Rapiscan

1. Name Of The Medicinal Product

Rapiscan 400 microgram solution for injection

2. Qualitative And Quantitative Composition

Each 5 ml vial contains 400 micrograms regadenoson (80 micrograms/ml).

Excipient(s):

Each 5 ml vial contains 19.26 mg of sodium.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Solution for injection

Clear, colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

This medicinal product is for diagnostic use only.

Rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging (MPI) in adult patients unable to undergo adequate exercise stress.

4.2 Posology And Method Of Administration

Treatment with Rapiscan is restricted to use in a medical facility where cardiac monitoring and resuscitation equipment are available.

Posology

The recommended dose of Rapiscan is a single injection of 400 micrograms regadenoson (5 ml) into a peripheral vein, with no dose adjustment necessary for body weight.

Patients should avoid consumption of any products containing methylxanthines (e.g. caffeine) as well as any medicinal products containing theophylline for at least 12 hours before Rapiscan administration (see section 4.5).

When possible, dipyridamole should be withheld for at least two days prior to Rapiscan administration (see section 4.5).

Aminophylline may be used to attenuate severe and/or persistent adverse reactions to Rapiscan (see section 4.4).

Rapiscan causes a rapid increase in heart rate (see sections 4.4 and 5.1). Patients should remain sitting or lying down and be monitored at frequent intervals after the injection until the ECG parameters, heart rate and blood pressure have returned to pre

Repeated use

This product is to be administered only once within a 24 hour period. Safety and tolerability of repeated use of this product within 24 hours has not been characterised.

Paediatric population

The safety and efficacy of Rapiscan in children below the age of 18 years have not yet been established.

No data are available.

Elderly

No dose adjustment is necessary (see section 5.2).

Hepatic impairment

No dose adjustment is necessary (see section 5.2).

Renal impairment

No dose adjustment is necessary (see section 5.2).

Method of administration

For intravenous use.

• Rapiscan should be administered as a rapid, 10

• 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection should be administered immediately after the injection of Rapiscan.

• The radiopharmaceutical for the myocardial perfusion imaging agent should be administered 10

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients (see section 6.1).

• Second or third degree atrioventricular (AV) block or sinus node dysfunction, unless these patients have a functioning artificial pacemaker.

• Unstable angina that has not been stabilised with medical therapy.

• Severe hypotension.

• Decompensated states of heart failure.

4.4 Special Warnings And Precautions For Use

Rapiscan has the potential to cause serious and life

Myocardial ischaemia

Fatal cardiac arrest, life

Sinoatrial and atrioventricular nodal block

Adenosine receptor agonists including regadenoson can depress the sinoatrial (SA) and AV nodes and may cause first, second or third degree AV block, or sinus bradycardia.

Hypotension

Adenosine receptor agonists including regadenoson induce arterial vasodilation and hypotension. The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, left main coronary artery stenosis, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency.

Bronchoconstriction

Adenosine receptor agonists may cause bronchoconstriction and respiratory compromise. For patients with known or suspected bronchoconstrictive disease, chronic obstructive pulmonary disease (COPD) or asthma, appropriate bronchodilator therapy and resuscitative measures should be available prior to Rapiscan administration.

Long QT syndrome

Regadenoson stimulates sympathetic output and may increase the risk of ventricular tachyarrhythmias in patients with a long QT syndrome.

Warnings related to excipients

This medicinal product contains less than 1 mmol sodium (23 mg) per dose. However, the injection of sodium chloride 9 mg/ml (0.9%) solution given after Rapiscan contains 45 mg of sodium. To be taken into consideration by patients on a controlled sodium diet.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No studies of interaction with other medicinal products have been performed.

Methylxanthines

Methylxanthines (e.g., caffeine and theophylline) are non-specific adenosine receptor antagonists and may interfere with the vasodilation activity of regadenoson (see section 5.1). Patients should avoid consumption of any products containing methylxanthines as well as any medicinal products containing theophylline for at least 12 hours before Rapiscan administration (see section 4.2).

Aminophylline (100 mg, administered by slow intravenous injection over 60 seconds) injected 1 minute after 400 micrograms regadenoson in subjects undergoing cardiac catheterisation, was shown to shorten the duration of the coronary blood flow response to regadenoson as measured by pulsed-wave Doppler ultrasonography. Aminophylline has been used to attenuate adverse reactions to Rapiscan (see section 4.4).

