CABERGAMOUN 2TAB; cabergoline, hormonal agents .
ACTIVE-INGREDIENT OF CABERGAMOUN 2TAB
calbergoline 0.5 mg .
INDICATION OF CABERGAMOUN 2TAB
inhibition/ suppression of physiological lactation : cabergamoun is inddicated for the inhibition of physiological lactation soon after delievry and for suppression of already established lactation : 1- after parturition , when the mother elects not to breast feed the infant or when breast feeding is contraindicated due to medical reasons releated to the mother or the new-born . 2- after stillbrith or abortion . cabergamoun prevents / supresses physiological lactation by inhibition prolactin secretion . in controlled clinical trials , cabergoline given as a single 1 mg administration during the first day post-partum , was effective in inhibiting milk secretion , as well as breast engorgement and pain in 70-90% of the women . less than 5% of women experienced rebound breast symptomatology during the third post-partum week ( which was usually mild in severity ) . suppression of milk secretion and relief of breast engorgement and pain are obtained in approximately 85% of nursing women treated with a total dose of 1 mg cabergamoun given in four divided doses over two days . rebound breast symptomatology after day 10 is uncommon ( approximately 2% of cases ) . treatment of hyperprolactinaemic disorders : cabergamoun is indicated for the treatment of dysfunctions associated with hyperprolactinaemia , including amenorrhoea , oligomenorrhoea , onovulation and galactorrhoea . cabergamoun is indicated in patients with prolactin -secreting pituitary adenomas ( micro – and macroprolactatinomas ) , idiopathic hyperprolactinaemia or empty sell syndrome with associated hyperprolactinaemia , which represent the basic underlying pathogenies contributing to the above clinical manifestations . on chronic therapy cabergamoun at doses ranging between 1 and 2 mg per week , was effective in normalising serum prolactin levels in approximately 84% of hyperprolactinaemic patients . regular cycles were resumed in 83% of previously amennohoeic women . restoring of ovulation was documented in 89% of women with progesterone levels monitored during the luteal phase . galactorrhoea disappeared in 90 % of cases showing this symptom before therapy . reduction in tumour size was obtained in 50-90 % of female and male patients with micro – or macroprolactinoma.
DOSAGE OF CABERGAMOUN 2TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
to be administrered by the oral route .since in clinical studies cabergoline has been mainly administered with food and since the tolerabilitiy of this class of compounds is improved with food , it is recommended that catergamoun be preferably taken with meals for all the therapeutic indications . inhibition /suppression of physiological lactation : for inhibition of lactation cabergamoun should be administered during the first day post -patrum .the recommended therapeutic dose is 1 mg “( two 0.5 mg tablets ) given as a single dose . for suppression of established lactation the recommended therapeutic dosage regimen is 0.25 mg ( one-half 0.5 mg tablet ) every 12 hours for two days ( 1 mg total dose ) . this dosage regimen has be demonstrated to be better tolerated than the single dose regimen in women electing to suppress lactation having a lower inicdence of adverse enevents , in particular of hypotensive symptoms . treatment of hyperolactinaemic disorders : the recommended initial dosage of cabergamoun is 0.5 mg per week given in one or two ( one half of one 0.5 mg tablet ) doses ( e.g on monday and thursday ) per week . the weekly dose should be increased gradually , preferably by adding 0.5 mg per week at monthly intervals until an optimal therapeutic response is achieved . the therapeutic dosage is usually 1 mg per week and ranges from 0.25 mg to 2 mg per week . the maximum dose should not exceed 3 mg per day . the weekly dose may be given as a single administration or divided into two or more doses per week are to be given since the tolerability of doses greater than 1 mg taken as a single weekly ( dose has been evaluated only in a few patients . patients should be evaluated during dose escalation to determine the lowest dosage that produces the therapeutic response . monitoring of serum prolactin levels at monthly intervals is advised since , once the effective therapeutic dosage regimen has been reached , serum prolactin nomalisation is usually observed within two to four weeks . after cabergamoun withdrawal , recurrence of hyperolactinaemia is usually observed . however , persistent suppression of prolactin levels has been observed for several months in some patients . of the group of women followed up , 23/29 had ovulatory cycles which continued for greater than 6 months after cabergamoun discontinuation . use in children : the safety and efficacy of cabergamoun has not been established in subjects less than 16 years of age . use in elderly : as a consequence of the indications for which cabergamoun is presently proposed , the experience in elderly is very limited . available data do not indicate a special risk .
OVER-DOSAGE OF CABERGAMOUN 2TAB
symptoms of overdose would likely be those of over-stimulation of dopmine receptors e.g nausea , vomiting gastric complaints , postural hypotension , confusion /psychosis or hallucinations . Supportive measures should be taken to remove and unabsorbed drug and maintain blood pressure , if necessary . in addition , the administration of dopamine antagonist drugs may be advisable .
CONTRA-INDICATION OF CABERGAMOUN 2TAB
hypersensitivity to cabergamoun , any excipient of the product or any ergot alkaloid . History of pulmonary , pericardial and retroperitoneal fribrotic disorders . cabergamoun is contraindicated in patients with hepatic insufficiency and with toxaemia of pregnancy . cabergamoun should not be co-administered with anti-psychotic medications or administrated to women with a history of puerperal psychosis . for long term treatment : evidence of cardiac valvulopathy as determined by pre-treatment echocardiography .
STORAGE OF CABERGAMOUN 2TAB
Store at temperature not exceeding 25 °C. Cabergamoun tablets absorb moisture, so you should always keep it in dry place.
PACK OF CABERGAMOUN 2TAB
Carton box contains ( All / white opaque PVC/PVDC ) strip of 2 tablets in packaging 1, 2, 3 strips with enclosed leaflet.
CABERGAMOUN 2TAB MANUFACTURED BY
AMOUN PHARMACEUTICAL CO . S.A.E. El-Obour City, Cairo, Egypt.