Deskripsi
Manufacturer
Xepa-Soul Pattinson (Malaysia) Sdn. Bhd.
Registraction Number
MAL19860195AZ
Content
- Each tablet contains 5 /mg of carbimazole, an imidazole antithyroid agent that is converted in the body to methimazole, which inhibits thyroid hormone synthesis by blocking thyroid peroxidase activity and reducing T3/T4 production
Indications
- Indicated for the treatment of hyperthyroidism (including Graves’ disease or thyrotoxicosis) in adults and children, to reduce excessive thyroid hormone levels.
- Used in preparation for thyroidectomy or radio-iodine therapy, to render patients euthyroid prior to these interventions
Instructions for Use
Dosage & Administration
- Adults: Start with 20–60 /mg daily, divided into 2–3 doses; once euthyroid, gradually reduce to a maintenance dose of 5–20 /mg daily.
- Children: Initial dose typically 15 /mg/day (age-dependent), tapered as needed; not recommended for children < /2 /years.
- Administration: Swallow tablets whole with water; do not crush or chew. May be taken with or without food, but maintain a regular dosing schedule.
Monitoring & Titration
- Thyroid function tests are required before starting treatment and regularly thereafter (e.g. every 6 weeks initially, then every 3 months when stable).
- Tapering is guided by laboratory results to avoid over-treatment (hypothyroidism) or relapse.
Missed Dose / Overdose
- If a dose is missed, take it as soon as possible unless it’s near the next scheduled dose—do not double up.
- Taking an extra single dose is unlikely to cause serious issues, but seek medical advice if two or more extra doses have been taken.
Precautions, Contraindications & Interactions
- Contraindicated in patients with:
- Allergy to carbimazole or other thionamides (e.g. methimazole, propylthiouracil)
- Severe liver dysfunction, blood dyscrasias, or history of drug-induced pancreatitis.
- Warnings:
- Monitor for agranulocytosis or neutropenia—stop treatment immediately if sore throat, fever, or signs of infection occur; prompt blood counts are essential.
- Use with caution in hepatic impairment; discontinue promptly upon abnormal liver function tests.
- In pregnancy, only use the minimum effective dose, typically discontinued 3–4 weeks before term; carbimazole crosses the placenta and can affect fetal thyroid, but untreated hyperthyroidism poses greater risk.
- Breastfeeding: excreted in breast milk—avoid feeding or monitor neonatal thyroid function closely if used.
- Drug interactions: May alter effects of anticoagulants, theophylline, prednisolone, digitalis, β blockers, erythromycin; conversely, these drugs may affect carbimazole metabolism—consult prescribing physician.
Side Effects (Common & Serious)
- Common: rash, pruritus, fever, malaise, nausea, arthralgia, headache, GI upset, taste disturbances, hair loss, urticarial.
- Serious: agranulocytosis, pancytopenia, aplastic anaemia, hepatic dysfunction—including cholestatic hepatitis and jaundice—requiring immediate discontinuation
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