. Do not store the mixture for future use.

You may take antacids while you are using Nexium Delayed-Release Capsules if you are directed to do so by your doctor.

Continue to take Nexium Delayed-Release Capsules even if you feel well. Do not miss any doses.

If you miss a dose of Nexium Delayed-Release Capsules, 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 Nexium Delayed-Release Capsules.

Important safety information:

Nexium Delayed-Release Capsules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Nexium Delayed-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Contact your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds, or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing.

Nexium Delayed-Release Capsules may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Nexium Delayed-Release Capsules in high doses, for longer than a year, or if you are over 50 years old. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Contact your doctor if you have any questions about this information.

Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Nexium Delayed-Release Capsules for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures).

Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Nexium Delayed-Release Capsules.

Nexium Delayed-Release Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Nexium Delayed-Release Capsules.

Use Nexium Delayed-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially hip, wrist, and spine fractures.

Caution is advised when using Nexium Delayed-Release Capsules in CHILDREN; they may be more likely to experience drowsiness from Nexium Delayed-Release Capsules.

Nexium Delayed-Release Capsules should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nexium Delayed-Release Capsules while you are pregnant. It is not known if Nexium Delayed-Release Capsules are found in breast milk. Do not breast-feed while taking Nexium Delayed-Release Capsules.

Possible side effects of Nexium Delayed-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; drowsiness; dry mouth; gas; headache; nausea; stomach pain.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; dark urine; fast heartbeat; fever or chills; persistent sore throat; red, swollen, blistered, or peeling skin; severe diarrhea; severe stomach pain or cramps; unusual bruising or bleeding; unusual tiredness; yellowing of the eyes or skin.

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: Nexium 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; fast heartbeat; flushing; increased sweating; severe headache, drowsiness, or nausea.

Proper storage of Nexium Delayed-Release Capsules:

Store Nexium Delayed-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nexium Delayed-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Nexium Delayed-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.

Nexium Delayed-Release Capsules are 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 Nexium Delayed-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Nexium resources

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

Compare Nexium with other medications

Barrett's Esophagus
Duodenal Ulcer Prophylaxis
Erosive Esophagitis
GERD
Helicobacter Pylori Infection
NSAID-Induced Gastric Ulcer
Pathological Hypersecretory Conditions
Zollinger-Ellison Syndrome

Saturday 23 June 2012

hydrochlorothiazide and lisinopril

Generic Name: hydrochlorothiazide and lisinopril (HYE droe KLOR oh THYE a zide and lye SIN oh pril)

Brand Names: Prinzide, Zestoretic

What is hydrochlorothiazide and lisinopril?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Lisinopril is in a group of drugs called ACE inhibitors. ACE stands for angiotensin converting enzyme. Lisinopril lowers blood pressure and also relieves symptoms of fluid retention.

The combination of hydrochlorothiazide and lisinopril is used to treat hypertension (high blood pressure).

Hydrochlorothiazide and lisinopril may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydrochlorothiazide and lisinopril?

Do not use hydrochlorothiazide and lisinopril if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Do not use this medication if you are unable to urinate.

You should not use this medication if you are allergic to any other ACE inhibitor, such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik).

Before taking hydrochlorothiazide and lisinopril, tell your doctor if you have kidney disease (or are on dialysis), liver disease, glaucoma, congestive heart failure, gout, lupus, diabetes, or an allergy to sulfa drugs or penicillin.

Avoid the regular use of salt substitutes in your diet, and do not take potassium supplements while taking hydrochlorothiazide and lisinopril, unless your doctor has told you to. Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

What should I discuss with my healthcare provider before taking hydrochlorothiazide and lisinopril?

Do not use this medication if you are unable to urinate.

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

kidney disease (or if you are on dialysis);

liver disease;

glaucoma;

heart disease or congestive heart failure;

asthma or allergies;

gout;

lupus;

diabetes; or

an allergy to sulfa drugs or penicillin.

FDA pregnancy category D. Do not use hydrochlorothiazide and lisinopril if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Lisinopril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking hydrochlorothiazide and lisinopril. Hydrochlorothiazide 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 hydrochlorothiazide and lisinopril?

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.

Take each dose with a full glass of water. Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking hydrochlorothiazide and lisinopril. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Your blood pressure will need to be checked often. Visit your doctor regularly.

Your blood and urine may also be tested if you have been vomiting or are dehydrated.

