Khrizstatin 40

Khrizstatin 40

atorvastatin

Manufacturer:

Celogen Generics

Distributor:

Khriz Pharma

Marketer:

Khriz Pharma
Concise Prescribing Info
Contents
Atorvastatin Ca
Indications/Uses
To reduce total-C & LDL-C in adults w/ HoFH as adjunct to other lipid-lowering treatments. Prevention of CV events in adults estimated to have a high risk for a 1st CV event.
Dosage/Direction for Use
Individualized dosage. Initially 10 mg once daily. Dose adjustment should be made at intervals of ≥4 wk. Max: 80 mg once daily. Patient w/ heterozygous familial hypercholesterolemia ≥10 yr Initially 10 mg once daily, may be increased to 80 mg daily.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Hypersensitivity. Patients w/ active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 x ULN. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Special Precautions
Discontinue use if clinically significant elevation of CK levels (>10 x ULN) occur or if rhabdomyolysis is diagnosed or suspected; ILD is suspected to have developed. Patients who consume substantial quantities of alcohol &/or have history of liver disease; w/ prior hemorrhagic stroke or lacunar infarct; predisposing factors for rhabdomyolysis. Perform LFTs prior to initiation of treatment & periodically thereafter. DM. Contains lactose. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not indicated in childn <10 yr. Childn 6-10 yr w/ heterozygous familial hypercholesterolemia.
Adverse Reactions
Nasopharyngitis; allergic reactions; hyperglycaemia; headache; pharyngolaryngeal pain, epistaxis; constipation, flatulence, dyspepsia, nausea, diarrhoea; myalgia, arthralgia, pain in extremity, muscle spasms, joint swelling, back pain.
Drug Interactions
Plasma conc & risk of myopathy may be increased w/ CYP3A4 or transport protein inhibitors; other medicinal products w/ potential to induce myopathy eg, fibric acid derivates & ezetimibe. Concomitant use w/ CYP3A4 inhibitors. Variable reductions in plasma conc w/ CYP3A4 inducers eg, efavirenz, rifampin, St. John's wort. Increased systemic exposure w/ transport protein inhibitors eg, ciclosporin. May increase risk of muscle-related events including rhabdomyolysis w/ gemfibrozil/fibric acid derivatives; ezetimibe; systemic fusidic acid. Lowered plasma conc w/ colestipol. Myopathy w/ colchicine. Increased steady-state conc of digoxin. Increased plasma conc of norethindrone & ethinyl oestradiol. Decreased prothrombin time w/ warfarin.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Khrizstatin 40 FC tab 40 mg
Packing/Price
100's
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