Dipyridamole

Dipyridamole increases blood adenosine levels and the response to regadenoson may be altered when blood adenosine levels are increased. When possible, dipyridamole should be withheld for at least two days prior to Rapiscan administration (see section 4.2).

Cardioactive medicinal products

In clinical studies, Rapiscan was administered to patients taking other cardioactive medicinal products (i.e., β

Other interactions

Regadenoson does not inhibit the metabolism of substrates for CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 in human liver microsomes, indicating that it is unlikely to alter the pharmacokinetics of medicinal products metabolised by these cytochrome P450 enzymes.

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate data from the use of Rapiscan in pregnant women. Animal studies on pre

Breast-feeding

It is unknown whether regadenoson is excreted in human breast milk. The excretion of regadenoson in milk has not been studied in animals. A decision should be made whether to discontinue breast-feeding or to abstain from Rapiscan administration taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. If Rapiscan is administered, the woman should not breast

Fertility

Fertility studies with Rapiscan have not been performed (see section 5.3).

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects of Rapiscan on the ability to drive and use machines have been performed. Rapiscan administration may result in adverse reactions such as dizziness, headache, and dyspnoea (see section 4.8) soon after administration. However, most adverse reactions are mild and transient, resolving within 30 minutes after receiving Rapiscan. Therefore, Rapiscan would be expected to have no or negligible influence on the ability to drive or operate machinery once treatment has been completed and these reactions have resolved. The physician is advised to provide a recommendation for the individual patient.

4.8 Undesirable Effects

Summary of the safety profile

Adverse reactions in most patients receiving Rapiscan in clinical trials were mild, transient (usually resolving within 30 minutes after receiving Rapiscan), and required no medical intervention. Adverse reactions occurred in approximately 80% of patients. The most common adverse reactions reported during clinical development in a total of 1,651 patients/subjects were: dyspnoea (29%), headache (27%), flushing (23%), chest pain (19%), electrocardiogram ST segment changes (18%), gastrointestinal discomfort (15%) and dizziness (11%).

Rapiscan may cause myocardial ischaemia (potentially associated with fatal cardiac arrest, life

Tabulated summary of adverse reactions

Assessment of adverse reactions for regadenoson is based on safety data from clinical studies and post-marketing experience. All adverse reactions are presented in the table below and are listed by system organ class and frequency. Frequencies are defined as very common (

Psychiatric disorders:
Uncommon	Anxiety, insomnia
Nervous system disorders:
Very common	Headache, dizziness
Common	Paraesthesia, hypoaesthesia, dysgeusia
Uncommon	Convulsions, syncope, transient ischaemic attack, unresponsiveness to stimuli, depressed level of consciousness, tremor, somnolence
Eye disorders:
Uncommon	Vision blurred, eye pain
Ear and labyrinth disorders:
Uncommon	Tinnitus
Cardiac disorders:
Very common	Electrocardiogram ST segment changes
Common	Angina pectoris, atrioventricular block, tachycardia, palpitations, other ECG abnormalities including electrocardiogram QT corrected interval prolonged
Uncommon	Cardiac arrest, myocardial infarction, complete AV block, atrial fibrillation/flutter, bradycardia
Vascular disorders:
Very common	Flushing
Common	Hypotension
Uncommon	Hypertension, pallor, peripheral coldness
Respiratory, thoracic and mediastinal disorders:
Very common	Dyspnoea
Common	Throat tightness, throat irritation, cough
Uncommon	Tachypnoea
Gastrointestinal disorders:
Very common	Gastrointestinal discomfort
Common	Vomiting, nausea, oral discomfort
Uncommon	Abdominal distension, diarrhoea, faecal incontinence
Skin and subcutaneous tissue disorders:
Common	Hyperhidrosis
Uncommon	Erythema
Musculoskeletal and connective tissue disorders:
Common	Back, neck or jaw pain, pain in extremity, musculoskeletal discomfort
Uncommon	Arthralgia
General disorders and administration site conditions:
Very common	Chest pain
Common	Malaise, asthenia
Uncommon	Pain at injection site, general body pain

Description of selected adverse reactions

Fatal cardiac arrest, life

Adenosine receptor agonists, including Rapiscan, can depress the SA and AV nodes and may cause first, second or third degree AV block, or sinus bradycardia requiring intervention. In clinical trials first degree AV block (PR prolongation> 220 msec) developed in 3% of patients within 2 hours of Rapiscan administration; transient second degree AV block with one dropped beat was observed in one patient receiving Rapiscan. In postmarketing experience, third degree heart block and asystole have been reported within minutes of Rapiscan administration.

