DRUGS & SUPPLEMENTS

Berlthyrox

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Berlthyrox uses


1 INDICATIONS AND USAGE

Berlthyrox for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between Berlthyrox for Injection and oral levothyroxine products has not been established. Caution should be used when switching patients from oral levothyroxine products to Berlthyrox for Injection as accurate dosing conversion has not been studied.

Berlthyrox is an L-thyroxine product. Levothyroxine (T4) Sodium for Injection is indicated for the treatment of myxedema coma. (1)

Important Limitations of Use:

The relative bioavailability of this drug has not been established. Use caution when converting patients from oral to intravenous levothyroxine.

2 DOSAGE AND ADMINISTRATION

  • An initial intravenous loading dose of Berlthyrox for Injection between 300 to 500 mcg followed by once daily intravenous maintenance doses between 50 and 100 mcg should be administered, as clinically indicated, until the patient can tolerate oral therapy.
  • Reconstitute the lyophilized Berlthyrox for Injection by aseptically adding 5 mL of 0.9% Sodium Chloride Injection, USP. Shake vial to ensure complete mixing. Reconstituted drug product is preservative free. Use immediately after reconstitution. Discard any unused portion. ( 2.3 )
  • Do not add to other IV fluids. ( 2.3 )

2.1 Dosage

An initial intravenous loading dose of Berlthyrox for Injection between 300 to 500 mcg, followed by once daily intravenous maintenance doses between 50 and 100 mcg, should be administered, as clinically indicated, until the patient can tolerate oral therapy. The age, general physical condition, cardiac risk factors, and clinical severity of myxedema and duration of myxedema symptoms should be considered when determining the starting and maintenance dosages of Berlthyrox for Injection.

Berlthyrox for Injection produces a gradual increase in the circulating concentrations of the hormone with an approximate half-life of 9 to 10 days in hypothyroid patients. Daily administration of Berlthyrox for Injection should be maintained until the patient is capable of tolerating an oral dose and is clinically stable. For chronic treatment of hypothyroidism, an oral dosage form of levothyroxine should be used to maintain a euthyroid state. Relative bioavailability between Berlthyrox for Injection and oral levothyroxine products has not been established. Based on medical practice, the relative bioavailability between oral and intravenous administration of Berlthyrox for Injection is estimated to be from 48 to 74%. Due to differences in absorption characteristics of patients and the oral levothyroxine product formulations, TSH and thyroid hormone levels should be measured a few weeks after initiating oral levothyroxine and dose adjusted accordingly.

2.2 Dosing in the Elderly and in Patients with Cardiovascular Disease

Intravenous levothyroxine may be associated with cardiac toxicity-including arrhythmias, tachycardia, myocardial ischemia and infarction, or worsening of congestive heart failure and death-in the elderly and in those with underlying cardiovascular disease. Therefore, cautious use, including doses in the lower end of the recommended range, may be warranted in these populations.

2.3 Reconstitution Directions

Reconstitute the lyophilized Berlthyrox for Injection by aseptically adding 5 mL of 0.9% Sodium Chloride Injection, USP only. Shake vial to ensure complete mixing. The resultant solution will have a final concentration of approximately 20 mcg per mL, 40 mcg per mL and and 100 mcg per mL for the 100 mcg, 200 mcg and 500 mcg vials, respectively. Reconstituted drug product is preservative free and is stable for 4 hours. Discard any unused portion. DO NOT ADD Berlthyrox FOR INJECTION TO OTHER IV FLUIDS. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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3 DOSAGE FORMS AND STRENGTHS

Berlthyrox for Injection is supplied as a lyophilized powder at three strengths in single use amber-colored vials: 100 mcg, 200 mcg and 500 mcg.

Lyophilized powder for injection in single use vials: 100 mcg, 200 mcg and 500 mcg. ( 3 )

4 CONTRAINDICATIONS

None.

None.

