Glamin may be available in the countries listed below.
Ingredient matches for Glamin
Amoxicillin
Amoxicillin is reported as an ingredient of Glamin in the following countries:
- Slovenia
International Drug Name Search
Wednesday, September 28, 2016
Ramipril 10 mg Tablets
1. Name Of The Medicinal Product
Ramipril 10 mg Tablets
2. Qualitative And Quantitative Composition
Each tablet contains 10 mg ramipril.
Excipients:
Each tablet contains 43.4 mg lactose monohydrate.
For a full list of excipients, see Section 6.1
3. Pharmaceutical Form
Tablet
White to almost white coloured, flat faced bevel edged oblong uncoated tablet debossed with “H” and “20” on either side of the scoreline on one side and scoreline on the other side. The tablet can be divided into two equal halves.
4. Clinical Particulars
4.1 Therapeutic Indications
- Treatment of hypertension
- Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:
• manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or
• diabetes with at least one cardiovascular risk factor (see section 5.1).
- Treatment of renal disease:
• Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria,
• Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1).
• Manifest glomerular non diabetic nephropathy as defined by macroproteinuria
- Treatment of symptomatic heart failure.
- Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction.
4.2 Posology And Method Of Administration
Oral use.
This strength is not suitable for dosages below 5 mg
For doses < 2.5 mg/day Ramipril is not suitable. Other medicinal products of ramipril in adequate strength are available.
It is recommended that Ramipril is taken each day at the same time of the day.
Ramipril can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2).
Ramipril has to be swallowed with liquid. It must not be chewed or crushed.
Adults
Diuretic-Treated patients
Hypotension may occur following initiation of therapy with Ramipril; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted.
If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with Ramipril (see section 4.4).
In hypertensive patients in whom the diuretic is not discontinued, therapy with Ramipril should be initiated with a 1.25mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of Ramipril should be adjusted according to blood pressure target.
Hypertension
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Ramipril may be used in monotherapy or in combination with other classes of antihypertensive medicinal products.
Starting dose
Ramipril should be started gradually with an initial recommended dose of 2.5 mg daily.
Patients with a strongly activated renin-angiotensin-aldosterone system may experience an excessive drop in blood pressure following the initial dose. A starting dose of 1.25 mg is recommended in such patients and the initiation of treatment should take place under medical supervision (see section 4.4).
Titration and maintenance dose:
The dose can be doubled at interval of two to four weeks to progressively achieve target blood pressure; the maximum permitted dose of Ramipril is 10 mg daily. Usually the dose is administered once daily.
Cardiovascular prevention
Starting dose
The recommended initial dose is 2.5 mg of Ramipril once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose should be gradually increased. It is recommended to double the dose after one or two weeks of treatment and – after another two to three weeks - to increase it up to the target maintenance dose of 10mg Ramipril once daily.
See also posology on diuretic treated patients above.
Treatment of renal disease
In patients with diabetes and microalbuminuria:
Starting dose:
The recommended initial dose is 1.25 mg of Ramipril once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the once daily dose to 2.5 mg after two weeks and then to 5 mg after a further two weeks is recommended.
In patients with diabetes and at least one cardiovascular risk
Starting dose:
The recommended initial dose is 2.5 mg of Ramipril once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the daily dose to 5 mg Ramipril after one or two weeks and then to 10 mg Ramipril after a further two or three weeks is recommended. The target daily dose is 10 mg.
In patients with non- diabetic nephropathy as defined by macroproteinuria
Starting dose:
The recommended initial dose is 1.25 mg of Ramipril once daily.
Titration and maintenance dose
Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the once daily dose to 2.5 mg after two weeks and then to 5 mg after a further two weeks is recommended.
Symptomatic heart failure
Starting dose
In patients stabilized on diuretic therapy, the recommended initial dose is 1.25 mg daily.
Titration and maintenance dose
Ramipril should be titrated by doubling the dose every one to two weeks up to a maximum daily dose of 10 mg. Two administrations per day are preferable.
Secondary prevention after acute myocardial infarction and with heart failure
Starting dose
After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5 mg twice daily for three days. If the initial 2.5 mg dose is not tolerated a dose of 1.25 mg twice a day should be given for two days before increasing to 2.5 mg and 5 mg twice a day. If the dose cannot be increased to 2.5 mg twice a day the treatment should be withdrawn.
See also posology on diuretic treated patients above.
Titration and maintenance dose
The daily dose is subsequently increased by doubling the dose at intervals of one to three days up to the target maintenance dose of 5 mg twice daily.
The maintenance dose is divided in 2 administrations per day where possible.
If the dose cannot be increased to 2.5 mg twice a day treatment should be withdrawn. Sufficient experience is still lacking in the treatment of patients with severe (NYHA IV) heart failure immediately after myocardial infarction. Should the decision be taken to treat these patients, it is recommended that therapy be started at 1.25 mg once daily and that particular caution be exercised in any dose increase.
Special populations
Patients with renal impairment
Daily dose in patients with renal impairment should be based on creatinine clearance (see section 5.2):
- if creatinine clearance is
- if creatinine clearance is between 30-60 ml/min, it is not necessary to adjust the initial dose (2.5 mg/day); the maximal daily dose is 5 mg;
- if creatinine clearance is between 10-30 ml/min, the initial dose is 1.25 mg/day and the maximal daily dose is 5 mg;
- in haemodialysed hypertensive patients: ramipril is slightly dialysable; the initial dose is 1.25 mg/day and the maximal daily dose is 5 mg; the medicinal product should be administered few hours after haemodialysis is performed.