Adenosine receptor agonists, including Rapiscan induce arterial vasodilation and hypotension. In clinical trials, decreased systolic blood pressure (> 35 mm Hg) was observed in 7% of patients and decreased diastolic blood pressure (> 25 mm Hg) was observed in 4% of patients within 45 minutes of Rapiscan administration. The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, left main coronary artery stenosis, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency. In postmarketing experience, syncope and transient ischaemic attacks have been reported.

Regadenoson increases sympathetic tone, which causes an increase in heart rate and a shortening of the QT interval. In a patient with a long QT syndrome, sympathetic stimulation can result in less shortening of the QT interval than is normal and may even cause a paradoxical increase in the QT interval. In these patients, the phenomenon of R

Headache was reported by 27% of subjects who received Rapiscan in clinical trials. The headache was considered severe in 3% of subjects.

Elderly population

Older patients (versus < 1%).

4.9 Overdose

In a study of healthy volunteers, symptoms of flushing, dizziness and increased heart rate were assessed as intolerable at regadenoson doses greater than 0.02 mg/kg.

Treatment

Aminophylline may be used to attenuate severe or persistent adverse reactions to Rapiscan (see section 4.4).

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations, ATC code: C01EB21

Mechanism of action

Regadenoson is a low affinity agonist (K_i≈ 1.3 µM) for the A_2A adenosine receptor, with at least 10₁ adenosine receptor (K_i> 16.5 µM), and very low, if any, affinity for the A_2B and A₃ adenosine receptors. Activation of the A_2A adenosine receptor produces coronary vasodilation and increases coronary blood flow (CBF). Despite low affinity for the A_2A adenosine receptor, regadenoson has high potency for increasing coronary conductance in rat and guinea pig isolated hearts, with EC₅₀ values of 6.4 nM and 6.7_2A1

Pharmacodynamic effects

Coronary blood flow

Regadenoson causes a rapid increase in CBF which is sustained for a short duration. In patients undergoing coronary catheterisation, pulsed-wave Doppler ultrasonography was used to measure the average peak velocity (APV) of CBF before and up to 30 minutes after administration of Rapiscan (400 micrograms, intravenously). Mean APV increased to greater than twice baseline by 30 seconds and decreased to less than half of the maximal effect within 10 minutes (see section 5.2).

Myocardial uptake of the radiopharmaceutical is proportional to CBF. Because regadenoson increases blood flow in normal coronary arteries with little or no increase in stenotic arteries, regadenoson causes relatively less uptake of the radiopharmaceutical in vascular territories supplied by stenotic arteries. Myocardial radiopharmaceutical uptake after Rapiscan administration is therefore greater in areas perfused by normal relative to stenosed arteries.

Haemodynamic effects

The majority of patients experience a rapid increase in heart rate. The greatest mean change from baseline (21 bpm) occurs approximately 1 minute after administration of Rapiscan. Heart rate returns to baseline within 10 minutes. Systolic blood pressure and diastolic blood pressure changes were variable, with the greatest mean change in systolic pressure of −3 mm Hg and in diastolic pressure of −4 mm Hg approximately 1 minute after Rapiscan administration. An increase in blood pressure has been observed in some patients (maximum systolic blood pressure of 240 mm Hg and maximum diastolic blood pressure of 138 mm Hg).

Respiratory effects

The A_2B and A₃ adenosine receptors have been implicated in the pathophysiology of bronchoconstriction in susceptible individuals (i.e., asthmatics). In in vitro studies, regadenoson has been shown to have little binding affinity for the A_2B and A₃ adenosine receptors. The incidence of bronchoconstriction (FEV₁ reduction> 15% from baseline) after Rapiscan administration was assessed in two randomised, controlled clinical studies. In the first study in 49 patients with moderate to severe COPD, the rate of bronchoconstriction was 12% and 6% following Rapiscan and placebo dosing, respectively (p = 0.31). In the second study in 48 patients with mild to moderate asthma who had previously been shown to have bronchoconstrictive reactions to adenosine monophosphate, the rate of bronchoconstriction was the same (4%) following both Rapiscan and placebo dosing. In both studies, dyspnoea was reported as an adverse reaction following Rapiscan dosing (61% for patients with COPD; 34% for patients with asthma) while no subjects experienced dyspnoea following placebo dosing. Dyspnoea did not correlate with a decrease in FEV₁.

