Nasirobin may be available in the countries listed below.
Ingredient matches for Nasirobin
Domperidone
Domperidone is reported as an ingredient of Nasirobin in the following countries:
- Japan
International Drug Name Search
Thursday, 29 September 2016
Nix Creme Rinse
Nix Creme Rinse may be available in the countries listed below.
Ingredient matches for Nix Creme Rinse
Permethrin
Permethrin is reported as an ingredient of Nix Creme Rinse in the following countries:
- Luxembourg
International Drug Name Search
Nestrolan
Nestrolan may be available in the countries listed below.
Ingredient matches for Nestrolan
Trazodone
Trazodone hydrochloride (a derivative of Trazodone) is reported as an ingredient of Nestrolan in the following countries:
- Belgium
International Drug Name Search
Nufex
Nufex may be available in the countries listed below.
Ingredient matches for Nufex
Cefalexin
Cefalexin is reported as an ingredient of Nufex in the following countries:
- Bangladesh
- India
International Drug Name Search
Nitrendipin Lindopharm
Nitrendipin Lindopharm may be available in the countries listed below.
Ingredient matches for Nitrendipin Lindopharm
Nitrendipine
Nitrendipine is reported as an ingredient of Nitrendipin Lindopharm in the following countries:
- Germany
International Drug Name Search
Wednesday, 28 September 2016
Nimesulide Mipharm
Nimesulide Mipharm may be available in the countries listed below.
Ingredient matches for Nimesulide Mipharm
Nimesulide
Nimesulide is reported as an ingredient of Nimesulide Mipharm in the following countries:
- Italy
International Drug Name Search
Nortem
Nortem may be available in the countries listed below.
Ingredient matches for Nortem
Temazepam
Temazepam is reported as an ingredient of Nortem in the following countries:
- Ireland
International Drug Name Search
Embutramide
In some countries, this medicine may only be approved for veterinary use.
Scheme
Rec.INN
CAS registry number (Chemical Abstracts Service)
0015687-14-6
Chemical Formula
C17-H27-N-O3
Molecular Weight
293
Therapeutic Categories
Opioid analgesic
Agent for animal euthanasia
Chemical Names
N-[2-Ethyl-2-(3-methoxyphenyl)butyl]-4-hydroxybutanamide
N-[2-Ethyl-2-(3-methoxyphenyl)butyl]-4-hydroxybutyramid (IUPAC)
Butanamide, N-[2-ethyl-2-(3-methoxyphenyl)butyl]-4-hydroxy-
N-(beta, beta-diethyl-m-methoxyphenethyl)-4-hydroxybutyramide (WHO)
N-Diethyl-Methoxyphenethyl-4-Hydroxybutyramid
Foreign Names
- Embutramidum (Latin)
- Embutramid (German)
- Embutramide (French)
- Embutramida (Spanish)
Generic Names
- Embutramida (OS: DCIT)
- Embutramide (OS: USAN, BAN)
- EINECS 239-780-4 (IS)
- Embutane (IS: HoechstRoussel)
- HOE 18 680 (IS)
- T-61 (IS: HoechstRoussel)
- UNII-3P4TQG94T1 (IS)
Brand Names
- T 61 (Embutramide and Mebezonium, + Tetracaine (veterinary use))
Intervet, Austria; Intervet, Belgium; Intervet, Germany; Veterinaria, Switzerland
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCIT | Denominazione Comune Italiana |
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
Click for further information on drug naming conventions and International Nonproprietary Names.
Nomagest
Nomagest may be available in the countries listed below.
Ingredient matches for Nomagest
Algestone
Algestone 16α,17α-acetonide (a derivative of Algestone) is reported as an ingredient of Nomagest in the following countries:
- El Salvador
- Guatemala
- Honduras
- Nicaragua
- Panama
Estradiol
Estradiol 17ß-enantate (a derivative of Estradiol) is reported as an ingredient of Nomagest in the following countries:
- El Salvador
- Guatemala
- Honduras
- Nicaragua
- Panama
International Drug Name Search
Nal-acid
Nal-acid may be available in the countries listed below.
Ingredient matches for Nal-acid
Nalidixic Acid
Nalidixic Acid is reported as an ingredient of Nal-acid in the following countries:
- Greece
International Drug Name Search
Nadem
Nadem may be available in the countries listed below.
Ingredient matches for Nadem
Escin
Escin is reported as an ingredient of Nadem in the following countries:
- Argentina
International Drug Name Search
entecavir
en-TEK-a-vir
Oral route(Tablet;Solution)
Severe acute exacerbations of hepatitis B have been reported upon discontinuation of anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely for at least several months in patients who discontinue therapy and reinitiation of anti-hepatitis B therapy may be warranted. Entecavir is not recommended in HIV/HBV co-infected patients not treated with highly active antiretroviral therapy because there is potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues .
Commonly used brand name(s)
In the U.S.
