Telmisartan and amlodipine

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 telmisartan and amlodipine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to telmisartan and amlodipine 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 telmisartan and amlodipine 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 telmisartan and amlodipine combination in the elderly.

Pregnancy

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 telmisartan and amlodipine, 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 telmisartan and amlodipine 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.

• Aliskiren

Using telmisartan and amlodipine 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.

• Amiodarone
• Atazanavir
• Benazepril
• Captopril
• Ceritinib
• Clarithromycin
• Clopidogrel
• Conivaptan
• Cyclosporine
• Dantrolene
• Digoxin
• Domperidone
• Droperidol
• Eliglustat
• Enalapril
• Enalaprilat
• Fosinopril
• Idelalisib
• Lacosamide
• Lisinopril
• Lithium
• Moexipril
• Netupitant
• Perindopril
• Piperaquine
• Quinapril
• Ramipril
• Simvastatin
• Tacrolimus
• Tegafur
• Telaprevir
• Trandolapril
• Trimethoprim

Using telmisartan and amlodipine 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.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indinavir
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

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 telmisartan and amlodipine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina (severe chest pain) or
• Electrolyte imbalances (e.g., low sodium in the body) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Heart attack, recent or
• Heart problems (e.g., aortic stenosis, heart failure) or
• Kidney problems—Use with caution. May make these conditions worse.

• Congestive heart failure, severe—Use may lead to kidney problems.

• Diabetes patients or those with kidney problems who are also taking aliskiren (Tektuna®)—Should not be used in these patients.

• Heart or blood vessel disease (e.g., severe obstructive coronary artery disease)—Use with caution. May increase the risk of experiencing chest pain or heart attacks.

• Liver disease (including biliary obstructive disorders)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• chills
• cough
• difficulty breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• rapid weight gain
• runny nose
• sneezing
• sore throat
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss

• Bladder pain
• bloody or cloudy urine
• blurred vision
• chest pain
• diarrhea
• difficult, burning, or painful urination
• dizziness
• frequent urge to urinate
• general feeling of discomfort or illness
• joint pain
• loss of appetite
• lower back or side pain
• muscle aches and pains
• nausea
• nervousness
• pounding in the ears
• shivering
• slow or fast heartbeat
• sweating
• trouble sleeping
• vomiting

• Abdominal or stomach pain
• arm, back, or jaw pain
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest tightness or heaviness
• cold sweats
• confusion
• constipation
• cough or hoarseness
• dark urine
• difficult or labored breathing
• difficulty swallowing
• dry mouth
• extreme fatigue
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• flushed, dry skin
• fruit-like breath odor
• hives
• increased hunger
• increased sweating
• increased thirst
• increased volume of pale, dilute urine
• irregular heartbeat
• irritation in the mouth
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lightheadedness, dizziness, or fainting
• loss of consciousness
• muscle cramps or stiffness
• pale, bluish-colored, or cold hands or feet
• pinpoint red spots on the skin
• rash
• redness and swelling of the gums
• redness, soreness, or itching skin
• severe or sudden headache
• sudden loss of coordination
• sudden slurring of speech
• swollen glands
• tightness in the chest
• trembling or shaking of the hands or feet
• unexplained weight loss
• unusual bleeding or bruising
• vomiting of blood
• weakness in the arms, hands, legs, or feet
• weight gain
• yellow eyes or skin

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:

• Acid or sour stomach
• belching
• difficulty with moving
• heartburn
• indigestion
• pain or tenderness around the eyes and cheekbones
• sleepiness or unusual drowsiness

• Abnormal dreams
• ankle, knee, or great toe joint pain
• anxiety
• bad, unusual, or unpleasant (after) taste
• bleeding after defecation
• blistering, crusting, irritation, itching, or reddening of the skin
• bloody nose
• burning feeling in the chest or stomach
• burning, dry, or itching eyes
• changes in vision
• cold and clammy skin
• continuing ringing or buzzing or other unexplained noise in the ears
• cough producing mucus
• cracked, dry, or scaly skin
• decreased sexual performance or desire
• depression
• dry mouth
• earache
• excess air or gas in the stomach or intestines
• feeling of constant movement of self or surroundings
• feeling of warmth
• full feeling
• hair loss or thinning of the hair
• headache, severe and throbbing
• hearing loss
• hives or welts
• hyperventilation
• inability to have or keep an erection
• increased appetite
• irritability
• lack of feeling or emotion
• lack or loss of strength
• loose stools
• loss of memory
• redness of the skin
• redness or swelling in the ear
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• restlessness
• tenderness in the stomach area
• toothache
• uncomfortable swelling around the anus

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.

