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MEDRONE Tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Medrone Tablets 2 mg.

Qualitative and quantitative composition

Each tablet contains 2 mg methylprednisolone. Excipients with known effect: lactose, sucrose, colour E123 (rose colour). For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablet.

Therapeutic indications

Medrone is indicated for conditions requiring glucocorticoid activity such as: Endocrine disordersPrimary and secondary adrenal insufficiency Congenital adrenal hyperplasia Rheumatic disordersRheumatoid ...

Posology and method of administration

The dosage recommendations shown in the table below are suggested initial daily doses and are intended as guides. The average total daily dose recommended may be given either as a single dose or in divided ...

Contraindications

Methylprednisolone tablets are contraindicated: In patients who have systemic fungal infections. In patients who have systemic infections unless specific anti-infective therapy is employed. In patients ...

Special warnings and precautions for use

Immunosuppressant Effects/Increased Susceptibility to Infections Corticosteroids may increase susceptibility to infection, may mask some signs of infection, and new infections may appear during their use. ...

Interaction with other medicinal products and other forms of interaction

Methylprednisolone is a cytochrome P450 enzyme (CYP) substrate and is mainly metabolized by the CYP3A4 enzyme. CYP3A4 is the dominant enzyme of the most abundant CYP subfamily in the liver of adult humans. ...

Fertility, pregnancy and lactation

Fertility Corticosteroids have been shown to impair fertility in animal studies (see section 5.3). Pregnancy The ability of corticosteroids to cross the placenta varies between individual drugs, however, ...

Effects on ability to drive and use machines

The effect of corticosteroids on the ability to drive or use machinery has not been systematically evaluated. Undesirable effects, such as dizziness, vertigo, visual disturbances and fatigue are possible ...

Undesirable effects

Infections and infestations Common: Infection (including increased susceptibility and severity of infections with suppression of clinical symptoms and signs) Not Known: Opportunistic infection; recurrence ...

Overdose

Administration of methylprednisolone should not be discontinued abruptly but tailed off over a period of time. Appropriate action should be taken to alleviate the symptoms produced by any side-effect that ...

Pharmacodynamic properties

Pharmacotherapeutic group: Glucocorticosteroids ATC Code: H02AB04 Methylprednisolone is a synthetic glucocorticoid and a methyl derivative of prednisolone. Methylprednisolone is a potent anti-inflammatory ...

Pharmacokinetic properties

Methylprednisolone pharmacokinetics is linear, independent of route of administration. Absorption Methylprednisolone is rapidly absorbed and the maximum plasma methylprednisolone concentration is achieved ...

Preclinical safety data

Based on conventional studies of safety pharmacology and repeated dose toxicity, no unexpected hazards were identified. The toxicities seen in repeated-dose studies were those expected to occur with continued ...

List of excipients

Lactose Rose colour (E123 and E127) Sucrose Maize starch Calcium stearate

Incompatibilities

Not applicable.

Shelf life

<u>Bottles:</u> 5 years. <u>Blister packs:</u> 3 years.

Special precautions for storage

Store below 25°C.

Nature and contents of container

High density polyethylene bottles with tamper evident caps. Each bottle contains 30 or 100 tablets. 20-25 micron hard tempered aluminium foil/lacquer, 250 micron opaque polyvinyl chloride film blister. ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Marketing authorization number(s)

PL 00057/1013

Date of first authorization / renewal of the authorization

Date of first authorisation: 1 December 1989 Date of latest renewal: 1 February 2005

Date of revision of the text

03/2019

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