, pathological fracture, and tendon disorder.
Nervous System
Central nervous system neoplasia, depression, dizziness, emotional lability, facial paralysis, insomnia, vasodilatation, and vertigo.
Respiratory System
Asthma, bronchitis, increased cough, dyspnea, epistaxis, laryngitis, pharyngitis, pneumonia, rhinitis, and sinusitis.
Skin
Alopecia, eczema, pruritus, and sweating.
Special Senses
Cataract.
Urogenital System
Cervix disorder, endometrial carcinoma, epididymitis, and impotence.
Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the events described below have been identified during post-approval use of LOVAZA. Because these events are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or to always establish a causal relationship to drug exposure.
The following events have been reported: anaphylactic reaction, hemorrhagic diathesis.
DRUG ABUSE AND DEPENDENCE
LOVAZA does not have any known drug abuse or withdrawal effects.
OVERDOSAGE
In the event of an overdose, the patient should be treated symptomatically, and general supportive care measures instituted, as required.
DOSAGE AND ADMINISTRATION
Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA, and should continue this diet during treatment with LOVAZA. In clinical studies, LOVAZA was administered with meals.
The daily dose of LOVAZA is 4 g per day. The daily dose may be taken as a single 4-g dose (4 capsules) or as two 2-g doses (2 capsules given twice daily).
HOW SUPPLIED
LOVAZA (omega-3-acid ethyl esters) capsules are supplied as 1-gram transparent soft-gelatin capsules filled with light-yellow oil and bearing the designation REL900.
Bottles of 60: NDC 0173-0783-01
Bottles of 120: NDC 0173-0783-02
Recommended Storage: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children.
Distributed by:
GlaxoSmithKline
Research Triangle Park, NC 27709
©2008 GlaxoSmithKline. All rights reserved.
November 2008 LVZ:3PI
PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _
PATIENT INFORMATION
LOVAZA® (lō-vā-ză)
(omega-3-acid ethyl esters) Capsules
Read the Patient Information that comes with LOVAZA before you start taking it, and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.
What is LOVAZA?
LOVAZA is a prescription medicine for adults called a lipid-regulating medicine. LOVAZA is made of omega-3 fatty acids. Omega-3 fatty acids are natural substances that your body needs. They are found naturally in some plants and in the oil of certain fish, such as salmon and mackerel.
LOVAZA is used along with a low-fat and low-cholesterol diet to lower very high triglycerides (fats) in your blood. Before taking LOVAZA, talk to your healthcare provider about how you can lower high blood fats by:
losing weight, if you are overweight
increasing physical exercise
lowering alcohol use
treating diseases such as diabetes and low thyroid (hypothyroidism)
adjusting the dose or changing other medicines that raise t