Hydrochlorothiazide can interfere with the results of a thyroid test. Tell any doctor who treats you that you are using a thiazide diuretic.

Keep using this medicine as directed, 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.

Store at room temperature away from moisture, heat, and light.

See also: Hydrochlorothiazide and lisinopril dosage (in more detail)

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.

Overdose symptoms may include nausea, weakness, dizziness, dry mouth, thirst, muscle pain or weakness, or feeling like you might pass out.

What should I avoid while taking hydrochlorothiazide and lisinopril?

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

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 increase certain side effects of hydrochlorothiazide and lisinopril.

Avoid the regular use of salt substitutes in your diet, and do not take potassium supplements while taking hydrochlorothiazide and lisinopril, unless your doctor has told you to.

Hydrochlorothiazide and lisinopril side effects

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

feeling like you might pass out;

eye pain, vision problems;

high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);

low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

dry mouth, thirst, nausea, vomiting;

feeling weak, drowsy, or restless;

a red, blistering, peeling skin rash;

jaundice (yellowing of the skin or eyes);

urinating less than usual or not at all;

swelling, weight gain, feeling short of breath; or

fever, chills, body aches, flu symptoms.

Less serious side effects may include:

cough;

dizziness, tired feeling, depressed mood;

headache, blurred vision;

diarrhea, constipation, upset stomach; or

mild skin rash, increased sweating.

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.

Hydrochlorothiazide and lisinopril Dosing Information

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 1 tablet of (hydrochlorothiazide-lisinopril 12.5 mg/10 mg) once a day. Determine dosage by individual titration.
Maintenance dose: May increase up to a maximum of 2 tablets of (hydrochlorothiazide-lisinopril 25 mg/20 mg) twice a day.

Usual Adult Dose for Hypertension:

What other drugs will affect hydrochlorothiazide and lisinopril?

Cold or allergy medicine, sedatives, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety can add to the side effects of hydrochlorothiazide and lisinopril. Tell your doctor if you regularly use any of these medicines, or any other blood pressure medications.

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

other diuretics (water pills) or blood pressure medications;

gold injections to treat arthritis;

lithium (Lithobid, Eskalith);

cholestyramine (Prevalite, Questran) or colestipol (Colestid);

steroids (prednisone and others);

NSAIDs (non-steroidal anti-inflammatory drugs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or

insulin or diabetes medicine taken by mouth.

This list is not complete and other drugs may interact with hydrochlorothiazide and lisinopril. 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 hydrochlorothiazide and lisinopril resources

Hydrochlorothiazide and lisinopril Dosage
Hydrochlorothiazide and lisinopril Use in Pregnancy & Breastfeeding
Drug Images
Hydrochlorothiazide and lisinopril Drug Interactions
Hydrochlorothiazide and lisinopril Support Group
18 Reviews for Hydrochlorothiazide and lisinopril - Add your own review/rating

Compare hydrochlorothiazide and lisinopril with other medications

Heart Failure
High Blood Pressure

Where can I get more information?

Your pharmacist can provide more information about hydrochlorothiazide and lisinopril.

amphotericin B

Generic Name: amphotericin B (am foe TER i sin)

Brand names: Fungizone, Fungizone For Tissue Culture, Amphocin

What is amphotericin B?

Amphotericin B is an antibiotic that fights fungal infections in the body.

Amphotericin B is used to treat serious, life-threatening fungal infections. It is not for use in treating a minor fungal infection such as a yeast infection of the mouth, esophagus, or vagina.

Amphotericin is usually given after other antifungal antibiotics have been tried without successful treatment of symptoms.

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

What is the most important information I should know about amphotericin B?

Do not receive this medication if you are allergic to any formulation of amphotericin B (Abelcet, AmBisome, Amphotec, or Fungizone).

Before you receive amphotericin B, tell your doctor if you are allergic to any drugs, or if you have kidney disease or heart disease.

Amphotericin B is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

The medicine must be given slowly through an IV infusion, and can take up to 6 hours to complete.

Amphotericin B may need to be given for up to several weeks or months, depending on the infection being treated.

What should I discuss with my health care provider before I receive amphotericin B?

You should not receive this medication if you are allergic to any formulation of amphotericin B (Abelcet, AmBisome, Amphotec, or Fungizone).

Before you receive amphotericin B, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease; or

heart disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive amphotericin B.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether amphotericin B passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is amphotericin B given?