Clinical efficacy

Clinical studies have demonstrated the efficacy and safety of Rapiscan in patients indicated for pharmacologic stress radionuclide MPI.

The efficacy and safety of Rapiscan were determined relative to adenosine in two randomised, double-blind studies (ADVANCE MPI 1 and ADVANCE MPI 2) in 2,015 patients with known or suspected coronary artery disease who were referred for a clinically

The most common cardiovascular histories included hypertension (81%), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or stenting (51%), angina (63%), and history of myocardial infarction (41%) or arrhythmia (33%); other medical history included diabetes (32%) and COPD (5%). Patients with a recent history of serious uncontrolled ventricular arrhythmia, myocardial infarction, or unstable angina, a history of greater than first degree AV block, or with symptomatic bradycardia, sick sinus syndrome, or a heart transplant were excluded. A number of patients took cardioactive medicinal products on the day of the scan, including β

Image agreement

Comparison of the images obtained with Rapiscan to those obtained with adenosine was performed as follows. Using the 17

	ADVANCE MPI 1 (n = 1,113)	ADVANCE MPI 2 (n = 758)	Combined Studies (n = 1,871)
Adenosine – Adenosine Agreement Rate (± SE) Number of Patients (n)	61 ± 3% 372	64 ± 4% 259	62 ± 3% 631
Adenosine – Rapiscan Agreement Rate (± SE) Number of Patients (n)	62 ± 2% 741	63 ± 3% 499	63 ± 2% 1,240
Rate Difference (Rapiscan – Adenosine) (± SE) 95% Confidence Interval	1 ± 4%		0 ± 3%

In ADVANCE MPI 1 and ADVANCE MPI 2, the Cicchetti

Safety and tolerability testing

In ADVANCE MPI 1 and ADVANCE MPI 2, the following pre-specified safety and tolerability endpoints comparing Rapiscan to adenosine achieved statistical significance: (1) a summed score of both the presence and severity of the symptom groups of flushing, chest pain, and dyspnoea was lower with Rapiscan (0.9 ± 0.03) than with adenosine (1.3 ± 0.05); and (2) the symptom groups of flushing (21% vs 32%), chest pain (28% vs 40%), and 'throat, neck or jaw pain' (7% vs 13%) were less frequent with Rapiscan; the incidence of headache (25% vs 16%) was more frequent with Rapiscan.

Paediatric population

The European Medicines Agency has deferred the obligation to submit the results of studies with Rapiscan in one or more subsets of the paediatric population with myocardial perfusion disturbances (see section 4.2 for information on paediatric use).

5.2 Pharmacokinetic Properties

Absorption

Rapiscan is administered by intravenous injection. The regadenoson plasma concentration-time profile in healthy volunteers is multi-exponential in nature and best characterised by 3

Distribution

Regadenoson is moderately bound to human plasma proteins (25

Biotransformation

The metabolism of regadenoson is unknown in humans. Incubation with rat, dog, and human liver microsomes as well as human hepatocytes produced no detectable metabolites of regadenoson. Following intravenous administration of ¹⁴C

Elimination

In healthy volunteers, 57% of the regadenoson dose is excreted unchanged in the urine (range 19

Special populations

A population pharmacokinetic analysis including data from subjects and patients demonstrated that regadenoson clearance decreases in parallel with a reduction in creatinine clearance (CLcr) and increases with increased body weight. Age, gender, and race have minimal effects on the pharmacokinetics of regadenoson.

Renal impairment

The disposition of regadenoson was studied in 18 subjects with various degrees of renal function and in 6 healthy subjects. With increasing renal impairment, from mild (CLcr 50 to < 80 ml/min) to moderate (CLcr 30 to < 50 ml/min) to severe renal impairment (CLcr < 30 ml/min), the fraction of regadenoson excreted unchanged in urine and the renal clearance decreased, resulting in increased elimination half-lives and AUC values compared to healthy subjects (CLcr

The pharmacokinetics of regadenoson in patients on dialysis has not been assessed.

Hepatic impairment

Greater than 55% of the regadenoson dose is excreted unchanged in the urine and factors that decrease clearance do not affect the plasma concentration in the early stages after dosing when clinically meaningful pharmacologic effects are observed. The pharmacokinetic parameters of regadenoson have not been specifically evaluated in those with varying degrees of hepatic impairment. However, post

Elderly patients

Based on a population pharmacokinetic analysis, age has a minor influence on the pharmacokinetics of regadenoson. No dose adjustment is needed in elderly patients.

