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  • Nifedilong
    / CTS

    Active Ingredient
    Nifedipine 30 mg, 60 mg

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Prolonged-Release Tablets

    30 X 30 mg

    full basket chart 87931 14469

    Prolonged-Release Tablets

    30 X 60 mg

    full basket chart 87932 14470

    Related information


    Adults: Dosage must be adjusted according to each patient’s needs. Therapy for either hypertension or angina should be initiated with 30 or 60 mg once daily. Nifedilong Prolonged Release tablets should be swallowed whole and should not be bitten or divided. In general, titration should proceed over at 7-14 day period so that the physician can fully assess the response to each dose level and monitor blood pressure before proceeding to higher doses. Since steady-state plasma levels are achieved on the second day of dosing, if symptoms so warrant, titration may proceed more rapidly provided the patient is assessed frequently. Titration to doses above 120 mg are not recommended.
    Switch over from Nifedipine capsules to Nifedilong: Angina patients controlled on Nifedipine capsules alone or in combination with other antianginal medications may be safely switched to Nifedilong Prolonged Release tablets at the nearest, equivalent total daily dose (e.g. 1 Nifedipine capsule of 10 mg t.i.d. up to q.i.d. may be changed to 30 mg once daily of Nifedilong Prolonged Release tablet). Subsequent titration to higher doses may be necessary and should be initiated as clinically warranted. Experience with doses greater than 90 mg in patients with angina is limited. Therefore, doses greater than 90 mg should be used with caution and only when clinically warranted. No “rebound effect” has been observed upon discontinuation of Nifedilong Prolonged Release tablets. However, if discontinuation of nifedipine is necessary the dosage should be decreased gradually with close physician supervision.
    Switch over from Nifedipine tablets to Nifedilong: Patients controlled on Nifedipine tablets may be safely switched to Nifedilong Prolonged Release tablets at the nearest equivalent total daily dose (e.g. 1 Nifedipine tablet of 10 mg t.i.d. or 20 mg b.i.d. may be changed to 30 mg once daily of Nifedilong Prolonged Release tablet).
    Co-administration with other Anti-anginal drugs: Sublingual nitroglycerin may be taken as required for the control of acute manifestations of angina, particularly during nifedipine titration. for information on co-administration of nifedipine with beta blockers or long acting nitrates. As a rule, Nifedilong Prolonged Release tablets should be swallowed whole with a little water independently of mealtimes. Under no circumstances should they be chewed or broken up. The medication is formulated in such way that it releases the active substance in the intestine with a practically constant rate over a 16 to 18 hour time period. see prescribing information.
    Elderly: A slight alteration of the pharmacokinetics of nifedipine may be seen in the elderly. Lower maintenance doses of nifedipine may be required compared to younger patients.
    Children: There are no recommendations for use in children.
    Duration of use: The attending doctor will determine the duration of use.


    Vasospastic angina, chronic stable angina, hypertension.


    Nifedilong should not be administered to patients with known hypersensitivity to the active substance, or to other dihydropyridines because of the theoretical risk of cross- reactivity, or to any of the excipients.
    Nifedilong 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.
    Nifedilong should not be used for the treatment of acute attacks of angina. The safety of Nifedilong in malignant hypertension has not been established.
    Nifedilong should not be used for secondary prevention of myocardial infarction.
    Owing to the duration of action of the formulation, Nifedilong should not be administered to patients with hepatic impairment.
    Nifedilong 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.
    Nifedilong must not be used in patients with a Kock pouch (ileostomy after proctocolectomy).
    Nifedilong is contra-indicated in patients with inflammatory bowel disease or
    Crohn’s disease.
    Nifedilong should not be administered concomitantly with rifampicin since effective plasma levels of nifedipine may not be achieved owing to enzyme induction.
    See prescribing information for full details.