Amphotericin B is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting.

The medicine must be given slowly through an IV infusion, and can take up to 6 hours to complete.

While you are receiving your amphotericin B infusion, your caregivers will check your blood pressure, pulse, temperature, and lung function about every 30 minutes.

To be sure this medication is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested on a regular basis. Amphotericin B can have long-lasting effects on your body. Do not miss any follow-up visits to your doctor for blood or urine tests.

Amphotericin B may need to be given for up to several weeks or months, depending on the infection being treated.

What happens if I miss a dose?

Since amphotericin B is usually given while you are in the hospital, it is not likely you will miss a dose of this medication.

If you are receiving amphotericin B in an outpatient clinic, call your doctor if you will miss an appointment for your amphotericin B injection.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include slow heart rate, and shallow breathing that slows or stops.

What should I avoid while receiving amphotericin B?

Amphotericin B may lower the blood cells that help your body fight other infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Amphotericin B side effects

Some people receiving an amphotericin B injection have had a reaction to the infusion (either when the medicine is injected into the vein or within 1 to 3 hours afterward). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, feverish or cold, or if you have a slow heartbeat, chest tightness, or trouble breathing. 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. Tell your doctor at once if you have any of these serious side effects:

dry mouth, increased thirst, nausea, vomiting;

extreme drowsiness, restless feeling, confusion;

urinating more or less than usual, or not at all;

muscle pain or weakness, fast or uneven heart rate, feeling light-headed, fainting;

seizure (convulsions);

fever, chills, body aches, flu symptoms;

pale skin, easy bruising or bleeding, unusual weakness; 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:

pain, swelling, or other irritation where the needle is placed;

mild nausea, vomiting, diarrhea, upset stomach, loss of appetite;

weight loss;

muscle or joint aches;

headache;

warmth, redness, or tingly feeling under your skin; or

skin itching or mild rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Amphotericin B Dosing Information

Usual Adult Dose for Fungal Infection Prophylaxis:

Prevention of invasive Candidiasis in solid-organ transplants: 10 to 20 mg per day IV

Prevention of invasive Candidiasis during periods of risk - ICU and Other Care Settings (stay of 3 days or longer): 0.25 mg/kg per day IV

Usual Adult Dose for Aspergillosis -- Aspergilloma:

0.25 mg/kg per day IV
Daily dosage may be gradually increased to 0.5 to 1 mg/kg over a period of 2 to 4 days. Total doses range from 1 to 2 g.

Usual Adult Dose for Aspergillosis -- Invasive:

0.5 to 0.6 mg/kg per day IV
Daily doses as high as 1 to 1.5 mg/kg have been suggested by some clinicians. Total doses of 1.5 to 4 g have been given over an 11-month period.

Usual Adult Dose for Blastomycosis:

0.5 to 1 mg/kg per day IV
A total dose ranging from 1.5 to 2.5 g is needed for life-threatening disease. Patients with CNS infection should receive 0.7 to 1 mg/kg per day (total dose, at least 2 g).

Usual Adult Dose for Candida Urinary Tract Infection:

Candiduria: 0.3 to 1 mg/kg per day IV for 1 to 7 days
Bladder irrigation: 5 to 50 mg/L instilled into the bladder for 60 to 90 minutes and drained 4 times a day for 2 to 5 days

Usual Adult Dose for Candidemia:

Nonneutropenia: 0.6 to 1 mg/kg per day IV
Treatment duration should last 14 days after last positive blood culture and resolution of signs and symptoms.

Neutropenia: 0.7 to 1 mg/kg per day IV
Treatment duration should last 14 days past last positive blood culture and resolution of signs and symptoms.

Meningitis: 0.7 to 1 mg/kg per day IV plus flucytosine
Therapy should be administered for a minimum of 4 weeks after resolution of all signs and symptoms associated with the infection.

Endocarditis: 0.6 to 1 mg/kg per day IV for at least 6 weeks after valve replacement; flucytosine may be used concomitantly

Chronic disseminated: 0.6 to 0.7 mg/kg per day IV
Treatment duration may last 3 to 6 months and resolution or calcification of radiologic lesions.

The addition of oral flucytosine may be considered for HIV-infected patients with invasive candidiasis.