Patients with hepatic impairment (see section 5.2)
In patients with hepatic impairment, treatment with Ramipril must be initiated only under close medical supervision and the maximum daily dose is 2.5 mg Ramipril.
Elderly
Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects especially in very old and frail patients. A reduced initial dose of 1.25 mg ramipril should be considered.
Paediatric population
Ramipril is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
4.3 Contraindications
• Hypersensitivity to ramipril, to any of the excipients or any other ACE (Angiotensin Converting Enzyme) inhibitors (see section 6.1)
• History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or AIIRAs)
• Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5)
• Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
• 2nd and 3rd trimester of pregnancy (see sections 4.4 and 4.6)
• Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.
4.4 Special Warnings And Precautions For Use
Special populations
Pregnancy: ACE inhibitors such as ramipril, or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy. Unless continued ACE inhibitor/ AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors/ AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
• Patients at particular risk of hypotension
- Patients with strongly activated renin-angiotensin-aldosterone system
Patients with strongly activated renin-angiotensin-aldosterone system are at risk of an acute pronounced fall in blood pressure and deterioration of renal function due to ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is given for the first time or at first dose increase.
Significant activation of renin-angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in:
- patients with severe hypertension
- patients with decompensated congestive heart failure
- patients with haemodynamically relevant left ventricular inflow or outflow impediment (e.g. stenosis of the aortic or mitral valve)
- patients with unilateral renal artery stenosis with a second functional kidney
- patients in whom fluid or salt depletion exists or may develop (including patients with diuretics)
- patients with liver cirrhosis and/or ascites
- patients undergoing major surgery or during anaesthesia with agents that produce hypotension.
Generally, it is recommended to correct dehydration, hypovolaemia or salt depletion before initiating treatment (in patients with heart failure, however, such corrective action must be carefully weighed out against the risk of volume overload).
- Transient or persistent heart failure post MI
- Patients at risk of cardiac or cerebral ischemia in case of acute hypotension
The initial phase of treatment requires special medical supervision.
• Elderly patients
See section 4.2.
Surgery
It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery.
Monitoring of renal function
Renal function should be assessed before and during treatment and dosage adjusted especially in the initial weeks of treatment. Particularly careful monitoring is required in patients with renal impairment (see section 4.2). There is a risk of impairment of renal function, particularly in patients with congestive heart failure or after a renal transplant.
Angioedema
Angioedema has been reported in patients treated with ACE inhibitors including ramipril (see section 4.8).
In case of angioedema, Ramipril must be discontinued.
Emergency therapy should be instituted promptly. Patient should be kept under observation for at least 12 to 24 hours and discharged after complete resolution of the symptoms.
Intestinal angioedema has been reported in patients treated with ACE inhibitors including Ramipril (see section 4.8). These patients presented with abdominal pain (with or without nausea or vomiting).
Anaphylactic reactions during desensitization
The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens are increased under ACE inhibition. A temporary discontinuation of Ramipril should be considered prior to desensitization.
Hyperkalaemia
Hyperkalaemia has been observed in some patients treated with ACE inhibitors including Ramipril. Patients at risk for development of hyperkalaemia include those with renal insufficiency, age (> 70 years), uncontrolled diabetes mellitus, or those using potassium salts, potassium retaining diuretics and other plasma potassium increasing active substances, or conditions such as dehydration, acute cardiac decompensation, metabolic acidosis. If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended (see section 4.5).
Neutropenia/agranulocytosis
Neutropenia/agranulocytosis, as well as thrombocytopenia and anaemia, have been rarely seen and bone marrow depression has also been reported. It is recommended to monitor the white blood cell count to permit detection of a possible leucopoenia. More frequent monitoring is advised in the initial phase of treatment and in patients with impaired renal function, those with concomitant collagen disease (e.g. lupus erythematosus or scleroderma), and all those treated with other medicinal products that can cause changes in the blood picture (see sections 4.5 and 4.8).
Ethnic differences
ACE inhibitors cause higher rate of angioedema in black patients than in non black patients.
As with other ACE inhibitors, ramipril may be less effective in lowering blood pressure in black people than in non black patients, possibly because of a higher prevalence of hypertension with low renin level in the black hypertensive population.
Cough
Cough has been reported with the use of ACE inhibitors. Characteristically, the cough is nonproductive, persistent and resolves after discontinuation of therapy. ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Contra-indicated combinations
Extracorporeal treatments leading to contact of blood with negatively charged surfaces such as dialysis or haemofiltration with certain high-flux membranes (e.g. polyacrylonitril membranes) and low density lipoprotein apheresis with dextran sulphate due to increased risk of severe anaphylactoid reactions (see section 4.3). If such treatment is required, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.
Precautions for use
Potassium salts, heparin, potassium-retaining diuretics and other plasma potassium increasing active substances (including Angiotensin II antagonists, trimethoprim, tacrolimus, ciclosporin):
Hyperkalaemia may occur, therefore close monitoring of serum potassium is required.
