Ukraine Product

Suprelax tablet

Suprelax tablet

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:

Peripheric circulation disorders of different genesis: limb arteriospasm, obliterating endarteritis, limb artery atherosclerosis, diabetic angiopathy, Raynaud’s disease and syndrome. Chronic cerebro-vascular insufficiency in genesis of atherosclerosis, atherosclerosis of retinal artery. Threat of premature delivery (as continuation of therapy by injection isoxsuprine).

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
Tachycardia, palpitation, arterial hypotension, chest pain, dizziness, weakness, flushes, nausea, vomiting, skin rash, dyspepsia.
In the preparation usage for premature delivery treatment it may be observed fetal and maternal tachycardia. In fetus and newborn, whose mothers have been used іsoxsuprine, it is possible appearance of such symptoms as tachycardia, arterial hypotension, hypocalcaemia, hypoglycemia and bowel obstruction.

WHAT TO DO IF YOU MISS A DOSE?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

One should not exceed the dosage and duration of the treatment course, prescribed by doctor. In case of any unusual reactions within the preparation treatment it is necessary to consult the doctor.

Peculiarities in usage:
It is necessary to administer the preparation with caution in stenocardia, tachycardia, flushes, blood coagulation disorder, glaucoma, acute phase of myocardial infarction and insult.

During the preparation treatment elderly patients should arise with caution and avoid upright posture change to prevent orthostatic hypotension.

The preparation effect can be decreased in patients who smoke.

It is necessary not to consume alcohol during the preparation treatment.

Influence on velocity reactions while driving motor transport and operating other mechanisms:

The preparation can cause somnolence and dizziness. In such cases it is necessary to avoid driving motor transport and operating other machines.

What to do if you accidentally take too much (overdose) of the medicine?

Symptoms: Tachycardia, palpitation, arterial hypotension, chest pain, arterial pressure reduction (collapse), dizziness, weakness, loss of consciousness, nausea and vomiting.
Treatment: Symptomatic.

Is it safe in pregnancy and breast-feeding?

If Suprelax is not used f threat of premature delivery it is contraindicated in pregnant. There is no data concerning іsoxsuprine safety administration during lactation period, but, as in case of other drugs, there has not been special studies, and it is necessary to avoid the preparation usage during lactation period.

Storage Conditions:

Keep it out of reach of children, in dry, protected from light place at the temperature not more than 25°C.

Drug Description

Active substance: іsoxsuprine hydrochloride;
1 tablet contains іsoxsuprine hydrochloride 10 mg or 20 mg;

Additional ingredients: microcrystalline cellulose, sodium crosscarmellose, magnesium stearate, colloidal silicon dioxide.

General physic-chemical properties: white circular flat uncoated tablets scored on one side.


Indications and dosage.

Indications:
Peripheric circulation disorders of different genesis: limb arteriospasm, obliterating endarteritis, limb artery atherosclerosis, diabetic angiopathy, Raynaud’s disease and syndrome. Chronic cerebro-vascular insufficiency in genesis of atherosclerosis, atherosclerosis of retinal artery. Threat of premature delivery (as continuation of therapy by injection isoxsuprine).

Dosage:
In diseases, which are accompanied by blood circulation disorders, it is administered 10–20 mg of the preparation 3–4 times per day after meal. The treatment course is 2–3 months.
In case of threat of premature delivery Suprelax in tablets is administered after previous course of intravenous treatment by іsoxsuprine in state’s improvement (labour relief); the recommended dose of іsoxsuprine in intake is 20 mg 4 times per day. The preparation treatment duration is 2 days.

Side effects and drug interactions.

Side effects:
Tachycardia, palpitation, arterial hypotension, chest pain, dizziness, weakness, flushes, nausea, vomiting, skin rash, dyspepsia.
In the preparation usage for premature delivery treatment it may be observed fetal and maternal tachycardia. In fetus and newborn, whose mothers have been used іsoxsuprine, it is possible appearance of such symptoms as tachycardia, arterial hypotension, hypocalcaemia, hypoglycemia and bowel obstruction.

 Drug interactions
There is no data concerning negative interaction of іsoxsuprine with other drugs.
It is possible enhancement of vasodilatory action in concurrent usage with vasodilators, which are used in cardiology.

Warnings and precautions

One should not exceed the dosage and duration of the treatment course, prescribed by doctor. In case of any unusual reactions within the preparation treatment it is necessary to consult the doctor.

Peculiarities in usage:
It is necessary to administer the preparation with caution in stenocardia, tachycardia, flushes, blood coagulation disorder, glaucoma, acute phase of myocardial infarction and insult.

During the preparation treatment elderly patients should arise with caution and avoid upright posture change to prevent orthostatic hypotension.

The preparation effect can be decreased in patients who smoke.

It is necessary not to consume alcohol during the preparation treatment.

Overdosage and Contraindications

Overdosage:
Symptoms: Tachycardia, palpitation, arterial hypotension, chest pain, arterial pressure reduction (collapse), dizziness, weakness, loss of consciousness, nausea and vomiting.
Treatment: Symptomatic.

 Contraindications
Hypersensitivity to isoxsuprine or other drug components, cerebral hemorrhages and metrorrhagia in anamnesis, arterial hemorrhage, stenocardia, arterial hypotension and lactation period.

Clinical pharmacology.

Pharmacodynamic properties

Peripheral vasodilator. Derivative of 2-amino-1-phenyletanol. ATC code C04A A01.

Isoxsuprine is a peripheral vasodilator, agonist of beta-adrenoreceptors. Due to stimulating influence on beta-adrenoreceptor іsoxsuprine decreases tonus of smooth muscle of blood vessel, eliminates their spasms, improves peripheral and cerebral circulation, and tissue blood supply, respectively. It has positive inotropic and chronotropic cardial effect and tocolytic effect. In in vitro and in vivo trials іsoxsuprine inhibited spontaneous and oxytocin-induced uterus activity in labor.
Isoxsuprine has also minor broncholytic action. In large doses it inhibits platelet aggregation and decreases blood viscosity.

Pharmacokinetic properties
Isoxsuprine is quickly absorbed from gastrointestinal tract. It is metabolized by partial conjugation in liver. In per oral usage maximal plasma concentration is reached approximately within 1 hour. Half-life period is approximately 1.25 hours. It is excreted mainly with urine, in pavro – with faeces. 

Pharmaceutical characteristics:

Shelf-life: 3 years.

Storage: Keep it out of reach of children, in dry, protected from light place at the temperature not more than 25 °C.

Package: 10 tablets are in a blister or strip, 1 or 3 blisters or strips are in a carton box.

Conditions of supply:
By prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780