• It is used to treat high blood pressure.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Stiff muscles, shakiness, or muscle movements that are not normal.

Telmisartan

Limited data are available with regard to overdosage in humans. The most likely manifestations of overdosage with telmisartan tablets would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Telmisartan is not removed by hemodialysis.

Amlodipine

Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of amlodipine is limited.

Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m2 basis) caused a marked peripheral vasodilation and hypotension.

If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.

See FDA-Approved Patient Labeling

Pregnancy

Female patients of childbearing age should be told about the consequences of exposure to Telmisartan and Amlodipine tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible [see WARNINGS AND PRECAUTIONS (5.1)].

® The brands listed are trademarks of their respective owners and are not trademarks of AvKARE, Inc. The makers of these brands are not affiliated with and do not endorse AvKARE, Inc. or its products.

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478

Mfg. Rev. 12/16

AV 03/17 (P)

Patient Information

Telmisartan and Amlodipine Tablets,

(TEL-mi-SAR-tan And am-LOE-di-peen)

40 mg/5 mg, 40 mg/ 10 mg, 80 mg/5 mg and 80 mg /10 mg

Rx only

Read this Patient Information before you start taking Telmisartan and Amlodipine tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about Telmisartan and Amlodipine Tablets?

Telmisartan and Amlodipine tablets can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking Telmisartan and Amlodipine tablets, tell your doctor right away.

What is Telmisartan and Amlodipine Tablet?

Telmisartan and Amlodipine tablet is a prescription medicine that contains Telmisartan and Amlodipine. Telmisartan and Amlodipine tablets may be used to treat high blood pressure (hypertension):

• when one of these medicines (or a similar one) is not enough to lower your high blood pressure
• as the first medicine to lower your high blood pressure if your doctor decides you are likely to need more than one medicine

It is not known if Telmisartan and Amlodipine tablets are safe and effective in children.

Who should not take Telmisartan and Amlodipine Tablets?

You should not take Telmisartan and Amlodipine tablets if you are allergic (hypersensitive) to the active ingredients (telmisartan or amlodipine) or any of the other ingredients listed at the end of this leaflet.

For patients with diabetes, if you are taking Telmisartan and Amlodipine tablets you should not take aliskiren.

What should I tell my doctor before taking Telmisartan and Amlodipine Tablets?

Before you take Telmisartan and Amlodipine tablets, tell your doctor if you:

• have liver problems
• have kidney problems
• have heart problems
• have any other medical conditions
• are pregnant or are planning to become pregnant. See "What is the most important information I should know about Telmisartan and Amlodipine tablets ?"
• are breast-feeding or plan to breast-feed. It is not known if Telmisartan and Amlodipine passes into your breast milk. You and your doctor should decide if you will take Telmisartan and Amlodipine tablets or breast-feed. You should not do both. Talk with your doctor about the best way to feed your baby if you take Telmisartan and Amlodipine tablets.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements.

For patients with diabetes, if you are taking Telmisartan and Amlodipine tablets you should not take aliskiren.

Telmisartan and Amlodipine tablets may affect the way other medicines work, and other medicines may affect how Telmisartan and Amlodipine tablets works. Especially tell your doctor if you take:

• aliskiren
• digoxin (Lanoxin®, Lanoxicaps®)
• lithium (Eskalith®, Lithobid®)
• medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors
• ramipril (Altace®) or other medicines that may be used to treat high blood pressure or a heart problem
• simvastatin (Zocor®, Vytorin®)
• water pills (diuretics)

Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine.

How should I take Telmisartan and Amlodipine Tablets?