Antihypertensive agents (e.g. diuretics) and other substances that may decrease blood pressure (e.g. nitrates, tricyclic antidepressants, anaesthetics, acute alcohol intake, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin): Potentiation of the risk of hypotension is to be anticipated (see section 4.2 for diuretics)
Vasopressor sympathomimetics and other substances (e.g. isoproterenol, dobutamine, dopamine, epinephrine) that may reduce the antihypertensive effect of Ramipril: Blood pressure monitoring is recommended.
Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count: Increased likelihood of haematological reactions (see section 4.4).
Lithium salts: Excretion of lithium may be reduced by ACE inhibitors and therefore lithium toxicity may be increased. Lithium level must be monitored.
Antidiabetic agents including insulin: Hypoglycaemic reactions may occur. Blood glucose monitoring is recommended.
Non-steroidal anti-inflammatory drugs and acetylsalicylic acid: Reduction of the antihypertensive effect of Ramipril is to be anticipated. Furthermore, concomitant treatment of ACE inhibitors and NSAIDs may lead to an increased risk of worsening of renal function and to an increase in kalaemia.
4.6 Pregnancy And Lactation
Ramipril is not recommended during the first trimester of pregnancy (see section 4.4) and contraindicated during the second and third trimesters of pregnancy (see section 4.3).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
ACE inhibitor/ Angiotensin II Receptor Antagonist (AIIRA) therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia). (See also 5.3 'Preclinical safety data'). Should exposure to ACE inhibitor have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Newborns whose mothers have taken ACE inhibitors should be closely observed for hypotension, oliguria and hyperkalaemia (see also sections 4.3 and 4.4).
Because insufficient information is available regarding the use of ramipril during breastfeeding (see section 5.2), ramipril is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
4.7 Effects On Ability To Drive And Use Machines
Some adverse effects (e.g. symptoms of a reduction in blood pressure such as dizziness) may impair the patient's ability to concentrate and react and, therefore, constitute a risk in situations where these abilities are of particular importance (e.g. operating a vehicle or machinery).
This can happen especially at the start of treatment, or when changing over from other preparations. After the first dose or subsequent increases in dose it is not advisable to drive or operate machinery for several hours.
4.8 Undesirable Effects
The safety profile of ramipril includes persistent dry cough and reactions due to hypotension. Serious adverse reactions include angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis.
Adverse reactions frequency is defined using the following convention:
Very common (
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
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4.9 Overdose
Symptoms associated with overdosage of ACE inhibitors may include excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure. The patient should be closely monitored and the treatment should be symptomatic and supportive. Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including, administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration. Ramiprilat, the active metabolite of ramipril is poorly removed from the general circulation by haemodialysis.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: ACE inhibitors, plain, ATC Code: C09A A05
Mechanism of action:
Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I (synonyms: angiotensin-converting enzyme; kininase II). In plasma and tissue this enzyme catalyses the conversion of angiotensin I to the active vasoconstrictor substance angiotensin II, as well as the breakdown of the active vasodilator bradykinin. Reduced angiotensin II formation and inhibition of bradykinin breakdown lead to vasodilatation.
Since angiotensin II also stimulates the release of aldosterone, ramiprilat causes a reduction in aldosterone secretion. The average response to ACE inhibitor monotherapy was lower in black (Afro-Caribbean) hypertensive patients (usually a low-renin hypertensive population) than in non-black patients.
Pharmacodynamic effects
Antihypertensive properties:
Administration of ramipril causes a marked reduction in peripheral arterial resistance. Generally, there are no major changes in renal plasma flow and glomerular filtration rate. Administration of ramipril to patients with hypertension leads to a reduction in supine and standing blood pressure without a compensatory rise in heart rate.
In most patients the onset of the antihypertensive effect of a single dose becomes apparent 1 to 2 hours after oral administration. The peak effect of a single dose is usually reached 3 to 6 hours after oral administration. The antihypertensive effect of a single dose usually lasts for 24 hours.
The maximum antihypertensive effect of continued treatment with ramipril is generally apparent after 3 to 4 weeks. It has been shown that the antihypertensive effect is sustained under long term therapy lasting 2 years.
Abrupt discontinuation of ramipril does not produce a rapid and excessive rebound increase in blood pressure.
Heart failure:
In addition to conventional therapy with diuretics and optional cardiac glycosides, ramipril has been shown to be effective in patients with functional classes II-IV of the New-York Heart Association. The drug had beneficial effects on cardiac haemodynamics (decreased left and right ventricular filling pressures, reduced total peripheral vascular resistance, increased cardiac output and improved cardiac index). It also reduced neuroendocrine activation.
Clinical efficacy and safety
Cardiovascular prevention/Nephroprotection;
A preventive placebo-controlled study (the HOPE-study), was carried out in which ramipril was added to standard therapy in more than 9,200 patients. Patients with increased risk of cardiovascular disease following either atherothrombotic cardiovascular disease (history of coronary heart disease, stroke or peripheral vascular disease) or diabetes mellitus with at least one additional risk factor (documented microalbuminuria, hypertension, elevated total cholesterol level, low high-density lipoprotein cholesterol level or cigarette smoking) were included in the study.
The study showed that ramipril statistically significantly decreases the incidence of myocardial infarction, death from cardiovascular causes and stroke, alone and combined (primary combined events).
The HOPE study: Main results
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The MICRO-HOPE study, a predefined substudy from HOPE, investigated the effect of the addition of ramipril 10 mg to the current medical regimen versus placebo in 3,577 patients at least
The primary analysis showed that 117 (6.5 %) participants on ramipril and 149 (8.4 %) on placebo developed overt nephropathy, which corresponds to a RRR 24 %; 95 % CI [3-40], p = 0.027.
