Sunday, September 29, 2013
MEDICINE
AMLODIPINE
TYPICAL USAGE: Mild to moderate hypertension. Angina pectoris. Prinzmetals angina.
SIDE EFFECTS: Headache, peripheral oedema, fatigue, somnolence, nausea, abdominal pain, flushing, dyspepsia, palpitations, dizziness. Rarely pruritus, rash, dyspnoea, asthenia, muscle cramps. Potentially Fatal: Hypotension, bradycardia, conductive system delay and CCF.
DRUG INTERACTION: Increased metabolism with rifampin. Reduced hypotensive effect with calcium. Potentiates effects of thiazide diuretics and ACE inhibitors. Avoid combination with ?-blockers in patients with markedly impaired left ventricular function. May increase serum levels of CYP1A2 substrates e.g. aminophylline, fluvoxamine, ropinirole. CYP3A4 inhibitors (e.g. clarithromycin, doxycycline, isoniazid, nicardipine) may increase the effects of amlodipine. Additive BP-lowering effects when used with sildenafil, tadalafil or vardenafil.
MECHANISM OF ACTION: Amlodipine relaxes peripheral and coronary vascular smooth muscle. It produces coronary vasodilation by inhibiting the entry of Ca ions into the voltage-sensitive channels of the vascular smooth muscle and myocardium during depolarisation. It also increases myocardial O2 delivery in patients with vasospastic angina.
For the Consumer
Applies to amlodipine: oral tablet, oral tablet disintegrating
Along with its needed effects, amlodipine 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 while taking amlodipine:
More common
- Swelling of the ankles or feet
Less common
- Difficult or labored breathing
- dizziness
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth
- redness of the face, neck, arms, and occasionally, upper chest
- shortness of breath
- tightness in the chest
- wheezing
Rare
- Black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- chills
- cold and clammy skin
- cold sweats
- confusion
- dark yellow urine
- cough
- diarrhea
- dilated neck veins
- dizziness or lightheadedness when getting up from a lying or sitting position
- extra heartbeats
- extreme fatigue
- fainting
- fever
- itching of the skin
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- numbness and tingling of the face, fingers, or toes
- pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
- painful or difficult urination
- pale, bluish-colored, or cold hands or feet
- pinpoint red or purple spots on the skin
- red, irritated eyes
- redness of the face, neck, arms, and occasionally, upper chest
- redness, soreness or itching skin
- shakiness in the legs, arms, hands, or feet
- slow or irregular heartbeat
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sores, welting, or blisters
- sudden sweating
- sweating
- swelling of the face, fingers, feet, or lower legs
- swollen glands
- trembling or shaking of the hands or feet
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- weak or absent pulses in the legs
- weakness in the arms, hands, legs, or feet
- weight gain
- yellow eyes or skin
Incidence not known
- Abdominal or stomach pain
- clay-colored stools
- diarrhea
- headache
- loss of appetite
- nausea
- rash
- unpleasant breath odor
- vomiting of blood
- yellow eyes or skin
Some side effects of amlodipine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Acid or sour stomach
- belching
- heartburn
- indigestion
- lack or loss of strength
- muscle cramps
- sleepiness or unusual drowsiness
- stomach discomfort, upset, or pain
Rare
- Abnormal dreams
- anxiety
- back pain
- bad unusual or unpleasant (after) taste
- bleeding gums
- blistering, crusting, irritation, itching, or reddening of the skin
- bloating
- bloody nose
- burning feeling in the chest or stomach
- burning while urinating
- burning, dry, or itching eyes
- change in color of the treated skin
- change in sense of smell
- change in taste
- changes in vision
- constipation
- continuing ringing or buzzing or other unexplained noise in the ears
- cracked, dry, or scaly skin
- decreased sexual performance or desire
- depression
- difficulty with moving
- difficulty with swallowing
- discharge, excessive tearing
- double vision
- dry mouth
- dryness of the skin
- excess air or gas in the stomach or intestines
- excessive muscle tone
- eye pain
- feeling of constant movement of self or surroundings
- feeling of unreality
- feeling unusually cold
- flushed, dry skin
- fruit-like breath odor
- full feeling
