LIPITOR Film-coated tablet (2023)
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Περιεχόμενα
Name of the medicinal product
Lipitor 10 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate). <u>Excipient(s) with known effect:</u> Each Lipitor 10 mg film-coated tablet contains 27.25 mg lactose monohydrate ...
Pharmaceutical form
Film-coated tablet. White, round, 5.6 mm, film-coated tablets debossed 10 on one side and ATV on the other.
Therapeutic indications
Hypercholesterolaemia Lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents ...
Posology and method of administration
Posology The patient should be placed on a standard cholesterol-lowering diet before receiving Lipitor and should continue on this diet during treatment with Lipitor. The dose should be individualised ...
Contraindications
Lipitor is contraindicated in patients: with hypersensitivity to the active substance or to any of the excipients listed in section 6.1 with active liver disease or unexplained persistent elevations of ...
Special warnings and precautions for use
Hepatic impairment Liver function tests should be performed before the initiation of treatment and periodically thereafter. Patients who develop any signs or symptoms suggestive of liver injury should ...
Interaction with other medicinal products and other forms of interaction
Effect of co-administered medicinal products on atorvastatin Atorvastatin is metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate of the hepatic transporters, organic anion-transporting polypeptide ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of child-bearing potential should use appropriate contraceptive measures during treatment (see section 4.3). Pregnancy Lipitor is contraindicated during pregnancy ...
Effects on ability to drive and use machines
Lipitor has negligible influence on the ability to drive and use machines.
Undesirable effects
In the atorvastatin placebo-controlled clinical trial database of 16,066 (8755 Lipitor vs. 7311 placebo) patients treated for a mean period of 53 weeks, 5.2% of patients on atorvastatin discontinued due ...
Overdose
Specific treatment is not available for Lipitor overdose. Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required. Liver function tests should ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Lipid modifying agents, HMG-CoA-reductase inhibitors <b>ATC code:</b> C10AA05 Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting ...
Pharmacokinetic properties
Absorption Atorvastatin is rapidly absorbed after oral administration; maximum plasma concentrations (C<sub>max</sub>) occur within 1 to 2 hours. Extent of absorption increases in proportion to atorvastatin ...
Preclinical safety data
Atorvastatin was negative for mutagenic and clastogenic potential in a battery of 4 <em>in vitro</em> tests and 1 <em>in vivo</em> assay. Atorvastatin was not found to be carcinogenic in rats, but high ...
List of excipients
<u>Tablet core:</u> Calcium carbonate Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Polysorbate 80 Hydroxypropyl cellulose Magnesium stearate <u>Film coat:</u> <em>Film coating containing: ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
The blisters consist of a forming film made of polyamide/aluminium foil/polyvinyl chloride and a backing made of aluminium foil/vinyl heat-seal coating. The bottle is made of HDPE, containing desiccant, ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Upjohn UK Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 50622/0036
Date of first authorization / renewal of the authorization
Date of first authorisation: 8 September 1997 Date of latest renewal: 03 March 2013
Date of revision of the text
03/2023
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