The REIN study, a multicenter randomized, double-blind parallel group, placebo-controlled study aimed at assessing the effect of treatment with ramipril on the rate of decline of glomerular function rate (GFR) in 352 normotensive or hypertensive patients (18-70 years old) suffering from mild (i.e. mean urinary protein excretion > 1 and < 3 g/24 h) or severe proteinuria (
The main analysis of patients with the most severe proteinuria (stratum prematurely disrupted due to benefit in ramipril group) showed that the mean rate of GFR decline per month was lower with ramipril than with placebo; -0.54 (0.66) vs. -0.88 (1.03) ml/min/month, p = 0.038. The intergroup difference was thus 0.34 [0.03-0.65] per month, and around 4 ml/min/year; 23.1 % of the patients in the ramipril group reached the combined secondary endpoint of doubling of baseline serum creatinine concentration and/or end-stage renal disease (ESRD) (need for dialysis or renal transplantation) vs. 45.5 % in the placebo group (p = 0.02).
Secondary prevention after acute myocardial infarction
The AIRE study included more than 2,000 patients with transient/persistent clinical signs of heart failure after documented myocardial infarction. The ramipril treatment was started 3 to 10 days after the acute myocardial infarction. The study showed that after an average follow-up time of 15 months the mortality in ramipril-treated patients was 16.9 % and in the placebo treated patients was 22.6 %. This means an absolute mortality reduction of 5.7 % and a relative risk reduction of 27 % (95 % CI [11-40 %]).
5.2 Pharmacokinetic Properties
Pharmacokinetics and Metabolism
Absorption
Following oral administration ramipril is rapidly absorbed from the gastrointestinal tract: peak plasma concentrations of ramipril are reached within one hour. Based on urinary recovery, the extent of absorption is at least 56 % and is not significantly influenced by the presence of food in the gastrointestinal tract. The bioavailability of the active metabolite ramiprilat after oral administration of 2.5 mg and 5 mg ramipril is 45 %.
Peak plasma concentrations of ramiprilat, the sole active metabolite of ramipril are reached 2-4 hours after ramipril intake. Steady state plasma concentrations of ramiprilat after once daily dosing with the usual doses of ramipril are reached by about the fourth day of treatment.
Distribution
The serum protein binding of ramipril is about 73 % and that of ramiprilat about 56 %.
Metabolism
Ramipril is almost completely metabolised to ramiprilat, and to the diketopiperazine ester, the diketopiperazine acid, and the glucuronides of ramipril and ramiprilat.
Elimination
Excretion of the metabolites is primarily renal.
Plasma con
Diskets
Ingredient matches for Diskets
Methadone
Methadone hydrochloride (a derivative of Methadone) is reported as an ingredient of Diskets in the following countries:
- United States
International Drug Name Search
Dermatop Cream
Dosage Form: cream
DERMATOP® Emollient Cream
(prednicarbate emollient cream) 0.1%
FOR DERMATOLOGIC USE ONLY.
NOT FOR USE IN EYES.
Dermatop Cream Description
DERMATOP® Emollient Cream (prednicarbate emollient cream) 0.1% contains prednicarbate, a synthetic corticosteroid for topical dermatologic use. The chemical name of prednicarbate is 11β, 17, 21-trihydroxypregna-1,4-diene- 3,20-dione 17-(ethyl carbonate) 21-propionate. Prednicarbate has the empirical formula C27H36O8 and a molecular weight of 488.58. Topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.
The CAS Registry Number is 73771-04-7. The chemical structure is:
Prednicarbate is a practically odorless white to yellow-white powder insoluble to practically insoluble in water and freely soluble in ethanol.
Each gram of DERMATOP Emollient Cream 0.1% contains 1.0 mg of prednicarbate in a base consisting of white petrolatum USP, purified water USP, isopropyl myristate NF, lanolin alcohols NF, mineral oil USP, cetostearyl alcohol NF, aluminum stearate, edetate disodium USP, lactic acid USP, and magnesium stearate DAB 9.
Dermatop Cream - Clinical Pharmacology
In common with other topical corticosteroids, prednicarbate has anti-inflammatory, antipruritic, and vasoconstrictive properties. In general, the mechanism of the anti-inflammatory activity of topical steroids is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics
The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Use of occlusive dressings with hydrocortisone for up to 24 hours have not been shown to increase penetration; however, occlusion of hydrocortisone for 96 hours does markedly enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.
Studies performed with DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1 % indicate that the drug product is in the medium range of potency compared with other topical corticosteroids.
Indications and Usage for Dermatop Cream
DERMATOP Emollient Cream 0.1% is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. DERMATOP Emollient Cream 0.1% may be used with caution in pediatric patients 1 year of age or older. The safety and efficacy of drug use for longer than 3 weeks in this population have not been established. Since safety and efficacy of DERMATOP Emollient Cream 0.1% have not been established in pediatric patients below 1 year of age, its use in this age group is not recommended.
Contraindications
DERMATOP Emollient Cream 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparations.
Precautions
General
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.