• Take Telmisartan and Amlodipine tablets exactly as your doctor tells you to take it.
• Your doctor will tell you how much Telmisartan and Amlodipine tablets to take and when to take it. Your doctor may change your dose if needed.
• Take Telmisartan and Amlodipine tablets one time each day at the same time.
• Take Telmisartan and Amlodipine tablets with or without food.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.
• If you take too much Telmisartan and Amlodipine tablets, call your doctor or go to the nearest hospital emergency room right away.

What are possible side effects of Telmisartan and Amlodipine Tablets?

Telmisartan and Amlodipine tablets may cause serious side effects, including:

• Injury or death to your unborn baby. See "What is the most important information I should know about Telmisartan and Amlodipine tablets? "
• Low blood pressure (hypotension) is most likely to happen if you also:

       • take water pills (diuretics)

       • are on a low-salt diet

       • get dialysis treatments

       • have heart problems

       • get sick with vomiting or diarrhea

If you feel faint or dizzy, lie down and call your doctor right away.

• Kidney problems. Kidney problems may get worse if you already have kidney disease. You may have changes in your kidney test results, and you may need a lower dose of Telmisartan and Amlodipine tablets. Call your doctor if you get:
  • swelling in your feet, ankles, or hands
  • unexplained weight gain

Call your doctor right away if you get any of the symptoms listed above.

• Heart problems or heart attack. Heart problems may get worse in people that already have heart disease. This may happen when you start Telmisartan and Amlodipine tablets or when there is an increase in your dose of Telmisartan and Amlodipine tablets. Get emergency help if you get worse chest pain or chest pain that does not go away.
• High potassium in the blood (hyperkalemia). Your doctor may check your potassium levels as needed.
• Muscle rigidity, tremor and/or abnormal muscle movement.

Rare, serious allergic reactions may happen. Tell your doctor right away if you get any of these symptoms:

• swelling of face, tongue, throat
• difficulty breathing
• skin rash

The most common side effects of Telmisartan and Amlodipine tablets  include:

• swelling in your hands, ankles, or feet
• feeling like your heart is pounding or racing
• flushing or sudden redness of the face and neck
• dizziness
• back pain
• feeling tired or sleepy
• abdominal pain, nausea, or diarrhea
• low blood pressure or a sudden drop in blood pressure with fainting

These are not all the possible side effects of Telmisartan and Amlodipine tablets. Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Telmisartan and Amlodipine Tablets?

• Store Telmisartan and Amlodipine tablets between 59 to 86°F (15 to 30°C).
• Do not remove Telmisartan and Amlodipine tablets from blisters until right before you take them.
• Keep Telmisartan and Amlodipine tablets out of the light and away from moisture.

Keep Telmisartan and Amlodipine tablets and all medicines out of the reach of children. General information about Telmisartan and Amlodipine tablets

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Telmisartan and Amlodipine tablets for a condition for which it was not prescribed. Do not give Telmisartan and Amlodipine tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Telmisartan and Amlodipine tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Telmisartan and Amlodipine tablets that is written for health professionals. For more information, contact AvKARE, Inc at 1-855-361-3993, or email drugsafety@avkare.com.

What are the ingredients in Telmisartan and Amlodipine Tablets?

Active ingredients: Telmisartan and Amlodipine besylate

Inactive ingredients: colloidal silicon dioxide, crosscarmellose sodium, ferric oxide red, ferric oxide yellow, mannitol, magnesium stearate, povidone, sodium hydroxide and sodium starch glycolate.

What is high blood pressure (hypertension)?

Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. Telmisartan and Amlodipine tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.

High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.

® The brands listed are trademarks of their respective owners and are not trademarks of AvKARE, Inc. The makers of these brands are not affiliated with and do not endorse AvKARE, Inc. or its products.

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478

Mfg. Rev. 02/16

AV 03/17 (P)                 

No dosage adjustment necessary. Titrate slowly in severe impairment.

Hemodialysis: Telmisartan and amlodipine: Nondialyzable

Avoid salt substitutes which may contain potassium.

Reactions/percentages reported with combination product; also see individual agents.