- general feeling of discomfort or illness
- hair loss or thinning of the hair
- headache, severe and throbbing
- hearing loss
- hyperventilation
- increased appetite
- increased hunger
- increased sweating
- increased thirst
- increased urge to urinate during the night
- increased urination
- irritability
- irritation in the mouth
- lack of feeling or emotion
- loose stools
- loss of memory
- muscle pains or stiffness
- muscle tension or tightness
- muscle weakness
- nervousness
- pain
- pains in the stomach, side, or abdomen, possibly radiating to the back
- passing gas
- problems with memory
- redness and swelling of the gums
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- restlessness
- runny nose
- seeing double
- sensation of spinning
- sense of detachment from self or body
- shakiness and unsteady walk
- shivering
- sleeplessness
- sneezing
- stuffy nose
- sweating
- swollen joints
- tenderness in the stomach area
- thirst
- trouble in holding or releasing urine
- trouble sleeping
- twitching
- unable to sleep
- uncaring
- unexplained weight loss
- unsteadiness, trembling, or other problems with muscle control or coordination
- waking to urinate at night
- weight loss
Incidence not known
- Swelling of the breasts or breast soreness in both females and males
For Healthcare Professionals
Applies to amlodipine: oral tablet
General
Amlodipine is generally well-tolerated at dosages up to 10 mg per day. Most side effects reported were of mild or moderate severity and were dose-related. Headache and edema are the most common side effects.
Amlodipine has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.
Amlodipine has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.
Other
Other side effects have included edema (up to 14.6%), flushing (up to 4.5%), fatigue (4.5%), and back pain (up to 2%). During studies in patients with documented coronary artery disease, the most common side effect was peripheral edema. Asthenia, hot flushes, malaise, pain, and rigors have been reported in less than 1% but greater than 0.1% of patients. Cold and clammy skin and parosmia have been reported in less than 0.1% of patients.
Cardiovascular
Cardiovascular side effects have included palpitation (up to 4.5%). Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, postural hypotension, tachycardia, and vasculitis have been reported in less than 1% but greater than 0.1% of patients. Cardiac failure, extrasystoles, and pulse irregularity have been reported in less than 0.1% of patients. Angina and myocardial infarction have occasionally been reported; however, these reactions could not be distinguished from coexisting disease states or medications. Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, especially in patients with severe obstructive coronary artery disease.
Nervous system
Nervous system side effects have included headache (7.3%), dizziness (up to 3.4%), and somnolence (up to 1.6%). Hypoesthesia, paresthesia, peripheral neuropathy, postural dizziness, syncope, tinnitus, tremor, and vertigo have been reported in less than 1% but greater than 0.1% of patients. Ataxia and migraine have been reported in less than 0.1% of patients. Myoclonus has been reported.
Gastrointestinal
Gastrointestinal side effects have included nausea (2.9%), dysphagia (up to 2%), and abdominal pain (1.6%). Anorexia, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gingival hyperplasia, pancreatitis, and vomiting have been reported in less than 1% but greater than 0.1% of patients. Gastritis, increased appetite, loose stools, and taste perversion have been reported in less than 0.1% of patients. At least one case of amlodipine-associated dysgeusia has been reported and confirmed upon rechallenge.
Hematologic
Hematologic side effects have included leukopenia, purpura, and thrombocytopenia in less than 1% but greater than 0.1% of patients.
A case study reports a 34-year-old woman with a history of chronic renal failure secondary to glomerulonephritis, who was started on amlodipine for uncontrolled hypertension. Three days later the patient developed severe thrombocytopenia. After discontinuation of the drug, the platelet count returned to normal.
Hepatic
Hepatic side effects have included jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis) during postmarketing experience. In some instances, these cases were severe enough to require hospitalization.
