DOSTINEX Tablets contain cabergoline, a dopamine receptor agonist. The chemical name for cabergoline is 1-[(6-allylergolin-8ß-yl)-carbonyl]-1-[3-(dimethylamino) propyl]-3-ethylurea. Its empirical formula is C₂₆H₃₇N₅O₂, and its molecular weight is 451.62. The structural formula is as follows:

Cabergoline 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.

DOSTINEX Tablets, for oral administration, contain 0.5 mg of cabergoline. Inactive ingredients consist of leucine, USP, and lactose, NF.

Last updated on RxList: 1/17/2008

DOSTINEX Tablets are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas.

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. Before initiating treatment, cardiovascular evaluation should be performed and echocardiography should be considered to assess for valvular disease.

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. Patients receiving long term treatment with DOSTINEX should undergo periodic assessment of their cardiac status and echocardiography should be considered.

After a normal serum prolactin level has been maintained for 6 months, DOSTINEX 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 breakline. The other side of the tablet is engraved with the number 700.

DOSTINEX is available as follows:

Bottles of 8 tablets   NDC 0013-7001-12

Storage

Store at controlled room temperature 20°to 25°C (68°to 77°F) [see USP].

Distributed by: Pharmacia & Upjolin Company, Division of Pfizer Inc, NY, NY 10017, Revised December 2007. FDA rev date: 12/19/2007

Last updated on RxList: 1/17/2008

The safety of DOSTINEX Tablets has been evaluated in more than 900 patients with hyperprolactinemic disorders. Most adverse events were mild or moderate in severity.

In a 4-week, double-blind, placebo-controlled study, treatment consisted of placebo or cabergoline at fixed doses of 0.125, 0.5, 0.75, or 1.0 mg twice weekly. Doses were halved during the first week. Since a possible dose-related effect was observed for nausea only, the four cabergoline treatment groups have been combined. The incidence of the most common adverse events during the placebo-controlled study is presented in the following table.

Incidence of Reported Adverse Events During the 4-Week, Double-Blind, Placebo-Controlled Trial

Adverse Event*	Cabergoline (n=168) 0.125 to 1 mg two times a week Number (percent)	Placebo (n=20)
Gastrointestinal
Nausea	45 (27)	4 (20)
Constipation	16 (10)	0
Abdominal pain	9 (5)	1 (5)
Dyspepsia	4 (2)	0
Vomiting	4 (2)	0
Central and Peripheral Nervous System
Headache	43 (26)	5 (25)
Dizziness	25 (15)	1 (5)
Paresthesia	2 (1)	0
Vertigo	2 (1)	0
Body As a Whole
Asthenia	15 (9)	2 (10)
Fatigue	12 (7)	0
Hot flashes	2 (1)	1 (5)
Psychiatric
Somnolence	9 (5)	1 (5)
Depression	5 (3)	1 (5)
Nervousness	4 (2)	0
Autonomic Nervous System
Postural hypotension	6 (4)	0
Reproductive - Female
Breast pain	2 (1)	0
Dysmenorrhea	2 (1)	0
Vision
Abnormal vision	2 (1)	0
*Reported at ≥ 1% for cabergoline

In the 8-week, double-blind period of the comparative trial with bromocriptine, DOSTINEX (at a dose of 0.5 mg twice weekly) was discontinued because of an adverse event in 4 of 221 patients (2%) while bromocriptine (at a dose of 2.5 mg two times a day) was discontinued in 14 of 231 patients (6%). The most common reasons for discontinuation from DOSTINEX were headache, nausea and vomiting (3, 2 and 2 patients respectively); the most common reasons for discontinuation from bromocriptine were nausea, vomiting, headache, and dizziness or vertigo (10, 3, 3, and 3 patients respectively). The incidence of the most common adverse events during the double-blind portion of the comparative trial with bromocriptine is presented in the following table.