Patients applying a topical steroid to a large surface area or under occlusion should be evaluated periodically for evidence of HPA-axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. DERMATOP Emollient Cream 0.1% did not produce significant HPA-axis suppression when used at a dose of 30g/day for a week in 10 adult patients with extensive psoriasis or atopic dermatitis. DERMATOP Emollient Cream 0.1% did not produce HPA-axis suppression in any of 59 pediatric patients with extensive atopic dermatitis when applied BID for 3 weeks to > 20% of the body surface (See PRECAUTIONS, Pediatric Use.)
If HPA-axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of the application, or to substitute a less potent corticosteroid. Recovery of HPA-axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS, Pediatric Use.)
If irritation develops, DERMATOP Emollient Cream 0.1% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as observed with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used.
If a favorable response does not occur promptly, use of DERMATOP Emollient Cream 0.1% should be discontinued until the infection has been adequately controlled.
Information for Patients
Patients using topical corticosteroids should receive the following information and instructions:
- This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
- This medication should not be used for any disorder other than that for which it was prescribed.
- The treated skin area should not be bandaged, otherwise covered or wrapped so as to be occlusive, unless directed by the physician.
- Patients should report to their physician any signs of local adverse reactions.
- Parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis. This medication should not be applied in the diaper area as diapers or plastic pants may constitute occlusive dressing (See DOSAGE AND ADMINISTRATION).
- This medication should not be used on the face, underarms, or groin areas.
- Contact between DERMATOP Emollient Cream 0.1% and latex containing products (eg. condoms, diaphragm etc.) should be avoided since paraffin in contact with latex can cause damage and reduce the effectiveness of any latex containing products. If latex products come into contact with DERMATOP Emollient Cream 0.1%, patients should be advised to discard the latex products. Patients should be advised that this medication is to be used externally only, not intravaginally.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, contact the physician.
Laboratory Tests
The following tests may be helpful in evaluating patients for HPA-axis suppression:
ACTH stimulation test
A.M. plasma cortisol test
Urinary free cortisol test
Carcinogenesis, Mutagenesis, and Impairment of Fertility
In a study of the effect of prednicarbate on fertility, pregnancy, and postnatal development in rats, no effect was noted on the fertility or pregnancy of the parent animals or postnatal development of the offspring after administration of up to 0.80 mg/kg of prednicarbate subcutaneously.
Prednicarbate has been evaluated in the Salmonella reversion test (Ames test) over a wide range of concentrations in the presence and absence of an S-9 liver microsomal fraction, and did not demonstrate mutagenic activity. Similarly, prednicarbate did not produce any significant changes in the numbers of micronuclei seen in erythrocytes when mice were given doses ranging from 1 to 160 mg/kg of the drug.
Pregnancy
Teratogenic Effects
Pregnancy Category C
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
Prednicarbate has been shown to be teratogenic and embryotoxic in Wistar rats and Himalayan rabbits when given subcutaneously during gestation at doses 1900 times and 45 times the recommended topical human dose, assuming a percutaneous absorption of approximately 3%. In the rats, slightly retarded fetal development and an incidence of thickened and wavy ribs higher than the spontaneous rate were noted.
In rabbits, increased liver weights and slight increase in the fetal intrauterine death rate were observed. The fetuses that were delivered exhibited reduced placental weight, increased frequency of cleft palate, ossification disorders in the sternum, omphalocele, and anomalous posture of the forelimbs.
There are no adequate and well-controlled studies in pregnant women on teratogenic effects of prednicarbate. DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when DERMATOP Emollient Cream 0.1% is administered to a nursing woman.
Pediatric Use
DERMATOP Emollient Cream 0.1% may be used with caution in pediatric patients 1 year of age or older, although the safety and efficacy of drug use longer than 3 weeks have not been established. The use of DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% is supported by results of a three-week, uncontrolled study in 59 pediatric patients between the ages of 4 months and 12 years of age with atopic dermatitis. None of the 59 pediatric patients showed evidence of HPA-axis suppression. Safety and efficacy of DERMATOP Emollient Cream 0.1% in pediatric patients below 1 year of age have not been established, therefore use in this age group is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA-axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. In an uncontrolled study in pediatric patients with atopic dermatitis, the incidence of adverse reactions possibly or probably associated with the use of DERMATOP Emollient Cream 0.1% was limited.
Mild signs of atrophy developed in 5 patients (5/59, 8%) during the clinical trial, with 2 patients exhibiting more than one sign. Two patients (2/59, 3%) developed shininess, and two patients (2/59, 3%) developed thinness. Three patients (3/59, 5%) were observed with mild telangiectasia. It is unknown whether prior use of topical corticosterioids was a contributing factor in the development of telangiectasia in 2 of the patients. Adverse effects including striae have also been reported with inappropriate use of topical corticosteroids in infants and children. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk for HPA-axis suppression.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
DERMATOP Emollient Cream 0.1% should not be used in the treatment of diaper dermatitis.
Adverse Reactions
In controlled adult clinical studies, the incidence of adverse reactions probably or possibly associated with the use of DERMATOP Emollient Cream 0.1% was approximately 4%. Reported reactions included mild signs of skin atrophy in 1% of treated patients, as well as the following reactions which were reported in less than 1% of patients: pruritis, edema, paresthesia, urticaria, burning, allergic contact dermatitis and rash.