5 WARNINGS AND PRECAUTIONS

  • Excessive bolus doses of Berlthyrox for Injection are associated with cardiac complications, particularly in the elderly and in patients with an underlying cardiac condition. Initiate therapy with doses at the lower end of the recommended range. ( 5.1 )
  • Close observation of the patient following the administration of Berlthyrox for Injection is advised. ( 5.1 )
  • Berlthyrox for Injection therapy for patients with previously undiagnosed endocrine disorders, including adrenal insufficiency, hypopituitarism, and diabetes insipidus, may worsen symptoms of these endocrinopathies. ( 5.2 )

5.1 Risk of Cardiac Complications in Elderly and in Patients with Cardiovascular Disease

Excessive bolus dosing of Berlthyrox for Injection (greater than 500 mcg) are associated with cardiac complications, particularly in the elderly and in patients with an underlying cardiac condition. Adverse events that can potentially be related to the administration of large doses of Berlthyrox for Injection include arrhythmias, tachycardia, myocardial ischemia and infarction, or worsening of congestive heart failure and death. Cautious use, including doses in the lower end of the recommended range, may be warranted in these populations. Close observation of the patient following the administration of Berlthyrox for Injection is advised.

5.2 Need for Concomitant Glucocorticoids and Monitoring for Other Diseases in Patients with Endocrine Disorders

Occasionally, chronic autoimmune thyroiditis, which can lead to myxedema coma, may occur in association with other autoimmune disorders such as adrenal insufficiency, pernicious anemia, and insulin‑dependent diabetes mellitus. Patients should be treated with replacement glucocorticoids prior to initiation of treatment with Berlthyrox for Injection, until adrenal function has been adequately assessed. Failure to do so may precipitate an acute adrenal crisis when thyroid hormone therapy is initiated, due to increased metabolic clearance of glucocorticoids by thyroid hormone. With initiation of Berlthyrox for Injection, patients with myxedema coma should also be monitored for previously undiagnosed diabetes insipidus.

5.3 Not Indicated for Treatment of Obesity

Thyroid hormones, including Berlthyrox for Injection, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss. 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 .

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6 ADVERSE REACTIONS

Excessive doses of levothyroxine can predispose to signs and symptoms compatible with hyperthyroidism. The signs and symptoms of thyrotoxicosis include, but are not limited to: exophthalmic goiter, weight loss, increased appetite, palpitations, nervousness, diarrhea, abdominal cramps, sweating, tachycardia, increased pulse and blood pressure, cardiac arrhythmias, angina pectoris, tremors, insomnia, heat intolerance, fever, and menstrual irregularities.

Excessive doses of L-thyroxine can predispose to signs and symptoms compatible with hyperthyroidism.


To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC, Medical Affairs Department at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

7 DRUG INTERACTIONS

Many drugs affect thyroid hormone pharmacokinetics and metabolism and may alter the therapeutic response to Berlthyrox for Injection. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs.

Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Berlthyrox for Injection. ( 7 , 12.3 )

7.1 Antidiabetic Therapy

Addition of levothyroxine to antidiabetic or insulin therapy may result in increased antidiabetic agent or insulin requirements. Careful monitoring of diabetic control is recommended, especially when thyroid therapy is started, changed, or discontinued.

7.2 Oral Anticoagulants

Levothyroxine increases the response to oral anticoagulant therapy. Therefore, a decrease in the dose of anticoagulant may be warranted with correction of the hypothyroid state or when the Berlthyrox for Injection dose is increased. Prothrombin time should be closely monitored to permit appropriate and timely dosage adjustments.

7.3 Digitalis Glycosides

The therapeutic effects of digitalis glycosides may be reduced by levothyroxine. Serum digitalis glycoside levels may be decreased when a hypothyroid patient becomes euthyroid, necessitating an increase in the dose of digitalis glycosides.

