Adalat retard 30mg

The impact of multiple oral doses of mg rifampin on the pharmacokinetics of nifedipine after a single oral dose of 20 mg nifedipine capsule was evaluated in a clinical study. Twelve healthy male volunteers received a single oral dose of 20 mg nifedipine capsule on study Day 1. Starting on study Day 2, the subjects received mg rifampin once daily for 14 days. On study Day 15, a second single oral dose of 20 mg nifedipine capsule was administered together with the last dose of rifampin.

Antiviral Drugs Amprenavir, atanazavir, delavirine, fosamprinavir, indinavir, nelfinavir and ritonavir, as CYP3A inhibitors, can inhibit the metabolism of nifedipine and increase the exposure to nifedipine. Caution is warranted and clinical monitoring of patients recommended.

Blood pressure should be monitored and a reduction of the dose of nifedipine considered. Fluoxetine, a CYP3A inhibitor, can inhibit the metabolism of nifedipine and increase the exposure to nifedipine during concomitant therapy. Valproic acid may increase the exposure to nifedipine during concomitant therapy. Phenytoin, Phenobarbital, and Carbamazepine: Nifedipine is metabolized by CYP3A. Phenobarbital and carbamazepine are also inducers of CYP3A.

Alternative antihypertensive therapy should be considered in patients taking phenytoin, phenobarbital, and carbamazepine. In patients taking dolasetron by the oral or intravenous route and nifedipine, no effect was shown on the clearance of hydrodolasetron.

Tacrolimus has been shown to be metabolized via the CYP3A system. Nifedipine has been shown to inhibit the metabolism of tacrolimus in vitro. Nifedipine can increase the exposure to tacrolimus. When nifedipine is co-administered with tacrolimus the blood concentrations of tacrolimus should be monitored and a reduction of the dose of tacrolimus considered.

A single 60 mg dose of nifedipine and a single 10 mg dose of sirolimus oral solution were administered to 24 healthy volunteers. Clinically significant pharmacokinetic drug interactions were not observed. Glucose Lowering Drugs Pioglitazone: Co-administration of pioglitazone for 7 days with 30 mg nifedipine ER administered orally q. In view of the high variability of nifedipine pharmacokinetics, the clinical significance of this finding is unknown. Co-administration of rosiglitazone 4 mg b.

Tmax and half-life were unaffected. Nifedipine appears to enhance the absorption of metformin. No effect of miglitol was observed on the pharmacokinetics and pharmacodynamics of nifedipine. Co-administration of 10 mg nifedipine with a single dose of 2 mg repaglinide after 4 days nifedipine 10 mg t.

Nifedipine tends to produce hyperglycemia and may lead to loss of glucose control. If nifedipine is co-administered with acarbose, blood glucose levels should be monitored carefully and a dose adjustment of nifedipine considered. Drugs Interfering with Food Absorption Orlistat: In 17 normal-weight subjects receiving orlistat mg t.

Dietary Supplements Grapefruit Juice: In healthy volunteers, a single dose co-administration of mL double strength grapefruit juice with 10 mg nifedipine increased AUC and Cmax by factors of 1. Ingestion of repeated doses of grapefruit juice 5 x mL in 12 hours after administration of 20 mg nifedipine ER increased AUC and Cmax of nifedipine by a factor of 2.

Grapefruit juice should be avoided by patients on nifedipine. The intake of grapefruit juice should be stopped at least 3 days prior to initiating patients on nifedipine.

Alternative antihypertensive therapy should be considered in patients in whom St. John's Wort therapy is necessary. In healthy volunteers, pretreatment with nifedipine 20 mg t. Thus, it is improbable that nifedipine inhibits in vivo the metabolism of other drugs that are substrates of CYP2D6. 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.

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.

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. This edema is a localized phenomenon, thought to be associated with vasodilation of dependent arterioles and small blood vessels and not due to left ventricular dysfunction or generalized fluid retention. With patients whose hypertension is complicated by congestive heart failure , care should be taken to differentiate this peripheral edema from the effects of increasing left ventricular dysfunction.

Use In Cirrhotic Patients Clearance of nifedipine is reduced and systemic exposure increased in patients with cirrhosis. It is unknown how systemic exposure may be altered in patients with moderate or severe liver impairment.

The relationship to nifedipine therapy is uncertain in most cases, but probable in some. These laboratory abnormalities have rarely been associated with clinical symptoms; however, cholestasis with or without jaundice has been reported.

