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Voltaren/Voltaren SR服他靈

Voltaren/Voltaren SR Dosage/Direction for Use

diclofenac

Manufacturer:

Novartis

Distributor:

DCH Auriga - Healthcare
/
Four Star
Full Prescribing Info
Dosage/Direction for Use
As a general recommendation, the dose should be individually adjusted and the lowest effective dose given for the shortest possible duration.
Voltaren EC tablet/suppository: Adults: The recommended initial daily dose is 100 to 150 mg. In milder cases, as well as for long-term therapy, 75 to 100 mg daily is usually sufficient.
The total daily dose should generally be divided into 2 to 3 doses. To suppress nocturnal pain and morning stiffness, treatment with tablets during the day can be supplemented by the administration of a suppository at bedtime (up to a total maximum daily dose of 150 mg).
In primary dysmenorrhoea, the daily dose should be individually adjusted and is generally 50 to 150 mg. A dose of 50 to 100 mg should be given initially and, if necessary, increased over the course of several menstrual cycles up to a maximum of 200 mg/day. Treatment should be started on appearance of the first symptoms and, depending on the symptomatology, continued for a few days.
Children and adolescents: Children aged 1 year or over and adolescents should be given 0.5 to 2 mg/kg body weight daily in 2 to 3 divided doses, depending on the severity of the disorder.
For treatment of juvenile rheumatoid arthritis, the dose can be raised up to a maximum of 3 mg/kg daily, given in divided doses.
The maximum daily dose of 150 mg should not be exceeded.
Voltaren EC tablet: The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed.
Children and adolescents: Because of their dosage strength, Voltaren 50 mg gastro-resistant tablets are not recommended for use in children and adolescents below 14 years of age. Voltaren 25 mg gastro-resistant tablets could be used in these patients.
Voltaren SR-FC tablet: Usual dosage: Adults: The usual daily dose of Voltaren is 100 mg, i.e. one 100 mg prolonged-release coated tablet. In milder cases and for long-term therapy, one 75 mg or 100 mg prolonged-release coated tablet per day is normally sufficient. If symptoms are most pronounced at night or in the morning, Voltaren should preferably be taken in the evening.
The maximum recommended daily dose is 100 mg.
The prolonged-release coated tablets should be swallowed whole with liquid, preferably with meals.
Special dosage instructions: Established cardiovascular disease or significant cardiovascular risk factors: Treatment with Voltaren is generally not recommended in patients with established cardiovascular disease or uncontrolled hypertension. If needed, patients with established cardiovascular disease, uncontrolled hypertension or significant risk factors for cardiovascular disease should be treated with Voltaren only after careful consideration, and only at doses of up to 100 mg daily if treated for more than 4 weeks (see Precautions).
Diclofenac, particularly at higher doses (150 mg per day), is associated with an increased risk of serious cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events which can be fatal) that is comparable to COX-2 inhibitors. Evidence suggests that the risk may increase with the dose and duration of use. Treatment with diclofenac is not recommended in patients with pre-existing cardiovascular disease or cerebrovascular disease, or presenting risk factors for cardiovascular disease. For these patients, treatment options other than NSAIDs, particularly COX-2 inhibitors and diclofenac, should be considered first.
Patients with hepatic impairment: Voltaren is contraindicated in patients with hepatic failure (see Contraindications).
No specific studies have been carried out in patients with hepatic impairment; therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Voltaren to patients with mild to moderate hepatic impairment (see Precautions).
Patients with renal impairment: Voltaren is contraindicated in patients with renal failure (GFR <15 ml/min/1.73 m2) (see Contraindications).
No specific studies have been carried out in patients with renal impairment; therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Voltaren to patients with renal impairment (see Precautions).
Elderly patients: No adjustment of the starting dose is generally required for elderly patients. However, caution is indicated on basic medical grounds, especially for frail elderly patients or those with a low body weight (see Precautions).
Children and adolescents: Voltaren must not be given to children under 1 year of age.
Voltaren 75 mg and 100 mg prolonged-release coated tablets are not suitable for children and adolescents.
Voltaren suppository: The suppositories should be inserted well into the rectum. It is recommended to take the suppositories after passing stools.
Not to be taken by mouth, as per rectal use only.
Adults: Treatment of migraine attacks with Voltaren suppositories should be started with a dose of 100 mg at the first signs of an impending attack. Additional suppositories up to 100 mg may be taken on the same day if required. Should the patient require further therapy on the following days, the maximum daily dose should be limited to 150 mg in divided doses.
Children and adolescents: Voltaren 12.5 mg or 25 mg suppositories are recommended for use in children and adolescents below 14 years of age. Because of their dosage strength, Voltaren 50 mg suppositories are not recommended for children and adolescents below 14 years of age.
Voltaren 100 mg suppositories are not suitable for children and adolescents.
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