- Baraclude
Available Dosage Forms:
- Solution
- Tablet
Therapeutic Class: Antiviral
Chemical Class: Guanosine Nucleoside Analog
Uses For entecavir
Entecavir belongs to the family of medicines called antivirals. Antivirals are used to treat infections that are caused by viruses. Entecavir is used to treat the liver infection caused by hepatitis B virus. entecavir will not cure the hepatitis B virus, but it will keep it from reproducing and causing more liver damage.
entecavir is available only with your doctor's prescription.
Before Using entecavir
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 entecavir, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to entecavir or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of entecavir in children and teenagers younger than 16 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of entecavir in the elderly. However, elderly patients are more likely to have age-related kidney disease, which may require an adjustment in the dose for patients receiving entecavir.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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 entecavir. Make sure you tell your doctor if you have any other medical problems, especially:
- Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.
- Liver disease—May increase chance for serious side effects.
Proper Use of entecavir
Take entecavir exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. When your supply of entecavir is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of entecavir. Also, do not stop taking entecavir without checking with your doctor first.
Take entecavir on an empty stomach (at least two hours after a meal and two hours before the next meal).
Read and follow carefully the patient information leaflet before starting entecavir treatment and each time you refill. Ask your doctor or pharmacist if you have any questions.
Measure the oral solution correctly using the marked measuring spoon that comes with the package. Rinse the dosing spoon with water after each use.
Dosing
The dose of entecavir 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 entecavir. 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 chronic hepatitis B infection:
- For oral dosage form (solution or tablets):
- Adults and teenagers above 16 years of age—0.5 to 1 milligram (mg) or 10 to 20 milliliters (mL) once per day.
- Children and teenagers below 16 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (solution or tablets):
Missed Dose
If you miss a dose of entecavir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Do not throw any unused medicine in the trash. Flush it down the toilet or take it to a community take-back program when available.
Precautions While Using entecavir
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.
It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking entecavir.
If you have or get HIV (human immunodeficiency virus) infection, be sure to discuss your treatment with your doctor. If you are taking entecavir to treat chronic hepatitis B and are not taking medicines for your HIV at the same time, some HIV treatments that you take in the future may be less likely to work. Your doctor may need you to get an HIV test before you start taking entecavir and anytime after that when there is a chance you were exposed to HIV. entecavir will not help your HIV infection.
Two rare but serious reactions to entecavir are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child feel tired, weak, dizzy, or nauseated, if you vomit or have stomach pain, dark urine, light-colored stools, unusual muscle pains, or trouble with breathing, or if your skin or eyes turn yellow.
Liver disease may become worse if treatment with entecavir is stopped. Do not stop taking entecavir unless your doctor tells you to stop.
Treatment with entecavir has not been shown to decrease the chance of giving hepatitis B virus infection to other people through sexual contact or blood contamination.
entecavir 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:
Incidence not known
- Abdominal or stomach discomfort
- decreased appetite
- diarrhea
- fast, shallow breathing
- general feeling of discomfort
- muscle pain or cramping
- nausea
- rash
- right upper abdominal or stomach pain and fullness
- shortness of breath
- sleepiness
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Headache
- Acid or sour stomach
- belching
- dizziness
- heartburn
- indigestion
- sleepiness or unusual drowsiness
- sleeplessness
- stomach discomfort, upset, or pain
- trouble sleeping
- vomiting
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: entecavir 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.
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More entecavir resources
- Entecavir Side Effects (in more detail)
- Entecavir Use in Pregnancy & Breastfeeding
- Entecavir Drug Interactions
- Entecavir Support Group
- 0 Reviews for Entecavir - Add your own review/rating
- Entecavir Professional Patient Advice (Wolters Kluwer)
- Entecavir Monograph (AHFS DI)
- Entecavir MedFacts Consumer Leaflet (Wolters Kluwer)
- Baraclude Prescribing Information (FDA)
- Baraclude Consumer Overview
Compare entecavir with other medications
- Hepatitis B
Axorid modified-release capsules
1. Name Of The Medicinal Product
Axorid 100 mg/20 mg modified-release capsules.
Axorid 200 mg/20 mg modified-release capsules.
2. Qualitative And Quantitative Composition
Each modified-release capsule contains 100 mg or 200 mg ketoprofen and 20 mg omeprazole.
Excipients:
Each capsule contains propyl-p-hydroxybenzoate, methyl-p-hydroxybenzoate, and 80 mg or 105 mg sucrose.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Modified-release capsule, hard.
(Modified-release capsule).
Capsule, hard with opaque yellow cap and opaque white body (100 mg/20 mg) or opaque white cap and body (200 mg/20 mg), containing white to greyish-white spherical microgranules.
4. Clinical Particulars
4.1 Therapeutic Indications
Symptomatic treatment of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis in patients with a previous history or who are at risk of developing NSAID associated gastric ulcers or duodenal ulcers.
4.2 Posology And Method Of Administration
For oral use.
The capsule should be swallowed whole with food once daily, with a large glass of water.
Adults and adolescents over the age of 15 years:
The daily dose is 100 mg/20 mg to 200 mg/20 mg depending of the severity of symptoms.