Paediatric population

The pharmacokinetic parameters of regadenoson have not yet been studied in the paediatric population (< 18 years).

5.3 Preclinical Safety Data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity, genotoxicity, or embryo-fetal development. Signs of maternal and fetal toxicity were seen in rats and rabbits (reduced fetal weights, delays in ossification [rats], reduced litter size and number of live fetuses [rabbits]), but not teratogenicity. Fetal toxicity was noted following repeated daily administration of regadenoson, but at doses sufficiently in excess of the recommended human dose. Fertility and pre

6. Pharmaceutical Particulars

6.1 List Of Excipients

Disodium phosphate dihydrate

Sodium dihydrogen phosphate monohydrate

Propylene glycol

Disodium edetate

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

42 months

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

5 ml solution in a single use Type 1 glass vial with (butyl) rubber stopper and aluminium over

Pack size of 1.

6.6 Special Precautions For Disposal And Other Handling

This medicinal product should be inspected visually for particulate matter and discolouration prior to administration.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Gilead Sciences International Limited

Cambridge

CB21 6GT

United Kingdom

8. Marketing Authorisation Number(S)

EU/1/10/643/001

9. Date Of First Authorisation/Renewal Of The Authorisation

06/09/2010

10. Date Of Revision Of The Text

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu

Anorex-SR

Generic Name: phendimetrazine (fen di MEH tra zeen)

Brand Names: Adipost, Bontril PDM, Bontril Slow Release, Melfiat

What is Anorex-SR (phendimetrazine)?

Phendimetrazine is similar to an amphetamine. Phendimetrazine stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite.

Phendimetrazine is used as a short-term supplement to diet and exercise in the treatment of obesity.

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

What is the most important information I should know about Anorex-SR (phendimetrazine)?

Phendimetrazine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Phendimetrazine may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Do not stop using phendimetrazine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using phendimetrazine. Do not crush, chew, break, or open the extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

What should I discuss with my healthcare provider before taking Anorex-SR (phendimetrazine)?

Do not use phendimetrazine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to phendimetrazine, or if you have:

• 
  

  coronary artery disease (hardening of the arteries);

  
  


• 
  

  heart disease;

  
  


• 
  

  severe or uncontrolled high blood pressure;

  
  


• 
  

  heart murmur or heart valve disorder;

  
  


• 
  

  pulmonary arterial hypertension (PAH);

  
  


• 
  

  overactive thyroid;

  
  


• 
  

  glaucoma;

  
  


• 
  

  severe agitation or nervousness;

  
  


• 
  

  if you have a history of drug or alcohol abuse; or

  
  


• 
  

  if you are allergic to other diet pills, amphetamines, stimulants, or cold medications.

  
  

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

• 
  

  high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  an anxiety disorder;

  
  


• 
  

  epilepsy or seizure disorder; or

  
  


• 
  

  if you have used other diet pills in the past year (prescription, over-the-counter, or herbal products).

  
  

It is not known whether phendimetrazine will harm an unborn baby. Do not take phendimetrazine without first talking to your doctor if you are pregnant. It is also not known whether phendimetrazine passes into breast milk. Do not take phendimetrazine without first talking to your doctor if you are breast-feeding a baby.

How should I take Anorex-SR (phendimetrazine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Phendimetrazine should be taken only for a short time, such as a few weeks.

Phendimetrazine is usually taken once daily. Follow your doctor's instructions.

Take phendimetrazine on an empty stomach, 30 to 60 minutes before your morning meal. Do not crush, chew, break, or open the extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. You should lose at least 4 pounds during the first 4 weeks of taking phendimetrazine and eating a low calorie diet. Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks. Do not stop using phendimetrazine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using phendimetrazine. Never take more of this medication than is prescribed for you. Too much phendimetrazine could be very dangerous to your health. Talk with your doctor if you have increased hunger or if you otherwise think the medication is not working properly. Taking more of this medication will not make it more effective and can cause serious, life-threatening side effects. Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

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

A dose taken too late in the day will cause insomnia.

What happens if I overdose?

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

Overdose symptoms of a phendimetrazine overdose include nausea, vomiting, diarrhea, stomach cramps, confusion, panic, hallucinations, extreme restlessness, feeling tired or depressed, ringing in your ears, chest pain, slow heart rate, weak pulse, fainting, seizure, or slow breathing (breathing may stop).

What should I avoid while taking Anorex-SR (phendimetrazine)?