7.4 Antidepressant Therapy

Concurrent use of tricyclic or tetracyclic (e.g., maprotiline) antidepressants and levothyroxine may increase the therapeutic and toxic effects of both drugs, possibly due to increased receptor sensitivity to catecholamines. Toxic effects may include increased risk of cardiac arrhythmias and CNS stimulation; onset of action of tricyclics may be accelerated. Administration of sertraline in patients stabilized on levothyroxine may result in increased levothyroxine requirements.

7.5 Ketamine

Concurrent use may produce marked hypertension and tachycardia; cautious administration to patients receiving thyroid hormone therapy is recommended.

7.6 Sympathomimetics

Concurrent use may increase the effects of sympathomimetics or thyroid hormone. Thyroid hormones may increase the risk of coronary insufficiency when sympathomimetic agents are administered to patients with coronary artery disease.

7.7 Drug-Laboratory Test Interactions

Changes in thyroxine binding globulin (TBG) concentration must be considered when interpreting levothyroxine and triiodothyronine values, which necessitates measurement and evaluation of unbound (free) hormone and/or determination of the free levothyroxine index. Pregnancy, infectious hepatitis, estrogens, estrogen containing oral contraceptives, and acute intermittent porphyria increase TBG concentrations. Decreases in TBG concentrations are observed in nephrosis, severe hypoproteinemia, severe liver disease, acromegaly, and after androgen or corticosteroid therapy. Familial hyper or hypo thyroxine binding globulinemias have been described, with the incidence of TBG deficiency approximating 1 in 9000.

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8 USE IN SPECIFIC POPULATIONS

  • Elderly and those with underlying cardiovascular disease should receive doses at the lower end of the recommended range.

8.1 Pregnancy

Pregnancy Category A – There are no reported cases of Berlthyrox for Injection used to treat myxedema coma in patients who were pregnant or lactating. Studies in pregnant women treated with oral levothyroxine to maintain a euthyroid state have not shown an increased risk of fetal abnormalities. Therefore, pregnant patients who develop myxedema should be treated with Berlthyrox for Injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the maternal patient and the fetus.

8.2 Labor and Delivery

Patients in labor who develop myxedema have not been reported in the literature. However, patients should be treated with Berlthyrox for Injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the maternal patient and the fetus.

8.3 Nursing Mothers

Adequate replacement doses of thyroid hormones are required to maintain normal lactation. There are no reported cases of Berlthyrox for Injection used to treat myxedema coma in patients who are lactating. However, such patients should be treated with Berlthyrox for Injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the nursing patient.

8.4 Pediatric Use

Myxedema coma is a disease of the elderly. An approved, oral dosage form of levothyroxine should be used in the pediatric patient population for maintaining a euthyroid state in non-complicated hypothyroidism.

8.5 Geriatric Use and Patients with Underlying Cardiovascular Disease

See Section 2, Dosage and Administration, for full prescribing information in the geriatric patient population. Because of the increased prevalence of cardiovascular disease in the elderly, cautious use of Berlthyrox for Injection in the elderly and in patients with known cardiac risk factors is advised. Atrial fibrillation is a common side effect associated with levothyroxine treatment in the elderly [see Dosage and Administration (2 ) and Warnings and Precautions (5 )].

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10 OVERDOSAGE

In general, the signs and symptoms of overdosage with levothyroxine are those of hyperthyroidism [see Warnings and Precautions (5 ) and Adverse Reactions (6 )]. In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been reported. Excessive doses of Berlthyrox for Injection (greater than 500 mcg) are associated with cardiac complications in patients with underlying cardiac disease.

Treatment of Overdosage

Berlthyrox for Injection should be reduced in dose or temporarily discontinued if signs or symptoms of overdosage occur. To obtain up-to-date information about the treatment of overdose, a good resource is the certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in the patient.

In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s medical status.

