Afeditab CR

Excessive Hypotension

Although in most patients the hypotensive effect of nifedipine is modest and well tolerated, occasional patients have had excessive and poorly tolerated hypotension. These responses have usually occurred during initial titration or at the time of subsequent upward dosage adjustment, and may be more likely in patients using concomitant beta-blockers.

Severe hypotension and/or increased fluid volume requirements have been reported in patients who received immediate-release capsules together with a beta-blocking agent and who underwent coronary artery bypass surgery using high dose fentanyl anesthesia. The interaction with high dose fentanyl appears to be due to the combination of nifedipine and a beta-blocker, but the possibility that it may occur with nifedipine alone, with low doses of fentanyl, in other surgical procedures, or with other narcotic analgesics cannot be ruled out. In nifedipine-treated patients where surgery using high dose fentanyl anesthesia is contemplated, the physician should be aware of these potential problems and, if the patient's condition permits, sufficient time (at least 36 hours) should be allowed for nifedipine to be washed out of the body prior to surgery.

Increased Angina And/Or Myocardial Infarction

Rarely, patients, particularly those who have severe obstructive coronary artery disease, have developed well-documented increased frequency, duration and/or severity of angina or acute myocardial infarction upon starting nifedipine or at the time of dosage increase. The mechanism of this effect is not established.

Beta-Blocker Withdrawal

When discontinuing a beta-blocker it is important to taper its dose, if possible, rather than stopping abruptly before beginning nifedipine. Patients recently withdrawn from beta-blockers may develop a withdrawal syndrome with increased angina, probably related to increased sensitivity to catecholamines. Initiation of nifedipine treatment will not prevent this occurrence and on occasion has been reported to increase it.

Congestive Heart Failure

Rarely, patients (usually while receiving a beta-blocker) have developed heart failure after beginning nifedipine. Patients with tight aortic stenosis may be at greater risk for such an event, as the unloading effect of nifedipine would be expected to be of less benefit to these patients, owing to their fixed impedance to flow across the aortic valve.

• Actavis Pharma, Inc.

• Bryant Ranch Prepack

• Watson Laboratories, Inc.

Serious side effects have been reported with nifedipine including:

• congestive heart failure (CHF). Tell your healthcare provider right away if you experience any of the following symptoms of CHF:
  • sudden weight gain
  • worsening shortness of breath
  • increased swelling of your feet, legs, or abdomen
  • needing more pillows or sleeping in a recliner
  • waking from sleep to catch your breath
  • a cough that does not go away
  • new or increasing irregularities in your heart rate
• hypotension. Hypotension, or low blood pressure, may cause you to feel faint or dizzy. Inadequate fluid intake, excessive sweating, diarrhea, or vomiting can lead to an excessive fall in blood pressure, too. Lie down if you feel faint or dizzy. Call your doctor right away.
• chest pain. Use of nifedipine may lead to an increased number or severity of heart attacks, particularly in those with coronary artery disease (when blood vessels to the heart become hardened and narrowed). Tell your healthcare provider right away if you have some or all of the following symptoms of angina:
  • a pressure, squeezing, burning, or tightness in the chest
  • pain in the chest, breastbone area, arms, neck, shoulders, or back
  • nausea
  • fatigue
  • shortness of breath
  • light headedness
  • weakness
• heart attack. Use of nifedipine may lead to an increased number or severity in heart attacks, particularly in those with coronary artery disease (when blood vessels to the heart become hardened and narrowed). Tell your healthcare provider right away or call 911 if you experience any of the following symptoms of a heart attack:
  • chest discomfort (pressure, squeezing, or pain)
  • shortness of breath
  • discomfort in the upper body (arms, shoulder, neck, back)
  • nausea, vomiting, dizziness, lightheadedness, sweating
• beta blocker withdrawal. Decreasing the dose of a beta blocker (see the “Drug Interactions” section for examples of beta blockers) while also taking nifedipine may cause chest pain. Your doctor will determine how to lower your beta blocker medication dose. Do not stop use of beta blockers all at once.
• gastrointestinal (refers to the stomach and bowels) blockage. There have been rare reports of this occurrence in patients with gastrointestinal structure abnormalities after taking the extended release form of nifedipine. Small clumps of partially digested or undigested material can get stuck in the GI tract in very rare cases and may require surgery for removal.
• gastrointestinal ulcers. The extended release form of nifedipine may cause ulcers, which are sores in the stomach or small intestines. Tell your healthcare provider right away if you experience any of the following symptoms of a gastrointestinal ulcer:
  • stomach pain
  • blood in the urine
  • dark, tarry stools

Do not take nifedipine if you:

• are allergic to nifedipine or any of this medication’s ingredients
• have a specific form of high blood pressure called “essential hypertension.” The cause of this type of high blood pressure is unknown.

Nifedipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.

Nifedipine is used to treat hypertension (high blood pressure) and angina (chest pain).

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

You should not use nifedipine if you have severe coronary artery disease, or if you have had a heart attack within the past 2 weeks.