The maximal daily dose is 200 mg/20 mg. The balance of risks and benefits should be carefully considered before commencing treatment with 200 mg/20 mg daily, and higher doses are not recommended (see section 4.4).
Ketoprofen/Omeprazole is not recommended for use in children below 15 years due to a lack of data on safety and efficacy.
In elderly patients, patients with renal impairment (creatinine clearance 30-50 ml/min), hepatic impairment or congestive heart failure, the starting dose is 100 mg/ 20mg. This may be increased incremently to a maximum dose of 200 mg/20 mg per day depending on the clinical response.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
4.3 Contraindications
• hypersensitivity to ketoprofen or to omeprazole or to any of the excipients
• last trimester of pregnancy (see section 4.6)
• history of asthma induced by administration of ketoprofen or similar acting substances, such as other non-steroidal anti-inflammatory agents (NSAIDs) or acetylsalicylic acid
• severe hepatic failure
• severe renal failure
• severe heart failure
• active peptic ulcer
• gastrointestinal bleeding, cerebrovascular bleeding or other active bleeding
• Concomitant use with St. John's Wort or atazanavir sulphate (see section 4.5)
• Combination therapy with clarithromycin should not be used in patients with hepatic impairment (see section 4.5)
4.4 Special Warnings And Precautions For Use
Linked to Ketoprofen component
The use of Axorid with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Elderly: the elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2).
Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.
Some epidemiological evidence suggests that ketoprofen may be associated with a high risk of serious gastrointestinal toxicity, relative to some other NSAIDs, especially at high doses (see also section 4.2 and 4.3).
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), in patients with a platelet function disorder and in the elderly. These patients should commence treatment on the lowest dose available.
Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).
The association with omeprazole allows to decrease gastrointestinal toxicity. Nevertheless gastrointestinal haemorrhage or ulcers/perforations can occur at any time in the course of treatment. They are not necessarily preceded by premonitory signs and can occur in patients with no history of such manifestations. They have to be closely monitored.
When GI bleeding occurs in patients receiving Axorid, the treatment should be withdrawn.
NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).
Patients with asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis are more likely to exhibit allergic reactions after taking acetylsalicylic acid and/or non-steroidal anti-inflammatory agents than the general population. Administration of this product may induce an attack of asthma (see section 4.3).
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for ketoprofen.
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ketoprofen after careful consideration. Similar consideration should be made before initiating longer-term treatment of the patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Urine output and renal function should be closely monitored in patients with renal or hepatic impairment, in patients on diuretic treatment, following major surgery which involved hypovolaemia, and particularly in the elderly.
In the elderly, as half-life of NSAIDs is longer, doses should be reduced (see section 4.2).
During long-term treatment, monitoring of blood count and hepatic and renal function is recommended.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of the therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Axorid should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.
Patients with a previous history of photosensitivity or phototoxicity reactions should be carefully monitored.
Ketoprofen, as any other NSAID, may mask symptoms of an underlying infectious disease.
Ketoprofen component in Axorid is a prolonged-release formulation, therefore this treatment is not suitable when a quick onset of efficacy at the beginning of the treatment is required.
Linked to Omeprazole component
Decreased gastric acidity increases gastric counts of bacteria normally present in the gastro-intestinal tract. Treatment with acid-reducing medicinal products leads to a slightly increased risk of gastrointestinal infections, such as Salmonella and Campylobacter.
In patients with severe impaired hepatic function, liver enzyme values should be checked periodically during treatment with omeprazole.
During concomitant regimens with omeprazole and other medicinal products caution should be exercised when administering additional medicinal products as interactions might occur (see section 4.5). This is particularly important with products with a narrow therapeutic index such as warfarin and phenytoin. Levels of these should be measured as a dose reduction may be needed. Levels of ciclosporin may be increased and therefore plasma levels should be monitored (see section 4.5).
Although not known with oral omeprazole, blindness and deafness have been reported with the injectable form; therefore, in severely ill patients, monitoring of visual and auditory senses is recommended.
Reactions to excipients
This product contains sucrose and patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this product.
The omeprazole formulation contains parahydroxybenzoates and may cause allergic reactions (possibly delayed).
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Linked to ketoprofen component
Certain substances or therapeutic classes have a potential to contribute to the occurrence of hyperkalaemia: potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), heparins (of low molecular weight or non-fractionated), cyclosporin and tacrolimus, and trimethoprim.
The occurrence of hyperkalaemia may depend upon the existence of a combination of factors.
This risk is increased by combined administration of the above-named substances.
Concomitant administration of ketoprofen with the following products calls for strict monitoring. If the combination can not be avoided, close clinical observation and monitoring of laboratory values are required.
Concomitant use not recommended
Other NSAIDs (including salicylates at high doses): increased risk of gastrointestinal ulcer and haemorrhage (due to additive synergic effects).
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin or heparin (see section 4.4).
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of a gastrointestinal bleeding (see section 4.4).
Lithium: elevation of the blood lithium levels, which may attain toxic levels (via reduced renal excretion of lithium).
