Evigrade

Manidipine

AEMPS

Calcium channel blockers, dihydropyridine

ATC code: C08CA11

Brand names: Manidipino Cinfa, Manyper

Updated · Methodology

Indications

A

Hypertension

First line

Stage 1–2 hypertension. Starting dose 10 mg once daily in the morning; up-titrate to 20 mg after 2–4 weeks. More effective in combination with an ACE inhibitor or ARB – Spanish SEH-LELHA 2022 recommends combination therapy from the start for BP >=160/100 or high-risk patients. Not validated for post-MI protection or heart failure (unlike ACE inhibitors).

ICD-10: I10 · ICD-11: BA00

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Anti-aging and longevity

Not recommended

Manidipine is a dihydropyridine calcium channel blocker. It is prescribed for hypertension (AEMPS Ficha Técnica, SEH-LELHA). In anti-aging regimens, manidipine is marketed as a mild long-acting CCB for healthy normotensives with promises of vessel protection from aging. In people with normal blood pressure, no clinical studies of prophylactic use exist. The drug can cause ankle edema, dizziness, tachycardia, and flushing. Manidipine is not approved by the . If manidipine was prescribed to a person with normal blood pressure, consider seeking a second opinion.

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

A dihydropyridine L-type calcium channel blocker with high arteriolar selectivity. 24-hour duration via long half-life (4–9 hours) and slow receptor dissociation. Compared with amlodipine, manidipine causes fewer peripheral edema – a known advantage in Spanish practice where manidipine (Chiesi's Artedil) is widely used in amlodipine-edema-intolerant patients. Metabolized by hepatic CYP3A4.

Safety

Contraindications

  • Manidipine or DHP hypersensitivity
  • Cardiogenic shock
  • Unstable angina
  • Severe heart failure NYHA III-IV
  • Severe hepatic impairment
  • Pregnancy and lactation

Serious adverse effects

  • Severe hypotension and reflex tachycardia
  • Gingival hyperplasia on chronic therapy

Common adverse effects

  • Headache
  • Flushing
  • Palpitations
  • Peripheral edema (less than amlodipine)
  • Fatigue

Pregnancy: can you take Manidipine?

AEMPS summary of product characteristics (section 4.6): there is no clinical experience and there are no clinical data on manidipine use in pregnant women, and animal studies of embryo-fetal development are insufficient. Other dihydropyridines have been teratogenic in animals and the potential risk in humans is unknown, so for safety reasons manidipine should not be given during pregnancy.

Breastfeeding: can you take Manidipine?

No milk excretion data. Not recommended during lactation – prefer nifedipine or verapamil.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Once daily in the morning, on empty stomach or with a light breakfast. Grapefruit and grapefruit juice raise manidipine levels (CYP3A4 inhibition) – exclude. In older patients and moderate hepatic impairment, start at 5 mg. No dose reduction needed in severe renal impairment (mainly hepatically cleared).

Drug–nutrient interactions

Grapefruit juice

Grapefruit juice slows the metabolism of dihydropyridines, so manidipine becomes more bioavailable and lowers blood pressure more. The Artedil SmPC says manidipine should not be taken together with grapefruit juice. Excess shows as dizziness on standing, palpitations, flushing and ankle swelling.

Source: AEMPS: Ficha técnica de Artedil 10 mg comprimidos (manidipino) (2024)

Label mentions14 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • ModerateAmiodarone
    «Como sucede con otras dihidropiridinas bloqueadoras del canal del calcio, es probable que el metabolismo de manidipino sea catalizado por el citocromo P450 3A4. No se poseen estudios de interacción…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateantiarrítmicosclass named in the label
    «Como sucede con otras dihidropiridinas bloqueadoras del canal del calcio, es probable que el metabolismo de manidipino sea catalizado por el citocromo P450 3A4. No se poseen estudios de interacción…»

