BTBOLIC - Levothyroxyne 50mcg + Liothyronine 12.5mcg

Category:- Hormones | Type:- Tablet

COMPOSITION

Each tablet contains: Levothyroxine (T4) 50 mcg Liothyronine (T3) 12.5 mcg

PHARMACOLOGICAL CLASSIFICATION

A. 21.3 Thyroid preparation.

PHARMACOLOGICAL ACTION

Thyroxine and Liothyronine have qualitatively similar biological actions, but Liothyronine (L-triiodothyronine) acts more promptly with a more intense but shorter lasting effect. The thyroid gland secretes both hormones and both are probably involved in maintaining the normal euthyroid state. Administration of thyroxine and Liothyronine provides a more natural replacement therapy than is given by one hormone alone. The soluble sodium salts are more efficiently and consistently absorbed than the free substances. Thyroid hormone drugs are natural or synthetic preparations containing T4 or T3 or both. T4 and T3 are produced in the human thyroid gland by the iodination and coupling of the amino acid tyrosine. BT-Bolic is a synthetic preparation of T4 and T3 in a 4:1 weight-based ratio. These hormones enhance oxygen consumption by most tissues of the body and increase the basal metabolic rate and the metabolism of carbohydrates, lipids and proteins. Thus, they exert a profound influence on every organ system in the body and are of particular importance in the development of the central nervous system.

Mechanism of action

The hormones, T4 and T3, are tyrosine-based hormones produced by the thyroid gland. Iodine is an important component in their synthesis. The major secreted form of thyroid hormone is T4. T4 is converted T3, the more active thyroid hormone, by deiodinases in peripheral tissues. T3 acts in the body to increase basal metabolic rate alter protein synthesis and increase the body's sensitivity to catecholamines (such as adrenaline). Thyroid hormones are essential for proper development and differentiation of all cells of the human body. T4 and T3 regulate protein, fat and carbohydrate metabolism to varying extents. The most pronounced effect of the hormones is in altering how human cells use energetic compounds. The thyroid hormone derivatives bind to the thyroid hormone receptors initially to initiate their downstream effects.

INDICATIONS: BT-Bolic Tablets are indicated:

1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and ordinary hypothyroidism in patients of any age (children, adults, the elderly), or state (including pregnancy); primary hypothyroidism resulting from functional deficiency, primary atrophy, partial or total absence of thyroid gland, or the effects of surgery, radiation, or drugs, with or without the presence of goiter; and secondary (pituitary), or tertiary (hypothalamic) hypothyroidism.

2. As pituitary TSH suppressants, in the treatment or prevention of various types of euthyroid goiters, including thyroid nodules, sub-acute or chronic lymphocytic

CONTRA-INDICATIONS

Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis, and apparent hypersensitivity to any of their active or extraneous constituents. There is no well documented evidence from the literature, however, of true allergic or idiosyncratic reactions to thyroid hormone.

WARNINGS

Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects. The use of thyroid hormones in the therapy of obesity, alone or combined with other drugs, is unjustified and has been shown to be ineffective. Neither is their use justified for the treatment of male or female infertility unless this condition is accompanied by hypothyroidism.

DOSAGE AND DIRECTIONS FOR USE

The dosage of BT-Bolic Tablets is determined by the indication and must in every case be individualized according to patient response and laboratory findings. Thyroid hormones are given orally. In acute, emergency conditions, injectable sodium levothyroxine may be given intravenously when oral administration is not feasible or desirable, as in the treatment of myxedema coma, or during total parenteral nutrition. Intramuscular administration is not advisable because of reported poor absorption.

Hypothyroidism

Therapy is usually instituted using low doses with increments which depend on the cardiovascular status of the patient. The usual starting dose is one tablet of BT-Bolic ½ with increments of one tablet of BT-Bolic ¼ every 2 to 3 weeks. Alower starting dosage, one tablet of BT-Bolic ¼/day, is recommended in patients with long-standing myxedema, particularly if cardiovascular impairment is suspected, in which case extreme caution is recommended. The appearance of angina is an indication for a reduction in dosage. Most patients require one tablet of BT-Bolic 1 to one tablet of BT-Bolic 2 per day. Failure to respond to doses of one tablet of BT-Bolic 3 suggests lack of compliance or malabsorption. Maintenance dosages of one tablet of BT-Bolic 1 to one tablet of BT-Bolic 2 per day usually result in normal serum levothyroxine (T4) and triiodothyronine (T3) levels. Adequate therapy usually results in normal TSH and T4 levels after 2 to 3 weeks of therapy. Readjustment of thyroid hormone dosage should be made within the first four weeks of therapy, after proper clinical and laboratory evaluations, including serum levels of T4, bound and free, and TSH. T3 may be used in preference to levothyroxine (T4) during radio-isotope scanning procedures, since induction of hypothyroidism in those cases is more abrupt and can be of shorter duration. It may also be preferred when impairment of peripheral conversion of T4 and T3 is suspected.