In an uncontrolled study in pediatric patients with atopic dermatitis, the incidence of adverse reactions possibly or probably associated with the use of DERMATOP Emollient Cream 0.1 % was limited. Mild signs of atrophy developed in 5 patients (5/59, 8%) during the clinical trial, with 2 patients exhibiting more than one sign. Two patients (2/59, 3%) developed shininess, and 2 patients (2/59, 3%) developed thinness. Three patients (3/59, 5 %) were observed with mild telangiectasia. It is unknown whether prior use of topical corticosteroids was a contributing factor in the development of telangiectasia in 2 of the patients (See PRECAUTIONS, Pediatric Use.)
The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, striae and miliaria.
Overdosage
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)
Dermatop Cream Dosage and Administration
Apply a thin film of DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% to the affected skin areas twice daily. Rub in gently.
DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1 % may be used in pediatric patients 1 year of age or older. Safety and efficacy of DERMATOP Emollient Cream 0.1% in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
DERMATOP Emollient Cream 0.1% should not be used with occlusive dressings unless directed by the physician. DERMATOP Emollient Cream 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.
How is Dermatop Cream Supplied
DERMATOP Emollient Cream (prednicarbate emollient cream) 0.1% is supplied in 60 g (NDC 0066-0507-60) tubes.
Store between 41 and 77°F (5 and 25°C).
Dermik Laboratories
a business of sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
Revised January 2011
© 2011 sanofi-aventis U.S. LLC
PRINCIPAL DISPLAY PANEL - 60g Tube Carton
NDC 0066-0507-60
DERMATOP® Emollient Cream
prednicarbate emollient cream 0.1%
FOR DERMATOLOGIC USE ONLY — NOT FOR USE IN EYES
One 60g Tube
DERMIK®
sanofi aventis
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA020279 | 10/29/1993 | |
| Labeler - Dermik Laboratories (824676584) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| sanofi-aventis Deutschland GmbH | 313218430 | MANUFACTURE, ANALYSIS, API MANUFACTURE, LABEL, PACK | |
Latonid
Latonid may be available in the countries listed below.
Ingredient matches for Latonid
Meloxicam
Meloxicam is reported as an ingredient of Latonid in the following countries:
- Finland
International Drug Name Search
Tuesday, September 27, 2016
Dexodryl Suspension
Pronunciation: KLOR-fen-IR-a-meen/METH-skoe-POL-a-meen
Generic Name: Chlorpheniramine/Methscopolamine
Brand Name: Dexodryl
Dexodryl Suspension is used for:
Relieving sneezing, runny nose, and watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.
Dexodryl Suspension is an antihistamine and anticholinergic combination. It works by blocking a substance in the body that causes sneezing, runny nose, and watery eyes. It also dries the nose and chest.
Do NOT use Dexodryl Suspension if:
- you are allergic to any ingredient in Dexodryl Suspension
- you are taking sodium oxybate (GHB) or a monamine oxidase inhibitor (MAOI) (eg, phenelzine)
- you have severe heart blood vessel disease, severe high blood pressure, narrow-angle glaucoma, severe bleeding, severe irritation or other serious problems with the esophagus (eg, esophageal achalasia), peptic ulcer, a blockage of the stomach or bowel, bowel motility problems, severe bowel inflammation (eg, ulcerative colitis), or muscle problems (eg, myasthenia gravis)
- you have a blockage of the bladder, are unable to urinate, or are having an asthma attack
Contact your doctor or health care provider right away if any of these apply to you.
Before using Dexodryl Suspension:
Some medical conditions may interact with Dexodryl 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 hernia, or a history of high blood pressure, diabetes, blood vessel problems, stroke, seizures, overactive thyroid, nerve problems, prostate gland problems, heart problems (eg, irregular heartbeat, congestive heart failure), sleep apnea, asthma, lung problems (eg, emphysema, chronic obstructive pulmonary disease [COPD]), or glaucoma, or you are at risk of developing glaucoma
- if you have trouble urinating or severe constipation
Some MEDICINES MAY INTERACT with Dexodryl Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Potassium products because they do not move properly through the intestines while you are taking Dexodryl Suspension
- Anticholinergic medicines (eg, benztropine), barbiturates (eg, phenobarbital), phenothiazines (eg, thioridazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Dexodryl Suspension's side effects
- MAOIs (eg, phenelzine) or sodium oxybate (GHB) because the risk of serious side effects, such as high blood pressure or severe drowsiness, may be increased
- Beta-blockers (eg, propranolol), digoxin, or hydantoins because the risk of their side effects may be increased by Dexodryl Suspension
This may not be a complete list of all interactions that may occur. Ask your health care provider if Dexodryl 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 Dexodryl Suspension:
Use Dexodryl Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Dexodryl Suspension by mouth with or without food.
- Shake well before each use.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Do not take an antacid or medicine for diarrhea within 1 hour before or 2 hours after you take Dexodryl Suspension.
- If you miss a dose of Dexodryl Suspension and you are using it regularly, 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 Dexodryl Suspension.
Important safety information:
- Dexodryl Suspension may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Dexodryl Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Dexodryl Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do not take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- If your symptoms do not get better within 7 days, if they get worse, or if they occur with a fever, check with your doctor.
- Dexodryl Suspension may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.
- Dexodryl Suspension may reduce sweating. Do not become overheated in hot weather or during exercise or during other activities; heatstroke may occur.
- Dexodryl Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Dexodryl Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Dexodryl Suspension may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Dexodryl Suspension.
- Use Dexodryl Suspension with caution in the ELDERLY; they may be more sensitive to its effects.
- Caution is advised with using Dexodryl Suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.
