Clinical beta

FMBM is currently in clinical beta. Content is for professional review/testing and must not replace local protocols, senior clinical judgment, or official prescribing references.

Drug Monograph

Cilostazol

Cilostazol

Phosphodiesterase-3 inhibitor β€” antiplatelet + vasodilator

PADPOAdult

Indication

Symptomatic PAD (lifestyle + statin + exercise still symptomatic)

At a glance

INDICATIONS (CORE USE)

Intermittent claudication β€” **HF contraindication**; **renal** cutoff; **tachycardia**.

ADULT DOSE (STANDARD)

**100 mg BID** (50 mg BID if on strong CYP3A4 inhibitors per label)

MAX DOSE

100 mg BID

Route

PO

PEDIATRIC DOSE

Not used

Do not miss

Must-not-miss safety points

Major warning

- **Contraindicated** HF reduced EF - **Tachycardia** - Bleed with aspirin

Indications

USE IF: Claudication after risk-factor optimization. AVOID IF: Heart failure, CrCl <50 per label, active bleed.

Primary

  • Intermittent claudication (reduce symptoms β€” does not replace risk-factor modification)

Dosing

STANDARD (ADULT PO)

100 mg PO BID on empty stomach (30 min before or 2h after meals per label)

ADULT DOSE

50 mg BID with strong CYP3A4 inhibitors β€” verify label.

PEDIATRIC DOSE

N/A

MAX DOSE

100 mg BID

Practical Note

Avoid grapefruit with drug.

Warnings

Clinical warnings

  • **Major bleeding** (GI, ICH, post-procedural) β€” higher with **DAPT**, triple therapy, renal failure, age β€” counsel early symptoms
  • Tachycardia
  • angina in severe underlying CAD

Adverse effects

  • Headache
  • palpitations
  • diarrhea
  • infection signal in some trials β€” context

Contraindications

  • **Active major bleeding** β€” hold until controlled unless embedded in explicit procedural plan
  • **Heart failure (reduced EF)** β€” **contraindicated**
  • **Severe renal failure** where label contraindicates (often **CrCl <50**)
  • Heart failure of any severity (reduced EF)
  • CrCl <50 (label)
  • active bleeding

Drug interactions

  • **Add aspirin or anticoagulant** β†’ **bleed risk ↑** β†’ **reassess**; **strong CYP3A4 inhibitor** β†’ dose interaction per label
  • Strong CYP3A4 inhibitors
  • other antiplatelets

Special populations

Pediatrics

Not used

Pregnancy

Contraindicated pregnancy category risk

Lactation

See lactation references and product labeling.

Renal impairment

**CrCl <50** β€” contraindicated many labels **Renal (FMBM β€” verify label):** **CrCl <50** β†’ contraindicated in many labels; minimal dialysis clearance

Hepatic impairment

Moderate-severe hepatic impairment β€” avoid

Elderly

Bleed + fall risk with aspirin combo

Administration

Empty stomach dosing per label for absorption

Monitoring

  • Monitor: - **Palpitations/tachycardia** β†’ **hold** if symptomatic - **HF signs** β†’ **stop** β€” **HF reduced EF contraindication** - **OTC aspirin / anticoagulant added** β†’ **reconcile** β€” bleed risk - HR symptoms - HF signs if cardiac history
  • Recheck: - **CrCl decline** β†’ label may **contraindicate** β€” reassess dose/agent - New or worsening **bleeding**, unexplained **Hb drop**, or planned invasive procedure within **48–72h** β†’ reassess antiplatelet plan with cardiology/surgery when on DAPT - If targets not met after reassessment of dose, organ function, and interactions β†’ escalate per protocol (DO NOT continue blindly)

Overdose / toxicity

Clinical Picture

**Overdose:** tachycardia, hypotension, headache. **Bleed** risk with other antiplatelets/anticoagulants.

Immediate Actions

Hold drug β†’ supportive; ECG if symptomatic tachycardia

Antidote

No specific antidote; treat complications (supportive care, platelets / hemostasis per protocol, anaphylaxis β†’ epinephrine per ACLS)

Decontamination

Charcoal if early

Escalation

Hemodynamic collapse, arrhythmia β†’ **ICU**

Clinical pearls

Common mistakes, resistance logic, and bedside traps

High-Yield Summary

**HF = never.** β†’ **CrCl <50** = no drug. β†’ BID empty stomach.

Clinical pearls

Symptom drug β€” still walk, quit smoking, statin, supervised exercise. *Antiplatelet (all agents):* **Primary vs secondary (aspirin):** primary **not routine**; secondary **strong** when guideline-supported. **DAPT:** **do not stop early** post-stent without expert; duration **ACS vs stable CAD**; procedures need **explicit review**. **Bleeding-first:** GI/ICH/peri-op; **duplicate/hidden aspirin** on med rec. **Aspirin toxicity** (salicylate) is a **separate pathway** from antiplatelet bleed.

Antiplatelet safety

  • HF screen
  • CrCl
  • Tachycardia symptoms

Pharmacokinetics

Extensive hepatic metabolism; contraindicated severe renal impairment per label.

Mechanism of action

PDE3 inhibition β†’ ↑ cAMP in platelets and vascular smooth muscle.

Common brand names

Saudi Arabia

Pletal, Cilostazol

Global

(placeholder β€” verify local product)

Common trade names are curated examples only β€” formulations and availability vary. Verify the exact product name with your local pharmacy and national regulator before prescribing or dispensing.

Country practice notes

  • DAPT duration and perioperative management follow **ESC/AHA/ACC** and local cardiology consensus β€” not one-size rules.
  • Primary prevention aspirin thresholds differ by guideline and age β€” verify regional primary-care policy.

References

Saudi Arabia

  • SFDA (Saudi Food & Drug Authority)
  • Saudi National Formulary / MOH (where available)

International

  • WHO Model List of Essential Medicines (verify current edition)
  • US FDA or EU EMA product information (when national SmPC is unavailable)
  • ACC / AHA / ESC cardiovascular guidelines (CAD, ACS, PCI)
  • FDA / SFDA product labeling
  • Local cath lab / antithrombotic protocol
  • ACC / AHA / ESC cardiovascular guidelines (CAD, ACS, PCI)
  • FDA / SFDA product labeling
  • Local cath lab / antithrombotic protocol

Do not miss

  • Document antiplatelet indication (primary vs secondary prevention vs stent DAPT)
  • Med reconciliation: OTC aspirin, NSAIDs, fish oil, anticoagulants
  • **HF:** **Contraindicated** in reduced EF β€” can worsen HF mortality class effect.
  • **Tachycardia:** Symptomatic β†’ hold; not interchangeable with other PAD pills.
  • **Bleed:** With aspirin/warfarin/DOAC β€” **reconcile all antithrombotics**; peri-op **explicit plan**.
  • Prescribing cilostazol in HFrEF patient β€” **class contraindication**.
  • HF screen
  • CrCl
  • Tachycardia symptoms