Myxedema Coma

Myxedema coma is usually precipitated in the hypothyroid patient of long-standing by intercurrent illness or drugs such as sedatives and anesthetics and should be considered a medical emergency. Therapy should be directed at the correction of electrolyte disturbances and possible infection besides the administration of thyroid hormones. Corticosteroids should be administered routinely. T4 and T3 may be administered via a nasogastric tube but the preferred route of administration of both hormones is intravenous. Sodium levothyroxine (T4) is given at a starting dose of 400 mcg (100 mcg/mL) given rapidly, and is usually well tolerated, even in the elderly. This initial dose is followed by daily supplements of 100 to 200 mcg given IV. Normal T4 levels are achieved in 24 hours followed in 3 days by threefold elevation of T3. Oral therapy with thyroid hormone would be resumed as soon as the clinical situation has been stabilized and the patient is able to take oral medication.

Thyroid Cancer

Exogenous thyroid hormone may produce regression of metastases from follicular and papillary carcinoma of the thyroid and is used as ancillary therapy of these conditions with radioactive iodine. TSH should be suppressed to low or undetectable levels. Therefore, larger amounts of thyroid hormone than those used for replacement therapy are required. Medullary carcinoma of the thyroid is usually unresponsive to this therapy. Thyroid Suppression Therapy—Administration of thyroid hormone in doses higher than those produced physiologically by the gland results in suppression of the production of endogenous hormone. This is the basis for the thyroid suppression test and is used as an aid in the diagnosis of patients with signs of mild hyperthyroidism in whom baseline laboratory tests appear normal, or to demonstrate thyroid gland autonomy in patients with Grave's ophthalmopathy. 131I uptake is determined before and after the administration of the exogenous hormone. Afifty percent or greater suppression of uptake indicates a normal thyroid-pituitary axis and thus rules out thyroid gland autonomy. For adults, the usual suppressive dose of levothyroxine (T4) is 1.56 mcg/kg of body weight per day given for 7 to 10 days. These doses usually yield normal serum T4 and T3 levels and lack of response to TSH. Thyroid hormones should be administered cautiously to patients in whom there is strong suspicion of thyroid gland autonomy, in view of the fact that the exogenous hormone effects will be additive to the endogenous source.

SIDE-EFFECTS AND SPECIALPRECAUTIONS

Thyroid may enhance the action of anticoagulants and upset the stability of patients receiving antidiabetic agents. The effect of thyroid preparations may be enhanced by phenytoin taken concomitantly; aspirin has been stated to have a similar effect. At the beginning of treatment, ordinary therapeutic doses may cause anginal pain, palpitations and cramps in the skeletal muscle. Patients with panhypopituitarism or other causes predisposing to adrenal insufficiency may react unfavourably to BT-Bolic treatment and it is advisable to initiate corticosteroid therapy before giving BT-Bolic in these cases. Special care is needed when there are symptoms of myocardial insufficiency or ECG evidence of myocardial infarction.

Precautions

General—Thyroid hormones should be used with great caution in a number of circumstances where the integrity of the cardiovascular system, particularly the coronary arteries, is suspected. These include patients with angina pectoris or the elderly, in whomthere is a greater likelihood of occult cardiac disease. In these patients therapy should be initiated with low doses, i.e., one tablet of BT-Bolic ½ or BT-Bolic ¼. When, in such patients, a euthyroid state can only be reached at the expense of an aggravation of the cardiovascular disease, thyroid hormone dosage should be reduced. Thyroid hormone therapy in patients with concomitant diabetes mellitus or diabetes insipidus or adrenal cortical insufficiency aggravates the intensity of their symptoms. Appropriate adjustments of the various therapeutic measures directed at these concomitant endocrine diseases are required. The therapy of myxedema coma requires simultaneous administration of glucocorticoidsInteractions: If you use other drugs or over the counter products at the same time, the effects of BT-Bolic Tablet may change. This may increase your risk for side-effects or cause your drug not to work properly. Tell your doctor about all the drugs, vitamins, and herbal supplements you are using, so that you doctor can help you prevent or manage drug interactions. BT-Bolic Tablet may interact with the following drugs and products: Amitriptyline, Antacids, Carbamazepine, Cholestyramine, Cimetidine, Digoxin, Epinephrine, Estrogen, Glipizide, Ketamine, Sertraline, Sucralfate and Warfarin.

KNOWN SYMPTOMS OFOVERDOSAGE AND PARTICULARS OFITS TREATMENT

The following effects are indicative of excessive dosage, and usually disappear on reduction of dosage or withdrawal of treatment for a few days: anginal pain, cardiac arrhythmias, palpitations and cramps in skeletal muscle; also tachycardia, diarrhoea, restlessness, excitability, headache, flushing, sweating, excessive loss of mass and muscular weakness. Gastric lavage or emesis is required if the patient is seen within several hours of taking the dose. The appearance of clinical hyperthyroidism may be delayed for up to five days. Treatment is symptomatic, and tachycardia has been controlled in an adult by 40 mg doses of propranolol given every six hours.

PRESENTATION

BT-Bolic is supplied 5 Blisters of 10 tablets packed in carton along with package insert.

STORAGE INSTRUCTIONS

Do not Store above 30°C, and protect from light.

Keep out of reach & sight of children. Do not use after the expiry date.

Manufactured by: COOPER PHARMALIMITED