Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dexamethasone
Almus Pharmaceuticals Ltd
H02AB02
Dexamethasone
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06030200; GTIN: 05060057404324 05060057404331
148 x 420 mm Zonder Laetuscode.indd 1 08-05-13 15:18 DEXAMETHASONE 2 MG TABLETS • calcium supplements • medicines for pain and inflammation called NSAIDs such as ibuprofen, diclofenac or naproxen • a medicine for urea cycle disorder called sodium phenylbutyrate (usually started by a specialist doctor or consultant) • medicines for diabetes • medicines for heartburn, indigestion or stomach ulcers, called antacids • medicines used to treat a condition called myasthenia gravis • medicine for glaucoma such as acetazolamide. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist BEFORE taking Dexamethasone. PREGNANCY AND BREAST-FEEDING If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Dexamethasone can reach your baby and may slow its growth. Small amounts of dexamethasone may get into breast milk; tell your doctor if you are breast-feeding. DRIVING AND USING MACHINES Steroids may cause a feeling of movement, even while you are still and this can cause you to feel dizzy (vertigo). Changes in your eyesight or muscle weakness may also happen. If you are affected you should not drive or operate machinery. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF DEXAMETHASONE This medicine contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. REMEMBER ALWAYS TO CARRY A STEROID TREATMENT CARD. MAKE SURE YOUR DOCTOR OR PHARMACIST GIVES YOU THIS AND HAS FILLED OUT THE DETAILS INCLUDING THE DOSE AND HOW LONG YOU WILL HAVE TREATMENT. If you have surgery, an accident or become unwell while taking this medicine, tell whoever is treating you that you are taking Dexamethasone tablets. Always take this medicine exactly as your doctor or pharmacist has told you. Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexamethasone 2mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.0 mg dexamethasone. Contains lactose monohydrate (68.8mg per tablet); for a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Round white tablet, one side marked DX 2 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated in a wide variety of disorders amenable to glucocorticoid therapy, as well as an adjunct in the control of cerebral oedema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION In general, glucocorticoid dosage depends on the severity of the condition and response of the patient. Under certain circumstances, for instance in stress and changed clinical picture, extra dosage adjustments may be necessary. If no favourable response is noted within a couple of days, glucocorticoid therapy should be discontinued. _1._ _ _ _Adults _ Usually, daily oral dosages of 0.5 - 10 mg are sufficient. In some patients higher dosages may be temporarily required to control the disease. Once the disease is under control, the dosage should be reduced or tapered off to the lowest suitable level under continuous monitoring and observation of the patient. (SEE SECTION 4.4) For a short dexamethasone suppression test, 1mg dexamethasone is given at 11 pm and plasma cortisol measured the next morning. Patients who do not show a decrease in cortisol can be exposed to a longer test: 500 micrograms dexamethasone is given at 6 hourly intervals for 48 hours followed by 2mg every 6 hours for a further 48 hours. Twenty-four hour urine collections are made before, during and at the end of the test for determination of 17-hydroxycorticosteroids. 2. _Children_ 0.01-0.1mg/kg of body weight daily Dosage of glucocorticoids should be adjusted on the basis of the individual patient's response. 4.3 CONTRAINDICATIONS • Systemic infection unless specific antimicrobial therapy given. • Avoid live virus vaccines in those receiving immunosuppressive doses as the serum antibod Прочитайте повний документ