Metabolic
Metabolic side effects have included hyperglycemia, thirst, weight decrease, and weight gain in less than 1% but greater than 0.1% of patients. New-onset diabetes has been reported. A single case of acute porphyria exacerbation has been associated with the use of amlodipine, and confirmed upon rechallenge in the same patient. Calcium channel blockers have been suggested as possibly unsafe in patients with this condition.
Musculoskeletal
Musculoskeletal side effects have included myalgia (up to 2%). Arthralgia, arthrosis, and muscle cramps have been reported in less than 1% but greater than 0.1% of patients. Hypertonia, muscle weakness, and twitching have been reported in less than 0.1% of patients.
Psychiatric
Psychiatric side effects have included male sexual dysfunction (up to 2%). Abnormal dreams, anxiety, depersonalization, depression, female sexual dysfunction, insomnia, and nervousness have been reported in less than 1% but greater than 0.1% of patients. Agitation, amnesia, and apathy have been reported in less than 0.1% of patients.
Dermatologic
A 62-year-old man with hypertension and psoriasis developed erythema multiforme within three days after starting amlodipine. The rash resolved upon substitution with nifedipine.
Dermatologic side effects have included rash and erythematous rash in up to 2% of patients. Angioedema, erythema multiforme, increased sweating, maculopapular rash, and pruritus have been reported in less than 1% but greater than 0.1% of patients. Alopecia, dermatitis, skin discoloration, skin dryness, and urticaria have been reported in less than 0.1% of patients. Amlodipine-associated lichen planus and telangiectasia have been rarely reported. At least one case of amlodipine-associated bullous pemphigoid (with erythema multiforme-like clinical features) has been reported.
Ocular
Ocular side effects have included abnormal vision, conjunctivitis, diplopia, and eye pain in less than 1% but greater than 0.1% of patients. Abnormal visual accommodation and xerophthalmia have been reported in less than 0.1% of patients.
Respiratory
Respiratory side effects have included epistaxis (up to 2%) and dyspnea (less than 1% but greater than 0.1%). Coughing and rhinitis have been reported in less than 0.1% of patients. Pulmonary edema was reported during a study of patients with NYHA Class III or IV heart failure without clinical symptoms or objective evidence of underlying ischemic disease.
Genitourinary
Genitourinary side effects have included micturition disorder, micturition frequency, and nocturia in less than 1% but greater than 0.1% of patients. Dysuria and polyuria have been reported in less than 0.1% of patients.
Hypersensitivity
Hypersensitivity side effects have included allergic reaction (less than 1% but greater than 0.1%).
Endocrine
In one case, a patient's gynecomastia resolved upon substitution of amlodipine with an unrelated antihypertensive agent.
Endocrine side effects have included gynecomastia during postmarketing experience.
Renal
Renal side effects have been reported rarely. At least one case of interstitial nephritis has been associated with amlodipine therapy.
METFORMIN
Metformin may rarely cause a serious and sometimes fatal condition called lactic acidosis. Most of these cases have occurred in diabetic patients who also have certain kidney problems. The risk of lactic acidosis may be greater if you have liver problems, kidney problems, or heart failure. The risk may also be greater in patients who are elderly or drink alcohol. Lab tests, including kidney function, may be performed while you take metformin.
Do not begin to take metformin if you are 80 years or older unless lab tests show that you do not have decreased kidney function. Do not take it if you have a severe infection, have low blood oxygen levels, or are dehydrated. Tell your doctor you take metformin before you have any surgery or lab procedures.
Contact your doctor right away if you notice symptoms such as muscle pain or tenderness; unusual drowsiness, dizziness, or light-headedness; slow or irregular heartbeat; fast or difficult breathing; unusual stomach discomfort; or unusual weakness or tiredness. Contact your doctor right away if you start to feel unusually cold or if you have a general feeling of being unwell.
Metformin is used for:
Treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.
Metformin is a biguanide antidiabetic. It works by decreasing the amount of sugar that the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.