If necessary, blood lithium levels should be closely monitored and the dosage of lithium adjusted during the combined treatment and after withdrawal of the NSAID.
Methotrexate (at doses above 15 mg/week):
Increased haematotoxicity of methotrexate (due to a reduction of renal clearance of methotrexate by anti-inflammatory agents in general and displacement of methotrexate from its plasma protein binding sites by NSAIDs).
Methotrexate should not be administered less than 12 hours before the start or after the end of a ketoprofen treatment.
Combinations to be administered with precaution
Diuretics, angiotensin converting enzyme inhibitors: acute renal failure in dehydrated patients (reduced glomerular filtration due to decreased renal prostaglandin synthesis).
Additionally, the antihypertensive effect is reduced.
The patient should be hydrated and renal function monitored at the start of treatment.
Methotrexate at low doses (less than 15 mg/week): increased haematotoxicity of methotrexate (due to a reduction of renal clearance of methotrexate by anti-inflammatory agents in general and displacement of methotrexate from its plasma protein binding sites).
Weekly monitoring of blood count is recommended during the first weeks of combined treatment.
Closer observation is necessary in the event of any (even mild) impairment of renal function and in elderly subjects.
Pentoxifylline: increased risk of haemorrhage.
Clinical observation should be increased and bleeding time monitored more frequently.
Zidovudine: risk of increased toxic effects on red blood cells (effect on the reticulocytes), with onset of severe anaemia eight days after the start of the NSAID treatment.
Full blood count and reticulocytes count are recommended eight to 15 days after the start of the NSAID treatment.
Beta-blockers (by extrapolation from reported interaction with indomethacin): reduced antihypertensive effect (inhibition of vasodilator prostaglandins by NSAIDs).
Ciclosporin, tacrolimus: risk of additive nephrotoxic effects, particularly in elderly subjects.
Intrauterine contraceptive device: there is a controversial possibility of decreased efficacy of the intrauterine contraceptive device.
Thrombolytics: increased risk of haemorrhage.
Linked to omeprazole component
Contraindications of concomitant use (see section 4.3)
St. John's Wort: potential clinically significant decrease in omeprazole plasma concentrations.
Atazanavir: reduction in atazanavir exposure levels.
Clarithromycin: increase of plasma concentrations of omeprazole and clarithromycin in patients with hepatic impairment.
Combinations to be administered with precaution
Medicinal products metabolized by cytochrome P450: omeprazole is metabolised in the liver through cytochrome P450 isoforms (mainly CYP 2C19, S-mephenytoin hydroxylase) and inhibits enzymes of the CYP2C subfamily (CYP 2C19 and CYP 2C9) and can delay the elimination of other active substances metabolised by these enzymes. This has been observed for phenytoin and warfarin and benzodiazepines such as diazepam, triazolam and flurazepam. Periodic monitoring of patients receiving warfarin or phenytoin is recommended and a reduction of warfarin or phenytoin dose may be necessary. Other active substances that could be affected are hexabarbital, citalopram, imipramine, and clomipramine. Omeprazole may inhibit the hepatic metabolism of disulfiram with some possibly related cases of muscular rigidity reported.
Ciclosporin: the plasma levels of ciclosporin should be monitored in the patients treated with omeprazole, as an increase in ciclosporin levels is possible.
Digoxin: simultaneous treatment with omeprazole and digoxin in healthy subjects led to a 10 % increase in the bioavailability of digoxin as a result of increased gastric pH.
Ketoconazole, itraconazole: due to the decreased intragastric acidity, the absorption of ketoconazole or itraconazole may be reduced during omeprazole treatment.
Vitamin B12: omeprazole may reduce the oral absorption of vitamin B12. This should be taken into account in patients with low basal levels who undergo a long-term treatment with omeprazole.
There is no evidence of an interaction of omeprazole with caffeine, propranolol, theophylline, metoprolol, lidocaine, quinidine, phenacetin, estradiol, amoxicillin, budesonide, diclofenac, metronidazole, naproxen, piroxicam, or antacids. The absorption of omeprazole is not affected by alcohol.
4.6 Pregnancy And Lactation
Pregnancy
Clinical experience of use in pregnancy is limited.
During the last trimester of pregnancy, all prostaglandin synthesis inhibitors might
• expose the fetus to:
o cardiopulmonary toxicity (pulmonary hypertension with premature closure of the ductus arteriosus)
o renal dysfunction which might progress to renal failure with oligoamnios
• expose the mother and child, at the end of pregnancy, to possible prolongation of bleeding time
• inhibit uterine contractions and delay/prolong delivery
Consequently, Axorid should be administered only if necessary during the first two trimesters of pregnancy. With the exception of very restricted obstetrical uses that require specialised monitoring, Axorid is contraindicated in the last trimester of pregnancy.
Lactation
Since NSAIDs and omeprazole are excreted in breast milk, their use should be avoided during breast-feeding as a precautionary measure.
Fertility
The use of ketoprofen, as with any drug known to inhibit cyclooxygenase / prostaglandin synthesis, might impair fertility and is not recommended in women attempting to conceive. In women who have difficulty conceiving or who are undergoing investigation of infertility, withdrawal of ketoprofen should be considered.
