Tomexia

Tomexia

Manufacturer:

Humanwell Puracap Pharmaceuticals

Distributor:

Corbridge
Concise Prescribing Info
Contents
EPA ethyl ester 465 mg, DHA ethyl ester 375 mg
Indications/Uses
Isolated or predominant endogenous hypertriglyceridemia in patient at risk of ischemic heart disease &/or pancreatitis. Endogenous hypertriglyceridemia as a supplement to diet when dietary measures alone are insufficient to produce an adequate response: Type IV in monotherapy; type IIb/III in combination w/ statins, when control of triglycerides is insufficient.
Dosage/Direction for Use
Initially 2 cap daily. May be increased to 4 cap daily if adequate response is not obtained.
Administration
Should be taken with food: Take w/ food to avoid GI disturbances.
Contraindications
Hypersensitivity to EPA ethyl ester, DHA ethyl ester, peanut or soya.
Special Precautions
Patients w/ known sensitivity or allergy to fish. Not indicated in exogenous hypertriglyceridemia (type 1 hyperchylomicronemia). Limited experience in secondary endogenous hypertriglyceridemia (especially uncontrolled diabetes). Make allowance for increased bleeding time in patients at high risk of hemorrhage (due to severe trauma, surgery). Fall in thromboxane A2 production during treatment. Reports of small but significant increase (w/in normal values) in AST & ALT in some patients. Monitor patients receiving anticoagulant therapy & adjust dosage if necessary. Monitor ALT & AST levels in patients w/ any signs of liver damage (in particular w/ high dosage ie, 4 cap). No experience regarding hypertriglyceridemia in combination w/ fibrates. Limited information on use in patients w/ renal impairment. Not to be used during pregnancy unless clearly necessary. Caution should be exercised when administered to a breastfeeding woman. Not recommended in childn. Limited clinical data in elderly >70 yr.
Adverse Reactions
GI disorders (including abdominal distension & pain, constipation, diarrhea, dyspepsia, flatulence, eructation, GERD, nausea or vomiting).
Drug Interactions
Potential increased bleeding time w/ ASA. Monitor prothrombin time/INR in combination w/ warfarin & coumarin, & when treatment w/ Tomexia is discontinued.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AX06 - omega-3-triglycerides incl. other esters and acids ; Belongs to the class of other lipid modifying agents.
Presentation/Packing
Form
Tomexia softgel cap
Packing/Price
30's