11 DESCRIPTION

Berlthyrox for Injection contains synthetic crystalline levothyroxine (L-thyroxine) sodium salt. Levothyroxine sodium has an empirical formula of C15H10I4NNaO4, a molecular weight of 798.85 g/mol (anhydrous), and the following structural formula:



Berlthyrox for Injection is a sterile, preservative-free lyophilized powder consisting of the active ingredient, Berlthyrox, and the excipients dibasic sodium phosphate heptahydrate, USP; mannitol, USP; and sodium hydroxide, NF in single-use amber glass vials. Berlthyrox for Injection is available at three dosage strengths: 100 mcg per vial, 200 mcg per vial and 500 mcg per vial.

structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine and levothyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins.

The physiological actions of thyroid hormones are produced predominantly by T3, the majority of which (approximately 80%) is derived from T4 by deiodination in peripheral tissues.

12.2 Pharmacodynamics

Thyroid hormone synthesis and secretion is regulated by the hypothalamic pituitary-thyroid axis. Thyrotropin releasing hormone (TRH) released from the hypothalamus stimulates secretion of thyrotropin stimulating hormone (TSH) from the anterior pituitary. TSH, in turn, is the physiologic stimulus for the synthesis and secretion of thyroid hormones, T4 and T3, by the thyroid gland. Circulating serum T3 and T4 levels exert a feedback effect on both TRH and TSH secretion. When serum T3 and T4 levels increase, TRH and TSH secretion decrease. When thyroid hormone levels decrease, TRH and TSH secretion increases. TSH is used for the diagnosis of hypothyroidism and evaluation of levothyroxine therapy adequacy with other laboratory and clinical data . There are drugs known to affect thyroid hormones and TSH by various mechanisms and those examples are diazepam, ethioamide, lovastatin, metoclopramide, 6-mercaptopurine, nitroprusside, perphenazine, and thiazide diuretics. Some drugs may cause a transient decrease in TSH secretion without hypothyroidism and those drugs (dose) are dopamine (greater than 1 mcg per kg per min), glucocorticoids (hydrocortisone greater than 100 mg per day or equivalent) and octreotide (greater than 100 mcg per day).

Thyroid hormones regulate multiple metabolic processes and play an essential role in normal growth and development, and normal maturation of the central nervous system and bone. The metabolic actions of thyroid hormones include augmentation of cellular respiration and thermogenesis, as well as metabolism of proteins, carbohydrates and lipids. The protein anabolic effects of thyroid hormones are essential to normal growth and development.

12.3 Pharmacokinetics

Absorption – Berlthyrox for Injection is administered via the intravenous route. Following administration, the synthetic levothyroxine cannot be distinguished from the natural hormone that is secreted endogenously.

Distribution – Circulating thyroid hormones are greater than 99% bound to plasma proteins, including thyroxine binding globulin (TBG), thyroxine binding prealbumin (TBPA), and albumin (TBA), whose capacities and affinities vary for each hormone. The higher affinity of both TBG and TBPA for T4 partially explains the higher serum levels, slower metabolic clearance, and longer half life of T4 compared to T3. Protein bound thyroid hormones exist in reverse equilibrium with small amounts of free hormone. Only unbound hormone is metabolically active. Many drugs and physiologic conditions affect the binding of thyroid hormones to serum proteins . Thyroid hormones do not readily cross the placental barrier .

Metabolism – T4 is slowly eliminated. The major pathway of thyroid hormone metabolism is through sequential deiodination. Approximately eighty percent of circulating T3 is derived from peripheral T4 by monodeiodination. The liver is the major site of degradation for both T4 and T3, with T4 deiodination also occurring at a number of additional sites, including the kidney and other tissues. Approximately 80% of the daily dose of T4 is deiodinated to yield equal amounts of T3 and reverse T3 (r T3). T3 and r T3 are further deiodinated to diiodothyronine. Thyroid hormones are also metabolized via conjugation with glucuronides and sulfates and excreted directly into the bile and gut where they undergo enterohepatic recirculation.

Elimination – Thyroid hormones are primarily eliminated by the kidneys. A portion of the conjugated hormone reaches the colon unchanged, where it is hydrolyzed and eliminated in feces as the free hormones. Urinary excretion of T4 decreases with age.