    Special Precautions

    The hypotensive effect of nifedipine in most patients is modest and well tolerated; however, occasional patients have hadexcessive and poorly tolerated hypotension during initial titration or at a time of subsequent upward dosage adjustment mostly in patients on concomitant β-blockers. Severe hypotension and/or increased fluid volume requirements have been reported inpatients receiving nifedipine together with a β-blocking agent who have undergone 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 β-blocking, 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 patients treated with nifedipine where surgery using high dose fentanyl anesthesia is contemplated, the physician should be aware of these potential problems and, if the condition of the patient permits, sufficient time (at least 36 hours) should be allowed for nifedipine to be washed out of the body prior to surgery.
    In single cases, obstructive symptoms have been described without known history of gastrointestinal disorders
    See prescribing information for full details.

    Side Effects

    Common: Headache, Oedema, Vasodilatation, Constipation, Feeling unwell.
    See prescribing information for full details.

    Drug interactions

    Interactions with other medicinal products and other forms of interaction The blood pressure lowering effect of nifedipine may be potentiated with other antihypertensive drugs.
    Inhibitors of the cytochrome P450 3A4: Upon co-administration of known inhibitors of the cytochrome P450 3A4 system, the blood pressure should be monitored and, if necessary, a reduction in the nifedipine dose considered. In the majority of these cases, no formal studies to assess the potential for a drug interaction between nifedipine and the drug(s) listed have been undertaken, thus far.
    Macrolide antibiotics (e.g. erythromycin) Anti-HIV protease inhibitors (e.g. ritonavir) Azole anti-mycotics (e.g. ketoconazole)
    Fluoxetine Nefazodone Quinupristin/dalfopristin Cispride Valproic acid Cimetidine/Ranitidine
    Inducers of the cytochrome P450 3A4: Upon co-administration of known inducers of the cytochrome P450 3A4 system, the clinical response to nifedipine should be monitored and, if necessary, an increase in the nifedipine dose considered. If the dose of nifedipine is increased during co-administration of both drugs, a reduction of the nifedipine dose should be considered when the treatment is discontinued. Carbamazepine Phenobarbital Rifampicin High Protein-Bound Drugs (phenytoin, quinidine).
    Nifedipine/β-Adrenergic Blocking Agents: Experience in over 1,400 patients in a non-comparative clinical trial has shown that concomitant administration of nifedipine and β-blocking agents is usually well tolerated, but there have been occasional literature reports suggesting that the combination may increase the likelihood of congestive heart failure, severe hypotension or exacerbation of angina.
    Caution should be taken in patients receiving nifedipine together with β-blockers, who have undergone coronary bypass surgery using high dose fentanyl for anesthesia.
    Nifedipine/Long Acting Nitrates: Nifedipine may be safely co-administered with nitrates, but there have been no controlled studies, to evaluate the antianginal effectiveness of this combination.
    Nifedipine/Digitalis: Administration of nifedipine with digoxin increased digoxin levels in 9 out of 12 normal volunteers. Theaverage increase was 45%. Another investigator found no increase in digoxin levels in 13 patientswith coronary artery disease. In an uncontrolled study of over 200 patients with congestive heartfailure during which digoxin blood levels were not measured, digitalis toxicity was not observed. Sincethere have been isolated reports of patients with elevated digoxin levels, it is recommended thatdigoxin levels be monitored when initiating, adjusting and discontinuing nifedipine to avoid possibleover-digitalisation or underdigitalisation.
    Nifedipine/Coumarin Anticoagulants:There have been rare reports of increased prothrombin time in patients taking coumarinanticoagulants to whom nifedipine was administered. However, the relationship to nifedipine therapy is uncertain.
    Nifedipine/Tacrolimus: Caution is advised when using nifedipine simultaneously withtacrolimus, since the dose of nifedipine may be reduced in individual cases. Upon coadministration ofboth drugs, the tacrolimus plasma concentrations should be monitored and, if necessary, a reductionin the tacrolimus dose considered.
    Diagnostic Interference: Rare, usually transient, but occasionally significant elevations of enzymes such as alkalinephosphatase, CPK, LDH, SGOT and SGPT have been noted. The relationship to nifedipine therapy isuncertain in most cases, but probable in some. These laboratory abnormalities have rarely beenassociated with clinical symptoms, however, cholestasis with or without jaundice has been reported.Rare instances of allergic hepatitis have been reported. Nifedipine, like other calcium channel blockers, decreases platelet aggregation in vitro. Limited clinicalstudies have demonstrated a moderate but statistically significant decrease in platelet aggregationand increase in bleeding time in some nifedipine-treated patients. This is thought to be a function ofinhibition of calcium transport across the platelet membrane. No clinical significance for these findingshas been demonstrated.
    Grapefruit Juice: Co-administration of nifedipine with grapefruit juice results in up to a 2-fold increase in AUC and C max, due to inhibition of CYP3A4 related first-pass metabolism. This effect of grapefruit juice may last forat least 3 days. Administration of nifedipine with grapefruit juice is to be avoided.
    Other forms of interaction: Nifedipine may increase the spectrophotometric values of urinary vanillymandelic acid, falsely.However, HPLC measurements are unaffected.
    For full details see prescribing information.

