Cyclandelate
Indications: Arteriosclerosis obliterans; Claudication, intermittent; Cramps, nocturnal; Ischemia, cerebrovascular; Raynaud's disease; Thrombophlebitis, adjunct
DESCRIPTION:
Each capsule contains 200 mg or 400 mg of cyclandelate. The inactive ingredients present are FD&C Blue 1, gelatin, magnesium stearate, methylcellulose, titanium dioxide, and other ingredients. The 200 mg strength also contains D&C Red 28. The 400 mg strength also contains FD&C Red 40 and FD&C Yellow 6.
Cyclandelate is a white amorphous powder having a faint menthol-like odor. It is slightly soluble in water and highly soluble in ethyl alcohol and organic solvents.
CLINICAL PHARMACOLOGY:
Cyclandelate is an orally acting vasodilator. The activity of this drug, as measured by pharmacological tests against various types of smooth muscle spasm produced by acetylcholine, histamine, and barium chloride, exceeds that of papaverine, particularly in regard to the neurotropic component produced by the acetylcholine. Cyclandelate is musculotropic, acting directly on vascular smooth muscle, and has no significant adrenergic stimulating or blocking actions.
The drug is not intended to substitute for other appropriate medical or surgical programs in the treatment of peripheral- or cerebral-vascular disease.
INDICATIONS AND USAGE:
Based on a review of this drug by the Nation Academy of Sciences - National Research Council and/or other information, FDA has classified the indications as follows:
"Possibly" effective: Cyclandelate is indicated for adjunctive therapy in intermittent claudication; arteriosclerosis obliterans; thrombophlebitis (to control associated vasospasm and muscular ischemia); nocturnal leg cramps; Raynaud's phenomenon; and for selected cases of ischemic cerebral-vascular disease.
Final classification of the less-than-effective indication requires further investigation.
CONTRAINDICATIONS:
Cyclandelate is contraindicated in cases of known hypersensitivity to the drug.
WARNINGS:
1. Cyclandelate should be used with extreme caution in patients with severe obliterative coronary-artery or cerebral-vascular disease, since there is a possibility that these diseased areas may be compromised by vasodilatory effects of the drug elsewhere.
2. Use in Pregnancy :The safety of cyclandelate for use during pregnancy or lactation has not been established; therefore, it should not be used in pregnant women or in women of childbearing age unless, in the judgement of the physician, its use is deemed absolutely essential to the welfare of the patient.
3. Although no prolongation of bleeding time has been demonstrated in humans in therapeutic dosages, it has been demonstrated in animals at very large doses. Therefore, the hazard of a prolonged bleeding time should be carefully considered when administering cyclandelate to a patient with active bleeding or a bleeding tendency.
PRECAUTIONS:
Since cyclandelate is a vasodilator, it should be used with caution in patients having glaucoma.
ADVERSE REACTIONS:
Gastrointestinal distress (pyrosis, pain, and eructation) may occur with cyclandelate. These symptoms occur infrequently and are usually mild. Relief can often be obtained by taking the medication with meals or by the concomitant use of antacids.
Mild flush, headache, feeling of weakness, or tachycardia may occur, especially during the first weeks of administration.
DOSAGE AND ADMINISTRATION:
It is often advantageous to initiate therapy at higher dosage; e.g.: 1200 to 1600 mg per day, given in divided doses before meals and at bedtime. When a clinical response is noted, the dosage can be decreased in 200 mg decrements until the maintenance dosage is reached. The usual maintenance dosage of cyclandelate is between 400 mg and 800 mg per day given in two to four divided doses.
Although objective signs of therapeutic benefit may be rapid and dramatic, more often, this improvement occurs gradually over weeks of therapy. It is strongly recommended that the patient be educated to the fact that prolonged use may be necessary. Short-term use of cyclandelate is rarely beneficial, nor is it likely to be of any permanent value.
Storage: Keep Tightly closed. Protect From light. Dispense in light- resistant, tight container.