Prosp Pharma


Prosp Pharma
Full Prescribing Info
Manidipine hydrochloride.
Each tablet contains Manidipine hydrochloride 20 mg.
Pharmacology: Pharmacodynamics: Manidipine is a third-generation dihydropyridine calcium antagonist. Because of its highly lipophilic with strong membrane binding and slow release to calcium channel, shows a long duration of action. Manidipine inhibits calcium influx by antagonism at calcium channel in vascular smooth muscle cell. Manidipine inhibits both L- and T-type calcium channels resulting in peripheral vasodilation and reduced blood pressure. In addition, inhibition of manidipine decreases contractility of the myocardium and reduces heart rate, potentially leading to diminished reflex tachycardia and improved coronary blood flow.
Manidipine treatment has beneficial effect on renal function in hypertensive patients with chronic renal failure. Moreover, vasodilation of the efferent and afferent renal arterioles by manidipine that may improve glomerular capillary pressure.
Pharmacokinetics: Absorption: Manidipine is rapidly absorbed about 36 to 60% following oral administration. Effect of food are increased bioavailability. Time to peak plasma concentrations are reached in about 2-4 hours.
Distribution: Plasma protein binding is 99%. Manidipine is widely distributed into tissues.
Metabolism: Manidipine undergoes an extensive hepatic first-pass metabolism mediated by CYP450 enzymes, with key pathways involving dehydrogenation and oxidation. Inactive metabolites of manidipine are M-IV, M-VII and MS-II.
Excretion: Elimination half-life is 5 to 8 hours. Excretion is mainly via the feces (63.3%) with only 31.4% of a dose appearing in urine as metabolites.
For treatment of mild to moderate essential hypertension and hypertension with renal impairment.
Dosage/Direction for Use
Adults: 10 to 20 mg once daily. The recommended starting dose is 10 mg daily. The dose may be increased to 20 mg daily if the antihypertensive effect is inadequate after 2 to 4 weeks.
Elderly: 10 mg daily.
Renal insufficiency: No dosage adjustment in patient with mild to moderate renal dysfunction.
Hepatic insufficiency: Dosage in patients with mild hepatic dysfunction should not exceed 10 mg daily.
Mode of Administration: Administration orally in the morning after breakfast.
Case of manidipine overdose is not known.
Symptoms: Symptoms of calcium channel blocker overdosage include marked and prolonged hypotension and bradycardia, both of which may result in decreased cardiac output. Junctional rhythms and second- or third-degree AV block may be seen.
Treatment: If the patient is seen shortly after oral ingestion, employ lavage, activated charcoal, and cathartics. Symptomatic hypotension requiring treatment are suggested to use dopamine, calcium chloride, isoproterenol HCl, metaraminol bitartrate and norepinephrine bitartrate. Bradycardia and AV block are suggested to use atropine, calcium chloride, cardiac pacing, isoproterenol HCl, and norepinephrine bitartrate. Moreover, supportive treatment is IV fluid.
Concomitant CYP3A4 inhibitors and inducers.
Moderate to severe hepatic dysfunction.
Hypersensitivity to any dihydropyridine agents.
Hypersensitivity to manidipine and any component of the product.
Myocardial infarction, in the first 4 weeks.
Pediatric use.
Severe renal dysfunction, creatinine clearance less than 10 mL/min.
Unstable angina pectoris.
Untreated heart failure.
Galactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency.
Pregnant women or women suspected of being pregnant.
Special Precautions
Coronary patients, stable; possible increased coronary risk.
Elderly patients; dosage adjustment is necessary.
Mild hepatic impairment, antihypertensive effect might be strengthened.
Isolated-right-sided heart failure.
Left ventricular dysfunction.
Obstruction of the outflow channel of the left ventricle.
Sick sinus syndrome, if a pacemaker is not present.
Use In Pregnancy & Lactation
Pregnancy: It has been reported that manidipine prolong the gestation period and delivery time in animal experiments. Therefore, administration to pregnant women or women suspected of being pregnant should be avoided.
Lactation: Transfer of this substance to mother's milk has been reported in an experimental animal. Administration of manidipine to nursing mothers is not recommended. If inevitable, the patient should be instructed to stop nursing.
Adverse Reactions
Cardiovascular: Facial hot flushes, feeling warmth, palpitation, peripheral edema, tachycardia, hypotension, chest pain.
Dermatologic: Pruritus, rash, eczema, erythema.
Gastrointestinal: Nausea, vomiting, anorexia, stomach discomfort, heartburn, enlarged feeling of abdomen, diarrhea, constipation and xerostomia, gastralgia, abdominal pain.
Hematologic: Leukopenia, prolong bleeding time.
Central nervous system: Headache, dizziness, vertigo, numbness, paresthesias, weakness, parkinsonian symptoms.
Psychiatric: Irritability, somnolence.
Hepatic: Elevation of GOT, GPT, γ-GTP, LDH and alkaline-P.
Renal: Elevation of BUN and serum creatinine.
Drug Interactions
Manidipine may intensify the action of other antihypertensive drugs, any combination with other drugs should be made with caution.
The action of other calcium antagonists (nifedipine) is reported to be intensified in combination with cimetidine.
Other calcium antagonists (nifedipine) reportedly increase the blood digoxin concentration. Coadministration of digoxin and calcium antagonist may have additive effect on Atrioventricular (AV) node conduction and increase the risk of bradycardia and advanced or complete heart block.
Concurrent use of amiodarone and calcium antagonist should be avoided in patient with sick sinus syndrome or partial AV block.
Dalfopristin/Quinupristin are a potent inhibitor of cytochrome P450 3A4 enzymes and may cause an increase in manidipine concentrations when administered concurrently and increase risk of manidipine toxicity including dizziness, hypotension, flushing, headache and peripheral edema.
Store below 30°C and protect from light.
MIMS Class
ATC Classification
C08CA11 - manidipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
Tab 20 mg (light yellow, round, flat with score on both sides) x 10 x 10's.
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