Incidence of Reported Adverse Events During the 8-Week, Double-Blind Period of the Comparative Trial With Bromocriptine

Adverse Event*	Cabergoline (n=221) Number (percent)	Bromocriptine (n=231)
Gastrointestinal
Nausea	63 (29)	100 (43)
Constipation	15 (7)	21 (9)
Abdominal pain	12 (5)	19 (8)
Dyspepsia	11 (5)	16 (7)
Vomiting	9 (4)	16 (7)
Dry mouth	5 (2)	2 (1)
Diarrhea	4 (2)	7 (3)
Flatulence	4 (2)	3 (1)
Throat irritation	2 (1)	0
Toothache	2 (1)	0
Central and Peripheral Nervous System
Headache	58 (26)	62 (27)
Dizziness	38 (17)	42 (18)
Vertigo	9 (4)	10 (4)
Paresthesia	5 (2)	6 (3)
Body As a Whole
Asthenia	13 (6)	15 (6)
Fatigue	10 (5)	18 (8)
Syncope	3 (1)	3 (1)
Influenza-like symptoms	2 (1)	0
Malaise	2 (1)	0
Periorbital edema	2 (1)	2 (1)
Peripheral edema	2 (1)	1
Psychiatric
Depression	7 (3)	5 (2)
Somnolence	5 (2)	5 (2)
Anorexia	3 (1)	3 (1)
Anxiety	3 (1)	3 (1)
Insomnia	3 (1)	2 (1)
Impaired concentration	2 (1)	1
Nervousness	2 (1)	5 (2)
Cardiovascular
Hot flashes	6 (3)	3 (1)
Hypotension	3 (1)	4 (2)
Dependent edema	2 (1)	1
Palpitation	2 (1)	5 (2)
Reproductive - Female
Breast pain	5 (2)	8 (3)
Dysmenorrhea	2 (1)	1
Skin and Appendages
Acne	3 (1)	0
Pruritus	2 (1)	1
Musculoskeletal
Pain	4 (2)	6 (3)
Arthralgia	2 (1)	0
Respiratory
Rhinitis	2 (1)	9 (4)
Vision
Abnormal vision	2 (1)	2 (1)
*Reported at ≥ 1% for cabergoline

Other adverse events that were reported at an incidence of <1.0% in the overall clinical studies follow.

Body As a Whole: facial edema, influenza-like symptoms, malaise

Cardiovascular System: hypotension, syncope, palpitations

Digestive System: dry mouth, flatulence, diarrhea, anorexia

Metabolic and Nutritional System: weight loss, weight gain

Nervous System: somnolence, nervousness, paresthesia, insomnia, anxiety

Respiratory System: nasal stuffiness, epistaxis

Skin and Appendages: acne, pruritus

Special Senses: abnormal vision

Urogenital System: dysmenorrhea, increased libido

The safety of cabergoline has been evaluated in approximately 1,200 patients with Parkinson's disease in controlled and uncontrolled studies at dosages of up to 11.5 mg/day which greatly exceeds the maximum recommended dosage of cabergoline for hyperprolactinemic disorders. In addition to the adverse events that occurred in the patients with hyperprolactinemic disorders, the most common adverse events in patients with Parkinson's disease were dyskinesia, hallucinations, confusion, and peripheral edema. Heart failure, pleural effusion, pulmonary fibrosis, and gastric or duodenal ulcer occurred rarely. One case of constrictive pericarditis has been reported.

Post-marketing Surveillance data: The following events have been reported in association with cabergoline: valvulopathy and fibrosis, (See WARNINGS, Valvulopathy and PRECAUTIONS, Fibrosis).

Others events have been reported in association with cabergoline: hypersexuality, increased libido, pathological gambling (See PRECAUTIONS, Psychiatric). In addition, during post-marketing surveillance, cases of alopecia, aggression and psychotic disorder have been reported in patients taking DOSTINEX. Some of these reports have been in patients who have had prior adverse reactions to dopamine agonist products.

DOSTINEX should not be administered concurrently with D2- antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide.