>10%: Cardiovascular: Peripheral edema (dose related: 1% to 11%)

1% to 10%:

Cardiovascular: Orthostatic hypotension (6%), edema (<2%), hypotension (<2%), syncope (<2%)

Central nervous system: Dizziness (3%)

Neuromuscular & skeletal: Back pain (2%)

Concerns related to adverse effects:

• Angioedema: Angioedema has been reported rarely with some angiotensin II receptor antagonists (ARBs) and may occur at any time during treatment (especially following first dose). It may involve the head and neck (potentially compromising airway) or the intestine (presenting with abdominal pain). Patients with idiopathic or hereditary angioedema or previous angioedema associated with ACE-inhibitor therapy may be at an increased risk. Prolonged frequent monitoring may be required, especially if tongue, glottis, or larynx are involved, as they are associated with airway obstruction. Patients with a history of airway surgery may have a higher risk of airway obstruction. Discontinue therapy immediately if angioedema occurs. Aggressive early management is critical. Intramuscular (IM) administration of epinephrine may be necessary. Do not readminister to patients who have had angioedema with ARBs.

• Angina/MI: Increased angina and/or MI have occurred with initiation or dosage titration of amlodipine. Reflex tachycardia may occur resulting in angina and/or MI in patients with obstructive coronary disease, especially in the absence of concurrent beta-blockade.

• Hyperkalemia: May occur with telmisartan use; risk factors include renal dysfunction, diabetes mellitus, concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium containing salts. Use cautiously, if at all, with these agents and monitor potassium closely.

• Hypotension: Symptomatic hypotension may occur upon initiation in patients who are salt- or volume-depleted (eg, those treated with high-dose diuretics); correct volume depletion prior to administration. Use caution during initiation of therapy, particularly in patients with heart failure, volume or salt depletion, severe aortic stenosis, or in post-MI patients or those undergoing surgery or dialysis. This transient hypotensive response is not a contraindication to further treatment with telmisartan/amlodipine.

• Peripheral edema: The most common side effect of amlodipine is peripheral edema; occurs within 2 to 3 weeks of starting therapy.

• Renal function deterioration: Telmisartan may be associated with deterioration of renal function and/or increases in serum creatinine, particularly in patients with low renal blood flow (eg, renal artery stenosis, heart failure) whose glomerular filtration rate (GFR) is dependent on efferent arteriolar vasoconstriction by angiotensin II; deterioration may result in oliguria, acute renal failure, and progressive azotemia. Small increases in serum creatinine may occur following initiation; consider discontinuation only in patients with progressive and/or significant deterioration in renal function.

Disease-related concerns:

• Aortic/mitral stenosis: Use with caution in patients with severe aortic stenosis or significant aortic/mitral stenosis; may reduce coronary perfusion resulting in ischemia.

• Heart failure (HF): Use caution when initiating in HF; may need to adjust dose, and/or concurrent diuretic therapy.

• Hepatic impairment: Use with caution in patients who have biliary obstructive disorders or hepatic impairment; amlodipine and telmisartan clearance is decreased so initiation at the lowest dose is recommended; the appropriate dose for hepatic impairment is not available in combination dosage form, therefore, initiation of treatment with this product is not recommended in patients with hepatic impairment.

• Hypertrophic cardiomyopathy (HCM) with outflow tract obstruction: Use amlodipine with caution in patients with HCM and outflow tract obstruction since reduction in afterload may worsen symptoms associated with this condition (ACCF/AHA [Gersh 2011]).

• Renal artery stenosis: Use telmisartan with caution in patients with unstented unilateral/bilateral renal artery stenosis. When unstented bilateral renal artery stenosis is present, use is generally avoided due to the elevated risk of deterioration in renal function unless possible benefits outweigh risks.

• Renal impairment: Use with caution in patients with renal impairment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Not recommended for initial therapy in patients ≥75 years of age. The appropriate combination dose is not available.

• Pregnancy: [US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected.

• Surgical patients: In patients on chronic angiotensin receptor blocker (ARB) therapy, intraoperative hypotension may occur with induction and maintenance of general anesthesia; however, discontinuation of therapy prior to surgery is controversial. If continued preoperatively, avoidance of hypotensive agents during surgery is prudent (Hillis, 2011).

Dosage forms specific issues:

• Sorbitol: Some products may contain sorbitol.