Endocrine / Other

bromocriptine (Parlodel ® )
Dopamine Agonist. Initial: 1.25 mg orally twice daily. Usual: 10-40mg/day.
Dosing (Adults):Parkinsons: 1.25 mg orally twice daily. Increased by 2.5 mg/day in 2 to 4 week intervals (usual dose range is 30-90 mg/day in 3 divided doses). Max: 100 mg/day.

Neuroleptic malignant syndrome: Oral: 2.5 to 5 mg tid.
Hyperprolactinemia: 2.5 mg orally bid - tid.
Acromegaly: Initial: 1.25-2.5 mg orally. Increasing as necessary every 3-7 days. Usual dose: 20-30 mg/day.

Supplied: Capsule: 5 mg. Tablet: 2.5 mg

cabergoline  (Dostinex ® )
Long acting dopamine receptor agonist with a high affinity for D2 receptor.

Dosing (Adults): Hyperprolactinemic disorders: Initial dose: 0.25 mg orally twice weekly. The dose may be increased by 0.25 mg twice weekly up to a maximum of 1 mg twice weekly according to the patient's serum prolactin level. Dosage increases should not occur more rapidly than every 4 weeks. Once a normal serum prolactin level is maintained for 6 months, the dose may be discontinued and prolactin levels monitored to determine if cabergoline is still required. The durability of efficacy beyond 24 months of therapy has not been established.

Supplied: 0.5 mg tab.

calcitonin (Calcimar ® )
Structurally similar to human calcitonin; it directly inhibits osteoclastic bone resorption; promotes the renal excretion of calcium, phosphate, sodium, magnesium and potassium by decreasing tubular reabsorption.

Dosing (Adults): Paget's disease: 100 units/day IM/SQ to start. Maint: 50 units/day or 50-100 units every 1-3 days.
Hypercalcemia: Initial: 4 units/kg IM/SQ q12h. May increase up to 8 units/kg q12h to a maximum of q6h.
Osteoporosis prevention (in postmenopausal women): 100 units/day (IM/SQ). Intranasal: 200 units (1 spray)/day

Supplied: Injection: 200 IU/ml (2 ml) (calcitonin-salmon). Nasal spray:200 IU/0.09 ml (3.7 ml)

cinacalcet (Sensipar ® )
MOA: Increases the sensitivity of the calcium-sensing receptor on the parathyroid gland.
Dosing (Adults): Secondary hyperparathyroidism: Initial: 30 mg orally once daily (maximum daily dose: 180 mg). Increase dose incrementally (60 mg, 90 mg, 120 mg, 180 mg once daily) as necessary to maintain iPTH level between 150-300 pg/mL.
Note: Do not titrate dose more frequently than every 2-4 weeks.

Parathyroid carcinoma: Initial: 30 mg orally twice daily (maximum daily dose: 360 mg daily as 90 mg 4 times/day). Increase dose incrementally (60 mg twice daily, 90 mg twice daily, 90 mg 4 times/day) as necessary to normalize serum calcium levels.

REFERENCE RANGE — Chronic kidney disease: Goal iPTH: 150-300 pg/mL.
Supplied: Tablet: 30 mg, 60 mg, 90 mg.

cosyntropin (Cortrosyn ®)
Exhibits the full cortico-steroidogenic activity of natural ACTH

MOA: Stimulates the adrenal cortex to secrete adrenal steroids (including hydrocortisone, cortisone), androgenic substances, and a small amount of aldosterone.

INTRO:
Severe hypofunction of the pituitary - adrenal axis is usually associated with subnormal plasma cortisol values but a low basal level is not per se evidence of adrenal insufficiency and does not suffice to make the diagnosis. Many patients with proven insufficiency will have normal basal levels and will develop signs of insufficiency only when stressed. For this reason a criterion which should be used in establishing the diagnosis is the failure to respond to adequate corticotropin stimulation. When presumptive adrenal insufficiency is diagnosed by a subnormal CORTROSYN test, further studies are indicated to determine if it is primary or secondary.

