Drug Interaction:
Ergot alkaloids.
Macrolides, Dopamine antagonists, ( phenothiazine, butyrophenones)
Thioxanthines ( metoclopramide )
Hypotensive medication
Indication:
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
BELVIQ/BELVIQ XR safely and effectively. See full prescribing information for BELVIQ/BELVIQ XR. BELVIQ® (lorcaserin hydrochloride) tablets, for oral use, CIV BELVIQ XR® (lorcaserin hydrochloride) extended-release tablets for oral use, CIV
Initial U.S. Approval: 2012
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
216. Cabergoline 1mg Tablets 01-10-08
(Addtl.Indication)
For the treatment of hyperprolactinemia and inhibition
of lactation
Hyperprolactinaemia
U.S.FDA APPROVED DRUGS DURING 2004
198. Cabergoline 1mg/2mg/4mg tablets 07-05-2004
For Parkinsons Disease
U.S FDA APPROVED DRUGS DURING 2007
33. Cabergoline 1mg tablet 06-03-07
(addl.stgth)
For Hyperprolacttinemia
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1.Cabergoline 1mg/2mg/4mg tablets 05-09-2002
For perkinsons disease
2.Cabergoline 1mg tablet 06-03-2007
Addl.Stgth
For Hyperprolacttemia
3. Cabergoline 1mg tablet 01-10-2008
Addl.Indication
For the treatment of hyperprolactemia and inhibition of lactation
4. Cabergoline For hyperprolactemia 06-09-2002
Adverse Reaction:
Dizziness, vertigo, syncope, nausea,
GI upset, headache, fatigue, breast pain, asthenia hot flushes,
aggretion and psychotic disorders,
nervousness, hypotension,
alopecia, dysmenorrhea,
paresthesia somnolence incresed
libido fibrosis valvulopathy
rarely epistaxis palpitations,
vision abnormalites
Contra-Indications:
Pregnancy hepatic insufficiency
Toxemia or pregnancy
Pre-eclampsia
History of peripheral pychosis
History of pulmonary , pericardial , cardiac vuvular or teroperitoneal fibrotic disorders Uncontrolled hypertension
Ergot alkaloid sensitivity
Special Precautions-
Evalute pitutiary prior to treatment
Renal, hepatic disease
Reynoauds syndrome
GI ulceration or bleeding
Monitor gynaecological changes, blood pressure and serum prolactin levels
Discontinue for at least for 1 month before trying to conceive
Use non-hormal methods of contraception if you do not want to conceive
Not for pregnancy induced hypertension or post-partum lactation or suppression
Respiratory or cardiac disease due to fibrosis
Lactation- not recommended
Monitor ESR ( for pleural effusion &/or fibrosis
Dosages/ Overdosage Etc:
Date of Approval 2002
Indication
Hyperprolactinaemia
Dosage-
1 tab per week in one or two doses
If reqd. increase gradually by 1 tab at monthly intervals
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Inform patients that BELVIQ/BELVIQ XR is indicated for chronic weight management only in conjunction with a reduced-calorie diet and increased physical activity.
• Caution patients not to increase their dose of BELVIQ/BELVIQ XR.
• Instruct patients to discontinue use of BELVIQ/BELVIQ XR if they have not achieved 5% weight loss by 12 weeks of treatment.
• Instruct patients to tell their healthcare provider about all the medications, nutritional supplements and vitamins (including any weight loss products) that they may take while taking BELVIQ/BELVIQ XR.
• Inform patients of the possibility of serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions with the combined use of BELVIQ/BELVIQ XR with other serotonergic drugs, including selective serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs), triptans, drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs]), dietary supplements such as St. John’s Wort and tryptophan, tramadol, or antipsychotics or other dopamine antagonists.
• Inform patients who develop signs or symptoms of valvular heart disease, including dyspnea or dependent edema to seek medical attention.
• Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that BELVIQ/BELVIQ XR therapy does not affect them adversely.
• Instruct patients to seek medical attention in the event of emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
• Instruct men who have an erection lasting greater than 4 hours, whether painful or not, to immediately discontinue the drug and seek emergency medical attention.
• Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider with a known or suspected pregnancy
• Advise women to avoid use of BELVIQ/BELVIQ XR while breastfeeding
BELVIQ® and BELVIQ XR® are registered trademarks of Arena Pharmaceuticals GmbH, Zofingen, Switzerland Manufactured by Arena Pharmaceuticals GmbH, Untere Brühlstrasse 4, CH-4800, Zofingen, Switzerland Distributed by Eisai Inc., Woodcliff Lake, NJ 07677
Interaction with Food:
Take with food
Pregnancy and lactation:
Contraindicated for use during pregnancy and lactation
Observe caution
Manufacturer Details