Last updated on RxList: 1/17/2008

Valvulopathy: Post marketing cases of cardiac valvulopathy have been reported in patients receiving DOSTINEX. These cases have generally occurred during long-term administration of high doses of DOSTINEX (>2mg/day) used for the treatment of Parkinson's disease. Rare cases have been reported associated with short-term treatment (<6 months) or in patients receiving lower doses for the treatment of hyperprolactinemia.

Physicians should use the lowest effective dose of DOSTINEX for the treatment of hyperprolactinemia and should periodically reassess the need for continuing therapy with DOSTINEX. In addition, patients receiving long term treatment with DOSTINEX should undergo periodic reassessment of their cardiac status, and echocardiography should be considered. Any patient who develops signs or symptoms of cardiac disease, including dyspnea, edema, congestive heart failure, or a new cardiac murmur, while being treated with DOSTINEX should be evaluated for possible valvulopathy.

DOSTINEX should be used with caution in patients who have hemodynamically significant valvular disease or have been exposed to other medications associated with valvulopathy.

Pregnancy: Dopamine agonists in general should not be used in patients with pregnancy- induced hypertension, for example, preeclampsia, eclampsia, and post partum hypertension, unless the potential benefit is judged to outweigh the possible risk.

General: Initial doses higher than 1.0 mg may produce orthostatic hypotension. Care should be exercised when administering DOSTINEX with other medications known to lower blood pressure.

Postpartum Lactation Inhibition or Suppression: DOSTINEX is not indicated for the inhibition or suppression of physiologic lactation. Use of bromocriptine, another dopamine agonist for this purpose, has been associated with cases of hypertension, stroke, and seizures.

Hepatic Impairment: Since cabergoline is extensively metabolized by the liver, caution should be used, and careful monitoring exercised, when administering DOSTINEX to patients with hepatic impairment.

Fibrosis: As with other ergot derivatives, pleural effusion or pulmonary fibrosis have been reported following long-term administration of cabergoline. Some reports were in patients previously treated with ergotinic dopamine agonists. DOSTINEX should not be used in patients with a history of, or current signs and or clinical symptoms of, respiratory or cardiac disorders linked to fibrotic tissue.

Following diagnosis of pleural effusion or pulmonary fibrosis, the discontinuance of cabergoline has been reported to result in improvement of signs and symptoms.

Erythrocyte sedimentation rate (ESR) has been found to be abnormally increased in association with pleural effusion/fibrosis. Chest x-ray examination is recommended in cases of unexplained ESR increases to abnormal values. Serum creatinine measurements can also be used to help in the diagnosis of fibrotic disorder.

Psychiatric: Pathological gambling, increased libido, and hypersexuality have been reported in patients treated with dopamine agonists including cabergoline. This has been generally reversible upon reduction of the dose or treatment discontinuation (See Post- marketing Surveillance data).

Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity studies were conducted in mice and rats with cabergoline given by gavage at doses up to 0.98 mg/kg/day and 0.32 mg/kg/day, respectively. These doses are 7 times and 4 times the maximum recommended human dose calculated on a body surface area basis using total mg/m²/week in rodents and mg/m²/week for a 50 kg human.

There was a slight increase in the incidence of cervical and uterine leiomyomas and uterine leiomyosarcomas in mice. In rats, there was a slight increase in malignant tumors of the cervix and uterus and interstitial cell adenomas. The occurrence of tumors in female rodents may be related to the prolonged suppression of prolactin secretion because prolactin is needed in rodents for the maintenance of the corpus luteum. In the absence of prolactin, the estrogen/progesterone ratio is increased, thereby increasing the risk for uterine tumors. In male rodents, the decrease in serum prolactin levels was associated with an increase in serum luteinizing hormone, which is thought to be a compensatory effect to maintain testicular steroid synthesis. Since these hormonal mechanisms are thought to be species-specific, the relevance of these tumors to humans is not known.

The mutagenic potential of cabergoline was evaluated and found to be negative in a battery of in vitro tests. These tests included the bacterial mutation (Ames) test with Salmonella typhimurium, the gene mutation assay with Schizosaccharomyces pombe P1 and V79 Chinese hamster cells, DNA damage and repair in Saccharomyces cerevisiae D4, and chromosomal aberrations in human lymphocytes. Cabergoline was also negative in the bone marrow micronucleus test in the mouse.