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

Call your doctor at once if you have:

• worsening angina;

• a light-headed feeling, like you might pass out;

• pounding heartbeats or fluttering in your chest;

• chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling;

• swelling in your ankles or feet; or

• upper stomach pain, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• mild dizziness;

• flushing (warmth, redness, or tingly feeling);

• weakness, headache, mood changes;

• heartburn, nausea;

• tremors, muscle cramps; or

• cough, wheezing, sore throat, stuffy nose.

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.

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
• cough
• difficult or labored breathing
• dizziness or lightheadedness
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• headache
• muscle cramps
• rapid weight gain
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• tightness in the chest
• tingling of the hands or feet
• trembling or shaking of the hands or feet
• unusual weight gain or loss
• weakness
• wheezing

• Blue lips and fingernails
• chest congestion
• chest pain
• chills
• coughing that sometimes produces a pink frothy sputum
• decreased urine output
• difficult, fast, or noisy breathing, sometimes with wheezing
• dilated neck veins
• extreme fatigue
• fever
• increased sweating
• irregular breathing
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pale skin
• severe unusual tiredness or weakness
• sweating
• troubled breathing
• vomiting

• Black, tarry stools
• bleeding gums
• blood in the eyes
• blood in the urine or stools
• bloody stools
• bluish color
• blurred vision
• body aches or pain
• changes in skin color
• cold sweats
• dark urine
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• dryness or soreness of throat
• ear congestion or pain
• extra heartbeats
• eye pain
• feeling unusually cold
• general tiredness and weakness
• headache, severe and throbbing
• hoarseness
• increased urge to urinate during the night
• irritation in the mouth
• itching
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• nasal congestion
• neck pain
• nervousness
• no blood pressure or pulse
• noisy breathing
• pain
• pain in the groin or genitals
• pain or burning while urinating
• painful or difficult urination
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness and swelling of the gums
• redness in the whites of the eyes
• runny nose
• shakiness and unsteady walk
• sharp back pain just below ribs
• shivering
• skin rash
• small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stopping of heart
• swelling around the eyes
• swollen glands
• tenderness
• tender, swollen glands in the neck
• troubled breathing with exertion
• unconsciousness
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• upper right abdominal or stomach pain
• vision changes
• voice changes
• vomiting of blood or material that looks like coffee grounds
• waking to urinate at night
• yellow eyes and 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:

• Belching
• feeling of indigestion
• mood changes
• pain in the chest below the breastbone
• redness of the face, neck, arms, and occasionally, upper chest

• Abnormal ejaculation
• bloody nose
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• decreased interest in sexual intercourse
• decreased sexual performance or desire
• diarrhea
• difficulty having a bowel movement (stool)
• excess air or gas in stomach or intestines
• feeling of constant movement of self or surroundings
• full feeling
• general feeling of discomfort or illness
• inability to have or keep an erection
• increased need to urinate
• joint stiffness
• leg cramps or pain
• loss in sexual ability, desire, drive, or performance
• nervousness
• passing gas
• passing urine more often
• sneezing
• stuffy nose
• trouble sleeping

• Acid or sour stomach
• ankle, knee, or great toe joint pain
• cracks in the skin
• difficulty with moving
• discouragement
• excessive muscle tone
• fear or nervousness
• feeling sad or empty
• hair loss or thinning of the hair
• heartburn
• increased sensitivity of the skin to sunlight
• irritability
• itching, pain, redness, swelling, tenderness, or warmth on the skin
• lack of appetite
• lack or loss of strength
• loss of heat from the body
• loss of interest or pleasure
• loss of strength or energy
• loss in sexual ability, desire, drive, or performance
• lower back or side pain
• muscle pain or weakness
• muscle stiffness
• muscle tension or tightness
• pain or burning in the throat
• red, swollen skin
• redness or other discoloration of the skin
• scaly skin
• severe sunburn
• sleepiness or unusual drowsiness
• sleeplessness
• stomach discomfort, upset, or pain
• swelling of the breasts or breast soreness in both females and males
• tiredness
• trouble concentrating
• unable to sleep

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.

AFEDITAB® CR
(NIFEdipine
Extended-Release Tablets)

Revised: September 2014

Rx only

40-9252

NDC: 0591-3193-01
Afeditab® CR
(NIFEdipine
Extended-release Tablets)
30 mg
Actavis      100 Tablets       Rx only

Applies to nifedipine: compounding powder, oral capsule, oral tablet extended release

General

The most commonly reported side effects included dizziness, giddiness, and lightheadedness.[Ref]

Nervous system

Syncope typically occurred with initial doses and/or dose titrations.[Ref]

Very common (10% or more): Dizziness (up to 27%), giddiness (up to 27%), lightheadedness (up to 27%), headache (up to 23%)
Common (1% to 10%): Tremor
Uncommon (0.1% to 1%): Migraine, syncope, vertigo
Rare (0.01% to 0.1%): Paresthesia, dysesthesia
Frequency not reported: Ataxia, cerebral ischemia, balance difficulty, hypertonia, hypoesthesia, shakiness, somnolence
Postmarketing reports: Taste perversion[Ref]