- Dexodryl Suspension should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Dexodryl Suspension can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dexodryl Suspension while you are pregnant. It is not known if Dexodryl Suspension is found in breast milk. Do not breast-feed while taking Dexodryl Suspension.
Possible side effects of Dexodryl 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:
Blurred vision; change in appetite; constipation; dizziness; drowsiness; dry mouth; nausea; nervousness; stomach upset or pain; trouble sleeping.
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); confusion; difficulty urinating; fainting or feeling faint; fast heartbeat; fever, chills, or persistent sore throat; flushing; hallucinations; seizures; severe clumsiness; severe or persistent nervousness, dizziness, or trouble sleeping; severe drowsiness; shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness.
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: Dexodryl 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 difficulty breathing; fixed/large pupils; flushing; hot, dry skin; irregular heartbeat; loss of consciousness; mental or mood changes; ringing in the ears; seizures; severe drowsiness, dizziness, or headache; severe or persistent nausea or vomiting.
Proper storage of Dexodryl Suspension:
Store 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 Dexodryl Suspension out of the reach of children and away from pets.
General information:
- If you have any questions about Dexodryl Suspension, please talk with your doctor, pharmacist, or other health care provider.
- Dexodryl 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 Dexodryl 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
Copyright © 2012 Wolters Kluwer Health, Inc.
More Dexodryl resources
- Dexodryl Side Effects (in more detail)
- Dexodryl Use in Pregnancy & Breastfeeding
- Dexodryl Drug Interactions
- Dexodryl Support Group
- 0 Reviews for Dexodryl - Add your own review/rating
- Allergy DN II Prescribing Information (FDA)
- aeroHist Concise Consumer Information (Cerner Multum)
Compare Dexodryl with other medications
- Rhinitis
Duexis
Generic Name: ibuprofen and famotidine (Oral route)
eye-bue-PROE-fen, fam-OH-ti-deen
Oral route(Tablet)
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use and in patients with cardiovascular disease or risk factors for cardiovascular disease. Famotidine/ibuprofen is contraindicated in the perioperative setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal and may occur at any time and without warning. Elderly patients are at greater risk of serious gastrointestinal events .
Commonly used brand name(s)
In the U.S.
- Duexis
Available Dosage Forms:
- Tablet
Pharmacologic Class: NSAID
Chemical Class: Propionic Acid (class)
Uses For Duexis
Ibuprofen and famotidine combination is used to relieve the symptoms of rheumatoid arthritis and osteoarthritis. It is used for patients who have an increased risk for stomach ulcers and who need to take a nonsteroidal anti-inflammatory drug (NSAID) for arthritis.
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat pain, inflammation, swelling, stiffness, and joint pain. Famotidine is a histamine H2-receptor antagonist or H2-blocker. It works by decreasing the amount of acid produced by the stomach.
This medicine is available only with your doctor's prescription.
Before Using Duexis
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of ibuprofen and famotidine combination in the pediatric population. 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 ibuprofen and famotidine combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Ketorolac
- Pentoxifylline
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abciximab
- Ardeparin
- Argatroban
- Atazanavir
- Beta Glucan
- Bivalirudin
- Certoparin
- Cilostazol
- Citalopram
- Clopidogrel
- Clovoxamine
- Dabigatran Etexilate
- Dalteparin
- Danaparoid
- Dasatinib
- Delavirdine
- Desirudin
- Dipyridamole
- Enoxaparin
- Escitalopram
- Femoxetine
- Flesinoxan
- Fluoxetine
- Fluvoxamine
- Fondaparinux
- Ginkgo
- Heparin
- Lepirudin
- Methotrexate
- Nadroparin
- Nefazodone
- Parnaparin
- Paroxetine
- Pemetrexed
- Protein C
- Reviparin
- Rilpivirine
- Rivaroxaban
- Sertraline
- Sibutramine
- Tacrolimus
- Ticlopidine
- Tinzaparin
- Tirofiban
- Tizanidine
- Tolazoline
- Vilazodone
- Zimeldine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acebutolol
- Acetohexamide
- Alacepril
- Alprenolol
- Amikacin
- Amiloride
- Arotinolol
- Aspirin
- Atenolol
- Azilsartan Medoxomil
- Azosemide
- Befunolol
- Bemetizide
- Benazepril
- Bendroflumethiazide
- Benzthiazide
- Betaxolol
- Bevantolol
- Bisoprolol
- Bopindolol
- Bucindolol
- Bumetanide
- Bupranolol
- Buthiazide
- Candesartan Cilexetil
- Canrenoate
- Captopril
- Carteolol
- Carvedilol
- Cefditoren Pivoxil
- Cefpodoxime Proxetil
- Celiprolol
- Chlorothiazide
- Chlorpropamide
- Chlorthalidone
- Cilazapril
- Clopamide
- Cyclopenthiazide
- Cyclosporine
- Delapril
- Desipramine
- Desvenlafaxine
- Dilevalol
- Duloxetine
- Enalaprilat
- Enalapril Maleate
- Eprosartan
- Esmolol
- Ethacrynic Acid
- Fosinopril
- Furosemide
- Gliclazide
- Glimepiride
- Glipizide
- Gliquidone
- Glyburide
- Hydrochlorothiazide
- Hydroflumethiazide
- Imidapril
- Indapamide
- Irbesartan
- Itraconazole
- Labetalol
- Landiolol
- Levobetaxolol
- Levobunolol
- Lisinopril
- Lithium
- Losartan
- Mepindolol
- Methyclothiazide
- Metipranolol
- Metolazone
- Metoprolol
- Milnacipran
- Moexipril
- Nadolol
- Nebivolol
- Nipradilol
- Olmesartan Medoxomil
- Oxprenolol
- Penbutolol
- Pentopril
- Perindopril
- Phenytoin
- Pindolol
- Piretanide
- Polythiazide
- Propranolol
- Quinapril
- Ramipril
- Sotalol
- Spirapril
- Spironolactone
- Tacrine
- Talinolol
- Tasosartan
- Telmisartan
- Temocapril
- Tertatolol
- Timolol
- Tolazamide
- Tolbutamide
- Torsemide
- Trandolapril
- Triamterene
- Trichlormethiazide
- Valsartan
- Venlafaxine
- Voriconazole
- Xipamide
- Zofenopril
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Anemia or
- Bleeding problems or
- Congestive heart failure or
- Crohn's disease, history of or
- Edema (fluid retention or swelling) or
- Heart attack, history of or
- Heart or blood vessel disease or
- Hypertension (high blood pressure) or
- Liver disease or
- Stomach ulcers or bleeding, history of or
- Stroke, history of or
- Systemic lupus erythematosus (autoimmune disease) or
- Ulcerative colitis, history of—Use with caution. May make these conditions worse.