In female rats, a daily dose of 0.003 mg/kg for 2 weeks prior to mating and throughout the mating period inhibited conception. This dose represents approximately ½8 the maximum recommended human dose calculated on a body surface area basis using total mg/m²/week in rats and mg/m²/week for a 50 kg human.

Pregnancy: Teratogenic Effects: Category B. Reproduction studies have been performed with cabergoline in mice, rats, and rabbits administered by gavage.

(Multiples of the maximum recommended human dose in this section are calculated on a body surface area basis using total mg/m²/week for animals and mg/m²/week for a 50 kg human.)

There were maternotoxic effects but no teratogenic effects in mice given cabergoline at doses up to 8 mg/kg/day (approximately 55 times the maximum recommended human dose) during the period of organogenesis.

A dose of 0.012 mg/kg/day (approximately 1/7 the maximum recommended human dose) during the period of organogenesis in rats caused an increase in post-implantation embryofetal losses. These losses could be due to the prolactin inhibitory properties of cabergoline in rats. At daily doses of 0.5 mg/kg/day (approximately 19 times the maximum recommended human dose) during the period of organogenesis in the rabbit, cabergoline caused maternotoxicity characterized by a loss of body weight and decreased food consumption. Doses of 4 mg/kg/day (approximately 150 times the maximum recommended human dose) during the period of organogenesis in the rabbit caused an increased occurrence of various malformations. However, in another study in rabbits, no treatment-related malformations or embryofetotoxicity were observed at doses up to 8 mg/kg/day (approximately 300 times the maximum recommended human dose).

In rats, doses higher than 0.003 mg/kg/day (approximately ½8 the maximum recommended human dose) from 6 days before parturition and throughout the lactation period inhibited growth and caused death of offspring due to decreased milk secretion.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from cabergoline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Use of DOSTINEX for the inhibition or suppression of physiologic lactation is not recommended (see PRECAUTIONS section).

The prolactin-lowering action of cabergoline suggests that it will interfere with lactation. Due to this interference with lactation, DOSTINEX should not be given to women postpartum who are breastfeeding or who are planning to breastfeed.

Pediatric Use: Safety and effectiveness of DOSTINEX in pediatric patients have not been established.

Geriatric Use: Clinical studies of DOSTINEX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Last updated on RxList: 1/17/2008

Overdosage might be expected to produce nasal congestion, syncope, or hallucinations. Measures to support blood pressure should be taken if necessary.

DOSTINEX Tablets are contraindicated in patients with

• Uncontrolled hypertension or known hypersensitivity to ergot derivatives.
• History of pulmonary, pericardial, cardiac valvular, or retroperitoneal fibrotic disorders. (See PRECAUTIONS, Fibrosis)

Last updated on RxList: 1/17/2008

Mechanism of Action: The secretion of prolactin by the anterior pituitary is mainly under hypothalamic inhibitory control, likely exerted through release of dopamine by tuberoinfundibular neurons. Cabergoline is a long-acting dopamine receptor agonist with a high affinity for D2 receptors. Results of in vitro studies demonstrate that cabergoline exerts a direct inhibitory effect on the secretion of prolactin by rat pituitary lactotrophs. Cabergoline decreased serum prolactin levels in reserpinized rats. Receptor-binding studies indicate that cabergoline has low affinity for dopamine D1, α1- and α2-adrenergic, and 5-HT₁- and 5-HT₂-serotonin receptors.

Clinical Studies: The prolactin-lowering efficacy of DOSTINEX was demonstrated in hyperprolactinemic women in two randomized, double-blind, comparative studies, one with placebo and the other with bromocriptine. In the placebo-controlled study (placebo n=20; cabergoline n=168), DOSTINEX produced a dose-related decrease in serum prolactin levels with prolactin normalized after 4 weeks of treatment in 29%, 76%, 74% and 95% of the patients receiving 0.125, 0.5, 0.75, and 1.0 mg twice weekly respectively.