This was an isolated finding and it rarely resulted in values which fell outside the normal range. Rare instances of allergic hepatitis have been reported with nifedipine treatment. In controlled studies, Adalat CC did not adversely affect serum uric acid , glucose, cholesterol or potassium.

Nifedipine, like other calcium channel blockers , decreases platelet aggregation in vitro. Limited clinical studies have demonstrated a moderate but statistically significant decrease in platelet aggregation and increase in bleeding time in some nifedipine patients.

This is thought to be a function of inhibition of calcium transport across the platelet membrane. No clinical significance for these findings has been demonstrated. Positive direct Coombs' test with or without hemolytic anemia has been reported but a causal relationship between nifedipine administration and positivity of this laboratory test, including hemolysis , could not be determined. Paediatric dosing forms are lacking. Maximum plasma and serum concentrations are reached at 1. Simultaneous food intake leads to delayed, but not reduced absorption.

The distribution half-life after intravenous administration was determined to be 5 to 6 minutes. Biotransformation After oral administration nifedipine is metabolized in the gut wall and in the liver, primarily by oxidative processes. These metabolites show no pharmacodynamic activity. The unchanged substance is recovered only in traces below 0. Elimination The terminal elimination half-life is 6 - 11 hours Adalat retard , because of delayed absorption.

No accumulation of the substance after the usual dose was reported during long-term treatment. In cases of impaired kidney function no substantial changes have been detected in comparison with healthy volunteers.

The pharmacokinetics of nifedipine has not been investigated in patients with severe hepatic impairment see section 4. Reproduction toxicology Nifedipine has been shown to produce teratogenic findings in rats, mice and rabbits, including digital anomalies, malformation of the extremities, cleft palates, cleft sternum, and malformation of the ribs.

Digital anomalies and malformation of the extremities are possibly a result of compromised uterine blood flow, but have also been observed in animals treated with nifedipine solely after the end of the organogenesis period. The risk to humans cannot be ruled out if a sufficiently high systemic exposure is achieved, however, all of the doses associated with the teratogenic, embryotoxic or foetotoxic effects in animals were maternally toxic and were several times the recommended maximum dose for humans see Section 4.

The tablets should be taken at approximately hour intervals, i. Adalat LA tablets must be swallowed whole; under no circumstances should they be bitten, chewed or broken up. Adalat LA should not be taken with grapefruit juice see section 4. Adalat LA should not be used in cases of cardiogenic shock, clinically significant aortic stenosis, unstable angina, or during or within one month of a myocardial infarction.

Adalat LA should not be used for the treatment of acute attacks of angina. The safety of Adalat LA in malignant hypertension has not been established. Adalat LA should not be used for secondary prevention of myocardial infarction. Owing to the duration of action of the formulation, Adalat LA should not be administered to patients with hepatic impairment. Adalat LA should not be administered to patients with a history of gastro-intestinal obstruction, oesophageal obstruction, or any degree of decreased lumen diameter of the gastro-intestinal tract.

Adalat LA must not be used in patients with a Kock pouch ileostomy after proctocolectomy. Adalat LA is contra-indicated in patients with inflammatory bowel disease or Crohn's disease.

Adalat LA should not be administered concomitantly with rifampicin since effective plasma levels of nifedipine may not be achieved owing to enzyme induction see section 4. Caution should be exercised in patients with hypotension as there is a risk of further reduction in blood pressure and care must be exercised in patients with very low blood pressure severe hypotension with systolic blood pressure less than 90 mm Hg.

Adalat LA should not be used during pregnancy unless the clinical condition of the woman requires treatment with nifedipine. Adalat LA should be reserved for women with severe hypertension who are unresponsive to standard therapy see section 4. Careful monitoring of blood pressure must be exercised when administering nifedipine with I. For further information regarding use in pregnancy, refer to section 4.

Adalat LA is not recommended for use during breast-feeding because nifedipine has been reported to be excreted in human milk and the effects of nifedipine exposure to the infant are not known see section 4. In patients with impaired liver function careful monitoring and, in severe cases, a dose reduction may be necessary. Adalat LA may be used in combination with beta-blocking drugs and other antihypertensive agents but the possibility of an additive effect resulting in postural hypotension should be borne in mind.

Adalat LA will not prevent possible rebound effects after cessation of other antihypertensive therapy.

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