Phendimetrazine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Anorex-SR (phendimetrazine) side effects

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

• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  chest pain, feeling like you might pass out;

  
  


• 
  

  swelling in your ankles or feet;

  
  


• 
  

  pounding heartbeats or fluttering in your chest;

  
  


• 
  

  confusion or irritability, unusual thoughts or behavior;

  
  


• 
  

  feelings of extreme happiness or sadness; or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  feeling restless or hyperactive;

  
  


• 
  

  headache, dizziness, tremors;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  flushing (warmth, redness, or tingly feeling);

  
  


• 
  

  dry mouth;

  
  


• 
  

  diarrhea or constipation, upset stomach; or

  
  


• 
  

  increased or decreased interest in sex, impotence.

  
  

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

What other drugs will affect Anorex-SR (phendimetrazine)?

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

• 
  

  insulin; or

  
  


• 
  

  any other diet pills.

  
  

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

More Anorex-SR resources

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

• Phendimetrazine Prescribing Information (FDA)


• Bontril PDM Advanced Consumer (Micromedex) - Includes Dosage Information


• Bontril PDM MedFacts Consumer Leaflet (Wolters Kluwer)


• Phendimetrazine Tartrate Monograph (AHFS DI)

Compare Anorex-SR with other medications

• Obesity

Where can I get more information?

• Your pharmacist can provide more information about phendimetrazine.

See also: Anorex-SR side effects (in more detail)

Lotrimin AF Powder

Pronunciation: mi-KON-a-zole
Generic Name: Miconazole
Brand Name: Examples include Lotrimin AF and Zeasorb-AF

Lotrimin AF Powder is used for:

Treating athlete's foot, jock itch, or ringworm and relieving the itching, scaling, burning, and discomfort due to those conditions. It may also be used for other conditions as determined by your doctor.

Lotrimin AF Powder is an antifungal. It works by weakening the fungal cell membrane, which kills the fungus.

Do NOT use Lotrimin AF Powder if:

• you are allergic to any ingredient in Lotrimin AF Powder

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

Before using Lotrimin AF Powder:

Some medical conditions may interact with Lotrimin AF Powder. 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

Some MEDICINES MAY INTERACT with Lotrimin AF Powder. Because little, if any, of Lotrimin AF Powder is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lotrimin AF Powder 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 Lotrimin AF Powder:

Use Lotrimin AF Powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Clean the affected area and dry it thoroughly.


• Sprinkle a thin layer of medicine over the entire affected area in the morning and evening unless otherwise directed by your doctor.


• Wash hands immediately after using Lotrimin AF Powder unless your hands are part of the treated area.


• For athlete's foot, pay special attention to the area between the toes. Wear well-fitting, ventilated shoes, and change your shoes and socks at least once daily.


• To clear up your infection completely, continue using Lotrimin AF Powder for the full course of treatment even if you feel better in a few days.


• Supervise children in the use of this product.


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

Ask your health care provider any questions you may have about how to use Lotrimin AF Powder.

Important safety information:

• Lotrimin AF Powder is for external use only. Avoid contact with the eyes. If you get Lotrimin AF Powder in your eyes, rinse them immediately with a generous amount of cool water.


• If Lotrimin AF Powder is swallowed, contact a doctor or poison control center immediately.


• Do not cover the treated area with a bandage or dressing unless directed otherwise by your doctor.


• If there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks, or if your condition persists, contact your health care provider.


• Lotrimin AF Powder is not effective on the scalp or nails.


• Do not use on CHILDREN younger than 2 years of age unless directed by a doctor.


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

Possible side effects of Lotrimin AF Powder:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); irritation.

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.

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 Lotrimin AF Powder:

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

General information:

• If you have any questions about Lotrimin AF Powder, please talk with your doctor, pharmacist, or other health care provider.


• Lotrimin AF Powder 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 Lotrimin AF Powder. 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 Lotrimin AF resources

• Lotrimin AF Use in Pregnancy & Breastfeeding
• Lotrimin AF Drug Interactions
• Lotrimin AF Support Group
• 1 Review for Lotrimin AF - Add your own review/rating

Compare Lotrimin AF with other medications

• Tinea Pedis

Imodium akut

Imodium akut may be available in the countries listed below.