In the 8-week, double-blind period of the comparative trial with bromocriptine (cabergoline n=223; bromocriptine n=236 in the intent-to-treat analysis), prolactin was normalized in 77% of the patients treated with DOSTINEX at 0.5 mg twice weekly compared with 59% of those treated with bromocriptine at 2.5 mg twice daily. Restoration of menses occurred in 77% of the women treated with DOSTINEX, compared with 70% of those treated with bromocriptine. Among patients with galactorrhea, this symptom disappeared in 73% of those treated with DOSTINEX compared with 56% of those treated with bromocriptine.

Pharmacokinetics

Absorption: Following single oral doses of 0.5 mg to 1.5 mg given to 12 healthy adult volunteers, mean peak plasma levels of 30 to 70 picograms (pg)/mL of cabergoline were observed within 2 to 3 hours. Over the 0.5-to-7 mg dose range, cabergoline plasma levels appeared to be dose-proportional in 12 healthy adult volunteers and nine adult parkinsonian patients. A repeat-dose study in 12 healthy volunteers suggests that steady- state levels following a once-weekly dosing schedule are expected to be twofold to threefold higher than after a single dose. The absolute bioavailability of cabergoline is unknown. A significant fraction of the administered dose undergoes a first-pass effect. The elimination half-life of cabergoline estimated from urinary data of 12 healthy subjects ranged between 63 to 69 hours. The prolonged prolactin-lowering effect of cabergoline may be related to its slow elimination and long half-life.

Distribution: In animals, based on total radioactivity, cabergoline (and/or its metabolites) has shown extensive tissue distribution. Radioactivity in the pituitary exceeded that in plasma by >100-fold and was eliminated with a half-life of approximately 60 hours. This finding is consistent with the long-lasting prolactin-lowering effect of the drug. Whole body autoradiography studies in pregnant rats showed no fetal uptake but high levels in the uterine wall. Significant radioactivity (parent plus metabolites) detected in the milk of lactating rats suggests a potential for exposure to nursing infants. The drug is extensively distributed throughout the body. Cabergoline is moderately bound (40% to 42%) to human plasma proteins in a concentration-independent manner. Concomitant dosing of highly protein-bound drugs is unlikely to affect its disposition.

Metabolism: In both animals and humans, cabergoline is extensively metabolized, predominately via hydrolysis of the acylurea bond or the urea moiety. Cytochrome P-450 mediated metabolism appears to be minimal. Cabergoline does not cause enzyme induction and/or inhibition in the rat. Hydrolysis of the acylurea or urea moiety abolishes the prolactin-lowering effect of cabergoline, and major metabolites identified thus far do not contribute to the therapeutic effect.

Excretion: After oral dosing of radioactive cabergoline to five healthy volunteers, approximately 22% and 60% of the dose was excreted within 20 days in the urine and feces, respectively. Less than 4% of the dose was excreted unchanged in the urine. Nonrenal and renal clearances for cabergoline are about 3.2 L/min and 0.08 L/min, respectively. Urinary excretion in hyperprolactinemic patients was similar.

Special Populations

Renal Insufficiency: The pharmacokinetics of cabergoline were not altered in 12 patients with moderate-to-severe renal insufficiency as assessed by creatinine clearance.

Hepatic Insufficiency: In 12 patients with mild-to-moderate hepatic dysfunction (Child- Pugh score ≤ 10), no effect on mean cabergoline Cmax or area under the plasma concentration curve (AUC) was observed. However, patients with severe insufficiency (Child-Pugh score >10) show a substantial increase in the mean cabergoline Cmax and AUC, and thus necessitate caution.

Elderly: Effect of age on the pharmacokinetics of cabergoline has not been studied.

Food-Drug Interaction

In 12 healthy adult volunteers, food did not alter cabergoline kinetics.