Usual Adult Dose for Coccidioidomycosis:

Respiratory infection: 0.5 to 1 mg/kg per day IV to a maximum of 1.5 mg/kg per day for 4 to 12 weeks

Usual Adult Dose for Coccidioidomycosis -- Meningitis:

0.01 to 1.5 mg intrathecal injection
It is administered at intervals ranging from daily to weekly, beginning at a low dose and increasing until patient intolerance appears. Concomitant azole therapy is started.

Usual Adult Dose for Cryptococcal Meningitis -- Immunocompetent Host:

0.7 to 1 mg/kg per day IV for 6 to 10 weeks
Therapy is given concomitantly with flucytosine.

Usual Adult Dose for Cryptococcal Meningitis -- Immunosuppressed Host:

0.7 to 1 mg/kg per day IV plus flucytosine for 2 weeks followed by fluconazole for a minimum of 10 weeks

Usual Adult Dose for Cryptococcosis:

Pulmonary: 0.5 to 1 mg/kg per day IV for 6 to 10 weeks
Total dose: 1 to 2 g

The addition of oral flucytosine may be considered.

Usual Adult Dose for Esophageal Candidiasis:

Severe and/or refractory esophageal candidiasis: 0.25 mg/kg per day IV
If tolerated, dosage may be gradually increased over 2 to 4 days to 0.3 to 0.7 mg/kg per day. Total doses range from 100 to 200 mg.

This drug should not be used to treat noninvasive fungal infections in patients with normal neutrophil counts.

Usual Adult Dose for Fungal Endocarditis:

0.25 mg/kg per day IV
Dosage may be gradually increased to 1 to 1.5 mg/kg per day over a period of 2 to 4 days. Total doses range from 1.5 to 3 g.

Usual Adult Dose for Histoplasmosis -- Immunocompenent Host:

Pulmonary: 0.7 mg/kg per day IV

Usual Adult Dose for Histoplasmosis -- Meningitis:

0.7 to 1 mg/kg per day IV to complete a 35 mg/kg total dose over 3 to 4 months

Usual Adult Dose for Oral Thrush:

Refractory or pharyngeal candidiasis: 0.25 mg/kg per day IV
Dosage may be gradually increased to 0.3 mg/kg per day over a period of 2 to 4 days. Total doses range from 100 to 200 mg.

This drug should not be used to treat noninvasive fungal infections in patients with normal neutrophil counts.

Usual Adult Dose for Paracoccidioidomycosis:

0.4 to 0.5 mg/kg per day IV to a maximum dose of 1.5 mg/kg per day in potentially fatal infections
Prolonged therapy is usually required.

Usual Adult Dose for Sporotrichosis:

0.4 to 0.5 mg/kg per day IV for 2 to 3 months
Therapy has ranged up to 9 months with a total dose up to 2.5 g.

Usual Adult Dose for Leishmaniasis:

Treatment of American cutaneous leishmaniasis (caused by L braziliense or L mexicana: 0.25 to 0.5 mg/kg per day IV
Dosage may be gradually increased to 0.5 to 1 mg/kg daily, at which time the drug is usually then given on alternate days. Duration of treatment may last from 3 to 12 weeks depending on severity of disease. Total dose ranges from 1 to 3 g.

Visceral Leishmaniasis: 0.5 to 1 mg/kg per day IV on alternate days for 14 to 20 doses

Maximum dose: 50 mg per day
Total dose: 1.5 to 2 g

Usual Pediatric Dose for Blastomycosis:

0.25 mg/kg per day IV
Total dose: greater than or equal to 30 mg/kg

Usual Pediatric Dose for Candidemia:

0.6 to 1 mg/kg per day IV for 14 to 21 days after resolution of signs and symptoms and negative repeat blood cultures

The addition of oral flucytosine may be considered for HIV-infected patients with invasive candidiasis.

Usual Pediatric Dose for Cryptococcal Meningitis -- Immunosuppressed Host:

HIV-infected patient: 0.25 to 1 mg/kg per day IV

The addition of oral flucytosine may be considered.

What other drugs will affect amphotericin B?

