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Isoxsuprine Uses, Dosage, Side Effects & Benefits | DrugsAtlas

Authoritative Clinical Reference

DRUG NAME: Isoxsuprine

Therapeutic Class: Vasodilator

Subclass: β2-Adrenergic Agonist

Speciality: Cardiology

Schedule (India): Schedule H

Route(s): Oral, Intramuscular, Intravenous (slow)

Formulations Available in India:
• Tablets: 10 mg, 20 mg
• Injection: 5 mg/mL (1 mL ampoule)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Peripheral Vascular Disease
(Buerger’s disease, Raynaud’s phenomenon, arteriosclerosis obliterans, cerebrovascular insufficiency)

Oral Administration:

Parameter	Recommendation
Starting dose	10 mg three times daily
Titration	Increase to 20 mg three times daily after 1–2 weeks if tolerated
Usual maintenance dose	10–20 mg three times daily (30–60 mg/day)
Maximum dose	80 mg/day in divided doses

Intramuscular Administration (acute symptoms or when oral not feasible):

Parameter	Recommendation
Starting dose	5 mg IM
Titration	Based on clinical response
Usual maintenance dose	5 mg IM three to four times daily
Maximum dose	20 mg/day IM

Clinical Notes:

Therapeutic response in PVD may take 2–4 weeks to manifest
IM route reserved for short-term use due to local tissue irritation
Combine with smoking cessation, exercise therapy, and risk factor management

2. Threatened Preterm Labour (Tocolysis)
Specialist use only — Obstetric supervision mandatory

Intravenous Administration (acute tocolysis):

Parameter	Recommendation
Starting dose	5–10 mg diluted in 10 mL normal saline, given over 5–10 minutes
Titration	Repeat dose after 4–6 hours if uterine contractions persist
Usual maintenance dose	As per clinical response
Maximum dose	Not to exceed 40 mg/day IV

Intramuscular Administration:

Parameter	Recommendation
Starting dose	5 mg IM
Titration	Based on uterine activity
Usual maintenance dose	5 mg IM every 6 hours
Maximum dose	20 mg/day; limit duration to 2–3 days

Oral Administration (maintenance after acute phase):

Parameter	Recommendation
Starting dose	10 mg three times daily
Titration	Increase to 20 mg three times daily if needed
Usual maintenance dose	10–20 mg three times daily
Maximum dose	60 mg/day; duration generally limited to 7 days

Clinical Notes:

Safer tocolytic alternatives available (nifedipine preferred in Indian practice)
Reserved for cases where first-line tocolytics are contraindicated or unavailable
Continuous maternal and fetal monitoring mandatory during parenteral use

Secondary Indications – Adults (Off-label)

Indication	Dose	Duration	Evidence Basis
Cervical ripening (late pregnancy) — OFF-LABEL	20 mg orally three times daily	3–5 days before expected delivery	Indian obstetric specialist practice; limited evidence

Note: Specialist only — practice varies among obstetricians; not routine recommendation

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not applicable. Isoxsuprine is not routinely indicated in paediatric populations.

Secondary Indications – Paediatrics (Off-label)

Not applicable. Peripheral vascular disease is uncommon in children.

Age Group	Recommendation
Below 12 years	NOT RECOMMENDED — insufficient safety and efficacy data
12–18 years	May be considered under specialist supervision only; dose as per adult guidelines with caution

Safety Monitoring (if used in adolescents):

Heart rate and blood pressure monitoring
Assessment for tremor, palpitations, dizziness

RENAL ADJUSTMENT

Renal Function	Recommendation
Mild to moderate impairment	No specific dose adjustment required
Severe impairment (eGFR <30 mL/min)	Use with caution; limited pharmacokinetic data available
Haemodialysis	Avoid IV use unless strongly indicated; not significantly dialyzable

HEPATIC ADJUSTMENT

Hepatic Function	Recommendation
Mild impairment (Child-Pugh A)	No dose adjustment required
Moderate impairment (Child-Pugh B)	Use with caution; monitor for hypotensive effects
Severe impairment (Child-Pugh C)	Avoid use — risk of drug accumulation and severe hypotension

CONTRAINDICATIONS

• Known hypersensitivity to isoxsuprine or any formulation component
• Active arterial bleeding
• Recent cerebral haemorrhage or haemorrhagic stroke
• Severe hypotension (systolic BP <90 mmHg)
• Significant cardiac arrhythmias or obstructive cardiac conditions
• Uncontrolled hyperthyroidism
• First trimester of pregnancy (for obstetric indications)
• Immediate postpartum period (increased bleeding risk)

CAUTIONS

• Ischaemic heart disease — risk of reflex tachycardia and angina
• Diabetes mellitus — may affect glycaemic control
• Narrow-angle glaucoma — β2-agonist activity may elevate intraocular pressure
• History of cerebrovascular disease
• Concurrent use of other sympathomimetics or tocolytics
• Elderly patients — increased susceptibility to hypotension and falls
• Repeated IM administration — risk of local tissue irritation and sterile abscess

