Duvadilan

Each tablet contains Isoxsuprine hydrochloride 10 mg.
Tablets (uncoated) for oral administration.
A round, flat, whitetablet with bevelled edges and insciption '111'.
Excipients/Inactive Ingredients: Lactose, corn starch, gelatin, talc, magnesium stearate.

Pharmacology: Pharmacodynamics: Pharmacodynamic effects: Isoxsuprine has a strong inhibitory effect on the muscular tissue of uterus and blood vessels. It has only a moderate effect on the smooth muscle of the respiratory, biliary and intestinal tracts. The effects of isoxsuprine are brought about mainly by its influence on the receptors in those organs responsive to stimuli from the sympathetic nervous system. Isoxsuprine hydrochloride is a beta-adrenergic receptor stimulator. Hence it is classified as beta-agonist drug, in particular a uterine relaxant. It is also a vasodilator.
The mechanism of action of isoxsuprine in the treatment of preterm labor is detailed as follows: β-sympathomimetic effect: By virtue of this effect, isoxsuprine has relaxant action on the muscular tissue of the uterus.
α-sympathomimetic effect: Isoxsuprine antagonizes the effects of α-receptor stimulation. Some uterine contraction, which can otherwise occur because of α-receptor stimulation, gets inhibited due to this effect of isoxsuprine.
Direct relaxant action on the smooth muscle fibers: Isoxsuprine induces a direct relaxant action on the smooth muscle fibers and so enhances those effects resulting from its action on the sympathetic receptors.
Pharmacokinetics: Isoxsuprine hydrochloride is well absorbed from the gastro-intestinal tract. The peak plasma concentrations occur one hour after oral administration. Plasma half-life is 1.5 hours.
Isoxsuprine is excreted in urine mainly as conjugates.

Treatment of premature labor. It has also been given in the treatment of celebral and peripheral vascular disease.

For use as a vasodilator, Isoxsuprine hydrochloride is given orally in doses of 10 to 20 mg 3 or 4 times daily. To arrest premature labor, Isoxsuprine hydrochloride is given initially by intravenous infusion in doses of 200 to 500 mcg/minute, adjusted according to the patient's response, until control is achieved. Once labor has been arrested intramuscular injections of 10 mg are given every 3 to 8 hours. Prophylaxis may be continued orally with 30 to 90 mg daily.

None known.

Pre-existing hypotension: If the blood pressure is already low, e.g. below 100 mmHg systolic, it must be borne in mind that the administration of isoxsuprine will, in most instances, bring about a further reduction in the blood pressure.
Prolonged premature rupture of membranes: If fetal membranes are ruptured/dilatation is >4 cm, chances of success are less. In the cases of prolonged premature rupture of membranes, the possible benefits to be gained from delaying emptying of the uterus must be weighed against the possibility that undue prolongation of the pregnancy may actually increase the maternal and fetal hazards.
Isoxsuprine should not be used in the presence of hemorrhage.

Isoxsuprine is contraindicated after recent arterial hemorrhage. It should not be given immediately post partum, nor should it be used for premature labor if there is infection.
In women being treated for premature labor, the risk of pulmonary edema means that extreme caution is required.

None known.

Isoxsuprine may cause transient nausea, vomiting, flushing, tachycardia, rashes, gastro-intestinal disturbances and maternal pulmonary edema. In few cases, mainly in hypertensive patients, parenteral administration of Isoxsuprine (Duvadilan) may lead to transitory fall in blood pressure. A change over to oral administration or reduction in dosage will usually avoid this effect.

None known.

Incompatibilities: None known.

Store at temperatures not exceeding 25°C.
Shelf life: 5 years.

Peripheral Vasodilators & Cerebral Activators / Drugs Acting on the Uterus

C04AA01 - isoxsuprine ; Belongs to the class of 2-amino-1-phenylethanol derivative agents. Used as peripheral vasodilators.

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