Do NOT use metformin if:
- you are allergic to any ingredient in metformin
- you have a severe infection, low blood oxygen levels, kidney or liver problems, high blood ketone or acid levels (eg, diabetic ketoacidosis), or dehydration
- you have had a stroke or a recent heart attack, or you are in shock
- you are 80 years or older and have not had a kidney function test
- you will be having surgery or certain lab procedures
Contact your doctor or health care provider right away if any of these apply to you.
Before using metformin:
Some medical conditions may interact with metformin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have heart failure, especially heart failure that is treated by medicine
- if you have a history of heart problems, lung or breathing problems, thyroid problems, stomach or bowel problems (eg, paralysis, blockage), adrenal or pituitary problems, or lactic acidosis
- if you have vomiting, diarrhea, poor health or nutrition, low blood calcium or vitamin B12levels, or anemia, or if you are dehydrated
- if you have an infection, fever, recent injury, or moderate to severe burns
- if you drink alcohol or have a history of alcohol abuse
- if you will be having surgery or certain lab procedures
- if you take a beta-blocker (eg, propranolol)
Some MEDICINES MAY INTERACT with metformin. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Amiloride, cimetidine, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin, or medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, tacrolimus) because they may increase the risk of metformin's side effects. Ask you doctor if you are unsure if any of your medicines might harm the kidney
- Calcium channel blockers (eg, nifedipine), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), insulin, isoniazid, nicotinic acid, phenothiazine (eg, chlorpromazine), phenytoin, sulfonylureas (eg, glipizide), sympathomimetics (eg, albuterol, pseudoephedrine), or thyroid hormones (eg, levothyroxine) because the risk of high or low blood sugar may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if metformin 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 metformin:
Use metformin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with metformin. Talk to your pharmacist if you have questions about this information.
- Take metformin by mouth with food.
- Take metformin on a regular schedule to get the most benefit from it. Taking metformin at the same time each day will help you remember to take it.
- Continue to take metformin even if you feel well. Do not miss any doses.
- If you miss a dose of metformin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use metformin.
Important safety information:
- Metformin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use metformin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it
- Follow the diet and exercise program given to you by your health care provider.
- Do not drink large amounts of alcohol while you take metformin. Talk to your doctor or health care provider before you drink alcohol while you take metformin.
- Tell your doctor or dentist that you take metformin before you receive any medical or dental care, emergency care, or surgery.
- Be careful not to become dehydrated, especially during hot weather or while you are being active. Dehydration may increase the risk of metformin's side effects.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take metformin exactly as prescribed, tell your doctor.
- Metformin does not usually cause low blood sugar. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. It may also be more likely if you take metformin along with certain medicines for diabetes (eg, sulfonylureas, insulin). Tell your doctor right away if you experience symptoms of low blood sugar (eg, fast heartbeat, headache, chills, sweating, tremors, increased hunger, vision changes, nervousness, weakness, dizziness, drowsiness, fainting).
- It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
- Fever, infection, injury, or surgery may increase your risk of high or low blood sugar levels. If any of these occur, check your blood sugar level closely and tell your doctor right away.
- Metformin may commonly cause stomach upset, indigestion, nausea, vomiting, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis.
- Lab tests, including kidney function, fasting blood glucose, hemoglobin A1c, and complete blood cell counts, may be performed while you take metformin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use metformin with caution in the ELDERLY; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to recognize in the elderly.
- Metformin should not be used in CHILDREN younger than 10 years; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking metformin while you are pregnant. It is not known if metformin is found in breast milk. Do not breast-feed while taking metformin.
When used for long periods of time, metformin may not work as well. If your blood sugar has been under control and then becomes hard to manage, contact your doctor. Do not change the dose of your medicine without checking with your doctor.
Possible side effects of metformin:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:Diarrhea; gas; headache; indigestion; nausea; stomach upset; temporary metallic taste; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or discomfort; dizziness or light-headedness; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; general feeling of being unwell; muscle pain or weakness; slow or irregular heartbeat; unusual drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness.
Substitutes for Amlodipine (5 Mg)
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# posted by vyas @ 3:43 AM 
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