Each tablet contains 2.5 mg bromocriptine (as mesylate).
Bromocriptine mesylate (Lactodel®) is a nonhormonal (nonestrogenic) agent inhibiting the secretion of prolactin in human without affecting other pituitary hormones except in patients with acromegaly where it lowers the elevated blood level of the growth hormone.
Lactodel® is a dopamine receptor (D2) agonist activating postsynaptic dopamine receptors, and modulating the secretion of prolactin from the anterior pituitary (prolactin-inhibiting effect). It significantly reduces the plasma level of prolactin in patients with hyperprolactinemia.
Lactodel® restores normal ovulatory menstrual cycle in hyperprolactinemic women. It also suppresses galactorrhea in pathological hyperprolactenemia without affecting the other anterior pituitary hormones. It also suppresses dopamine receptors in the corpus striatum which leads to a remarkable improvement in patients with Parkinson’s disease. (Parkinson’s disease is characterized by progressive deficiency in dopamine secretion.)
Lactodel® stimulates dopmine receptors (D2) around the ovary inducing ovulation.
Lactodel® indications In Females
- Prolactin-dependent amenorrhea and galactorrhea
- Prolactin-independent infertility, such as Polycystic ovary syndrome
2-Drug-induced hyperprolactinemia, i.e. antihypertensive and antipsychotic drugs.
- Luteal phase deficiency
- Breast tenderness
- Cyclical edema
- Breast engorgement
- Mood disturbance
5-Benign breast disease
- Benign cystic and/or nodular cases, particularly fibrocystic disease of the breast
Lactodel® indications In Males
- Loss of libido
- Impotence and small genitalia
Lactodel® indication In Both Sexes
1-Acromegaly: To reduce the elevated level of the growth hormone, and as an adjuvant treatment, or, in particular cases, as an alternative to surgery or radiotherapy
2-Parkinson’s Disease: All types and degrees of the disease either by itself or combined with other anti-Parkinsonian drugs.
3-Prolactinomas, macro- and microadenomata of the pituitary gland:
- As a conservative treatment
- Preoperative preparation to reduce the size of tumor and facilitate its removal
- Postoperative, if the serum level of prolactin remains elevated
Hypersensitivity to any ergot alkaloid, uncontrolled hypertension, and toxemia of pregnancy.
Side Effects and Precautions
Upon starting the treatment, the patient may feel slight nausea or (rarely) dizziness, fatigue or vomiting.
Orthostatic hypotension may occur.
Blood pressure should be monitored during therapy especially during puerperium.
In very high doses psychotic symptoms may rarely occur which necessitate decreasing the dose to control symptoms.
In prolonged therapy, Raynaud-like phenomenon may occur especially in patients who have shown this phenomenon before. (The drug should be administered with caution in hepatic and renal impairments, and during pregnancy.)
Phenothiazine should be avoided during treatment with bromocriptine. In combination with antihypertensives, it should be considered that bromocriptine is an ergot-alkaloid derivative. Concomitant use of erythromycin may increase bromocriptine’s plasma level.
Unless otherwise prescribed by the physician, the recommended dose is one tablet twice or three times daily with meals, considering the following:
(Lactodel®) should always be taken with food.
It is preferred to begin treatment with half or one tablet daily to be increased gradually to the full therapeutic dose.
If a high dose should be taken for a long time (six months, for example), withdrawal of the drug should be gradual over 4-8 weeks.
N.B.: The same oral tablet formulation may be applied vaginally.
Strips of 10 tablets in packs of 2 strips.
Keep all medicaments out of reach of children
Product of: AMOUN PHARMACEUTICAL CO. El-Obour City, Cairo, Egypt. ATC Code: G02CB01