Pharmacodynamics

Dose response with inhibition of plasma prolactin, onset of maximal effect, and duration of effect has been documented following single cabergoline doses to healthy volunteers (0.05 to 1.5 mg) and hyperprolactinemic patients (0.3 to 1 mg). In volunteers, prolactin inhibition was evident at doses >0.2 mg, while doses ≥ 0.5 mg caused maximal suppression in most subjects. Higher doses produce prolactin suppression in a greater proportion of subjects and with an earlier onset and longer duration of action. In 12 healthy volunteers, 0.5, 1, and 1.5 mg doses resulted in complete prolactin inhibition, with a maximum effect within 3 hours in 92% to 100% of subjects after the 1 and 1.5 mg doses compared with 50% of subjects after the 0.5 mg dose.

In hyperprolactinemic patients (N=51), the maximal prolactin decrease after a 0.6 mg single dose of cabergoline was comparable to 2.5 mg bromocriptine; however, the duration of effect was markedly longer (14 days vs. 24 hours). The time to maximal effect was shorter for bromocriptine than cabergoline (6 hours vs. 48 hours).

In 72 healthy volunteers, single or multiple doses (up to 2 mg) of cabergoline resulted in selective inhibition of prolactin with no apparent effect on other anterior pituitary hormones (GH, FSH, LH, ACTH, and TSH) or cortisol.

Last updated on RxList: 1/17/2008

Patients should be instructed to notify their physician if they suspect they are pregnant, become pregnant, or intend to become pregnant during therapy. A pregnancy test should be done if there is any suspicion of pregnancy and continuation of treatment should be discussed with their physician.

Patients should notify their physician if they develop shortness of breath, persistent cough, difficulty with breathing when lying down, or swelling in their extremities.

Last updated on RxList: 1/17/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

CABERGOLINE - ORAL

(kah-BURG-oh-leen)

COMMON BRAND NAME(S): Dostinex

USES: This medication is used to treat a certain hormone problem (hyperprolactinemia) that causes unusual breast milk production. Cabergoline belongs to a class of drugs known as dopamine receptor agonists. It works by stimulating a part of the brain that can decrease the production of the hormone that causes milk production (prolactin). Decreasing high prolactin levels can improve the unusual breast milk production.

HOW TO USE: Take this medication by mouth with or without food, usually twice weekly or as directed by your doctor.

Dosage is based on your medical condition and response to therapy. Your doctor will start you at a low dose and gradually increase your dose over several months to help decrease side effects. Follow your doctor's instructions carefully.

Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Nausea, vomiting, headache, constipation, dry mouth, dizziness, tiredness, stomach/abdominal pain, or sleepiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression, nervousness, anxiety), difficulty concentrating, tingling, numbness, fainting, swelling around the eyes, hand/leg swelling, painful breasts, menstrual cramps, hot flashes, acne, itching, diarrhea, gas, vision changes, stuffy nose.

Tell your doctor immediately if any of these rare but very serious side effects occur: breathing problems, persistent cough, chest pain, hallucinations, confusion.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking cabergoline, tell your doctor or pharmacist if you are allergic to it; or to ergot-like drugs (e.g., ergotamine); or if you had any serious reactions to other dopamine agonists (e.g., bromocriptine, pramipexole); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled high blood pressure, heart valve problems, conditions caused by abnormal scarring/thickening of the lining in the lungs/heart/behind the abdomen (e.g., pulmonary fibrosis, retroperitoneal fibrosis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, pregnancy complications with high blood pressure (e.g., pre-eclampsia, eclampsia).

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Limit alcoholic beverages.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the drowsiness effect.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. If you become pregnant or think you may be pregnant, inform your doctor immediately.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: certain medications for mental/mood disorders (e.g., phenothiazines such as chlorpromazine and promethazine, butyrophenones such as haloperidol, thioxanthenes such as thiothixene and chlorprothixene), metoclopramide.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting cabergoline.

Before using this medication, tell your doctor or pharmacist of all other prescription and nonprescription/herbal products you may use.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood prolactin levels, blood pressure) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.