Other

Very common (10% or more): Heat sensation (up to 25%), weakness (up to 12%)
Common (1% to 10%): Asthenia, fatigue, feeling unwell
Uncommon (0.1% to 1%): Chills, malaise, pain, unspecific pain
Frequency not reported: Abnormal lab test, fever, inflammation, jitteriness, tinnitus[Ref]

Cardiovascular

Very common (10% or more): Flushing (up to 25%)
Common (1% to 10%): Congestive heart failure, edema/peripheral edema, myocardial infarction, palpitations, transient hypotension, vasodilation
Uncommon (0.1% to 1%): Angina pectoris/chest pain (excluding unstable), erythromelalgia, hypotension, postural hypotension, syncope, tachycardia
Rare (0.01% to 0.1%): Cardiovascular disorder, substernal chest pain
Frequency not reported: Arrhythmia, atrial fibrillation, bradycardia, cardiac arrest, conduction disturbances, extrasystole, hot flashes, increased angina, myocardial ischemia, nonspecific chest pain, phlebitis, ventricular arrhythmias[Ref]

Gastrointestinal

Very common (10% or more): Heartburn (up to 11%), nausea (up to 11%)
Common (1% to 10%): Constipation, cramps, diarrhea, flatulence
Uncommon (0.1% to 1%): Abdominal/gastrointestinal (GI) pain, dyspepsia, dry mouth, gum hyperplasia
Rare (0.01% to 0.1%): Gingival hyperplasia
Frequency not reported: Bezoar, dysphagia, eructation, esophagitis, gastroesophageal reflux, gastroesophageal sphincter insufficiency, GI bleeding, GI disorder, GI hemorrhage, GI irritation, GI obstruction, GI ulceration, gum disorder, gum hemorrhage, melena, tablet adherence to GI wall, vomiting[Ref]

Respiratory

Common (1% to 10%): Dyspnea, chest congestion, cough, nasal congestion, shortness of breath, sore throat, wheezing
Uncommon (0.1% to 1%): Larynx edema, nosebleed
Frequency not reported: Epistaxis, increased cough, pharyngitis, pulmonary edema, rales, respiratory disorder, rhinitis, rigors, sinusitis, stridor, upper respiratory tract infection[Ref]

Psychiatric

Common (1% to 10%): Mood changes, nervousness
Uncommon (0.1% to 1%): Anxiety reactions, insomnia, sleep disorders
Frequency not reported: Anxiety, confusion, decreased libido, depression, paroniria/paranoid syndrome, sleep disturbances[Ref]

Musculoskeletal

Common (1% to 10%): Muscle cramps
Uncommon (0.1% to 1%): Joint pain
Frequency not reported: Arthralgia, arthritis with antinuclear antibody positive tests, back pain, joint disorder, joint stiffness, leg cramps, leg pain, myalgia, myasthenia, neck pain, worsening of myasthenia gravis[Ref]

Genitourinary

Uncommon (0.1% to 1%): Dysuria, erectile dysfunction, polyuria
Frequency not reported: Breast engorgement, breast pain, hematuria, impotence, nocturia, pelvic pain, sexual difficulties, urinary frequency, urogenital disorder[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction, allergic edema, angioedema/oropharyngeal edema
Frequency not reported: Anaphylactic/anaphylactoid reaction, systemic allergic reactions[Ref]

Dermatologic

Uncommon (0.1% to 1%): Erythema, face edema
Rare (0.01% to 0.1%): Pruritus, rash, urticaria
Frequency not reported: Cellulitis, cutaneous angiectases, dermatitis, exfoliative dermatitis, palpable purpura, pemphigoid reaction, petechial rash, photosensitivity allergic reaction, sweating/increased sweating, telangiectasia, toxic epidermal necrolysis
Postmarketing reports: Acute generalized exanthematous pustulosis, alopecia, bullous skin adverse events, erythema multiforme, Stevens-Johnson syndrome[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal liver function tests, transient liver enzyme increase
Frequency not reported: Allergic hepatitis, gamma glutamyltransferase increased, intra-hepatic cholestasis, jaundice[Ref]

Ocular

Uncommon (0.1% to 1%): Visual disturbances
Frequency not reported: Abnormal lacrimation, abnormal vision, amblyopia, blurred vision, conjunctivitis, diplopia, eye disorder, eye hemorrhage, eye pain, periorbital edema, transient blindness (at Cmax), transient unilateral vision loss[Ref]

Hematologic

Frequency not reported: Anemia, agranulocytosis, eosinophilia, leukopenia, lymphadenopathy, purpura, thrombocytopenia[Ref]

Metabolic

Frequency not reported: Gout, hyperglycemia, weight gain/loss[Ref]

Renal

Frequency not reported: Kidney calculus[Ref]

Endocrine

Frequency not reported: Gynecomastia[Ref]

Some side effects of Afeditab CR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.