Adalat CC

Name: Adalat CC

What is the dosage for nifedipine?

  • The usual dose for nifedipine capsules for treating angina is 10 to 20 mg three times daily. Up to 20 to 30 mg every 6-8 hours daily may be required. The dose should not exceed 180 mg daily. For extended release tablets, the usual dose is 30 or 60 mg once daily. The maximum dose is 120 mg daily.
  • Hypertension is treated with 30-60 mg daily using extended release tablets. The maximum dose is 90 mg/day (Adalat CC) or 120 mg/day (Procardia XL).
  • Nifedipine can be taken with or without food.
  • The tablets and capsules should be swallowed whole and not bitten or cut in half.

Indications

Adalat CC is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Warnings

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Adalat CC 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:

More common
  • 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
Less common
  • 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
Rare
  • 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:

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

Indication and usage

Adalat CC is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Overdosage

Experience with nifedipine overdosage is limited. Symptoms associated with severe nifedipine overdosage include loss of consciousness, drop in blood pressure, heart rhythm disturbances, metabolic acidosis, hypoxia, cardiogenic shock with pulmonary edema. Generally, overdosage with nifedipine leading to pronounced hypotension calls for active cardiovascular support including monitoring of cardiovascular and respiratory function, elevation of extremities, judicious use of calcium infusion, pressor agents and fluids. After oral ingestion, thorough gastric lavage is indicated, if necessary in combination with irrigation of the small intestine. In cases involving overdosage of a slow-release product like nifedipine, elimination must be as complete as possible, including from the small intestine, to prevent the subsequent absorption of the active substance.  Additional liquid or volume must be administered with caution because of the risk of fluid overload.

Clearance of nifedipine would be expected to be prolonged in patients with impaired liver function. Since nifedipine is highly protein bound, dialysis is not likely to be of any benefit; however, plasmapheresis may be beneficial.

There has been one reported case of massive overdosage with tablets of another extended release formulation of nifedipine. The main effects of ingestion of approximately 4800 mg of nifedipine in a young man attempting suicide as a result of cocaine-induced depression was initial dizziness, palpitations, flushing, and nervousness. Within several hours of ingestion, nausea, vomiting, and generalized edema developed. No significant hypotension was apparent at presentation, 18 hours post ingestion. Blood chemistry abnormalities consisted of a mild, transient elevation of serum creatinine, and modest elevations of LDH and CPK, but normal SGOT. Vital signs remained stable, no electrocardiographic abnormalities were noted and renal function returned to normal within 24 to 48 hours with routine supportive measures alone. No prolonged sequelae were observed.

The effect of a single 900 mg ingestion of nifedipine capsules in a depressed anginal patient on tricyclic antidepressants was loss of consciousness within 30 minutes of ingestion, and profound hypotension, which responded to calcium infusion, pressor agents, and fluid replacement. A variety of ECG abnormalities were seen in this patient with a history of bundle branch block, including sinus bradycardia and varying degrees of AV block. These dictated the prophylactic placement of a temporary ventricular pacemaker, but otherwise resolved spontaneously. Significant hyperglycemia was seen initially in this patient, but plasma glucose levels rapidly normalized without further treatment.

A young hypertensive patient with advanced renal failure ingested 280 mg of nifedipine capsules at one time, with resulting marked hypotension responding to calcium infusion and fluids. No AV conduction abnormalities, arrhythmias, or pronounced changes in heart rate were noted, nor was there any further deterioration in renal function.

Bradycardiac heart rhythm disturbances may be treated symptomatically with ß-sympathomimetics, and in life-threatening bradycardiac disturbances of heart rhythm temporary pacemaker therapy can be advisable.

What is nifedipine (procardia)?

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.

What should i avoid while taking nifedipine (procardia)?

Grapefruit and grapefruit juice may interact with nifedipine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can lower your blood pressure further and may increase certain side effects of nifedipine.

Where can i get more information?

Your pharmacist can provide more information about nifedipine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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