Ingredient matches for Imodium akut

Loperamide

Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Imodium akut in the following countries:

• Germany

Simeticone

Simeticone is reported as an ingredient of Imodium akut in the following countries:

• Germany

International Drug Name Search

Prenate DHA

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Prenate DHA (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

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

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins side effects

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

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

• 
  

  upset stomach;

  
  


• 
  

  headache; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

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

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

• 
  

  diuretics (water pills);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  tretinoin (Vesanoid);

  
  


• 
  

  isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

  
  


• 
  

  trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

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

More Prenate DHA resources

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

• Prenate DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)


• CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal Assure Prescribing Information (FDA)


• CitraNatal Harmony Prescribing Information (FDA)


• Concept DHA Prescribing Information (FDA)


• Docosavit Prescribing Information (FDA)


• Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)


• Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)


• Natelle One Prescribing Information (FDA)


• Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)


• OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)


• PreNexa Prescribing Information (FDA)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)


• Prenate Elite Prescribing Information (FDA)


• Prenate Elite tablets


• Prenate Essential Prescribing Information (FDA)


• PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)


• PrimaCare ONE capsules


• PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Prescribing Information (FDA)


• Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• TriAdvance Prescribing Information (FDA)


• Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Triveen-PRx RNF Prescribing Information (FDA)


• UltimateCare ONE NF Prescribing Information (FDA)


• Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)


• Vinate AZ Prescribing Information (FDA)


• Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Zatean-CH Prescribing Information (FDA)

Compare Prenate DHA with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

• Your pharmacist can provide more information about prenatal vitamins.

See also: Prenate DHA side effects (in more detail)

Lotrel

Generic Name: amlodipine and benazepril (Oral route)

am-LOE-di-peen BES-i-late, ben-AZ-e-pril hye-droe-KLOR-ide

Oral route(Capsule)

When pregnancy is detected, discontinue amlodipine besylate/benazepril hydrochloride as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus .

Commonly used brand name(s)

In the U.S.

• Lotrel

Available Dosage Forms:

• Capsule

Therapeutic Class: ACE Inhibitor/Calcium Channel Blocker Combination

Pharmacologic Class: Amlodipine

Chemical Class: Amlodipine

Uses For Lotrel

Amlodipine and benazepril is a combination of medicines that is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

Benazepril is an angiotensin-converting enzyme (ACE) inhibitor. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, benazepril relaxes blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

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

Before Using Lotrel

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 amlodipine and benazepril 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 amlodipine and benazepril combination in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving amlodipine and benazepril combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Amlodipine

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.

Benazepril

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is 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.

• Alteplase, Recombinant


• Amiloride


• Amiodarone


• Atazanavir


• Azathioprine


• Azilsartan Medoxomil


• Candesartan Cilexetil


• Canrenoate


• Conivaptan


• Dantrolene


• Droperidol


• Eplerenone


• Eprosartan


• Losartan


• Olmesartan Medoxomil


• Potassium


• Simvastatin


• Spironolactone


• Telaprevir


• Telmisartan


• Triamterene


• Valsartan

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


• Aceclofenac


• Acemetacin


• Alclofenac


• Aliskiren


• Alprenolol


• Apazone


• Atenolol


• Azosemide


• Bemetizide


• Bendroflumethiazide


• Benoxaprofen


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bromfenac


• Bucindolol


• Bufexamac


• Bumetanide


• Bupivacaine


• Buthiazide


• Capsaicin


• Carprofen


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorthalidone


• Clometacin


• Clonixin


• Clopamide


• Clopidogrel


• Cyclopenthiazide


• Cyclothiazide


• Dalfopristin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dilevalol


• Diltiazem


• Dipyrone


• Droxicam


• Esmolol


• Ethacrynic Acid


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Fluconazole


• Flufenamic Acid


• Flurbiprofen


• Furosemide


• Gold Sodium Thiomalate


• Hydrochlorothiazide


• Hydroflumethiazide


• Ibuprofen


• Imatinib


• Indapamide


• Indinavir


• Indomethacin


• Indoprofen


• Isoxicam


• Itraconazole


• Ketoconazole


• Ketoprofen


• Ketorolac


• Labetalol


• Levobunolol


• Lithium


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Nabumetone


• Nadolol


• Naproxen


• Nebivolol


• Nesiritide


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxprenolol


• Oxyphenbutazone


• Penbutolol


• Phenylbutazone


• Pindolol


• Pirazolac


• Piretanide


• Piroxicam


• Pirprofen


• Polythiazide


• Propranolol


• Propyphenazone


• Proquazone


• Quinethazone


• Quinupristin


• Rifapentine


• Ritonavir


• Sotalol


• St John's Wort


• Sulindac


• Suprofen


• Talinolol


• Tenidap


• Tenoxicam


• Tertatolol


• Tiaprofenic Acid


• Timolol


• Tolmetin


• Torsemide


• Trichlormethiazide


• Xipamide


• Zomepirac

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:

• Angina (chest pain) or


• Heart attack, acute or


• Heart or blood vessel disease (e.g., coronary artery disease) or


• Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

• Angioedema (swelling of the face, lips, tongue, or throat), history of—Should not be used in patients with these conditions.

