Nifedipine @ ( *** ) - Calcium channel Blocker- (FDC- List )- (Mar 2008)
Drug Interaction:
Calcium Channel Blockers include - Bepridil, Diltiazem, Felodipine, Isradipine, Nicardipine, Nifedipine, Nimodipine, Verapramil, Amlodipine, Nisodipine, Clevidipine, Lercandipine
Refer verapramil-
Increases digoxin blood levels. May cause hypotension,angina and cardiac failure if concurrently used with beta blockers,(uncommon).
Potentiates antihypertensives,
Plasma quinidine levels may be reduced.
Levels of theophylline and phenytoin increased.
Synergism with beta blockers
Reverses depression of cardiac function,caused by beta blkrs.
Cimetidine increases bioavailability and potentiates hypotensive action.
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
94. Nifedipine SR Tablets 10mg/20mg 24-03-08
For the treatment of essential hypertension
Vasospastic angina
Calcium Channel Blockers include - Bepridil, Diltiazem, Felodipine, Isradipine, Nicardipine, Nifedipine, Nimodipine, Verapramil, Amlodipine, Nisodipine, Clevidipine, Lercandipine
Refer Verapramil-
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Nifedipine Cardiovascular Pfizer 25-11-2001
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Nifedipine 0.3% 26-02-2009
+ Lidocaine 1.5% cream
For the treatment of Anal fissures
2.Nifedipine SR Tablets 24-03-2008
10mg/20mg
For the treatment of Essential hypertension
Adverse Reaction:
.
Calcium Channel Blockers include - Bepridil, Diltiazem, Felodipine, Isradipine, Nicardipine, Nifedipine, Nimodipine, Verapramil, Amlodipine, Nisodipine, Clevidipine, Lercandipine
Refer verapramil-
NIFEDIPINE-
Generally not serious, rarely requires discontinuation or dosage adjustment
CNS - Dizziness/lightheadedness 25%, Headache 22 %
Weakness/shakiness/jitteriness 10%
Nervousness < 7%,
Parathesia , Somnolence Asthenia, Insomnia 3%,
Sleep disturbances, Blurred vision 2%,
Abnornal dreams, Tinnitus , Maliase < 1%
GASTROINTESTINAL - Nausea 10%, diarrhea, Constipation,
Abdominal discomfort,cramps, dyspesia,
Dry mouth/thirst, flatulance 3%,
Dyspeusia, Vomiting, < 1%
CARDIOVASCULAR - Peripheral edema 30%,
Palpitation, Pulmonary edema 7%,
Congestive heart failure,Myocardial infarction 6%
Hypotension 5%
Syncope , Arrhythmias, Tachcardia < 1%
DERMATOLOGIC - Dermatitis, rash, Pruritis, urticaria 3%
Hair loss , 1%
HEMATOLOGIC - Anemia, Leukopenia, Thrombocytopenia ,
Petechiae, Purpura 1%
OTHER- Flushing 25%,
Muscle cramps, Pain, Inflammation, 8%,
Cough , Rhinitis 6%
Joint stiffness, Arthiritis, Mituration disorder,
Noctiria, Dysuria, frequency , Sexual difficulties 3%
Sweating < 2%
Nasal or chest congestion, Sinusitis, < 6%
Contra-Indications:
Hypersens,acute M.I.,hypotension,pregnancy,cardiogenic shock.
Special precautions:
Fixed ventricular outflow obstruction.Has no inherant antiarrhythmic action.
Withdrawal of beta blkrs should be gradual.
May potentiate existing hypertensive therapy.
Poor cardiac reserve.
Large doses of beta blkrs..
Diabetes.
Safey for use in pregnancy and lactation not established.
CCF.Heptic impairment.
Dosages/ Overdosage Etc:
Date of Approval 2008
Indications:
Vasospastic angina
Dosage:
Individualise dose. Initial- 10mg 3 times a day. Usual range is 10 to 20mg 3 times a day. Dosage more than 120mg is not recommended.
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Patient Information:
Calcium channel blockers-
1.Take the medicine exactly as directed by the physician.
2.Swallow the tablet whole,without crushing or chewing it. However if advised by the doctor, you may break into half.
3.Take the medicine with food or milk.
Pharmacology/ Pharmacokinetics:
Refer- Verapramil - Calcium Channel blocker
Interaction with Food:
Refer - Verapramil- Calcium Channel blocker
Pregnancy and lactation:
Refer - Verapramil - Calcium blocker