    AEMPS, section 4.5 · Open on CIMA

  • «Como sucede con otras dihidropiridinas bloqueadoras del canal del calcio, es probable que el metabolismo de manidipino sea catalizado por el citocromo P450 3A4. No se poseen estudios de interacción…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateDigoxin
    «Como sucede con otras dihidropiridinas bloqueadoras del canal del calcio, es probable que el metabolismo de manidipino sea catalizado por el citocromo P450 3A4. No se poseen estudios de interacción…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateErythromycin
    «Como sucede con otras dihidropiridinas bloqueadoras del canal del calcio, es probable que el metabolismo de manidipino sea catalizado por el citocromo P450 3A4. No se poseen estudios de interacción…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateinductores del CYP3A4class named in the label
    «Como sucede con otras dihidropiridinas bloqueadoras del canal del calcio, es probable que el metabolismo de manidipino sea catalizado por el citocromo P450 3A4. No se poseen estudios de interacción…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateItraconazole
    «Como sucede con otras dihidropiridinas bloqueadoras del canal del calcio, es probable que el metabolismo de manidipino sea catalizado por el citocromo P450 3A4. No se poseen estudios de interacción…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateKetoconazole
    «Como sucede con otras dihidropiridinas bloqueadoras del canal del calcio, es probable que el metabolismo de manidipino sea catalizado por el citocromo P450 3A4. No se poseen estudios de interacción…»

    AEMPS, section 4.5 · Open on CIMA

  • «Como sucede con otras dihidropiridinas bloqueadoras del canal del calcio, es probable que el metabolismo de manidipino sea catalizado por el citocromo P450 3A4. No se poseen estudios de interacción…»

    AEMPS, section 4.5 · Open on CIMA

  • ModeratePhenytoin
    «Como sucede con otras dihidropiridinas bloqueadoras del canal del calcio, es probable que el metabolismo de manidipino sea catalizado por el citocromo P450 3A4. No se poseen estudios de interacción…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateQuinidine
    «Como sucede con otras dihidropiridinas bloqueadoras del canal del calcio, es probable que el metabolismo de manidipino sea catalizado por el citocromo P450 3A4. No se poseen estudios de interacción…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateRifampicin
    «Como sucede con otras dihidropiridinas bloqueadoras del canal del calcio, es probable que el metabolismo de manidipino sea catalizado por el citocromo P450 3A4. No se poseen estudios de interacción…»

    AEMPS, section 4.5 · Open on CIMA

  • betabloqueantesclass named in the label
    «El efecto antihipertensivo de manidipino puede potenciarse al ser administrado conjuntamente con diuréticos, beta-bloqueantes y, en general, con otros fármacos antihipertensivos.»

    AEMPS, section 4.5 · Open on CIMA

  • diuréticosclass named in the label
    «El efecto antihipertensivo de manidipino puede potenciarse al ser administrado conjuntamente con diuréticos, beta-bloqueantes y, en general, con otros fármacos antihipertensivos.»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Manidipine used for?

Manidipine is evaluated for the following indications with varying evidence strength: Hypertension (evidence tier A), Anti-aging and longevity (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Manidipine?

Common side effects of Manidipine (≥ 1 in 100): Headache, Flushing, Palpitations, Peripheral edema (less than amlodipine), Fatigue. See the Safety section for uncommon and serious reactions.

Is Manidipine safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): there is no clinical experience and there are no clinical data on manidipine use in pregnant women, and animal studies of embryo-fetal development are insufficient. Other dihydropyridines have been teratogenic in animals and the potential risk in humans is unknown, so for safety reasons manidipine should not be given during pregnancy.

Is Manidipine compatible with breastfeeding?

No milk excretion data. Not recommended during lactation – prefer nifedipine or verapamil.

Who should not take Manidipine?

Manidipine is contraindicated in: Manidipine or DHP hypersensitivity; Cardiogenic shock; Unstable angina; Severe heart failure NYHA III-IV; Severe hepatic impairment. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Amlodipine, Diltiazem, Lercanidipine, Nifedipine, Verapamil