Before receiving amphotericin B, tell your doctor if you are using any of the following drugs:

flucytosine (Ancobon);

digoxin (digitalis, Lanoxin, Lanoxicaps);

pentamidine (Nebupent, Pentam);

tacrolimus (Prograf);

muscle relaxers;

steroids (prednisone and others);

antifungal antibiotics such as clotrimazole (Mycelex Troche), fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox);

antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);

antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

This list is not complete and there may be other drugs that can interact with amphotericin B. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More amphotericin B resources

Amphotericin B Use in Pregnancy & Breastfeeding
Amphotericin B Drug Interactions
Amphotericin B Support Group
0 Reviews for Amphotericin B - Add your own review/rating

Amphotericin B Prescribing Information (FDA)

Amphotericin B Professional Patient Advice (Wolters Kluwer)

Amphotericin B Monograph (AHFS DI)

Amphotericin B MedFacts Consumer Leaflet (Wolters Kluwer)

Fungizone Prescribing Information (FDA)

amphotericin b Intravenous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information

Compare amphotericin B with other medications

Aspergillosis, Aspergilloma
Aspergillosis, Invasive
Blastomycosis
Candida Infections, Systemic
Candida Urinary Tract Infection
Coccidioidomycosis
Coccidioidomycosis, Meningitis
Cryptococcal Meningitis, Immunocompetent Host
Cryptococcal Meningitis, Immunosuppressed Host
Cryptococcosis
Esophageal Candidiasis
Fungal Endocarditis
Fungal Infection Prophylaxis
Histoplasmosis, Immunocompenent Host
Histoplasmosis, Meningitis
Leishmaniasis
Oral Thrush
Paracoccidioidomycosis
Sporotrichosis

Where can I get more information?

Your pharmacist can provide more information about amphotericin B.

Thursday 21 June 2012

Prednisolone Acetate Suspension

Pronunciation: pred-NIS-oh-lone AS-e-tate
Generic Name: Prednisolone Acetate
Brand Name: Flo-Pred

Prednisolone Acetate Suspension is used for:

Treating certain types of allergies, arthritis, autoimmune diseases, blood disorders, bowel problems, cancer, endocrine problems, eye problems, kidney problems, lung or breathing problems, nervous system problems, or skin conditions. It is also used to treat conditions related to organ transplants or certain infections. It may also be used for other conditions as determined by your doctor.

Prednisolone Acetate Suspension is a corticosteroid. It works by modifying the body's immune response to various conditions and decreasing inflammation.

Do NOT use Prednisolone Acetate Suspension if:

you are allergic to any ingredient in Prednisolone Acetate Suspension or to other corticosteroids (eg, methylprednisolone)

you have a systemic fungal infection, a malaria infection in the brain, inflammation of the optic nerve (optic neuritis), or herpes infection of the eye

you are scheduled to have a live or attenuated live vaccination (eg, smallpox)

you are taking mifepristone

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

Before using Prednisolone Acetate Suspension:

Some medical conditions may interact with Prednisolone Acetate Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

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

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

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

if you have a history of adrenal gland problems, diabetes, eye problems (eg, cataracts, glaucoma, infection), heart problems (eg, congestive heart failure), a recent heart attack, high blood pressure, kidney problems, liver problems, mental or mood problems (eg, depression), seizures, swelling or fluid retention (edema), or thyroid problems

if you have or have recently had a fungal, bacterial, viral, or other type of infection; herpes infection of the eye; chickenpox; measles; or shingles

if you have HIV infection or tuberculosis (TB) infection, or if you have had ever had a positive TB skin test

if you have any stomach problems (eg, ulcers), bowel problems (eg, blockage, perforation, or infection; unexplained diarrhea; diverticulitis; ulcerative colitis), recent bowel surgery, or inflammation of the esophagus

if you have trouble sleeping, muscle problems (eg, myasthenia gravis), or weak bones (eg, osteoporosis) or a risk of osteoporosis (eg, family history of osteoporosis)

if you have had a recent vaccination (eg, smallpox)

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

Amphotericin B, cyclosporine, estrogens (eg, estradiol), oral contraceptives (birth control pills), ketoconazole, macrolide antibiotics (eg, clarithromycin), or tacrolimus because they may increase the risk of Prednisolone Acetate Suspension's side effects

Aminoglutethimide, barbiturates (eg, phenobarbital), carbamazepine, cholestyramine, hydantoins (eg, phenytoin), or rifamycins (eg, rifampin) because they may decrease Prednisolone Acetate Suspension's effectiveness

Anticholinesterases (eg, pyridostigmine), digoxin, certain diuretics (eg, furosemide, hydrochlorothiazide), live or attenuated live vaccines (eg, smallpox), methotrexate, mifepristone, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), quinolone antibiotics (eg, ciprofloxacin), ritodrine, or salicylates (eg, aspirin) because the risk of their side effects may be increased by Prednisolone Acetate Suspension

Anticoagulants (eg, warfarin), insulin or other diabetes medicines, interleukin-2 (eg, aldesleukin), isoniazid, or killed or inactivated vaccines because their effectiveness may be decreased by Prednisolone Acetate Suspension

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

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

Take Prednisolone Acetate Suspension by mouth with food.