- Aspirin-sensitive asthma or
- Aspirin sensitivity, history of or
- Kidney disease, severe—Should not be used in patients with these conditions.
- Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of famotidine from the body.
Proper Use of Duexis
Use this medicine exactly as ordered by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.
This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Swallow the tablet whole. Do not break, crush, divide, or chew it.
This medicine contains ibuprofen. Do not take this medicine with other products containing ibuprofen.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For rheumatoid arthritis and osteoarthritis:
- Adults—One tablet three times per day.
- Children—Use and dose must be determined by your doctor.
- For rheumatoid arthritis and osteoarthritis:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Duexis
It is very important that your doctor check your progress at regular visits while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
Ibuprofen may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.
Ibuprofen may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner).
Stop using this medicine and check with your doctor right away if you have the following symptoms while using the medicine: blood in the urine; change in the frequency of urination or amount of urine; difficulty with breathing; drowsiness; increased thirst; loss of appetite; nausea or vomiting; or swelling of the feet or lower legs.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have any of the following symptoms while using this medicine: blistering, peeling, or loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.
Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.
Check with your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or eyes.
Some people who have used this medicine had symptoms of meningitis. If you have fever, headache, nausea, vomiting, and stiff neck or back while using this medicine, check with your doctor right away.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in color vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop the medicine for a while, or to change to a different medicine before your procedure.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Duexis 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:
Less common
- Abdominal or stomach pain, cramping, or burning
- bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or black, tarry stools
- blurred vision
- chills
- clay-colored stools
- cloudy urine
- constipation
- cough
- dark-colored urine
- diarrhea
- difficult, burning, or painful urination
- dizziness
- fever
- frequent urge to urinate
- general feeling of discomfort or illness
- general feeling of tiredness or weakness
- headache
- heartburn
- indigestion
- itching
- joint pain
- light-colored stools
- loss of appetite
- lower back or side pain
- muscle aches and pains
- nausea
- nervousness
- pale skin
- pounding in the ears
- rapid weight gain
- rash
- runny nose
- severe stomach pain
- shivering
- slow or fast heartbeat
- sore throat
- stomach pain, continuing
- sweating
- tingling of the hands or feet
- trouble sleeping
- troubled breathing with exertion
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
- vomiting of blood or material that looks like coffee grounds
- yellow eyes or skin
- Blistering, peeling, or loosening of the skin
- change in consciousness
- confusion as to time, place, or person
- cracks in the skin
- darkening of the skin
- dry mouth
- fainting
- hallucinations
- holding false beliefs that cannot be changed by fact
- loss of consciousness
- loss of heat from the body
- mental depression
- pain in lower back or side
- pains in the chest, groin, or legs, especially calves of the legs
- red skin lesions, often with a purple center
- red, irritated eyes
- red, swollen skin
- scaly skin
- seizures
- severe headaches of sudden onset
- sores, ulcers, or white spots in the mouth or on the lips
- stiff neck or back
- sudden loss of coordination
- sudden onset of shortness of breath for no apparent reason
- sudden onset of slurred speech
- sudden vision changes
- thirst
- troubled breathing with exertion
- unusual excitement, nervousness, or restlessness
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
- Acid or sour stomach
- back pain
- belching
- body aches or pain
- cough producing mucus
- difficulty having a bowel movement (stool)
- difficulty with moving
- ear congestion
- loss of voice
- muscle stiffness
- nasal congestion
- pain or tenderness around the eyes and cheekbones
- sneezing
- stuffy nose
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: Duexis side effects (in more detail)
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More Duexis resources
- Duexis Side Effects (in more detail)
- Duexis Dosage
- Duexis Use in Pregnancy & Breastfeeding
- Duexis Drug Interactions
- Duexis Support Group
- 0 Reviews for Duexis - Add your own review/rating
- Duexis Prescribing Information (FDA)
- Duexis MedFacts Consumer Leaflet (Wolters Kluwer)
- Duexis Consumer Overview
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