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DOSTINEX TABLET :
DOSTINEX Tablets are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas. DOSTINEX Tablets, for oral administration, contain 0.5 mg of cabergoline. Inactive ingredients consist of leucine, USP, and lactose, NF.
DOSTINEX is a white powder soluble in ethyl alcohol, chloroform, and N, N-dimethylformamide (DMF); slightly soluble in 0.1N hydrochloric acid; very slightly soluble in n-hexane; and insoluble in water.
The recommended dosage of DOSTINEX Tablets for initiation of therapy is 0.25 mg twice a week. Dosage may be increased by 0.25 mg twice weekly up to a dosage of 1 mg twice a week according to the patient's serum prolactin level.
Dosage increases should not occur more rapidly than every 4 weeks, so that the physician can assess the patient's response to each dosage level. If the patient does not respond adequately, and no additional benefit is observed with higher doses, the lowest dose that achieved maximal response should be used and other therapeutic approaches considered.
After a normal serum prolactin level has been maintained for 6 months, DOSTINEX Tablets may be discontinued, with periodic monitoring of the serum prolactin level to determine whether or when treatment with DOSTINEX should be reinstituted. The durability of efficacy beyond 24 months of therapy with DOSTINEX has not been established.
DOSTINEX Tablets are white, scored, capsule-shaped tablets containing 0.5 mg cabergoline. Each tablet is scored on one side and has the letter P and the letter U on either side of the break line. The other side of the tablet is engraved with the number 700.Dostinex Tablet store at controlled room temperature 20° to 25°C (68° to 77°F).
DOSTINEX Tablets are contraindicated in patients with uncontrolled hypertension or known hypersensitivity to ergot derivatives. |
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