4.7 Effects On Ability To Drive And Use Machines
Dizziness and drowsiness are common reactions associated with ketoprofen and omeprazole. Visual disturbances (see section 4.8) have also been reported. If patients are affected they should not drive, operate machinery or take part in activities where these symptoms could put themselves or others at risk.
4.8 Undesirable Effects
Linked to ketoprofen component
The most commonly-observed adverse events are gastrointestinal in nature.
Oedema, hypertension and cardiac failure, have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4)
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Linked to omeprazole component
Some of the common reactions such as sleepiness, insomnia, vertigo and headache, GI symptoms, improve during continued therapy.
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4.9 Overdose
Symptoms
Linked to ketoprofen component
In adults and adolescents, the main signs of overdose are headache, dizziness, drowsiness, nausea, vomiting, diarrhoea and abdominal pain. In serious intoxication, hypotension, respiratory depression and gastrointestinal haemorrhage have been observed.
Linked to omeprazole component
There have been rare reports of omeprazole overdoses up to 2,400 mg as a single oral dose. Symptoms including nausea, vomiting, dizziness, abdominal pain, diarrhoea, headache, apathy, depression and confusion have been reported. However, these were transient and without serious outcome and no specific treatment was needed.
Management of overdose due to ketoprofen
The patient should be transferred immediately to a specialised hospital unit where symptomatic treatment should be instituted. Owing to the slow release characteristics of the product, ketoprofen will continue to be absorbed 16 hours after ingestion.
Evacuation of gastric content or administration of activated charcoal may be performed in order to reduce the absorption of ketoprofen.
There is no specific antidote.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Propionic acid derivates: ATC Code: M01AE53, associated to a proton pump inhibitor.
Ketoprofen is a non-steroidal anti-inflammatory agent of the propionic group, derived from arylcarboxylic acid.
It has the following properties:
• analgesic activity
• antipyretic activity
• anti-inflammatory activity
• inhibition of platelet functions
All these properties result from the reduction of prostaglandin synthesis by inhibition of the cyclo-oxygenase pathway.
Omeprazole, a substituted benzimidazole, is a gastric proton pump inhibitor, directly and dose-dependently inhibiting the enzyme H+,K+-ATPase, so blocking the final step of acid production from gastric parietal cells. It inhibits both basal and stimulated acid secretion, irrespective of the type of stimulus, increasing the pH-value and reducing the volume of the gastric acid secretion. It has low affinity for other membrane-bound receptors (such as the histamine H2, muscarine M1 or gastrinergic receptors).
Omeprazole is a pro-drug and, as a weak base, accumulates in the acid environment of the parietal cells and will only become effective after being protonised and rearranged. In an acid environment (pH of less than 4) the protonised omeprazole is converted to the active metabolite - omeprazole sulphonamide which covalently binds to the proton pump. The duration of the inhibition of acid secretion is therefore substantially longer than the period in which omeprazole-base is present in plasma. The degree of inhibition of acid secretion is directly correlated to the area under the plasma concentration-time curve (AUC) but not to the plasma concentration at any given time.
5.2 Pharmacokinetic Properties
Axorid includes a prolonged-release form of ketoprofen and a gastroresistant release form of omeprazole, both suitable for a once-a-day therapeutic dosage regimen.
Pharmacokinetic profiles of ketoprofen and omeprazole components in Axorid are comparable to those of ketoprofen and omeprazole components administered separately.
Ketoprofen
Absorption
After oral administration, ketoprofen is almost completely absorbed from the intestinal tract but undergoes first-pass metabolism.
A maximum plasma concentration of about 4.5 µg/ml is attained about 6 hours after administration of a dose of 200 mg; levels are found at the 24th hour. The product does not accumulate after repeated administration in the course of treatment.
The degree of absorption is not influenced by concomitant food intake.
Distribution
Ketoprofen prolonged-release formulation procures continuous, regular impregnation with ketoprofen.
Ketoprofen is 99 % bound to plasma proteins.
Ketoprofen diffuses into synovial fluid, where levels higher than the serum concentrations are found more than 4 hours after oral administration.
It crosses the placental barrier.
Metabolism
Two processes are involved in the biotransformation of ketoprofen: one very minor (hydroxylation), and the other largely predominant (conjugation with glucuronic acid).
Less than 1 % of the dose of ketoprofen administered is recovered in unchanged form in the urine, whereas the glucuronide metabolite accounts for about 65 to 75 %.
Excretion
The drug is excreted as metabolites essentially by the urinary route. The rate of excretion is rapid, since 50 % of the dose administered is eliminated in the first 6 hours, regardless of the route of administration. The prolonged-release form does not alter the renal excretion processes.
The half-life for the terminal elimination phase is about 7 hours.
In the 5 days after oral administration, 75 to 90 % of the dose is excreted by the kidneys and 1 to 8 % in the faeces.
Populations at risk
The elimination of ketoprofen is decreased in the elderly and the half-life is prolonged.
