Afeditab CR

What Is Afeditab CR?

Afeditab CR (nifedipine extended-release tablets) is an extended release calcium channel blocker indicated for the treatment of hypertension. Afeditab CR may be used alone or in combination with other antihypertensive agents.

What Are Side Effects of Afeditab CR?

Common side effects of Afeditab CR include:

• headache,
• flushing (warmth, redness, tingly feeling),
• dizziness,
• fatigue,
• weakness,
• nausea, or
• constipation

Dosage for Afeditab CR

Dosage of Afeditab CR is adjusted according to each patient's needs. The general starting dose of Afeditab CR is 30 mg once daily.

What Drugs, Substances, or Supplements Interact with Afeditab CR?

Afeditab CR may interact with beta-adrenergic blocking agents, antiarrhythmics, flecainide, other calcium channel blockers, verapamil, ACE inhibitors, angiotensin-II blockers, candesartan, beta-blockers, timolol, central alpha1-blockers, digitalis, antithrombotics, platelet aggregation inhibitors, antifungals, antisecretory drugs, antibacterials, antitubercular drugs, antivirals, CNS drugs, antiemetics, immunosuppressive drugs, glucose lowering drugs, grapefruit juice, and St. John's Wort. Tell your doctor all medications and supplements you use.

Afeditab CR During Pregnancy or Breastfeeding

During pregnancy, Afeditab CR should only be taken if prescribed. Tell your doctor if you are pregnant or become pregnant before taking Afeditab CR. Afeditab CR passes into breast milk. Breastfeeding while taking Afeditab CR is not recommended.

Additional Information

Our Afeditab CR (nifedipine extended-release tablets) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Afeditab CR Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• worsening chest pain;
• pounding heartbeats or fluttering in your chest;
• a light-headed feeling, like you might pass out;
• swelling in your hands or lower legs; or
• upper stomach pain, jaundice (yellowing of the skin or eyes).

You may have more severe or more frequent episodes of angina when you first start taking nifedipine or whenever your dose is changed.

Common side effects may include:

• swelling;
• flushing (warmth, redness, or tingly feeling);
• headache, dizziness;
• nausea, heartburn; or
• feeling weak or tired.

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.

Read the entire detailed patient monograph for Afeditab CR (Nifedipine Extended-Release Tablets)

 

Afeditab CR Professional Information

SIDE EFFECTS

Adverse Experiences

The incidence of adverse events during treatment with nifedipine extended-release tablets in doses up to 90 mg daily were derived from multi-center placebo-controlled clinical trials in 370 hypertensive patients. Atenolol 50 mg once daily was used concomitantly in 187 of the 370 patients on nifedipine extended-release tablets and in 64 of the 126 patients on placebo. All adverse events reported during nifedipine extended-release tablets therapy were tabulated independently of their causal relationship to medication.

The most common adverse event reported with nifedipine extended-release tablets was peripheral edema. This was dose related and the frequency was 18% on nifedipine extended-release tablets 30 mg daily, 22% on nifedipine extended-release tablets 60 mg daily and 29% on nifedipine extended-release tablets 90 mg daily versus 10% on placebo.

Other common adverse events reported in the above placebo-controlled trials include:

Adverse Event	NIFEDIPINE EXTENDED-RELEASE TABLETS(%) (n=370)	PLACEBO (%) (n=126)
Headache	19	13
Flushing/heat	4	0
Dizziness	4	2
Fatigue/asthenia	4	4
Nausea	2	1
Constipation	1	0

Where the frequency of adverse events with nifedipine extended-release tablets and placebo is similar, causal relationship cannot be established.

The following adverse events were reported with an incidence of 3% or less in daily doses up to 90 mg:

Body as a Whole/Systemic: chest pain, leg pain

Central Nervous System: paresthesia, vertigo

Dermatologic: rash

Gastrointestinal: constipation

Musculoskeletal: leg cramps

Respiratory: epistaxis, rhinitis

Urogenital: impotence, urinary frequency

Other adverse events reported with an incidence of less than 1.0% were:

Body as a Whole/Systemic: allergic reaction, asthenia, cellulitis, substernal chest pain, chills, facial edema, lab test abnormal, malaise, neck pain, pelvic pain, pain, photosensitivity reaction

Cardiovascular: atrial fibrillation, bradycardia, cardiac arrest, extrasystole, hypotension, migraine, palpitations, phlebitis, postural hypotension, tachycardia, cutaneous angiectases

Central Nervous System: anxiety, confusion, decreased libido, depression, hypertonia, hypesthesia, insomnia, somnolence

Dermatologic: angioedema, petechial rash, pruritus, sweating

Gastrointestinal: abdominal pain, diarrhea, dry mouth, dysphagia, dyspepsia, eructation, esophagitis, flatulence, gastrointestinal disorder, gastrointestinal hemorrhage, GGT increased, gum disorder, gum hemorrhage, vomiting

Hematologic: eosinophilia, lymphadenopathy

Metabolic: gout, weight loss

Musculoskeletal: arthralgia, arthritis, joint disorder, myalgia, myasthenia

Respiratory: dyspnea, increased cough, rales, pharyngitis, stridor

Special Senses : abnormal vision, amblyopia, conjunctivitis, diplopia, eye disorder, eye hemorrhage, tinnitus

Urogenital/Reproductive: dysuria, kidney calculus, nocturia, breast engorgement, polyuria, urogenital disorder

The following adverse events have been reported rarely in patients given nifedipine in coat core or other formulations: allergenic hepatitis, alopecia, anaphylactic reaction, anemia, arthritis with ANA (+), depression, erythromelalgia, exfoliative dermatitis, fever, gingival hyperplasia, gynecomastia, hyperglycemia, jaundice, leukopenia, mood changes, muscle cramps, nervousness, paranoid syndrome, purpura, shakiness, sleep disturbances, Stevens-Johnson syndrome, syncope, taste perversion, thrombocytopenia, toxic epidermal necrolysis, transient blindness at the peak of plasma level, tremor and urticaria.

Read the entire FDA prescribing information for Afeditab CR (Nifedipine Extended-Release Tablets)