PREGNANCY

Parameter	Recommendation
Overall safety	Limited human data; use only when benefit clearly outweighs risk
First trimester	Contraindicated for obstetric indications
Second/Third trimester	May be used for tocolysis under obstetric supervision
Preferred alternatives	Nifedipine (first-line tocolytic); Atosiban (if available); Progesterone (maintenance)
Maternal monitoring	Blood pressure, pulse rate, fluid balance, uterine activity
Fetal monitoring	Continuous fetal heart rate monitoring during parenteral use

LACTATION

Parameter	Information
Compatibility	Limited data; use with caution
Expected milk levels	Likely low; minimal systemic absorption
Preferred alternatives	Nifedipine if tocolysis needed in breastfeeding mother
Infant monitoring	Irritability, tachycardia, feeding difficulties
Recommendation	Avoid during high-dose IV therapy; oral use acceptable with monitoring

ELDERLY

Parameter	Recommendation
Starting dose	10 mg once or twice daily (lower end of range)
Titration	Slow — increase only after 1–2 weeks if tolerated
Special risks	Postural hypotension, falls, dizziness, reflex tachycardia, confusion
Route preference	Oral preferred; avoid IM due to muscle fragility and pain
Monitoring	Blood pressure (supine and standing), heart rate, symptoms of orthostasis

MAJOR DRUG INTERACTIONS

Interacting Drug	Mechanism/Effect	Recommendation
MAO inhibitors	Potentiation of adrenergic effects; risk of hypertensive crisis	Avoid concurrent use
Non-selective beta-blockers	Antagonism of vasodilatory effect	Avoid combination; therapeutic failure likely
Other sympathomimetics (salbutamol, terbutaline)	Additive cardiovascular stimulation	Avoid concurrent use; risk of severe tachycardia
Ergot alkaloids	Antagonistic vascular effects	Avoid concurrent use

MODERATE DRUG INTERACTIONS

Interacting Drug	Effect	Recommendation
Antihypertensives (CCBs, ACE inhibitors)	Additive hypotensive effect	Monitor blood pressure; adjust doses as needed
Loop/thiazide diuretics	Enhanced hypotension; potential electrolyte disturbance	Monitor BP and electrolytes
Antidiabetic agents	Possible interference with glycaemic control	Monitor blood glucose
General anaesthetics	Enhanced cardiovascular instability	Inform anaesthetist; perioperative monitoring
Digoxin	Potential for additive cardiac effects	Monitor heart rate and rhythm

COMMON ADVERSE EFFECTS

• Headache
• Palpitations
• Tachycardia
• Dizziness
• Flushing
• Nausea
• Tremor
• Mild hypotension
• Injection site discomfort (IM route)

SERIOUS ADVERSE EFFECTS

Adverse Effect	Clinical Action
Tachyarrhythmias	Discontinue; ECG monitoring; supportive care
Severe hypotension	Discontinue IV infusion; fluid resuscitation; consider vasopressors
Angina / Myocardial ischaemia	Discontinue immediately; cardiac evaluation
Pulmonary oedema (with tocolysis)	Discontinue; diuretics; oxygen support
Hypersensitivity reactions (rash, bronchospasm)	Discontinue; antihistamines; supportive care
Confusion / CNS disturbance (elderly)	Dose reduction or discontinuation

MONITORING REQUIREMENTS

Baseline:
• Blood pressure and heart rate
• Cardiovascular history and examination
• Blood glucose (in diabetics)
• Assessment of peripheral circulation (for PVD)

After initiation / dose change:
• Blood pressure and pulse — daily during parenteral use; weekly during oral initiation
• Uterine activity and fetal heart rate (obstetric use)
• Fluid balance (during IV tocolysis)
• Symptoms of postural hypotension

Long-term:
• Periodic cardiovascular assessment
• Review of symptomatic improvement in PVD
• Blood glucose monitoring in diabetics
• Assessment of continued need for therapy

BRANDS AVAILABLE IN INDIA

Brand Name	Manufacturer	Formulation
Duvadilan	Abbott	Tablets 10 mg, 20 mg; Injection 5 mg/mL
Isoxilan	Various	Tablets 10 mg, 20 mg
Vasoprine	Various	Tablets 10 mg, 20 mg
Ausprin	Various	Tablets

Note: Some brands available as FDCs — verify composition before prescribing

PRICE RANGE (INR)

Formulation	Approximate Price
Tablet 10 mg	₹2–5 per tablet
Tablet 20 mg	₹3–7 per tablet
Injection 5 mg/mL (1 mL)	₹8–15 per ampoule

• NLEM status: Not listed
• NPPA price control: Not applicable
• Availability: Widely available in private pharmacies

CLINICAL PEARLS

• Use in preterm labour has declined significantly — nifedipine is now preferred first-line tocolytic in Indian obstetric practice due to better safety profile

• Efficacy in peripheral vascular disease is modest — must be combined with smoking cessation, exercise rehabilitation, and cardiovascular risk factor control for meaningful outcomes

• Avoid repeated IM injections — risk of sterile abscess and local tissue necrosis; switch to oral route as soon as feasible

• Always assess cardiovascular status before initiation — even for peripheral vascular indications, cardiac risk is elevated in this population

• Counsel patients about postural hypotension — advise slow position changes, adequate hydration, and reporting dizziness promptly

• Not a rescue medication — therapeutic effect in PVD takes weeks; set appropriate patient expectations

Clinical Responsibility

This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

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