Isoxilan

Isoxilan

isoxsuprine

Manufacturer:

BIOFEMME, Inc

Distributor:

BIOFEMME, Inc
Full Prescribing Info
Contents
Isoxsuprine hydrochloride.
Description
Each tablet contains: Isoxsuprine hydrochloride 10 mg.
Each 2 mL ampule contains: Isoxsuprine hydrochloride 10 mg.
Action
Pharmacology: Pharmacodynamics: Isoxsuprine hydrochloride is a β2-adrenoceptor agonist that causes vasodilation by direct relaxation of vascular smooth muscle. Its β2-adrenergic effects, however, are not essential to its vasodilating effect. Isoxsuprine decreases peripheral vascular resistance; blood pressure may be decreased by parenteral administration or large oral doses of isoxsuprine. lsoxsuprine may also have positive inotropic and chronotropic effects on the heart and may increase cardiac output.
Isoxsuprine also relaxes uterine smooth muscle and is valuable in arresting contractions in threatened abortion and premature labor.
Pharmacokinetics: Isoxsuprine is almost completely absorbed from the gastrointestinal tract after oral administration and peak plasma concentrations occur within 1 hour and persist for about 3 hours. lsoxsuprine's mean plasma half-life is about 1.25 hours. It crosses the placenta.
Isoxsuprine is conjugated partially in the body and is excreted in urine. Isoxsuprine's fecal excretion is negligible.
No data is available on the onset of effect and peak plasma concentration of isoxsuprine hydrochloride when administered parenterally. With intramuscular (IM) injection, isoxsuprine's effect lasts for 3 to 4 hours.
Indications/Uses
Uterine hypermotility disorders such as threatened abortion and uncomplicated premature labor.
An adjunct therapy in the treatment of peripheral vascular disease such as arteriosclerosis obliterans, thromboangiitis obliterans (Buerger's disease), and Raynaud's disease.
For the relief of symptoms associated with cerebrovascular insufficiency.
Dosage/Direction for Use
Uterine Hypermotility: See Table 1.

Click on icon to see table/diagram/image

Maintain patients in preterm labor in the lateral position during infusion.
Monitor blood pressure (maternal) and heart rate (maternal and fetal) regularly during infusion and reduce the rate of infusion or discontinue infusion if prolonged fall in blood pressure occurs.
Circulatory Disturbances: See Table 2.

Click on icon to see table/diagram/image

IM administration may be used for the initial control of acute severe symptoms, after which patients are maintained on oral therapy.
Overdosage
Overdosage with isoxsuprine has not been reported. When this occurs, however, cardiovascular symptoms are expected.
Overdosage with the oral format should be managed by gastric lavage. A nonselective β-blocker may be administered intramuscularly if necessary.
Contraindications
Following recent arterial hemorrhage; In patients with known heart disease; In patients with severe anemia.
Parenteral use of isoxsuprine hydrochloride is also contraindicated in the following conditions: Hypotension; Tachycardia; Premature detachment of the placenta; Immediately postpartum; Premature labor if there is infection.
Special Precautions
Immediately discontinue isoxsuprine treatment if rash develops.
To avoid pulmonary edema in women being treated for premature labor, very carefully monitor the patient's state of hydration, and cardiac and respiratory function. Keep fluid infusion volume to the minimum. For infusion, hypotonic dextrose is preferred over isotonic saline solution. Discontinue isoxsuprine immediately and institute diuretic therapy when signs of pulmonary edema develop.
Use in Children: lsoxsuprine is not indicated for pediatric patients.
Use in Elderly: No specific information is available on the use of isoxsuprine in elderly patients. lsoxsuprine may reduce tolerance to cold temperatures in these patients.
Use In Pregnancy & Lactation
Ileus and respiratory distress syndrome has been found to be more common in the offspring of pregnant women who received isoxsuprine. Incidence of respiratory distress syndrome increases as the isoxsuprine concentration in cord blood exceeds 10 ng/mL. The incidence of hypocalcemia and hypotension rises progressively with increasing isoxsuprine concentration in the cord blood.
Use isoxsuprine in pregnant women only when the potential benefit outweighs the potential risk to mother and infant.
There are no reports of problems with isoxsuprine in breastfeeding babies.
Adverse Reactions
Isoxsuprine adverse effects may include trembling, nervousness, weakness, dizziness, flushing, transient palpitation, tachycardia, chest pain, hypotension, abdominal distress, nausea, vomiting, intestinal distention, and severe rash.
Parenteral isoxsuprine administration can result in tachycardia, palpitations, hypotension, dizziness, and flushing. These can be controlled by dose reduction and by supine position of the patient. These effects are reversed, if necessary, by parenteral administration of noradrenaline.
Isoxsuprine may also cause slight increase in fetal heart rate if used as IV infusion in premature labor.
Drug Interactions
Isoxsuprine may cause severe hypotension when administered with other vasodilators and anti-hypertensive drugs.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
ATC Classification
C04AA01 - isoxsuprine ; Belongs to the class of 2-amino-1-phenylethanol derivative agents. Used as peripheral vasodilators.
Presentation/Packing
Tab 10 mg (pink, round, flat, and bevel-edge, 5/16" in diameter, bisected on one side and plain on the other side) x 100's. Inj (amp) 5 mg/mL (clear colorless liquid free from extraneous matter) x 2 mL x 5's.
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