The half-life in patients with renal insufficiency increases with the severity of the impairment (see section 4.2).
Omeprazole
Absorption and Distribution
Omeprazole is acid labile and is formulated as gastroresistant granules. Absorption takes place in the small intestine with peak plasma concentrations of omeprazole occurring within 1 to 3 hours after oral administration. Absolute bioavailability is about 30-40 % at doses of 20-40 mg. The distribution volume of omeprazole in the body is relatively small (0.3 l/kg of body weight) and corresponds to that of the extracellular fluid and approximately 95% is protein bound.
After intravenous administration of 40 mg omeprazole for 5 days, the absolute measured bioavailability increased by about 50 %; this can be explained by decreased hepatic clearance due to saturation of the CYP2C19 enzyme.
Concomitant administration with food
Concomitant administration of food delays omeprazole absorption with lower peak concentrations but without affecting bioavailability.
Metabolism
Omeprazole is entirely metabolised, mainly in the liver by CYP 2C19. A small percentage of the patients lack a functional CYP2C19 enzyme and have reduced elimination rate of omeprazole. The sulphone, sulphide and hydroxy-omeprazole metabolites are found in plasma but have no significant effect on acid secretion.
About 20% of administered dose is excreted in faeces and the remaining 80% is excreted in urine as metabolites (mainly hydroxy-omeprazole and the corresponding carboxylic acid).
Elimination
The plasma half-life is about 40 minutes, and the total plasma clearance is 0.3 to 0.6 l/min. In a small percentage of the patients (CYP 2 C19 poor metabolisers) a reduced elimination rate of omeprazole has been observed. In these cases, the terminal elimination half-life can be approximately 3 times as long as the normal value, and the area under the plasma concentration-time curve (AUC) can increase by up to 10 fold.
Pharmacokinetics in the elderly
The bioavailability of omeprazole is slightly elevated in the elderly and the elimination rate slightly diminished, but individual values are nearly equal to that of young healthy subjects and there is no indication that elderly patients on therapeutic doses of omeprazole are at increased risk of increased adverse effects
Pharmacokinetics in renal impairment
In patients with renal impairment, the kinetics of omeprazole was very similar to that in healthy subjects. But, as renal elimination is the most important excretory pathway for metabolised omeprazole, the elimination rate is reduced corresponding to the degree of renal function reduction.
Pharmacokinetics in hepatic impairment
In patients with chronic hepatic disease the clearance of omeprazole is reduced, and the plasma half-life can increase up to approximately 3 hours. The bioavailability can then be greater than 90%. 20 mg of omeprazole once daily for 4 weeks was tolerated well, and no accumulation of omeprazole or its metabolites was observed.
5.3 Preclinical Safety Data
No preclinical data on the combination of active substances are available.
Ketoprofen
In several in vitro and in vivo mutagenicity tests ketoprofen had no significant positive effects. Long-term experiments in rats and mice showed no evidence of a carcinogenic potential of ketoprofen.
Experiments in various animal species showed no evidence of a teratogenic effect of ketoprofen.
From 6 mg/kg/day, ketoprofen resulted in an impairment of implantation and fertility in female rats.
Omeprazole
Preclinical data reveal no special hazards for humans based on conventional studies of repeated dose toxicity, toxicity to reproduction or genotoxicity. Gastric enterochromaffin-like-cell hyperplasia and carcinoids have been observed in life-long studies in rats treated with omeprazole or subjected to partial fundectomy. These changes are the result of sustained hypergastrinaemia secondary to acid inhibition.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Capsule contents:
Sucrose
Maize starch
Hypromellose
Dimethicone emulsion (containing propyl-p-hydroxybenzoate (E216), methyl-p-hydroxybenzoate (E218), sorbic acid, sodium benzoate, polysorbate 20, octylphenoxy polyethoxy ethanol and propylene glycol)
Polysorbate 80
Mannitol
Diacetylated monoglycerides
Talc
Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%
Polyacrylate dispersion 30%
Ammonio methacrylate copolymer type A
Ammonio methacrylate copolymer type B
Triethyl citrate
Stearoyl macrogolglycerides
Colloidal anhydrous silica
Capsule shell:
Yellow iron oxide (E 172) in 100 mg/20 mg capsules only
Titanium dioxide (E 171)
Gelatin
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
18 months.
6.4 Special Precautions For Storage
Do not store above 25°C.
Store in the original container in order to protect from moisture.
6.5 Nature And Contents Of Container
Polyethylene bottles with a tamper evident polypropylene screw cap containing silica gel desiccant, packed in cardboard boxes. Pack sizes: 10, 28 or 30 capsules.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Meda Pharmaceuticals Ltd.
Skyway House,
Parsonage Road,
Takeley,
Bishop's Stortford,
CM22 6PU,
United Kingdom
8. Marketing Authorisation Number(S)
Axorid 100 mg/20 mg: PL 15142/0090
Axorid 200 mg/20 mg: PL 15142/0092
9. Date Of First Authorisation/Renewal Of The Authorisation
23/2/2009
10. Date Of Revision Of The Text
28/10/2010
Droxol
Droxol may be available in the countries listed below.