    Pregnancy and Lactation

    Use in pregnancy: As stated above, nifedipine is contraindicated in pregnancy before week 20. In animal studies, nifedipine has been shown to produce embryotoxicity, foetotoxicity and teratogenicity. There are no adequate well controlled studies in pregnant women. From the clinical evidence available a specific prenatal risk has not been identified, although an increase in perinatal asphyxia, caesarean delivery, as well as prematurity and intrauterine growth retardation have been reported. It is unclear whether these reports are due to the underlying hypertension, its treatment, or to a specific drug effect. The available information is inadequate to rule out adverse drug effects on the unborn and newborn child. Therefore any use in pregnancy after week 20 requires a very careful individual risk benefit assessment and should only be considered if all other treatment options are either not indicated or have failed to be efficacious.
    breastfeeding: As stated above, nifedipine is contraindicated during lactation.


    Experience with nifedipine overdose is limited. Generally, overdose 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. 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. The benefit of gastric decontamination is uncertain.
    Consider activated charcoal (50 g for adult, 1 g/kg for children) if the patient presents within 1 hour of ingestion of the potentially toxic amount. Although it may seem reasonable to assume that late administration of activated charcoal may be beneficial for sustained release preparations there is no evidence to support this. Alternatively consider gastric lavage in adults within 1 hour of a potentially life-threatening overdose. Consider further doses of activated charcoal every 4 hours if a clinically significant amount of a sustained release preparation has been ingested with a single dose of an osmotic laxative (e.g. sorbitol, lactulose or magnesium sulphate). Asymptomatic patients should be observed for at least 4 hours after ingestion and for 12 hours if a sustained release preparation has been taken.
    The following symptoms are observed in cases of severe nifedipine intoxication: Disturbances of consciousness to the point of coma, a drop in blood pressure, tachycardiac/bradycardiac heart rhythm disturbances, hyperglycaemia, metabolic acidosis hypoxia, cardiogenic shock with pulmonary oedema. Bradycardiac heart rhythm disturbances may be treated symptomatically with β-sympathomimetics, atropine or a temporary cardiac pacemaker and in life-threatening bradycardiac disturbances of heart rhythm temporary pacemaker therapy can be advisable. Hypotension as a result of cardiogenic shock and arterial vasodilation can be treated with calcium (10-20 ml of a 10% calcium gluconate solution administered slowly i.v. and repeated if necessary). As a result, the serum calcium can reach the upper normal range to slightly elevated levels. If the effects are inadequate the treatment can be continued, with ECG monitoring, with additional β-sympathomimetics (e.g. Isoprenaline 0.2 mg slowly i.v., if necessary as a continuous infusion of 5 μg/min). If an insufficient increase in blood pressure is achieved with calcium and isoprenaline, vasoconstricting sympathomimetics such as dopamine or noradrenaline are additionally administered. The dosage of these drugs is determined solely by the effect obtained. Additional liquid or volume must be administered with caution because of the danger of overloading the heart.
    Additional fluids should be administered with caution to avoid cardiac overload.

    Valpharma S.P.A., Republic of San Marino