Dosing (Adults):
IM: Reconstitute 0.25 mg (250 mcg) with 1mL NS and inject intramuscularly. OR
IV: Dilute in 2 to 5 mL of saline and give over a 2-minute period.
The usual normal response in most cases is an approximate doubling of the basal level, provided that the basal level does not exceed the normal range.

Diagnosis of adrenocortical insufficiency: IM, IV (over 2 minutes): Peak plasma cortisol concentrations usually occur 45-60 minutes after cosyntropin administration: 0.25 to 0.75 mg. Note: When greater cortisol stimulation is needed, an I.V. infusion may be used: 0.25 mg administered at 0.04 mg/hour over 6 hours.
Normal response: Many patients with normal adrenal function, however, do not respond to the expected degree so that the following criteria have been established to denote a normal response:
1. The control plasma cortisol level should exceed 5 micrograms/100 mL.
2. The 30-minute level should show an increment of at least 7 micrograms/100 mL above the basal level.
3. The 30-minute level should exceed 18 micrograms/100 mL.

Monitoring: Plasma cortisol levels usually peak about 45 to 60 minutes after an injection of CORTROSYN and some prefer the 60-minute interval for testing for this reason. While it is true that the 60-minute values are usually higher than the 30-minute values, the difference may not be significant enough in most cases to outweigh the disadvantage of a longer testing period. If the 60-minute test period is used, the criterion for a normal response is an approximate doubling of the basal plasma cortisol value.


ADDITIONAL INFO:
Primary adrenal insufficiency (Addison’s disease) is the result of an intrinsic disease process, such as tuberculosis within the gland. The production of adrenocortical hormones is deficient despite high ACTH levels (feedback mechanism). Secondary or relative insufficiency arises as the result of defective production of ACTH leading in turn to disuse atrophy of the adrenal cortex. It is commonly seen, for ex-ample, as result of corticosteroid therapy, Sheehan’s syndrome and pituitary tumors or ablation.

The differentiation of both types is based on the premise that a primarily defective gland cannot be stimulated by ACTH whereas a secondarily defective gland is potentially functional and will respond to adequate stimulation with ACTH. Patients selected for further study as the result of a subnormal CORTROSYNTM test should be given a 3 or 4 day course of treatment with Repository Corticotropin Injection USP and then retested. Suggested doses are 40 USP units twice daily for 4 days or 60 USP units twice daily for 3 days. Under these conditions little or no increase in plasma cortisol levels will be seen in Addison’s disease whereas higher or even normal levels will be seen in cases with secondary adrenal insufficiency.

Supplied: Inj (powder for reconstitution): 0.25 mg

desmopressin  (DDAVP ®)

Indications:
Hemophilia (increases factor VIII levels): 0.3 mcg/kg in 50ml normal saline over 15-30 minutes.
Diabetes insipidus: 2-4 mcg/day IV push or SC.
Decrease bleeding following cardiac bypass: 0.3 mcg/kg ivpb.

Provide short term protection for uremic hemorrhagic tendency: 0.3 mcg/kg ivpb q8h x 2 doses (diminishing response).

PHARMACODYNAMICS / KINETICS
Greatly enhanced ADH activity. Less vasopressor activity.
Longer DOA. (Synthetic analog of vasopressin-posterior pituitary hormone).
ADH activity : Pressor activity [DDAVP: 2000-4000: 1 Vasopressin: 1:1]

Leuprolide  (Lupron ®)
Gonadotropin Releasing Hormone Agonist.

Dosing (Adults): 
Advanced prostatic carcinoma: 7.5 mg IM given monthly OR 22.5 mg IM every 3 months OR 30 mg IM every 4 months. Eligard ®: may be given SQ at same doses above.
Endometriosis: 3.75 mg I.M. each month for up to 6 months or
11.25 mg IM every 3 months for up to 2 doses (e.g. 6 months total).
Fibroids: 3.75 mg IM each month for up to 3 months or 11.25 mg IM x 1.

octreotide (Sandostatin ® )
Somatostatin analog.
Dosing (Adults): 
Bleeding esophageal varices: IV bolus: 25-50 mcg followed by continuous IV infusion of 25-50 mcg/hour.

