- Approval Id
- a47b13235e1aa9dc
- Drug Name
- ROVEXINE-50 TABLETS 50MCG
- Product Name
- ROVEXINE-50 TABLETS 50MCG
- Approval Number
- SIN16628P
- Approval Date
- 2022-10-10
- Registrant
- SRS LIFE SCIENCES PTE. LIMITED.
- Licence Holder
- SRS LIFE SCIENCES PTE. LIMITED.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- **DOSAGE AND ADMINISTRATION**
In order to treat each patient according to his/her individual needs, tablets are available with a levothyroxine sodium content ranging from 25 – 100 microgram.
The dosage recommendations given are only for guidance. Determination of the individual daily dose on the basis of laboratory tests and clinical examinations is recommended.
In children with a sound heart, and for neonates where rapid replacement is important, the entire dose may be started. In adults, initiation of thyroid hormone therapy at low dose is recommended. The dose may be increased gradually every 2 – 4 weeks until the full replacement dose is reached.
In elderly patients, in patients with coronary heart disease, and in patients with severe or long-existing hypothyroidism, special caution is required when initiating therapy with thyroid hormones: Treatment is initiated at a low dose, which is increased slowly and at lengthy intervals with frequent monitoring of thyroid hormones. A maintenance dose lower than that required for complete correction of TSH levels may be considered.
Experience has shown that a lower dose is sufficient in low-weight patients and in patients with a large nodular goitre.
_applies only to tablets of 100 microgram:_
Administration
The daily doses can be given in a single administration.
Ingestion: as a single daily dose in the morning on an empty stomach, half an hour before breakfast, preferably with a little liquid (for example, half a glass of water).
Infants receive the entire dose at once at least 30 minutes before the first meal of the day. Tablets are suspended in some water and the resultant suspension is administered with some more liquid. The suspension must be prepared freshly prior to each administration.
Duration of treatment
- In the case of substitution in hypothyroidism and after strumectomy or thyroidectomy as well as for relapse prophylaxis after euthyroid goitre removal treatment is usually continued for lifespan.
- Concomitant therapy of hyperthyroidism after achieving euthyroid status is indicated for the period in which the anti-thyroid agent is given.
- For benign euthyroid goitre, treatment duration is for some months up to lifespan. If the medical treatment was not sufficient within this time, surgery or radioiodine therapy of the goitre should be considered.
- Route Of Administration
- ORAL
- Indication Info
- **INDICATIONS**
- Treatment of benign euthyroid goitre
- Prophylaxis of relapse after surgery for euthyroid goitre
- Substitution therapy in hypothyroidism
- Concomitant therapy during anti-thyroid medicinal treatment of hyperthyroidism
- Suppression therapy in thyroid cancer
_applies only to tablets of 100 microgram:_
- Diagnostic use for thyroid suppression testing.
- Contraindications
- **CONTRAINDICATIONS**
Rovexine must not be used in patients with:
- hypersensitivity to any of the excipients of the product (see 'Composition' – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)
- untreated adrenal insufficiency
- untreated pituitary insufficiency
- hyperthyroidism or untreated thyrotoxicosis, including untreated subclinical (suppressed serum TSH level with normal T3 and T4 levels) hyperthyroidism.
Treatment with levothyroxine must not be initiated in patients with acute myocardial infarction, acute myocarditis, or acute pancarditis.
Combination therapy of Rovexine and an antithyroid agent for hyperthyroidism is not indicated during pregnancy.
- Atc Code
- H03AA01
- Atc Item Name
- levothyroxine sodium
- Pharma Manufacturer Name
- SRS LIFE SCIENCES PTE. LIMITED
- Company Detail Path
- /organization/71f38d5deb0e00d2/srs-life-sciences-pte-limited