• Bee-sting allergy treatments or


• Dialysis—Increased risk of serious allergic reaction occurring.

• Dehydration or


• Heart failure or other heart problems (e.g., aortic stenosis) or


• Hyponatremia (low sodium in the blood) or


• Hypovolemia (low blood volume)—Use with caution. The blood pressure-lowering effects of this medicine may be increased.

• Diabetes—Increased risk of potassium levels in the body becoming too high.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Kidney disease, severe or


• Scleroderma (an autoimmune disease) or


• Systemic lupus erythematosus (SLE), history of—Increased risk of blood problems caused by ACE inhibitors.

Proper Use of Lotrel

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and a change in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

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 (capsules):
  
  • For high blood pressure:
    
    • Adults—At first, one capsule containing 2.5 milligrams (mg) of amlodipine and 10 mg of benazepril once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 mg of amlodipine and 40 mg of benazepril per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Lotrel

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions including 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, lips, tongue, or throat while you are using this medicine.

Check with your doctor right away if you have a strong stomach pain (with or without nausea or vomiting). This could be a symptom of a condition called intestinal angioedema.

Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert.

Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.

Check with your doctor if you notice any signs of fever, sore throat, or chills. These could be symptoms of an infection resulting from low white blood cell counts.

Check with your doctor if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water, possibly resulting in low blood pressure.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

In some patients, tenderness, swelling, or bleeding of the gums may appear soon after treatment with this medicine is started. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine.

Black patients may be less sensitive to the blood pressure-lowering effects of this medicine. In addition, the risk of a serious allergic reaction involving swelling of the face, mouth, hands, or feet may be increased.

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.

Lotrel 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

• Dizziness, lightheadedness, or fainting


• swelling of the ankles, feet, or lower legs

Signs and symptoms of too much potassium in the body

• Confusion


• irregular heartbeat


• nervousness


• numbness or tingling in the hands, feet, or lips


• shortness of breath


• weakness or heaviness of the legs

Rare

• Bleeding gums


• blisters in the mouth spreading to the trunk, scalp, or other areas


• chills


• fever


• nausea or vomiting


• nosebleeds


• pale skin


• sore throat


• sores in the mouth, or on the arms, feet, hands, legs, or lips (sudden)


• stomach pain or bloating with fever, nausea, or vomiting


• swelling of the face, mouth, hands, or feet


• trouble with swallowing or breathing (sudden) or hoarseness


• unusual bleeding or bruising


• unusual tiredness or weakness


• yellow eyes or skin

Incidence not known

• Chest pain


• difficulty with swallowing


• heartburn


• pain or burning in the throat


• sores, ulcers, or white spots on the lips, tongue, or inside the mouth

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

• Awareness of heartbeat


• cough (dry, continuing)


• feeling of warmth


• redness of the face, neck, arms, and occasionally upper chest


• sleepiness

Incidence not known

• Acid or sour stomach


• belching


• blistering, crusting, irritation, itching, or reddening of the skin


• body aches or pain


• congestion


• cracked, dry, or scaly skin


• decreased interest in sexual intercourse


• difficulty having a bowel movement (stool)


• fear


• frequent urination


• inability to have or keep an erection


• increased volume of pale, dilute urine


• indigestion


• lack or loss of strength


• loss in sexual ability, desire, drive, or performance


• muscle or bone pain


• runny nose


• shakiness in the legs, arms, hands, or feet


• sleeplessness


• small lump under the skin


• stomach discomfort or upset


• sudden sweating


• swelling


• tender, swollen glands in the neck


• trembling or shaking of the hands or feet


• trouble with sleeping


• trouble with swallowing


• unable to sleep


• voice changes

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: Lotrel side effects (in more detail)

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

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

More Lotrel resources

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

• Lotrel Prescribing Information (FDA)


• Lotrel MedFacts Consumer Leaflet (Wolters Kluwer)


• Lotrel Consumer Overview

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