Read the instructions for use before you start using Prednisolone Acetate Suspension and each time you get a refill. Only use the syringe that is provided with Prednisolone Acetate Suspension to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.

Shake well before each use.

Follow the instructions for cleaning the syringe after each use.

If you miss a dose of Prednisolone Acetate Suspension, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prednisolone Acetate Suspension.

Important safety information:

Prednisolone Acetate Suspension may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Contact your doctor if you are exposed to chickenpox or measles.

Report to your doctor any injuries or signs of infection (fever, chills, sore throat, pain during urination, or muscle aches) for up to 12 months after stopping Prednisolone Acetate Suspension.

Carry an ID card at all times that says you take Prednisolone Acetate Suspension.

Do not receive a live vaccine (eg, measles, mumps) while you are taking Prednisolone Acetate Suspension. Talk with your doctor before you receive any vaccine.

Tell your doctor or dentist that you take Prednisolone Acetate Suspension before you receive any medical or dental care, emergency care, or surgery.

Prednisolone Acetate Suspension may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Prednisolone Acetate Suspension may cause an increase in blood pressure, salt and water retention, and increased potassium loss. It may be necessary to restrict the use of salt in your diet and take a potassium supplement if instructed to do so by your doctor. Discuss any questions or concerns with your doctor.

Prednisolone Acetate Suspension can cause a decrease in the amount of calcium in your bones and increase the risk of osteoporosis. Talk with doctor about taking calcium and vitamin D while you are taking Prednisolone Acetate Suspension.

Prednisolone Acetate Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Prednisolone Acetate Suspension for a few days before the tests.

Lab tests, including adrenal function, blood glucose levels, blood potassium and sodium levels, blood pressure monitoring, weight checks, chest x-rays, and eye pressure, may be performed while you use Prednisolone Acetate Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Caution is advised when using Prednisolone Acetate Suspension in CHILDREN; they may be more sensitive to its effects.

Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Prednisolone Acetate Suspension.

PREGNANCY and BREAST-FEEDING: Prednisolone Acetate Suspension may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prednisolone Acetate Suspension while you are pregnant. Prednisolone Acetate Suspension is found in breast milk. If you are or will be breast-feeding while you use Prednisolone Acetate Suspension, check with your doctor. Discuss any possible risks to your baby.

If you are on long-term or high-dosage therapy and you suddenly stop taking Prednisolone Acetate Suspension, you may have WITHDRAWAL symptoms, including fever, vomiting, appetite loss, diarrhea, nausea, dizziness, weight loss, weakness, general body discomfort, or joint or muscle pain. If you need to stop Prednisolone Acetate Suspension, your doctor will gradually lower your dose.

Possible side effects of Prednisolone Acetate Suspension:

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:

Acne; dizziness; facial flushing; headache; increased appetite; increased sweating; mild swelling; nausea; nervousness; trouble sleeping; upset stomach; weight gain.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry stools; burning, numbness, or tingling; calf or leg pain, swelling, redness, or tenderness; changes in body fat; changes in menstrual period; changes in skin color; chest pain; easy bruising or bleeding; fainting; fast, slow, or irregular heartbeat; mental or mood changes (eg, depression); muscle pain, cramps, weakness, or wasting; numbness of an arm or leg; persistent trouble sleeping; seizures; severe or persistent dizziness or headache; severe or persistent nausea, vomiting, or stomach or back pain; severe or persistent swelling of the hands, arms, feet, or legs; shortness of breath; symptoms of infection (eg, fever, chills, persistent sore throat); tendon or bone pain; thinning of skin; unusual weight gain; vision changes or other eye problems; vomit that looks like coffee grounds.

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 Prednisolone Acetate Suspension:

Store Prednisolone Acetate Suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not refrigerate. Keep in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prednisolone Acetate Suspension out of the reach of children and away from pets.

General information:

If you have any questions about Prednisolone Acetate Suspension, please talk with your doctor, pharmacist, or other health care provider.