Table 1: Pharmacokinetic Parameters of Thyroid Hormones in Euthyroid Patients


Hormone


Ratio in

Thyroglobulin


Biologic

Potency


Half-Life

(Days)


Protein

Binding

(%)2


T4


10 to 20


1


6 to 81


99.96


T3


1


4


≤ 2


99.5


T4: Levothyroxine

T3: Liothyronine

1 3 to 4 days in hyperthyroidism, 9 to 10 days in hypothyroidism.

2 Includes TBG, TBPA, and TBA.

Drug Interactions

A listing of drug interaction with T4 is provided in the following tables, although it may not be comprehensive due to the introduction of new drugs that interact with the thyroidal axis or the discovery of previously unknown interactions. The prescriber should be aware of this fact and should consult appropriate reference sources (e.g., package inserts of newly approved drugs, medical literature) for additional information if a drug-drug interaction with levothyroxine is suspected.

Table 2: Drugs That May Alter T4 and T3 Serum Transport Without Affecting free T4 Concentration (Euthyroidism)


Drugs That May Increase Serum TBG Concentration


Drugs That May Decrease Serum TBG Concentration



Clofibrate

Estrogen-containing oral contraceptives

Estrogens (oral)

Heroin / Methadone

5-Fluorouracil

Mitotane

Tamoxifen


Androgens / Anabolic Steroids

Asparaginase

Glucocorticoids

Slow-Release Nicotinic Acid


Drugs That May Cause Protein-Binding Site Displacement

Potential impact : Administration of these agents with levothyroxine results in an initial transient increase in FT4. Continued administration results in a decrease in serum T4 and normal FT4 and TSH concentrations and, therefore, patients are clinically euthyroid.


Salicylates (> 2 g/day)


Salicylates inhibit binding of T4 and T3 to TBG and transthyretin. An initial increase in serum FT4 is followed by return of FT4 to normal levels with sustained therapeutic serum salicylate concentrations, although total-T4 levels may decrease by as much as 30%.


Other drugs:

Furosemide (> 80 mg IV)

Heparin

Hydantoins

Non-Steroidal Anti-inflammatory Drugs

- Fenamates

- Phenylbutazone




Table 3: Drugs That May Alter Hepatic Metabolism of T4 (Hypothyroidism)

Potential impact: Stimulation of hepatic microsomal drug-metabolizing enzyme activity may cause increased hepatic degradation of levothyroxine, resulting in increased levothyroxine requirements.


Drug or Drug Class



Carbamazepine

Hydantoins


Phenytoin and carbamazepine reduce serum protein binding of levothyroxine, and total- and free- T4 may be reduced by 20% to 40%, but most patients have normal serum TSH levels and are clinically euthyroid.


Other drugs:

Phenobarbital

Rifampin




Table 4: Drugs That May Decrease Conversion of T4 to T3

Potential impact: Administration of these enzyme inhibitors decreases the peripheral conversion of T4 to T3, leading to decreased T3 levels. However, serum T4 levels are usually normal but may occasionally be slightly increased.


Drug or Drug Class


Effect


Beta-adrenergic antagonists

(e.g. Propranolol > 160 mg/day)


In patients treated with large doses of propranolol (> 160 mg/day), T3 and T4 levels change slightly, TSH levels remain normal, and patients are clinically euthyroid. It should be noted that actions of particular beta-adrenergic antagonists may be impaired when the hypothyroid patient is converted to the euthyroid state.


Glucocorticoids

(e.g. Dexamethasone > 4 mg/day)



Short-term administration of large doses of glucocorticoids may decrease serum T3 concentrations by 30% with minimal change in serum T4 levels. However, long-term glucocorticoid therapy may result in slightly decreased T3 and T4 levels due to decreased TBG production.


Other drug:

Amiodarone



13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility of Berlthyrox for Injection.

13.2 Animal Toxicology and Pharmacology

No animal toxicology studies have been conducted with Berlthyrox for Injection.