Ingredient matches for Droxol
Sulfamethoxazole
Sulfamethoxazole is reported as an ingredient of Droxol in the following countries:
- Peru
Trimethoprim
Trimethoprim is reported as an ingredient of Droxol in the following countries:
- Peru
International Drug Name Search
Nortifen
Nortifen may be available in the countries listed below.
Ingredient matches for Nortifen
Ketotifen
Ketotifen fumarate (a derivative of Ketotifen) is reported as an ingredient of Nortifen in the following countries:
- Indonesia
International Drug Name Search
Josezon
Josezon may be available in the countries listed below.
Ingredient matches for Josezon
Pentazocine
Pentazocine is reported as an ingredient of Josezon in the following countries:
- Ethiopia
International Drug Name Search
Fenoprofene
Fenoprofene may be available in the countries listed below.
Ingredient matches for Fenoprofene
Fenoprofen
Fenoprofene (DCIT) is known as Fenoprofen in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
Click for further information on drug naming conventions and International Nonproprietary Names.
Ontak
Pronunciation: DEN-i-loo-kin DIF-ti-toks
Generic Name: Denileukin Diftitox
Brand Name: Ontak
Ontak is used for:
Treating certain kinds of lymphoma. It may also be used for other conditions as determined by your doctor.
Ontak is an anticancer agent called a fusion protein. It works by interfering with the growth of cancer cells, which results in the death of the cells.
Do NOT use Ontak if:
- you are allergic to any ingredient in Ontak, including diphtheria toxin or interleukin-2
Contact your doctor or health care provider right away if any of these apply to you.
Before using Ontak:
Some medical conditions may interact with Ontak. 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 heart disease or low blood levels of albumin
Some MEDICINES MAY INTERACT with Ontak. However, no specific interactions with Ontak are known at this time.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ontak 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 Ontak:
Use Ontak as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ontak is usually administered as an infusion at your doctor's office, hospital, or clinic. Ask your doctor or pharmacist any questions that you may have about Ontak.
- Do not shake; mix solution by gently swirling it.
- If Ontak contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
- If nausea, vomiting, diarrhea, or loss of appetite occurs, do not discontinue your medicine. Ask your doctor or pharmacist for ways to lessen these effects.
- Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
- If you miss a dose of Ontak, contact your doctor immediately.
Ask your health care provider any questions you may have about how to use Ontak.
Important safety information:
- Ontak may cause dizziness or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ontak. Using Ontak alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Ontak may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Notify your doctor of any signs of infection, including fever, sore throat, rashes, or chills.
- Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Ontak.
- LAB TESTS, including complete blood cell counts, blood chemistry, liver function, kidney function, blood pressure, and serum albumin, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
- Use Ontak with caution in the ELDERLY because they may be more sensitive to its effects.
- Use Ontak with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Ontak during pregnancy. It is unknown if Ontak is excreted in breast milk. Do not breast-feed while taking Ontak.
Possible side effects of Ontak:
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:
Abnormal skin sensations; confusion; constipation; cough; diarrhea; dizziness; headache; indigestion; injection site reaction; lightheadedness; loss of appetite; muscle or joint aches; nausea; nervousness; pain; runny nose; sleeplessness; sweating; vomiting; weakness; weight loss.
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); back pain; chest pain; difficulty swallowing; fainting; fast or irregular heartbeat; flu-like symptoms (eg, fever, chills, sore throat); leg pain; severe diarrhea with nausea and vomiting; sudden unusual weight gain; swelling of the hands, legs, or ankles; vision changes (eg, loss of color vision).
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: Ontak 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 Ontak:
Store Ontak frozen at or below 14 degrees F (−10 degrees C). The vials may be thawed in the refrigerator at 36 to 46 degrees F (2 to 8 degrees C) for not more than 24 hours or at room temperature for 1 to 2 hours. Ontak MUST NOT BE HEATED. Do not refreeze. Once diluted, the prepared solutions should be administered within 6 hours. Unused portions should be properly discarded immediately. Keep Ontak out of the reach of children and away from pets.
General information:
- If you have any questions about Ontak, please talk with your doctor, pharmacist, or other health care provider.
- Ontak 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 Ontak. 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 Ontak resources
- Ontak Side Effects (in more detail)
- Ontak Use in Pregnancy & Breastfeeding
- Ontak Drug Interactions
- Ontak Support Group
- 0 Reviews for Ontak - Add your own review/rating
- Ontak Prescribing Information (FDA)
- Ontak Advanced Consumer (Micromedex) - Includes Dosage Information
- Ontak Concise Consumer Information (Cerner Multum)
- Ontak Monograph (AHFS DI)
- Denileukin Diftitox Professional Patient Advice (Wolters Kluwer)
Compare Ontak with other medications
- Lymphoma
fosinopril
Generic Name: fosinopril (foe SIN oh pril)
Brand Names: Monopril
What is fosinopril?