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Prednisolone Acetate resources

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Prednisolone Acetate Support Group
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Sotradecol

Generic Name: sodium tetradecyl sulfate (SOO dee um TET ra DES il SUL fate)

Brand Names: Sotradecol

What is Sotradecol (sodium tetradecyl sulfate)?

Sodium tetradecyl sulfate is a sclerosing (skler-OH-sing) agent. It works by increasing the formation of blood clots and scar tissue inside certain types of veins. This helps decrease dilation of enlarged veins.

Sodium tetradecyl sulfate is used to treat small uncomplicated varicose veins in the legs.

Sodium tetradecyl sulfate is not a cure for varicose veins and the effects of this medication may not be permanent.

Sodium tetradecyl sulfate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Sotradecol (sodium tetradecyl sulfate)?

You should not be treated with sodium tetradecyl sulfate if you are allergic to it, if you are bedridden due to serious illness, or if you have a serious blood clot or a clotting disorder, allergies, cancer, severe blood infection, or any untreated or uncontrolled disease such as diabetes, overactive thyroid, tuberculosis, asthma, a blood cell disorder, or skin disease.

Sodium tetradecyl sulfate should not be used to treat varicose veins that are caused by a tumor in your stomach or pelvis area, unless the tumor has been surgically removed.

You will be watched closely for several hours after your injection, to make sure this medication is not causing harmful effects. Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected. Call your doctor at once if you have a serious side effect such as pain or swelling in one or both legs, chest pain, sudden cough, wheezing, rapid breathing, fast heart rate, or skin changes where the medicine was injected.

What should I discuss with my health care provider before receiving Sotradecol (sodium tetradecyl sulfate)?

You should not receive sodium tetradecyl sulfate if you are allergic to it, or if you have:

a blood clot disorder such as deep vein thrombosis (DVT) or thrombophlebitis (swelling of a vein caused by a blood clot);

Buerger's disease (a blood clotting disorder affecting the arms and legs);

allergies;

cancer;

a severe infection of your blood (sepsis);

any untreated or uncontrolled disease such as diabetes, overactive thyroid, tuberculosis, asthma, blood cell disorder, or skin disease; or

if you are bed-ridden due to severe illness.

Sodium tetradecyl sulfate should not be used to treat varicose veins that are caused by a tumor in your stomach or pelvis area, unless the tumor has been surgically removed.

FDA pregnancy category C. It is not known whether sodium tetradecyl sulfate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether sodium tetradecyl sulfate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is sodium tetradecyl sulfate given?

Sodium tetradecyl sulfate is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

You will be watched closely for several hours after your injection, to make sure this medication is not causing harmful effects.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

You may need to wear compression stockings for several days or weeks after your treatment. Carefully follow your doctor's instructions about caring for yourself after receiving this medication.

What happens if I miss a dose?

Since sodium tetradecyl sulfate is given as needed by a healthcare professional, you are not likely to miss a dose.

What happens if I overdose?

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

An overdose is not likely to occur in a medical setting.

What should I avoid while receiving Sotradecol (sodium tetradecyl sulfate)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sotradecol (sodium tetradecyl sulfate) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; sneezing, runny nose, difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

pain or swelling in one or both legs;

chest pain, sudden cough, wheezing, rapid breathing, fast heart rate; or

pain, itching, peeling, skin sores, or skin changes where the medicine was injected.

Less serious side effects may include:

mild headache;

nausea, vomiting; or

discolored skin along the treated vein (may be permanent).

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 Sotradecol (sodium tetradecyl sulfate)?

Tell your doctor if you are taking birth control pills or other medications that stop or prevent ovulation (ovaries releasing eggs).

There may be other drugs that can interact with sodium tetradecyl sulfate. 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 Sotradecol resources

Sotradecol Side Effects (in more detail)
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0 Reviews for Sotradecol - Add your own review/rating

Sotradecol Prescribing Information (FDA)

Sotradecol Advanced Consumer (Micromedex) - Includes Dosage Information

Sotradecol MedFacts Consumer Leaflet (Wolters Kluwer)

Sodium Tetradecyl Sulfate Professional Patient Advice (Wolters Kluwer)

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Varicose Veins

Where can I get more information?

Your doctor or pharmacist can provide more information about sodium tetradecyl sulfate.

See also: Sotradecol side effects (in more detail)