14 CLINICAL STUDIES

No clinical studies have been conducted with Berlthyrox for Injection in patients with myxedema coma. However, data from published literature support the intravenous use of Berlthyrox for the treatment of myxedema coma.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Berlthyrox for Injection is available in three dosage strengths.

Product

No.

NDC

No.


Strength


Reconstituted

Concentration

506107

63323-649-07


100 mcg/vial


20 mcg/mL

506247

63323-647-10

200 mcg/vial

40 mcg/mL

506248

63323-648-10


500 mcg/vial


100 mcg/mL


16.2 Storage and Handling

Protect from light and store dry product at 20° to 25°C (68° to 77°F). Reconstituted drug product is preservative free. Discard any unused portion.

This container closure is not made with natural rubber latex.

451253C

Revised: April 2013


PACKAGE LABEL - PRINCIPAL DISPLAY - Levothyroxine 100 mcg Single Use Vial Label

NDC 63323-649-07

506107

Berlthyrox for Injection

100 mcg/vial

For Intravenous Use

Single Use Vial

Discard any unused portion.

Rx only




PACKAGE LABEL - PRINCIPAL DISPLAY - Levothyroxine 100 mcg Single Use Vial Carton Panel

NDC 63323-649-07

506107

Berlthyrox for Injection

100 mcg/vial

For Intravenous Use

Single Use Vial

Discard any unused portion.

Rx only




P ACKAGE LABEL - PRINCIPAL DISPLAY - Levothyroxine 500 mcg Single Use Vial Label

NDC 63323-648-10

506248

Berlthyrox for Injection

500 mcg/vial

For Intravenous Use

Single Use Vial

Discard any unused portion.

Rx only



P ACKAGE LABEL - PRINCIPAL DISPLAY - Levothyroxine 500 mcg Single Use Vial Carton Panel

NDC 63323-648-10

506248

Berlthyrox for Injection

500 mcg/vial

For Intravenous Use

Single Use Vial

Discard any unused portion.

Rx only



P ACKAGE LABEL - PRINCIPAL DISPLAY - Levothyroxine 200 mcg Single Use Vial Label

NDC 63323-647-10

506247

Berlthyrox for Injection

200 mcg/vial

For Intravenous Use

Single Use Vial

Discard any unused portion.

Rx only


P ACKAGE LABEL - PRINCIPAL DISPLAY - Levothyroxine 200 mcg Single Use Vial Carton Label

NDC 63323-647-10

506247

Berlthyrox for Injection

200 mcg/vial

For Intravenous Use

Single Use Vial

Discard any unused portion.

Rx only

logo 506107-vial 506107-box 506248-vial 506248-box 506247-vial 506247-box

Berlthyrox pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Berlthyrox available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Berlthyrox destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Berlthyrox Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Berlthyrox pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."THYRO-TABS CANINE (LEVOTHYROXINE SODIUM) TABLET [LLOYD, INC. OF IOWA]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Berlthyrox?

Depending on the reaction of the Berlthyrox after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Berlthyrox not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Berlthyrox addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Berlthyrox, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Berlthyrox consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported side effects

Did you get side effects while taking the Berlthyrox drug, or were there no side effects?
According to the survey conducted by website sDrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Berlthyrox medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
Visitors%
No side effects1
100.0%

Three visitors reported doses

What is the dose of Berlthyrox drug you are taking?
According to the survey conducted among sDrugs.com website users, the maximum number of people are using the following dose 51-100mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
51-100mg3
100.0%

Three visitors reported time for results

What is the time duration Berlthyrox drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sDrugs.com website users needed > 3 month to notice the result from using Berlthyrox drug. The time needed to show improvement in health condition after using the medicine Berlthyrox need not be same for all the users. It varies based on other factors.
Visitors%
> 3 month2
66.7%
3 month1
33.3%

Two visitors reported age

Visitors%
16-291
50.0%
> 601
50.0%

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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