Name: Adalat CC
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Adalat CC extended release tablets are supplied as 30 mg, 60 mg, and 90 mg round film coated tablets. The different strengths can be identified as follows:
|30 mg||Pink||30 on one side and ADALAT CC on the other side|
|60 mg||Salmon||60 on one side and ADALAT CC on the other side|
|90 mg||Dark Red||90 on one side and ADALAT CC on the other side|
Adalat® CC Tablets are supplied in:
|Bottles of 100||30 mg||50419-701-05|
|Bottles of 1000||30 mg||50419-701-10|
The tablets should be protected from light and moisture and stored below 86°F (30°C). Dispense in tight, light-resistant containers.
Manufactured for: Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470. Manufactured in Germany. Revised: Dec 2015
Adalat CC is an extended release tablet and should be swallowed whole and taken on an empty stomach. It should not be administered with food. Do not chew, divide or crush tablets.
What is Adalat CC (nifedipine)?
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 discuss with my healthcare provider before taking Adalat CC (nifedipine)?
You should not use this medicine if you are allergic to nifedipine, if you have severe coronary artery disease, or if you have had a heart attack within the past 2 weeks.
To make sure nifedipine is safe for you, tell your doctor if you have:
severe COPD (chronic obstructive pulmonary disease);
congestive heart failure; or
if you take other medications, especially an antibiotic or antifungal medicine, an antidepressant, heart or blood pressure medicine, or drugs to treat HIV/AIDS or hepatitis C.
It is not known whether nifedipine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Nifedipine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
The nifedipine extended-release tablet may contain lactose. Talk to your doctor before using this form of nifedipine if you have galactose intolerance, or severe problems with lactose (milk sugar).
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Before Using Adalat CC
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Appropriate studies have not been performed on the relationship of age to the effects of nifedipine in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nifedipine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems which may require caution and an adjustment in the dose for patients receiving nifedipine.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
Studies in women suggest that this medication poses minimal risk to the infant when used during 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 this medicine, 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 this medicine 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.
- St John's Wort
Using this medicine 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.
- Vincristine Sulfate Liposome
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Aortic stenosis (narrowing of a valve in your heart) or
- Bowel blockage, severe or
- Congestive heart failure or
- Coronary artery disease or
- Heart attack or
- Hypotension (low blood pressure)—Use with caution. May increase risk of serious side effects.
- Cardiogenic shock (shock caused by heart attack)—Should not be used in patients with these conditions.
- Galactose intolerance (rare hereditary problem) or
- Glucose-galactose malabsorption (rare hereditary problem) or
- Lapp lactase deficiency (rare hereditary problem)—The extended release tablet form of this medicine contains lactose (milk sugar), and should not be given to patients with these conditions.
- Kidney problems or
- Liver problems (including cirrhosis)—Use with caution. The effects of nifedipine may be increased because of the slower removal of the medicine from the body.
Adalat CC Description
Adalat® CC is an extended release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-dimethyl ester, C17H18N2O6, and has the structural formula:
Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Adalat CC tablets consist of an external coat and an internal core. Both contain nifedipine, the coat as a slow release formulation and the core as a fast release formulation. Adalat CC tablets contain either: 30, 60, or 90 mg of nifedipine for once-a-day oral administration.
Inert ingredients in the formulation are: hydroxypropylcellulose, lactose, corn starch, crospovidone, microcrystalline cellulose, silicon dioxide, and magnesium stearate. The inert ingredients in the film coating for Adalat CC 30 and 60 are: hypromellose, polyethylene glycol, ferric oxide, and titanium dioxide. The inert ingredients in the film coating for Adalat CC 90 are: hypromellose, polyethylene glycol and ferric oxide
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
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