Madiplot

Madiplot

manidipine

Manufacturer:

Takeda

Distributor:

DKSH
Full Prescribing Info
Contents
Manidipine HCl.
Action
Madiplot produces long-acting antihypertensive effect by dilating blood vessels, mainly by calcium-channel blockade.
Clinically, it has been proven that Madiplot made possible good control of blood pressure in a single dose once a day, and is useful for treatment of essential hypertension (mild to moderate), hypertension with renal impairment and severe hypertension.
Indications/Uses
Mild, moderate, severe hypertension.
Hypertension with renal impairment.
Dosage/Direction for Use
Adults: 10-20 mg once a day is orally administered after breakfast, starting with the initial dose of 10 mg. The dosage can be increased gradually if necessary.
The usual adult dosage and administration for each preparation are as follows:
Tablet 10 mg: 1-2 tabs orally once a day after breakfast.
Tablet 20 mg: ½-1 tab orally, once a day after breakfast.
Contraindications
Pregnant women or women suspected of being pregnant.
Special Precautions
It has been reported that sudden withdrawal of a calcium antagonist causes aggravation of symptoms. Therefore, if discontinuation of Madiplot is necessary, the dosage should be gradually decreased under close observation. The patient should be cautioned against discontinuing the drug without the physician's instruction.
Madiplot may rarely cause an excessive drop of blood pressure. In such a case, appropriate measures eg, dosage reduction and cessation should be taken. Madiplot should be cautiously administered to patients with severe hepatic impairment.
Effects on the Ability to Drive or Operate Machinery: Since symptoms eg, dizziness or the like, may occur because of the drop in blood pressure, the patient should be admonished against working at a height or operating hazardous machinery eg, driving a car.
Use in pregnancy: It has been reported that Madiplot prolongs the gestation period and delivery time in animal experiments. Therefore, administration to pregnant women or women suspected of being pregnant should be avoided.
Use in lactation: Transfer of manidipine HCl to the milk has been reported in an experimental animal. Administration of Madiplot to nursing mothers is not recommended. If inevitable, the patient should be instructed to stop nursing.
Use in children: The safety of Madiplot in children has not been established (no clinical experience).
Use in the elderly: It is generally acknowledged that excessive fall of blood pressure should be avoided in the elderly. Therefore, when Madiplot is given in the elderly, it is advisable to start with a low dose and treat with due attention and under close observation.
Use In Pregnancy & Lactation
Use in pregnancy: It has been reported that Madiplot prolongs the gestation period and delivery time in animal experiments. Therefore, administration to pregnant women or women suspected of being pregnant should be avoided.
Use in lactation: Transfer of manidipine HCl to the milk has been reported in an experimental animal. Administration of Madiplot to nursing mothers is not recommended. If inevitable, the patient should be instructed to stop nursing.
Side Effects
Liver: Since elevation of GOT, GPT, γ-GTP, LDH and alkaline-P may infrequently occur, close observation is required. If any abnormality is found, appropriate measures eg, discontinuation of Madiplot should be taken.
Kidneys: Since elevation of BUN and serum creatinine may infrequently occur, close observation is required. If any abnormality is found, appropriate measures eg, discontinuation of this drug, should be taken.
Blood: Leukopenia may infrequently occur, so close observation is required. If any abnormality is found, appropriate measures eg, discontinuation of this drug should be taken.
Hypersensitivity: Rash or pruritus may infrequently occur. If such symptoms occur, Madiplot should be discontinued.
Cardiovascular: Facial hot flushes, feeling of warmth, conjunctival congestion, palpitation or tachycardia may infrequently occur.
Psychoneurologic: Dizziness, dizziness on standing up, headache, dull headache, sleepiness or numbness may infrequently occur.
Gastrointestinal: Nausea, vomiting, stomach discomfort, enlarged feeling of abdomen, constipation or oral dryness may infrequently occur.
Others: General malaise, weakness, edema, pollakiuria and elevation of total serum cholesterol, uric acid or triglycerides may infrequently occur.
Drug Interactions
Since Madiplot may intensify the action of other antihypertensive drugs, any combination with other drugs should be made with caution.
Other calcium antagonists (nifedipine) reportedly increase the blood digoxin concentration.
The action of other calcium antagonists (nifedipine, etc) is reported to be intensified in combination with cimetidine.
Storage
Store at room temperature. Keep away from light after unsealing.
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.
Presentation/Packing
Tab 10 mg (pure yellow, scored) x 10 x 10's. 20 mg (light orange-yellow, scored) x 10 x 10's.
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