Fosinopril is in a group of drugs called ACE inhibitors. ACE stands for angiotensin converting enzyme.
Fosinopril is used to treat high blood pressure (hypertension) or heart failure.
Fosinopril may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about fosinopril?
Do not use this medication without telling your doctor if you are pregnant or planning a pregnancy. Fosinopril could cause birth defects in the baby if you take the medication during pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.
Avoid taking an antacid within 2 hours before or after you take fosinopril.
Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of fosinopril. Do not use salt substitutes or potassium supplements while taking fosinopril, unless your doctor has told you to.
Vomiting, diarrhea, or heavy sweating can cause you to become dehydrated. This can lead to very low blood pressure, electrolyte disorders, or kidney failure while you are taking fosinopril. Drink plenty of water daily while you are taking this medication.
What should I discuss with my healthcare provider before taking fosinopril?
You should not use this medication if you are allergic to fosinopril or to any other ACE inhibitor, such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik).
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use fosinopril:
kidney disease (or if you are on dialysis);
liver disease;
heart disease or congestive heart failure;
diabetes;
a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, lupus, scleroderma, or rheumatoid arthritis; or
if you have ever had a severe allergic reaction.
FDA pregnancy category D. Do not use this medication without telling your doctor if you are pregnant or planning a pregnancy. Fosinopril could cause birth defects in the baby if you take the medication during pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment. Fosinopril 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. Do not give this medication to a child younger than 6 years old.
How should I take fosinopril?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results from this medication.
Take each dose with a full glass of water.
Fosinopril can be taken with or without food.
Vomiting, diarrhea, or heavy sweating can cause you to become dehydrated. This can lead to very low blood pressure, electrolyte disorders, or kidney failure while you are taking fosinopril. Drink plenty of water each day while you are taking this medication.
To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled visits to your doctor.
If you need to have any type of surgery, tell the surgeon ahead of time that you are taking fosinopril. You may need to stop using the medicine for a short time.
This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using fosinopril.
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.
Store fosinopril at room temperature away from moisture and heat.
See also: Fosinopril dosage (in more detail)
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Overdose symptoms may include feeling extremely dizzy or light-headed, or fainting.
What should I avoid while taking fosinopril?
Avoid taking an antacid within 2 hours before or after you take fosinopril.
Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of fosinopril. Do not use salt substitutes or potassium supplements while taking fosinopril, unless your doctor has told you to.
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.
Fosinopril 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 light-headed, fainting;
urinating less than usual, or not at all;
fever, chills, body aches, flu symptoms;
severe blistering, peeling, and red skin rash;
pale skin, easy bruising or bleeding, unusual weakness;
pounding or uneven heartbeats;
slow heart rate, weak pulse, muscle weakness, tingly feeling;
jaundice (yellowing of the skin or eyes);
chest pain; or
swelling, rapid weight gain.
Less serious side effects may include:
cough;
muscle or joint pain;
dizziness, headache, tired feeling;
runny or stuffy nose;
nausea, vomiting, diarrhea; or
mild skin itching or rash.
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.
Fosinopril Dosing Information
Usual Adult Dose for Hypertension:
Initial dose: 10 mg orally once a day, both as monotherapy and when the drug is added to a diuretic.
Maintenance dose: 20 to 40 mg orally once a day.
Some patients appear to have a further response to 80 mg.
Usual Adult Dose for Left Ventricular Dysfunction:
Initial dose: 10 mg orally once a day (5 mg if volume depleted or hypotensive).
Maintenance dose: 20 to 40 mg orally once a day.
Dosage should be increased, over a several week period, to a dose that is maximal and tolerated but not exceeding 40 mg once a day.
Usual Adult Dose for Diabetic Nephropathy:
Initial dose: 10 mg orally once a day.
What other drugs will affect fosinopril?
Before taking fosinopril, tell your doctor if you are taking any of the following drugs:
gold injections to treat arthritis;
lithium (Lithobid, Eskalith);
a potassium supplement such as K-Dur, Klor-Con;
salt substitutes that contain potassium; or
a diuretic (water pill).
This list is not complete and there may be other drugs that can interact with fosinopril. 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 fosinopril resources
- Fosinopril Side Effects (in more detail)
- Fosinopril Dosage
- Fosinopril Use in Pregnancy & Breastfeeding
- Drug Images
- Fosinopril Drug Interactions
- Fosinopril Support Group
- 2 Reviews for Fosinopril - Add your own review/rating
- fosinopril Advanced Consumer (Micromedex) - Includes Dosage Information
- Fosinopril Prescribing Information (FDA)
- Fosinopril MedFacts Consumer Leaflet (Wolters Kluwer)
- Fosinopril Sodium Monograph (AHFS DI)
- Monopril Prescribing Information (FDA)
- Monopril Consumer Overview
Compare fosinopril with other medications
- Diabetic Kidney Disease
- High Blood Pressure
- Left Ventricular Dysfunction
Where can I get more information?
- Your pharmacist can provide more information about fosinopril.
See also: fosinopril side effects (in more detail)
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