Carcinoid tumors: Initial: 50 mcg IV/SQ qd-bid. Titrate dose based on response/tolerance. Range: 100-600 mcg/day in 2-4 divided doses - usual range 50-1500 mcg/day.
VIPomas: Initial 2 weeks: 200-300 mcg/day IV/SQ in 2-4 divided doses. Titrate dose based on response/tolerance. Range: 150-750 mcg/day (doses >450 mcg/day are rarely required).

Diarrhea: Initial: 50-100 mcg IV q8h - increase by 100 mcg/dose at 48-hour intervals. Maximum dose: 500 mcg q8h.
In another prospective trial [10], a high-dose continuous infusion of octreotide acetate (100-150 µg/h) was used by Petrelli et al. in 16 patients with colorectal carcinoma and 5-FU-induced severe diarrhea who had failed to respond to conventional therapy with diphenoxylate atropine. Complete resolution of diarrhea was observed in 15 of 16 patients (94%). However, recurrence of diarrhea was seen in two patients after a complete cycle of octreotide. The authors also reported an absence of toxicity and no adverse effects of the treatment.

In a phase I trial by Wadler et al. [13], octreotide was administered in 35 patients with 5-FU-induced diarrhea to determine the maximum tolerated dose. The doses of octreotide studied were 50 to 2,500 µg administered s.c. three times daily for five days. The authors reported that the efficacy of the treatment correlated significantly (p < 0.01) with the dose of octreotide administered. Furthermore, patients experienced significant toxicities, including hypoglycemia and allergic reaction, which argued against the administration of higher doses.

The current trial has demonstrated a statistically significant benefit in the management of 5-FU-induced diarrhea in favor of the 500 µg regimen versus 100 µg octreotide administered s.c. three times per day. These results are in support of the dose-response effect of octreotide acetate.

13. Wadler S, Haynes H, Wiernik PH. Phase I trial of the somatostatin analogue octreotide acetate in the treatment of fluoropyramidine-induced diarrhea. J Clin Oncol 1995;13:222-226.

vasopressin  (Pitressin ® )
ADH analog (Posterior pituitary hormone).
Dosing (Adults): 
Diabetes insipidus: Note: Dosage is highly variable - titrated based on serum and urine sodium and osmolality in addition to fluid balance and urine output. 5-10 units IM/SQ 2-4 times daily as needed (dosage range 5-60 units/day). Abdominal distention: 5 units IM stat, then 10 units every 3-4 hours.

GI hemorrhage: Continuous IV infusion: 0.5 milliunits/kg/hour (0.0005 unit/kg/hour). Double dosage as needed every 30 minutes to a maximum of 10 milliunits/kg/hour.
IV: Initial: 0.2-0.4 unit/minute, then titrate dose as needed. If bleeding stops, continue at same dose for 12 hours, taper off over 24-48 hours.
Out-of-hospital asystole (unlabeled use): Adults: 40 units IV. If spontaneous circulation is not restored in 3 minutes, then repeat dose.
Pulseless VT/VF: 40 units IV (as a single dose only). If no IV access - administer 40 units diluted with NS (to a total volume of 10 ml) endotracheally.

Vasodilatory shock/septic shock: Vasopressin may be used in patients with refractory shock despite adequate fluid resuscitation and the use of high-dose conventional catecholamines such as norepinephrine and dopamine, however, further studies are needed to determine its exact place in therapy. Current evidence does not support the use of vasopressin as a replacement for norepinephrine or dopamine as a first-line agent.
The recommended infusion rate for vasopressin in the treatment of shock in adults is 0.01– 0.04 units/min. This dosage range is reported to be effective in about 85% of patients with norepinephrine resistant hypotension. Doses greater than 0.04 units/min may lead to cardiac arrest.

 O'Brien A et al reported rapid rebound hypotension as a common problem after treatment with vasopressin is stopped. Potential side effects of vasopressin infusion range from ischemic skin lesions to possible intestinal ischemia. Vasopressin therapy may also result in decreased cardiac output and hepatosplanchnic flow.
Supplied: Injection: 20 units/ml (0.5 ml, 1 ml, 10 ml)
 

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David F. McAuley, Pharm.D., R.Ph.  GlobalRPh Inc.

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